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
Examiner notes that no certified translation of the Foreign Application JP2022-050275, filed 03/25/2022, has been placed on record. If applicant wants the application to be accorded benefit of the non-English language application, a certified translation is required, see 35 U.S.C 119(b)(3). Applicant is advised that any showing of priority that relies on a non-English language application is prima facie insufficient if no certified translation of the application is on file.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 12/17/2024, 08/06/2025, 04/08/2026, and 06/29/2026 were considered by the examiner.
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.
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 10-17 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.
Claims 10 and 14 are dependent on canceled claim 1
Claims 11-13 are dependent on canceled claim 2
Claims 15-17 are dependent on claim 14, that is dependent on canceled Claim 1
The claims need to be rewritten to only include dependency and subject matter from examined claims.
For example:
Claim 10 states, “The aqueous composition according to claim 1”, should state, “The aqueous composition according to claim 9”
Appropriate correction is required.
For the purposes of applying prior art, the Examiner is interpreting claims 11-14 to depend from claim 10, and claims 15-17 to depend from claim 14 as written.
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.
Claim 9 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deng (Guan-hua Deng, CN 111024960 A, Pub. Date: 04/17/2020, as cited on IDs dated 04/08/2026, machine translation).
Regarding Claims 9, Deng teaches phenylbutyric acid as an angiotensin-converting enzyme inhibitor additive for detecting blood samples for hypertension (Pg. 2, Claim 3).
(4-Phenylbutyric acid (4-PBA) is the International Union of Pure and Applied Chemistry (IUPAC) name of Phenylbutyric acid, therefore 4-PBA and phenylbutric acid are considered equivalent).
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.
Claims 10-12, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Deng (Guan-hua Deng, CN 111024960 A, Pub. Date: 04/17/2020, as cited on IDs dated 04/08/2026, machine translation) in view of Raina (as cited on IDS dated 04/08/2026, in Non-Patent Literature).
The teachings of Deng are set forth in the above 102 rejection and are incorporated herein by reference.
Regarding Claim 10, Deng teaches phenylbutyric acid as an angiotensin-converting enzyme inhibitor additive for detecting blood samples for hypertension (Pg. 2, Claim 3).
Regarding Claims 11 and 16, Deng teaches a buffer agent as a further addition to the composition containing phenylbutyric acid (Pg. 2, Claim 5).
Regarding Claims 12 and 14, Deng teaches dipottasium ethylenediaminetetraacetate (EDTA), as an anticoagulant additive to the aqueous composition (Pg. 2. Claim 5).
Deng does not teach the aqueous composition of phenylbutyric acid “stored in a container of which a portion in contact with the aqueous composition is partly or wholly made of a resin containing a polyolefin”.
Raina teaches polyethylene as the most widely used material for plastic containers for pharmaceutical purposes. Raina also discloses high density polyethylene is preferred over low-density polyethylene because as the density increases, the material becomes less permeable to reactive gases, and is better for packing of oxygen sensitive drugs (Pg. 252, Plastic).
Regarding Claims 10-12, 14, and 16, It would have been prima facie obvious for one of ordinary skill in the arts before the effective filing date, to take the aqueous composition disclosed in Deng, and combine with the technique of packaging pharmaceuticals in polyethylene containers disclosed in Raina to yield a predictable result of dispensing/storing the aqueous composition.
Regarding Claim 15, Deng teaches 1-8 parts of phenylbutyric acid by weight, and 6-20 parts of dipotassium EDTA (Pg. 7, [0031]). The concentration by weight of the chelating agent, dipotassium EDTA, disclosed in Deng, overlaps with the ranges of 1 part by mass of 4-phenylbutyric acid and 0.0002 to 1,200 parts by mass of a chelating agent in instant Claim 15.
Regarding Claim 15, The courts found that, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.
Claims 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Deng (Guan-hua Deng, CN 111024960 A, Pub. Date: 04/17/2020, as cited on IDs dated 04/08/2026, machine translation) in view of Raina (as cited on IDS dated 04/08/2026, in Non-Patent Literature), as applied to claims 10 and 14 above, and further in view of Truog (Peter Truog et al., “Pharmaceutical Unit Dosage Form Comprising 4-phenylbutyric Acid”, EP 2698155 A1, Pub. Date: 2014-02-19).
The teachings of Deng are set forth in the above 102 rejection and are incorporated herein by reference. The teachings of Raina are set forth in the above 102 rejections and are incorporated herein by reference.
