Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of Application, Amendments, and/or Claims
2. The preliminary amendment filed 12 June 2025 has been entered in full. Claims 1, 11 and 19 have been amended, claims 2-4, 6-7, 9-10, 12, 14-18 and 20-36 have been canceled, and claims 37-41 have been added. Therefore, claims 1, 5, 8, 11, 13, 19 and 37-41 are pending and the subject of this Office Action.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on 01 May 2024 and 14 May 2024 have been considered by the Examiner. It is noted that NPL References 285-286 have been lined through as they do not provide a date. They have been considered, but will not appear on the cover of the issued patent as they do not provide a date.
Specification
4. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: ANTIBODIES WHICH BIND ZINC TRANSPORTER-8 AND USES THEREOF.
Appropriate correction is required.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
5. 37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.831(a) and 1.831(b). However, this application fails to comply with the requirements of 37 CFR 1.831-1.834. The examiner has noted that Figure 1B recites amino acid sequences without an accompanying sequence identifier, and the sequences are not found in the Sequence Listing XML. 37 CFR 1.831 requires that “applications disclosing a nucleotide and/or amino acid sequence(s) by enumeration of its residues, as defined in paragraph (b) of this section, must contain, as a separate part of the disclosure, a computer readable Sequence Listing in XML format (a "Sequence Listing XML"). Disclosed nucleotide or amino acid sequences that do not meet the definition in paragraph (b) of this section must not be included in the "Sequence Listing XML."” Paragraph (b) of 37 CFR 1.831 states that amino acid sequences encompass “an unbranched sequence or linear region of a branched sequence containing 4 or more specifically defined amino acids. Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2., as well as
• A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 1.835(b)(3);
• A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
• A statement that the “Sequence Listing XML” includes no new matter in accordance with 1.835(b)(5); and
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o A statement that the substitute specification contains no new matter.
Drawings
6. The Drawings are objected to because Figure 1B discloses amino acid sequences without an accompanying sequence identifier (i.e., SEQ ID NO: #). The SEQ ID NO: may be inserted into the Figure or the Brief Description of the Drawings. If the Sequence Identifiers are added to the Figures, corrected drawing sheets will be required in reply to the Office action to avoid abandonment of the application.
7. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
8. Furthermore, if the sequences are not present in the sequence listing, as indicated supra Applicant is required to provide (1) a substitute computer readable form (CRF) copy of a “Sequence Listing” which includes all of the sequences that are present in the instant application and encompassed by these rules, (2) a substitute paper copy of that “Sequence Listing”, (3) an amendment directing the entry of that paper into the specification, and (4) a statement that the content of the paper and computer readable copies are the same, and, where applicable, include no new matter, as required by 37 C.F.R. § 1.821 through 1.825. The claims and/or instant specification will also need to be amended so that it complies with 37 C.F.R. § 1.821(d) which requires a reference to a particular sequence identifier (i.e., SEQ ID NO: #) be made in the specification and claims wherever a reference is made to that sequence (See M.P.E.P. 2422.04). It is noted that Sequence identifiers can also be used to discuss and/or claim parts or fragments of a properly presented sequence. For example, language such as "residues 14 to 243 of SEQ ID NO:23" is permissible and the fragment need not be separately presented in the "Sequence Listing XML." See 37 CFR 1.831(c).
Claim Rejections - 35 USC § 112
9. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
10. Claims 11, 13 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
11. Claim 11 is rejected as being indefinite for reciting “one or more of a therapeutic agent, and an imaging agent”. Since it isn’t clear if “one or more therapeutic agents”, “one or more imaging agents”, or “one or more therapeutic agents and imaging agents” are intended, the metes and bounds of the claim cannot be determined.
12. Claim 13 is rejected as being indefinite because a composition, by definition, must contain two or more elements. Amending the claim to recite, for example, “A composition comprising the antibody or antigen-binding fragment thereof of claim 1 and a pharmaceutical carrier” would be remedial.
