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. Applicant's preliminary amendment filed on 04/27/2026 is acknowledged.
Claims 1-24 are pending.
3. 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.
4. Claim 22 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 22 is indefinite, because the recitation of “the immune cells” lacks proper antecedent basis in claim 1 on which claim 22 depends. It appears that claim 22 was intended to depend on claim 24, which dependence is provisionally assumed for examination purposes.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
5. 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.
6. Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patents listed below.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by or obvious over the claims of each of the patents listed below, which are directed to therapeutic methods comprising administration of antibodies according to the same dosage regime as recited in instant claims, and further recite the following limitations:
Patent No.
Condition
Antibody specificity
9,394,365*
Alzheimer's
PD-1
9,512,225*
Alzheimer's
TIM-3
9,512,227*
Alzheimer's
PD-L1
9,534,052*
Alzheimer's
PD-1
9,856,318*
Alzheimer's
ICOS
9,982,047*
Alzheimer's
PD-L1
9,982,048*
Alzheimer's
PD-L1
9,982,049*
Alzheimer's
PD-L1
9,982,050*
Alzheimer's
PD-L1
9,982,051*
Alzheimer's
PD-L1
10,144,778*
Alzheimer's
Immune checkpoint
10,214,585*
Alzheimer's
PD-L1
10,519,237*
Tauopathy
PD-1, PD-L1, TIM-3
10,618,963*
Tauopathy
PD-1, PD-L1, TIM-3
10,961,309
Alzheimer's
Immune checkpoint
10,981,989
Alzheimer's
PD-L1
11,492,405*
Tauopathy
PD-1, PD-L1, TIM-3
11,643,464*
RD**
PD-1, PD-L1, TIM-3
11,884,727
ALS**
OX-40
11,884,728
ALS**
PD-L1
* Cited on IDS
** RD – Retinal Degeneration, ALS – Amyotrophic Lateral Sclerosis
Instantly recited frontotemporal dementia, a progressive supranuclear palsy, and corticobasal degeneration, as well as Alzheimer's disease and other forms of tauopathy, Retinal Degeneration, and Amyotrophic Lateral Sclerosis are neurodegenerative diseases which share many aspects of pathogenesis and molecular mechanisms, therefore, a person of skill in the art would at once envisage treatment of instantly recited conditions in view of the diseases recited in the claims of the above-listed patents.
7. Claims 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 19/668,246.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by or obvious over the claims of USSN ‘246, which are directed to methods of treating Alzheimer's disease comprising administering an anti-PD-1, anti-PD-L1, and/or anti-TIM-3 antibody according to the same dosage regime as recited in instant claims, for the same reasons as articulated in section 6 above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
8. The following copending US application shares a coinventor and/or an assignee with the present application, and claims subject matter similar to that of the present claims, but does not contain currently pending claims which would anticipate or make obvious the presently claimed invention, for the following reasons:
The claims of USSN 18/557,941 (published as US 20250208135) recite a method for treating Alzheimer's Disease comprising administering to the subject an immune checkpoint modulator (claim 1), but do not recite a specific administration regime or specify the nature of immune checkpoint modulator. This generic recitation neither anticipates not makes obvious the specific dosage regime of the presently claimed invention.
9. Conclusion: no claim is allowed.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
