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
This Office Action is in response to Applicant’s Arguments and Amendment filed, 06/24/2026, wherein the Amendment amended claims 1, 3, 8, 10, and 14-18, and cancelled claims 2 and 4.
Claims 1, 3, and 5-18 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
35 U.S.C. § 112(b)
Applicant’s amendments to claims 1, 3, 10, 14-15, and 17-18, and deletion of claims 2 and 4, are sufficient to overcome most of these rejections. See the 35 USC 112(b) rejections below for details regarding which rejections have been maintained/modified.
35 U.S.C. § 102 over WO 2014/058083
Applicant’s amendment to claim 1 that incorporates the limitations of previous claim 4, is sufficient to overcome this rejection.
35 U.S.C. § 102 over Oh
The 37 CFR 1.130(a) Declaration, filed 06/24/2026, in combination with the certified translation of the instant foreign priority document, is sufficient to show that the subject matter disclosed in 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), was obtained directly from the inventor/join inventor of this application, and is therefore, not prior art as set forth in 35 USC 102(b)(1)(A).
REJECTIONS-NEW & MODIFIED
Applicant’s amendments to the claims and the IDS filed 06/24/2026, have resulted in the below new and modified rejections. WO 2014/058083 and Jang continue to be relied upon as prior art references.
Claim Objections
(New) Claim 14 is objected to because of the following informalities:
-In claim 14, “γ-PGABM” should be replaced with - - γ-PGAbm- -, as recited in independent claims 1 and 16.
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.
(New & Modified) Claims 1, 3, 5-18 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.
-In claims 1, 3 and 14-16, the terms “γ-PGAbm” and “γ-PGAcm” render these claims indefinite because it is not clear if “bm” or “cm” following PGA impart structural or functional properties to the γ-PGA, or if they are merely descriptive of molecular weight (MW) of γ-PGA. 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. The prior art does not further define “γ-PGAbm” and “γ-PGAcm.”
Further, while independent claims 1 and 16 recite γ-PGAbm having a MW of 50-400kDa and γ-PGAcm as having a MW of 400kDa, it is not clear if γ-PGAbm having a MW of 400 kDa is the same as γ-PGAcm having a MW of 400 kDa, or if the “bm” and “cm” render 400kDa γ-PGAbm and 400kDa γ-PGAcm distinct.
In view of compact prosecution, for the purpose of applying prior art, 400kDa “γ-PGAbm” and 400kDa “γ-PGAcm” are interpreted as the same.
-Claims 14-15 are indefinite because they depend from a deleted base claim. If the base claim has been canceled, a claim which is directly or indirectly dependent thereon should be rejected as incomplete. MPEP 608.01(n).
In view of compact prosecution, for the purpose of applying prior art, claims 14-15 are interpreted as depending on claim 1.
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.
(Modified) Claims 1 and 5-18 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014/058083 Translation (published 2014, PTO-892 of 03/24/2026).
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 1, while ‘083 teaches a method of treating obesity by administering a 100-5000 kDa poly-γ-glutamic acid, it differs from that of instant claim 1 in that it does not specify a poly-γ-glutamic acid having a molecular weight of 50-400kDa or of 400kDa.
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 select 400kDa as the molecular weight of the poly-γ-glutamic acid in ‘083, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘083 teaches administration of poly-γ-glutamic acid have a molecular weight of 100-5000kDa, and
-in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05.
Regarding independent 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 having a MW of 400 kDa), 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 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 that 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 having a MW of 400 kDa to an obese patient. Since the method of ‘083 teaches the same method as instantly claimed, the limitations of these claims are met.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2014/058083 Translation (published 2014, PTO-892 of 03/24/2026), as applied to claims 1 and 5-18 above, and further 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 of 03/24/2026) and Lee (Physicochemical properties, production, and biological functionality of poly γ-D-glutamic acid with constant molecular weight from halotolerant Bacillus sp. SJ-10, published 2018, IDS of 06/24/2026).
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 are addressed below.
‘083 is applied 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 have a MW of 400kDa, 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”).
Lee teaches γ-PGA with constant molecular weight from halotolerant Bacillus sp. SJ-10 (title, abstract). Lee teaches that the γ-PGA with a molecular weight of 400kDa exhibited antioxidant activity, and thus teaches this γ-PGA as useful in biomedical industries, such as pharmaceutical industries (abstract, pg. 605, Col. 2; pg. 606, Conclusion). Lee further teaches producing γ-PGA from Bacillus sp. SJ-10 as an economical method for controlling the molecular weight of the γ-PGA produced (abstract).
Specifically, Lee teaches γ-PGA from Bacillus sp. SJ-10 as having potential for disease suppression effects associated with oxidative stress (pg. 605, Col. 2).
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 with a 400kDa MW taught by ‘083 with the γ-PGA with a 400kDa MW taught by Jang or Lee, 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 and Lee teach 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 and Lee 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.
Response to Arguments
On pg. 9, Remarks, Applicant argues that the rejection relies on a generalized disclosure of γ-PGA and does not disclose or suggest γ-PGAbm having a MW of 50kDa-400kDa or γ-PGAcm having a MW of 400 kDa.
This argument has been fully considered, but is not found persuasive. As discussed above, ‘083 teaches administration of poly-γ-glutamic acid have a molecular weight of 100-5000kDa, and in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05.
On pg. 10, Remarks, Applicant argues that Jang is directed toward the genome sequence of Bacillus sp. SJ-10 and does not teach or suggest the treatment of obesity or regulation of intestinal bacteria caused by obesity.
This argument has been fully considered, but is not found persuasive. While Jang teaches the genome sequence of Bacillus sp. SJ-10, it also specifically teaches γ-PGA of MW 400kDa from Bacillus sp. SJ-10 as useful in medicine. Regarding claim 3, it is respectfully pointed out that Applicant is arguing against the references individually when the rejection is made over a combination of references; one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The rejection is over ‘083 in view of Jang and Lee, wherein ‘083 is relied upon to teach ‘083 teaches a method of treating obesity in subjects by administering a composition comprising γ-PGA have a MW of 400kDa, and Jang and Lee are relied upon to specifically teach a γ-PGA from Bacillus sp. SJ-10.
For these reasons, Applicant’s arguments are not persuasive to overcome the instant rejections.
Conclusion
No claims are allowed.
Applicant's amendment necessitated, and Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 06/24/2026, prompted the new ground(s) of rejection presented in this Office action. necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622
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