DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the claims
Applicant’s amendment filed 09/02/2026 is acknowledged and enter. Claims 1, 4-7, 10-13, 17-30 and 33-34 are pending. Claims 17-32 were previously withdrawn. See the office action of 01/25/2024 for the withdrawal of the claims 17-32 as being directed to non-elected invention. Therefore, claims 1, 4-7 and 10-13 and 33-34 are examined on merits in this office action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and dependent claims 4-7, 10-13 and 33-34 thereon, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The term “co-factor protein” has not been clearly defined or described in the specification and the specification does clearly describe any specific co-factor protein that enhances binding between the target of the drug and the receptor. Claim 1 recites “co-factor protein” and recites “the co-factor protein enhances binding between the target of the drug and the receptor” without clear description of the nature of the co-factor protein. The binding partner of the target as claimed encompasses various types of molecules that binds the target, the drug includes various types of distinct drugs including hormones, various types of small molecules, toxins and antibody as drugs (therapeutic drugs) and the target includes various types of molecules that binds the drug.
The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117.
To satisfy the written description requirement, MPEP §2163 states, in part “…a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.” Moreover, the written description requirement for a genus may be satisfied through sufficient description of a representative number of species by “…disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between functional and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.”
The claims are drawn to a method of identifying an anti-drug antibody (antibody against a drug) in a sample by a process of enhancing binding between the target and the binding partner of the target with a co-factor protein, specifically, with a receptor and a co-factor protein, to enhance binding between the target and binding partner of the target. The application discloses generic “co-factor” in figures 1 and 4-6 with no clear disclosure and nature/binding properties of the co-factor let alone a specific co-factor the enhances binding of a specific target of a drug and a specific binding partner. Throughout the specification, the only disclosure of “target receptor” and “protein” combination (cofactor-protein) could be found in paragraph [0068] wherein the paragraph recites “The soluble target receptor and co-factor proteins were purchased from Sigma (St Louis, MO)” without any description of the nature, properties or description of the target receptor and the co-factor protein. Paragraphs [0080] and [0081] describes some of the anti-target antibodies that are frequently used to mitigate target interference. Paragraph [0080] recites that “various combinations of these antibodies were also evaluated but they failed to sufficiently inhibit target interference in monkey serum samples”. Paragraph [0080] also discusses that among the anti-target antibodies screened, only one partially inhibit target-mediated false positive signal and two anti-target antibodies actually potentiated (increased) the target-mediated false-positive signal. The limited or no clear description in the specification and without clearly identifying or describing receptor and proteins (co-factor protein) combination that enhances binding of the receptor to the target of the drug, wherein the genus encompassed by “receptor for the target” and “protein” (i.e. co-factor protein) potentially incudes a vast number of different protein molecules, does not adequately describe the entire genus of receptor for the target and protein (i.e. co-factor protein) combination, for different types of drug targets, that enhances binding between the receptor and the target of the drug.
Fig. 4A of the specification shows incorporation of target receptor and co-factor to bridging ADA assay. Specification teaches different concentrations of co-factor (without clearly identifying the co-factor and the target receptor) were added to the solution containing target receptor for conducting bridging ADA. So both the receptor and co-factor are required in the assay but the specification does not clearly describe which proteins (i.e. co-factor proteins) are utilized for different types of receptors of the target. Specification teaches incorporation of both target receptor and co-factor to bridging ADA assay to improve ADA detection (paragraph [0083]), but however, specification does not provide a clear definition and clear guidance of target receptor in combination with co-factor that enhances binding of target and binding partner of the target.
“Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” Ex parte Kubin, 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or sub combinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representatives, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
The court and the Board have repeatedly held (Amgen Inc. v. Chugai Pharmaceutical Co. Ltd.,18 USPQ2d 1016 (CA FC, 1991); Fiers v. Revel, 25 USPQ2d 1601 (CA FC 1993); Fiddes v. Baird, 30 USPQ2d 1481 (BPAI 1993) and Regents of the Univ. Calif. v. Eli Lilly & Co., 43 USPQ2d 1398 (CA FC, 1997)) that an adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it, irrespective of the complexity or simplicity of the method; what is required is a description of the nucleic acid itself.
