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 Arguments and Amendment filed, 08/20/2026, wherein the Amendment cancelled claims 1-4, 6-8, 13-16, 19-23, 30-31, 34 and 38, and added claims 39-58.
Claims 39-58 are pending.
Priority
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Election/Restrictions
Applicant elected a) Group I, the method, b) Osimertinib as the EFGR-TK inhibitor species; and c)
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as the proliferating cell nuclear antigen inhibitor, in the reply filed on 03/24/2026.
Claims 41, 47-48 and 54-58 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.
Claims 39-40, 42-46 and 49-53 are examined on the merits herein.
REJECTIONS-WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
35 USC 103 over Malkas in view of Martens
Applicant’s deletion of the previously examined claims and addition of new claims is sufficient to overcome this rejection.
Double Patenting
Applicant’s amendment to the claims is sufficient to overcome the rejection of US Patent Nos. 10,550,070, 12,054,447, and 10,913,706.
There is no motivation in ‘070 or ‘447 to specifically select the compound of instant formula (A) to treat cancer, let alone to combine it with Osimertinib or neratinib to treat cancer.
While ‘706 does teach instant Formula (A), ‘706 specifically teaches cisplatin as the only anti-cancer agent that is combined with the compound. There is no motivation to substitute the cisplatin with Osimertinib. As such, the rejection is withdrawn.
REJECTIONS—MODIFIED & MAINTAINED
Applicant’s deletion of all previously pending claims and addition of new claims has resulted in the below new rejections. Malkas continues to be relied upon as the primary prior art reference.
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 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.
Claims 39-40, 42-43, 45, and 49-53 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/049206 to Malkas (published 2017, PTO-892 of 05/21/2026) in view of Soria (Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cel Lung Cancer, published 2018, PTO-892).
Malkas teaches
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, AOH1996 for the treatment of NSCLC, wherein the following are NSCLC cell lines:
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, as referenced in Table 5 ([0572]-[0573] ;pg. pg. 201, claim 83; pg. 181, Table 3).
Regarding claim 39, while Malkas teaches a method of treating NSCLC by administering instant Formula (A), it differs from that of instant claim 39 in that it does not teach osimeritinib.
Soria teaches a method of treating advanced NSCLC with EGFR mutations by administering Osimertinib (abstract), wherein Osimertinib treatment results in longer progression-free survival and a lower rate of adverse events (pg. 124, last paragraph; pg. 121, last full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add osimertinib to the method of Malkas, to arrive at instant claim 39. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-Malkas exemplifies a method of treating NSCLC by administering AHO1996, i.e., instant Formula (A),
-Malkas teaches that additional anti-cancer agents can be added to its methods, and specifically teaches EGFR-TK inhibitors as such anti-cancer agents ([0077]), and
-Soria teaches treating advanced NSCLC with EGFR mutations by administering Osimertinib.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a therapeutically effective method of treating EGFR mutated NSCLC that increases quality of life and survival.
Moreover, "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 (treat NSCLC), in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), MPEP 2144.06.
Regarding claim 40, 42-43, and 45 the combination of Malkas and Soria teaches NSCLC and Osimertinib.
Regarding claims 49-50, Malkas teaches compositions comprising its compounds, i.e., AOH1996, a pharmaceutically acceptable excipient, and an anti-cancer agent (pg. 201, claims 85-86). Malkas further teaches that its compounds can be administered alone or can be co-administered to the patient, wherein coadministration includes simultaneous or sequential administration of the compound individually or in combination with other active substances. ([0104]-[0105]). Thus, an ordinary skilled artisan would have been motivated to modify the administration as a single administration or co-administration of separate compositions, to arrive at a method of administration that is optimized to effectively treat NSCLC and to minimize adverse side effects.
Regarding claims 51-52, Soria teaches the treatment of EGFR mutation-positive NSCLC, wherein the mutation is an exon 19 deletion or L858R (abstract).
Regarding claim 53, Soria teaches Osimertinib as an EGFR-TKI that inhibits both EGFR TKI-sensitizing and EGFR T790M resistance mutations in NSCLC (abstract). As such, an ordinary skilled artisan would have been motivated to select the methods of the combination of Malkas and Soria to treat EGFR-TK resistant cancer since the combination of Malkas and Soria teach the treatment NCSCL with an EGFR mutation and Soria specifically teaches that Osimertinib treats NSCLC with an EGFR T790M resistance.
