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 .
Claim Status
Claims 13-22 were pending.
Claims 1-12, 15, 18, 22 are canceled.
Claims 13, 14, 20 are amended.
Claims 23-33 are new.
Claims 13-14, 16-17, 19-21, 23-33 are under consideration.
Information Disclosure Statement
(new) The information disclosure statement (IDS) submitted on 07/15/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
(previous objection, withdrawn) The drawings were objected to because there are brackets around the figure labels, e.g., [FIG. 1].
Applicant contends: Applicant respectfully submits replacement figures herewith.
Office response: Based on amended, replacement figures, the objection is withdrawn.
Specification
The abstract of the disclosure was objected to because of misspellings of the word therefore.
Change “therefor” to “therefore”.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant contends: Applicant respectfully submits replacement abstract herewith.
Office response: Based on amended, replacement abstract, the objection is withdrawn.
Claim Objections
Claim 14 was objected to because of the following informality:
Claim 14: Change “administeringthe” to “administering the”.
Applicant contends: Claim 14 is objected to for the reasons set forth on page 4 of the office action. Applicant has amended claim 14, rendering this objection moot.
Office response: Based on the amendment, the objection is withdrawn.
Claim Interpretation
Regarding claim 14, “A method for preventing or treating infectious disease caused by Clostridium perfringens (CP)” is interpreted to only include disease that are directly caused by C. perfringens and not, for example, an opportunistic infection.
Applicant contends: Applicant submits that Applicant does not necessarily concede with the Examiner's interpretations but nonetheless has amended claims, rendering the Examiner's interpretation moot.
Office response: The claim interpretation of record is maintained as was applied herein to claim 14, as amended.
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.
Deposit
Claims 13-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Applicant contends: In response, Applicant respectfully files the Deposit Receipt and a deposit statement to satisfy the deposit requirement herewith, as suggested by the office.
Office response: Based on applicant’s submission, the rejection is withdrawn.
Scope of Enablement
Claims 14 - 16 are 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 treating an infectious disease caused by Clostridium perfringens (CP), does not reasonably provide enablement for preventing any infectious disease caused by Clostridium perfringens. 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.
Applicant contends: Without acquiescing to the merits of the rejections, Applicant has amended independent claim 13, from which the remaining rejected claims depend, rendering the above rejection moot.
Office response: Applicant’s response does not seem to apply to the rejection. However, it is noted that claim 14 was amended and based on that amendment the rejection of claims 14 and 16 is withdrawn. Claim 15 is canceled and so its rejection is withdrawn as moot.
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 15, 18, and 22 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. The term “specific bactericidal activity” is an inherent function of the bacteriophage. As such it does not further limit the claim. 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.
Applicant contends: Without acquiescing to the merits of the rejections, Applicant has cancelled certain claims rendering the above rejection moot.
Office response: Claims 15, 18 and 22 are canceled and so their rejection is withdrawn as moot.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
(previous rejection, maintained as to claims 13, 20, and modified to incorporate a species of claim 21, and new dependent claims 23-25, withdrawn as to canceled claim 22) Claims 13, 20, 21, 23-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP § 2106 for analysis framework.
See claims 13, 20, 21, 23-25 as submitted 07/22/2026.
Examiner’s Note: Based on Applicant’s election in the Response filed on 03/23/2026, claim 21 was previously examined based only on the elected species, i.e., a “preservative”. In view of the withdrawal of rejections of claim 21, for the reasons set forth above, all the species recited in claim 21 were fully considered in this Office action. Like “preservative”, both “stabilizer” and “cryoprotectant” are also eligible subject matter. However, of the four embodiments recited in claim 21, “excipient” is not an eligible embodiment. The broadest reasonable interpretation of an additive that is an excipient includes, for example, naturally occurring water as stated below in the analysis. In view of the expanded consideration of all the species of claim 21, the claim has been included in the rejection to encompass the newly considered species.
The instant claims are drawn to a bacteriophage in formulation of emulsion, pill, capsule, granule, tablet, troche, lozenge, powder, syrup, or elixir, which is a statutory category of invention, i.e., a composition of matter (Step 1: YES).
The instant Specification evidences that KCCM12935P was isolated from fecal samples and was not altered (p. 17-19). As such, KCCM12935P is a naturally occurring bacteriophage. Claims 23-25 only further limit claim 13 by providing different ranges of either pfu/mL or pfu/g of the phage.
