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
This application was filed 04/18/2024 and claims priority to 63/557251 (02/23/2024) and 63/580824 (09/06/2023) and 63/496859 (04/18/2023). Claims 1-8, 10, 12, 14, 16,22, 30, 31, 32, 35, 50, 52, 58, 70, 74, 85, 87-91, 94-95, 98-102, 105-107, 110-111, 114 and 117 are before the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(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.
Claims 94-95, 105-107 and 110-111 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
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”. These factors include 1) the breadth of the claims, 2) the nature of the invention, 3) the state of the prior art, 4) the level of one of ordinary skill, 5) the level of predictability in the art, 6) the amount of direction provided by the inventor, 7) the existence of working examples, and 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The nature of the invention: The nature of the invention is the method of treating a disorder or disease associated with activity of KRAS or immunological or inflammatory disorders.
The state of the prior art: The state of the prior art is that it involves screening in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can treat which specific disease). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face. Tian teaches that there are possible future uses for KRAS inhibitors in immune-responsive therapies (see abstract). Homan teaches that KRAS mutations are recognized in 25% of tumors and that there is a possibility that KRAS might be involved in inflammation or immunotherapy in the future (abstract). Due to this, there is nothing in the prior art showing any link between KRAS and immunological or inflammatory disorders. Further, only cancer treatment has been currently linked to KRAS activity.
The predictability in the art: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instantly claimed invention is highly unpredictable since one skilled in the art would recognize that in regards to the therapeutic effects of all diseases, whether or not the modulation of KRAS receptors would make a difference in the disease. Hence, in the absence of a showing of a nexus between any and all known diseases and the modulation of KRAS receptors, one of ordinary skill in the art is unable to fully predict possible results from the administration of the compound of claim 1 due to the unpredictability of the role of modulation of KRAS receptors.
The presence or absence of working examples: The compounds have been tested for in vitro activity but not activity for treating diseases broadly or specifically inflammation or immunological diseases.
The amount of direction or guidance present: The guidance present in the specification is that of the compounds are active for KRS and an treat cancers with a certain mutation. Page one of the specification states that KRAS is thought to play an important role in a variety of inflammatory and/or immunological diseases. The specification does not seem to enable a correlation between the mediation of KRAS receptors and the treatment of any and all known and unknown diseases.
The breadth of the claims: The claims are drawn to the treatment of any and all diseases mediated by the KRAS receptor or the treatment of immunological or inflammatory diseases with the compound of claim 1.
The quantity of experimentation needed: The quantity of experimentation needed is undue. One skilled in the art would need to determine what diseases out of all known diseases would be benefited by the mediation of KRAS receptors and then would further need to determine which of the claimed compounds would provide treatment of the disease.
The level of the skill in the art: The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
Thus, the specification fails to provide sufficient support of the broad use of the compounds of claim 1 for the treatment of any disease. As a result necessitating one of ordinary skill to perform an exhaustive search for which diseases can be treated by which compound of claim 1 in order to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, one of ordinary skill in the art would have to engage in undue experimentation to test which diseases can be treated by the compounds of the instant claims, with no assurance of success.
This rejection can be overcome by deleting the claims.
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.
Claims 1-8, 10, 12, 14, 16, 22, 30-32, 35, 50, 52, 58, 70, 74, 85, 87-91, 94-95, 98-102, 105-107, 110-111, 114 and 117 are rejected under 35 U.S.C. 103 as being unpatentable over WO2021/211864, WO2024/015731 and WO2023/064857. All three WOs teach a Markush such as
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with the variables being such that encompass the instantly claimed Markush and compounds. All three WOs have the utility to treat KRAS activity cancers. However, none of the WOs teach the instantly claimed compounds having the specific bridged piperidine ring attached to the five membered ring of the tricyclic core. For WO2021 examples 41 and 42 on page 201 are closest. For WO2024 page 98 line 8 and page 99 line 21 are the closest compounds. For WO2023, example 27 page 211 and page 161 line 25 are the closest. The cited WOs teach a Markush of compounds having KRAS cancer treating activity that fully overlap with the instant Markush. The WOs do not teach any specific compound having the bridged 6-membered piperidine ring. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to use the disclosures of the three WOs and their markushes to make a different substituted compound within the Markush that they taught with the reasonable expectation of getting a compound having the ability to act on KRAS and treat cancer. Rationale: The use of the teachings of three WO patents to make another compound having activity as a KRAS cancer treatment is within the skill of the ordinary artisan.
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 1-8, 10, 12, 14, 16, 22, 30-32, 35, 50, 52, 58, 70, 74, 85, 87-91, 94-95, 98-102, 105-107, 110-111, 114 and 117 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 19/366209, 18/980424, 19/325693, 18/909683 and 18/909691 (reference applications). Although the claims at issue are not identical, they are not patentably distinct from each other because the later filed applications have the same inventive company and have significant overlap with Markush and compounds. 19/366209 has overlap in claim 17. 18980424 has overlap in claim 1. 19325693 has overlap in claim 1. 18909683 has overlap with claim 14. 18909691 has overlap with claim 19. This application has the earlier filing date.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern.
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/D MARGARET M SEAMAN/Primary Examiner, Art Unit 1625
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