DETAILED ACTION
Notice of Pre-AIA or 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
Applicant’s response dated 25 August 2025 to the previous Office action dated 25 February 2025 is acknowledged. Claims 2, 4, 6-11, 15-18, and 20 are pending in the application.
The rejection under 35 U.S.C. 103 made in the previous Office action is maintained.
The double patenting rejections made in the previous Office action are maintained.
Election/Restrictions
Claims 4 and 6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 23 November 2022.
Applicant’s election without traverse of inhibitor of an Aβ oligomer (AβO) biological activity species memantine in the reply filed on 23 November 2022 is acknowledged.
Claims 9-11, 15-17, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 23 November 2022. It is noted that claim 20 is drawn to nonelected inhibitor of an Aβ oligomer (AβO) biological activity species nitromemantine, rather than elected species memantine.
Claims 2, 7-8, and 18 are under current consideration.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 2, 7-8, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kozachuk (US 2004/0102525 A1; published 27 May 2004; of record) in view of Laruelle (FR 2 977 159 A1; published 04 January 2013; of record; citations herein to English machine translation made 20 February 2025; of record) and Koo et al. (WO 2018/062941 A1; published 05 April 2018; of record; citations herein to English language version EP 3 520 792 A1 published 07 August 2019; of record).
Kozachuk discloses a pharmaceutical composition comprising a pharmaceutically effective amount of a compound such as memantine (claim 1) and a method of treatment or prophylaxis (i.e., prevention) of a neurological disease comprising administering to a patient a pharmaceutically effective amount of a compound such as memantine (claim 2) wherein the neurological disease may be familial Alzheimer’s disease (FAD) (claim 3) wherein memantine will have efficacy in FAD patients at risk (increased ApoE4) for developing dementia but clinically normal (paragraph [0040]).
However, Kozachuk does not explicitly disclose any working examples of prophylaxis (i.e., prevention) of Alzheimer’s disease by administering to a patient a pharmaceutically effective amount of memantine wherein the memantine is in a composition.
Laruelle discloses a memantine as an active ingredient for preventing Alzheimer’s disease (title) wherein memantine is disclosed as being prescribed for the prevention of Alzheimer’s disease (page 2 at paragraph 2).
Koo et al. discloses a pharmaceutical composition for preventing dementia comprising memantine (title) wherein memantine is known as a useful drug for the prevention of Alzheimer’s disease (paragraph [0050]).
Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Kozachuk as discussed above and to administer to a patient/subject a pharmaceutically effective amount of memantine in a pharmaceutical composition for prophylaxis (i.e., prevention) of familial Alzheimer’s disease (i.e., inhibiting development of all symptoms associated with Alzheimer’s disease, the subject is pre-symptomatic for Alzheimer’s disease), with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so because not only does Kozachuk suggest doing so but also both Laruelle and Koo et al. provide further motivation to use and a reasonable expectation of success in using memantine as a prophylactic for Alzheimer’s disease because they disclose that memantine is prescribed for the prevention of Alzheimer’s disease and memantine is known as a useful drug for the prevention of Alzheimer’s disease.
Additionally regarding claim 18, it also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Kozachuk as discussed above and to additionally perform such method as discussed above wherein the patient/subject is a FAD patient with increased ApoE4 (i.e., APOE4-positive) and therefore at risk for developing dementia but clinically normal, with a reasonable expectation of success.
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 § 2146 et seq. 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 2 and 7-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 17/436,882 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add the memantine of the ‘882 claims to the composition of the ‘882 claims for the convenience and ease of administering a single composition rather than two compositions, with a reasonable expectation of success, and a subject at risk for developing disease as in the ‘882 claims is necessarily pre-symptomatic.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 7-8, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 17/436,882 in view of Kozachuk and Laruelle and Koo et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add the memantine of the ‘882 claims to the composition of the ‘882 claims for the convenience and ease of administering a single composition rather than two compositions, with a reasonable expectation of success, and a subject at risk for developing disease as in the ‘882 claims is necessarily pre-symptomatic.