Claims 39-40, 42, 44, 46, and 49-52 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/049206 to Malkas (published 2017, PTO-892 of 05/21/2026) in view of Dong (Design, Synthesis and Biological Evaluation of Novel Osimertinib-Based HDAD and EGFR Dual Inhibitors, published 2019, PTO-892).
Malkas teaches
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, AOH1996 for the treatment of breast cancer ([0572]-[0573] ;pg. pg. 201, claim 83; pg. 181, Table 3). Malkas specifically teaches AOH1996 as effective in treating MDA-MB231 and MDA-MB-468 breast cancer cell lines ([0572]-[0573]).
Regarding claim 39, while Malkas teaches a method of treating breast cancer by administering instant Formula (A), it differs from that of instant claim 39 in that it does not teach osimeritinib.
Dong teaches a method of treating breast cancer by administering Osimertinib, i.e., AZD9291 (abstract). Specifically, Dong teaches Osimertinib as decreasing the proliferation of MDA-MB-231 and MDA-MB-468 breast cancer cell lines (pg. 7, “2.4”).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add osimertinib to the methods of Malkas, to arrive at instant claim 39. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-Malkas exemplifies a method of treating breast cancer, and specifically MDA-MB-231 and MDA-MB-468, by administering AHO1996,
-Malkas teaches that additional anti-cancer agents can be added to its methods, and specifically teaches EGFR-TK inhibitors as such anti-cancer agents ([0077]), and
-Dong teaches osimertinib , an EGFR-TK inhibitor, as decreasing the proliferation of MDA-MB-231 and MDA-MB-468 breast cancer cell lines.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a more therapeutically effective method of treating MDA-MD-231 and MDA-MB-468 breast cancer.
Moreover, "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 (treat MDA-MD-231 and MDA-MB-468 breast cancer), in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), MPEP 2144.06.
Regarding claim 40, 42, 44, and 46 the combination of Malkas and Dong teaches breast cancer and Osimertinib.
Regarding claims 49-50, Malkas teaches compositions comprising its compounds, i.e., AOH1996, pharmaceutically acceptable excipients, and an anti-cancer agent (pg. 201, claims 85-86). Malkas further teaches that its compounds can be administered alone or can be co-administered to the patient, wherein coadministration includes simultaneous or sequential administration of the compound individually or in combination with other active substances. ([0104]-[0105]). Thus, an ordinary skilled artisan would have been motivated to modify the administration as a single administration or co-administration of separate compositions, to arrive at a method of administration that is most therapeutically effective to treat the breast cancer and minimize adverse side effects.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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.
(Modified) Claims 39-40, 42-43, 45, and 49-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 14-15, 17-19, 22-23 of U.S. Patent No. 11,345,656 (PTO-892 of 05/21/2026) in view of WO 2017/049206 to Malkas (published 2017, PTO-892 of 05/21/2026) and Soria (Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cel Lung Cancer, published 2018, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘656 claims a method of treating cancer by administering a compound of instant Formula (A) (claims 15, 17), and teaches combining the compound with an anticancer agent in a pharmaceutical composition (claims 10-11, 14-15, 17).
‘656 differs from that of instant claim 39 in that it does not teach Osimertinib.
Malkas and Soria are applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add osimertinib to the method of ‘656, to arrive at instant claim 39. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-‘656 claims a method of treating cancer by administering instant Formula (A) and an anticancer agent,
-Malkas exemplifies a method of treating NSCLC by administering AHO1996, i.e., instant Formula (A), and
- Soria teaches treating advanced NSCLC with EGFR mutations by administering Osimertinib.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a therapeutically effective method of treating EGFR mutated NSCLC that increases quality of life and survival.
Moreover, "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 (treat NSCLC), in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), MPEP 2144.06.
Regarding claim 40, 42-43, and 45 the combination of ‘656, Malkas and Soria teaches NSCLC and Osimertinib.
Regarding claims 49-50, Malkas teaches compositions comprising its compounds, i.e., AOH1996, a pharmaceutically acceptable excipient, and an anti-cancer agent (pg. 201, claims 85-86). Malkas further teaches that its compounds can be administered alone or can be co-administered to the patient, wherein coadministration includes simultaneous or sequential administration of the compound individually or in combination with other active substances. ([0104]-[0105]). Thus, an ordinary skilled artisan would have been motivated to modify the administration as a single administration or co-administration of separate compositions, to arrive at a method of administration that is most therapeutically effective to treat the NSCLC and minimize adverse side effects.
Regarding claims 51-52, Soria teaches the treatment of EGFR mutation-positive NSCLC, wherein the mutation is an exon 19 deletion, or L858R (abstract).
