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Enzo Biochem, Inc. v. Gen-Probe Incorporated, and Chugai Pharma U.S.A., Inc. And Chugai Pharmaceutical Co., Ltd., and Biomerieux, Inc., and Becton Dickinson and Company, and Biomerieux Sa
Citations: 323 F.3d 956; 2002 U.S. App. LEXIS 28124Docket: 01-1230
Court: Court of Appeals for the Federal Circuit; July 15, 2002; Federal Appellate Court
Enzo Biochem, Inc. filed a petition for rehearing en banc following an earlier decision by the United States Court of Appeals for the Federal Circuit, which affirmed the Southern District of New York's ruling that claims 1-6 of U.S. Patent 4,900,659 were invalid due to a lack of written description under 35 U.S.C. § 112. The patent pertains to nucleic acid probes for detecting Neisseria gonorrhoeae, which poses challenges in detection due to its high genetic homology with Neisseria meningitidis. The Circuit Court, upon reviewing Enzo's petition and the defendants' response, concluded that its previous interpretation—that a deposit cannot fulfill the written description requirement—was incorrect. The court granted Enzo's petition, vacated the prior ruling, and reversed the summary judgment, identifying genuine issues of material fact concerning the written description requirement. The case is remanded for further proceedings. Enzo developed three chromosomal DNA probe sequences specific for Neisseria gonorrhoeae that showed a preferential hybridization to various strains of N. gonorrhoeae over N. meningitidis, achieving a hybridization ratio exceeding fifty. The inventors hypothesized that a ratio greater than five to one would ensure the sequences hybridize to nearly all N. gonorrhoeae strains while avoiding hybridization with N. meningitidis strains. These sequences were deposited as recombinant DNA in an E. coli host at the American Type Culture Collection. Claim 1 outlines a composition of matter for detecting N. gonorrhoeae, specifying that the nucleotide sequence's hybridization ratio to chromosomal DNA of N. gonorrhoeae must exceed five compared to N. meningitidis. The claim details a method to determine this ratio, including steps such as providing radioactively labeled nucleotide sequences, creating dilution series from purified chromosomal DNA of both bacteria, hybridizing the sequences, and quantifying the results to calculate the hybridization ratio. Claims 2 and 3 further refine the hybridization ratios to be greater than twenty-five and fifty, respectively. Claim 4 pertains to three deposited nucleotide sequences, specifically the Neisseria gonorrhoeae DNA inserts ATCC 53409, ATCC 53410, and ATCC 53411, alongside their variants and subsequences. Claim 5 involves an assay for detecting N. gonorrhoeae utilizing the composition from claim 1, while claim 6 narrows the method of claim 5 to the sequences deposited by Enzo and their variants. Enzo sued the defendants for infringing the '659 patent, but the defendants successfully moved for summary judgment on the grounds that the claims failed to meet the written description requirement outlined in 35 U.S.C. § 112. The district court concluded that the claimed composition was defined solely by its biological activity, specifically its hybridization ratio to N. gonorrhoeae compared to N. meningitidis, which did not satisfy the written description requirement as established in prior court cases. Enzo's argument that the specification's reference to biological material deposits inherently demonstrated possession of the claimed sequences was rejected. The court emphasized that relevant precedents pertain to enablement rather than written description. Enzo has since appealed to this court, which has jurisdiction under 28 U.S.C. § 1295(a)(1). Summary judgment is appropriate when no genuine material fact issues exist, and a patent is presumed valid unless clear and convincing evidence suggests otherwise. Compliance with the written description requirement is treated as a factual question. Enzo contends that the testimony of its expert, Dr. Wetmer, raises a genuine factual dispute regarding whether the deposits inherently described the claimed nucleotide sequences. Enzo asserts that its description of the binding affinity of these sequences meets the requirements of the 35 U.S.C. § 112, 1 'Written Description' Requirement. Enzo claims the court erred by not evaluating the patentability of claims 4 and 6 separately, which pertain specifically to the deposited sequences and their variations. Enzo argues that these claims satisfy the written description requirement since they are verbatim in the written description. Furthermore, Enzo maintains that the court's interpretation of the written description requirement for genetic materials, established in Eli Lilly, should not apply here because Enzo has demonstrated 'possession' of the invention by reducing it to practice and depositing the biological materials. In contrast, the defendants argue that the district court properly granted summary judgment on the basis that the patent only described the claimed nucleotide sequences by their function, which is insufficient under § 112, 1. They assert that Dr. Wetmer's opinion did not remedy the inventors' failure to distinguish the deposited materials by their structural characteristics. Additionally, they point out that claims 4 and 6 encompass a broad genus of nucleic acids and argue that mere verbatim support in the specification does not satisfy the written description requirement. The defendants contend that the district court correctly determined that Enzo's