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 .
DETAILED ACTION
Claims 1, 6-8, 10, 12-14, 17-20, and 28 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/04/2025 has been entered.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, Application No. 62/953,299, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Independent claim 1 recites the limitation “Brevibacterium aureum, Brevibacterium sediminis, and/or Brevibacterium epidermis”. Provisional application 62/953,299 filed on 12/24/2019 does not disclose the recited strains. However, Brevibacterium aureum, Brevibacterium sediminis, and/or Brevibacterium epidermis are disclosed in Application PCT/US2020/066783 filed on 12/23/2020. Accordingly, claims 1, 6-8, 10, 12-14, 17-20, and 28 are not entitled to the benefit of the prior application 62/953,299, and will be examined as having an effective filing date of 12/23/2020.
Claim Objections
Claims 6 and 12 are objected to because of the following informalities:
In claim 6, “that is one or more of” recited in line 2 should be replaced with “selected from the group consisting of” or with “comprising”.
In claim 12, Vergibacillus spp should be replaced with Virgibacillus spp.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 6-8, 10, 12-14, 17-20, and 28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification does not reasonably provide enablement for treating clostridial dermatitis, clostridial enteric disease and/or gut inflammation in a subject in need thereof by administering a composition comprising Brevibacterium aureum, Brevibacterium sediminis, and/or Brevibacterium epidermis. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
In making a determination that a disclosure does not satisfy the enablement requirement, the factors that may be considered include: (A) the breadth of the claims, (B) the nature of the invention, (C) the state of the prior art, (D) the level of one of ordinary skill, (E) the level of predictability in the art, (F) the amount of direction provided by the inventor, (G) the existence of working examples, and (H) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. While it is not essential that every factor be examined in detail, those factors deemed most relevant should be considered.
Nature of the invention. The claims are drawn to “method of treating clostridial dermatitis, clostridial enteric disease, and/or gut inflammation by administering a composition comprising Brevibacterium aureum, Brevibacterium sediminis, and/or Brevibacterium epidermis. Enablement of the claimed invention is based on whether one of ordinary skill in the art can reliably treat clostridial dermatitis, clostridial enteric disease and gut inflammation when administering a composition comprising Brevibacterium aureum, Brevibacterium sediminis, and/or Brevibacterium epidermis.
Breadth of the claims. The breadth of the claims is exceedingly large and fails to receive adequate support in the specification. Claims 1, 6-8, 10, 12-14, 17-20, and 28 encompass treatment of clostridial dermatitis, clostridial enteric disease and gut inflammation in a subject in need thereof.
Guidance in the specification and working examples. The guidance in the specification is not commensurate in scope with the claimed invention. Example 1 discloses Clostridium perfringens isolated from turkeys with clostridial dermatitis produces histamine in vitro. Example 2 discloses Brevibacterium aurantiacum is capable of degrading histamine in vitro. Example 3 discloses Clostridium septicum samples are able to produce histamine in vitro. Example 4 discloses Enterococcus cecorum strains are capable of degrading histamine in vitro. Example 5 discloses Lactobacillus crispatus is capable of degrading histamine in vitro. Example 6 discloses feeding chickens histamine, collecting fecal material and cecal content, and identifying histamine-degrading bacteria. Example 7 discloses Brevibacterium spp, Enterococcus spp, Pseudomonas spp, and Candida krusei decrease the amount of histamine in histamine-supplemented minimal media in vitro. Example 8 discloses green pea shoots extract decreases histamine content in histamine-supplemented media. FIG. 18 and 19 show Brevibacterium aureum, Brevibacterium sediminis, and Brevibacterium epidermis decrease the amount of histamine in a culture medium in vitro. The specification fails to provide guidance pertaining to treating clostridial dermatitis, clostridial enteric disease and gut inflammation by administering a probiotic composition comprising Brevibacterium aureum, Brevibacterium sediminis, and/or Brevibacterium epidermis.
State of the prior art and unpredictability. No prior art teachings demonstrate the treatment of clostridial dermatitis, clostridial enteric disease and gut inflammation in a subject in need thereof by administering a composition comprising Brevibacterium aureum, Brevibacterium sediminis, and/or Brevibacterium epidermis.
Waneck (of record in Office correspondence mailed on 04/03/2025) teaches administering probiotic Enterococcus faecium and Lactobacillus reuteri to subjects with clostridial gangrenous dermatitis (GD) (Title, page 30 para 2 and 3). Anast (of record in IDS filed on 06/24/2022) teaches Brevibacterium is capable of degrading histamine and can be added in food (Title). Yoshinaga (Applied and Environmental Microbiology 44.2 (1982): 447-452) teaches C. perfringens produces histamine (Abstract).
Amount of experimentation necessary. The above mentioned details establish that one skilled in the art would not be able to make or use the full scope of the claimed invention with a reasonable expectation of success and without undue experimentation. Based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make the full scope of the claimed invention without undue experimentation.
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 8, 12-13, and 17 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.
Claim 8 recites the subject is an aquaculture species. Aquaculture species comprise a diverse range of freshwater and marine fish, shellfish, and plants. The metes and bounds of the claim are not definite since it is not clear how aquaculture plants and shellfish can have clostridium dermatitis.
Claim 12 recites Pinchia spp. While Pichia spp. is recognized in the art, Pinchia spp. is not known genus. It is not clear if Applicant is referring to Pichia sp. since the specification discloses Pinchia spp., and Pichina pastoris (page 24 line 14) but does not disclose Pichia sp..
Claim 13 recites the limitation “wherein a microorganism in the commensal microbiota”. This limitation is indefinite because it does not limit the commensal microbiota to the subject. Applicant may consider amending the claim to recite “wherein a microorganism in the commensal microbiota in the subject” in order to obviate the rejection.
Claim 17 recites the probiotic composition is a spore. Brevibacterium genus is a non-spore-forming genus as taught by Gruner (Journal of clinical microbiology 31.6 (1993): 1408-1412, page 1408 left column para 2). The claim is indefinite because it is not clear what spores are contained in the composition.
Response to Arguments
Applicant’s arguments with respect to claims 1, 6-8, 10, 12-15, and 17-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699