DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to filed provisions of the AIA .
2. Claims 16-18, 20-28, 30-37, 39-42, 44 and 45 are pending upon entry of amendment filed on 7/15/26.
Claims 16-18, 20-28, 30-37, 39-42, 44 and 45 are under consideration in the instant application.
3. IN light of Applicant’s amendment to the claims and response filed on 7/15/26 and the terminal disclaimer filed on 7/15/26, the double patenting rejections in part have been withdrawn (see sections 10, 12 and 15-18 of the office action mailed on 5/12/26).
4. The following rejections remain.
5. 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 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.
6. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
7. Claims 16-18, 20-24, 26-28, 30-34, 36, 37, 39-42, 44 and 45 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO2017/009312 (IDS reference, of record) in view of WO2018/178950 (IDS reference, of record) for the reasons set forth in the office action mailed on 5/12/26.
The ‘312 publication teaches methods of treating synucleinopathy defined as multiple system atrophy in p.1 of the instant application in a human patient comprising intravenous administration of alpha synuclein antibody set forth in the SEQ ID NO:17-18 including the CDR set forth in SEQ ID NO:1, 34, 3-6 ([143-146, claims 34-37, 46-49). The synucleionopathy includes Parkinson’s disease, Dementia with Lewy Bodies or Multiple System Atrophy (MSA) (claims, [0102]).
The ‘312 publication further teaches that the KD is near 0.5-10nM and the enhancement is expected to be about 65 fold and the chronic treatment of at least 2 weeks, 1 month, 6 months or year is included ([0167]).
The disclosure of the ‘312 publication differs from the instant claimed invention in that it does not teach the use of a dose between 1000-4500mg as in claim 16, 19-20 of the instant application.
The ‘950 publication teaches treatment of synucleinopathy comprising administration of alpha synuclein antibody at dose including 1050mg, 1125mg, 1250mg, 3150mg, 3375 mg or 3500mg (p. 26) especially in treatment of Parkinsons’ Disease at extended doses of at least 2 doses.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize known regimen taught by the ‘950 publication into the synucleinopathy treatment method taught by the ‘312 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of known dosage of the similar antibody for the same treatment may facilitate the therapeutic efficacy.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Applicant’s response filed on 7/15/26 has been fully considered but they were not persuasive.
Applicant has asserted that the combination of the references is not obvious and there is no reasonable expectation of success. Applicant has asserted that the reliance on BIIB054 as similar antibody to the claimed alpha synuclein antibody is erred and the dosage that is relevant to BIIB054 cannot be applicable to the claimed antibody. The PD/PK data do not contribute to the claimed antibody.
Unlike Applicant’s assertion, the dose applicable to BIIB054 is deemed also applicable to the claimed antibody. As seen in the Fig 5 of the ‘950 publication, the dose response between EC50 low-mid-high dose rang is 0.25nM to 2.1nM and plateau and the dose is linear in Cmx and mean dose (Fig 4). Regardless, the ‘950 publication includes at least 70% structurally similar antibody to the BII054 (p.27). Note the conditions and pathologies of anti-synuclein antibodies in treatment of MSA overlaps with the antibody of the ‘312 and the ‘950 publications. As such, there seems reasonable expectation of success in applying the dose of the ‘950 publication to the claimed antibody. See MPEP 2143.01.
8. Claim(s) 25 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2017/009312 (IDS reference, of record) and WO2018/178950 (IDS reference, of record) as applied to claims 16 or 24 above, and further in view of Zhang et al (BMC Medicine, vol. 20:446, p. 1-9, 2022, of record) for the reasons set forth in the office action mailed on 5/12/26.
The teachings of the ‘312 and ‘950 publications have been discussed, supra.
The disclosure of the ‘312 and ‘950 publications differ from the claimed invention in that it does not teach monitoring UMSARS as in claims 16 or 24 of the instant application.
Zhang et al teach the use of UMSARS as diagnosis of early stage MSA and following up for 2 years and uses total UMSARS and assess progression of disease.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize known regimen taught by the ‘950 publication and diagnosis of early stage of MSA with UMSARS score into the synucleinopathy treatment method taught by the ‘312 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of known dosage of the similar antibody for the same treatment may facilitate the therapeutic efficacy.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Applicant’s response filed on 7/15/26 has been fully considered but they were not persuasive.
