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 .
Claims 1-22 are pending in this application.
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.
Claim 11 is 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. The following reason(s) apply:
Claim 11 recites the limitation "or any combination thereof" in lines 2-3 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 7 and 11-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nolan et al., Journal of Alzheimer’s Disease. Nolan teaches the composition of the instant invention which comprises lutein, zeaxanthin, meso-zeaxanthin, Vitamin E, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), in a ratio lutein:zeaxanthin:meso-zeaxanthin (5:1:5) as set forth in Table 2.
Claim(s) 1-5, 11 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bone et al., Nutrients. Bone discloses the composition of Lumega-Z with concentrations included. Lumega-Z contains the following in addition to the 15 mg lutein, 3 mg zeaxanthin and 10 mg meso-zeaxanthin (ratio 5:1:3.3): the composition contains 500 milligrams of Vitamin C; 50 micrograms of Vitamin D3; 134 milligrams of Vitamin E; 1.5 milligrams of thiamin; 1.7 milligrams of riboflavin; 20 milligrams of niacin; 10 milligrams of Vitamin B6; 800 micrograms of folate; 1000 micrograms of Vitamin B12; 100 micrograms of biotin; 10 milligrams of panthothenic acid; 250 milligrams of calcium; 100 milligrams of magnesium; 25 milligrams of zinc; 3 milligrams of copper; 70 milligrams of selenium; and 2 milligrams of manganese.
Claim(s) 1-5, 7 and 9-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Power et al., Clinical Nutrition. Power teaches the composition of the instant invention which comprises lutein, zeaxanthin, meso-zeaxanthin, Vitamin E, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), in a ratio lutein:zeaxanthin:meso-zeaxanthin (5:1:5) 15 milligrams of Vitamin E; 430 milligrams of docosahexaenoic acid; 90 milligrams of eicosapentaenoic acid as set forth in 2.1.
Claim(s) 1, 4, 5, 7, 9, 11-15 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Firger et al., U.S. Patent Application No. 2020/0108039. Firger teaches the composition of the instant invention which comprises lutein (10 mg), zeaxanthin (2 mg), meso-zeaxanthin (2 mg), Vitamin C (500 mg), Vitamin E, niacin (20 mg) (Vitamin B3), zinc (15 mg), copper (2 mg), omega-3 (1000 mg) as set forth in paragraph [0070].
Claim(s) 1-5, 7, 9-19 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nolan et al., U.S. Patent No. 9,603,813; 9,463,167; 8,962,043; and 8,623,428. Nolan teaches the composition of the instant invention which comprises lutein (5 mg), zeaxanthin (1 mg), meso-zeaxanthin (5 mg), Vitamin A (0.8 mg), thiamin (1.1 mg), riboflavin (1.4 mg), Vitamin B6 (2.0 mg), Vitamin B12 (.0025 mg), folic acid (0.4 mg), niacin (20 mg), pantothenic acid (6 mg), biotin (.050 mg), Vitamin C (80 mg), Vitamin D (.020 mg), Vitamin E (12 mg), calcium (120 mg), magnesium (60 mg), iron (14 mg), zinc (10 mg), copper (1 mg), iodine (0.15 mg), manganese (3 mg), selenium (0.055 mg) as well as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), and microcellulose. Wherein the ratio lutein:zeaxanthin:meso-zeaxanthin (5:1:5) as set forth in Group 2 and examples 6 and 9. The applicant’s attention is also directed to the claimed compositions of which two patents cannot issue to the same subject matter.
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 1-7 and 9-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19 and 20 of copending Application No. 18/394,591 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the composition of 18/394,591 embraces the composition of the instant invention where the composition comprises lutein, zeaxanthin, meso-zeaxanthin, docosahexaenoic acid and eicosapentaenoic acid as claimed herein. Additionally, the composition may further comprise Vitamin A, Vitamin C, Vitamin D3, Vitamin E, Vitamin B1, Vitamin B2, niacin, Vitamin B6, folic acid, Vitamin B12, biotin, panthothenic acid, calcium, iron, iodine, magnesium, zinc, copper, choline, selenium, manganese, ginger or any combination thereof.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Objections
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. None of the art of record nor a search in the pertinent art area teaches the specific formulation as claimed herein.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (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, Jeffrey H. Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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