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 09/03/2024 and is a 371 of PCT/EP2023/055469 (03/003/2023) which claims foreign priority to EP 22159896.4 (03/03/2022). Claims 1-10 and 15-24 are before the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6, 8-10 and 15-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Specifically, claim 1 defines R” and R”’ which have no showing elsewhere in the claim. Correction is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 3 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 2 and 3 fail to further limit claim 1 due to the claims new limitations being of a “method of treatment” nature. A compound claim is not limited by adding in that the compound is a modulator of ACKR3. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 18-24 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 that is modulated by the ACKR3 receptor (claim 18) or treating cancer, autoimmune disorder, inflammatory disease, transplant rejection, fibrosis, or pain (claims 19-24).
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. Pouzol teaches that inflammation, demyelination and neurodegeneration in inflammatory demyelinating diseases like MS that a potent ACKR3 antagonist shows promise and might show efficacy in the future for the treatment of demyelinating diseases. Azad teaches that ACKR3 is overexpressed in various cancers and plays a pivotal role in cancer. However, further research is needed. Samus teaches that ACKRs are involved in cancer functions and should be considered in targeting new and effective therapies. Fumagalli teaches that ACKR3 research will shed new light on pathophysiological functions and could lead to new treatments of diseases. These all lead to the need of further research before such receptor activity would lead to new treatments.
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 bradykinin 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 ACKR3 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 ACKR3 receptors. Those of skill in the art recognize that in vitro assays and or cell-cultured based assays are generally useful to observe basic physiological and cellular phenomenon such as screening the effects of potential drugs. However, clinical correlations are generally lacking.
The presence or absence of working examples: The compounds of the instant invention have been shown to express GPR119 activity. However, a nexus between expression of GPR119 activity and the treatment of autoimmune diseases, cancer, inflammatory diseases, transplant rejection, fibrosis or pain have not been shown. Nor has the instant specification shown any of the instant compounds treating any of these diseases or even modulating ACKR3 activity.
The amount of direction or guidance present: The guidance present in the specification is that of the compounds have ACKR3 activity and therefore can treat any disease linked to ACKR3 activity. However, there are no examples of such activity or such treatment. Further, the specification does not seem to enable a correlation between the mediation of ACKR3 receptors and the treatment of any and all diseases.
The breadth of the claims: The claims are drawn to the treatment of any and all diseases mediated by the ACKR3 receptor 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 ACKR3 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.
Allowable Subject Matter
Claims 1-10 and 15-17 are free of prior art. The closest prior art is WO 2012/177263 which teaches similar compounds but the compounds are different due to the presence or absence of a linker between the piperidine ring and the NC(O) part of the compound or between A and the phenyl ring.
Claim Objections
Claim 7 is objected to because of the following informalities: Claim 7 is objected to as being dependent from a rejected base claim but would be allowable if rewritten in independent form with all of the limitations of the intervening claims. Appropriate correction is required.
Conclusion
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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