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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/6/26 has been entered.
Applicants are informed that the rejections of the previous Office action not stated below have been withdrawn from consideration in view of the Applicant’s arguments and/or amendments.
Election/Restrictions
Applicant's election with traverse of invention in the reply filed on 10/10/2023 is acknowledged. The traversal is on the ground(s) that Richardson does not teach the special technical feature of a “heterogenous virus-like particles (VLPs) obtain from the gastrointestinal tract of a subject” because Richardson teaches recombinantly producing norovirus VLPs. This is not found persuasive because the obtaining the VLPs from the gastrointestinal tract of a subject are not structurally different from those of Richardson et al since those VLPs are of a virus found in the gastrointestinal tract.
The requirement is still deemed proper and is therefore made FINAL.
Claims 4, 6-10, 12, 16-19, 21, 29, 33 and 36-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/10/2023.
Claims 1-3 are examined on the merits.
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.
(New Rejection) Claims 1-3 are rejected under 35 U.S.C. 102a1 as being anticipated by Deaton et al. (US PGPub 2015/0297648).
The claimed invention is drawn to a pharmaceutical composition comprising: a preparation of heterogeneous gastrointestinal virus-like particles (VLPs) capable of infecting a broad spectrum of resident, non-pathogenic bacteria of the human microbiome, fungi of the human gut microbiome, or archaea of the human gut microbiome; and a pharmaceutically-acceptable carrier. The composition also comprises an adjuvant. The composition comprises at least 10^9 VLPs/ml.
*Of note, the specification states that harmless resident gut bacteria become pathogenic when exposed to genes for shiga toxin [see page 16, lines 4-5]. In addition, the claims nor the specification provide specific examples of bacteria of the human gut microbiome that are “resident, non-pathogenic”. The specification at pages 19-20 state that VLPs from feces of one mouse were able to restore bacterial populations of the gut of a mouse that was induced to have dysbiosis of the gastrointestinal tract. This process relied on VLPs targeting bacterial overgrowth of what appears to be resident, non-pathogenic bacteria of the murine gut microbome. This information from the specification is being used to help interpret the claimed invention, which would appear to include bacteriophages specific for resident bacteria of a human gut that under normal, healthy conditions are non-pathogenic, but when exposed to a toxin or environmental stress may become pathogenic.
Deaton et al. teach the formulation of bacteriophages for promoting the growth of beneficial bacteria and decreasing the harmful bacteria in the gastrointestinal system. [see abstract] These bacteriophages would function as a prebiotic in the human gut and would ultimately change the bacterial microbiome to help those afflicted with gastrointestinal inflammation. [see abstract and paragraphs 8 and 9] Similar to applicants intent of creating their invention, Deaton et al. teach in paragraphs 25-27, the gut microbiota is important to human health, and novel interventions to selectively modulate the microbiota are actively being sought. Bacteriophages (bacterial viruses) have the potential to selectively eliminate specific detrimental microbes while enhancing beneficial microbe populations. Examples of the bacteriophage to be formulated for oral consumption and delivery to a human patient can target E. coli or Helicobacter presented in the gastrointestinal tract of humans. [see paragraphs 29 and 34] Deaton et al. also teach the use of adjuvants, carriers or diluents with their pharmaceutical compositions. [see paragraph 46 and 47] Deaton et al. also teach that the amount of bacteriophage to be administered can be up to 10^13 plaque forming unites/dose, which would meet the limitation “at least 10^9 VLPs/ml” of claim 1. [see paragraph 56] Therefore, Deaton et al. anticipate the instant invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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, Michael Allen can be reached on (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671