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 included in the prosecution are claims 11-15 and 20.
Election/Restrictions
Applicant's election with traverse of Group II and Compound of Formula AA1 in the reply filed on 06/30/2026 is acknowledged. The traversal is on the ground(s) that unity of invention does exist and there is no burden. This is not found persuasive because Applicant has not explained why the technical feature is a special technical feature that makes a contribution over the prior art. Also, unity of invention is not based on whether there is a burden.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 1-6, 8, 9, 17, 18 and 21-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim 6 is withdrawn since Applicant elected Compound of Formula AA1 and the formula (I) of claim 6 cannot meet the structure of Compound of Formula AA1.
Claim Rejections - 35 USC § 103
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.
Claims 11-15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia-Garcia et al. (Osteoprotective effect of the marine alkaloid norzzoanthamine on an osteoporosis model in ovariectomized rat, Jan. 13, 2022) (hereinafter García-García) in view of Hsu et al. (Zoanthamine-Type Alkaloids from the Zoanthid Zoanthus Kuroshio Collected in Taiwan and Their Effects on Inflammation, 2016) (hereinafter Hsu).
García-García discloses wherein norzoanthamine (NZ), an alkaloid that has been isolated from the marine cnidiaria Zoanthus sp., has been shown an interesting anti-osteoporotic activity (abstract). Norzoanthamine has the following structure:
PNG
media_image1.png
284
242
media_image1.png
Greyscale
wherein R1=H, R2 = H, R3 = H, R4 = H and R5 = H (page 2).
García-García differs from the instant claims insofar as not disclosing wherein R3 is Cl.
However, Hsu discloses wherein Zoanthus kuroshio is a colorful zoanthid with a fluorescent pink oral disc and brown tentacles, which dominates certain parts of the Taiwanese and Japanese coasts. This sea anemone is a rich source of biologically active alkaloids. Compound 2 was isolated from Z. Kuroshio. All isolated compounds were evaluated for their anti-inflammatory activities (abstract). The hydroxy group at C-11 was replaced by a chlorine atom (page 2675, last paragraph right column). The role of halogen atoms in promoting the anti-inflammatory activity of the zoanthamines is worthy of further detailed investigation (page 2678, left, column).
PNG
media_image2.png
172
157
media_image2.png
Greyscale
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have synthesized norzoanthamine with chlorine as R3 motivated by the desire to impart anti-inflammatory properties to norzoanthamine since halogen atoms, like chlorine, may promote anti-inflammatory activity as taught by Hsu.
In regards to instant claims 15 and 20 reciting a composition, the claimed composition does not need to comprise an inert carrier and is only required to comprise the claimed compound. As such, meeting the claimed compound meets the limitation of a composition.
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.
Claims 11-15 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 4-6 of copending Application No. 18/548,641 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite a narrower compound) and thus read on the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 11-15 and 20 are rejected.
Claims 1-6, 8, 9, 17, 18 and 21-25 are withdrawn.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 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, Ali Soroush can be reached at 571-272-9925. 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.
/TRACY LIU/Primary Examiner, Art Unit 1614
Prosecution Insights