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
This office action is in reply to the Response to Restriction/Election filed 04 June 2026 for application 18/293,761 filed on 30 January 2024, 371 of PCT/CN2022/088776 filed 02 April 2022, claiming priority from CN202110932229.9 filed 13 August 2021. Currently, claims 1-8 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election of Group I without traverse in the reply filed on 04 June 2026 is acknowledged.
Applicant’s election of Example 63, illustrated below, in the reply filed on 04 June 2026 is acknowledged:
PNG
media_image1.png
163
182
media_image1.png
Greyscale
The elected species, per Applicant’s Remarks, reads on claims 1-3. As such, claims 4-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention or species, there being no allowable generic or linking claim. Election was made in the reply filed 04 June 2026.
Claim Objections
Claims 1-2 are objected to because of the following informalities: formulas V and VI are not well resolved (i.e. too blurry). Appropriate correction is required.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Man et al. (Substituted phenethysulfones and methods of reducing TNFa levels, AU 200600033 A1, 2006; entered into the IDS on 30 January 2024).
Man discloses (R)-N-{2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl}-acetamide (pg. 43, line 15) where R = H, R1 = R3 = R4 = Me, and R2 = Et:
PNG
media_image2.png
98
171
media_image2.png
Greyscale
As such, Man anticipates claim 1.
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 non-obviousness.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Man et al. (Substituted phenethysulfones and methods of reducing TNFa levels, AU 200600033 A1, 2006; entered into the IDS on 30 January 2024) in view of Allen et al. (Ansel’s pharmaceutical dosage forms and drug delivery systems 10th edition, Wolters Kluwer Health 2005).
Man discloses (R)-N-{2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl}-acetamide.
They also teach the use of various oral dosage forms (pg. 16, lines 11-16) and pharmaceutical compositions (pg. 16-17, lines 17-15).
This is reinforced by Allen who extensively covers many topics within the field of drug formulation, including, but not limited to, typical properties of select excipients, incompatibilities, safety, related substances, along with numerous other examples in categories such as disintegrants, adhesives, and surfactants (select reading; pg. 1 – section I: introduction to drugs, drug dosage forms, and drug delivery systems; pg. 101 – section II: drug dosage form and drug delivery system design).
As such, it would be prima facie obvious, to a person of ordinary skill in the art, before the effective filing date, to incorporate the teachings of Allen to help develop an appropriate formulation for a structure of formula V for use in the desired method of treatment utilizing well established literature that is exemplified by Allen.
Allowable Subject Matter
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The elected species Example 63 was found to be free of the prior art:
PNG
media_image1.png
163
182
media_image1.png
Greyscale
Reasons For Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: the elected species Example 63 was found to be free of the prior art. Formula VI of claim 2 was also not found in the prior art in a 100% embodiment. The closest match is disclosed by Lee et al. (Novel isoindoline derivative, a pharmaceutical composition and use thereof, US 2020/0061033 A1, 2020), compound 115 (pg. 4)
PNG
media_image3.png
169
217
media_image3.png
Greyscale
Further elaboration by homologation of the nitrile is not described.
Summary
Claims 1-2 are objected to. Claim 1 is rejected under 35 U.S.C. 102(a)(1). Claim 3 is rejected under 35 U.S.C. 103. Claim 2 is objected to as being dependent on a rejected base claim.
Conclusion
Claims 1 and 3 are rejected. Claims 1-2 are objected to. Claim 2 is objected to as being allowable on a rejected base claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allen Chao whose telephone number is (571)272-7001. The examiner can normally be reached Monday - Friday 0700-1300.
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, James H Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALLEN CHAO/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
Prosecution Insights