DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/23/26 has been entered.
3. Claims 1 and 5-27 are pending upon entry of amendment filed on 1/23/26.
Claims 1 and 5-27 are under consideration in the instant application.
4. Applicant’s IDS filed on 1/23/26 has been acknowledged.
5. The oath filed on 12/22/25 has been entered.
6. IN light of Applicant’s amendment and response filed on 1/23/26, the rejections of record have been withdrawn.
7. The following new ground of rejections are set forth.
8. 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.
9. 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.
10. Claims 1 and 5-27 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO2017/009312 (IDS reference, of record) in view of WO2018/178950 (of record) and Zhang et al (BMC Medicine, vol. 20:446, p. 1-9. 2022, newly cited).
The ‘312 publication teaches methods of treating synucleinopathy 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]). Given that the ‘312 publication teaches the antibody that binds to the same epitope as evidenced by the prior art SEQ ID NO:9 that is identical to the claimed SEQ ID NO:9, the claimed and prior antibody is deemed identical and readable upon Amlenetug of claim 8 of the instant application.
Products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01.
Where the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may be an inherent characteristic of the prior art, it has the authority to require the applicant to prove that the subject matter shown in the prior art does not possess the characteristics relied on. In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997). The claiming of a new use, new function of unknown property which is inherently present in the prior art does not necessarily make the claims patentable. See In re Best, 194 USPQ 430, 433 (CCPA) and In re Crish 73 USPQ2d 1364, 1368 (Fed. Cir 2004). Also see MPEP 2112. Claims 8 and 13 are included in this rejection.
The ‘312 publication further teaches that the KD is near 0.5-10nM and the enhancement is expected to be about 65fold 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 claims 11-12 and use of UMSARS score of below 40 for initiation of treatment as in claim 1 of the instant application, respectively.
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.
Further, Zhang et al teach uses UMSARS as diagnosis of early stage of MSA and follow up for 2 years and uses UMSARS total score of 28 (Table 1, p. 4) and assess progression of disease. The sensitivity to change progression raises the score to 48 over two-year period.
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 at 28 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.
11. 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.
12. Claims 1 and 5-27 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, newly cited).
.
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.
Further, Zhang et al teach uses UMSARS as diagnosis of early stage of MSA and follow up for 2 years and uses UMSARS total score of 28 (Table 1, p. 4) and assess progression of disease. The sensitivity to change progression raises the score to 48 over two-year period.
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 at 28 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.
13. Claims 1 and 5-27 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, newly cited).
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.
Further, Zhang et al teach uses UMSARS as diagnosis of early stage of MSA and follow up for 2 years and uses UMSARS total score of 28 (Table 1, p. 4) and assess progression of disease. The sensitivity to change progression raises the score to 48 over two-year period.
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 at 28 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.
14. Claims 1 and 5-27 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, newly cited).
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.
Further, Zhang et al teach uses UMSARS as diagnosis of early stage of MSA and follow up for 2 years and uses UMSARS total score of 28 (Table 1, p. 4) and assess progression of disease. The sensitivity to change progression raises the score to 48 over two-year period.
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 at 28 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.
15. Claims 1 and 5-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Pat. 12,077,578 in view of WO2018/178950 and Zhang et al (BMC Medicine, vol. 20:446, p. 1-9. 2022, newly cited).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘578 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 ‘578 patent differ from the claimed invention in that they do not recite dose between 1000-4500mg of antibody and UMSARS score below 40.
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.
Further, Zhang et al teach uses UMSARS as diagnosis of early stage of MSA and follow up for 2 years and uses UMSARS total score of 28 (Table 1, p. 4) and assess progression of disease. The sensitivity to change progression raises the score to 48 over two-year period.
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 at 28 into the synucleinopathy treatment method taught by the ‘578 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.
16. Claims 1 and 5-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US 18/774,608 (allowed) in view of WO2018/178950 and Zhang et al (BMC Medicine, vol. 20:446, p. 1-9. 2022, newly cited).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘608 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 ‘608 application differ from the claimed invention in that they do not recite dose between 1000-4500mg of antibody and UMSARS score below 40.
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.
Further, Zhang et al teach uses UMSARS as diagnosis of early stage of MSA and follow up for 2 years and uses UMSARS total score of 28 (Table 1, p. 4) and assess progression of disease. The sensitivity to change progression raises the score to 48 over two-year period.
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 at 28 into the synucleinopathy treatment method taught by the ‘608 application.
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.
17. Claims 1 and 5-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US 18/774,629 (allowed) in view of WO2018/178950 and Zhang et al (BMC Medicine, vol. 20:446, p. 1-9. 2022, newly cited).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘629 application recites a method of treating Parkinson’s Disease comprising administering synuclein antibody set forth in SEQ ID NO:1, 3-6, 34.
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.
Further, Zhang et al teach uses UMSARS as diagnosis of early stage of MSA and follow up for 2 years and uses UMSARS total score of 28 (Table 1, p. 4) and assess progression of disease. The sensitivity to change progression raises the score to 48 over two-year period.
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 at 28 into the synucleinopathy treatment method taught by the ‘629 application.
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.
18. Claims 1 and 5-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US 18/774,646 (allowed) in view of WO2018/178950 and Zhang et al (BMC Medicine, vol. 20:446, p. 1-9. 2022, newly cited).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘646 application recites a method of treating Parkinson’s Disease comprising administering synuclein antibody set forth in SEQ ID NO:1, 3-6, 34.
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.
Further, Zhang et al teach uses UMSARS as diagnosis of early stage of MSA and follow up for 2 years and uses UMSARS total score of 28 (Table 1, p. 4) and assess progression of disease. The sensitivity to change progression raises the score to 48 over two-year period.
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 at 28 into the synucleinopathy treatment method taught by the ‘646 application.
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.
19. No claims are allowable.
20. 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
February 4, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641