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 Status
Claims 1-18 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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The foreign priority document is not in English. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 9/15/23 and 1/7/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated Shimada et al. (JP2019214556; English translation provided).
Regarding claims 1-18, Shimada et al. disclose a food or beverage containing silicon microparticles/fine particles for treating inflammatory disease of the digestive tract (Claims) and is therefore also a pharmaceutical product. Shimada et al. disclose a composition with 2.5 wt% silicon (Example 5, Test example; page 12, last paragraph). The instantly claimed preamble of “an intestinal bacteria reducing agent” and the functional use of “reduces the number of bacteria in an intestine” has been considered and is merely an intended use of the silicon fine particles of Shimada et al. and inherent in the food/beverage containing silicon microparticles/fine particles of Shimada et al. All the descriptive limitations for the bacteria in claims 2-5 and 8-18 have been considered but are not given patentable weight. These limitations are inherent in the food/beverage/pharmaceutical composition of Shimada et al. In other words, since the composition of Shimada et al. is the same as instantly claimed then it inherently reduces anaerobic gram-negative bacteria including Bacteriodaceae and reduces a ratio of a number of 16S rRNA gene fragments of anaerobic bacteria to a total number of 16S rRNA gene fragments contained in a PCR amplification product obtained by amplifying the 16S rRNA gene using a PCR method.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated Canham et al. (WO2007012847).
Regarding claims 1-18, Canham et al. disclose a food or beverage (Claims 31-32) comprising silicon (Claims 1-5) of submicron diameter particles (Claim 11) thus being fine, and present from 0.01 to 50 wt% (Claims 19-21). It is merely semantics to describe the composition of Canham et al. as a pharmaceutical product. The instantly claimed preamble of “an intestinal bacteria reducing agent” and the functional use of “reduces the number of bacteria in an intestine” has been considered and is merely an intended use of the silicon fine particles of Canham et al. and inherent in the food/beverage containing silicon microparticles/fine particles of Canham et al. All the descriptive limitations for the bacteria in claims 2-5 and 8-18 have been considered but are not given patentable weight. These limitations are inherent in the food/beverage composition of Canham et al. In other words, since the composition of Shimada et al. is the same as instantly claimed then it inherently reduces anaerobic gram-negative bacteria including Bacteriodaceae and reduces a ratio of a number of 16S rRNA gene fragments of anaerobic bacteria to a total number of 16S rRNA gene fragments contained in a PCR amplification product obtained by amplifying the 16S rRNA gene using a PCR method.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated Shimada et al. (JP2020007300; English translation provided).
Regarding claims 1-18, Shimada et al. disclose a food or beverage or pharmaceutical composition containing silicon microparticles/fine particles for treating depression (Claims). Shimada et al. disclose a composition with 2.5 wt% silicon (Example 5, Test example; page 10). The instantly claimed preamble of “an intestinal bacteria reducing agent” and the functional use of “reduces the number of bacteria in an intestine” has been considered and is merely an intended use of the silicon fine particles of Shimada et al. and inherent in the food/beverage/pharmaceutical composition containing silicon microparticles/fine particles of Shimada et al. All the descriptive limitations for the bacteria in claims 2-5 and 8-18 have been considered but are not given patentable weight. These limitations are inherent in the food/beverage/pharmaceutical composition of Shimada et al. In other words, since the composition of Shimada et al. is the same as instantly claimed then it inherently reduces anaerobic gram-negative bacteria including Bacteriodaceae and reduces a ratio of a number of 16S rRNA gene fragments of anaerobic bacteria to a total number of 16S rRNA gene fragments contained in a PCR amplification product obtained by amplifying the 16S rRNA gene using a PCR method.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated Perry et al. (WO2009115827).
Regarding claims 1-18, Perry et al. disclose a food or drink (beverage) comprising a food supplement (Claims 30-31) that comprises silica/silicon salt particles (Claims 1-2). The term “silica” is understood to mean silicon dioxide. It is merely semantics to describe the composition of Perry et al. as a pharmaceutical product. The instantly claimed preamble of “an intestinal bacteria reducing agent” and the functional use of “reduces the number of bacteria in an intestine” has been considered and is merely an intended use of the silicon fine particles of Perry et al. and inherent in the food/beverage containing silica/silicon salt particles of Perry et al. All the descriptive limitations for the bacteria in claims 2-5 and 8-18 have been considered but are not given patentable weight. These limitations are inherent in the food/beverage/pharmaceutical composition of Perry et al. In other words, since the composition of Perry et al. is the same as instantly claimed then it inherently reduces anaerobic gram-negative bacteria including Bacteriodaceae and reduces a ratio of a number of 16S rRNA gene fragments of anaerobic bacteria to a total number of 16S rRNA gene fragments contained in a PCR amplification product obtained by amplifying the 16S rRNA gene using a PCR method.