13. Claim 19 is rejected as being indefinite for reciting the limitation “disease or condition associated with ZnT8.” Since neither the specification nor the prior art provide a limiting definition of what constitutes a disease or condition associated with ZnT8, the metes and bounds of the claim cannot be determined.
Claim Rejections - 35 USC § 112 (Written Description)
14. The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
15. Claims 1, 5, 8, 11, 13, 19 and 38-41 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
16. The U.S. Court of Appeals for the Federal Circuit recently reaffirmed, in an en banc decision, that the written description requirement for a genus may be satisfied either by (i) the disclosure of a representative number of species falling within the scope of the genus or (ii) 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. Ariad Pharmaceuticals', Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350, 94 U.S.P.Q.2d 1161, 1171 (en banc) (Fed. Cir. 2010), citing Regents" of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568-69, 43 U.S.P.Q.2d 1398, 1406 (Fed. Cir. 1997).
17. The representative ways of satisfying the written description requirement as set out by the Federal Circuit in Ariad Pharmaceuticals comport with statements set out in the USPTO's Manual of Patent Examining Procedure (M.P.E.P.). In particular, the M.P.E.P. provides that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species of relevant identifying characteristics. M.P.E.P. § 2163, II, A, 3, (a), (ii).
18. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed, and correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art. “Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163.
19. In the instant case, the claims are drawn quite broadly to antibodies and antigen-binding binding fragments thereof that specifically binds to three extracellular loops of the transmembrane domain of Zinc Transporter-8 (ZnT8), wherein the three extracellular loops of ZnT8 comprise amino acids 95-99, 169-175 and 242-245 of SEQ ID NO: 31. The claims also recite wherein the antibody or antigen-binding fragment thereof comprises:(a) a heavy chain variable region sequence having at least 90% sequence identity to SEQ ID NO: 2 or SEQ ID NO: 19; and (b) a light chain variable region sequence having at least 90% sequence identity to SEQ ID NO: 7. The claims also recite wherein the antibody or antigen-binding fragment thereof comprises:(a) heavy chain complementarity determining regions (CDRs) 1, 2 and 3 comprising SEQ ID NOs: 3-5, respectively; and(b) light chain CDRs 1, 2 and 3 comprising SEQ ID NOs: 8-10, respectively, wherein the heavy chain CDRs comprise at least one conservative amino acid substitution within one or more of SEQ ID NOs: 3-5 and/or the light chain CDRs comprises at least one conservative amino acid substitution within one or more of SEQ ID NOs: 8-10. The claims also recite methods of treatment, utilizing said antibody or antigen-binding fragment thereof. Thus, the claims have been broadly interpreted by the Examiner as reading upon an extremely large genus of antibodies that are defined only by a desired function/activity.
20. For genus claims, an adequate written description of a claimed genus requires more than a generic statement of an invention's boundaries. A patent must set forth either a representative number of species falling within the scope of the genus or structural features common to the members of the genus. Kubin, Exparte, 83 USPQ2d 1410 (Bd. Pat. App. & Int. 2007); Ariad Pharms., Inc. v. Eli Lilly& Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010).
A “patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”), see MPEP 2163.IIAii.
21. Several recent court decisions speak to the notion that claiming a molecule with unknowable structural heterogeneity solely by reciting its function is not sufficient to establish possession of a genus so claimed. For example, quoting Eli Lilly the court states in Ariad, 598 F.3d at 1350: "[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." (quoting Eli Lilly, 119 F.3d at 1568-69).
22. A "representative number of species" means that the species which are described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG V. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.").
23. In the instant case, the claims encompass in their breadth antibodies and antigen-binding binding fragments thereof that specifically binds to three extracellular loops of the transmembrane domain of Zinc Transporter-8 (ZnT8), wherein the three extracellular loops of ZnT8 comprise amino acids 95-99, 169-175 and 242-245 of SEQ ID NO: 31 (claim 1), as well as antibody or antigen-binding fragments having variations in the heavy and light chain variable regions or variations in the heavy and/or light chain CDRs.