possession of three nucleotide sequences did not fulfill the written description requirement. The written description requirement under § 112, 1 mandates that the specification provide a clear and concise description of the invention, enabling skilled individuals to make and use it, while also outlining the best mode of carrying it out. This requirement is distinct from enablement and is a fact-based inquiry that varies based on the nature of the claimed invention. The written description requirement for biotechnology patents necessitates that genetic material be adequately described beyond mere functional statements. In the Eli Lilly case, it was determined that a claim describing a microorganism containing human insulin cDNA was insufficient because it failed to provide distinguishing structural or physical characteristics of the DNA sequence. An adequate written description should include precise definitions such as structure, formula, chemical name, or physical properties, rather than vague intentions. While not all functional descriptions are inadequate, the PTO's Guidelines suggest that compliance with the written description requirement can be met through detailed identifying characteristics, including partial or complete structure, physical or chemical properties, or functional characteristics paired with known correlations to structure. For example, a claim to an antibody could satisfy the requirement if it includes well-defined structural characteristics alongside its functional capabilities. The court supports the PTO's Guidelines and will evaluate whether the nucleotide sequences in question and their functional ability to hybridize with specific strains meet the written description requirement. Enzo argues that the claimed nucleotide sequences are inherently described through deposits of three sequences that fall within the scope of its claims. The court considers whether referring to a biological deposit adequately describes that sequence, marking this as a novel issue. It concludes that referencing a public depository where the biological material is accessible suffices to meet the written description requirement under 35 U.S.C. § 112. The practice of depositing biological material primarily addresses the enablement requirement, as illustrated in In re Argoudelis, where a microorganism was deposited to allow public access to the antibiotic compounds it produced, which could not be adequately described in writing. Although previous cases like Amgen and In re Lundak acknowledged the role of biological deposits in meeting enablement, they clarified that deposits were not mandatory for satisfying other requirements such as best mode. The Patent and Trademark Office (PTO) has established procedural rules for biological deposits but has not linked these to specific statutory requirements of 35 U.S.C. § 112. The PTO’s guidance suggests deposits are necessary when biological materials are involved and cannot be sufficiently described in writing, while also indicating situations where deposits are unnecessary if the material is readily available or can be isolated without undue experimentation. Thus, inventions that cannot be adequately described in text may be represented by a deposit referenced in the specification. Deposits in a public depository can satisfy the written description requirement for claimed materials, as seen in Enzo's case where the deposits were incorporated by reference in the patent specification. A skilled person can access the claimed nucleotide sequences using the provided accession numbers and techniques, despite the exact nucleotide structures not being explicitly listed in the specification. The specification acknowledged that the complete structures were not known to Enzo at the time of application due to sequencing constraints. Enzo's claims 4 and 6 extend beyond the deposited sequences, including subsequences, mutated variations, and mixtures. The specification defines subsequences as sequences longer than approximately 12 nucleotides, suggesting there are numerous subsequences that could meet the claimed hybridization ratio. Enzo's expert indicated there are potentially vast numbers of mutated variations within the claims' scope, which is deemed necessary for protecting against minor alterations that could evade infringement. Defendants argue that the broad claim scope undermines the written description's adequacy. However, since the deposited sequences are referenced, it is plausible that various related sequences are also sufficiently described. This matter is seen as a factual issue for remand. The prior district court ruling that invalidated claims 4 and 6 due to insufficient written description is reversed, directing the court on remand to assess whether a skilled person would find adequate possession of the claims’ broader scope through the written description and associated deposit information. The adequacy of the descriptions for genus claims 1-3 and 5, based on Enzo's deposit of three sequences, is under examination regarding compliance with 35 U.S.C. § 112. For the claims to be valid, the sequences must represent the genus, indicating that the inventor has sufficiently disclosed species to substantiate the broader claims. The district court previously found that the sequences were not adequately described, failing to assess their representativeness. This issue is critical and should be revisited on remand. In prior case law, specifically Eli Lilly, it was established that a single sequence (rat cDNA) did not adequately describe a broader genus