DETAILED ACTION
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/21/2026 has been entered.
AIA Status of the Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, filed 1/21/2026, have been fully considered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Specifically, the rejection of claims under 35 U.S.C. 103(a) as being unpatentable based primarily on Currais et al (WO 2017/015660; of record) has been WITHDRAWN in view of Applicant’s amendments to the claims, rendering Applicant’s arguments moot.
The claims are NEWLY rejected under 35 U.S.C. 112(b) and 35 U.S.C. 103(a) as being unpatentable based primarily on Maze et al (US 2016/0333088).
The rejection of claims on the grounds of nonstatutory double patenting over copending Application No. 17/435,683 has been modified based on Applicant’s amendments to the claims.
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.
Claim 70 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 70 is drawn to the method of claim 60, wherein the subject, or subject at risk, is at least 60 years of age”.
Claim 60 does not provide antecedent basis for the limitation in claim 70 of a “subject at risk”.
As such, claim 70 is rejected as indefinite.
Claim Rejections - 35 USC § 103
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, 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.
Claims 60 and 69-70 are rejected under 35 U.S.C. 103(a) as being unpatentable over Maze et al (US 2016/0333088) in view of Chen et al (Critical Care 19:159, 12 pages, 2015), Daugherty et al (Neuropharmacology 129:26-35, 2018), and Currais et al (WO 2017/015660; of record).
As amended, claim 60 is drawn to a method of preventing, reducing the severity of, delaying the onset of, or treating Post-Intensive Care Cognitive Dysfunction (PICCD) in a subject (more specifically, wherein the PICCD comprises a presentation of, or worsening of memory loss, etc. (claim 69)), comprising administering to the subject a therapeutically effective amount of a compound of Formula IV:
PNG
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(aka J147),
wherein the subject is and has been operably connected to a ventilator for at least one day.
Maze et al teach a “method... for preventing or reducing cognitive decline in a patient following a planned inflammatory trigger” such as “a surgical procedure” (Abstract) and, more specifically, “for preventing post-operative cognitive dysfunction (POCD) in said patient” (Paragraph 0012) – wherein, “[b]y ‘post operative cognitive dysfunction’, we include deterioration of intellectual function reflected as memory and concentration impairment presenting in that patient after that patient has undergone a surgical procedure” (Paragraph 0015) – “the method comprising administering a therapeutically effective amount of a Tumor Necrosis Factor alpha (TNF-α) antagonist to said patient” (Paragraph 0008) wherein, as further demonstrated by Maze et al, “anti-TNFα reduced the amount of systemic IL-1β” and “also reduced the systemic levels of IL-6” (Paragraph 0102; see also Figure 14).
As such, the method of Maze et al differs from the instantly claimed method in the following ways:
(a) Maze et al does not teach treating PICCD in a subject that is and has been operably connected to a ventilator for at least one day; and
(b) Maze et al teaches the administration of a Tumor Necrosis Factor alpha (TNF-α) antagonist but does specify administration of J147.
Yet, as to (a): as taught by Chen et al, “[p]atients undergoing surgery frequently develop neuropsychological disturbances, including cognitive decline or memory impairment, and routine clinical procedures such as mechanical ventilation (MV) may affect acute-phase brain outcome” (Abstract; see also Page 1, Column 1: critical care patients who undergo long-term MV show distinctive neurological impairment, including memory and cognitive decline”). Significantly, as further taught by Chen et al, “[o]ur data suggest that prolonged MV further aggravates cognitive decline after surgery that may stem from upregulation of hippocampal IL-1β, IL-6 and TNFα” (Page 11, Column 1).
Accordingly, in further view of Chen et al, it would have been prima facie obvious to apply the method of Maze et al to the treatment of PICCD in a subject that is and has been operably connected to a ventilator for at least one day. It would have been obvious to do so considering that Chen et al teach that “prolonged MV further aggravates cognitive decline after surgery... from upregulation of hippocampal IL-1β, IL-6 and TNFα” and Maze et al teach administration of TNF-α to reduce the amounts of TNF-α, IL-1β and IL-6.
And, as to (b): as further taught by Maze et al, “[b]y ‘TNFα antagonist’ we include the meaning that the antagonist is any compound that antagonizes, thus decreases or ablates, the effects of TNFα. Thus the antagonist may be a compound that targets TNFα itself” wherein “[b]y ‘targeting TNFα itself’ we mean blocking or reducing the transcription, translation, post-translational modification of precursors, or release of TNFα from cells where it is synthesized” (Paragraph 0055).
And, as taught by Daugherty et al, “J147 reverses cognitive impairment in a mouse model of Alzheimer’s disease, and enhances memory in both transgenic AD mice, and aged wild type mice” (Page 2) and, “in the streptozotocin-induced mouse model of type I diabetes... systemic J147 treatment was confirmed to decrease TNFα pathway activation and several other markers of neuroinflammation in the CNS” (Abstract).
Similarly, as taught by, Currais et al – disclosing “agents to treat or prevent neurodegenerative disease” (Abstract) wherein “[e]xamples of such diseases include… Alzheimer’s disease… mild cognitive impairment, dementia (including, for example, frontotemporal dementia, AIDS dementia, and the like)” and so on (Page 15, Lines 28-33; see also Page 45, Lines 14-20) – “J147 improves locomotor and cognitive function in old SAMP8 mice” (Page 6, Lines 18-25 and Figures 2A-2G) which function as “a model for sporadic AD and dementia” (Page 3, Lines 1-2), results in “an overall decrease in the expression of inflammatory markers in old mice, indicative of a reduction in stress-associated inflammation” (Page 60, Lines 4-5), “restored… inflammation to those approaching the young phenotype” (Page 4, Lines 4-6; see also Figures 5A-5G) and, significantly, reduces TNFα expression in aging mice with (Figures 22B).
Accordingly, in further view of Daugherty et al and Currais et al, it would have been prima facie obvious to administer J147 as the TNFα antagonist in the method of Maze et al in view of Chen et al. The simple substitution of one known agent that targets TNFα itself (i.e., J147 as taught by Daugherty et al and Currais et al) for another known agent that targets TNFα itself (as taught by Maze et al) is prima facie obvious.
For all the foregoing reasons, claims 60 and 69 are rejected as prima facie obvious.
Claim 70 is drawn to the method of claim 60, wherein the subject is at least 60 years of age.
As taught by Maze et al, “[w]hen the patient is a human, it is envisaged that they may be often over 50 years of age” (Paragraph 0054).
As such, claim 70 is also rejected as prima facie obvious.
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 §§ 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.
Claims 60 and 69-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 17/435,683 in view of Maze et al (US 2016/0333088), Chen et al (Critical Care 19:159, 12 pages, 2015), Daugherty et al (Neuropharmacology 129:26-35, 2018), and Currais et al (WO 2017/015660; of record).
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘683 claims are similarly drawn to a method of reducing, delaying the onset of, or treating post-operative cognitive dysfunction in a subject in need thereof (over the age of 60 (claim 8)), wherein the POCD is induced by, or is a result of a surgery, comprising administering a compound of Formula I which embraces J147.
It would have been obvious to apply the ‘683 method to a subject a risk that is and has been operably connected to a ventilator for at least one day (as instantly claimed) in view of Maze et al, Chen et al, Daugherty et al, and Currais et al for the reasons discussed above. Namely, because the prior art teach that “prolonged MV further aggravates cognitive decline after surgery... from upregulation of hippocampal IL-1β, IL-6 and TNFα” and, further, that J147 reduces TNFα in the CNS.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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