Regarding claim 53, Soria teaches Osimertinib as an EGFR-TKI that inhibits both EGFR TKI-sensitizing and EGFR T790M resistance mutations in NSCLC (abstract). As such, an ordinary skilled artisan would have been motivated to select the methods of the combination of ‘656, Malkas and Soria to treat EGFR-TK resistant cancer since the combination of’656, Malkas and Soria teach the treatment NCSCL with an EGFR mutation and Soria specifically teaches that Osimertinib treats NSCLC with an EGFR T790M resistance.
(Modified) Claims 39-40, 42, 44, 46, and 49-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 14-15, 17-19, 22-23 of U.S. Patent No. 11,345,656 (PTO-892 of 05/21/2026) in view of WO 2017/049206 to Malkas (published 2017, PTO-892 of 05/21/2026) and Dong (Design, Synthesis and Biological Evaluation of Novel Osimertinib-Based HDAD and EGFR Dual Inhibitors, published 2019, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘656 is applied as discussed above and incorporated herein.
Regarding claim 39, ‘656 differs in that it does not teach osimeritinib.
Dong is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add osimertinib to the methods of ‘656, to arrive at instant claim 39. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-‘656 claims a method of treating cancer by administering instant Formula (A) and an anticancer agent,
-Malkas exemplifies a method of treating breast cancer by administering AHO1996, i.e., instant Formula (A), and
-Malkas teaches that additional anti-cancer agents can be added to its methods, and specifically teaches EGFR-TK inhibitors as such anti-cancer agents ([0077]), and
-Dong teaches osimertinib as decreasing the proliferation of MDA-MB-231 and MDA-MB-468 cells in breast cancer.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a therapeutically effective method of treating breast cancer.
Moreover, "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 (treat breast cancer), in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), MPEP 2144.06.
Regarding claim 40, 42, 44, and 46 the combination of ‘656, Malkas and Dong teaches breast cancer and Osimertinib.
Regarding claims 49-50, Malkas teaches compositions comprising its compounds, i.e., AOH1996, a pharmaceutically acceptable excipient, and an anti-cancer agent (pg. 201, claims 85-86). Malkas further teaches that its compounds can be administered alone or can be co-administered to the patient, wherein coadministration includes simultaneous or sequential administration of the compound individually or in combination with other active substances. ([0104]-[0105]). Thus, an ordinary skilled artisan would have been motivated to modify the administration as a single administration or co-administration of separate compositions, to arrive at a method of administration that is most therapeutically effective to treat the breast cancer and minimize adverse side effects.
(Modified) Claims 39-40, 42, 44, 46, and 49-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,435,030 (PTO-892 of 05/21/2026) in view of WO 2017/049206 to Malkas (published 2017, PTO-892 of 05/21/2026) and Dong (Design, Synthesis and Biological Evaluation of Novel Osimertinib-Based HDAD and EGFR Dual Inhibitors, published 2019, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘030 claims a method of treating cancer, such as breast and lung cancer by administering a pharmaceutical composition comprising instant Formula (A), and the species of instant claim 30, and an EGFR inhibitor (claims 1, 13-19).
Regarding claim 39, ‘030 differs in that it does not teach osimeritinib.
Dong is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add osimertinib to the methods of ‘030, to arrive at instant claim 39. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-‘030 claims a method of treating breast cancer by administering instant Formula (A) and an EGFR inhibitor,
-Malkas exemplifies a method of treating breast cancer by administering AHO1996, i.e., instant Formula (A), and
-Dong teaches osimertinib as decreasing the proliferation of MDA-MB-231 and MDA-MB-468 cells in breast cancer.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a therapeutically effective method of treating breast cancer.
Moreover, "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 (treat breast cancer), in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), MPEP 2144.06.
Regarding claim 40, 42, 44, and 46 the combination of ‘656, Malkas and Dong teaches breast cancer and Osimertinib.
Regarding claims 49-50, Malkas teaches compositions comprising its compounds, i.e., AOH1996, a pharmaceutically acceptable excipient, and an anti-cancer agent (pg. 201, claims 85-86). Malkas further teaches that its compounds can be administered alone or can be co-administered to the patient, wherein coadministration includes simultaneous or sequential administration of the compound individually or in combination with other active substances. ([0104]-[0105]). Thus, an ordinary skilled artisan would have been motivated to modify the administration as a single administration or co-administration of separate compositions, to arrive at a method of administration that is most therapeutically effective to treat the NSCLC and minimize adverse side effects.
