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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/11/2025 has been entered.
Status of the Claims
Claims 19-20 and 23-33 are pending.
Claims 1-18 and 21-22 are cancelled.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/AU2021/000036, filed 5/5/2021; and further claims priority to foreign application number AU2020901435, filed 05/06/2020.
Information Disclosure Statement
All references from IDS(s) received on 11/07/2022 have been considered unless marked with a strikethrough.
Response to Arguments
Applicant's arguments filed 3/11/2026 have been fully considered but they are not persuasive.
In a final rejection dated 12/11/2025, claims 19-20 and 23-33 were examined upon their merits.
In a final rejection dated 12/11/2025, claims 19-20 and 23-33 were rejected under USC 103 and non-statutory double patenting. Claim 33 was rejected under USC 112(b). In response, the applicant amended claim 33.
With respect to the 112 rejection, the Applicant amended claim 33 to include “and selumetinib.” This addresses the issues raised by the Examiner and therefore the rejection is moot and withdrawn.
With respect to the 103 rejection, the Applicant argues that the prior art provided by the Examiner (“Wang”):
teaches a broad genus and list of structures to choose from, so broad that a person skilled in the art would have no motivation to select the compound, the type of cancer, or the type of kinase inhibitor of the instant claims. More specifically, the Applicant mentions that the compound taught by Wang is one out of the finite list of 108 compounds. Further, the Applicant argues that a person skilled in the art would not be motivated to choose this specific compound out of the list of 108 because other compounds have better inhibitory activity for CDK4.
Fails to teach an example of the combination of the compound with temozolamide for the treatment of specific cancers. Further, the Applicant argues that the instant application reflects a synergistic effect between the compound and temozolomide, which sets it apart from the teachings of Wang.
The Applicant argues that the Examiner relies on inherency improperly. Please see discussion on this below.
The Examiner argues that:
Although the genus structure taught by Wang allows for thousands of compounds, a finite list of compounds is provided. Within that finite list, the compound of the instant claims is found. Therefore, the Examiner does not find the argument that one would not at once envisage choosing this compound in the treatment of cancer. Further, the Examiner argues that compound 47 taught by Wang has a Ki 0f 0.002 uM for CDK4 (Table 2). The Examiner believes this is a reflection of the compound being potent towards CDK4. The Examiner also argues that the instant application lists compounds with Ki of CDK4 ranging from 0.0003-0.279 uM. Along the same line, Wang teaches compound 47 of having anti-proliferative activity against MV4-11 and MB453 to be approximately 0.107 uM and 0.349 uM, respectively. The Examiner the same as before that she these numbers do not reflect a lack of activity and further argues that the instant application lists compounds with GI50 of MV4-11 and MB453 to be in the approximate range of 0.01-0.29 uM and 0.07-1.45 uM, respectively. Although other compounds may have slightly improved Ki or GI50 in Wang, the Ki/GI50 of Compound 47 would not deter a person skilled in the art from trying it in their method.
With respect to in the treatment of specifically CNS related cancers, this is also within a finite list found in the claims of Wang and therefore the same reasoning applies. With respect to the use of a kinase inhibitor, the Examiner argues that Wang specifically mentions temozolamide as an additional agent to be used in combination with the compounds of interest and therefore teaches this limitation of the instant claims. With respect to the discussion fo the synergistic effect between the compound and temozolomide, the Examiner argues that although this may be true, the claims of the instant application do not reflect specific limitations that would result in this synergy. The Examiner suggests amending the claims to reflect the necessity of each compound in order to achieve such synergy.
The Examiner argues that she does not rely on inherency for her previous rejection. The compound of the instant claims is taught for the treatment of proliferative disorders. Within the same publication, use of the compound with an additional agent, such as temozolomide, is taught. The MPEP clearly states that “products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. This is not a reliance on inherency to reject the claims. This is the rejection of the argument of “unexpected results” which the Examiner does not find persuasive. The claims are rejected as the limitations of the claims are directly taught in the art. See MPEP 2112.01(II). Therefore, the 103 rejection is maintained.
