DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s response and amendments received March 6, 2026 are acknowledged.
Claims 1-77 have been canceled.
Claims 78-92 are newly presented.
Applicant is remined of their election without traverse of the invention of group I, drawn to antigen binding molecules comprising a mutated Fc domain, and the species of residues 120-447 of SEQ ID NO:3 comprising the M252W/N434W double substitution in the reply filed on August 26, 2025.
Information Disclosure Statement
The IDS form received 3/6/2026 is acknowledged and the references cited therein have been considered.
Specification
Applicant’s amendments to the specification to correct formal matters are acknowledged.
Claim Rejections - 35 USC § 112
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.
The rejection of claim 59 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is moot as the claim in question was canceled as part of the March 6, 2026 response.
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.
The rejection of claims 58-75 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 have been rendered moot by their cancelation as part of the March 6, 2026 response.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
The rejection of claims 58-75 under pre-AIA 35 U.S.C. 102(b) as being anticipated by Yeung et al. as evidenced by Patton et al technically is moot as said claims have been canceled, but the art has not been applied to the newly presented claims as they require Fc mutations not disclosed by Yeung et al.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
The rejection of claims 62, 63, 68, 69, and 72-75 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Igawa et al. (WO2009/125,825) in view of Yeung et al. is moot as said claims have been canceled and the grounds of rejection have not been applied to the newly presented claims as they require Fc mutations not disclosed in the cited art documents.
The rejection of claims 62, 63, 68, 69, and 72-75 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Igawa et al. (WO2009/125,825) in view of Lowman et al. (US 2010/0098730) is moot as said claims have been canceled and the grounds of rejection have not been applied to the newly presented claims as they require Fc mutations not disclosed in the cited art documents.
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.
The rejection of claims 58-75 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,827,699 as evidenced by Patton et al. is moot as said claims were canceled as part of the March 6, 2026 response.
The rejection of claims 58-75 on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,371,485 is moot as said claims were canceled as part of the March 6, 2026 response.
The rejection of claims 58-75 on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 10,618,965 is moot as said claims were canceled as part of the March 6, 2026 response.
The rejection of claims 58-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,556,949 is moot as said claims were canceled as part of the March 6, 2026 response.
The rejection of claims 58-75 on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 11,891,434 is moot as said claims were canceled as part of the March 6, 2026 response.
The rejection of claims 58-75 on the ground of nonstatutory double patenting as being unpatentable over claims 1-51 of U.S. Patent No. 11,673,947 as evidenced by Patton et al. is moot as said claims were canceled as part of the March 6, 2026 response.
The rejection of claims 58-75 on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 10,253,100 as evidenced by Patton et al. is moot as said claims were canceled as part of the March 6, 2026 response.
The rejection of claims 58-75 on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,718,678 is moot as said claims were canceled as part of the March 6, 2026 response.
The rejection of claims 58-75 on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,820,793 is moot as said claims were canceled as part of the March 6, 2026 response.
The following are new grounds of rejection necessitated by applicant’s claim amendments received March 6, 2026
Claims 80-82, 85-87, and 90-92 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 80-82 all depend directly from independent claim 78. Independent claim 78 claims a variant human IgG1 Fc sequence which comprises specifically chosen mutations selected from a small group although classical Markush language is not recited. Dependent claim 80 explicitly recites “wherein the variant human IgG1 Fc region comprises the amino acid sequence shown as residues 120-447 of SEQ ID NO:3”. Thus the claimed “variant” must comprise residues 120-447 of SEQ ID NO:3, and since there are no Xaa or otherwise undefined residues in SEQ ID NO:3 the sequence is fixed. It should be made explicitly clear that with regard to biological sequences “comprising” allows, but does not require, additional biological sequence at one or both ends but importantly does not allow for internal modifications. Note that if internal alterations were permissible the resulting sequence would no longer 100% align to SEQ ID NO:3 and therefore the resulting sequence could not “comprise” SEQ ID NO:3. However, after fixing the sequence of the “variant” claimed in claim 80 to minimally be residues 120-447 of SEQ ID NO:3, the claim then further recites “comprising the M428L substitution according to the EU numbering system.” It cannot be said strongly enough that the residue in SEQ ID NO:3 corresponding top EU position 428 is a methionine and NOT a leucine (i.e. the M428L mutation is not present in SEQ ID NO:3). Thus, how is claim 80 to be interpreted? Is the claimed Fc polypeptide limited to things 100% identical to SEQ ID NO:3 (i.e. those “comprising” SEQ ID NO:3), is it limited to Fc sequences comprising EU M428L but the other residues are unspecified, is applicant claiming a variant of SEQ ID NO:3, wherein the change relative to SEQ ID NO:3 is limited to M428L, or something else entirely? Given that some possible claim interpretations are mutually exclusive the claim necessarily is indefinite. Claims 81 and 82 have the same problem albeit they recite different mutations, namely T256Q (claim 81) and V308P (claim 82), and again it is unclear if such mutations are in addition to those already in SEQ ID NO:3, read out the sequence of SEQ ID NO:3 as a limitation, are to be ignored as they are not present in SEQ ID NO:3, or something else entirely. Claims 85-87 depend direct from claims 80-82 respectively yet fail to address the logic problems in claims 80-82. Similarly, claims 90-92 depend from claims 85-87 respectively but do not address the indefiniteness of claims 80-82 respectively. Amending claims 80-82 to clearly and unambiguously identify exactly what it is that applicant wishes to claim is likely to be beneficial in overcoming this rejection.
