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 invention II, a process for treating a feed product or of preventing or reducing a Clostridium perfringens infection on or in a feed product, and of a strain of a species of a Myoviridae family bacteriophage with the genome enumerated by SEQ ID NO:11 of the instant application, in the reply filed on 08/11/2026 is acknowledged.
Claims 15, 17–19, and 21–27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/11/2026.
Claim Status
Claims 1–14 and 16 are cancelled.
Claims 15, 17–19, and 21–27 are withdrawn.
Claim 20 is under examination on the merits.
Priority
This is a National Stage Entry under 35 U.S.C. 371 of International Patent Application No. PCT/GB2022/050887, filed 04/08/2022. Acknowledgement is made of Applicants’ claim to priority from U.S. application 63/173,041, filed on 04/09/2021.
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. 63/173,041, 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 claim 20 of the instant application because it does not disclose the process for treating a feed product or of preventing or reducing a Clostridium perfringens infection on or in a feed product by applying a composition comprising one or more bacteriophages to said feed product. For purposes of applying prior art, the effective filing date for claim 20 is 04/08/2022, the filing date of PCT/GB2022/050887.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 11/29/2023, 01/12/2024, 01/30/2024, 08/01/2025, and 08/11/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDSs are being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, “the list may not be incorporated into the specification but must be submitted in a separate paper.” Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to because the figure label of Figures 3–4 are not appropriately oriented relative to the figure itself, i.e., the figure label is in portrait orientation whereas the figure is in landscape orientation. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete.
Required response - Applicant must:
Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The disclosure is objected to because of the following informalities:
On pg. 15, line 1, “capable of lysing a bacteriophage” should presumably read “capable of lysing by a bacteriophage”.
In the Brief Description of the Figures section (p. 28), Figures 3–4 and 5–6 each share a brief description. Each numbered figure should have its own brief description.
On pg. 28, line 5, “Toxin gene typing … carried out polymerase chain reaction” should presumably read “Toxin genotyping … carried out by polymerase chain reaction”.
Appropriate correction is required.
The use of the following terms, which is a trade name or a mark used in commerce, has been noted in this application:
ELISA: p. 24, line 23
ILLUMINA: p. 29, line 18
GENEIOUS: p. 29, line 20
BLAST: p. 29, line 26
GENBANK: p. 30, table 5
NCBI: p. 30, line 10
BMD: p. 35, table 8
The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Interpretation
Regarding claim 20, a “C. perfringens infection on or in a feed product” is interpreted to mean a contamination of said feed product by C. perfringens, such that the pathogen has established physical contact with said feed product and is present on and/or inside of it.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
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 20 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 recitation of “a composition comprising one or more bacteriophages, wherein the bacteriophage has a genome with a nucleotide sequence…” (italics added) in claim 20 lends to multiple claim interpretations which renders the claim indefinite. It is unclear from the text of the claim as written if, for embodiments comprising a composition with more than one bacteriophage, only one of the bacteriophages has a genome with a nucleotide sequence selected from the group consisting of SEQ ID NOs:1–7 and 9–11, or if each of the bacteriophages in said composition has a genome from said group of sequence identifiers. The presence of multiple claim interpretations renders the claim indefinite. Applicant is recommended to redraft claim 20 to recite “a composition comprising one or more bacteriophages, wherein each bacteriophage has a genome with a nucleotide sequence…”
See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (“[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112[(b)], as indefinite.”).
Claim Rejections - 35 USC § 112(a) - Enablement
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.
Claim 20 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a process for treating a feed product or reducing a C. perfringens infection on or in a feed product, comprising the step of applying a composition further comprising one or more bacteriophages to the feed product, does not reasonably provide enablement for a process of preventing the infection of a feed product, comprising the step of applying a composition further comprising one or more bacteriophages to the feed product. 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.
The Wands factors include but are not limited to the breadth of the claims, nature of the invention, state of the prior art, level of one of ordinary skill, level of predictability in the art, amount of direction provided by the inventor, existence of working examples, and the quantity of experimentation needed to make or use the invention based on the content of the disclosure. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
The breadth of the claims is found in claim 20 drawn to a method for treating a food product or of preventing or reducing a Clostridium perfringens infection on or in a feed product by applying to said feed product a composition comprising one or more bacteriophages, wherein the bacteriophages have genomes that are selected from a group consisting of SEQ ID NOs:1–7 and 9–11 of the instant application.
The nature of the invention is a method for removing C. perfringens bacteria from a feed product with a bacteriophage that can lyse the same.