encompassing all mammalian and vertebrate cDNAs due to a lack of common distinguishing features and insufficient representation of the genus. The Patent and Trademark Office (PTO) has illustrated this concept through guidelines, noting that claims based on hybridization properties could be adequately described if the conditions ensure structural similarity across the genus. On remand, the district court is tasked with evaluating whether the deposits and the knowledge of someone skilled in the art sufficiently describe the genus for claims 1-3 and 5, in line with established precedents and PTO guidelines. Enzo contends that its claims are sufficiently described through the correlation between hybridization function and bacterial DNA. In its petition for rehearing, Enzo asserts that describing biological materials by their affinity to specified deposited strains of N. gonorrhoeae and N. meningitidis inherently indicates structure, which is a common practice in the field. Claim 1 identifies the deposit numbers for six strains of each bacterium to which the claimed nucleotide sequences hybridize. Although the genomic DNA sequences of these bacteria are not disclosed—due to the impracticality of sequencing at the time—access to the deposited strains allows for adequate description via their accession numbers. The claimed nucleotide sequences preferentially bind to the genomic DNA of these strains, suggesting they may be adequately described under the PTO Guidelines, despite the lack of specific binding locations. The court finds that a genuine issue of material fact exists regarding whether the claimed sequences are described by their hybridization to publicly accessible structures. Thus, the district court's summary judgment on the invalidity of the claims due to failure to satisfy the written description requirement was erroneous. On remand, the court should evaluate whether a skilled person in the art would find the sequences adequately described based on Enzo's disclosure of hybridization function and accessible structures, in line with PTO Guidelines. Additionally, Enzo argues that the written description requirement is met as a matter of law because the claim language is verbatim in the specification. The court disagrees, stating that the specification must describe the claimed invention sufficiently for an expert to recognize what is claimed. Merely repeating indistinct terms does not satisfy this requirement. The court illustrates this by referencing examples from the chemical arts, emphasizing that descriptions focusing on function rather than specific structure fail to distinguish one material from another. In Eli Lilly, it was determined that a claim's wording alone may not sufficiently describe an invention, regardless of its original specification support under 35 U.S.C. § 112, paragraph 1. Even if a claim appears in the original specification, it does not automatically fulfill the descriptive requirement mandated by the statute. The case emphasized that merely repeating or maintaining a claim does not enhance its descriptiveness. Enzo's argument, which suggested that reducing sequences to practice inherently constituted a description of the invention, was rejected. The purpose of the written description requirement is to demonstrate that an applicant clearly possessed the invention at the desired filing date, but possession alone is insufficient to meet the requirement. Previous rulings, such as in Lockwood v. American Airlines, clarified that satisfying the written description requirement involves providing detailed disclosures, including words and diagrams, that accurately convey the claimed invention. The written description requirement is particularly relevant when claiming priority under 35 U.S.C. § 119 or 120. While showing possession can be achieved through affidavits, it does not remedy the absence of an adequate written description in the specification, as required by law. Proof of a reduction to practice does not fulfill the written description requirement under 35 U.S.C. § 112, paragraph 1, unless there is an adequate specification describing what has been reduced to practice. While such proof may establish priority of invention or allow an applicant to antedate prior references, it alone does not satisfy the written description requirement. The argument made by Enzo, citing the PTO's Guidelines, that actual reduction to practice constitutes a "safe haven" for compliance with this requirement is unpersuasive. The Guidelines acknowledge that actual reduction to practice is significant in rare cases where those skilled in the art struggle to describe a composition or process distinctly. However, for biological inventions, compliance can also be achieved by depositing the biological material publicly, as established in this opinion; this compliance is based on the deposit and its accession number rather than the reduction to practice. The court concludes that the district court erred in granting summary judgment declaring the claims of the 659 patent invalid for lack of written description. Although the district judge correctly applied existing precedent, this case introduces a new interpretation: a reference to a deposit of genetic material in a patent specification may adequately describe that material. Consequently, the court reverses the lower court's decision and remands the case for further proceedings consistent with this ruling. The order includes notes on the filing of amicus briefs, a petition for rehearing, and details regarding the en banc poll, which did not result