Regarding Claims 13 and 17, Deng teaches a buffer solution of acetic acid and sodium acetate at a pH of 5.5 to 6.5 (Pg. 13, [0072]).
Deng does not teach the full pH range of the aqueous composition disclosed in instant Claim 13 as 6.0 to 9.0, and 5.0 to 9.0 in instant Claim 17.
Truog teaches a composition containing 4-phenylbutyric, and a buffer agent. The pH of the composition is disclosed as 6 to 9 in a preferred embodiment (Abstract, and Pg. 14, [[0135]).
Regarding Claim 13, The courts found that, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.
It would have been obvious for one of ordinary skill in the art
Regarding claims 13 and 17, it would have been obvious for one of ordinary skill in the art to use the pH range disclosed in Truog for 4-PB compositions and combine it with the teachings of Deng, to arrive at the pH ranges disclosed in instant claims 13 and 17 because Deng and Truog both teach pharmaceutical compositions containing 4-phenylbutyric. It would be obvious to use the pH range in Truog because it is a larger range, and one of ordinary skill in the arts would optimize the pH of the 4-PB composition for pharmaceutical use.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims1 of copending Application No. 19/519,004, herein ‘004 (reference application).
Instant Claim 9 teaches “an aqueous composition comprising: 4-phenylbutyric acid or esters thereof, or a pharmacologically acceptable salts therof.”
Claim 1 in copending application ‘004, discloses:
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Although the claims at issue are not identical, they are not patentably distinct from each other because both applications claim an aqueous composition comprising 4-phenylbutyric acid.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 10-13 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 5 of copending Application No. 19/519,004 in view of Raina (as cited on IDS dated 04/08/2026, in Non-Patent Literature).
Instant Claims 10-14, and 16-17 disclose:
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Claims 1, 4 and 5 in copending application ‘004, discloses:
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Although the claims at issue are not identical, they are not patentably distinct from each other because both applications claim an aqueous composition comprising 4-phenylbutyric acid, a buffer agent, a chelating agent, and a pH of 6.0 to 9.0 for the composition.
Copending application ‘004 does not disclose the aqueous composition stored in a container partly or wholly made of a resin containing a polyolefin.
Raina teaches polyethylene as the most widely used material for plastic containers for pharmaceutical purposes. Raina also discloses high density polyethylene is preferred over low-density polyethylene because as the density increases, the material becomes less permeable to reactive gases, and is better for packing of oxygen sensitive drugs (Pg. 252, Plastic Material).
Regarding instant Claims 10-14, and 16, It would have been prima facie obvious for one of ordinary skill in the arts before the effective filing date, to take the aqueous composition disclosed in copending application ‘004, and combine with the technique of packaging pharmaceuticals in polyethylene containers disclosed in Raina to yield a predictable result of dispensing/storing the aqueous composition.
Regarding instant Claim 17, the pH range disclosed in Claim 1 of copending application ‘004, for an aqueous composition as 6.0 to 9.0 overlaps with the range disclosed in instant Claim 17, as 5.0 to 9.0 for the aqueous composition.
Regarding Claim 17, The courts found that, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.
This is a provisional nonstatutory double patenting rejection.
Claim 15 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 5 of copending Application No. 19/519,004 in view of Raina (as cited on IDS dated 04/08/2026, in Non-Patent Literature), and in further view of Deng (Guan-hua Deng, CN 111024960 A, Pub. Date: 04/17/2020, as cited on IDS dated 04/08/2026, machine translation).
The teachings of Raina are set forth in the above Provisional Non-Statutory Double Patenting rejection and are incorporated herein by reference.
Instant Claim 15 discloses:
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Claim 5 in Copending application ‘004, and Raina do not disclose the content of the chelating agent.
Regarding Claim 15, Deng teaches 1-8 parts of phenylbutyric acid by weight, and 6-20 parts of dipotassium EDTA (Pg. 7, [0031]).
Regarding Claim 15, the range disclosed in Deng as 1-8 parts by weight of phenylbutyric and 6-20 parts by weight of a chelating agent dipotassium EDTA overlaps with the ranges of 1 part by mass of 4-phenylbutyric acid and 0.0002 to 1,200 parts by mass of a chelating agent.
Regarding Claim 15, The courts found that, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.
Therefore, it would have been prima facie obvious for one of ordinary skill in the arts to take the aqueous composition taught in copending application ‘004, and combine it with the teachings in Deng, because it was disclosed in the art to use an aqueous composition containing phenylbutyric acid with chelating agent dipotassium EDTA with the disclosed range in the instant claims.
Conclusion
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/C.M.R./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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