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 reply filed on March 3, 2026.
Status of Claims
Amendment of claims 1, 5, 10-11, 13-14 and 23; addition of claims 26-34 and cancellation of claims 2-4 and 7
Claims 1, 5-6, 8-14, 23 and 26-34 are currently pending and are the subject of this office action.
Claim 23 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 11, 2025.
Claims 33 and 34 are further withdrawn since they do not encompass the species being examined:
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Claims 1, 5-6, 8-14 and 26-32 are under the examination.
Priority
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Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 112 (New Rejection not Necessitated by Amendment)
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.
Claim 5 is 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.
A broad range or limitation together with a narrow range or limitation that falls
within the broad range or limitation (in the same claim) is considered indefinite, since
the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the
Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033
(Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as"
and then narrow language. The Board stated that this can render a claim indefinite
by raising a question or doubt as to whether the feature introduced by such language
is (a) merely exemplary of the remainder of the claim, and therefore not required, or
(b) a required feature of the claims. Note also, for example, the decisions of Ex parte
Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App.
1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
In the instant case, claim 5 recites a broad limitation: “R7 is halo”, and then the claim also recites: “preferably F”, which is the narrower limitation.
Claim Rejections - 35 USC § 102 (Modified Rejection not Necessitated by Amendment).
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(s) 1, 5-6, 8-10, 14 and 26-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oxford et. al. (WO 2005/080367, 09-01-2005, cited by Applicant, cited in prior office action) as evidenced by Senior (GB 2293101, 03/20/1996).
For claims 1, 5-6, 8-10 and 26-31, Oxford teaches a method of treating preterm labor (see page 1, lines 24-25 citing GB 2293101; page 6, line 16; and claim 17) comprising administering to a subject in need thereof (i.e. a preterm pregnant subject) a composition comprising the EP2 agonist:
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(see top compound on page 209).
Wherein “treating preterm labor” (in a preterm pregnant subject) means: “preventing pre-term labor” (in a preterm pregnant subject) as evidenced by GB 2293101. GB 2293101 teaches a method of preventing pre-term labor (in a preterm pregnant subject) comprising the administration of the EP2 agonist butaprost (see title (54) and abstract (57). The phrase “preventing pre-term-labor” means that the subject (a preterm pregnant subject) has not yet suffered from pre-term labor (i.e. has not yet entered labor early), which is equivalent to “prophylactically delaying the onset of labor” (in a preterm pregnant subject).
For claim 14, Oxford teaches that the compounds can be administered via an intramuscular, intraperitoneal, subcutaneous or intravenous injection (see page 30, lines 10-16).
Claim Rejections - 35 USC § 103 (Modified Rejection not Necessitated by Amendment).
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.
1) Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oxford et. al. (WO 2005/080367, 09-01-2005, cited by Applicant, cited in prior office action) as evidenced by Senior (GB 2293101, 03/20/1996), in view of Woodward (US 9,820,954, cited in prior office action).
Oxford, as evidenced by GB 2293101, teaches all the limitations of claim 11 (see 102(a)(1) above), except for the compound being:
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However, the above compound is the isopropyl ester of the compound disclosed above by Oxford.
Further, Woodward teaches that the compound:
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is an EP2 agonist like:
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(see column 7, lines 1-25).
Since Oxford teaches a method of treating preterm labor comprising the administration of a composition comprising the EP2 agonists in general, and
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in particular, and since Woodward teaches that the compound:
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is an EP2 agonist like:
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before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (any EP2 agonist, in particular the above carboxylic acid) for another (the isopropyl ester of the above carboxylic acid) with an expectation of success, since the prior art establishes that both function in similar manner.
All this will result in the practice of claim 11, with a reasonable expectation of success.
2) Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oxford et. al. (WO 2005/080367, 09-01-2005, cited by Applicant, cited in prior office action) as evidenced by Senior (GB 2293101, 03/20/1996).
Oxford, as evidenced by GB 2293101, teaches all the limitations of claim 12 (see 102(a)(1) above), except for the woman being at higher risk than normal for onset of preterm labor.
However, before the effective filing date of the invention, it would have been prima facie obvious for the skilled in the art, knowing that the above EP2 agonist is effective in preventing the onset of preterm labor, to administer an EP2 agonist to those at higher risk for onset of preterm labor, thus resulting in the practice of claim 12 with a reasonable expectation of success.
Oxford, as evidenced by GB 2293101, teaches all the limitations of claim 13 (see 102(a)(1) above), except for the woman being at higher risk than normal for the compound being administered at less or equal to 37 weeks gestation. However, it is universally accepted that preterm birth is defined as childbirth occurring at less than 37 completed weeks (see for example instant specification, page 1, lines 21-22), as such, before the effective filing date of the invention, it would have been prima facie obvious for the skilled in the art, to administer the compound of formula (II) to a preterm pregnant subject at less than or equal to 37 weeks gestation, thus resulting in the practice of claim 13 with a reasonable expectation of success.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 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, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
March 11, 2026.
Prosecution Insights