DETAILED ACTION
Notice of 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 .
Status of the Claims
The amendments filed 12/02/2025 have been entered.
Response to Arguments
Applicant’s arguments, filed 12/02/2025, have been fully considered. All rejections in the previous Action mailed on 9/02/2025 have been WITHDRAWN in view of Applicant’s amendments to the claims, rendering Applicant’s arguments moot. The following rejections are newly applied and constitute the complete set presently being applied to the instant application.
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 1 and 3-7 are rejected under 35 U.S.C. 103(a) as being unpatentable over Brus et al (WO 2016/151484; of record) in view of Madari et al (Applied Animal Behavior Science 171:138-145, 2015) and Studzinski et al (Progress in Neuro-Psychopharmacology & Biological Psychiatry 29:489-498, 2005).
As amended, claims 1 and 3 (drafted independently) are drawn to a method of treating canine cognitive dysfunction in a dog in need thereof (more specifically, wherein the dog shows moderate cognitive impairment based on a canine dementia scale (CADES) score), the method comprising administering to the dog an effective amount of a compound (claim 1) or a composition comprising a compound (claim 3) of formula (I):
PNG
media_image1.png
262
428
media_image1.png
Greyscale
.
Brus et al teach “inhibitors of butyrylcholinesterase… for the treatment of Alzheimer’s disease and other forms of dementia” (Abstract) with symptoms including “bad judgment, confusion, behavioral changes” and so on (Paragraph 0002), “for human or mammal therapy” (Page 56, claim 8) wherein the inhibitor is instantly claimed formula (I) (Page 13, final compound; see also Paragraph 0235, Example 2).
As such, the method of Brus et al differs from the instantly claimed method in that Brus et al teach treating cognitive dysfunction in a human or mammal generically, but do not teach treating cognitive dysfunction in a dog specifically, and, in particular, a dog showing moderate cognitive impairment based on a canine dementia scale (CADES) score as claimed.
Yet, as taught by Madari et al, “[c]ognitive dysfunction (CDS) represents a serious health problem for aged dogs” wherein “[t]he prevalence of CDS is extremely high, ranging from 28% in 11-12 years old dogs to 68% in 15-16 years old dogs” (Page 138, Column 2). As further taught by Madari et al, “[w]e have assessed the psychometric properties of the CADES scale, and validated it as a screening tool for CDS that is also suitable for long-term assessment of the progression of cognitive-impairment in canines” (Page 144, Column 2).
And, as taught by Studzinski et al, “dogs develop cognitive deficits and neuropathology seen in human aging and dementia” and “research indicates that dogs… accurately predict the efficacy of known AD treatments and the absence or limited efficacy of treatments that failed clinical trials” (Abstract).
Accordingly, in further view of Madari et al and Studzinski et al, it would have been prima facie obvious to extend the method of Brus et al of treating cognitive dysfunction in a human or mammal generically, specifically to a dog and, in particular, a dog showing moderate cognitive impairment based on a canine dementia scale (CADES) score as claimed. It would have been obvious to do so considering that dogs are known to suffer from CDS, which can be validated and assessed via the CADES scale (as taught by Madori et al) and with a reasonable expectation of success since “research indicates that dogs… accurately predict the efficacy of known AD treatments and the absence or limited efficacy of treatments that failed clinical trials” (as taught by Studzinski et al).
As such, claims 1 and 3 are rejected as prima facie obvious.
Claims 4-7 are drawn to the methods of claims 1 or 3, wherein the method comprises administering the compound of formula (I) in the form of an enantiomer (claims 1 and 6) or a mixture of at least two enantiomers (claims 5 and 7).
As taught by Brus et al, “[t]he compounds can be in the form of a mixture of enantiomers or in the form of pure enantiomers” (Paragraph 0001).
As such, claims 4-7 are 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 1 and 3-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19 of U.S. Patent No. 10,071,964 in view of Madari et al (Applied Animal Behavior Science 171:138-145, 2015) and Studzinski et al (Progress in Neuro-Psychopharmacology & Biological Psychiatry 29:489-498, 2005).
Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are drawn to a compound of formula (I):
PNG
media_image1.png
262
428
media_image1.png
Greyscale
and compositions thereof, as well as the use of said compound.
The ‘964 claims recite the instantly claimed compound (claim 3) and a composition thereof (claim 7), as well as methods comprising administering the compound to a human or mammal (claim 10) having Alzheimer’s disease or dementia (claims 18-19).
For the same reasons as discussed above, it would have been prima facie obvious to extend the method of Brus et al of treating cognitive dysfunction in a human or mammal generically, specifically to a dog and, in particular, a dog showing moderate cognitive impairment based on a canine dementia scale (CADES) score as claimed, in further view of Madari et al and Studzinski et al.
Conclusion
The new ground(s) of rejection presented in this Office action are necessitated by Applicant’s amendments to the claims. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
Prosecution Insights