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 4-6 are presented for examination.
Acknowledgement is made of the present application as a National Stage (371) entry of PCT Application No. PCT/JP2021/043186, filed November 25, 2021, which claims benefit under 35 U.S.C. §119(a-d) to Japanese Patent Application No. 2020-195818, filed November 26, 2020. Receipt is acknowledged of a certified copy of this ‘818 application in the instant application on May 23, 2023, as required by 37 C.F.R. §1.55.
Information Disclosure Statement
Applicant’s Information Disclosure Statements filed August 23, 2023 (one page), October 15, 2024 (one page), June 16, 2025 (one page) and July 10, 2025 (one page) have each been received and entered into the present application. As reflected by the attached, completed copies of form PTO-1449 (four pages total), the Examiner has considered the cited references.
Priority
Acknowledgement is made of the present application as a National Stage (371) entry of PCT Application No. PCT/JP2021/043186, filed November 25, 2021, which claims benefit under 35 U.S.C. §119(a-d) to Japanese Patent Application No. 2020-195818, filed November 26, 2020. The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original non-provisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. §112(a) or the first paragraph of pre-AIA 35 U.S.C. §112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
As Applicant’s prior-filed Japanese Patent Application No. 2020-195818, filed November 26, 2020, is not filed in English and a certified English translation of the same has not been provided, this earlier filed application cannot be fully evaluated to determine sufficiency of support for the claimed subject matter.
As a result, instant claims 4-6 are not afforded the benefit of the earlier filing date of this ‘818 foreign application.
Accordingly, the effective filing date of claims 4-6 under examination is November 25, 2021 (the filing date of the ‘186 PCT application).
The Examiner will revisit the issue of priority as necessary each time the claims are amended.
Objections to the Claims
Claim 4 is objected to for reciting “provide” in the limitation “provide that X and Y do not simultaneously represent a methylene group”, which is grammatically awkward.
Appropriate correction is required.
Applicant may wish to consider amending the term “provide” to “provided” to correct this informality, but is reminded that the adoption of such suggestion does not necessarily obviate any other objection and/or rejection set forth infra.
Claim 6 is objected to for reciting “wherein the compound represented by Formula (I) is carbacyclic phosphatidic acid”, which is grammatically awkward.
Appropriate correction is required.
Applicant may wish to consider amending the limitation to recite “wherein the compound represented by Formula (I) is a carbacyclic phosphatidic acid” to correct this informality, but is reminded that the adoption of such suggestion does not necessarily obviate any other objection and/or rejection set forth infra.
Claim Rejections - 35 USC § 112(b) (Pre-AIA Second Paragraph)
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.
(1) Claims 4-6 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.
Applicant’s claim 4 recites “[a] method for treatment of pulmonary fibrosis, which comprises administering a compound represented by the aforementioned Formula (I) to a subject with pulmonary fibrosis”.
The term “the aforementioned Formula (I)” as recited at l.2 of the claim lacks sufficient antecedent basis because formula (I) is not recited or referenced in the preceding text of the claim, but rather later in the claim (and, thus, cannot be “aforementioned Formula (I)” as recited).
Clarification is required.
Applicant’s claim 4 defines R as “a linear or branched alkyl group having 1 to 30 carbon atoms, a linear or branched alkenyl group having 2 to 30 carbon atoms, or a linear or branched alkynyl group having 2 to 30 carbon atoms, which may contain a cycloalkane or aromatic ring”.
It is unclear if the phrase “which may contain a cycloalkane or aromatic ring” modifies only the preceding “linear or branched alkynyl group having 2 to 30 carbon atoms”, or any one of the preceding (i) “linear or branched alkyl group having 1 to 30 carbon atoms”, (ii) “linear or branched alkenyl group having 2 to 30 carbon atoms”, or (iii) “linear or branched alkynyl group having 2 to 30 carbon atoms”.
Clarification is required.
As claim 5 does not remedy these points of ambiguity in claim 4, it must also be rejected on the same grounds applied thereto claim 4.
Applicant’s claim 6 depends from claim 4 and recites “[t]he method for treatment of pulmonary fibrosis according to claim 4, wherein the compound represented by [f]ormula (I) is carbacyclic phosphatidic acid of 1-oleoyl-cyclic phosphatidic acid, 1-palmitoleoyl-cyclic phosphatidic acid, or a derivative thereof”.
It is unclear if the limitation “a derivative thereof” is intended to circumscribe “a derivative” of the carbacyclic phosphatidic acid of 1-oleoyl-cyclic phosphatidic acid or 1-palmitoleoyl-cyclic phosphatidic acid, or “a derivative” of 1-oleoyl-cyclic phosphatidic acid per se or 1-palmitoleoyl-cyclic phosphatidic acid per se, or something else.
Clarification is required.
The term “derivative” also renders the claim indefinite because the identity of the recited “derivatives” permitted by the claim is not clearly set forth. There is no indication of the degree of derivatization that the recited “derivative” may have from its parent compound (which, notably, is also not clearly identified, for the reasons set forth in the directly preceding paragraphs) and constitute a “derivative” within the meaning of the claim. As a result, the determination of the scope of “derivatives” circumscribed by the objective boundaries of the claim would rely on the subjective interpretation of the ordinarily skilled artisan before the effective filing date of the claimed invention and, thus, fails to clearly and precisely define the metes and bounds of the claimed subject matter.
