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 .
Applicant's arguments filed 4/8/2026 have been fully considered but they are not persuasive.
Claims 43, 45-47, 49, 52, 57, and 59 have been cancelled.
With respect to claim 37, the claim is directed to one of the six antibodies having the HC/LC sequences of SEQ ID NOS: 9/10, 18/19, 25/10, 25/19, 25/28 and 35/36. See claim 24. Claims 3, 11, 14, and 17 are directed to the same antibodies but these claims differ in scope as compared to claim 37.
With respect to claim 54, Table 10 indicates that antibodies Ab1-Ab5 inhibit human TNFα. It does not appear that antibody Ab6 was tested.
Specification
The disclosure remains objected to because of the following informalities: The incorporation of sequence listing paragraph on page 1 of the specification should reference the size of the file in bytes not kilobytes (KB). See MPEP 2422.03(I).
Appropriate correction is required.
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.
Claim 58 is 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.
Claims 58 has been amended to recite “the antibody has lower immunogenicity compared to a reference control TNFα antibody.” This is a comparison against an unidentified and structurally uncharacterized reference control. There is no basis for this limitation in the specification.
Claim 58 constitutes new matter.
Claims 42, 44, 48, 50-51, 53-56, and 58 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 methods as discussed below, does not reasonably provide enablement for all methods embraced by the 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 use the invention commensurate in scope with these claims.
Claims 42 and 48 are directed to methods of treatment by administering a therapeutically effective amount of an antibody.
The term “therapeutically effective amount” as defined in the specification means, as an amount of antibody that will elicit the desired biological or medical response of a subject, for example, reduction or inhibition of a protein activity, or ameliorate symptoms, alleviate conditions, slow or delay disease progression, or prevent a disease, etc.
The term “treatment” or “treating” as defined in the specification refers to all processes wherein there may be a slowing, controlling, delaying or stopping of the progression of the disorders or disease disclosed herein, or ameliorating disorder or disease symptoms, but does not necessarily indicate a total elimination of all disorder or disease symptoms.
The methods do not require any particular therapeutic effect and so all therapeutic effects encompassed by “treatment” and “therapeutically effective amounts” must be enabled. To the degree that the claimed methods encompass cure or prevention(i.e. delaying or stopping of the progression), the claims are not enabled. At least for example, there are no known cures or ways to prevent rheumatoid arthritis or Crohn’s disease (see at least claims 44 and 50). With respect to ameliorating all disorder or disease symptoms, there is no evidence of record nor reason to believe that administering any of the claimed antibodies will reverse joint damage that has occurred in rheumatoid arthritis. At least for example, there is no evidence of record nor reason to believe that administering any of the claimed antibodies will reverse fistulas caused by Crohn’s disease. As set forth in the specification, administration of anti-TNFα antibodies are known to reduce inflammation. However, the specification does not enable all aspects of treatment, including prevention and cure, for all diseases (and all of their symptoms or characteristics) encompassed by the claims.
The scope of the claims is not enabled.
Applicant’s arguments are not persuasive. The claims have been amended to recite that the TNFα associated disorder is a chronic autoinflammatory immune disorder but the claims do not include any particular therapeutic effect that must be achieved.
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.
Claims 56 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 56 has been amended to recite “the antibody is a membrane-bound internalizing antibody or a dendric cell internalizing antibody.” It is unclear what this means. If applicant intended that the claimed antibody is internalized upon binding to cell membrane expressed TNFα (such as the cell membrane of a dendritic cell), this language does not convey that concept. See for example, Example 3 at page 29 and Example 5 at page 35. For example, the language could be interpreted as meaning that the antibody is itself membrane-bound and/or that it internalizes on its own/by itself. The claim is confusing and unclear. The metes and bounds of the claim cannot be determined.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 53 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 53 depends upon claim 51 and recites that the antibody has “low to no binding to anti-drug antibodies against Adalimumab.” Claim 51 depends upon claim 48 and claim 48 now depends upon claim 12. Claim 12 is directed to a single antibody having the particular properties recites in claim 53. As such, claim 53 does not further limit the subject matter of claim 51 as the only antibody being administered in claim 51 has the properties recited in claim 53 Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19, 38-42, 44, 48, 50-51, 53-56, and 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of copending Application No. 18/312,653 (9/8/2023 claim set). Although the claims at issue are not identical, they are not patentably distinct from each other.
The sequence identifiers in the co-pending and instant claims correspond to the same sequences.
Co-pending claim 1 is directed to antibody conjugates for antibodies with CDRs as recited in instant claims 1 and 4. See conjugates of instant claims 38-39. Co-pending claims 10 have antibodies corresponding to instant claims 1-3. Co-pending claims 13-28 have antibodies as recited in instant claims 5-17. Co-pending claim 28 has cysteines as in instant claims 18-19. Co-pending claim 31 is directed to a pharmaceutical composition as in instant claims 41-42. Co-pending claims 32-35 are directed to methods of treating autoimmune disease or an inflammatory disease in a subject as in instant claims 42, 44, 48, 50-51, and 53. Antibodies of the co-pending claims would inherently possess the properties recited in co-pending claims 53-56 and 58. The antibody conjugates of the co-pending claims would have placed the antibodies in the hands of one of ordinary skill in the art. The compositions and method claims do not preclude conjugates.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 20-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/312,653 in view of Bacica et al. (WO 2018/232088, of record).
The co-pending claims are as described above. They are not directed to human IgG1 isotypes as in instant claims 20-21. They are not directed to nucleic acids, vectors, host cells, recombinant methods of production, and antibodies so produced as in instant claims 22-37.
The antibody conjugates of the co-pending claims would have placed the antibodies in the hands of one of ordinary skill in the art.
Bacica et al. discloses human IgG1 antibodies. See at least page 10, lines 24-27. Recombinant production of antibodies using nucleic acids where each chain is encoded by a single vector or by two separate vectors is disclosed. Mammalian host cells are disclosed. Recovery of the antibody from the culture medium is disclosed. See at least pages 23-24.
It would have been obvious to produce nucleic acids encoding the heavy and light chains of the co-pending antibodies (particularly as human IgG1 isotypes), vectors, and mammalian host cells in order to produce the co-pending antibodies recombinantly as taught by Bacica et al. One would have been motivated to so as recombinant production of antibodies would have been conventional.
This is a provisional nonstatutory double patenting rejection.
Applicant has acknowledged these provisional double patenting rejections. No arguments were made.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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