The specification does not provide an adequate written description of the genus of molecule encompassed by the “receptor of the target” and “protein”(i.e. co-factor protein) as encompassed in the claims, nor does the specification provide sufficient guidance that would allow one of skill in the art to readily identify the members of the claimed genus of “binding partner of a target” and its co-factor that enhances binding of the target and the binding partner of the target, without further experimentation. Thus, one of skill at the time of the invention could not have concluded that Applicant was in possession of the genus of molecules that is required to practice any of the claimed method.
Response to argument
Applicant's arguments and amendments filed 05/11/2026 have been fully considered but are not found persuasive to overcome the rejections under 35 USC 112(a).
Applicant argued that the co-factor protein is not claimed as a composition or product in its own right and instead, it is a component used to perform the claimed assay. Applicant argued that it specifically requires a co-factor protein that “enhances binding between the target of the drug and the binding partner of the target” and thus the claimed co-factor proteins defined by the role in the disclosed method and specific functional characteristic relevant to the method. Applicant argued that the functional limitation in claim 1 provides a relevant identifying characteristics. Applicant argued that examples are not necessarily required to satisfy the written description. Applicant argued that it expressly identifies the pertinent class by a functional characteristic: the ability to enhance the binding interaction between the target and its binding partner in the claimed assay. Applicant argued that the inquiry does not require an exhaustive identification of every embodiment within the scope of the claim where the claimed subject matter is adequately identified by the other characteristics. Based on the above arguments, Applicant argued that the specification provides adequate written description support for the co-factor recited in claim 1.
The above arguments have fully been considered but are not found persuasive.
“When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus" (Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005)) (emphasis added).
“[A] sufficient description of a genus . . . requires the disclosure of either a representative number* of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus” (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69) (emphasis added).
It is true that functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date” (AbbVie, 759 F.3d at 1298, reiterating Enzo Biochem, Inc., 323 F.3d at 964)(emphasis added).
In the present case, however, there is insufficient evidence of such an established structure-function correlation of the various types binding partners of the targets, with the various types of targets (i.e. target of the drugs) and co-factor proteins, which co-factor proteins enhances binding between the target of the drug and the binding partner of the target under an assay condition of pH 4.0 -7.0. Throughout the specification, the only disclosure of “target receptor” and undisclosed “protein” combination (cofactor-protein) could be found in paragraph [0068] wherein the paragraph recites “The soluble target receptor and co-factor proteins were purchased from Sigma (St Louis, MO)” without any description of the nature, properties or description of the target receptor and the co-factor protein. The limited or no clear description in the specification and without clearly identifying or describing receptor and proteins (co-factor protein) combination with no structure-function correlation that enhances binding of the receptor to the target of the drug, does not provide a representative of the genus of co-factor proteins for enhancing binding of the various receptors and targets. The non-disclosure of a single co-factor protein cannot be considered that the applicant has invented species sufficient to support a claim to the functionally-defined genus". A skilled artisan cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus that would exhibit this functional property. The structural features common to the members of the genus are unknown.
Amgen Inc. v. Sanofi notes, pointing to Ariad Pharms., Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed Cir. 2010):
To show invention, a patentee must convey in its disclosure that it “had possession of the claimed subject matter as of the filing date.” Id. at 1350. Demonstrating possession “requires a precise definition” of the invention. Id. To provide this “precise definition” for a claim to a genus, a patentee must disclose “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Id. Amgen at pages 7-8.
Co-factor protein that enhances binding between the target of the drug and the binding partner is an essential component is the process and the disclosure of limited species (here, in this case, disclosure of no species) is insufficient to represent the claimed genus claimed by the functional language.
Therefore, the specification does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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