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 .
Response to Arguments
Applicant’s arguments, see page 6, filed 29 July 2026, with respect to the 35 USC§112 rejection have been fully considered and are persuasive. The rejection of claims 28-32, 34-38, 40-44 has been withdrawn.
Applicant's arguments filed 29 July 2026 regarding the Double Patenting rejection have been fully considered but they are not persuasive.
(OLD) 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Note: Claims 24-44 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-7 of U.S. Patent No. 12,083,082. The rejection is corrected to apply to claims 24-44, not claims 22-44, because claims 1-23 are cancelled and claims 24-44 are pending.
Claims 24-44 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7 of U.S. Patent No. 12,083,082. Although the claims at issue are not identical, they are not patentably distinct from each other because although the claims are not identical, the claimed invention is not patentably distinct from the patented invention because both are directed to treating Alzheimer’s disease by administering Formula I compounds directed to the same 3-SPA-based therapeutic mechanism, and the instant claims merely recite selection of patients having low CSF 3-SPA and administration of tramiprosate/ALZ-801-type Formula I alternatives disclosed in the common specification as ways to maintain or increase 3-SPA.
Applicant argues that the pending claims are patentably distinct because claim 1 of U.S. Patent No. 12,083,082 is directed to administration of Formula I wherein R is —COOH, whereas the pending claims require R to be CH₂NH-(AA¹)q(AA²)t-H and therefore do not permit administration of the compound claimed in the ’082 patent. Applicant’s argument has been considered but is not persuasive.
The present rejection is not a statutory double patenting rejection based on identical claim scope. Rather, the rejection is a nonstatutory double patenting rejection because the pending claims are not patentably distinct from the patented claims. Under nonstatutory double patenting practice, the issue is whether the examined claims are an anticipated or obvious variant of the reference claims, not whether the claims are identical. MPEP § 804 further provides that the reference patent disclosure is not used as prior art; however, the specification may be considered to construe the scope of the reference claims and the portion of the specification supporting the claimed invention may be considered in determining whether the pending claims define an obvious variation of the claimed invention.
Claim 1 of the ’082 patent recites a method of treating a subject suffering from Alzheimer’s disease by administering an effective amount of a compound having Formula I, wherein R is —COOH. Claims 3-7 of the ’082 patent further limit the treated Alzheimer’s subject by MMSE score and ApoE4 genotype, including MMSE 16-30, MMSE 22-28, MMSE 22-26, ApoE4 heterozygous or ApoE4/4 homozygous status, and ApoE4/4 homozygous status.
Pending claim 24 is likewise directed to treating a subject suffering from Alzheimer’s disease by selecting the subject based on CSF 3-SPA concentration and administering Formula I, wherein R is CH₂NH-(AA¹)q(AA²)t-H.
Pending claims 25-27 further narrow the CSF 3-SPA selection threshold, and pending claims 28-32 add the same type of MMSE and ApoE4 patient-selection limitations recited in claims 3-7 of the ’082 patent. Pending claims 33-44 further limit the administered Formula I compound to specific 3-SPA/tramiprosate/ALZ-801-type treatment alternatives.
Applicant’s structural distinction between R=—COOH and R=CH₂NH-(AA¹)q(AA²)t-H does not establish patentable distinctness. The patented claims and the pending claims are directed to the same disease treatment method, namely treatment of Alzheimer’s disease by administration of Formula I compounds tied to the same 3-SPA-centered therapeutic approach. The dependent claims also substantially overlap in the same clinically selected Alzheimer’s patient populations, including MMSE-defined and ApoE4-defined subjects. The pending claims do not recite a new therapeutic use, a different disease, a different patient-treatment objective, or a patient population patentably distinct from those already claimed in the ’082 patent.
The difference in the administered Formula I species is an obvious variation rather than a patentable distinction. The patented claims cover direct administration of the 3-SPA compound where R is —COOH. The pending claims recite closely related Formula I alternatives that are directed to the same Alzheimer’s treatment context and same 3-SPA therapeutic rationale. The additional CSF 3-SPA selection language in claim 24 and the narrower thresholds in claims 25-27 do not render the claims patentably distinct from the patented method because they merely define which Alzheimer’s subjects receive the same type of 3-SPA-based treatment. The MMSE and ApoE4 limitations in claims 28-32 likewise do not distinguish over the ’082 patent because claims 3-7 of the ’082 patent already claim treatment of Alzheimer’s subjects selected by the same or overlapping MMSE and ApoE4 criteria.
Accordingly, claims 24-44 remain not patentably distinct from claims 1 and 3-7 of U.S. Patent No. 12,083,082. The rejection is maintained. The rejection may be overcome by filing a proper terminal disclaimer in compliance with 37 CFR 1.321, provided the requirements for such disclaimer are satisfied.
Conclusion
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 DEBORAH D CARR whose telephone number is (571)272-0637. The examiner can normally be reached Monday-Friday (10:30 am -6:30 pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at 572-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEBORAH D CARR/Primary Examiner, Art Unit 1691
