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 .
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.
This office action is a response to applicant’s communication submitted February 12, 2024, wherein claims 1-19 were canceled and claims 20-38.
Claims 20-38 are pending in this application.
Priority
This application is a 371 of PCT/EP2022/072681 filed 08/12/2022 and claims foreign priority to EP21191387.6 filed 08/13/2021. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been received.
Claim Interpretation
Claim 20 recites the phrase “pharmaceutically active derivative thereof”. According to the instant specification, "Pharmaceutically active derivative" refers to any compound that upon administration to the recipient is capable of providing directly or indirectly, the activity disclosed herein (pg. 10, lines 1-2). According to the instant specification the compounds of the invention inhibit mitochondrial pyruvate carrier (MPC, pg. 66, lines 20-22), obtain and/or maintain T-cells with a memory phenotype (pgs. 68-69, examples 3-4), thus any compound that does so anticipates the claim.
Specification
The disclosure is objected to because of the following informalities:
On page 47, the bond lines in structures in Scheme 7 are obscured (lines 1-4). See particularly the hydrazine in structure 4c. Also label 4c conflicts with the structure.
On page 48, in scheme 8 the structures are missing hydrogen atoms on nitrogen (lines 22-24). On page 49 compounds 50 and 51 are missing hydrogen atoms on nitrogen (lines 15-17). On page 52, in scheme 10 the structures are missing hydrogen atoms on nitrogen (lines 1-3).
On pages 53- 62, in some compounds atoms are illegible, particularly compounds 54, 57, 59, 62, 66, 69, 71, 73-77, 78-87, 90-99.
Appropriate correction is required.
Claim Objections
Claims 33, 35-36 are objected to because of the following informalities:
In claim 33, on the bottom of page 8 of the claims, a few compounds are missing hyphens in the beginning:
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In claims 35-36, the phrase “excipient thereof.” should read “excipient.”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (b)
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 20-33, 35, and 37-38 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.
Regarding claims 20-33, 35, and 37-38: In claims 20, 35, and 37-38, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 21-33 which depend from claim 20 are similarly rejected.
Claim Rejections - 35 USC § 112 (d)
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 23, 27, 35, 37 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.
Claim 23 states “wherein R1 is a moiety R6.”. However claim 20 of which claim 23 depends limits R1 to a moiety R5-R6. Thus, claim 23 fails to properly limit claim 20 by omitting an element previously described. The Examiner suggests that the claim should be amended to include wherein R5 is a bond, in order to properly limit R1 to R6, such as “wherein R5 is a bond” or similar.
Claim 27 states “wherein R4 is H”. However claim 20 of which claim 27 depends already limits R4 to H. Thus claim 27 fails to further limit the claim.
Claim 35 which is drawn to a composition and depends on the compounds of claim 20 fails to properly limit the claim as the composition does not include the limitations of the claimed method.
Claim 37 which is drawn to an vitro method for obtaining and/or maintaining T-cells and depends on the compounds described in claim 20 fails to properly limit the claim because it does not require the same method of treating a subject as in claim 20
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.
Claim Rejections - 35 USC § 102
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.
Claims 20 and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koprivica (Molecules, 2020, cited on PTO-892).
Regarding claims 20 and 37: Koprivica teaches Ethyl pyruvate (EP) application prevented the clinical manifestation of type 1 diabetes in mice by augmenting regulatory T cell (Treg) number and function (abstract). Koprivica teaches that EP increases Treg proliferation and suppressive function (perforin and IL-10 expression) (abstract). Koprivica teaches providing Treg CD4+ cells with conventional Treg differentiation cocktail and applying EP which increased the proportion of Treg cells (pg. 2, last para.). Koprivica teaches comparison between conventionally-induced and EP-treated Treg (i.e. analyzed after isolation, pg. 3, last para., pg. 4, figure 2).
Claims 20-21, 24, 26, 27-28, 30, 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sheridan (WO 2012/080729, cited on PTO-892).
Regarding claims 20-21, 24, 26, 27-28, 30, 32: Sheridan teaches pharmaceutical compositions comprising casein kinase 1 delta inhibitors and to the use of said inhibitors in the treatment of neurodegenerative disorders such as Alzheimer's disease (pg. 1, lines 3-5). Sheridan teaches compound 553
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(pg. 138, compound 553).
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.
Claims 20-21, 24-25, 28, 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Blay (Acta Pharmaceutica Sinica B., 2020, cited on PTO-892).
Regarding claims 20-21, 24-25, 28, 30-31: Blay teaches hit compounds which are potential hepsin inhibitors against prostate cancer and kidney stones (abstract). Blay teaches one of the hits has the following structure
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(pg. 1315, table 1). Although Blay does not teach administration of the compound for the treatment of cancer, wherein blay suggests it binds hepsin, it would have been prima facie obvious to administer the compound for the treatment of prostate cancer, given that Blay identifies this compound as a potential binder for hepsin.
Claims 35 are rejected under 35 U.S.C. 103 as being unpatentable over Blay (Acta Pharmaceutica Sinica B., 2020, cited on PTO-892) as applied to claims 20-21, 24-25, 28, 30-31 above in view of Hemstreet (J. Immunotherap., 2013, cited on PTO-892).
Regarding claim 35: As discussed above, Blay renders obvious the method of claim 20.
Blay does not teach wherein the compound is included in a pharmaceutical composition comprising an immunotherapeutic and a pharmaceutical carrier.
However, Hemstreet teaches an immunotherapy in pancreatic patients expressing immunogenic protein hepsin (abstract). Hemstreet teaches the immunotherapeutic was formulated in a sterile cell suspension and injected into the patient (pgs. 58-59, bridging para.).
Taken together, it would have been prima facie obvious to combine the composition rendered obvious over Blay with the composition comprising an immunotherapeutic as taught by Hemstreet for the purpose of treating prostate cancer in a subject. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the art establishes them both as therapeutics for prostate cancer and it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose (see MPEP 2144.06 (I)).
Allowable Subject Matter
Claim 34 is allowed.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Sheridan (WO 2012/080729, cited on PTO-892).
Sheridan teaches pharmaceutical compositions comprising casein kinase 1 delta inhibitors and to the use of said inhibitors in the treatment of neurodegenerative disorders such as Alzheimer's disease (pg. 1, lines 3-5). Sheridan teaches compound 553
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(pg. 138, compound 553).
However, there is no teaching or suggestion to modify the compound of Sheridan to arrive at the instantly claimed compounds comprising a substituted aryl.
It would be improper hindsight to suggest a person of ordinary skill in the art would have had the motivation to do so as there is no teaching or suggestion that any of the substitutions would benefit the compound in anyway.
Thus claim 34 is allowed.
Conclusion
Claim 34 is allowed in this action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wang (J. Nat. Prod., 2016, cited on PTO-892) teaches compound 4
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(pg. 1220, figure 1, compound 4).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL L GALSTER whose telephone number is (571)270-0933. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Y Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL L GALSTER/Examiner, Art Unit 1693
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