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 .
Claims 1-17 are pending. Claims 16-17 are withdrawn. Claims 1-15 are under examination.
Election/Restrictions
Applicant's election with traverse of Group I claims 1-15 in the reply filed on 2/27/26 is acknowledged. The traversal is on the ground(s) that Moon is limited to a single specific product: a soluble glucan oligomer having a molecular weight of 1-10 Kda, isolated exclusively from S. cerevisiae variant strain IS2 (KCTC 0959BP) and prepared by a specific enzymatic hydrolysis process.
Applicant argues that Moon does not teach or suggest the use of a yeast cell-derived product-as that term is discussed in the instant specification-such as yeast cells, a yeast cell culture, a yeast cell extract, a yeast-cell conditioned medium, or a yeast cell culture supernatant, for preventing or treating a viral respiratory infection. Indeed, a "yeast cell-derived product" is distinct from the single processed fraction disclosed in Moon.
This is not found persuasive because the specification defines “yeast cell-derived product” as relating to any product which can be obtained from yeast cells. See paragraph 34. Thus, the soluble glucan oligomer having a molecular weight of 1-10 Kda, isolated exclusively from S. cerevisiae variant strain IS2 (KCTC 0959BP) and prepared by a specific enzymatic hydrolysis process as stated by Applicant is a product which can be obtained from yeast cells used for treating or preventing bronchitis, pneumonia, influenza and cold linked to an influenza virus (A, B,C).
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/27/26.
Information Disclosure Statement
The information disclosure statement filed 3/27/24 has been considered and an initialed copy is enclosed.
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.
Claims 1-15 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 a method of treating a H1N1 PR8 infection in an individual comprising administering S. boulardii CNCM I-745 or its supernatant;
does not reasonably provide enablement for:
a method of preventing viral respiratory infection.
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.
Enablement is considered in view of the Wands factors (MPEP 2164.01(A)). These include: nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the Invention
The claims are drawn to a method of treating or preventing, viral respiratory infection in an individual comprising yeast cell derived product administered to the individual
Breadth of the Claims
The specification teaches that yeast cell-derived product relates to any product which can be obtained from yeast cells. See p. 4 lines 7-8.
Viral respiratory infections include virus of the Orthomyxoviridae family, Paramyxoviridae family, Hantaviridae family, Coronaviridae family, Picornaviridae family, Adenoviridae family, Herpesviridae family, Papillomaviridae family, and Parvoviridae family. Examples of such viruses are Influenza A virus, Influenza B virus, Influenza C virus, Parainfluenza virus, Mumps virus, Respiratory syncytial virus, Measles virus, SARS-Cov-1, SARS-Cov-2, MERS-Cov, Rhinovirus, Coxsachievirus, Echovirus and mutants or variants thereof.
Guidance in the Specification/The Existence of Working Examples
The specification teaches that S. boulardii CNCM I-745 supernatant post treatment significantly reduced the effects of H1N1 infection by increasing cell viability of +18% and +23% (p<0.01 and p<0.001) respectively compared to H1N1 infected control cells. In addition, the specification teaches that H1N1 PR8 infected cells post-treated with S. boulardii CNCM I-745 supernatant has no cytopathic effect. Furthermore, S. Boulardii CNCM I-745 supernatant increased H1N1-infected cell survival in comparison to H1N1 infected cells.
The specification does not correlate the increase in cell viability of H1N1 PR8 infected cells with prevention of the H1N1 PR8 infection or prevention of any other viral respiratory infection.
State of the Art and Predictability of the Art and Amount of experimentation Necessary
The prior art teaches that Sen et al (Fungal Genetics and Biology (2020), 10333, cited in IDS) prophylactic administration of yeast such as S. boulardii does not prevent infection such as GI infections and that potential benefits of using S. boulardii may vary largely based upon the nature of the infection or the host itself.
Several studies with S. boulardii have focused on treating infections which have various degrees of success, often case-specific. See Sen et al sections 2.1-2.2 and table 1.
Thus, it is unpredictable that S. boulardii and other yeast and their cell derived products can be used to prevent viral respiratory diseases without further experimentation and preventing viral respiratory disease is complex. The specification does not provide the mechanism of action of how S. boulardii and other yeast and their cell derived products prevent viral respiratory diseases
The specification does not correlate any of the in vitro effects of S. boulardii post treatment of H1N1 infected cells bacteria with preventing the full scope of viral respiratory diseases which all have different pathogenesis.
"The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art." "The "amount of guidance or direction" refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling". In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) and MPEP 2164.03.
More information needed to have been stated in the specification in order to enable the full scope of the intended use of the yeast to prevent viral respiratory diseases.