MPEP §2173.05(b)(IV) clearly states that “[c]laim scope cannot depend solely on the unrestrained subjective opinion of a particular individual purported to be practicing the invention” (citing to Datamize LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. 2005)).
Clarification is required.
For these reasons, the claims fail to meet the tenor and express requirements of 35 U.S.C. §112(b) (pre-AIA second paragraph) and are, thus, properly rejected.
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.
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.
(2) Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Tager et al. (“The Lysophosphatidic Acid Receptor LPA1 Links Pulmonary Fibrosis to Lung Injury by Mediating Fibroblast Recruitment and Vascular Leak”, Nature Medicine, 2008; 14(1):45-54, cited by Applicant on the 08/23/23 IDS) in view of Higuchi et al. (“Antifibrotic Effects of 2-Carba Cyclic Phosphatidic Acid (2ccPA) in Systemic Sclerosis: Contribution to the Novel Treatment”, Arthritis Research & Therapy, 2019; 21:103, cited by Applicant on the 08/23/23 IDS).
Tager et al. teaches that aberrant wound healing responses to injury in the lung are thought to contribute to the pathogenesis of idiopathic pulmonary fibrosis (col.1, para.1, p.45). Tager et al. discloses an experimental study in a bleomycin mouse model of pulmonary fibrosis, in which lysophosphatidic acid (LPA) levels were found to be increased in bronchoalveolar lavage fluid following lung injury, but that mice lacking in one of the LPA receptors – LPA1 – were markedly protected from pulmonary fibrosis in this same model by mitigating excessive accumulation of fibroblasts in the injured lung and markedly attenuating the persistent vascular leak induced by lung injury, thereby demonstrating that the LPA-LPA1 pathway mediates both of these aberrant wound healing responses implicated in pulmonary fibrosis (abstract; col.2, para.2, p.50-col.1, para.1, p.51). Tager et al. teaches a follow-up study in humans with idiopathic pulmonary fibrosis in which it was observed that LPA levels in bronchoalveolar lavage fluid was greater in humans with idiopathic pulmonary fibrosis as compared to normal controls, and that the inhibition of LPA signaling by administration of a LPA1 antagonist (Ki16425) markedly reduced fibroblast migration and accumulation (abstract; col.2, para.3, p.49-col.2, para.1, p.51).
Tager et al. differs from the instant claims only insofar as it teaches the administration of the LPA antagonist Ki16425 to a human subject with idiopathic pulmonary fibrosis, but not a cyclic or carbacyclic phosphatidic acid compound of formula (I) (claims 4-6).
Higuchi et al. teaches that the 2-carba derivative of cyclic phosphatidic acid (cPA) (also known as 2ccPA1) is an antagonist of the ATX/LPA axis (col.1, para.2, p.2).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in substituting Tager’s LPA antagonist Ki16425 with Higuchi’s known LPA antagonist 2ccPA because each compound was known to function as an LPA antagonist. The substitution, therefore, of Tager’s LPA antagonist Ki16425 with Higuchi’s known LPA antagonist 2ccPA would have been prima facie obvious before the effective filing date of the claimed invention because each was known in the art at such time as a LPA antagonist and, therefore, would have been reasonably interchanged with one another in Tager’s method of treating human pulmonary fibrosis based upon this functional equivalency with the reasonable expectation of successfully mitigating excessive fibroblast migration and accumulation that contributes to pulmonary fibrosis in such subjects. “When a patent ‘simply arranges old elements with each performing the same function it has been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex, Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-96, quoting Sakraida v. AG Pro., Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1981) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
Claim 5 requires that “either X or Y represents an oxygen atom and the other represents a methylene group”.
As set forth above in footnote 1, the chemical structure of 2ccPA described by Higuchi et al. demonstrates that X is methylene and Y is oxygen, thereby meeting the limitations of Applicant’s claim 5.
Claim 6 defines the compound of formula (I) as a “carbacyclic phosphatidic acid of 1-oleoyl-cyclic phosphatidic acid, 1-palmitoleoyl-cyclic phosphatidic acid, or a derivative thereof”.
As Applicant fails to clearly and unambiguously define the objective boundaries of the “derivatives” of claim 6, the structure of 2ccPA described by Higuchi et al. is understood to constitute a “derivative” thereof as recited in claim 6, absent any specific objective boundaries thereon.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
Rejection of claims 4-6 is proper.
No claims of the present application are allowed.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Leslie A. Royds Draper whose telephone number is (571)272-6096. The examiner can normally be reached Tuesday to Thursday (08:30 AM to 05:00 PM).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren can be reached at (571)-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Leslie A. Royds Draper/Primary Examiner, Art Unit 1629
September 18, 2025
1 In the instant specification, Applicant defines the compound “2ccPA” (also referred to as “2-carbacyclic phosphatidic acid”) as having the structural formula
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, which corresponds to Applicant’s instantly claimed formula (I), in which X is methylene, Y is oxygen, M is a sodium (alkali metal) atom, and R is a linear alkenyl of 17 carbons (which falls within the claimed range of 2 to 30 carbon atoms).