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 1-16 and 19 are currently pending in the instant application. Claims 1-11 are rejected, claim 12 is objected and claims 13-16 and 19 are withdrawn from consideration in this Office Action.
I. Priority
The instant application is a 371 of PCT/AU2021/050644, filed on June 21, 2021 and claims benefit of Foreign Application AUSTRALIA 2020902036 06/19/2020.
The Examiner wants to point out that the Foreign Applications AUSTRALIA 20200902035, filed on June 19, 2020 and AUSTRALIA PCT/AU2021/050638, filed on June 18, 2021 do not provide support for the instant claimed compounds of formula I wherein J is
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. The compounds in the Forein Applications have -SO2 at the J position and therefore do not read on the same compounds. Applicants do not get the priority date of the above two applications.
II. Information Disclosure Statement
The information disclosure statements (IDS) submitted on May 11, 2023, February 6, 2024 and October 22, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
III. Restriction/Election
A. Election: Applicant's Response
Applicants' election of Group I in the reply filed on August 4, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Subject matter not encompassed by elected Group I are withdrawn from further consideration pursuant to 37 CFR 1.142 (b), as being drawn to nonelected inventions.
Applicants’ elected species
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has been search and no prior art has been found.
B. Status of the Claims
i. Scope of the Search and Examination of Elected Subject Matter
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The above structure is the provisional elected species.
ii. Extended Prior Art Search M.P.E.P. §803.02
Following election, the Markush-type claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. If the Markush-type claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush-type claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration. On the other hand, should the examiner determine that the elected species is allowable, the examination of the Markush-type claims will be extended. If prior art is then found that anticipates or renders obvious the Markush-type claim with respect to a nonelected species, the Markush-type claim shall be rejected and claims to the non-elected species held withdrawn from further consideration. The prior art search, however, will not be extended unnecessarily to cover all nonelected species.
As indicated above, Examiner searched the compound based on the elected species, above, in response to the requirement to restrict the products of Formula (I), wherein: there was no prior art of record that anticipated or rendered obvious the elected species and therefore the scope of the subject matter was extended or broadened in pursuant to M.P.E.P. § 803.02.
The prior art search was extended to include the products of formula (I) wherein:
All variables are as defined in claim 1.
IV. Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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 1-11 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. Specifically, variables Y and Z are present in formula I
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but Applicants have failed to provide a definition for these two variables so that one of ordinary skill in the art would know what subject matter is included for the claimed invention. The claims are considered indefinite because it is unclear what Applicants are intending to claim as their invention. To overcome the rejection, Applicants are suggested to amend claim 1 so that the structural formula I now reads
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which is clearly supported in the specification (see page 2 of the specification).
Claim Rejections - 35 USC § 102
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.
Claims 1, 2 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adams, et al. (WO 2003072541 A2 (abstract), retrieved from STN; Document No. 139:246025). The instant invention claims
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The Adams, et al. reference teaches saccharin-anion derivatives such as
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(See RN 594981-61-0) wherein Q1 is N-Me; Q2 is N; Y and Z are H; R2 is H; J is carbonyl; G is NH; X is phenyl substituted with Cl. This species of compound anticipates the genus compound of the instant invention, wherein the genus structure and its definitions are stated above.
35 USC § 103 - OBVIOUSNESS REJECTION
The following is a quotation of 35 U.S.C. § 103(a) that forms the basis for all
obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Graham v. John Deere Co. set forth the factual inquiries necessary to determine obviousness under 35 U.S.C. §103(a). See Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Specifically, the analysis must employ the following factual inquiries:
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.
Claim 11 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Adams, et al. (WO 2003072541 A2 (abstract), retrieved from STN; Document No. 139:246025). Applicants claim
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The Scope and Content of the Prior Art (MPEP §2141.01)
Adams, et al. teaches pyrazole compounds that are inhibitors of VEGFR kinase and TIE-2 kinase and useful in treating diseases associated with inappropriate angiogenesis. The prior art teaches compounds such as
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(See RN 594981-61-0) wherein Q1 is N-Me; Q2 is N; Y and Z are H; R2 is H; J is carbonyl; G is NH; X is phenyl substituted with Cl.
The Difference Between the Prior Art and the Claims (MPEP §2141.02)
The difference between the prior art of Adams, et al. and the instant invention is that R1 is H in the instant compounds whereas the equivalent of R1 in the prior art is Me. The difference would be Me vs. H.
Prima Facie Obviousness-The Rational and Motivation (MPEP §2142-2413)
Compounds that differ only by the presence or absence of an extra methyl group or two are homologues. Homologues are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue. As was stated in In re Grose, 201 USPQ 57, 63, “The known structural relationship between adjacent homologues, for example, supplies a chemical theory upon which a prima facie case of obviousness of a compound may rest.” The homologue is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing homologues. Of course, these presumptions are rebuttable by the showing of unexpected effects, but initially, the homologues are obvious even in the absence of a specific teaching to add or remove methyl groups. See In re Wood, 199 USPQ 137. For example, it is obvious to prepare a hydrogen substituted pyrazole when the art teaches a methyl substituted pyrazole with a reasonable expectation of success. Specifically, methyl and hydrogen are considered homologues and are obvious absent unexpected results. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to prepare homologs based on the teachings of the preferred embodiments in the prior art. For example, a skilled artisan would be motivated to prepare a hydrogen substituted pyrazole instead of a methyl substituted pyrazole as seen in the prior art reference of Adams, et al. (WO 2003072541 A2). A strong prima facie obviousness has been established.
V. Objections
Dependent Claim Objections
Dependent Claim 12 is objected to as being dependent upon a rejected based claim. To overcome this objection, Applicant should rewrite said claims in an independent form and include the limitations of the base claim and any intervening claim.
VI. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached on 7:00 AM-3:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Joseph McKane can be reached on 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626