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 .
The current application is a continued examination under 37 CFR 1.114, as filed 6/16/2025.
Applicant’s remarks, filed 11/6/2025, are acknowledged and entered into the record. Applicants amended claims 67, 69, 71, 73, 76, 78, 80, 82, 84, 86, 88 and 90, and canceled claims 68, 70, 72, 74, 77, 79, 81, 83, 85, 87, 89 and 91, in the remarks of 11/6/2025.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The present application is drawn from PCT/KR2018/014123, filed 11/16/2018; and claims benefit under 35 U.S.C. 119(e) to U.S. Provisional applications 62/687848, filed 6/21/2018 and 62/588018, filed 11/17/2017.
Status of Claims
Claims 32-33, 35, 37-51, 53-67, 69, 71, 73, 75-76, 78, 80, 82, 84, 86, 88 and 90 are pending and are being examined on the merits.
Claim Objections
Applicant is advised that should claims 42-44 and 73 be found allowable, claims 67, 69, 71 and 75 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
The examiner believes that claims 42-44, drawn to isolated polynucleotide(s) encoding both the heavy and light chains of the antibody of claim 32, expression vector(s) comprising polynucleotide(s), and a host cell comprising the nucleic acids cover substantially the same, or identical, scope of subject matter as claims 67, 69 and 71, which are also dependent on the antibody of claim 32, and merely claim “a first and a second” polynucleotide or expression vector encoding the heavy and light chain amino acid sequence, respectively. Thus, a host cell transformed with the expression vectors of claim 69 (re. claim 73) and a host cell transformed with the expression vector(s) of claim 43 (re. claim 75), are identical.
Claim Rejections - Withdrawn
Claim Rejections - 35 USC § 112
The rejection of claims 67-74 and 76-91 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, is withdrawn.
Applicants amended claims 67, 69, 71, 76, 78, 80, 84, 86 and 88 such that the polynucleotides, expression vectors and host cells of the claims require both the heavy and light chains of the antibody, and thus obviate the rejection for limiting the encoding constructs to only a light or heavy chain of the antibody. Applicants canceled claims 68, 70, 72, 74, 77, 79, 81, 83, 85, 87, 89 and 91, rendering the rejection over those claims moot.
Claim Rejections - Maintained
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 32-33, 35, 37, 40, 46-48, and 53-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6 and 9-18 of U.S. Patent No. 12,071,483. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the claims of US ‘483 anticipates that of the instant claims.
US ‘483 claims alpha synuclein (α-syn)/ IGF1R bispecific antibodies that recognize α-syn aggregates (claim 1); whereby the anti-α-syn antibody is of the IgG1 isotype (claim 6). Specifically, ‘483 teaches one such species wherein the anti-α-syn antibody comprises the HCDRs of SEQ ID NOs: 434, 435, 438; and the LCDRs of SEQ ID NOs: 443-445 (claim 9). Further US ‘483 claims wherein the anti-α-syn antibody comprises a VH of SEQ ID NO: 531 and a VL of SEQ ID NO: 548 (claim 10); or a VH of SEQ ID NO: 532 and a VL of SEQ ID NO: 548 (claim 11). The CDRs of US ‘483 SEQ ID NOs: 434, 435, 438 and 443-445 are 100% identical to the CDRs of instant SEQ ID NOs: 1, 2, 5 and 10-12, respectively, of instant claim 32. The VH regions of SEQ ID NOs: 531 and 532 comprise the HFR1 of instant SEQ ID NO: 17 and the HFR4 of instant SEQ ID NO: 34, of instant claim 32, with 100% sequence identity; the VL regions of SEQ ID NO: 548 comprises the LFR1 of instant SEQ ID NO: 58 and the LFR3 of instant SEQ ID NO: 67, of instant claim 32, with 100% sequence identity. Thus the anti-α-syn antibody of US ‘483 meets all the limitations of the anti-α-syn antibody of the instant claim 32, including at least one of the humanized FR domains. Further, US ‘483 SEQ ID NOs: 532 (VH) and 548 (VL) are identical to instant SEQ ID NOs: 99 (VH) and 115 (VL) or claim 53, or whereby they are attached to an IgG1 constant region (US ‘483, claim 6) of SEQ ID NOs: 129 (HC) or 130 (LC) of instant claim 54.
