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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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 20, 25, 26, 27, and 26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claims recite the broad recitations, such as “>=60 µg lutein per 100 g of composition”, and the claims also recites “preferably 60-430 µg per 100g of composition” which is the narrower statement of the range/limitation. Any time a narrower group is claimed by the modifier “preferably”, it is a narrower group. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
With regards to claim 25, the claim includes a range, but not the component that the range modifies.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 19-36 are rejected under 35 U.S.C. 103 as being unpatentable over CN102422900A (CN ‘900) in view of Reynolds (US 6,780,844) and Newburg (US 20120294840).
CN ‘900 teaches OPO (1,3-dioleoyl-2-palmitoylglycerol) added to infant milk powder for simulating breast milk to improve fat and minerals absorption (description and ¶ 6). Each 100g of the formula comprises protein: 8.7-15.9g, OPO: 3.2-9.6g, calcium: 252-734mg, CPP (casein phosphopeptide)L 10-300 mg, zinc: 2.1-7.55mg, magnesium: 25.2-75.5mg, iron: 2.10-7.55mg, lutein: 22/2-148g. polysaccharides 0.2-6.45g, DHA 10-139mg, ARA: 20-278mg, walnut oil: 0.2-6g, etc (¶¶ 13, 18-51, and 57). The oligosaccharides include fructo-oligosaccharides, galacto-oligosaccharides, and the like. The carbohydrates are derived from lactose and oligosaccharides.
CN ‘900 does not teach the addition of calcium phosphopeptide of the addition of 2’-FL.
Reynolds teaches calcium phosphopepide complexes were known in the art and useful for treating calcium deficiencies (claims 5, 11, 12, and 26).
Newburg teaches it was well known to add purified 2’-FL, a human milk oligosaccharide, to infant milks or foods for children and adults (¶ 12) to stimulate commensal or symbiotic microbes (¶ 13).
It would have been obvious to one of ordinary skill in the art to add the calcium phosphopeptides of Reynolds to the composition of CN ‘900, thereby aiding the improvement of the mineral absorption, given the desired to add calcium and the suitability of phosphopeptide actives. See MPEP 2144.06.
Additionally, it would have been obvious to add known human milk oligosaccharides to supplement the infant milk and to administer the compositions to infants and adults, as taught by Newburg.
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 19-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/969,363 (reference application) in view of Reynolds (US 6,780,844) and Newburg (US 20120294840). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘363 appears to claim the same composition instantly claimed, with the lack of calcium phosphopeptides. As discussed above, Reynolds (US 6,780,844) and Newburg (US 20120294840) make obvious the addition of calcium phosphopeptides and 2’-FL to the composition. Further, where the prior art simply includes the administration of the active, it would inherently also treat mineral deficiency as a symptom or cause of the condition to be treating in ‘363.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 19-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/207,464 (reference application) in view of Reynolds (US 6,780,844) and Newburg (US 20120294840). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘464 appears to claim the same composition instantly claimed, with the lack of calcium phosphopeptides. As discussed above, Reynolds (US 6,780,844) and Newburg (US 20120294840) make obvious the addition of calcium phosphopeptides and 2’-FL to the composition. Further, where the prior art simply includes the administration of the active, it would inherently also treat mineral deficiency as a symptom or cause of the condition to be treating in ‘363.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri 9:30am-6:30pm + mid-day flex.
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, Sahana S. Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
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