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 .
Applicant’s preliminary amendments filed 4/27/2023 have been entered.
Claims 1-10 are pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 6-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because there is no active method steps recited in the claims. And the claims do not belong to any one of the four categories to be patented.
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 3 and 6-10 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.
Claims 3 and 8 respectively recite the limitation "Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6 and Vitamin B9 ("Vitamin Mix")" in line 2 and 3. There is insufficient antecedent basis for this limitation in the claim. The examiner will favorably consider the adding the phrase “further comprising” in the claims.
Claims 6-10 are rejected because there is no active method steps recited and therefore, the metes and bounds of the claims cannot be ascertained.
For compact prosecution, the use claims will be treated as if the claims are directed to the method of using the herein claimed actives for treating the symptoms of microbial dysbiosis.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2016/172658 (‘658) in view of WO2020/043797 (‘797). ‘797 is reference of record in IDS filed 4/27/2023.
‘658 teaches a method of balancing and treating microbial dysbiosis in the GI tract by using microbiome regulators comprising micronutrients (see the abstract; page 22, last paragraph). The micronutrients are intended to be released substantially in the gastrointestinal tract (e.g., the stomach, small intestine and large intestine) (see page 1, last paragraph). ‘658 teaches the micronutrients can comprise various vitamins including vitamin C, vitamin B1, B2, B3, B5, B6, B7, and B9 (see page 62, last paragraph). One of the conditions is treated with the microbiome regulator of ‘658 is antibiotic-associated diarrhea.(see page 23, line 6).
‘658 does not teach the administration of the vitamin composition resulting in the effects recited in claims 5 and 10.
‘797 teaches a method of improving gut health by administering a composition to the colon and such composition comprising “active ingredients include of riboflavin, vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, folic acid, β-carotene, vitamin B1, niacin, vitamin B5, vitamin B6, biotin, vitamin B12, omega−3 fatty acids and combinations thereof. Benefits include increased concentration of at least one short-chain fatty acid its salt thereof in the intestine… and reduced redox potential of the gut,” See the abstract.
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the micronutrients to the colon in the method of treating GI microbial dysbiosis.
One of ordinary skill in the art would have been motivated to employ the micronutrients to the colon in the method of treating GI microbial dysbiosis since it is well-known in the art that the micronutrients such as vitamin C and B complex as useful to produce the herein claimed effect. Employing the vitamin composition directly to the colon would be reasonably expected to be effective in balancing the microbial environment and treating the dysbiosis.
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 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18/250.377 (‘377) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘377 teaches the use of the same composition to reduce the pathogens in the gut (see claim 1-3). ‘377 does not expressly teach the treating of microbial dysbiosis. However, it would have been obvious to one of ordinary skill in the art at the time of filing to employ the herein claimed vitamin composition to reduce the pathogenic bacteria, thereby treating microbial dysbiosis in the gut.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/ Primary Examiner, Art Unit 1627