in the appeal being heard en banc. Circuit Judge Linn, joined by Judges Rader and Gajarsa, dissents from the decision not to rehear a case en banc, while Judge Lourie, joined by Judge Pauline Newman, concurs with the court's decision. Judge Lourie emphasizes that the earlier panel majority has reversed its decision in response to the rehearing petition, arguing that an en banc hearing would delay the remand intended to refine written description law. He asserts that the current written description requirement is sound and does not need the proposed revisions from the dissenters, who mistakenly equate it solely with enablement. The statutory requirement, as outlined in 35 U.S.C. § 112, mandates a written description of the invention and its use in clear terms sufficient for someone skilled in the art to reproduce it. Lourie interprets this statute as maintaining separate written description and enablement requirements, a distinction supported by historical interpretations and recent Supreme Court rulings. He cites cases emphasizing that what is claimed in a patent must align with what is disclosed in the specification. Lourie notes that the evolution of patent doctrine, including the written description requirement, stems from increasing attempts by patent owners to extend their claims beyond original disclosures, necessitating judicial clarification. Dissenters propose a limitation of the written description requirement to priority issues, arguing that the statute does not explicitly state this limitation. Although the written description has primarily been invoked in priority cases, the statute should not be interpreted as confined to such issues. The absence of earlier cases on this matter is attributed to the necessity of presenting issues for adjudication. A written description issue typically arises only when a patentee attempts to interpret claims to encompass inadequately disclosed subject matter. While some recent cases have rigorously enforced the written description requirement, the decisions were appropriate as the patents did not sufficiently disclose the claimed inventions, such as specific ratios or features. The written description requirement is essential to ensure that claims align with public disclosures. The dissenters misunderstand the relevance of original claims in the specification, which must adequately describe the invention. Vague claim language does not satisfy the written description requirement or demonstrate possession of a generic invention. The court has consistently upheld the separate written description requirement, which is not limited to priority disputes; rather, it applies in various contexts. The language in earlier cases addressing priority issues does not create a binding precedent that restricts the written description requirement's application. Courts decide specific issues based on the facts before them, and any overlap between written description and "new matter" does not diminish the requirement's significance. Failure to meet statutory requirements can occur in multiple ways, with the case In re Rasmussen distinguishing between claims lacking support in original disclosures (under section 112) and the prohibition against introducing new matter (under section 132). The court emphasizes that while "possession" is relevant for determining if an invention is adequately described, it does not fulfill the written description requirement on its own. Judge Rader's dissent cites various commentators, noting that critiques of judicial decisions should not dictate legal interpretation. The document references a positive appraisal of the ruling by an Eli Lilly patent associate, arguing that the decision prevented potential setbacks for the biotechnology sector by affirming the written description requirement's importance. It also highlights that a robust written description requirement benefits the public by ensuring that patents are awarded only for inventions the inventor fully understands, thus enhancing the utility of the patent system and ensuring that these inventions can be built upon by others. The Federal Circuit's interpretation of the written description requirement in biotechnology serves to prevent unregulated claims related to nucleotide sequences. The court emphasizes that decisions are made based on case-specific arguments and established law, rather than on external commentary. In biotechnology, a functional description of DNA does not clarify which specific DNA has been invented; simply noting a DNA's function and proposing a method to identify it constitutes a research plan, not a valid description of an invention. Complying with the written description requirement is fundamental when drafting a patent application, distinct from the separate enabling requirement that allows skilled individuals to make and use the invention. Misinterpreting the written description as merely an enabling provision undermines the specificity required, particularly in chemical inventions. For instance, in the context of a patent claiming a genus of nucleic acids, the process begins with securing specific materials, which then informs a broader genus claim supported by examples. Proper disclosure entails clearly stating what the invention is before detailing how to make and use it. A distinction exists between enabling an invention and adequately describing it; for example, a process for making a compound does not equate to a description of all related compounds unless explicitly stated. Thus, without clear mention of additional compounds, they cannot be patented. A