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 .
Response to Amendment
The amendment filed 13 April 2026 in which claims 13-14, and 19-21 were amended, claims 23-25 were added, and claims 15, 18, and 22 were cancelled has been entered.
Claims 13-14, 16-17, 19-21, and 23-25 are under examination on the merits.
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.
(Previous rejection, withdrawn as to claims 13-14, 16-17, 19-21, and 23-25). Claims 13-14, 16-17, and 19-21 were 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. The rejection is withdrawn due to Applicant’s filing of the Deposit receipt and Deposit Statement on 13 April 2026.
(Previous rejection, withdrawn as to claim 15 due to cancellation of the claim and withdrawn as to claims 14 and 16). Claims 14-16 were 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. The rejection to claim 15 is withdrawn due to Applicant’s cancellation of the claim submitted 13 April 2026 and to claims 14 and 16 due to Applicant’s amendment to claim 14 submitted 13 April 2026.
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.
(Previous rejection, withdrawn as to claims 15, 18, and 22 due to cancellation of the claims). Claims 15, 18, and 22 were 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 rejection to claims 15, 18, and 22 is withdrawn due to Applicant’s cancellation of the claims submitted 13 April 2026.
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 and 20-21, withdrawn as to 22 due to cancellation of the claim, and extended to newly added claims 23-25 as set forth below).
Claims 13, 20-21, 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 of invention (STEP 1: YES).
The instant Specification evidences 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. Additionally, the broadest reasonable interpretation of an additive recited by instant claim 20 and an excipient recited by instant claim 21 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.
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 no 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. There 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 4-5 of the Remarks submitted 13 April 2026 that formulating the bacteriophage into an emulsion, pill, capsule, granule, tablet, troche, lozenge, powder, syrup, or elixir makes the bacteriophage structurally different from the naturally occurring bacteriophage.
In response: The addition of formulating the bacteriophage into a capsule, syrup, etc. does not 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. 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, and 19 are allowed.
Conclusion
CLAIMS 13, 20-21, AND 23-25 ARE REJECTED.
CLAIMS 14, 16-17, AND 19 ARE ALLOWED.
THIS ACTION IS MADE FINAL. 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 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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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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