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 of the Application
Claims 1-13 are pending and are examined herein.
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112(b):
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 6, 8 are rejected under 35 U.S.C. 112(b) or 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Specifically, claims 4, 6, 8 recite the limitations "deuterated arachidonic acid" and “deuterated linoleic acid” while depending from independent claim 3. There is insufficient antecedent basis for these limitations in the claims. If Applicants are referring to terms recited in claim 3, Examiner suggest that the same nomenclature be used in claim 3 and the claims depending therefrom.
Claim 8 is rejected under 35 U.S.C. 112(b) or 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Regarding claim 8, the phrase “including, renders the claim indefinite because it is unclear whether the limitations following the phrases are part of the claimed subject matter. See MPEP § 2173.05(d).
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.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 17/831,358.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of treating ALS by administering 11,11-D2-linoleic acid in a primer or loading dose followed by a lower maintenance dose.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 17/949,713.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of treating ALS by administering 11,11-D2-linoleic acid in a primer or loading dose followed by a lower maintenance dose.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1-13 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-11 of copending Application No. 18/851,852.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of treating ALS by administering 11,11-D2-linoleic acid in a dose of about 5-10 grams/day.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1-13 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-7, 13, 17 of copending Application No. 18/863,394.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of treating ALS by administering 11,11-D2-linoleic acid in a dose of about 7-12 grams/day.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,351,143.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of treating ALS by administering 11,11-D2-linoleic acid in a primer or loading dose followed by a lower maintenance dose.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,491,130.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of treating ALS by administering 11,11-D2-linoleic acid in a primer or loading dose followed by a lower maintenance dose.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 9-10 of U.S. Patent No. 12,109,194.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of treating ALS by administering 11,11-D2-linoleic acid in a primer or loading dose followed by a lower maintenance dose.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623