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 .
Claims 1-3 and 105-118 are currently pending in this Application. Claims 117-118 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention. The withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations.
Priority
CONTINUING DATA
This application is a 371 of PCT/CN2022/114058 08/22/2022
FOREIGN APPLICATIONS
CHINA 202110998156.3 08/27/2021
CHINA 202210358729.0 04/06/2022
Information Disclosure Statement
Applicants’ Information Disclosure Statements, filed on February 20, 2024, and February 14, 2024, have been considered. Please refer to Applicant’s copies of the 1449 submitted herewith.
Response to Restriction
Applicants’ election, the invention of Group I, claims 1-3 and 105-116, drawn to products of Formula I, and the specific species, compound 9,
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in response filed July 08, 2026, is acknowledged. Because applicants 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)).
Therefore, the restriction requirement is considered proper and is maintained.
Applicants are reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a petition under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
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.
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.
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 1-3 and 105-116 are rejected under 35 U.S.C. 103(a) as being unpatentable over US Patent No. 11,407,732 B1 to Henderson et al, in view of Patani et al. (Chemical Reviews, 1996, Vol. 96, 3147-3176).
The instant elected invention of claims 1-3 and 105-116 are directed to isoindolinone products of Formula I,
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.
Determination of the scope and contents of the prior art
Henderson et al teach isoindolinone products of Formula
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.
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etc. see table 2, Columns 855-893.
Ascertaining the differences between the instant claims and the prior art
The product of the instant claims differs from Henderson et al in that there is a F substituent on the phenyl moiety of the present invention (R2 variable of the instant claims) as opposed to H of the prior art.
Resolving the Level of Ordinary Skill in the Pertinent Art
Secondary reference, Patani et al. teaches that “bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds into safer and more clinically effective agents,” and further that the concept of bioisosterism is “intuitive” (page 3147, Introduction, column 1-column 2). It is known in the art that bioisosteres are substituents or groups with similar physical or chemical properties that impart similar biological properties to a chemical compound. In drug design, the purpose of exchanging one bioisostere for another is to enhance the desired biological or physical properties of a compound without making significant changes in chemical structure. Fluorine and Hydroxyl, Amino, or Methyl Groups as Replacements for Hydrogen (Grimm’s Hydride Displacement Law)).
“Factors that may be considered in determining level of ordinary skill in the art include: (1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) the education level of active workers in the field.” Envtl. Designs, Ltd. V. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.3d 1376, 1381-82 (Fed. Cir. 1983)). The above factors are not exhaustive but are a guide. Id.
In this case, the education level of the inventor and the education level of active workers in the field of organic chemistry, as well as the high degree of sophistication required to solve problems encountered in the art, a person of ordinary skill in the art would likely have at least a college degree in the field of organic chemistry, with industry experience, i.e., a masters or doctorate level of skill and knowledge in the laboratory. Thus, the level of skill in the art is relatively high.
Objective Evidence in the Application Indicating Obviousness or Nonobviousness
“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.
Secondary reference, Patani et al teaches that ring hydrogen, F, or Cl as bioisosteric and can be interchangeable according to Grimm's Hydride Displacement Law. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to make the modification (i.e., to replace the H of the compounds disclosed in Henderson et al with a F group) and to arrive at a compounds of the instant claims with a reasonable expectation of success for obtaining a compound with the same or similar activity. The motivation would have been to make additional compounds which have similar properties. The compounds are expected to have similar properties differing only in degree. 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). In the instant application, changing fluorine to another halogen, chlorine, in the compounds of Henderson et al would give rise to compounds of the instant invention.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Accordingly, claims 1-3 and 105-116 are rendered obvious in view of the references above. Applicant might consider providing evidence of unexpected results to overcome the rejection.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMAL A SAEED whose telephone number is (571) 272-0705.
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, Adam C Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kamal A Saeed/
Primary Examiner, Art Unit 1626
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