US ‘483 also claims a method of reducing α-syn aggregates comprising administering the antibody (claims 12 and 17); wherein the α-synucleinopathy is Parkinson’s disease or multiple system atrophy (claims 13 and 18); whereby the antibody is in a pharmaceutical composition (claims 14 and 16); whereby the bispecific antibody comprises the heavy chain of SEQ ID NO: 614 and the light chain of SEQ ID NO: 566, which comprise the VH of SEQ ID NO: 532 and the VL of SEQ ID NO: 548, respectively (claim 15).
Specifically, the anti-α-syn antibody of US ‘483 claims 1, 6, 9-11 and 15 anticipates the anti-α-syn antibody of instant claims 32-33, 35, 37, 40 and 53-54; and the methods and pharmaceutical compositions of US ‘483 claims 12-14 and 16-18 anticipate the methods and pharmaceutical compositions of instant claims 46-48, 55-66.
Claims 32-33, 35, 37, 40, 46-48, 53-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15, 27, 31-34, 38-39 and 44-50 of copending Application No. 17/616,799 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the claims of application ‘799 anticipate that of the instant claims.
Application ‘799 claims alpha synuclein (α-syn)/ IGF1R bispecific antibodies that recognize α-syn aggregates (claim 1); whereby the anti-α-syn antibody is of the IgG1 isotype (claim 27). Specifically, ‘799 teaches one such species wherein the anti-α-syn antibody comprises the HCDRs of SEQ ID NOs: 135, 136, 138; and the LCDRs of SEQ ID NOs: 139-141 (claim 31). Further application ‘799 claims wherein the anti-α-syn antibody comprises a VH of SEQ ID NO: 143 and a VL of SEQ ID NO: 147 (claim 32); or a heavy chain of SEQ ID NO: 166 and a light chain of SEQ ID NO: 150 (claim 33), which comprise the VH of SEQ ID NO: 143 and the VL of SEQ ID NO: 147, respectively. The CDRs of ‘799 SEQ ID NOs: 135, 136, 138 and 139-141 are 100% identical to the CDRs of instant SEQ ID NOs: 1, 2, 5 and 10-12, respectively, of instant claim 32. The VH regions of SEQ ID NO: 143 comprises the HFR1 of instant SEQ ID NO: 17 and the HFR4 of instant SEQ ID NO: 34, of instant claim 32, with 100% sequence identity; the VL regions of SEQ ID NO: 147 comprises the LFR1 of instant SEQ ID NO: 58 and the LFR3 of instant SEQ ID NO: 67, of instant claim 32, with 100% sequence identity. Thus the anti-α-syn antibody of application ‘799 meets all the limitations of the anti-α-syn antibody of the instant claim 32, including at least one of the humanized FR domains. Further, application ‘799 SEQ ID NOs: 143 (VH) and 147 (VL) are identical to instant SEQ ID NOs: 99 (VH) and 115 (VL) of instant claim 53, or whereby they are attached to an IgG1 constant region (‘799, claim 27) of SEQ ID NOs: 129 (HC) or 130 (LC) of instant claim 54.
Application ‘799 also claims a method of reducing α-syn aggregates comprising administering the antibody (claims 38 and 45); wherein the α-synucleinopathy is Parkinson’s disease or multiple system atrophy (claims 39 and 46-50); whereby the antibody is in a pharmaceutical composition (claims 34 and 44); whereby the bispecific antibody comprises the heavy chain of SEQ ID NO: 614 and the light chain of SEQ ID NO: 566, which comprise the VH of SEQ ID NO: 532 and the VL of SEQ ID NO: 548, respectively (claim 15).
Specifically, the anti-α-syn antibody of application ‘799 claims 1, 15, 27 and 31-33 anticipates the anti-α-syn antibody of instant claims 32-33, 35, 37, 40 and 53-54; and the methods and pharmaceutical compositions of US ‘483 claims 34, 38-39 and 44-50 anticipate the methods and pharmaceutical compositions of instant claims 46-48, 55-66.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. However, it is noted that the claims of application 17/616799 were allowed on 7/1/2025.