24. Given the exceedingly large genus of antibodies and fragments encompassed by the claims, one of skill in the art cannot possibly envision the structures contained within this genus that will have the property of binding to three extracellular loops of the transmembrane domain of Zinc Transporter-8 (ZnT8), wherein the three extracellular loops of ZnT8 comprise amino acids 95-99, 169-175 and 242-245 of SEQ ID NO: 31.
25. The specification discloses one particular antibody that is defined by particular amino acid sequences for the three CDR sequences of both the VH and VL domains. This antibody, designated mAb43, having a VH of SEQ ID NO: 2 or SEQ ID NO: 19 (CDRs: SEQ ID NO: 3, SEQ ID NO: 4 and SEQ ID NO: 5) and a VL of SEQ ID NO: 7 (CDRS: SEQ ID NO: 8, SEQ ID NO: 9 and SEQ ID NO: 9) is disclosed as binding to an epitope including the ECL-2 loop of ZnT8 (See Example 4 at pg. 5), and prevents binding of autoantibodies from patients with type 1 diabetes (See Example 8 at pp. 59-61). However, 1 species of antibody which bind the ECL2 loop of ZnT8 is not representative of the unlimited breadth of the claimed antibodies and fragments recited in the claims.
26. It is well established in the art that the amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences which maintain their required conformation, are required in order to produce a protein having antigen-binding function and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites. Even minor changes in the amino acid sequences of the heavy and light variable regions, particularly in the CDRs, may dramatically affect antigen-binding function as evidenced by Rudikoff, et al. (PNAS, 1982. Vol. 79, page 1979; cited by Applicant). Rudikoff et al. teach that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function. MacCallum, et al. (J. Mol. Biol., 262:732-745; cited by Applicant) analyzed many different antibodies for interactions with antigen and state that although CDR3 of the heavy and light chain dominate, a number of residues outside the standard CDR definitions make antigen contacts (see page 733, right column) and non-contacting residues within the CDRs coincide with residues as important in defining canonical backbone conformations (see page 735, left column). De Pascalis, et al. (Journal of Immunology, 2002. 169:3076-3084; cited by Applicant) demonstrate that grafting of the CDRs into a human framework was performed by grafting CDR residues and maintaining framework residues that were deemed essential for preserving the structural integrity of the antigen binding site (see page 3079, right column). Although abbreviated CDR residues were used in the constructs, some residues in all 6 CDRs were used for the constructs (see page 3080, left column).
27. Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Abbvie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (759 F.3d 1285 (Fed. Cir. 2014). “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).
28. An adequate written description of a chemical invention requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that “[w]ithout such disclosure, the claimed methods cannot be said to have been described.”). See MPEP 2163IIA3(a).
29. Consequently, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus of antibodies and antigen-binding binding fragments thereof that bind to an epitope in the B2 or C domain of human NRP2 encompassed in the breadth of the instant claims.
30. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that in order to satisfy the written description requirement, “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). As discussed above, the skilled artisan cannot envision the detailed structure of the encompassed genus of therapeutic antibodies and antigen-binding binding fragments thereof that bind to an epitope in the B2 or C domain of human NRP2, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
31. Without a correlation between structure and function, the claims do little more than define the claimed invention by function, which is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 ("definition by function does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is").
32. Therefore, only an antibody or antigen-binding fragment thereof comprising: (1) a heavy chain variable region CDR1 comprising the sequence SEQ ID NO: 3; a heavy chain variable region CDR2 comprising the sequence SEQ ID NO: 4; a heavy chain variable region CDR3 comprising the sequence SEQ ID NO: 5; a light chain variable region CDR1 comprising the sequence SEQ ID NO: 8; a light chain variable region CDR2 comprising the sequence SEQ ID NO: 9; and a light chain variable region CDR3 comprising the sequence SEQ ID NO: 10, but not the full breadth of the claims meets the written description provision of 35 U.S.C. § 112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. § 112 is severable from its enablement provision (see page 1115).