Claims 78-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,827,699. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
Specifically, the issued claims recite methods of making antibodies that bind an antigen less tightly at acid as compare to neutral pH wherein such an antibody comprise a mutated Fc domain that increases the strength of FcRn binding, and wherein such an antibody comprises Fc mutation as recited in the instant claims (see all issued claims, particularly claims 1 and 9). Importantly, antibodies comprising mutations at positions M252W and N434W are explicitly claimed (see again issued claim 9) as are M428L, T256Q and V308P (ibid). Administration of such antibodies to patients to reduce plasma antigen concentration is also recited (see issued claim 6) and as such pharmaceutical composition are necessarily present.
It is noted that the issued claims are methods while the instant claimed inventions are products. There is no restriction requirement which necessitated the filing of the application which gave rise to the ‘699 patent as it is in a completely separate patent family lineage as is readily evidenced by inspection of the filing receipt mailed April 7, 2023 in the instant application. As such the safe harbor provisions of 35 USC 121 are not applicable to the instant situation.
Claims 78-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,371,485. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
Specifically, the issued claims recite methods of making a pharmaceutical composition wherein the antibody a) binds to the target antigen more tightly at pH 7.4 (neutral) as compared to 5.8 (acidic) and b) comprises the F14 Fc domain (see all issued claims, particularly claim 1). Notably, the recited “F14” Fc construct is defined in Table 5 of the ‘485 patent as comprising the M252W and N434W substitution mutations in a human IgG1 background. Additionally, M252W/M428L/N434W is “F93”, N252W/T256Q/N434W is “F84” and M252W/V308P/N434W is “F90” (all claimed, see issued claim 1).
It should be noted that the issued claims are methods while the instant claimed inventions are products. There is no restriction requirement which necessitated the filing of the application which gave rise to the ‘485 patent as it is in a completely separate patent family lineage as is readily evidenced by inspection of the filing receipt mailed April 7, 2023 in the instant application. As such the safe harbor provisions of 35 USC 121 are not applicable to the instant situation.
Claims 78-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 10,618,965. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
Specifically, the issued claims recite methods of reducing the immunogenicity of an antibody, wherein the antibody a) bind FcRn better than a native human IgG1 sequence at pH 7.0, b) binds to the target antigen more tightly at pH 7.4 (neutral) as compared to 5.8 (acidic) and c) comprises mutations at one or more of in the Fc region identified by EU numbering (see all issued claims, particularly claim 1). Notably, mutations to 252W, 434W, 428L, and 308P are all claimed (see particularly claim 8).
It is acknowledged that the issued claims are methods while the instant claimed inventions are products. There is no restriction requirement which necessitated the filing of the application which gave rise to the ‘965 patent as it is in a completely separate patent family lineage as is readily evidenced by inspection of the filing receipt mailed April 7, 2023 in the instant application. As such the safe harbor provisions of 35 USC 121 are not applicable to the instant situation.
Claims 78-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-51 of U.S. Patent No. 11,673,947. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
Specifically, the issued claims recite antigen binding molecules comprising an antigen binding domain and an Fc domain that is mutated from native human IgG sequence wherein such antibodies comprise 252W, 434W, 428L, 256Q, and 308P mutations (see all issued claims, particularly claims 1, 31, and 32). Pharmaceutical compositions comprising such antibodies are also explicitly claimed (see particularly issued claims 39-42).
Additionally it should be noted that there is no restriction requirement which necessitated the filing of the application which gave rise to the ‘947 patent as it is in a completely separate patent family lineage as is readily evidenced by inspection of the filing receipt mailed April 7, 2023 in the instant application. As such the safe harbor provisions of 35 USC 121 are not applicable to the instant situation.
Claims 78-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,718,678. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
Specifically, the issued claims recite methods improving antibody pharmacokinetics by making a derivative of a staring antibody wherein said derivative a) binds FcRn at pH 7.0, b) binds antigen in a pH-dependent manner and c) comprises 252W, 434W, 428L, 256Q, and 308P mutations per EU numbering (see all issued claims, particularly claims 1, 3, 13, and 14).
Additionally it should be noted that the issued claims are methods while the instant claimed inventions are products. There is no restriction requirement which necessitated the filing of the application which gave rise to the ‘678 patent as it is in a completely separate patent family lineage as is readily evidenced by inspection of the filing receipt mailed April 7, 2023 in the instant application. As such the safe harbor provisions of 35 USC 121 are not applicable to the instant situation.
Claims 78-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,820,793. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
Specifically, the issued claims recite methods of reducing the amount of antigen in the blood of a subject by administering an antibody that a) binds antigen in a pH-dependent manner and b) comprises 252W, 434W, 428L, 256Q, and 308P mutations per EU numbering (see all issued claims, particularly claims 1, 12, and 15).
Additionally it should be noted that the issued claims are methods while the instant claimed inventions are products. There is no restriction requirement which necessitated the filing of the application which gave rise to the ‘793 patent as it is in a completely separate patent family lineage as is readily evidenced by inspection of the filing receipt mailed April 7, 2023 in the instant application. As such the safe harbor provisions of 35 USC 121 are not applicable to the instant situation.
No claims are allowable.
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 Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641
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