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 .
DETAILED ACTION
Claims 1, 6-8, 10, 12-14, 17-20, and 28-31 are pending.
Response to Amendment
Applicant amended claim 6 and added the limitation “comprising”.
Applicant amended claim 8 and limited the aquaculture species to “aquaculture fish species”.
Applicant amended claim 12, replacing “Vergibacillus” with “Virgibacillus”, and deleting “Pinchia spp”.
Applicant amended claim 13 and added “in the subject”.
Applicant amended claim 17 and deleted “a spore that is germinated into a histamine degrader in the subject”.
Applicant added new claims 29-31.
The objection to claims 6 and 12 is withdrawn in view of the amendment.
The rejection of claims 8, 12-13, and 17 under 35 U.S.C. 112(b) is withdrawn in view of the amendment.
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 28-31 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 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 remain rejected and claims 29-31 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 28-31 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.
New rejection Necessitated by the Amendment
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 29 and 30 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 29 requires Brevibacterium sediminis, and claim 30 requires Brevibacterium aureum, Brevibacterium sediminis, and Brevibacterium epidermis. Claims 29 and 30 do not further limit claim 1 because claim 1 encompasses the limitation “Brevibacterium aureum, Brevibacterium sediminis, and Brevibacterium epidermis”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Response to Arguments
The affidavit under 37 CFR 1.132 filed 05/08/2026 is insufficient to overcome the rejection of claims based upon insufficiency of disclosure under 35 U.S.C. 112(a) as set forth in the last Office action because: the facts presented are not germane to the rejection at issue and the showing is not commensurate in scope with the claims.
The affidavit shows that administering a composition comprising B. sediminis to chicken fed a histamine-containing diet reduced histamine levels in vivo. However, the claims are drawn to a method of treating clostridial dermatitis, clostridial enteric disease, and/or gut inflammation in a subject in need of treatment. While the evidence presented in the affidavit shows that administering Brevibacterium sediminis reduces histamine levels in vivo in chicken fed histamine, the affidavit does not show treatment of clostridial dermatitis, clostridial enteric disease, and/or gut inflammation in a subject in need of treatment. The affidavit discloses that Clostridium perfringens and Clostridium septicum, organisms associated with clostridial dermatitis, produce histamine, and that histamine overproduction contributes to the pathology of clostridial dermatitis, clostridial enteric disease, and gut inflammation. The affidavit, as well as the specification, do not show that administering Brevibacterium sediminis to a subject with clostridial dermatitis, clostridial enteric disease, and/or gut inflammation treats the disorders, as required by the claims. While Applicant argues that histamine production is a result of the infection with Clostridium perfringens and Clostridium septicum, there is no evidence that lowering the histamine levels in a subject with clostridial dermatitis, clostridial enteric disease, and gut inflammation would treat the diseases in the subject. Thus, 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.
Applicant argues that the in vitro examples constitute working examples and that the correlation as explained by the specification is straightforward: Clostridium species produce histamine; histamine overproduction drives the pathology of the claimed conditions; and the claimed Brevibacterium species degrade histamine. One skilled in the art, upon seeing the results of the in vitro studies described in the specification, would reasonably expect the results to correlate to in vivo performance.
In response to the argument, the overproduction of histamine is not the cause of the clostridial dermatitis and/or clostridial enteric. Feeding chicken a diet with increased histamine did not cause clostridial dermatitis and/or clostridial enteric diseases. The overproduction of histamine is a result of the infection by Clostridium perfringens and/or Clostridium septicum. Thus, lowering histamine overproduction does not necessarily treat the infection and the diseases.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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