The state of the prior art at the time of the effective filing date is that it is well established in the art that treating a feed product with a composition of lytic bacteriophages can reduce mortality levels in subjects against necrotic enteritis caused by C. perfringens infection. See for example Miller et al. (Avian Dis, 54:33–40, 2010; hereinafter “Miller”; see IDS). Miller teaches that orally delivering a bacteriophage composition reduced necrotic enteritis mortality rates in broiler chickens upon challenge with C. perfringens relative to control groups and even those who were treated by oral gavage (p. 35, col. 2, para.5; p. 38, col. 1, para. 3, lines 7–13, table 6). The art lacks studies, however, correlating these results with the prevention of bacterial infection. Yoon et al. (US 2017/0340685 A1, published 11/30/2017) teaches the bacteriophage Clo-PEP-1 and its incorporation into a disinfectant, water additive, or feed additive for treatment of C. perfringens infections (p. 2, para. [0017]). This phage kills C. perfringens selectively (p. 1, para. [0009]; p. 2, para. [0018]). However, it is clear that the phage must contact the bacterium to function (p.4, para. [0042]). Although the prior art was aware of such methods of incorporating phages or lytic enzymes therefrom into feed to treat bacterial infections therein before the filing of the instant application, this cannot occur without contact with the bacteria. Bacteria being present on or in feed which contains the phage would indicate the feed is infected, and so logically no prevention of feed infection can occur using said phage.
The level of skill of one in this art is high.
The specification discloses a group of 11 bacteriophages capable of lysing one or more strains of C. perfringens, each with a genome identified as the nucleotide sequences given as SEQ ID NOs:1–11 (p. 6, para. 2). The bacteriophages of the invention are identified as belonging to families Podoviridae, Myoviridae, and Siphoviridae (p. 7, para 5; Table 2). Preferred embodiments of the invention are able to lyse five or more strains of C. perfringens associated with poultry, pigs, or cows (p. 14, para. 1), and lytic activity is specific to C. perfringens (p. 15, paras. 1–2). The specification provides evidence that the 11 selected bacteriophages has lytic capacity against a range of C. perfringens isolates by way of a spot assay (p. 31, paras. 2–3; fig. 2). Multiplicities of infection (p. 32, para. 1; table 6) and virulence indexes (pp. 32, para. 2; figs. 3–4; table 7) of the bacteriophages against C. perfringens were also experimentally derived. The specification further provides evidence that the continuous treatment of feed products with a composition comprising the bacteriophages ACP22, ACP45, and SMS460 (p. 40, para. 1; SEQ ID NOs: 9–11) was as effective as the antibiotic BMD® (bacitracin methylenedisalicylate) in preventing mortality in 500 healthy male baby chicks 28 days following a very strong C. perfringens challenge, with no observed negative side effects (p. 42, para. 1; Table 17). The effects of the treated feed product on subject immune response is not reported by the specification.
However, the specification does not correlate the evidence of lytic activity of the bacteriophages against C. perfringens nor the increased survival rates in survival studies by a composition of said bacteriophages with the prevention of C. perfringens infection. Protective efficacy against entry into and colonization of a subject has to be empirically tested in the appropriate C perfringens model. Prevention of infection by C. perfringens cannot be predicted by lytic activity, virulence, and survival studies alone. Further, and of utmost relevance, although evidence is provided that a bacteriophage-treated feed product may reduce a C perfringens infection in baby male chicks, as measured through survival post-challenge, the specification does not provide evidence that said treatment will prevent a C. perfringens infection in the feed product itself. Logically, the bacteria must infect the feed to encounter the phage.
Thus, the bacteriophage composition does not prevent infection of a feed product from occurring, and has not been demonstrated to reduce an infection on a feed product. The immune response generated by baby male chicks combats the infection.
For these reasons, the specification does not reasonably provide enablement for the claimed method for preventing infection by C. perfringens in or on a feed product.
Claim Rejections - Improper Markush Groupings
Claim 20 is rejected on the basis that it contains an improper Markush grouping of alternatives.
See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of ten bacteriophages enumerated by SEQ ID NOs:1–7 and 9–11 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use that flows from said similarity for the following reasons: The grouping of bacteriophages come from three different families of viruses. Each family of viruses, as well as the species within, have different genomes containing different ORFs. They will infect cells and enter the lytic and/or lysogenic cycles using different enzymes which exploit distinct mechanisms. Said another way, there is no common sequence essential to the function of the members (lytic capacity) that is shared by all of said members. Thus, this rejection is made.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael J.A. Bellecourt whose telephone number is 571-270-5356. The examiner can normally be reached Monday through Thursday, 8:00 a.m. to 3:00 p.m. ET.
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/MICHAEL J.A. BELLECOURT/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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