DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election of Group II in the reply filed on February 20, 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)).
3. The election of species requirement is withdrawn. The full scope of the elected product claims was searched and examined.
4. Claim 1 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter. Election was made without traverse in the reply filed on February 20, 2026.
5. Claims 2-11 directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 17 and 19, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement between Groups II and III as set forth in the Office action mailed on February 17, 2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 17 and 18 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of diseases, does not reasonably provide enablement for prevention of diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The standard for determining whether the specification meets the enablement
requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242
ITS, 261,270 (1918) which postured the question: is the experimentation needed to
practice the invention undue or unreasonable? That standard is still the one to be
applied, at re Wands, 858 F.2d 731, 737, 8USPQ2s 1400, 1404 (Fed. Cir. 1988). MPEP 2184. 01(a) slates “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue.” The factors are applied below to the instant claims.
The breadth of the claims and nature of invention
The claims are drawn to methods of treating and preventing diseases.
The state of the prior art, level of ordinary skill, level of predictability, amount of guidance provided
The state of the art and present specification recognizes that the diseases can be treated with the claimed compounds. However, neither the state of the art nor the present specification recognizes that the diseases can be prevented. See for example reference of 10 Commandments of Cancer Prevention. In the state of the art, cancer is not known to be prevented. The lifestyle choices suggested for minimizing the risk reduces the death by cancer by up to 75%. However, the risk reduction is known to be effected by lifestyle choices, and not by the administration of medications.
The quantity of experimentation needed to make or use the invention
In the absence of working examples/direction, enablement rests on the existence of an
art recognized predictable correlation between the disclosed activity and the claimed
method. Evidence suggests that this requirement is not met for the instant case. The
amount of experimentation is undue. The experimentation required is to find a method for preventing cancer and other diseases using animal and other models. It is therefore determined that the instant disclosure does not enable one of ordinary skill to practice the scope of the claimed invention.
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.
7. Claims 2-11, 17 and 18 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-42 and 48-49 of copending Application No. 18,666,100 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons provided below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Determination of Scope and Contents of the Claims of the Copending Application
The claims are drawn to a compound of formula I
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and processes of using for treatment of diseases. The claims are also directed to specific embodiments of the compounds of formula I, such as,
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. The compound corresponds to the present claims in the following manner: X1=C(R8=O(Z1a=aryl)); X2=X3=X4=CH; A=aryl substituted with R7=CF3; n=1; R2=H; R1=CO(R3=alkyl).
Ascertaining the differences between claims of copending application and claims at issue
The specific embodiment of the copending application anticipates the present claims.
Resolving the level of ordinary skill in the pertinent art - Prima Facie Case of
Obviousness
MPEP 2144.08.11.A.4(c) states "...consider teachings of a preferred species within the
genus. If such a species is structurally similar to that claimed, its disclosure may
motivate on of ordinary skill in the art to choose the claimed species or subgenus from
the genus, based on the reasonable expectation that structurally similar species usually
have similar properties." This is a "Genus-Species Guidelines” for the examination
based on 35 USC 103. An analogous guideline was followed here for the analysis of
obviousness type double patenting. As such the claims suggest to the skilled artisan to practice the invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUN JAE YOO whose telephone number is (571)272-9074. The examiner can normally be reached Mon-Fri 8-5.
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/SUN JAE YOO/Primary Examiner, Art Unit 1621
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