skilled individual could potentially create and utilize compounds B and C; however, the collective class of compounds A, B, and C remains undescribed, highlighting issues in biotechnology patents. Over time, a consistent body of patent law has developed, and there is no justification for an en banc review to amend the statute. Enzo's claim 1 is not original, having been amended to reflect language from the original specification, thus appearing verbatim in it. Judge Newman emphasizes the essential role of the invention description within patent specifications, countering dissenting views that minimize its importance. She asserts that the description establishes what has been invented and outlines claim boundaries, challenging the dissent's claim that the description only serves to establish priority or antedate prior art. The law mandates that the invention covered by claims must be both described and enabled, a requirement that remains consistent historically. Judge Dyk concurs, recognizing that the issues raised merit future en banc consideration but believes this case is not ripe for it, suggesting further examination by the district court first. Judge Rader, joined by Judges Gajarsa and Linn, dissents from the decision not to rehear the case en banc, expressing concern over disregarding statutory requirements and established case law on written description. The dissent argues that the court’s prior rulings have overlooked the necessity of demonstrating "possession of the invention" in written descriptions. An inventor demonstrates possession of an invention through deposit in an internationally recognized repository. The court acknowledges a prior misapplication of the written description requirement from the case Enzo I and remands the issue back to the district court for further examination. The written description, as historically interpreted, does not apply to this case, prompting a call for en banc review to rectify further misapplications of the requirement. The amicus curiae brief from the United States highlights a misinterpretation of statutory text in section 112, which emphasizes that a written description must provide sufficient information for others to make and use the invention. The historical context of the written description requirement dates back to the 1793 Patent Act, which initially aimed to distinguish inventions and enable their use. The Supreme Court's interpretation in Evans v. Eaton established that specifications must enable inventions and serve the public notice function. However, subsequent legal frameworks shifted the notice function to claims, maintaining that the written description primarily serves enablement. Recent Supreme Court cases, including J.E.M. AG Supply, reaffirm that enablement is the sole disclosure requirement in the Patent Act, with no additional general disclosure mandates. Prior to 1967, the United States Court of Customs and Patent Appeals did not distinguish between written description and enablement, recognizing only enablement and best mode as essential requirements under section 112. In 1967, the Court of Customs and Patent Appeals established a new written description (WD) requirement, separate from the enablement requirement under 35 U.S.C. § 112, to prevent patent applicants from retroactively updating their disclosures during the application process. This separation arose from the need to maintain accurate priority of invention, a critical aspect in patent prosecution. Before this ruling, the Patent Office relied on a "new matter" rejection, based on 35 U.S.C. § 132, to prevent applicants from introducing new information after the original filing date. The introduction of the WD doctrine allowed the court to enforce priority without relying solely on § 132. In the case of In re Ruschig, the court differentiated between new matter in claims and specifications, deciding that new matter in claims warranted a § 132 rejection, while new matter in specifications led to a § 132 objection. This distinction was less significant as the WD doctrine served a similar function to the new matter doctrine, preventing new information from being added to claims. Judge Rich, who authored the decision in Ruschig, emphasized the WD doctrine's role in ensuring that an inventor possessed the claimed subject matter as of the application’s filing date. This was reiterated in In re Wertheim, where the court examined whether claims were supported by prior applications to determine entitlement to earlier filing dates. Overall, the WD doctrine emerged as a mechanism to uphold priority by preventing the introduction of new matter in claim amendments, reinforcing the requirement that inventors disclose their inventions fully at the time of filing. After 1967, the PTO utilized new matter rejections under 35 U.S.C. § 132 while also adopting a written description analysis related to § 112. For many years, the PTO employed both § 132 and § 112 to reject priority errors in claims. In 1981, the Court of Customs and Patent Appeals (CCPA) determined that rejections under § 132 were interchangeable with those under § 112, first paragraph, effectively eliminating § 132 and designating § 112 as the basis for new matter rejections. The purpose of this doctrine remained unchanged; both § 112 and its corollary § 132 served to police priority issues. Neither the CCPA nor the Federal Circuit applied these new matter/written description rejections to original claims or claims without priority issues. Original claims were deemed to constitute their own description, fulfilling