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 .
DETAILED ACTION
Claims 1-18 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Claim Objections
Claim 8 is objected to because of the following informalities:
-In claim 8, the term “the” prior to “expression of adipogenesis-related genes” should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-15 and 17-18 are 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.
-The term “improving” in claim 1, line 1, is a relative term which renders the claim indefinite. The term “improving” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably be apprised of the scope of the invention. It is not known what baseline measure is being relied upon to determine “improving,” and it is not known what measure from baseline differentiates “improving” from “not improving.” As such, the metes and bounds of the phrase a “method for improving obesity” is not clear.
Note: While the term “improvement” is defined in [0061] of the specification, this definition is not a limiting definition, but an example of what it may be. “The ‘improvement’ used herein may mean all actions that at least reduce parameters associated with conditions to be treated, for example, the degree of symptoms.”
-In claims 2-4 and 14-15, the terms “γ-PGAbm” and “γ-PGAcm” render these claims indefinite because the metes and bounds of “bm” or “cm” following PGA, are unclear. While [0091] of the specification state that γ-PGAbm encompasses a wide range of molecular weights and γ-PGAcm is a constant molecular weight, this definition, itself, is indefinite. Neither the range of molecular weights nor the constant molecular weight are defined. Further, it is not clear if γ-PGAbm encompasses more than one range of molecular weights or if it encompasses only one range of molecular weights, and it is not clear if γ-PGAcm encompasses one or more than one constant molecular weight. And since γ-PGAbm encompasses a wide range of molecular weights, it is not clear of γ-PGAcm is a species of γ-PGAbm, or of these γ-PGAs are distinct.
In view of compact prosecution, for the purpose of applying prior art, since “γ-PGAbm” is taught as comprising a wide range of molecular weight, “γ-PGAbm” is interpreted as any γ-PGA.
-In claim 10, the phrase “diet efficiency” renders the claim indefinite since neither the specification nor the prior art define this term, and the metes and bounds of this phrase are unclear. For example, it is not known if diet efficiency means choice of foods to meet a caloric requirement, or if it means how well the food is broken down and utilized as energy once the food is consumed, or if it means something else entirely.
-Claim 14 recites the limitation " γ-PGABM" in line 1. There is insufficient antecedent basis for this limitation in the claim.
-Claim 15 recites the limitation " γ-PGAcm" in line 1. There is insufficient antecedent basis for this limitation in the claim.
-In claim 14 the phrase “wherein when γ-PGABM is treated in the gut microorganisms…and Lactobacillus” renders the claim indefinite. Since γ-PGABM is administered to a subject, and the subject requires regulating gut microorganisms, it is not clear what the γ-PGABM is further treated with or how this method step relates to the method of administering γ-PGA to an obese patient. Moreover, it is not clear if the gut microorganisms are selected from “Clostridia, Clostridiales…and Lactobacillus,” or if the γ-PGA is treated by the species recited in lines 2-5 of the claim.
In view of compact prosecution, for the purpose of applying prior art, claim 14 is interpreted as “The method of claim 12, wherein the method increases clostridia. . .and lactobacillus, and decreases erysipelotrichia. . .and Lactobacillus.”
-For the same reason stated above, in claim 15, the phrase “wherein when γ-PGAcm is treated in the gut microorganisms. . .and Lactobacillus” is indefinite.
This claim is interpreted similarly to claim 14.
-In claims 17 and 18, the phrase “comprising treating poly-γ-glutamic acid,” in the last lines of the claims, renders the claims indefinite. Since poly-γ-glutamic acid is administered to a subject, it is not clear how increasing and decreasing different bacteria treats poly-γ-glutamic acid. It is not clear if the bacterium chemically modify the poly-γ-glutamic acid or if something else “treats” the poly-γ-glutamic acid. And it is further not clear how this relates to the step of administering γ-PGA to an obese subject.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
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 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.
Claims 1-2 and 5-18 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2014/058083 Translation (published 2014, PTO-892).
Regarding claim 1, ‘083 teaches a method of treating and preventing obesity in a subject, by administering compositions comprising a 100-5000 kDa poly-γ-glutamic acid, wherein the composition reduces the size of triglycerides and fat cells in the blood (abstract; pg. 5, “3-1”; pgs. 7-8, “4-2”; pg. 9, last paragraph).
‘083 specifically exemplifies administering γ-PGA to overweight rats (pg. 5) resulting in decreased triglycerides, HDL-cholesterol, and body weight (pgs. 5-7), and results in statistically significant changes in glucose and Cl (pgs. 8-9).
Regarding claim 16, Applicant is reminded that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. MPEP 2111.02.
‘083 teaches the same method steps as instantly claimed—the method of ‘083 administers the same active ingredient (γ-PGA), in an amount effective to treat obesity, to the same patient population (obese patients), as instantly claimed. As such, the method of ‘083 would necessarily regulate intestinal bacterial. See MPEP 2112.02.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art do not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claim 2, as discussed the 35 USC 112(b) rejection, “In view of compact prosecution, for the purpose of applying prior art, “γ-PGAbm” and “γ-PGAcm” and are interpreted as any γ-PGA.”
Regarding claims 5-15 and 17-18, these limitations are requirements of obese subjects. Since the subjects of ‘083 are obese, these limitations are considered met.
Moreover, ‘083 teaches inhibition of fat in adipocytes, reduction in adipocyte differentiation-related transcription factors; analyzing fat synthase gene expression; analyzing weight gain, lipid metabolism, adipocyte histologic morphology, and lipase gene expression; determining the triglyceride improvement function, and teaches the administered composition as having an inhibitor effect on adipocyte production, glycerol-6-phophsate dehydrogenase activity which regulated triglyceride biosynthesis, triglyceride accumulation (abstract; pgs. 3-5).
