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 .
Status of the Claims
Claims 1 and 26-48 are pending.
Claims 26, 28, 43-44, 47, and 48 are withdrawn (see restriction/election below).
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/EP2021/070238, filed 7/20/2021; and further claims priority to FOR application number EP20187542.4, filed 07/23/2020.
Information Disclosure Statement
All references from IDS(s) received on 01/19/2023 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election of Group I with traverse in the reply filed on 8/29/2025 is acknowledged.
The traversal is on the ground(s) that the Examiner has failed to establish that a search of the complete application would be an undue burden. This is not found persuasive because an argument to establish a search burden is not a criterion for Unity of Invention restrictions, rather it is only for U.S. Practice. Since the instant application is a national stage entry of PCT, the Examiner is within their own rights to determine unity and is not held to the standard of WIPO.
The requirement is still deemed proper and is therefore made FINAL.
Claims 43-44, 47, and 48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of use or apparatus, there being no allowable generic or linking claim.
Applicant’s election of species of the Compound 10 elected in the reply with traverse filed on 8/29/2025 is acknowledged.
The traversal is on the ground(s) that the Examiner has failed to establish that a search of the complete application would be an undue burden. This is not found persuasive because an argument to establish a search burden is not a criterion for Unity of Invention restrictions, rather it is only for U.S. Practice. Since the instant application is a national stage entry of PCT, the Examiner is within their own rights to determine unity and is not held to the standard of WIPO.
No anticipatory art was found of the elected species, so the Examiner expanded the species to compound 9 pursuant to MPEP 803.02. The elected species is free of the art. Claims 26 and 28 are withdrawn as not reading on the expanded species. Claims 1, 27, 29-42 and 45-46 will be examined on their merits.
See 102 and 103 rejections below.
Claim Rejection – Improper Markush
Claims 1, 27, 29-42, and 45-46 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of R1, including all variations; W1-4, including Rw1-4 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: The structures do not both share a structural similarity. The Applicant has presented an almost infinite amount of possibilities for the structures. It is the Examiner’s position that the members of the Markush group were separately classifiable and separately patentable. For example, the following prior art (see non-exhaustive list below) all have overlapping genus structures with the instant application and all identify a different functional use for the compounds.
Truesdale, L. et al. (US6469021B1; cited in the IDS filed 1/19/2023). Functions as a GLP-1 antagonist.
Sako, K. et al. (Bioorg. Med. Chem. 16 (2008) 3780–3790). Functions as an anti-viral agent.
Kuki, A. et al. (WO2004067531A1; cited in the IDS filed 1/19/2023). Functions as a HIV-integrase inhibitor.
Wu, J. et al. (EP1634881B1; cited in the IDS filed 1/19/2023). Functions as antitumor treatment.
More specifically, Sako teaches different carboline derivatives having varying potency when it comes to biological activity (Figure 3).
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Therefore, not only is the genus structure so broad it could be applied to various targets, the ability to move the nitrogen around the ring also changes the activity within the narrowed target group, as shown by Sako.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1).
The Examiner also encourages the Applicant to request an interview to discuss possible amendments before responding to best put the application in condition for allowance.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 27, 33, 38, and 39 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Truesdale (US6469021B1; “Truesdale”).
This rejection applies to an expanded species where instant Z2 is N; Z1, Z3, W1-4 are CH, R2 is C(=O)-OR2a, where R2a is a C1-8 aliphatic, and R1 is L1-Ar1, where L1 is CH2 and Ar1 is a phenyl ring substituted with two halogens.
Truesdale teaches an overlapping genus with instant formula I (Claim 1).
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(Truesdale, Claim 1)
Truesdale also teaches a structural example with all the embodiments required by instant claim 1, see below.
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(Truesdale, tenth compound listed in claim 8)
Therefore, claims 1, 27, 33, 38, and 39 are anticipated by Truesdale.
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.
Claims 1, 27, 29-42, and 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Truesdale, L. et al. (US6469021B1; “Truesdale”).
Claims 1, 27, 33, 38, and 39 were rejected in a 102 analysis above, and incorporated herein.
This rejection applies to the expanded species, compound 9.
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Truesdale teaches an overlapping genus with instant formula I (Claim 1).
Truesdale fails to teach a structural example of the expanded species, however Truesdale does teaches all the embodiments of the expanded species, see table below for comparison to instant claims.
Embodiment
Instant Position
Position in Prior Art (Truesdale)
-CH3
RW4
R4
-COOH
R2
R2
-CH
Z1, Z3, W1-3
Shown in genus structure
-CH2-phenyl-CF3
R1, where R1 is L1-Ar1
R1, where R1 is a phenyl substituted with trifluoromethyl
Truesdale fails to teach the N in the ring in the instant Z1 position. However, this would be considered a ring positional isomer. Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09.
Therefore, although Truesdale does not explicitly teach a structural example of the expanded species, it would be obvious to a person skilled in the art at the time to combine the embodiments taught by Truesdale to arrive at the compound of the expanded specie.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (B), it would have been prima facie obvious to substitute the Z2 position with a -CH and the -Z1 position with an -N. A skilled artisan would have had a reasonable expectation that this substitution would result in similar results because it is a ring positional isomer, and the instant application gives many structural examples of the -N position in either position having the same activity. Therefore, claims 1, 27, 29-42, and 45-46 would be obvious to a person skilled in the art at the time.
Conclusion
Claims 1, 27, 29-42 and 45-46 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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, Clint Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
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