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 .
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 1-4, 6-8, 10, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of copending Application No. US 19/662,708 in view of Fletcher (NZ 599976).
Claim 19 of the ‘708 application recites a synthetic nutritional composition in the form of an infant formula, where the formula comprises a whey protein concentrate from milk and further recites a milk fat content of the concentrate that falls within the claimed range and overlaps instant dependent claims 2-4, wherein the milk fat comprises sphingomyelin in an amount that is identical to instant claim 6 and overlaps instant dependent claims 7-8, a total phospholipid content identical to instant claim 1 and overlapping with instant dependent claim 22, a ganglioside GD3 content in an amount identical to instant claim 1 and overlapping instant dependent claim 24, and recites wherein the components of the milk fat globule membranes of the concentrate provide at least 65% of the total amount of sphingomyelin in the nutritional composition which overlaps the range of instant claim 1 of greater than 90%. Copending claim 19 does not require how much of the concentrate be provided in the nutritional composition, however, one of ordinary skill must select a value. Fletcher discloses incorporation of a lipid-depleted dairy product into an infant formula in an amount of 6-8wt% which overlaps the claimed range and is indicative of suggestive amounts known to those of ordinary skill of a lipid-depleted concentrate that has low amounts (5-11wt%) of fat to be added to an infant formula to incorporate the milk fat globules and their beneficial contents (pages 9-10 if Fletcher).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s amendments to claim 1 and accompanying arguments, filed 08/06/2026, with respect to have been fully considered and are persuasive. The 112, 102 and 103 rejections previously made of record have been withdrawn.
The amendment to the claims and filing of application 19/662708 have necessitate the nonstatutory double patenting rejection made above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. 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 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 JENNIFER C MCNEIL whose telephone number is (571)272-1540. The examiner can normally be reached M-F 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tiffany Legette-Thompson can be reached at 5712707078. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1723
/Jennifer McNeil/Primary Examiner, Art Unit 1723
