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 .
Priority
The instant application is a national stage entry of PCT/US2022/011226, filed January 5, 2022, which claims priority to U.S. Provisional Application no. 63/138,581, filed January 18, 2021.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on April 1, 2024 was in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS documents was considered. A signed copy of form 1449 is enclosed herewith.
Election/Restrictions
4. Applicant’s election with traverse of Group I in the reply filed on January 8, 2026 is acknowledged.
5. Applicant's election with traverse of Group I in the reply filed on January 8, 2026 is acknowledged. The traversal is on the ground(s) that the restriction requirement is erroneous even if there is lack of unity of invention and that it increases burden on the Applicant. This is not found persuasive because the prongs under which the restriction requirement is valid and legal are that a) there is a lack of unity of invention, which is evidenced by the prior art applied herein and b) that there is a burden on Examiner to search multiple structurally divergent chemical formulae, which is also evidenced in the present office action and in the prior art search.
The requirement is still deemed proper and is therefore made FINAL.
6. In accordance with the 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 (see MPEP 803.02). 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 reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
7. As per MPEP 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species
PNG
media_image1.png
198
195
media_image1.png
Greyscale
wherein in a compound of formula II, makes a contribution over the prior art of record. Therefore, according to MPEP 803.02: should the elected species appear allowable, the search of the Markush-type claim will be extended. If art is found on a non-elected species, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. Since art was found on a non-elected species, subject matter not embraced by the elected species is therefore withdrawn from further consideration. It has been determined that the entire scope claimed is not patentable.
Status of Claims
8. Claims 26-44 are pending in the instant application. Claims 29-32, 35-36, 38-41, and 43-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 26-28, 33-34, 37, and 42 read on an elected invention and species and are therefore under consideration in the instant application.
Claim Rejections - 35 USC § 102
9. 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 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.
10. 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.
11. Claims 26-27, and 42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2010/0298347.
US 2010/0298347 teaches the following anticipatory compounds on page 13:
PNG
media_image2.png
268
282
media_image2.png
Greyscale
anticipates compounds of formula III wherein R1 is CF3, R2 is COOH, R3 is 1,2,4-triazole. Pharmaceutical compositions are taught starting on page 41.
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 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.
12. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
13. Claims 26-28, 33-34, 37, and 42 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 11,584,736.
U.S. Patent No. 11,584,736 teaches compounds and compositions that render obvious the instant claims. For example, compound
PNG
media_image3.png
276
262
media_image3.png
Greyscale
of claim 4 of ‘736 renders obvious the compound of instant claim 37
PNG
media_image4.png
209
263
media_image4.png
Greyscale
. The difference between the two compounds is that the bicyclic heterocyclic ring system of the claimed compound is a pyrrolidine fused with a cyclopentyl ring versus a piperidine fused with a cyclobutyl ring of the compound of claim 4 of ‘736, both rings contain an identical numbers of total members.
To those skilled in the chemical art, one homologue is not an advance over an adjacent member of a homologous series. The reason for this is that one of ordinary skill, knowing the properties of one member of series, would know what properties to expect in other homologous members. In re Henze, 85 USPQ 261 (1950), In re Wood, 199 USPQ 137 (CCPA 1978), and In re Lohr, 137 USPQ 548, 549 (CCPA 1963).
For example, “Position isomerism has been used as a tool to obtain new and useful drugs” (Englehardt) and “Position isomerism is a fact of close structural similarity” (Mehta, emphasis in the original). Note also In re Jones, 21 USPQ2d 1942, which states at 1943 “Particular types or categories of structural similarity without more, have, in past cases, given rise to prima facie obviousness”; one of those listed is “adjacent homologues and structural isomers.” positional isomers are the basic form of close “structural isomers.” Similar is In re Schechter and LaForge, 98 USPQ 144, 150, which states “a novel useful chemical compound which is homologous or isomeric with compounds of the prior art is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compounds.” Note also In re Deuel 34 USPQ2d 1210, 1214 which states, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds … a known compound may suggest its analogs or isomers, either geometric isomers (cis v. trans) or position isomers (e.g., ortho v. para).”
MPEP 2144.09.II. states, “Compounds which are positional isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) 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, 195USPQ 426 (CCPA 1977).
“Structural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions, create a prima facie case of obviousness.” Takeda v. Alphapharm, 83 USPQ2d 1169 (Fed. Cir. 2007) (quoting In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990). “The ‘reason or motivation’ need not be an explicit teaching that the claimed compound will have a particular utility; it is sufficient to show that the claimed and prior art compounds possess a ‘sufficiently close relationship…to create an expectation,’ in light of the totality of the prior art, that the new compound will have ‘similar properties’ to the old.” Aventis v. Lupin, 84 USPQ2d 1197 (Fed. Cir. 2007) (citing Dillion, 919 F.2d 692). “Once such prima facie case is established, it falls to the applicant or patentee to rebut it, for example with a showing that the claimed compound has unexpected properties.” Id.