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 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 10-17 of copending Application No. 17995206. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending discloses a medicament (Claim 5) and food additive/product (claims 14-15) comprising silicon particles or silicon fine particles (Claims 1 and 4). The instantly claimed preamble of “an intestinal bacteria reducing agent” and the functional use of “reduces the number of bacteria in an intestine” has been considered and is merely an intended use of the silicon fine particles of 17995206 and inherent in the food/medicament containing silica/silicon salt particles of 17995206. All the descriptive limitations for the bacteria in claims 2-5 and 8-18 have been considered but are not given patentable weight. These limitations are inherent in the food/medicament composition of 17995206. In other words, since the composition of 17995206 is the same as instantly claimed then it inherently reduces anaerobic gram-negative bacteria including Bacteriodaceae and reduces a ratio of a number of 16S rRNA gene fragments of anaerobic bacteria to a total number of 16S rRNA gene fragments contained in a PCR amplification product obtained by amplifying the 16S rRNA gene using a PCR method.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-11, 16 and 17 of copending Application No. 185674794. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending discloses a composition for use in the method comprising silicon small particles or silicon fine particles (Claims 1, 9-11, 16 and 17). The instantly claimed preamble of “an intestinal bacteria reducing agent” and the functional use of “reduces the number of bacteria in an intestine” has been considered and is merely an intended use of the silicon fine particles of 18567479 and inherent in the food/medicament containing silica/silicon salt particles of 18567479. All the descriptive limitations for the bacteria in claims 2-5 and 8-18 have been considered but are not given patentable weight. These limitations are inherent in the food/medicament composition of 18567479. In other words, since the composition of 18567479 is the same as instantly claimed then it inherently reduces anaerobic gram-negative bacteria including Bacteriodaceae and reduces a ratio of a number of 16S rRNA gene fragments of anaerobic bacteria to a total number of 16S rRNA gene fragments contained in a PCR amplification product obtained by amplifying the 16S rRNA gene using a PCR method. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 22, 25, 28 and 31 of copending Application No. 17113886. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending discloses a composition for use in the method comprising silicon small particles or silicon fine particles (Claims 1, 22, 25, 31) for GI tract disease (Claims 2-4) in the form of a powder or capsule (Claim 28). The instantly claimed preamble of “an intestinal bacteria reducing agent” and the functional use of “reduces the number of bacteria in an intestine” has been considered and is merely an intended use of the silicon fine particles of 17113886 and inherent in the powder/capsule containing silicon fine particles of 17113886. All the descriptive limitations for the bacteria in claims 2-5 and 8-18 have been considered but are not given patentable weight. These limitations are inherent in the powder/capsule composition of 17113886. In other words, since the composition of 17113886 is the same as instantly claimed then it inherently reduces anaerobic gram-negative bacteria including Bacteriodaceae and reduces a ratio of a number of 16S rRNA gene fragments of anaerobic bacteria to a total number of 16S rRNA gene fragments contained in a PCR amplification product obtained by amplifying the 16S rRNA gene using a PCR method. While the copending does not expressly teach a food or beverage, it is obvious to add the powder to food or water to create a beverage for ease of oral administration. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-12 of U.S. Patent No. 10617712. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses solid preparations comprising silicon fine particles (Claims 1-12);
claims 1-19 of U.S. Patent No. 11103527. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses a drug for disease comprising silicon fine particles for oral ingestion in water, hence at least a beverage, (Claims 1-19);
claims 1-4 of U.S. Patent No. 11583483. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses a material comprising silicon fine particles in a gel, cream, paste, emulsion or mousse form (Claim 1) and therapeutic material (Claim 4) thus reading on a pharmaceutical product/food;
claims 1-13 of U.S. Patent No. 11707063. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses a medicine or food comprising silicon fine particles (Claims 1-4, 10-13) in the form of liquid form, a gel form, a cream form, a paste form, an emulsion form, and a mousse form (Claim 5) where a liquid form renders obvious a beverage;
claims 1-6 of U.S. Patent No. 11840450. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses methods of producing silicon fine particles (Claims 1-6) where use as a food, beverage or pharmaceutical product is inherent in the silicone fine particles;
claims 1-19 of U.S. Patent No. 12070519. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses a food/pharmaceutical composite composition comprising silicon fine particles (Claims 1-19);
claims 1-12 of U.S. Patent No. 11311572. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses an orally ingestible preparation comprising silicon fine particles (Claims 1-12);
claims 1-15 of U.S. Patent No. 11752170. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses a food comprising silicon fine particles (Claims 1-15).
Regarding the double patenting rejections over the patents above, the instantly claimed preamble of “an intestinal bacteria reducing agent” and the functional use of “reduces the number of bacteria in an intestine” has been considered and is merely an intended use of the silicon fine particles of the patents and inherent in the compositions comprising the silicon fine particles of the patents. All the descriptive limitations for the bacteria in claims 2-5 and 8-18 have been considered but are not given patentable weight. These limitations are inherent in the silicon fine particle compositions of the patents. In other words, since the compositions of the patents are the same as instantly claimed then it inherently reduces anaerobic gram-negative bacteria including Bacteriodaceae and reduces a ratio of a number of 16S rRNA gene fragments of anaerobic bacteria to a total number of 16S rRNA gene fragments contained in a PCR amplification product obtained by amplifying the 16S rRNA gene using a PCR method.
Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter.
Conclusion
No claims are allowed.
This field appears crowded. The examiner has carefully compared the references with one another and with the applicant’s disclosure to avoid an unnecessary number of rejections over similar references. The examiner is not called upon to cite all references that may be available, but only the "best." (See 37 CFR 1.104(c).) Multiplying references, any one of which is as good as, but no better than, the others, adds to the burden and cost of prosecution and should therefore be avoided. See MPEP 904.03.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613