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 04/13/2026 in which claims 13, 14, 19, 20, and 21 were amended and claims 15, 18, and 22 were canceled, has been entered. Claims 1 – 12 were previously cancelled.
Claims 13, 14, 16, 17, and 19 -21 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.
Deposit
(Previous rejection, withdrawn as to claims 13 – 22) Claims 13 – 22 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the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.
Applicant has filed the Deposit receipt and a deposit statement to satisfy the deposit requirements.
Applicant has cancelled claims 15, 18, and 22.
Scope of Enablement
(Previous rejection, withdrawn as to claims 14 – 16) Claims 14 -16 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being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 infectious disease caused by enterotoxigenic Escherichia coli (ETEC), does not reasonably provide enablement for preventing any infectious disease caused by ETEC.
Applicant’s amendment to claim 14 has overcome the previous rejection.
Applicant has cancelled claim 15.
Claim Rejections - 35 USC § 112
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) 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.
Applicant has cancelled claims 15, 18, and 22.
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 and modified as to claims 13 and 20 – 21 in view of the amendment, withdrawn as to now canceled claim 22) Claims 13 and 20 – 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because for the reasons set forth below. See MPEP § 2106 for analysis parameters.
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 claims are directed to a bacteriophage in formulation of emulsion, pill, capsule, granule, tablet, troche, lozenge, powder, syrup, or elixir. The KCCM12936P bacteriophage is readily found in nature and is a naturally occurring biological entity. As evidenced by Example 1 in the Specification of the instant application, KCCM12936P was found and isolated in fecal samples from pigs, chicken, and bovine in Seoul.
Moreover, the broadest reasonable interpretation of an additive recited in claim 20 and an excipient in claim 21 would, include, e.g., water. In regards to an emulsion formulation, an emulsion would include naturally found mixtures of fat and water such as milk. In regards to a syrup formulation, an emulsion would include naturally found such as maple syrup. In regards 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 regards to a powder formulation, a powder would include bacteriophage in the absence of a liquid. In regards to a pill, granule, and tablet, bacteriophage powders can be naturally compressed and formulated using usually naturally occurring components, e.g., gelatin, cellulose, pectin, 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.
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 claims are limited to the JE. As such, the claims do not recite any additional elements that integrate the JE into a practical application, such as a specific treatment of prophylaxis (STEP 2A, Prong Two: NO).
Since, as discussed above, the claims are limited to solely the JE, the claims do not recite any additional elements that amount to significantly more than the JE itself. (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 page 4 of the Remarks: 35 U.S.C. § 112(a) rejection: Applicant states Claims 13-22 are rejected as allegedly failing to satisfy the enablement requirement as set forth on pages 3-5 of the office action and has filed the Deposit Receipt and a deposit statement to satisfy the deposit requirement. The Applicant also states claim 14 was amended to overcome the enable requirement set forth on pages 5-7 of the office action.
In response: i) Applicant has filed the Deposit receipt and a deposit statement to satisfy the deposit requirement.
ii) The newly amended claim 14 does overcome the 35 U.S.C. § 112(a) rejection.
Applicant contends on page 4 of the Remarks: 35 U.S.C. § 112(d) rejection: Applicant states “35 USC 112(d) 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, as set forth on page 7 of the office action. Without acquiescing to the merits of the rejections, Applicant has cancelled certain claims rendering the above rejection moot.”
In response: Applicant has cancelled claims 15, 18, and 22 overcoming the 35 U.S.C. § 112(d) rejection.
Applicant contends on page 5 of the Remarks: 35 U.S.C. § 101 rejection: Applicant states the amendments to claims 13 and 20-22 satisfy the requirement of no longer being directed to a judicial exception without significantly more and that "a pharmaceutical composition in a formulation of emulsion, pill, capsule, granule, tablet, troche, lozenge, powder, syrup, or elixir" is structurally different from the naturally occurring substances.
In response: As discussed above, under the broadest reasonable interpretation of the claims, formulating a naturally bacteriophage using naturally occurring components, e.g., gelatin, cellulose, pectin, 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, there is no recitation of any effective amount of additives, i.e., the claims encompass any de minimis amount of additive, e.g., a single molecule of trehalose, which would not impart any markedly different characteristics Therefore, these formulations do not rise to the level of a marked difference.
Conclusion
NO CLAIMS 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 Danyal H Alam whose telephone number is (571)272-1102. The examiner can normally be reached M - F 9am - 5pm.
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/DANYAL HASSAN ALAM/ Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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