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 .
DETAILED ACTION
This office action is in response to applicant’s filing dated March 27, 2024.
Status of Claims
Claims 1-4, 6-8, 10, 12, 14-20, 26-28, 46 and 52 are currently pending and are the subject of this office action.
Claims 1-4, 6-8, 10, 12, 14-20, 26-28, 46 and 52 are presently under examination.
Priority
The present application is a 371 of PCT/FI2022/2050646 filed on 09/27/2022 and claims priority to foreign application FINLAND FI0217146 filed on 09/28/2021.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 6-8, 10, 12, 14-20, 26-28, 46 and 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Din Belle (US 2019/0359601) in view of Lallous et. al. (Genome Biology (2016) 17:1-15, cited by Applicant).
For claims 1-3 and 6-8, 10, 12 and 14, Din Belle teaches a method of treating prostate cancer comprising administering to a subject in need thereof of a composition comprising a compound of Formula (I) (see abstract for example, see also claims 29-31):
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wherein the compound of Formula (I) is a CYP11A1 inhibitor, and wherein the specific compound of Formula (I) is compound 185 (see page 96):
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wherein in the instantly claimed formula R1 is Hydrogen.
Din Belle does not teach that the patient is having an activating androgen receptor (AR) gene alteration, wherein the activating AR gene alteration is an activating AR-LBD (Ligand Binding Domain) mutation, and wherein the activating AR-LBD mutation is selected from the group consisting of: F8771 or T878A.
However, Din Belle teaches that prostate cancer is an AR dependent condition (see for example [0001]-[[0006]). Further, Lallous teaches AR-LBD mutations associated to prostate cancer patients like: F877L, T878A (see title, abstract and page 2, left column first full paragraph), W742C (see page 4, left column, third line). These mutations confer anti-androgen resistance in prostate cancer patients that do not respond to drugs like abiraterone and enzalutamide (anti-androgen drugs) (see backgrounds on page 1).
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to treat any prostate cancer patient, including the subgroup of those who are suffering from AR-LBD mutations like: F8771 and/or T878A, that cause resistance to other known prostate cancer treatments like abiraterone and enzalutamide, since it will be expected that this subgroup of prostate cancer patients (that have AR-LBD mutations like F8771 and/or T878A, that did not respond to conventional treatments like abiraterone and enzalutamide) might respond to a different drug that has already been proven to be effective in the general population of patients suffering from prostate cancer, thus resulting in the practice of claims 1-3 and 6-8, 10, 12 and 14 with a reasonable expectation of success.
For claims 4, the prior art is silent regarding the statement:
“wherein the patient having an activating AR gene alteration has a higher probability to be responsive to the treatment than the patient who does not have an activating AR gene alteration”.
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method for treating prostate cancer in a patient having an AR-LBD mutation like F8771 and/or T878A, comprising the administration of a composition comprising the compound 185 above".
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case: “wherein the patient having an activating AR gene alteration has a higher probability to be responsive to the treatment than the patient who does not have an activating AR gene alteration” appears to be the result of the process made obvious by the prior art: “a method for treating prostate cancer in a patient having an AR-LBD mutation like F8771 and/or T878A, comprising the administration of a composition comprising the compound 185 above", e. g. the intended result of a process step positively recited. As such, this limitation in the instantly claimed method has not been given any weight.
All this will result in the practice of claim 4 with a reasonable expectation of success.
For claims 15-16, Lallous further teaches that the prostate cancer can be castration resistant prostate cancer (CRPC), thus resulting in the practice of claims 15-16 with a reasonable expectation of success.
For claims 17-19, 22, 46 and 52, Din Belle teaches a method of treating prostate cancer comprising administering to a subject in need thereof of a composition comprising a compound of Formula (I) (see abstract for example, see also claims 29-31):
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102
250
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wherein the compound of Formula (I) is a CYP11A1 inhibitor, and wherein the specific compound of Formula (I) is compound 185 (see page 96):
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126
274
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wherein in the instantly claimed formula R1 is Hydrogen.
Din Belle does not teach:
a) obtaining or having obtained a sample from the patient;
b) assaying or having assayed the sample to determine whether the patient has an activating AR gene alteration; and
c) if the patient has an activating AR gene alteration, treating the patient with a therapeutically effective amount of a CYP11Al inhibitor,
and wherein the activating AR gene alteration is an activating AR-LBD mutation.
However, Din Belle teaches that prostate cancer is an AR dependent condition (see for example [0001]-[[0006]). Further, Lallous teaches AR-LBD mutations associated to prostate cancer patients like: F877L, T878A (see title, abstract and page 2, left column (first full paragraph), W742C (see page 4, left column, third line). These mutations confer anti-androgen resistance in prostate cancer patients that do not respond to drugs like abiraterone and enzalutamide (anti-androgen drugs) (see backgrounds on page 1). These mutations were obtained from patient’s samples and then assaying these samples to determine whether the patent has an activating AR-LBD mutation (see for example on page 2 under Results)
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to: treat any prostate cancer patient, including the subgroup of those who are suffering from AR-LBD mutations like: F8771 and/or T878A (determined after obtaining a sample from the patient and assaying to determine if the patient has an AR-LBD gene mutation) that cause resistance to other known prostate cancer treatments like abiraterone and enzalutamide, since it will be expected that this subgroup of prostate cancer patients (that have AR-LBD mutations like F8771 and/or T878A, that did not respond to conventional treatments like abiraterone and enzalutamide) might respond to a different drug that has already been proven to be effective in the general population of patients suffering from prostate cancer, thus resulting in the practice of claims 17-19, 22, 46 and 52 with a reasonable expectation of success.
For claims 20, the prior art is silent regarding the statement:
“wherein the patient having an activating AR gene alteration has a higher probability to be responsive to the treatment than the patient who does not have an activating AR gene alteration”.
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method for treating prostate cancer in a patient having an AR-LBD mutation like F8771 and/or T878A, comprising the administration of a composition comprising the compound 185 above".
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case: “wherein the patient having an activating AR gene alteration has a higher probability to be responsive to the treatment than the patient who does not have an activating AR gene alteration” appears to be the result of the process made obvious by the prior art: “a method for treating prostate cancer in a patient having an AR-LBD mutation like F8771 and/or T878A, comprising the administration of a composition comprising the compound 185 above", e. g. the intended result of a process step positively recited. As such, this limitation in the instantly claimed method has not been given any weight.
All this will result in the practice of claim 20 with a reasonable expectation of success.
For claim 26, Lallous teaches that the samples are subjected to a gene panel assay targeting AR-LBD region (see pages 2-3 under Results), thus resulting in the practice of claim 26 with a reasonable expectation of success.
For claims 27-28, Lallous further teaches that the prostate cancer can be castration resistant prostate cancer (CRPC), thus resulting in the practice of claims 27-28 with a reasonable expectation of success.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
April 16, 2026.
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