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
The instant application claims the priority benefit of U.S. Provisional Application No. 63/544648, filed on 10/18/2023, under 35 U.S.C. 119(e).
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.
Claim 3 is rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim 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 claimed invention uses a novel biological material, specifically the Streptoccus thermophilus strain iHA318 deposited under accession number “DSM 33978”. Since this biological material is essential to the claimed invention, it must be 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 requirements of 35 U.S.C. 112(a) may be satisfied by a deposit of the biological material. Applicant must meet all the requirements of 37 C.F.R. 1.801-1.809, including providing an indication of the viability of the sample when the deposit was made.
According to the Specification (par. [0037]), the biological material was deposited in Deutsche Sammlung von Mikroorganismen und Zellkulturen on August 7, 2021 under the deposit accession number DSM 33978. If the deposit was made under the Budapest Treaty, then an affidavit or declaration by applicant, or a statement by the attorney of record over his/her signature and registration number, stating that the biological material will be released to the public irrevocably and without restriction or condition upon the issuance of a patent, would satisfy the requirement. Furthermore, applicant must state that the deposited material will be maintained for a period of 30 years, or 5 years after the most recent request date, whichever is longer.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) The deposit will be maintained in a public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit. 37 CFR 1.807 requires that the deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. A viability statement for each deposit of a biological material not made under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure must be filed in the application and must contain:
(1) The name and address of the depository;
(2) The name and address of the depositor;
(3) The date of deposit;
(4) The identity of the deposit and the accession number given by the depository;
(5) The date of the viability test;
(6) The procedures used to obtain a sample if the test is not done by the depository; and
(7) A statement that the deposit is capable of reproduction.
Claims 1-11 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for treating ocular cell damage using Streptococcus thermophilus iHA318, does not reasonably provide enablement for preventing ocular cell damage and using all strains of Streptococcus thermophilus. 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.
The factors considered when determining if there is sufficient evidence to support that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue” 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. See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). But MPEP § 2164.04 also states that although the analysis and conclusion of a lack of enablement are based on these factors and the evidence as a whole, it is not necessary to discuss each factor in the enablement rejection.
The nature of the invention is a method directed to preventing and/or repairing ocular cell damage by administering to a subject in need thereof a pharmaceutical composition comprising an effective amount of a S. thermophilus strain.
The level of one of ordinary skill is high and includes M.D. or Ph.D. level researchers.
The state of the art is that probiotics have only been known to be useful for treating inflammatory-related diseases like dry eye disease. For example, Tavakoli et al. (Journal of Clinical Medicine 2022, Vol. 11, article # 4889, pages 1-9) teaches that orally administering capsules of a probiotic composition for 4 months alleviates dry eye symptoms (Figure 1, page 4). The probiotic composition contains 21 billion CFU bacteria per capsule including Streptococcus, Lactobacillus, and Bifidobacterium species (second par., page 3). Based on what little is known in the art, it cannot be determined if all species of S. thermophilus are capable of preventing and/or repairing ocular cell damage. Thus, the nature of the invention seems unpredictable.
The claims are considered broader than what is enabled by the disclosure. Claims 1-11 recite that one aspect of the claimed method is “preventing” ocular cell damage. The term “preventing” is defined to means “preventing or delaying symptoms of disease onset when a drug or therapy is used to an individual who does not have symptoms of disease onset but is at high risk of disease onset” (par. [0033]). In working examples, the effects of S. thermophilus strain iHA318 were tested on retinal and corneal cells in vitro (par. [0054], [0056], [0058], [0060]), as well as in vivo in humans (par. [0064]-[0065]). Although less reduction in cell viability was observed in cells treated with S. thermophilus strain iHA318 compared to the damage group, some cells still no longer remained viable which indicate that said strain did not block the occurrence of ocular cell damage caused by UV radiation or hyperosmolarity (Figures 1-6). Thus, it cannot be clearly established that administering a S. thermophilus strain can effectively prevent cell damage.
Furthermore, claims 1-2 and 4-11 recite the use of any strain of S. thermophilus. However, only the S. thermophilus strain iHA318 was assessed by the applicant (par. [0061]). There is therefore no data regarding the effectiveness of other S. thermophilus strains in repairing ocular eye damage. MPEP § 2164.02 states that “For a claimed genus, representative examples together with a statement applicable to the genus as a whole will ordinarily be sufficient if one skilled in the art (in view of level of skill, state of the art and the information in the specification) would expect the claimed genus could be used in that manner without undue experimentation”. Given the unpredictability of the art and insufficient guidance from the applicant, claiming the use of the entire S. thermophilus species is not enabling because one cannot, following the guidance presented therein, practice the claimed method without making a substantial inventive contribution of proving that any strains other than iHA318 (DSM 33978) would necessarily repair ocular cell damage. The Court has held that when results are unpredictable, the disclosure of a single species does not provide an adequate basis to support generic claims.
Thus, claims 1-11 are not commensurate in scope with the disclosure as they are not enabled for the preventive aspect of the claimed method and for all strains of S. thermophilus.
Claim Rejections - 35 USC § 112
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.
Claim 6 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 6 recites “an external product”, which renders the instant claim indefinite because it cannot be determined what type of composition it is. In the interest of compact prosecution, the term “external product” is interpreted to mean a topical product suitable for application on a body surface.
Conclusion
No claim is allowed. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Tavakoli et al. (Journal of Clinical Medicine 2022, Vol. 11, article # 4889, pages 1-9).
Tavakoli et al. discloses a probiotic composition called “MULTIBIOTIC Probiotics™” in capsule form that contains 21 billion CFU bacteria per capsule including Streptococcus, Lactobacillus, and Bifidobacterium species (second par., page 3). Oral administration said probiotic composition for 4 months resulted in less dry eye symptoms as indicated by reduced Ocular Surface Disease Index scores (Figure 1, page 4; Table 1, page 5).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651
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