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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 26 August 2026 has been entered.
Response to Amendment
The amendment filed 26 August 2026 in which claims 13-14, and 20 were amended, claim 21 was cancelled, and claims 26-33 were added has been entered.
Claims 13-14, 16-17, 19-20, and 23-33 are under examination on the merits.
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, maintained and modified as to claims 13, 20, and 23-25). Claims 13, 20, and 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.
The instant claims are broadly drawn to a bacteriophage and compositions comprising the same. As such, the instant claims are drawn to a composition of matter, which is a statutory category invention (STEP 1: YES).
The instant Specification evidence that KCCM12932P was isolated from fecal samples and was not altered (Pg. 17-20). As such, KCCM12932P is a naturally occurring bacteriophage. Moreover, the broadest reasonable interpretation of a capsule, syrup, etc. recited by instant claims 13 and 20 encompasses e.g. placing the bacteriophage in a cellulose (also naturally occurring) capsule or mixing with glucose (also naturally occurring) to create a syrup, neither of which change the function, structure, or any other property of the claimed bacteriophage. Additionally, the broadest reasonable interpretation of an additive recited by instant claim 20 encompasses, e.g., water.
Isolating bacteriophage and, in some embodiments, formulating with glucose or in a cellulose capsule 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 claimed bacteriophage from their naturally occurring counterparts as formulating bacteriophage with other naturally occurring products does not alter the bacteriophage.
Accordingly, the instant claims recite a natural phenomenon, i.e., naturally occurring bacteriophage, which is a judicial exception (JE) (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).
Murthy, et al. (US 2009130196, hereinafter “Murthy”) evidences that it was well-understood, routine, and conventional (WURC) at the time of filing to formulate the composition for administration to subjects (¶0015). As such, beyond the JE, the instant claims only recite WURC formulations for administration to a subject. The WURC formulations constitute insignificant extra-solution activities, which do not reasonably provide an inventive concept. As such, 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.
Response to Arguments
Applicant contends on pages 5-6 of the Remarks submitted 26 August 2026 that a) a pharmaceutical composition is a non-natural structure, and therefore, structurally different from the naturally occurring substance and b) that placing the bacteriophage is an emulsion, capsule, powder, or syrup changes that functional characteristics of the naturally occurring product.
In response: Formulating the bacteriophage into a capsule, syrup, etc. does not result in any markedly different characteristics with respect to function, structure, or any other property to distinguish the claimed bacteriophage from their naturally occurring counterparts. For example, Applicant contends that Richard, et al. (Pharmaceuticals (Basel). 2021 May 2;14(5):424., NPL-IDS, filed, 07/16/2026, hereinafter “Richards”) teaches that encapsulating a bacteriophage changes the functional characteristic by allowing the bacteriophage to survive longer in low pH (Remarks pg. 5-6). Richards specifically teaches about encapsulation in polymer formulations (Abstract). The broadest reasonable interpretation of the claim would allow for polymer encapsulation but would also allow for encapsulation in a cellulose capsule, or any other generic capsule, which would not confer the same protections against low pH that Richard teaches. Therefore, the act of formulating into a capsule does not markedly change the structure, function, or any other characteristic of the bacteriophage to be able to distinguish it from the naturally occurring counterpart. Furthermore, Murthy evidences that it was well-understood, routine, and conventional (WURC) at the time of filing to formulate the composition for administration to subjects (¶0015). As such, the instant claims still do not recite significantly more than JE.
Allowable Subject Matter
Claims 14, 16-17, 19, and 26-33 are allowed.
Conclusion
CLAIMS 13, 20, AND 23-25 ARE REJECTED.
CLAIMS 14, 16-17, 19, AND 26-33 ARE ALLOWED.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cassandra Senn Grizer whose telephone number is (571)272-2292. The examiner can normally be reached M-Th 0630 - 1700 ET.
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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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/CASSANDRA SENN GRIZER/ Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
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