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 reply filed on May 19, 2026
Status of Claims
Amendment of claims 1, 7-11 and 15; and cancellation of claims 2-6, 12-14 and 16-20
Claims 1, 7-11 and 15 are currently pending and are the subject of this office action.
Claims 1, 7-11 and 15 are presently under examination.
Priority
The present application claims priority to provisional application No. 60/492,367 filed on 08/04/2003.
Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 112 (New Rejection Necessitated by Amendment).
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.
Claim 1 is 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.
Claim 1 recites the limitation “wherein the modulator of Orai1 is IA65”.
However, there is insufficient antecedent basis for this limitation in the claim, since claim 1 recites a modulator of SOCE, not a modulator of Orai1.
Claim Rejections - 35 USC § 103 (New Rejection Necessitated by Amendment)
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 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, 7-11 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Umemura et. al. (PLOS ONE (2014) 9:1-11, cited by Applicant) in view of Azimi et. al. (Pharmacology and Translational Science (2020) 3:135-147, cited by Applicant).
For claims 1, 7, Umemura teaches a method of treating melanoma in vitro, comprising administering to melanoma cells a composition comprising the compound YM58483 (BTP2, a modulator of SOCE and Orai1, see instant specification on paragraph bridging pages 51-52) (see Figure 4 B; see page 7 under “inhibition of SOCE suppresses melanoma cell proliferation”; and see page 8 under “inhibition of SOCE suppresses melanoma cell migration/metastasis”).
Umemura does not teach the treatment of a subject in vivo. However, Umemura teaches that “SOCE is a potential target for the treatment of melanoma” (see page 10, left column, last paragraph).
Umemura doe does not teach that the Orai1 modulator is IA65. However, Azimi teaches that IA65 is a selective modulator of Orai1 Ca channel (and hence SOCE) (see title and page 141 under discussion, first two paragraphs).
Since there is a presumption of a correlation between in vitro and in vivo assays, 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 melanoma (a disease associated with reduced levels of Calcium) in a subject suffering from melanoma comprising the administration of the Orai1 modulator YM58483 that has already proven to be effective in vitro,
Further, since Umemura teaches a method of treating melanoma comprising the administration of a composition a Orai1 modulator (YM58483), and since Azimi teaches that IA65 is a Orai1 modulator, 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 substitute one functional equivalence (a Orai1 modulator like YM58483) for another (IA65) with an expectation of success, since the prior art establishes that both function in similar manner
All this will result in the practice of claims 1 and 7 with a reasonable expectation of success.
Regarding claim 8 The prior art is silent regarding the statement: “wherein administering the composition to the subject downregulates anabolic metabolic pathways in cancerous cells”.
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 of treating melanoma comprising administering to a subject in need thereof a composition comprising the Orai1 modulator IA65".
MPEP 2114.04 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 administering the composition to the subject downregulates anabolic metabolic pathways in cancerous cells” appears to be the result of the process made obvious by the prior art: “a method of treating melanoma comprising administering to a subject in need thereof a composition comprising the Orai1 modulator IA65", 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.
Similar arguments can be made for the “wherein” clauses in claims 9-11 and 15.
All this will result in the practice of claims 8-11 and 15.
Response to Applicant’s arguments
Since a new rejection was issued (see above), it is the Examiner’s belief that most of the arguments presented by Applicant are no longer applicable or have been considered/answered in the rejection itself.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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
May 27, 2026.
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