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 .
Election/Restrictions
Applicant’s election without traverse of Group III, corresponding to claims 18 – 20, 28, 30, and 32 – 36 in the reply filed on 09/02/2026 is acknowledged.
Claims 1 – 9, 10, 11, 13 – 17, and 37 – 42 are withdrawn from further consideration pursuant to 37
CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or
linking claim.
Claims 18 – 20, 28, 30, and 32 – 36 are under examination.
Priority
This is a National Stage Entry under 35 U.S.C. 371 of International Patent Application
No. PCT/US2022/046449, filed October 12, 2022. This application also claims priority to US Provisional Application No. 63/255,105, filed on October 13, 2021.
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 34 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 term “about” in claim 34 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim 34 recites “about one to three days.”
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)(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) 18 – 20, 28, 30, 32 – 34, and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin et al (WO2019231712A1, hereinafter, “Lin”).
Lin discloses a pharmaceutical composition comprising virus-like particles (VLPs) obtained from the gastrointestinal tract of a subject and a pharmaceutically acceptable carrier (Abstract). Lin discloses the VLPs can include bacteriophages, eukaryotic viruses, or gene transfer agents (Abstract). Lin discloses the VLP composition may be administered to a subject having, or at risk of having dysbiosis, in an amount effective to ameliorate at least one symptom or clinical sign of dysbiosis (Abstract).
Regarding claim 18, Lin discloses a method of treating dysbiosis in a subject having, or at risk of having dysbiosis, the method comprising administering to the subject a virus-like particle (VLP) preparation in an amount effective to ameliorate at least one symptom or clinical sign of dysbiosis (Claim 4).
Regarding claim 19, Lin discloses the method further comprises administering to the subject a second pharmaceutical composition for treating dysbiosis (Claim 6).
Regarding claim 20, Lin discloses the second pharmaceutical composition for treating dysbiosis comprises an antibiotic (Claim 7).
Regarding claim 28, Lin discloses the dysbiosis is localized to an epithelial tissue (Claim 11).
Regarding claim 30, Lin discloses the VLP preparation is incorporated into a medical device (Claim 13).
Regarding claim 32, Lin discloses the dysbiosis causes bacterial overgrowth (Claim 15).
Regarding claim 33, Lin discloses a sustained period of nutrient deprivation of epithelial bacterial population prior to administering the VLP preparation to the subject (claim 19).
Regarding claim 34, Lin discloses the sustained period of nutrient deprivation is about one to three days (Claim 20).
Regarding claim 36, Lin discloses the VLP preparation is administered parenterally (Claim 29).
Accordingly, the claimed invention was anticipated by Lin.
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 35 is rejected under 35 U.S.C. 103 over Lin as applied to claims 18 – 20, 28, 30, 32 – 34, and 36 above, and further view of Park et al (Food Sci BIotechnol, July 2021, 10.1007/s10068-021-00930-y, hereinafter, “Park”).
As discussed above, claims 18 – 20, 28, 30, 32 – 34, and 36 were anticipated by the teachings of Lin.
The reference does not teach the administration of a bacteriophage prep before, during, or after one or more meals.
However, regarding claim 35, Park teaches the characterization of bacteriophages in fermented food to determine the phage ecology of lactic acid bacteria (Abstract). Park teaches that heterogenous bacteriophage populations exist in different kinds of fermented foods (Section: Characteristics of phages isolated during Baek-kimchi fermentation; Profile and characteristics of phages during Dongchimi fermentation). Specifically, Park teaches 29 different bacteriophages comprises the heterogenous bacteriophage population found in baek-kimchi (Section: Characteristics of phages isolated during Baek-kimchi fermentation, ¶1).
Lin and Park are considered to be analogous to the claim invention because they deal with the properties of bacteriophage. Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to administer bacteriophage with a meal such as kimchi, as taught by Park, in the method taught by Glasgow, because doing so would introduce bacteriophage and probiotics for gut health. One of ordinary skill in the art would have had a reasonable expectation of success in administering bacteriophage with a meal given the consumption of bacteriophage and kimchi, together, is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
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 18 – 20, 28, and 33 – 34, and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 6, 7, 12, 19, and 29 of copending Application No. 17/058,565 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because regarding claim 18, ‘565 discloses a method of treating dysbiosis in a subject having, or at risk of having dysbiosis, the method comprising administering to the subject a virus-like particle (VLP) preparation in an amount effective to ameliorate at least one symptom or clinical sign of dysbiosis (Claim 4). ‘565 discloses the VLPs can include bacteriophages, eukaryotic viruses, or gene transfer agents (Claim 3).
Regarding claim 19, ‘565 discloses the method further comprises administering to the subject a second pharmaceutical composition for treating dysbiosis (Claim 6).
Regarding claim 20, ‘565 discloses the second pharmaceutical composition for treating dysbiosis comprises an antibiotic (Claim 7).
Regarding claim 28, ‘565 discloses the dysbiosis is localized to an epithelial tissue (Claim 12).
Regarding claim 33, ‘565 discloses the method of claim 4 further comprising a sustained period of nutrient deprivation of epithelial bacterial population prior to administering the VLP preparation to the subject (claim 19).
Regarding claim 36, ‘565 discloses the VLP preparation is administered parenterally (Claim 29).
This is a provisional nonstatutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claim 35 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 6, 7, 12, 19, and 29 of copending Application No. 17/058,565 in view of Park.
As discussed above, claims 18 – 20, 28, and 33 – 34, and 36 are provisionally rejected on the ground of statutory double patenting over claims 4, 6, 7, 12, 19, and 29 of copending Application No. 17/058,565.
The ‘565 does not teach the administration of a bacteriophage prep before, during, or after one or more meals.
However, regarding claim 35, Park teaches the characterization of bacteriophages in fermented food to determine the phage ecology of lactic acid bacteria (Abstract). Park teaches that heterogenous bacteriophage populations exist in different kinds of fermented foods (Section: Characteristics of phages isolated during Baek-kimchi fermentation; Profile and characteristics of phages during Dongchimi fermentation). Specifically, Park teaches 29 different bacteriophages comprises the heterogenous bacteriophage population found in baek-kimchi (Section: Characteristics of phages isolated during Baek-kimchi fermentation, ¶1).
The scope of the conflicting application and the instant application significantly overlap. ‘565 and Park are considered to be analogous to the claim invention because they deal with the properties of bacteriophage. Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to administer bacteriophage with a meal such as kimchi, as taught by Park, in the method taught by ‘565, because doing so would introduce bacteriophage and probiotics for gut health. One of ordinary skill in the art would have had a reasonable expectation of success in administering bacteriophage with a meal given the consumption of bacteriophage and kimchi, together, is well known, has been successfully demonstrated, and commonly used in the prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danyal H Alam whose telephone number is (571)272-1102. The examiner can normally be reached M - F 9am - 5pm.
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/DANYAL HASSAN ALAM/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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