If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990). Rebuttal evidence and arguments can be presented in the specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by counsel, In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089, 1094-95 (Fed. Cir. 1995), or by way of an affidavit or declaration under 37 CFR 1.132, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir. 1984). However, arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). See MPEP 2145.
One of ordinary skill would be motivated, from the disclosure in the prior art, to make the modifications required, to arrive at the instant invention with reasonable expectation of success for obtaining a compound with the same utility. The motivation to make the change would be to make additional compound for the quoted purpose.
Please note, if Applicant intends to rely on unexpected or unforeseen results, attention is invited to MPEP 716.02. Absent clear, convincing, side-by-side date demonstrating unobviousness vis-à-vis the prior art commensurate with the scope of protection sought, the claims are considered prima facie obvious.
Double Patenting
14. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
15. Claim 26-28, 33-34, 37, and 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,584,736. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-25 of U.S. Patent No. 11,584,736 render obvious the instant claims. For example, compound
PNG
media_image3.png
276
262
media_image3.png
Greyscale
of claim 4 of ‘736 renders obvious the compound of instant claim 37
PNG
media_image4.png
209
263
media_image4.png
Greyscale
. The difference between the two compounds is that the bicyclic heterocyclic ring system of the claimed compound is a pyrrolidine fused with a cyclopentyl ring versus a piperidine fused with a cyclobutyl ring of the compound of claim 4 of ‘736, both rings contain an identical numbers of total members.
To those skilled in the chemical art, one homologue is not an advance over an adjacent member of a homologous series. The reason for this is that one of ordinary skill, knowing the properties of one member of series, would know what properties to expect in other homologous members. In re Henze, 85 USPQ 261 (1950), In re Wood, 199 USPQ 137 (CCPA 1978), and In re Lohr, 137 USPQ 548, 549 (CCPA 1963).
For example, “Position isomerism has been used as a tool to obtain new and useful drugs” (Englehardt) and “Position isomerism is a fact of close structural similarity” (Mehta, emphasis in the original). Note also In re Jones, 21 USPQ2d 1942, which states at 1943 “Particular types or categories of structural similarity without more, have, in past cases, given rise to prima facie obviousness”; one of those listed is “adjacent homologues and structural isomers.” positional isomers are the basic form of close “structural isomers.” Similar is In re Schechter and LaForge, 98 USPQ 144, 150, which states “a novel useful chemical compound which is homologous or isomeric with compounds of the prior art is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compounds.” Note also In re Deuel 34 USPQ2d 1210, 1214 which states, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds … a known compound may suggest its analogs or isomers, either geometric isomers (cis v. trans) or position isomers (e.g., ortho v. para).”
MPEP 2144.09.II. states, “Compounds which are positional isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) 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, 195USPQ 426 (CCPA 1977).
“Structural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions, create a prima facie case of obviousness.” Takeda v. Alphapharm, 83 USPQ2d 1169 (Fed. Cir. 2007) (quoting In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990). “The ‘reason or motivation’ need not be an explicit teaching that the claimed compound will have a particular utility; it is sufficient to show that the claimed and prior art compounds possess a ‘sufficiently close relationship…to create an expectation,’ in light of the totality of the prior art, that the new compound will have ‘similar properties’ to the old.” Aventis v. Lupin, 84 USPQ2d 1197 (Fed. Cir. 2007) (citing Dillion, 919 F.2d 692). “Once such prima facie case is established, it falls to the applicant or patentee to rebut it, for example with a showing that the claimed compound has unexpected properties.” Id.
If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990). Rebuttal evidence and arguments can be presented in the specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by counsel, In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089, 1094-95 (Fed. Cir. 1995), or by way of an affidavit or declaration under 37 CFR 1.132, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir. 1984). However, arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). See MPEP 2145.
One of ordinary skill would be motivated, from the disclosure in the prior art, to make the modifications required, to arrive at the instant invention with reasonable expectation of success for obtaining a compound with the same utility. The motivation to make the change would be to make additional compound for the quoted purpose.
Please note, if Applicant intends to rely on unexpected or unforeseen results, attention is invited to MPEP 716.02. Absent clear, convincing, side-by-side date demonstrating unobviousness vis-à-vis the prior art commensurate with the scope of protection sought, the claims are considered prima facie obvious.
Conclusion
7. No claims allowed.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha Shterengarts whose telephone number is (571)270-5316. The examiner can normally be reached on Monday thru Thursday 9-6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Adam Milligan can be reached on 571-270-7674. 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).
If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623