DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. This Office Action is in response to the amendments filed 23 April 2026 and 27 April 2026, wherein Applicant amended claims 14-15 and 20-21; canceled claims 17 and 19; and added new claims 22-29.
Claims 13-16, 18, and 20-29 are under consideration.
Priority
3. Receipt is acknowledged of certified copies of papers required by 35 CFR 1.55.
Claim Interpretation
4. Regarding claim 13, “A method for treating or ameliorating infectious diseases caused by Clostridium perfringens” is interpreted to only include diseases that are directly caused by C. perfringens and not, for example, an opportunistic infection.
It is noted that treatment does not encompass prevention. See the definitions of both terms on page 4 of the Instant specification.
Objections Withdrawn
Claim Objections
5. The warning over claims 17 and 19 for being substantial duplicates of claim 16 and 18, respectively, has been withdrawn in view of Applicant’s amendments.
Rejections Withdrawn
Claim Rejections - 35 USC § 112(b)
6. The rejection of claim 14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in view of Applicant’s amendments.
Claim Rejections - 35 USC § 112(a) – Enablement
7. The rejection of claims 13-21 under 35 U.S.C. § 112 (pre-AIA ), first paragraph or 35 U.S.C. 112(a), because 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, because the specification does not provide evidence that the claimed biological materials are (1) known and readily available to the public; (2) reproducible from the written description, is withdrawn in view of the Deposit Receipt and deposit statement field 23 April 2026.
8. The rejection of claims 15 and 20-21 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for using the bacteriophage deposited as KCCM12934P against strains of C. perfingens, does not reasonably provide enablement for similar uses against just any and all bacteria, is withdrawn in view of Applicant’s amendments.
Claim Rejections - 35 USC § 112(d)
9. The rejections of claims 20-21 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, for failing to include all the limitations of the claim upon which it depends, are withdrawn in view of Applicant’s amendments.
Objections Maintained
Specification
10. The objection to the Abstract for its implicative language (“The present disclosure provides”) is maintained.
New Objections
Claim Objections
11. Claim 21 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 20. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Page 9 of the Instant Specification defines disinfectant to “remove C. perfringens” while the cleaning agent “cleans the skin surface or body part of animals”. However, both of these compositions will ultimately remove C. perfringens and thus the only difference between these claims is semantics.
New Rejections
12. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112(b)
13. Claims 22-23 and 25-26 are 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.
Regarding claims 22-23 and 25-26, “effective amount of bacteriophage” to administer should be given in doses. The units of PFU/mL or PFU/g are concentrations and thus is it unclear if this is X PFU per milliliter/gram of composition or in relation to the subject. Said another way, these do not seem to be therapeutic doses but that is what the claims require.
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, second paragraph, as indefinite.").
Claim Rejections - 35 USC § 112(a) – New Matter
14. Claims 22-23 and 25-26 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Page 4 of the Instant Specification gives support for a composition comprising the CJ_CP_20-25 bacteriophage at 1 x 102 PFU/mL to 1 x 1012 PFU/mL or 1 x 105 PFU/g to 1 x 1010 PFU/g. These are concentrations within the composition, not doses. Therefore, there is no support for specific doses that will be administered to subjects in the Instant Specification.
This is a new matter rejection.
Art-Free Subject Matter
15. A bacteriophage with the accession number KCCM12934P is currently free of the prior art.
Conclusion
16. Claims 13-16, 18, 20, 24, and 27-29 are in an allowable state. 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 KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KRISTINA E. LY/Examiner, Art Unit 1671
/Michael Allen/Supervisory Patent Examiner, Art Unit 1671
Prosecution Insights