Claim Rejections - 35 USC § 112 (Scope of Enablement)
33. Claims 19 and 41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for treating type 1 diabetes, does not reasonably provide enablement for a method of treating every disease or condition recited in or encompassed by the instant claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
34. The factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” include, but are not limited to: 1) nature of the invention, 2) state of the prior art, 3) relative skill of those in the art, 4) level of predictability in the art, 5) existence of working examples, 6) breadth of claims, 7) amount of direction or guidance by the inventor, and 8) quantity of experimentation needed to make or use the invention. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
35. The claims are drawn quite broadly to a method of treating a disease or condition associated with ZnT8 (See 112(b) rejection supra). The claims also recite wherein the disease or condition comprises type 1 or type 2 diabetes.
36. The Specification discloses an antibody designated mAb43, having a VH of SEQ ID NO: 2 or SEQ ID NO: 19 (CDRs: SEQ ID NO: 3, SEQ ID NO: 4 and SEQ ID NO: 5) and a VL of SEQ ID NO: 7 (CDRS: SEQ ID NO: 8, SEQ ID NO: 9 and SEQ ID NO: 9) which is disclosed as binding to an epitope including the ECL-2 loop of ZnT8 (See Example 4 at pg. 5), and prevents binding of autoantibodies from patients with type 1 diabetes (See Example 8 at pp. 59-61).. Therefore, while one of skill in the art would expect that this antibody would teat type 1 diabetes, there is insufficient guidance and a lack of working examples to support a conclusion that the claimed antibodies could be used to treat the broad scope of diseases and conditions encompassed by the claims, or what the diseases/conditions are. One skilled in the art would not know, with any level of predictability, that the administration of the antibodies of the invention would lead to the treatment of every type of disease or condition encompassed by the claims.
37. The specification fails to disclose how to assess in vivo a pharmaceutically effective amount of an anti-ZnT8 antibody, nor has it established that administering said antibody would be useful for the treatment of every type of disease or condition recited in the claims. In the absence of this guidance, a practitioner would have to resort to a substantial amount of undue experimentation involving the variation in the amount and duration of administration of the antibody, and making a determination of whether a successful result was achieved. The instant situation is analogous to that which was addressed in In re Colianni, 195 USPQ 150, (CCPA 1977), which held that:
“a “[d]isclosure that calls for application of “sufficient” ultrasonic energy to practice claimed method of fusing bones but does not disclose what “sufficient” dosage of ultrasonic energy might be or how those skilled in the art might select appropriate intensity, frequency, and duration, and contains no specific examples or embodiment by way of illustration of how claimed method is to be practiced does not meet requirements of 35 U.S.C. 112 first paragraph”.
38. In the instant case, there are no working examples presented in the instant specification that describe diseases or conditions associated with ZnT8, or the successful treatment of any disease or condition by administering the claimed antibodies. Therefore, without this guidance, one skilled in the art would not know, with any level of predictability, that the administration of an undetermined amount of an anti-ZnT8 antibody would lead to the treatment of any disease or condition associated with ZnT8.
39. A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. In the decision of Genentech, Inc, v. Novo Nordisk, 42 USPQ 2d 100, (CAFC 1997), the court held that:
“[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”, and that “[t]ossing out the mere germ of an idea does not constitute enabling disclosure”. The court further stated that “when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art”, “[I]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement”.
40. Thus, in view of the breadth of the claims, the lack of guidance, and the lack of working examples, the instant specification is not found to be enabling for a method of treating a disease or condition associated with ZnT8, or treatment of type 2 diabetes, comprising administering an antibody that binds three extracellular loops of the transmembrane domain of ZnT8. It would require undue experimentation and making a substantial inventive contribution for the skilled artisan to discover how to make and/or use the claimed invention in its full scope.
Summary
41. No claim is allowed.
Claim 37 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jon M. Lockard whose telephone number is (571) 272-2717. The examiner can normally be reached on Monday through Friday, 8:00 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached on (571) 272-2911. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JON M LOCKARD/
Examiner, Art Unit 1647
August 3, 2026
Prosecution Insights