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 .
Status of Claims
Claims 1-25 are pending.
Priority
Instant application 18/662,751, filed 05/13/2024 claims priority as follows:
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Information Disclosure Statement
All references from IDS(s) received 05/13/2024, 11/13/2024, and 11/03/2025 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election of the compound:
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in the reply filed on 07/08/2026 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 § 818.01(a)). The elected species reads on claims 1, 3-4, 6-21, and 23-25.
Examination will begin with the elected species. In accordance with MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and applicable prior art was not identified. Therefore, the search was expanded to the species recited in claims 23-24 and applicable prior art was not identified. Therefore, the search was expanded to claim 21 and applicable prior art was identified for the compound:
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.
Claims 1, 3-4, 6-21, and 23-25 read on the elected species or expanded species compound above.
Claims 2, 5, and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/08/2026.
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.
(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, 3-4, and 6-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by BLOXHAM (WO 2006018662 A2).
Bloxham discloses the compound (page 36, example 31):
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The above compound reads on the formula of claim 1 when ring A1 is
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; ring A2 is
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; R3a is hydrogen or cyano; and R4a is H or fluoro.
The above compound anticipates claims 1, 3-4, and 6-21.
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.
US 12,098,117 B2
Claims 1, 3-4, 6-15, and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,098,117 (“the reference patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent recites compounds such as:
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(reference patent claim 7) and
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(reference patent claim 1).
The above compounds anticipate instant claims 1, 3-4, 6-15, and 17-20.
Claims 16, 21, and 23-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,098,117 in view of FLEMING (Journal of Medicinal Chemistry, vol. 53, no. 22, Nov. 2010, pp. 7902–17).
With respect to claims 16, 21, and 23-25, the reference patent recites compounds such as
those shown above but fails to recite compound having a para-cyano substituent, particularly the compound of claim 25 having the formula:
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However, the reference patent recites the following compound which merely differs from instant claim 25’s compound by the substitution of the cyano group for a fluoro group (reference patent claim 1):
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FLEMING is relied upon for the teaching that nitriles are well-known to the person having ordinary skill as a bioisostere of halogens such as fluorine. See page 7909 of FLEMING:
“Halogen bioisostere is another role. The nitrile mimics the polarization of the halides and is often an excellent halogen bioisostere. Being smaller than bromine or iodine, the nitrile is capable of achieving better contact with amino acids lining an active site.”
See also page 7905:
“During screening of a series of analogues the most efficacious leads contained electron withdrawing groups, with the nitrile or fluorine substituents being the most potent. Computed molecular electrostatic potentials and dipole moments showed a strong homology suggesting that the nitrile can function as a fluorine bioisostere. Electrostatic mapping performed during the development of the muscarinic agonist, sabcomeline, gene rated similar electrostatic potential maps for the respective imidoyl nitrile, fluoride, and chloride, again suggesting the nitrile as a halogen bioisostere.”
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. See MPEP 2143.
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) and/or (G), it would have been prima facie obvious to substitute the fluoro group in the reference patent’s compound with a cyano group as taught by Fleming in order to prepare a compound having utility as an HSF1 inhibitor. A person having ordinary skill in the art would have enjoyed a reasonable expectation of success in view of the teaching that cyano is a known bioisostere of halogens such as fluorine.
Therefore, claims 16, 21, and 23-25 are obvious over US 12,098,117 in view of Fleming.
18/812,888
Claims 1, 3-4, and 6-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 18/812,888 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application recites compounds such as:
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(reference patent claim 23).
The above compounds anticipate instant claims 1, 3-4, 6-15, and 17-20.
Additionally, the reference application recites in claim 22:
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.
Claim 22 of the reference application therefore reads on instant claim 16.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 16, 21, and 23-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of 18/812,888 in view of FLEMING (Journal of Medicinal Chemistry, vol. 53, no. 22, Nov. 2010, pp. 7902–17).
With respect to claims 16, 21, and 23-25, the reference application recites compounds
such as those shown above but fails to recite compound having a para-cyano substituent, particularly the compound of claim 25 having the formula:
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However, the reference application recites the following compound which merely differs from instant claim 25’s compound by the substitution of the cyano group for a fluoro group (reference patent claim 1):
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FLEMING is relied upon for the teaching that nitriles are well-known to the person having ordinary skill as a bioisostere of halogens such as fluorine. See page 7909 of FLEMING:
“Halogen bioisostere is another role. The nitrile mimics the polarization of the halides and is often an excellent halogen bioisostere. Being smaller than bromine or iodine, the nitrile is capable of achieving better contact with amino acids lining an active site.”
See also page 7905:
“During screening of a series of analogues the most efficacious leads contained electron withdrawing groups, with the nitrile or fluorine substituents being the most potent. Computed molecular electrostatic potentials and dipole moments showed a strong homology suggesting that the nitrile can function as a fluorine bioisostere. Electrostatic mapping performed during the development of the muscarinic agonist, sabcomeline, gene rated similar electrostatic potential maps for the respective imidoyl nitrile, fluoride, and chloride, again suggesting the nitrile as a halogen bioisostere.”
Applying KSR example rationale (B) and/or (G), it would have been prima facie obvious to substitute the fluoro group in the reference application’s compound with a cyano group as taught by Fleming in order to prepare a compound having utility as an HSF1 inhibitor. A person having ordinary skill in the art would have enjoyed a reasonable expectation of success in view of the teaching that cyano is a known bioisostere of halogens such as fluorine.
Therefore, claims 16, 21, and 23-25 are obvious over 18/812,888 in view of Fleming.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 3-4, 6-21, and 23-25 are rejected. Claims 2, 5, and 22 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 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, Clinton 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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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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