Along with the reasoning presented in (1), the 103 rejection is maintained because a person skilled in the art would be motivated to combine the compound taught by Wang with another anti-cancer compound if the goal is the treatment of cancer. Since Wang explicitly teaches temozolamide as an additional agent and also explicitly teaches the combination for use in treating proliferative diseases such as cancers of the brain and CNS, there would be no reason for a person skilled in the art at the time to not combine the elements taught by Wang. Obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Therefore, the 103 rejection is maintained.
With respect to the non-statutory double patenting rejection, the applicant argued the same points as above. Therefore, the rejection is maintained for the same reasons as above.
NEW/MAINTAINED REJECTIONS
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. (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 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.
Claims 19-20 and 23-33 are rejected under 35 U.S.C. 103 as being unpatentable over Wang, S. et al. (WO2017020065A1; published 2/9/2017; cited in IDS filed 11/07/2022; “Wang”) in further view of Manoj, L. et al. (International Journal of Pharma and Bio Sciences; 2011, 2, 1; “Manoj”).
Wang teaches an overlapping genus structure (Claim 1) with the elected specie for use as an anti-proliferative agent for treatment of cell proliferative diseases including cancer of the brain and central nervous system (Abstract), as required by independent claim 19. More specifically, Wang teaches a structural example of the elected specie (Compound 47). Wang teaches the compound can be in a pharmaceutical composition adapted for oral or intravenous administration (p.0074), as required by instant claims 20. Wang also teaches the compound can be administered in combination with other anti-cancer drugs such as, temozolamide or kinase inhibitors such as MEK inhibitors (p.0066), as required by instant claims 23-24.
Wang teaches examples of target brain cancers including glioblastoma and medulloblastoma (p.0069), as required by instant claims 25-27.
Wang fails to explicitly mention the use of the compound in the treatment of primary CNS lymphoma, astrocytoma, ependymoma, oligodendroglioma, or metastatic brain tumors, as required by instant claims 28-32. However, these specific diseases fall within the genus of brain cancer, as evidenced by Manoj, with a broader genus of cell proliferative diseases, which is taught by Wang.
It would be obvious to a person skilled in the art to use the compound known to treat CNS and brain cancer/cell proliferative disorders, as taught by Wang, and treat an expanded patient population of the same genus, as evidenced by Manoj.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (G), it would have been prima facie obvious to extract the compound known to treat cell proliferative disorders and brain/CNS cancers taught by Wang and treat other types of brain/CNS cancers known to fall within the same genus, as evidenced by Manoj. A person skilled in the art would be motivated to do so in order to expand the patient population of a known drug.
Applying KSR example rationale (E), it would have been prima facie obvious to extract the specific types of brain cancer, such as glioblastoma, as taught by Manoj, and apply it to the method of treating a proliferative cell disease of CNS condition, including brain cancer, as taught by Wang.
Therefore, claims 19-20 and 23-33 would have been obvious to a person skilled in the art at the time.
Double Patenting
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 19-20 and 23-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. US10479785B2 in view of Liu, X. et al. (PLoS One. 2013 Nov 26;8(11):e81345; “Liu”) in further view of Manoj, L. et al. (International Journal of Pharma and Bio Sciences; 2011, 2, 1; “Manoj”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘785 patent recite an overlapping gneus structure (Claim 1) as well as the elected specie (Claim 29) of the instant claims. The claims of the ‘785 patent also recite a method of using the compound in treating brain and CNS cancers. The claims do not explicitly recite the types of brain cancer, as required by instant claims 25-32, however this would be considered as falling within the genus of “brain cancer”, as evidenced by Manoj.
The claims of the ‘785 patent fail to explicitly recite the use of the compound in combination with another anti-cancer agent, such as a kinase inhibitor or temozolomide. However, Liu teaches that combination therapy of temozolomide and a kinase inhibitor augments the known antitumor activity of temozolomide against glioma. Therefore, it would be obvious to a person skilled in the art at the time to use a combination of the instant compound and compounds known to have an anti-brain cancer effect.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (A), it would have been prima facie obvious to extract the drug structure taught by the ‘785 patent (the elected specie of the instant claims) and use a combination therapy with anti-cancer agents known to be used in brain and CNS related cancers, as taught by Liu. Therefore, claims 19-20 and 23-33 would have been obvious to a person who is skilled in the art prior to the effective filing date.
Conclusion
Claims 19-20 and 23-33 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clint Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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