the description requirement without additional necessity. The Federal Circuit continued to uphold this precedent, emphasizing that the adequacy of support for claims is often analyzed under both the written description requirement of § 112 and the concept of new matter under § 132. When amendments to claims suggested they represented a different invention, it became necessary to assess whether the newly claimed subject matter was adequately described in the original application. The written description requirement's essence lies in whether the original disclosure conveys to a skilled artisan that the inventor possessed the claimed subject matter at the time of filing, rather than simply checking for literal support in the specification. The written description doctrine was not applied to claims without priority issues, as its purpose was solely to address priority concerns. In 1997, however, the Federal Circuit deviated from thirty years of precedent by applying the written description doctrine as a general disclosure requirement rather than strictly as a priority doctrine in Regents of the University of California v. Eli Lilly and Company. The court in Lilly determined that the '525 patent specification lacked a sufficient written description (WD) of human insulin cDNA, despite detailing a general method for its production and providing amino acid sequences for the insulin chains. The court emphasized that a description must provide a precise definition, such as through structure or chemical properties, to meet the written description requirement under 35 U.S.C. § 112, paragraph 1 (112.1). It indicated that the absence of a nucleotide-by-nucleotide specification rendered the invention inadequately described. This marked a departure from traditional standards, as the Lilly court introduced a new WD requirement independent of priority issues, contrasting with previous case law. The court also criticized that enablement, which requires a patent to demonstrate how to make and use the invention, was not properly applied, as the patent only demonstrated the cloning of rat insulin while claiming a broader category of vertebrate insulin cDNA. The opinion suggested that the statutory standard for disclosure, which allows competitors to exploit and design around the invention, was compromised by the new WD doctrine, which had not historically served as an independent standard. Prior cases had maintained that written description assessments were tied to priority principles rather than standing alone. The written description requirement under 35 U.S.C. 112, along with the prohibition on new matter from 35 U.S.C. 132, ensures that a patent applicant fully possesses the claimed subject matter as of the filing date. When an applicant, like Brandon, amends claims or specifications post-filing, such changes must be supported by the original specification. Historical context shows that while the written description has been part of patent law since 1870, it has only been distinctly recognized from enablement since 1967, primarily serving to address priority issues. In this case, no priority issues invoke the written description requirement since the inventor narrowed the original claims by adding material already contained in the specification. Consequently, there are no new matter or priority concerns related to the written description doctrine. The court should assess if a skilled person would recognize the claimed sequences based on the original specification, as this would fulfill the written description requirement. If questions remain, they would pertain to enablement rather than written description. The panel's reliance on the Lilly case misapplies the written description doctrine by suggesting it applies to claims within the original specification, which is inconsistent with statutory and case law. The evolving application of the written description standard, particularly evident in Lilly, imposes a more stringent disclosure requirement than enablement, potentially disrupting the patent system by overshadowing the statutory enablement test. The Lilly decision extended the written description requirement to original claims, treating it as a heightened standard for disclosure. The Lilly decision imposes stringent requirements on the description of biotechnological inventions, shifting the written description doctrine toward a heightened "super enablement" standard. This change disrupts established expectations within the inventing community, a concern highlighted by the Supreme Court, which emphasized that only Congress should amend settled law. The alterations introduced by Lilly and subsequent cases create challenges for inventors who cannot retroactively modify patents that meet existing enablement standards but fail to satisfy the new, more rigorous disclosure expectations. The replacement of enablement doctrines with a vague written description doctrine threatens the patent system's integrity, as enablement serves critical functions, including distinguishing between theoretical and practical contributions to the arts and delineating the boundary between pioneering inventions and improvements. The written description standard lacks the capacity to fulfill these roles effectively. Scholars, including Professor Janis, argue that the written description requirement has gained undue prominence and that attempts to clarify the possession standard reveal redundancies in the enablement and written description requirements. For biotechnological claims, the Lilly standard necessitates a