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the subjects of the prior art do not possess the same material, structural and functional characteristics of the claimed subjects. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed patient requirements are different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Further regarding claims 13-15, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In the instant case, the wherein clause expresses the desired result of the positive step of administering γ-PGA to an obese patient. Since the method of ‘083 teaches the same method, the limitations of these claims are met.
Claims 1-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oh (Poly-γ-D-glutamic acid ameliorates metabolic dysfunction by modulating metabolic gene expression and attenuating intestinal barrier injury, published 2022, IDS of 10/03/2023).
Note: There is no evidence on the record that the information relevant to the rejection originated from Lee, Jang, and Oh, the inventors of the instant application. This rejection may be overcome by invoking 102(b)(1)(A) because it appears that the publication date may be within the one year grace period. This exception can be invoked by filing a declaration or affidavit under 37 CFR 1.130(a) establishing that the subject matter disclosed was obtained directly or indirectly from the common joint inventors AND providing a reasonable explanation of additional names.
Regarding claim 1, Oh teaches a method of treating obesity by administering poly γ-glutamic acid, and specifically teaches its effect in alleviating metabolic dysfunction in high-fat diet induced obese mice (abstract, Materials & Methods). The recited “subject” of the claimed methods encompasses obese mice. “Subject” is not defined in Applicant’s specification.
Regarding claims 16-18, Oh teaches a method for regulating intestinal bacteria in obese mice by administering γ-PGA (“Histopathological analysis”).
Regarding claims 2-4, Oh teaches the γ-PGA as γ-PGAbm and γ-PGAcm, and teaches it as having a molecular weight of 100 and 160 kDa (Results & Discussion, Histopathological
Further regarding claim 3, Oh teaches the γ-PGA as isolated from SJ-10, i.e. Bacillus sp. SJ-10 (Introduction). It is further noted that the phrase “wherein the γ-PGAbm or γ-PGAcm is isolated from Bacillus sp. SJ-10 according to a molecular weight composition” is interpreted as a product-by-process limitation. However, due to the indefinite nature of γ-PGAbm and γ-PGAcm, the structures of γ-PGAbm and γ-PGAcm are unclear. As, such, “isolated from Bacillus sp. SJ-10” is fully addressed to meet this limitation.
Regarding claims 5-12, and 17-18, these limitations are requirements of obese subjects. Since the subjects of Oh are obese, these limitations are considered met.
Moreover, Oh teaches that the effects include reduced body weight, glucose tolerance, insulin resistance, glucose regulation, adipocyte size and infiltration, and lipid metabolism and gene expression (abstract, Results & Discussion, Histopathological analysis).
Regarding claims 13-15, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In the instant case, the wherein clause expresses the desired result of the positive step of administering γ-PGA to an obese patient, as instantly claimed. Since the method of Oh teaches the same method, the limitations of these claims are met.
Regarding claims 5-15, and 17-18, Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the subjects or products of the prior art do not possess the same material, structural and functional characteristics of the claimed subjects or products. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed subject is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
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.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014/058083 Translation (published 2014, PTO-892) in view of Jang (Complete Genome Sequence of Bacillus sp. SJ-10 (KCCM 90078) Producing 400-kDa Poly-γ-glutamic acid, published 2018, PTO-892).
Note: Claim 3 is interpreted as a product-by-process limitation. However, due to the indefinite nature of γ-PGAbm and γ-PGAcm, the structures of γ-PGAbm and γ-PGAcm are unclear. As such, the specific limitations of claim 3 and claim 4, which depends from claim 3, are addressed below.
‘083 is applied to claims 1-2 and 5-18, as discussed above, and incorporated herein.
Regarding claim 3, while ‘083 teaches a method of treating obesity in subjects by administering a composition comprising γ-PGA, it differs from that of instant claim 3, in that it does not teach the γ-PGA as isolated from Bacillus sp. SJ-10.‘083 further teaches its γ-PGA as a substance produced by Bacillus subtilis Chungkukjang strain, a salt-tolerant strain (pg. 2).
Jang teaches Bacillus sp. SJ-10 as a bacterium isolated from a traditional Korean food that can survive and engage in metabolism at high salt concentrations, and that encodes a subunit of γ-PGA with a molecular weight of approximately 400 kDa (abstract).
Jang teaches γ-PGA for use in medicine (pg. 1378, “Introduction”). It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the γ-PGA taught by ‘083 with that taught by Jang, to arrive at instant claim 3. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-‘083 teaches its γ-PGA as derived from salt tolerant Bacillus subtilis (i.e., “Bacillus sp.”),
-Jang teaches its γ-PGA as derived from salt tolerant Bacillus subtilis and as useful in medicine,
-083 teaches its γ-PGA as having a molecular weight of 100-5000kDa,
-Jang teaches its γ-PGA as having a molecular weight of 400kDa, and
-substituting equivalents known for the same purpose is prima facie obvious, see MPEP 2144.06.
As such, an ordinary skilled artisan would have been motivated to make such a substitution, to predictably arrive at a γ-PGA that is effective for treating obesity, since both γ-PGA’s are isolated from salt tolerant Bacillus subtilis and appear to be substantially similar.
Regarding claim 4, the combination of ‘083 and Jang teach the γ-PGA as 400kDa.
Conclusion
No claims are allowed.
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/LAUREN WELLS/Examiner, Art Unit 1622