Response to Arguments
Applicant's arguments filed 11/6/2025 have been fully considered but they are not persuasive. Applicants contend that the non-statutory double patent (NSDP) rejections were an obviousness-type double patenting (ODP) rejection and was a legal error (remarks, pg. 14, paras. 3-5). Applicants cite the MPEP guidance of 35 U.S.C. 103 that such a rejection requires that the invention would have been obvious before the effective filing date of the claimed invention, that the ‘483 patent has a later effective filing date than the instant application, and therefore the ‘483 patent is not prior art (remarks, pg. 15, paras. 1-2). Applicants cite MPEP 804(I)(B)(1)(b)(i), that if a provisional NSDP is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection and allow the earlier filed application to issue as a patent. Thus, as the instant application has the earlier effective filing date over the ‘483 patent, it should be allowed to issue (remarks, pg. 15, paras. 5-6). Further, applicants contend that such guidance should hold regardless of whether an ODP reference is an application or an issued patent (pg. 15, para. 7). Applicants cite Allergan USA, Inc. v. MSN Laboratories Private Ltd, whereby the CAFC explained that the purpose of the ODP doctrine intends for a claimed invention, upon expiration of the issued patent, to be free to use, including any modification or variants thereof which would have been obvious to those of skill in the art; and thus, a first-filed invention cannot be a modification or variant of something that did not yet exist when the subject application was filed (remarks, pg. 16, paras. 1-2). Applicants cite Allergan which found that later filed reference patents are not proper ODP references that can be used to invalidate claims of an earlier patent (pg. 16, paras. 4-5). In support, applicant cites Ex parte Baurin, which found the reasoning in Allergan compelling; stating that the claims of an earlier filed patent would be a first patent to cover the invention, and it is not a second, later expiring patent for the same invention whereby it would extend the period of exclusivity on the claimed subject matter (pg. 17, paras. 1-4). Applicants cite Baurin, which stated that the risk of separate ownership is immaterial where the asserted reference is not a proper NSDP reference. Applicants cite that Allergan states that the purpose of the ODP doctrine is to prevent patentees from extending the life of a first patent, and that in Novartis AG v. Ezra Ventures LLC, the CAFC also held that a reference patent did not qualify as an ODP reference, and also did not discuss the threat of harassment by multiple assignees. Therefore, applicants state it can only be concluded that the threat of harassment by multiple assignees is not sufficient to support an ODP rejection (remarks, pg. 17 – pg. 18, para. 1).
Regarding the provisional rejection over application 17/616,799, applicants contend that the patent term filing date of the ‘799 application is later than that of the instant application; thus, if the provisional NSDP is the only rejection remaining in the subject application, the examiner should withdraw the provisional NSDP rejection under MPEP 804(I)(B)(1)(b)(i), (remarks, pg. 18, para. 4).
In response, the examiner holds that the NSDP rejections were based on the guidance of MPEP 804(II)(B), which states that a NSDP rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claims because the application claim is either anticipated by, or would have been obvious over, the reference claims. Examiner is instructed to apply the test, and in this case, the answer is yes. As the bispecific antibodies of the reference patent comprises an anti-αSyn antibody binding domain that is identical to that of (at least) instant claim 32, then the bispecific antibody of the reference patent anticipates the anti-αSyn aggregate antibody of the instant claims. Regarding applicant’s contention that the ‘483 patent is not prior art, the examiner points out that there is no provision in 804(II)(B) that the conflicting reference has to be prior art. Indeed, NSDP rejections are not prior art rejections, and are made based on the doctrine to prevent the unjustified or improper timewise extension of the right to exclude and to prevent the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention, as per MPEP 804(B). In this case, a one-way test for distinctness is applied, as per MPEP 804(B)(4), such that the bispecific antibody of patent ‘483 anticipates the instant anti-αSyn aggregate antibody by way of comprising an identical anti-αSyn aggregate binding domain.