detailed, nucleotide-by-nucleotide listing of DNA sequences, while enablement only requires that one skilled in the art can independently derive that sequence. Consequently, the written description standard may undermine a significant portion of pre-Lilly claims, which were not prepared for this heightened scrutiny. This shift disproportionately affects smaller inventors and academic institutions lacking the resources to navigate these new requirements, potentially stifling innovation and development in biotechnology. The heightened written description requirement under 35 U.S.C. § 112 for biotechnological inventions is criticized for potentially discouraging investment in innovation by limiting patentees' ability to benefit from their research. The Federal Circuit's decisions, particularly in the Lilly case, do not establish a new general disclosure doctrine but instead perpetuate confusion around the existing enablement requirements. The written description requirement has been part of the Patent Act since 1870 but has evolved in its interpretation since 1967. Recent cases, including the Lilly case, have attempted to create a disclosure doctrine that replaces enablement, though these interpretations fail to adhere to the original purposes of § 112. Historical cases illustrate the necessity for a clear and concise written description to support claims, emphasizing that the disclosure must adequately convey the invention to those skilled in the art at the time of filing. The central issue is whether the appellant's specification adequately describes the subject matter of claims 42, 44, and 46, which were amended from the Taylor patent. Compliance with 35 U.S.C. § 112, first paragraph, is critical, as it determines if these claims can benefit from the earlier filing date of the parent application. A successful claim would also allow the Swiss application to establish foreign priority, thereby negating the Pfluger 1966 patent as prior art. The description requirement ensures that the inventor possessed the claimed subject matter at the time of filing. Various cases, including In re Wertheim and In re Blaser, emphasize that the written description must demonstrate possession of the specific subject matter at the application’s filing date. There are indications that previously filed applications lack sufficient disclosure to support the claims, and if the earlier application (S.N. 782,756) does not adequately describe the subject of claim 13, the claim would be anticipated by prior art. The appellant’s parent application must meet the written description requirement to retain its filing date under 35 U.S.C. § 120. Further, any rejection based on lack of support for amended claims should cite § 112, first paragraph, rather than § 132, which addresses the introduction of new matter. The written description requirement, as outlined in various cases, emphasizes that an application must convey to an artisan that the inventor possessed the subject matter claimed at the time of the original filing, rather than merely having literal support in the specification. Key cases include: 1. Ralston Purina Co. v. Far-Mar-Co: The sufficiency of support in a parent application is assessed by whether it reasonably conveys the inventor's possession of the later claimed subject matter. 2. Kennecott Corp. v. Kyocera Int'l Inc.: Section 112's requirements integrated into section 120 establish possession of the later-claimed invention as of the earlier application's filing date. 3. Utter v. Hiraga: A Japanese specification complies with Section 112 if it conveys possession of the later claimed subject matter at the time of original filing. 4. Bigham v. Godtfredsen: The requirement applies to priority claims under 35 U.S.C. 119, determining if the described halogen supports claims for other species. 5. United States Steel Corp. v. Phillips Petroleum Co.: Claims must be assessed as if filed on the earlier date, and rejection for lack of support must be justified based on the specification from that time. 6. In re Wright: Changes in claim scope warrant inquiry into whether the new subject matter was described in the original application. 7. Chester v. Miller: An application must meet the written description requirement to support subsequent claims. 8. Vas-Cath Inc. v. Mahurkar: The purpose of the requirement is to ensure that claims made after filing were sufficiently disclosed at the time of filing. 9. In re Hayes Microcomputer Products, Inc.: Reiterates that the application must convey possession of the later claimed subject matter. 10. Fiers v. Revel: The burden is on the applicant to prove compliance with Section 112 for entitlement to an earlier filing date. These cases collectively illustrate the necessity for adequate disclosure to establish a valid claim under patent law. In Mendenhall v. Cedarapids, Mr. Mendenhall testified that he did not have an invention related to introducing virgin aggregate and RAP as outlined in the `904 claims until December 1977, with no description of this invention present in prior applications. Consequently, a patentee cannot claim the benefit of an earlier application's filing date if the relevant claims were not present in that earlier application. Eiselstein v. Frank established that the 'written description' requirement for prior applications requires that the disclosure must indicate the inventor had possession of the claimed subject matter at the time of the earlier filing. Similarly, In re Alton emphasizes that this requirement ensures the inventor possessed the specific subject matter by the