Moreover, although the ‘882 claims do not disclose that the patient/subject is APOE4-positive as in claim 18, Kozachuk discloses a pharmaceutical composition comprising a pharmaceutically effective amount of a compound such as memantine (claim 1) and a method of treatment or prophylaxis (i.e., prevention) of a neurological disease comprising administering to a patient a pharmaceutically effective amount of a compound such as memantine (claim 2) wherein the neurological disease may be familial Alzheimer’s disease (FAD) (claim 3) wherein memantine has efficacy in FAD patients at risk (increased ApoE4) for developing dementia but clinically normal (paragraph [0040]).
Moreover, Laruelle discloses a memantine as an active ingredient for preventing Alzheimer’s disease (title) wherein memantine is disclosed as being prescribed for the prevention of Alzheimer’s disease (page 2 at paragraph 2).
And Koo et al. discloses a pharmaceutical composition for preventing dementia comprising memantine (title) wherein memantine is known as a useful drug for the prevention of Alzheimer’s disease (paragraph [0050]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the ‘882 claims and Kozachuk by using a patient/subject having increased ApoE4 (i.e., APOE4-positive) and therefore at risk for developing dementia but clinically normal as suggested by Kozachuk as the patient/subject in the method of the ‘882 claims, with a reasonable expectation of success, given that the ‘882 claims suggest inhibiting disease in a subject at risk for developing the disease, and Kozachuk identifies subjects having increased ApoE4 (i.e., APOE4-positive) as such subjects that are at risk for developing dementia from Alzheimer’s disease, and given that both Laruelle and Koo et al. provide further motivation to use and a reasonable expectation of success in using memantine as a prophylactic for Alzheimer’s disease because they disclose that memantine is prescribed for the prevention of Alzheimer’s disease and memantine is known as a useful drug for the prevention of Alzheimer’s disease.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 25 August 2025 have been fully considered but they are not persuasive.
Applicant argues that the obviousness rejection lacks articulated reasoning and a reasonable expectation of success (remarks pages 4-8). In response, Kozachuk specifically teaches a method of treatment or prophylaxis (i.e., prevention) of a neurological disease comprising administering to a patient a pharmaceutically effective amount of a compound such as memantine (claim 2) wherein the neurological disease may be familial Alzheimer’s disease (FAD) (claim 3) wherein memantine will have efficacy in FAD patients at risk (increased ApoE4) for developing dementia but clinically normal (paragraph [0040]). Laruelle and Koo et al. both teach use of memantine for prevention of Alzheimer’s disease. Thus, following such teachings of Kozachuk would have been obvious given that two other references also teach the use of memantine for prevention of Alzheimer’s disease, and such teachings in the references provide a reasonable expectation of success.
Applicant argues that the cited references lack experimental evidence (remarks pages 5-6). In response, it is not necessary that references provide experimental evidence in order for such references to be used in an obviousness rejection. See, e.g., MPEP 2121(III)(“Efficacy Is Not A Requirement For Prior Art Enablement”).
Applicant argues that Kozachuk teaches away from sporadic, pre-mild, moderate, or severe Alzheimer’s disease (remarks pages 5-8). Kozachuk clearly discloses a method of treatment or prophylaxis (i.e., prevention) of a neurological disease comprising administering to a patient a pharmaceutically effective amount of a compound such as memantine (claim 2) wherein the neurological disease may be familial Alzheimer’s disease (FAD) (claim 3) wherein memantine will have efficacy in FAD patients at risk (increased ApoE4) for developing dementia but clinically normal (paragraph [0040]), which is encompassed by the current claims.
Applicant requests that the double patenting rejections be held in abeyance until allowance (remarks page 9). In response, double patenting rejections cannot be held in abeyance, as “[O]nly compliance with objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated” per MPEP 804(I)(B)(1).
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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, Sue Liu can be reached on (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617