Regarding the use of a one-way versus a two-way analysis of distinctness, MPEP 804(B)(4) teaches that even if the application under examination has the earlier patent term filing date (as is the case here), only a one-way determination of distinctness is needed to support a double patenting rejection in the absence of a finding: (A) that the PTO is solely responsible for any delays in prosecution of that application, and (B) that the applicant could not have filed the conflicting claims in a single application. The prosecution history of the instant application shows that applicants delayed responses to the USPTO’s pre-examination letters such that the application was abandoned on 8/18/2022, petitioned for revival on 12/22/2022, granted revival on 1/19/2023, the revival was vacated on 7/03/2023 for non-compliance, petitioned for revival again on 8/30/2023, and granted revival on 9/25/2023, more than one year from when it was first abandoned. Both petitions for revival state that the delay was unintentional. Thus, the delays in prosecution, of more than one year, were not solely the fault of the USPTO, and therefore the conditions requiring a two-way test for distinctness were not met; thus only a one-way test for distinctness was applied, in which the invention of the ‘483 patent anticipates that of the instant claims. Therefore the examiner asserts that the test for NSDP was applied, consistent with the guidance of MPEP 804, and the NSDP rejections over patent ‘483 are correct and maintained.
Regarding applicant’s reference to Baurin, the USPTO has requested reconsideration of the opinion, with the belief that the board errored in its consideration. Examiner points to the recent PTAB decision of Ex parte Baumeister, over application 17/409019 (attached and cited on PTO-892). While not precedential, it recently decided a similar legal issue and set forth why the examiner’s rejection was appropriate. The examiner rejected the pending claims on the ground of NSDP over 6 US Patent references, while the appellant argued that none of the reference patents qualify as an NSDP reference because each reference patent has a later patent term filing date compared to the instant application, and expires later than any patent issuing from the instant application (pg. 5, para. 2). Appellants relied on several Federal Circuit cases, including Allergan and Novartis. Appellants contend that an NSDP reference must not have a later expiration date compared to the expiration date of a target claim (pg. 6, para. 1). The PTAB stated that Allergan answered a narrow question: “can a first-filed, first-issued, later-expiring claim be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date?”, and held that it cannot. However, the PTAB said that a case with a (more) similar fact pattern to the instant case would be In re Fallaux, 564 F.3d 1313, 1316 (Fed. Cir. 2009). In Fallaux, the examiner rejected the pending claims in the Fallaux application for obviousness-type double patenting over certain claims of two reference patents, whereby the reference patents had a later filing date than the Fallaux application (pg. 7, para. 3). “The Federal Circuit upheld the Board’s decision, affirming the NSDP rejection of the pending claims over the reference patents with later patent term filing dates and later expiration dates because there is a second justification for obviousness-type double patenting- harassment by multiple assignees,” (pg. 8, para. 1). The PTAB held that “Fallaux remains good law,” and did not find the appellant’s arguments persuasive (pg. 8, para. 2). Thus, the Board’s decision supports that later-filed patent claims can be used as an ODP reference in a NSDP rejection over earlier-filed application claims. As such, the examiner maintains that the NSDP rejections over the claims of patent ‘483 are proper and justified, and the NSDP rejections over patent ‘483 are maintained.
Regarding the NSDP rejections over application 17/616,799; because the examiner maintains the NSDP rejections over patent ‘483, the provisional NSDP rejections over application ‘799 would not be the only rejections remaining; therefore the guidance of MPEP section 804 (I)(B)(1)(b)(i) does not apply. Examiner maintains the provisional NSDP rejections over application 17/616,799.
Conclusion
Claims 32-33, 35, 37, 40, 46-48, 53-66 are rejected; claims 67, 69, 71, 73, 75-76, 78, 80, 82, 84, 86, 88 and 90 are objected to because they depend from rejected claims 32, 53 or 54.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES R. MELCHIOR whose telephone number is (703)756-4761. The examiner can normally be reached M-F 8:00-5:00 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E. Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES RYLAND MELCHIOR/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644