application's filing date. Kolmes v. World Fibers Corp. questioned whether claims added in a preliminary amendment were adequately supported by earlier applications to meet the description requirement. Lockwood v. American Airlines reinforced that prior applications must adequately describe the invention, allowing a skilled individual to conclude that the inventor had invented the claimed invention at the relevant filing date. Gentry Gallery, Inc. v. Berkline indicated that an original disclosure limits the scope of subsequent claims. Tronzo v. Biomet highlighted that claims in a later application must comply with the written description requirement to benefit from the earlier application's filing date. Union Oil Co. of Cal. v. Atlantic Richfield clarified that neither the Patent Act nor case law mandates detailed disclosure, only sufficient description to demonstrate possession of the claimed invention at filing. Reiffin v. Microsoft emphasized that claims not supported by earlier applications under the written description requirement are not invalidated but do not receive the earlier filing date. Lampi Corp. v. American Power Products reiterated that for later claims to benefit from an earlier application, the earlier application must meet the written description requirement, ensuring the disclosure indicates the inventor's possession of the later claimed subject matter. Finally, Purdue Pharma L.P. v. Faulding confirmed the district court's finding regarding the sufficiency of disclosures in earlier applications. The `360 patent's later claimed subject matter is examined in the context of the written description requirement and the prohibition on introducing new matter after the original filing date, as established by 35 U.S.C. § 132. To be valid, any claims or amendments made post-filing must be supported by the original specification. The Federal Circuit has historically upheld the notion that the written description doctrine primarily serves as a priority control, rather than a general disclosure mechanism like enablement. This distinction is critical, as applying the written description outside its intended context could undermine the enablement standard. The Supreme Court in Festo recognized a separate description requirement but did not alter over thirty years of case law regarding this issue. Furthermore, both claims and specifications are considered part of the patent "disclosure" under § 132, which addresses new matter objections comprehensively. The written description's application has been consistently focused on priority, with only two cases—the LILLY and ENZO cases—attempting to extend it as a general disclosure requirement. The exploration of the written description's evolving role emphasizes its connection to ensuring inventors held possession of their inventions by the filing date of their earlier applications. Cloning during the relevant period was highly unpredictable and required extensive experimentation, which undermined the patent's assertion that it enabled the production of human insulin cDNA. The Federal Circuit, instead of properly addressing this issue, introduced a new general disclosure test that diverged from established statutes and case law. A referenced article highlights significant conflicts within Federal Circuit patent law, particularly focusing on the "Written Description Requirement" under 35 U.S.C. § 112. Notably, the Federal Circuit has failed to establish consistent standards for what constitutes sufficient disclosure to satisfy this requirement, leading to three distinct tests for compliance. A dissenting opinion from Circuit Judge Linn emphasized disagreements with the panel's treatment of written description and enablement issues, particularly regarding the conflation of these concepts. Judge Linn argued that the "possession of the invention" test, discussed in prior cases, is appropriate for assessing entitlement to priority dates but irrelevant for evaluating disclosure sufficiency. He maintained that once a written description is confirmed, the focus should shift to whether it meets the enablement standard, rather than the possession test. Furthermore, the critical question under § 112 is whether the written description accurately reflects the invention outlined in the claims, rather than merely describing its functionality. The legal excerpt emphasizes the statutory requirement for patent claims to enable individuals skilled in the art to make and use the claimed invention, as mandated by prior case law, particularly before the ruling in Regents of the University of California v. Eli Lilly & Co. The distinction between "enablement" and "possession of the invention" is highlighted, arguing that conflating these concepts complicates the understanding of patentability. The U.S. Patent and Trademark Office (PTO) supports an en banc review due to the inconsistent interpretations of the 'written description' requirement under section 112. This inconsistency particularly impacts the biotech sector, influencing how patent applications are drafted and enforced. The excerpt discusses the implications of the Lilly decision, which has sparked debate regarding the integrity of patent disclosures and the protection of nascent ideas. The ongoing uncertainty around these issues necessitates clarification from the court to guide the PTO’s responsibilities and the conduct of businesses in emerging technology fields. The author expresses dissent regarding the court's decision not to consider the case en banc, advocating for a resolution to these critical issues.