In regard to an emulsion formulation, an emulsion would include naturally found mixtures of fat and water such as milk. In regard to a syrup formulation, an emulsion would include naturally found such as maple syrup. In regard to an elixir formulation, an elixir would include naturally found mixtures of water and alcohol such as fermented grapes which are in contact with yeast and naturally produce alcohol, which is combined by the water found within grapes. In regard to a powder formulation, a powder would include bacteriophage in the absence of a liquid. In regard to a pill, granule, capsule, lozenge, troche, and tablet, bacteriophage powders can be naturally compressed and formulated using usually naturally occurring components, e.g., gelatin, cellulose, pectin, sugar, etc., which would not impart any markedly different characteristics with respect to structure, function, or any other property to distinguish the claimed bacteriophage from its naturally occurring counterparts.
Moreover, the broadest reasonable interpretation of an additive recited by instant claim 20, and an excipient, as an example of an additive, as recited in instant claim 21, includes, e.g., water.
Isolating naturally occurring bacteriophage and, in some embodiments, combining the naturally occurring bacteriophage with water, alcohol, syrup, or in dehydrated form, would not, absent evidence to the contrary, result in any markedly different characteristics with respect to structure, function, or any other property to distinguish the bacteriophage from its naturally occurring counterpart. As such, the claims recite a judicial exception (JE) in the form of a natural phenomenon (STEP 2A, Prong One: YES).
The instant claims are drawn solely to the JE, and not a method of using the JE for, e.g., a specific treatment or prophylaxis. As such the instant claims do not recite any additional elements that integrate the JE into a practical application (STEP 2A, Prong Two: NO).
Since the instant claims are limited to only the JE, the instant claims do not recite any additional elements that amount to significantly more than the JE (STEP 2B: NO).
In view of the foregoing, the instant claims do not constitute patent eligible subject matter under 35 U.S.C. §101.
Applicant contends: Without acquiescing to the merits of the rejections, Applicant has amended independent claim 13, from which the remaining rejected claims depend, to better capture commercial embodiments.
In making the rejection, the office alleges that the instant claims recite a natural phenomenon, which is a judicial exception, and do not recite any additional elements that integrate the judicial exception into a practical application. See Page 11 of the office action.
Applicant respectfully submits that the present claim is not directed to a judicial exception and qualifies as eligible subject matter. As described in Example 3 of the 2014 Interim Eligibility Guidance (Nature-Based Products), a particular pharmaceutical composition in a non-natural structure (i.e., core of amazonic acid surrounded by a layer of natural polymeric material) is structurally different from the naturally occurring substances, and this structural difference results in the claimed composition having different functional characteristics in vivo than the naturally occurring substances by themselves. Therefore, these different structural and functional characteristics rise to the level of a marked difference, thus the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter. See Example 3 of the 2014 Interim Eligibility Guidance (Nature- Based Products).
Similarly, the present claim of "the pharmaceutical composition is in a formulation of emulsion, pill, capsule, granule, tablet, troche, lozenge, powder, syrup, or elixir" is structurally different from the naturally occurring substance by itself (i.e., bacteriophage deposited under Accession number KCCM12935P) and this structural difference results in the claimed composition having different functional characteristics in vivo (e.g., bacteriophage deposited under Accession number KCCM12935P is not released until the composition reaches certain points). Therefore, these different structural and functional characteristics rise to the level of a marked differences, resulting the claimed composition is not a "product of nature" exception. Accordingly, Applicant respectfully requests reconsideration and withdrawal of the above rejection.
Office response: See above modified 35 USC § 101 rejection above as necessitated by amendment. As discussed above, under the broadest reasonable interpretation of the claims, formulating a naturally bacteriophage using naturally occurring components, e.g., gelatin, cellulose, pectin, sugar, etc., would not impart any markedly different characteristics with respect to structure, function, or any other property to distinguish the claimed bacteriophage from its naturally occurring counterpart. For example, formulating a naturally occurring bacteriophage within a gelatin capsule would not result in a bacteriophage having any markedly different characteristics with respect to structure, function, or any other property to distinguish the claimed bacteriophage from its naturally occurring counterpart. Furthermore, the additive encompasses inert, naturally occurring products such as water. Therefore, these formulations do not rise to the level of a marked difference.
Conclusion
Claims 17, 19, 30-33 are allowed.
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 Claire Cornelius whose telephone number is (571)272-0860. The examiner can normally be reached M-F, 0930-1700.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. Visone can be reached at (571) 270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.C./Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
