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 .
Priority
This is a National Stage Entry under 35 U.S.C. 371 of International Patent Application
No. PCT/KR2021/007481, filed June 15, 2021 and Foreign Patent Application, KR10-2021-0024235, filed February 23, 2021.
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.
The invention appears to employ a specific bacteriophage, i.e., KCCM12936P. It is not clear if the written description is sufficiently repeatable to avoid the need for a deposit. Further it is unclear if the starting materials were readily available to the public at the time of invention.
It appears that a deposit was made in this application as filed as noted on pages 18 and 19 of the specification. However, it is not clear if the deposit meets all of the criteria set forth in 37 CFR 1.801-1.809. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
1. Identifies declarant.
2. States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
3. States that the deposited material has been accorded a specific (recited) accession number.
4. States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
5. States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
6. States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
7. That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g. see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
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 infectious disease caused by enterotoxigenic Escherichia coli (ETEC), does not reasonably provide enablement for preventing any infectious disease caused by ETEC . 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.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to:
• (A) The breadth of the claims;
• (B) The nature of the invention;
• (C) The state of the prior art;
• (D) The level of one of ordinary skill;
• (E) The level of predictability in the art;
• (F) The amount of direction provided by the inventor;
• (G) The existence of working examples; and
• (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Here, the instant claims are broadly drawn to a method for preventing infectious disease caused by enterotoxigenic Escherichia coli (ETEC) within a subject by administering the bacteriophage of claim 13. It is noted that the term “preventing” was interpreted in an absolute sense to mean to always keep something from happening or arising. The level of skill in the art is high and would include, e.g., Ph.D. level scientists
Koutsianos et al. (Vet Sci, 2020) teaches that the prevention of colibacillosis has been “investigated through vaccination, with variable outcomes” (Abstract). Wernicki et al. (Virol J. 2017) also teaches that while there are limitations and unpredictability in the use of bacteriophages to eliminate pathogens, with preventative treatment phage therapy not guaranteed to prevent colonization (Section: The main obstacles to the use of phage therapy in poultry, ¶ 1) and further teach a necessity to determine the optimal timing and delivery of phage therapy in in-vivo settings (Section: The main obstacles to the use of phage therapy in poultry, ¶ 2). Similarly, Tsonos et al. (Vet Microbiol, 2014) also teaches that the “outcome of phage therapy [is] highly variable depending on the disease incidence” (Abstract). Indeed, Kittler et al. (Pathogens, 2020), in a practical in-vivo experiment teach that preventative phage therapy was not enough to reduce enterotoxigenic Escherichia coli colonization (Abstract). As such, the art offers no predictability for the prevention of colibacillosis with the use of bacteriophage therapy in any subject.
The Specification only exemplifies and reduces to practice bacteriolysis of enterotoxigenic Escherichia coli (ETEC) strains with KCCM12936P in an in-vitro cell culture setting. However, the Specification offers no reasonable direction or working example for the absolute prevention of any infectious disease caused by ETEC in virtually any subject in-vivo.
In view of the foregoing, a vast quantity of experimentation, including expansive clinical trials, would be needed to use the invention based on the content of the disclosure.
Taken together, 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.
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.
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 against ETEC." is an inherent function of the bacteriophage. As such, it does not further limit the claims since the claims 15, 18, and 22 are already limited to a single bacteriophage that inherently possesses specific bactericidal activity against ETEC . 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.
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.
Claims 13 and 20 - 22 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, which is a statutory category of invention, i.e., a composition of matter (Step 1: YES).
The instant claims are directed to a bacteriophage. The KCCM12936P bacteriophage is readily found in nature and is a naturally occurring biological entity. As evidenced by Example 1 in the Specifications 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.
Isolating naturally occurring bacteriophage and, in some embodiments, combining the naturally occurring bacteriophage with water, 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.
Conclusion
NO CLAIMS ARE ALLOWED
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