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 .
DETAILED ACTION
Claim Status
2. This Office Action is in response to the amendment filed 23 April 2024, wherein Applicant cancelled claims 1-12 and added new claims 13-21.
Claims 13-21 are being considered.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 24 August 2023 and 14 August 2024 and the references cited therein have been considered, unless indicated otherwise.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
4. Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
5. Applicant is advised that should claims 16 or 18 be found allowable, claims 17 or 19, respectively, will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. 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).
Appropriate correction is required.
Claim Interpretation
6. 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.
Claim Rejections - 35 USC § 112
7. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
8. Claim 14 is 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.
Claim 14 recites “the infectious diseases” but only gives one example and therefore it is unclear what else is to be treated. Examiner suggests to amend claims 13 and 14 to make “diseases” singular.
9. 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.
10. Claims 13-21 are rejected 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.
The claims are drawn to a bacteriophage that has been deposited with the accession number KCCM12934P. However, no statements or declarations have been provided as described below related to the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent. Furthermore, the specification does not recite any deposit information as detailed in the MPEP under 37 CFR 1.809(d). In addition, the biological deposit form filed on 24 August 2023 does not have an English translation.
It is apparent that KCCM12934P is required to practice the claimed invention because it is a necessary limitation for the success of the invention as stated in the claims. As a required element it must be known and readily available to the public or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the enablement requirements of 35 U.S.C. § 112, first paragraph, may be satisfied by a deposit of KCCM12934P. See 37 CFR 1.802. One cannot practice the claimed invention without the bacteriophage that specifically treats the strain. One cannot determine whether a bacteriophage has the necessary characteristics without access to KCCM12934P. Therefore, access to KCCM12934P is required to practice the invention. The specification does not provide a repeatable method for KCCM12934P without access to KCCM12934P and it does not appear to be readily available material.
Deposit of KCCM12934P in a recognized deposit facility would satisfy the enablement requirements of 35 U.S.C. 112., because the strains would be readily available to the public to practice the invention claimed, see 37 CFR 1.801 - 37 CFR 1.809.
If a deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made at an acceptable depository and that the following criteria have been met:
(a) during the pendency of this application, access to the invention will be afforded to one determined by the Commissioner to be entitled thereto;
(b) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained for a term of at least thirty (30) years and at least five (5) years after the most recent request for the furnishing of a sample of the deposited material;
(d) a viability statement in accordance with the provisions of 37 CFR 1.807; and
(e) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.803 - 37 CFR 1.809 for additional explanation of these requirements.
11. Claims 15 and 20-21 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 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. 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.
With respect to claim 15, In making a determination as to whether an application has met the requirements for enablement under 35 U.S.C. 112 ¶ 1, the courts have put forth a series of factors. See, In re Wands, 8 USPQ2d 1400, at 1404 (CAFC 1988). The factors considered include: (1) the breadth of the claims, (2) the nature of the invention, (3) the relative skill of those in the art, (4) the presence of absence of working examples, (5) the amount of direction or guidance provided, (6) the state of the prior art, (7) the level of predictability in the art, and (8) the quantity of experimentation necessary.
The claim is drawn to killing or reducing the growth of any and all types of bacteria using the claimed bacteriophage.
The nature of the invention is a bacteriophage with the accession number KCCM12934P.
The relative skill of those in the art is high.
The specification provides working examples for in vitro testing of KCCM12934P against different strains of C. perfringens, but does not provide working examples for any other type of bacterium.
The specification does not provide direction or guidance for using KCCM12934P in a context other than with C. perfringens.
The state of the prior art is such that it is well established that bacteriophages are species and often even strain-specific, as described by Koskella (Viruses, 2013, 5(3): 806-823; Introduction, ¶ 3) (See PTO-892: Notices of References Cited). Even in the event of evolution and mutation to better adapt to their hosts and increase host range, it is often short-lived (Introduction, ¶ 3). Furthermore, “We emphasize that there is currently insufficient evidence to make broad generalizations about phage host range in natural populations, the limits of phage adaptation to novel hosts, or the implications of phage specificity in shaping microbial communities.” (Abstract). Bacteriophage infectivity often is related to adsorption, structural changes of both the phage and host, and avoidance of degradation (Introduction, ¶ 3), all of which are specific for each bacteria species. In relation to C. perfringens, Seal (Poult. Sci., February 2013, 92(2): 526-533) (See PTO-892: Notice of References Cited) teaches that even within C. perfringens strains, bacteriophages that work against certain strains may face resistance in other strains (Results and Discussion, ¶ 5). Therefore, it can be said that bacteriophages isolated from C. perfringens often have a restricted host range for specific isolates, which can likely be attributed to evolution of the receptor and anti-receptor molecules in both the bacteriophage and isolates themselves (Results and Discussion, ¶ 5).
Thus, the state of the art recognized that it would be highly unpredictable to assume that KCCM12934P can infect other types of bacteria outside of C. perfringens without proper evidence to prove otherwise. Therefore, there would be no expectation of success for such function of the bacteriophage, as broadly as claimed and undue experimentation would be required to both identify any additional target of the phage and test successful treatment thereof in a host organism. Such work rises to the level of invention, well beyond routine experimentation.
In view of the lack of predictability in the art to which the invention pertains as evidenced by the art above, the lack of guidance and direction provided by Applicant, and the absence of working examples, undue experimentation would be required to determine which bacterial species are susceptible to KCCM12934P, of which is encompassed by the Instant claims.
With respect to claims 20-21, claim 13 requires treating internal diseases of a subject. However, these claims recite compositions for external use only to include disinfectant and cleaning agent. Since these cannot be given to the subject internally, the scope of these claims is not enabled.
12. 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.
13. Claims 20-21 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 limitations of claim 13 requires that the bacteriophage KCCM12934P be administered into a subject. However, claims 20-21 recite a disinfection and cleaning agent composition, respectively. This does not encompass all the limitations of claim 13, from which they depend, as these compositions cannot be given to a subject to treat the disease. 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.
Art-Free Subject Matter
14. A bacteriophage with the accession number KCCM12934P is currently free of the prior art.
Conclusion
15. No claim is allowed. 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.
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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.
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/KRISTINA E. LY/Examiner, Art Unit 1671
/Michael Allen/Supervisory Patent Examiner, Art Unit 1671