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 .
Status of the Claims
Claims 22-29 are pending (claim set as filed on 12/19/2024).
Priority
This application is a DIV of application no.: 17/576,444 (now abandoned), which has a provisional application no.: 63/137,945 filed on 01/15/2021.
Drawings
No drawings were filed in this application.
Information Disclosure Statement
No Information Disclosure Statement (IDS) has been filed in this application. Applicant is reminded that each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the U.S. Patent and Trademark Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability (see 37 C.F.R. §1.56).
Claim Interpretation
Independent claims 22 and 26’s preamble recitation of “A method for treating an animal for subclinical or clinical coccidiosis through modulation of the TLR pathway” denotes that the claimed inventions, as a whole, are directed to methodologies of use or treatment (i.e., its statutory category of invention) (MPEP 2111.02: Effect of the Preamble and MPEP 2141.02(I)). In other words, the principle or primary mode of operation is the application of a product (i.e., a biomass-based bacteria mixture) to treat a disease or disorder of a specific patient population.
However, said claims also recite, in part, the phrases of “the composition being formed from …” which invokes the interpretation of product-by-process limitations. The MPEP 2113 states that “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”. Therefore, said phrases have been considered but they have limited patentable weight because it drafts or employs a process of making within an overall method of treatment (i.e., a nested or embedded product-by-process claims).
Accordingly, the emphasis of patentability analysis will be based upon the treatment of the disease with its respective pharmaceutical ingredients of the product and not how the product was made or manufactured.
Claim Rejections - 35 USC §112, Indefinite
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.
Claims 22-29 are 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.
Claims 22 and 26 are rejected as being indefinite because it recites the abbreviation of “TLR”. An abbreviation should be preceded in its first occurrence by the specific identity of the entity which said abbreviation is intended to represent. A review of the specification does not define the meaning of “TLR” and therefore, the abbreviation may have multiple meanings (e.g., Toll-Like Receptor, T-lymphocyte recognition, etc.) which leads to confusion of the precise definition. As noted in the quotation above, the specification should have clear and concise support for the claimed term “TLR” because otherwise, Applicant may change its intended meaning throughout different points in prosecution.
Claims 23-25 and 27-29 are rejected because they are dependent claims that do not overcome the deficiencies of the rejected claim from which they depend.
Claim Rejections - 35 USC §103, Obviousness
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 non-obviousness.
Claims 22-29 are rejected under 35 U.S.C. 103 as being unpatentable over: (1°) Ulsemer (US 2023/0277607 A1, with a PCT filing date of 07/14/2020) in view of
(2°) Tate (The Effects of Plant Growth Substances and Mixed Cultures on Growth and Metabolite Production of Green Algae Chlorella sp.: A Review, 2013),
(3°) Chaudhary (Effect of Sphingomonas sp., as a Probiotic on Survival, Growth and Biochemical Constituents of Vibrio anguillarum Challenged Labeo rohita Fingerlings, 2020),
(4°) Ushakova (Microbacterium oxydans, a Symbiont of Djungarian Hamster Which Displays Probiotic Properties, 2004).
Ulsemer’s general disclosure relates to a composition comprising modified non-pathogenic microorganisms for oral drug delivery systems and anti-infectious agents as well as for various applications and/or treatments (see abstract & ¶ [0001]). Non-pathogenic microorganisms especially food graded microorganisms displaying a specific structure (e.g., oligosaccharide, peptide, proteins) on their surface have a broad application potential in food and medicine (claim interpretation: this reads on the claim limitation of “active sites” of claim 26 (see ¶ [0002], [0005], [0282]-[0283]). Ulsemer teaches the disease to be treated includes gastrointestinal disease including intestinal coccidiosis (see ¶ [0203]).
Ulsemer teaches a mixture of microorganisms are naturally occurring and are used as an active ingredient in a pharmaceutical composition (see ¶ [0067]-[0073], [0141], [0144]). From a laundry list, Ulsemer does mention wherein said microorganism is selected from the group that includes: Algoriphagus sp., Bosea sp., Brevundimonas sp., Desulfovibrio sp., Microbacterium sp., Sphingomonas sp., and Variovorax sp. (see ¶ [0279]-[0280]).
However, Ulsemer does not particularly teach: the algal biomass comprising the claimed bacteria combination that includes two of the claimed bacteria.
Regarding the Brevundimonas and algal biomass, Tate discloses that microalgae provide a number of valuable products that includes food supplements, animal feed additives, and aquaculture feed wherein some important bioproducts produced by microalgae include the high-value carotenoid astaxanthin (see page 417, right col.). Tate teaches the co-culture of Chlorella cells with Brevundimonas sp. wherein the bacteria appeared to promote the growth of the algae (see abstract & page 423, left col.).
Regarding the Sphingomonas sp., Chaudhary discloses that “probiotics are live microbial cultures when added to feed or rearing water, result in improved health status and growth of host animals” (see page 1, left col.). Probiotics are microbes to enhance the nutritional values of food (see page 6, left col.). Chaudhary teaches Sphingomonas sp. as a probiotic bacterium and enhanced survival rate (see abstract, & page 4: Results, & page 7: Conclusion). Chaudhary discloses feed additive or supplement may include microalgae (see page 1, right col.).
Regarding the Microbacterium, Ushakova discloses that “Probiotics stimulate uptake and digestibility of feed, thereby providing intensive growth and development in animals” (see page 555, left col.). Ushakova teaches the isolated bacterium of Microbacterium species displayed probiotic properties which manifested itself in increased overall body weight and weight of several organs and stimulation of both cell-mediated and humoral immunities (see abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ or combine the bacterial strains of Brevundimonas, Sphingomonas, and Microbacterium as respectively taught above by Tate, Chaudhary, and Ushakova into the composition of Ulsemer. The ordinary artisan would have been motivated to do so is because each of the bacterial strains and their functional benefits are already known and individually taught in the prior art. Moreover, the MPEP 2141(III) provides examples of rationales that may support a conclusion of obviousness include:
(a) combining prior art elements according to known methods to yield predictable results; (e) obvious to try – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; or
(g) some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Accordingly, it would have been reasonable for an ordinary artisan to select and use each of the claimed bacterial strains for its documented probiotic or beneficial advantages/effects. The ordinary artisan would have had a reasonable expectation of success because all of the references are in the same field of endeavor directed to compositions comprising bacterial microorganisms.
Regarding the claimed concentration or amount, first note that the claimed term of “about”, the recitation of said term without definition in the specification of how much variation permits a broad interpretation of the range allowed (MPEP 2173.05(b)(II)(A): Relative Terminology). Furthermore, the MPEP 2144.05(II) states that: “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. Where 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”. Therefore, one of ordinary skill in the art would recognize the claimed concentration or amount is a result effective variable dependent on various factors. For example, Ulsemer discloses that “The appropriate dosage, or therapeutically effective amount, will depend on the condition to be treated, the severity of the condition, prior therapy, and the patient’s clinical history and response to the therapeutic agent. The proper dose can be adjusted according to the judgment of the attending physician such that it can be administered to the patient one time or over a series of administrations. The pharmaceutical composition can be administered as a sole therapeutic or in combination with additional therapies as needed” (see ¶ [0189]). This is motivation for someone of ordinary skill in the art to practice or test the parameter values widely to find those that are functional or optimal which then would be inclusive or cover those values as instantly claimed. Absent any teaching of criticality by the Applicant concerning the claimed concentration or amount, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variable which can be met as a matter of routine optimization (MPEP 2144.05 II).
Conclusion
No claims were allowed.
Correspondence Information
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