Applicant has asserted that the combination of the references is not obvious and there is no reasonable expectation of success. Applicant has asserted that the reliance on BIIB054 as similar antibody to the claimed alpha synuclein antibody is erred and the dosage that is relevant to BIIB054 cannot be applicable to the claimed antibody. The PD/PK data do not contribute to the claimed antibody. Merely, Zhang et al discusses UMSARS as tool to follow progression.
Unlike Applicant’s assertion, Table 1 of Zhang reference uses UMSARS score of 28 as baseline and the score is increased to 48 over time. Given that the method taught by the combination of the references teach treatment of MSA comprising administering synuclein antibody set forth in SEQ ID NO:31 and 8 at dose of 1050mg, 1125mg, 1250mg, 3150mg, 3375 mg or 3500mg monthly, the population group is identical in prior art and the claimed invention, the patient group is expected to be quantified by the UMSARS score. Further, in light of discussion above in section 7, the rejection is maintained.
9. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
10. Claims 16-18, 20-28, 30-37, 39-42, 44 and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Pat. 10,647,764 in view of WO2018/178950 and Zhang et al (BMC Medicine, vol. 20:446, p. 1-9, 2022).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘764 patent recites a method of treating Parkinson’s Disease comprising administering synuclein antibody set forth in SEQ ID NO:1, 3-6, 34.
The claims of the ‘764 patent differ from the claimed invention in that they do not recite dose between 1000-4500mg of antibody.
The ‘950 publication teaches treatment of synucleinopathy comprising administration of alpha synuclein antibody at dose including 1050mg, 1125mg, 1250mg, 3150mg, 3375 mg or 3500mg (p. 26) especially in treatment of Parkinsons’ Disease at extended doses of at least 2 doses.
Zhang et al teach the use of UMSARS as diagnosis of early stage MSA and following up for 2 years and uses total UMSARS and assess progression of disease.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize known regimen taught by the ‘950 publication and diagnosis of early stage of MSA with UMSARS score into into the synucleinopathy treatment method taught by the ‘764 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of known dosage of the similar antibody for the same treatment may facilitate the therapeutic efficacy.
In light of discussion above in sections 7-8 of the office action, the rejection is maintained.
11. Claims 16-18, 20-28, 30-37, 39-42, 44 and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Pat. 11,542,323 in view of WO2018/178950 and Zhang et al (BMC Medicine, vol. 20:446, p. 1-9, 2022).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘323 patent recites a method of treating Parkinson’s Disease comprising administering synuclein antibody set forth in SEQ ID NO:1, 3-6, 34.
The claims of the ‘323 patent differ from the claimed invention in that they do not recite dose between 1000-4500mg of antibody.
The ‘950 publication teaches treatment of synucleinopathy comprising administration of alpha synuclein antibody at dose including 1050mg, 1125mg, 1250mg, 3150mg, 3375 mg or 3500mg (p. 26) especially in treatment of Parkinsons’ Disease at extended doses of at least 2 doses.
Zhang et al teach the use of UMSARS as diagnosis of early stage MSA and following up for 2 years and uses total UMSARS and assess progression of disease.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize known regimen taught by the ‘950 publication into the synucleinopathy treatment method taught by the ‘323 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of known dosage of the similar antibody for the same treatment may facilitate the therapeutic efficacy.
In light of discussion above in sections 7-8 of the office action, the rejection is maintained.
12. Claims 16-18, 20-28, 30-37, 39-42, 44 and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 68-72 of U.S. Application 17/992,403 in view of WO2018/178950 Zhang et al (BMC Medicine, vol. 20:446, p. 1-9, 2022).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘403 application recites a method of treating Parkinson’s Disease comprising administering synuclein antibody set forth in SEQ ID NO:1, 3-6, 34.
The claims of the ‘403 publication differ from the claimed invention in that they do not recite dose between 1000-4500mg of antibody.
The ‘950 publication teaches treatment of synucleinopathy comprising administration of alpha synuclein antibody at dose including 1050mg, 1125mg, 1250mg, 3150mg, 3375 mg or 3500mg (p. 26) especially in treatment of Parkinsons’ Disease at extended doses of at least 2 doses.
Zhang et al teach the use of UMSARS as diagnosis of early stage MSA and following up for 2 years and uses total UMSARS and assess progression of disease.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize known regimen taught by the ‘950 publication into the synucleinopathy treatment method taught by the ‘403 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of known dosage of the similar antibody for the same treatment may facilitate the therapeutic efficacy.
In light of discussion above in sections 7-8 of the office action, the rejection is maintained.
13. No claims are allowable.
14. 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.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5. 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 on 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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Yunsoo Kim
Primary Examiner
Technology Center 1600
August 4, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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