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 January 29, 2026.
Status of Claims
Amendment of claims 1, 22 and 44 is acknowledged.
Claims 1-19, 22 and 43-44 are currently pending and are the subject of this office action.
Claims 6-7, 15-16 and 22-44 were previously withdrawn
Claims 1-5, 8-14, 17-19 and 43 are under examination as they relate to the following species:
pancreatic and breast cancer.
Priority
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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Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.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 § 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 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.
1) Claim(s) 1-5 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lowe et. al. (WO 2018/022868, 02-01-2018) in view of Glenn et. al (WO 2017/147526, August 31, 2017, cited by Applicant).
For claim 1, Lowe teaches that PI4-kinases are implicated in cancer onset and progression and are responsible for cell proliferation and migration (see page 4, lines 9 through 27). Based on that, the authors stated that there is a plethora of evidence that PI4-kinases are potential therapeutic targets for several diseases, including cancer (see page 5, line 28 through page 6, line 4).
As such, the authors discovered a method of treating cancer comprising the administration of an effective amount of a composition comprising a PI4-kinase inhibitor (see title, abstract, page 7 under summary of the invention).
Lowe does not teach that the PI4-kinase is a 5-aryl-thiazole or a 5-heteroaryl-thiazole.
However, Glenn teaches that 5-aryl-thiazole or a 5-heteroaryl-thiazoles are PI4-kinase inhibitors (see abstract, see page 16 under compounds).
Since Lowe teaches a method of treating cancer comprising the administration of a composition comprising a PI4-kinase inhibitor, and since Glenn teaches that 5-aryl-thiazole or a 5-heteroaryl-thiazole are PI4-kinase inhibitors, 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 (any PI4-kinase inhibitor) for another (5-aryl-thiazole or a 5-heteroaryl-thiazoles) with an expectation of success, since the prior art establishes that both function in similar manner, thus resulting in the practice of claim 1, with a reasonable expectation of success.
For claims 2-3 and 5, Lowe teaches that the cancer can be breast cancer (a carcinoma and a solid tumor) and pancreatic cancer (see claim 15), thus resulting in the practice of claims 2-3 and 5 with a reasonable expectation of success.
For claim 4, Lowe does not explicitly teach: “wherein the compound (a PI4-kinase antagonist) inhibits metastasis of the solid tumor”.
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 cancer comprising administering to a subject in need thereof a composition comprising an effective amount of a PI4-kinase antagonist like 5-aryl-thiazole or a 5-heteroaryl-thiazole ".
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 “inhibition of metastasis of the solid tumor” appears to be the result of the process made obvious by the prior art: “a method of treating cancer comprising administering to a subject in need thereof a composition comprising an effective amount of a PI4-kinase antagonist like 5-aryl-thiazole or a 5-heteroaryl-thiazole", e. g. the intended result of a process step positively recited.
Further, MPEP 2112 V recites:
“[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same [footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).
MPEP 2112 III recites:
“Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim, but the function or property is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102/103 rejection is appropriate for these types of claims as well as for composition claims.”
Finally, the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the PI4-kinases disclosed in the prior art do not possess the same material, structural and functional characteristics (inhibition of metastasis of solid tumors) of the PI4-kinases claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the PI4-kinases in the claimed method is different from the PI4-kinases taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
All this will result in the practice of claim 4 with a reasonable expectation of success.
For claim 14, Glenn teaches that the 5-aryl-thiazoles or a 5-heteroaryl-thiazoles are selective for PI4-kinase over PI3-kinase (see for Example 2, Table 3 on pages 112-115), thus resulting in th practice of claim 14 with a reasonable expectation of success.
2) Claim(s) 8-10, 13 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lowe et. al. (WO 2018/022868, 02-01-2018) in view of Glenn et. al (WO 2017/147526, August 31, 2017, cited by Applicant) as evidenced by Morrow et. al. (Molecular Cancer Research (2014), 12: 1492-1508).
Lowe in view of Glenn teach all the limitations of claims 8-10 and 43, except for breast cancer cells showing increased levels of PI4KIIIbeta and increased PI4KIIIbeta activity. However, breast cancer cells inherently comprise 20% increased levels of PI4KIIIbeta and increased PI4KIIIbeta activity as evidenced by Morrow (see abstract and see page 1493, left column, second paragraph).
All this will result in the practice of claims 8-10 and 43 with a reasonable expectation of success.
Lowe in view of Glenn teach all the limitations of claim 13, except for the cancer cell having greater than diploid copy number of the PI4IIIbeta gene.
However, Morrow teaches 1q21 gene which encodes PI4IIIbeta was highly amplified in breast cancer (see page 1492, column 1, lines 12-15 and column 2, lines 1-2) which reads on “greater than diploid copy number of the PI4KIIIbeta gene”.
All this will result in the practice of claim 13 with a reasonable expectation of success.
3) Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lowe et. al. (WO 2018/022868, 02-01-2018) in view of Glenn et. al (WO 2017/147526, August 31, 2017, cited by Applicant) as applied to claims 1-5 and 14 above, further in view of Morrow et. al. (Molecular Cancer Research (2014), 12: 1492-1508, cited in prior office action).
CLAIM INTERPRETATION: claim 11 does not require the cancer cells of the subject to be inhibited by a PI4KIIIbeta inhibitor, but instead the claim describes a property of the cells: that in the eventuality of administering a PI4KIIIbeta inhibitor, the cells will be sensitive to that inhibitor.
Lowe in view of Glenn teach all the limitations of claim 11, except for the cancer cells of the subject being sensitive to PI4KIIIbeta inhibition. However, since Morrow teaches that PI4KIIIbeta is highly expressed in breast tumors (see title for example) it will be expected, that these breast cancer cells will be sensitive to an eventual PI4KIIIbeta inhibition, thus resulting in the practice of claim 11 with a reasonable expectation of success.
Lowe in view of Glenn teach all the limitations of claim 12 except for:
1- measuring the expression level or activity level of PI4KIIIP in cancer cells of a biological sample obtained from the subject; and
2- determining whether the expression level or activity level of PI4KIIIP in the cancer cells is elevated relative to one or more control cells.
However, Morrow teaches that PI4KIIIbeta is highly expressed in breast tumors (see title for example), it will be obvious to measure the expression level of the PI4KIIIbeta and to determine if the expression level of PI4KIIIbeta in breast cancer cells is elevated as taught by Morrow, thus resulting in the practice of claim 12 with a reasonable expectation of success.
4) Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lowe et. al. (WO 2018/022868, 02-01-2018) in view of Glenn et. al (WO 2017/147526, August 31, 2017, cited by Applicant) as applied to claims 1-5 and 14 above, further in view of Li et. a. (Cancer Research (2017) 77:6253-6266).
Lowe in view of Glenn teach all the limitations of claims 17-19, except for:
Further administering an effective amount of an additional agent to the subject, wherein the additional agent is a chemotherapeutic agent and wherein the additional agent is an inhibitor of a compound-metabolizing enzyme).
However, Li teaches the treatment of breast cancer comprising administering to a subject in need thereof an effective amount of a PI4KIIalpha inhibitor (PI-273) thus resulting in the practice of claims 17-19 with a reasonable expectation of success.
Double Patenting (Maintained Rejection).
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 1-5, 8-14, 17-19 and 43 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims: 1, 13-14 and 16-19 of copending Application No. 17/439,085 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both: the instant application and the co-pending application recite methods of treating cancer comprising the administration of compositions comprising PI4-Kinase inhibitors
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 January 30, 2026.