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
Claims 4, 6-10, 12, 16-19, 21, 29, 33 and 36-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 as they read on the elected invention.
Response to Amendment
The declaration under 37 CFR 1.132 filed 5/13/26 is insufficient to overcome the rejection of claims 1-3 based upon 35 USC 102a1 as set forth in the last Office action because: see response below.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
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.
(Prior Rejection Maintained) 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 applicant’s 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.
Response to arguments:
Applicant presents the following arguments in traversal of the rejection:
Applicants argue in the 37 CFR 1.132 declaration that the bacteriophage of Deaton do not target resident, non-pathogenic, rather the bacteriophage target harmful bacteria populations, which applicants are interpreting as pathogens. Applicant’s invention however is a preparation of VLPs that are capable of infecting non-pathogenic species naturally resident in the gut. These VLPs are not targeted to specifically infect any particular species and the VLPs have a broad spectrum of activity. The VLP composition of claim 1 is designed to provide a top-down regulation of the gut microbiome, which maintains homeostasis and biodiversity.
In response, the rejection at hand is a 35 USC 102(a)(1) rejection. Unless applicants are attempting to question the inoperability of references (see MPEP 716.07), 37 CFR 1.132 declarations are not a means to overcome such a rejection. Applicants are informed of MPEP 2152.06 with regard to overcoming the rejection maintained herein.
Furthermore, as stated in the previous Office action and reiterated above, 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. [emphasis added] Therefore, the gut microbome at times may possess bacteria that are not harmful, but under times of stress (hormonal or environmental), those same bacteria can adapt and cause gastrointestinal issues. While Deaton et al. refer to harmful bacteria being the target of their bacteriophages, such bacteria may be resident and non-pathogenic when the gut is in homeostatis. Furthermore, in response to applicant’s statement that the claimed VLPs are not targeted to specifically infect any particular species and the VLPs have a broad spectrum of activity [see section 5 of arguments of declaration], the Examiner disagrees since the nature of each VLP (in this case bacteriophages) are capable of infecting a specific host. This selective infection or tropism is due to each virus particle binding to receptor or ligand on the surface of the target bacteria. A mixture of heterologous bacteriophages would be capable of infection a broad spectrum of bacteria, but each bacteriophage would be restricted to infecting a smaller grouping of bacteria. Therefore, applicant’s declaration is insufficient to overcome the 35 USC 102(a)(1) rejection.
Lastly, argue that the Examiner is misinterpreting the claim limitation of what it means to be non-pathogenic and that the definition the Examiner is providing is not consistent with the term by those of ordinary skill in the art. The claim limitation of “resident, non-pathogenic” is mentions once in the specification at page 5, line 12. Specific examples of what bacteria meet this limitation are not provided. However, with regard to what constitutes a resident, non-pathogenic bacteria, the specification does say that environmental factors have a big impact on the behavior of these resident, non-pathogenic bacteria. For example, the specification at page 16, lines 3-5 states “For example, presence of genes for shiga toxin in the metagenome can make otherwise harmless resident gut bacteria become pathogenic.”; Page 15, lines 22-23, states “Dysbiosis is ultimately a change in the composition of the microbiome. The compositional change promotes pathogenic behavior of the microbiome's members.”. The “members” mention in this text appear to include resident bacteria, which can become pathogenic if a host is experiencing Dysbiosis, and applicants also refer to diets high in fat being a cause of dysbiosis (see abridging paragraph of pages 14-15). Applicant’s working example reflects how a diet change can cause a shift in resident, non-pathogenic bacteria in the gut as they fed laboratory mice a high fat diet for 30-days because it was suspected that bacterial populations of different types would shift due to this diet. However, the working example makes no mention of new bacteria being given to the mice that would introduce pathogenic bacteria into the gut. Therefore, it is the Examiner’s interpretation of the specification that resident, non-pathogenic bacteria can turn pathogenic if the host experiences extreme stress or dietary changes or exposure to select toxins, for example.
This rejection is maintained for reasons of record.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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