(Modified) Claims 39-40, 42-43, 45, and 49-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,435,030 (PTO-892 of 05/21/2026) in view of WO 2017/049206 to Malkas (published 2017, PTO-892, of 05/21/2026) and Soria (Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cel Lung Cancer, published 2018, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘030 is applied as discussed above and incorporated herein.
‘030 differs from that of instant claim 39 in that it does not teach Osimertinib.
Malkas and Soria are applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add osimertinib to the method of ‘030, to arrive at instant claim 39. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-‘030 claims a method of treating lung cancer by administering instant Formula (A) and an anticancer agent,
-Malkas exemplifies a method of treating NSCLC by administering AHO1996, i.e., instant Formula (A), and
- Soria teaches treating advanced NSCLC with EGFR mutations by administering Osimertinib.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a therapeutically effective method of treating EGFR mutated NSCLC that increases quality of life and survival.
Moreover, "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 (treat NSCLC), in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), MPEP 2144.06.
Regarding claim 40, 42-43, and 45 the combination of ‘030, Malkas and Soria teaches NSCLC and Osimertinib.
Regarding claims 49-50, Malkas teaches compositions comprising its compounds, i.e., AOH1996, a pharmaceutically acceptable excipient, and an anti-cancer agent (pg. 201, claims 85-86). Malkas further teaches that its compounds can be administered alone or can be co-administered to the patient, wherein coadministration includes simultaneous or sequential administration of the compound individually or in combination with other active substances. ([0104]-[0105]). Thus, an ordinary skilled artisan would have been motivated to modify the administration as a single administration or co-administration of separate compositions, to arrive at a method of administration that is most therapeutically effective to treat the NSCLC and minimize adverse side effects.
Regarding claims 51-52, Soria teaches the treatment of EGFR mutation-positive NSCLC, wherein the mutation is an exon 19 deletion, or L858R (abstract).
Regarding claim 53, Soria teaches Osimertinib as an EGFR-TKI that inhibits both EGFR TKI-sensitizing and EGFR T790M resistance mutations in NSCLC (abstract). As such, an ordinary skilled artisan would have been motivated to select the methods of the combination of ‘656, Malkas and Soria to treat EGFR-TK resistant cancer since the combination of’656, Malkas and Soria teach the treatment NCSCL with an EGFR mutation and Soria specifically teaches that Osimertinib treats NSCLC with an EGFR T790M resistance.
Response to Arguments
On pgs. 5-8, Remarks, Applicant argues that unexpected results have been achieved and points to several figures and portions of the specification.
Regarding Figures 1C and 4-8, since these figures are line graphs that do not specify the numeric coordinates of the “x” and “y” axis position of each single point, it is not clear if Applicant has achieved an unexpected result or has achieved an additive effect of the combination of instant Formula (A), i.e., AOH1996 and Osimertinib.
Regarding Figure 1C, which is referenced in Example 2, paragraphs [0386]-[0387] of the specification, while it appears that an unexpected result in the survival of NSCLC cells may have been achieved at a combination of 0.25uM AOH1996 and 1.8uM neratinib, this result is not commensurate in scope with instant claim 39 that is not limited to the treatment of any single cancer and is not limited to any amount of (i) Osimertinib or neratinib, or (ii) AOH1996, i.e., instant Formula (A). Moreover, it appears that most of the combinations of AOH1996 and neratinib resulted in an additive effect in reference to survival of the NSCLC cells.
Similarly, regarding Figures 4A-4C, 5A-5F, 6A, and 8A-8D, while it appears that an unexpected result in the survival of either specific NSCLC or breast cancer cells may have been achieved at specific combinations of concentrations of AOH1996 and Osimertinib this result is not commensurate in scope with instant claim 39 since claim 39 is not limited to the treatment of any single cancer and is not limited to any amount of (i) Osimertinib or neratinib, or (ii) AOH1996, i.e., instant Formula (A). Moreover, it appears that most of the combinations of AOH1996 and osimertinib resulted in an additive effect in the survival of the NSCLC and breast cancer cells, and not an unexpected effect/result.
It is respectfully pointed out that Figures 6B-C, 7A-B, and 9 do not show any type of unexpected or surprising results that are commensurate in scope with the instantly claimed method.
Applicant is reminded that unexpected results a) are greater than expected results, b) show superiority of a property shared with the prior art, c) exhibit the presence of an unexpected property, and/or d) exhibit the absence of an expected property. MPEP 716.02 additionally states that unexpected results must be commensurate in scope with the claimed invention and provide a comparison with the closest prior art.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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/LAUREN WELLS/Primary Examiner, Art Unit 1622
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