For these reasons the specification is not enabling for the full scope of the claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-7, 9-11 and 13-15 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Bellgrau et al. WO 2011/032119 3/17/2011.
Bellgrau et al disclose a method for preventing or treating a viral infection in an individual, comprising administering effective amounts of yeast cell-derived product and pharmaceutical compositions thereof to the individual. Bellgrau et al disclose with respect to infectious disease and other diseases, the methods of the invention can result in one or more of: prevention of the disease or condition, prevention of infection, delay of the onset of disease or symptoms caused by the infection, increased survival, reduction of pathogen burden (e.g., reduction of viral titer), reduction in at least one symptom resulting from the infection in the individual, reduction of organ or physiological system damage resulting from the infection or disease, improvement in organ or system function, and/or improved general health of the individual. See paragraph 109. Bellgrau et al disclose the pharmaceutical compositions comprising effective amounts of the yeast cell derived product and carriers or excipients. See paragraph 236 and 246. Bellgrau et al disclose the virus in influenza virus, adenovirus, parainfluenza virus, coronavirus and respiratory syncytial virus. See paragraph 201-202. Bellgrau et al disclose the yeast cell derived product is a whole or intact yeast cell, yeast spheroplast, yeast cytoplast, yeast ghost, subcellular yeast membrane extract or fraction thereof (aka yeast membrane particle) or yeast cell wall preparation. See paragraph 182 and 187-189.
Bellgrau et al disclose the yeast cell derived product is derived from Saccharomyces. See paragraph 189.
Bellgrau et al disclose further administering to the individual at least one additional compound useful for the prevention or treatment of the viral infection such as viral antigens. See paragraph 201-202. Bellgrau et al disclose the same method of claim 10 and thus will necessarily prevent or treat cell death induced by the viral respiratory infection. Bellgrau et al disclose the composition is administered orally, intradermally, subcutaneously, intramuscularly, intravenously, rectally, topically, nasally or arterially. See paragraph 245. Bellgrau et al disclose the yeast cell derived product is prepared from lyophilized yeast cells. See paragraph 236.
Claim(s) 1-7, 9-11 and 13-15 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Farber et al. US 2021/0085729 3/25/2021 cited in IDS.
Farber et al disclose a method for preventing or treating a viral respiratory infection such as influenza e.g. H1N1 influenza virus (influenza A) and coronavirus in an individual comprising administering a prophylactically or therapeutically effective amount of Saccharomyces boulardii or Kluyveromyces cells to the subject. See abstract, and paragraphs 10,96, 97, 145, 146, 190-191. Farber et al disclose the same method step and thus will necessarily result in preventing or treating cell death induced by the viral respiratory infections. Farber et al disclose that the Saccharomyces boulardii is lyophilized. See paragraph 120. Farber et al disclose the composition further comprises administering at least one additional compound useful for the prevention or treatment of a viral respiratory infection. See paragraph 175. Farber et al disclose pharmaceutical composition comprising effective amounts of S. boulardii administered orally, rectally, intravenous, etc. See paragraphs 159-175. Farber et al disclose the pharmaceutical composition comprises 1 to 10 lg CFU/mL. See claim 5.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 8, 10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farber et al. US 2021/0085729 3/25/2021 cited in IDS.
Farber et al disclose a method for treating a viral respiratory infection such as influenza e.g. H1N1 influenza virus (influenza A) and coronavirus in an individual comprising administering a prophylactically or therapeutically effective amount of Saccharomyces boulardii or Kluyveromyces cells to the subject. See abstract, and paragraphs 10,96, 97, 145, 146, 190-191. Farber et al disclose the same method step and thus will necessarily result in preventing or treating cell death induced by the viral respiratory infections. Farber et al disclose that the Saccharomyces boulardii is lyophilized. See paragraph 120. Farber et al disclose the composition further comprises administering at least one additional compound useful for the prevention or treatment of a viral respiratory infection. See paragraph 175. Farber et al disclose pharmaceutical composition comprising effective amounts of S. boulardii administered orally, rectally, intravenous, etc. See paragraphs 159-175. Farber et al disclose the pharmaceutical composition comprises 1 to 10 lg CFU/mL. See claim 5.
Regarding the yeast cell derived product is administered at a 0.00125 g/kg/d to 25 g/kg/d or a dosage of from 50-250 mg, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The Farber et al disclose the S. boulardii administered at 1 to 10 lg CFU/mL and administering 0.00125 g/kg/d to 25 g/kg/d or a dosage of from 50-250 mg would not have been inventive because this dose could have been discovered by one of ordinary skill in the art as of the effective filing date of the instant invention by routine experimentation starting with the dose disclosed by Farber et al.
Status of Claims
Claim 16-17 are withdrawn. Claims 1-15 are rejected.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
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