DETAILED ACTION
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 .
Applicant’s amendment and response filed on 1/28/2026 has been received and entered into the case.
Claims 7-10 and 23-24 have been canceled, claims 27-32 are newly added, claims 1-4, 18-22 and 25-26 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 5-6, 11-17 and 27-32 have been considered on the merits. All arguments have been considered.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description Rejection
Claims 5-6, 11-17 and 27-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 5 discloses a method of “treating” a p53-deficient cancer in a subject comprising administering to the subject the combination therapy comprising a glycolysis inhibitor and a histone deacetylase inhibitor.
Claim 12 discloses a cancer treatment regimen comprising a step of detecting the expression of Fxbw7 in a cancer and administer a glycolysis inhibitor and/or a HDACi if there is Fxbw7 expression or if there is no Fxbw7 expression, administer
The scope of the term “treating” includes the administration of a composition with the intent or purpose of partially or completely delaying, healing, alleviating, relieving, altering, remedying, ameliorating, improving, stabilizing, mitigating, and/or reducing the intensity or frequency of one or more a diseases or conditions, a symptom of a disease or condition, or an underlying cause of a disease or condition.” (p.8-9).
Thus, the scope of the term “treating” encompasses not only partial effect of delaying, healing, alleviating, etc. but also completely delaying, healing, alleviating, etc., which would be considered to encompass “preventing” or “curing” of the p53-deficient cancer by the claimed method.
As defined, the scope encompasses “preventing” or “curing” of any cancer having p53 deficiency by the claimed method.
The instant specification discloses that pramlintide, a glycolysis inhibitor, induces tumor regression in spontaneous UV-driven cutaneous squamous cell carcinoma (cuSCC) model, and pramlintide caused rapid tumor regression in p53 deficient thymic lymphomas, lung cancers, and cutaneous squamous cell carcinomas according to Fig. 3. However, the disclosure of the instant specification does not provide sufficient written description for the “preventing” or “curing” not only those carcinomas listed in claim 6 but also any other p53-deficient cancer encompassed by the scope of the instant claims.
M.P.E.P. §2163 recites, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus…when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.”
Thus, the instant specification fails to provide sufficient written description to support that the inventors had possession on the entire scope of the claimed invention, particularly for preventing or curing any cancer as claimed.
Scope of Enablement Rejection
Claims 5-6 and 11-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for alleviating, relieving, altering, ameliorating, improving, stabilizing, mitigating, and/or reducing the intensity or frequency or symptoms of a p53-deficient cancer, does not reasonably provide enablement for preventing or curing of the p53-deficient cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case are discussed below.
The scope of “treating” is extensive according to the definition in the instant specification. The scope of the term “treating” includes the administration of a composition with the intent or purpose of partially or completely delaying, healing, alleviating, relieving, altering, remedying, ameliorating, improving, stabilizing, mitigating, and/or reducing the intensity or frequency of one or more a diseases or conditions, a symptom of a disease or condition, or an underlying cause of a disease or condition.” (p.8-9).
Thus, the scope of the term “treating” encompasses not only partial effect of delaying, healing, alleviating, etc. but also completely delaying, healing, alleviating, etc., which would be considered to encompass “preventing” or “curing” of the p53-deficient cancer by the claimed method.
The court has recognized that physiological activity is unpredictable. In re Fisher, 166 USPQ 18 (CCPA 1970). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved. In re Fisher, 166 USPQ 18 (CCPA 1970).
It is not to be left up to the skilled artisan to figure out how to make the necessary starting materials and then to figure out how to use them to produce the biological effects as recited in the claims. The courts held that the disclosure of an application shall inform those skilled in the art how to use applicant's claimed invention, not how to find out how to use it for themselves. In re Gardner et al. 166 USPQ 138 (CCPA 1970). For the broad scope of the claims, this specification only teaches what is intended to be done and how it is intended to work, but does not actually teach how to do that which is intended.
Given the limited working examples, the limited guidance provided in the specification, the broad scope of the claims with regard to the treatment encompassing prevention and/or cure of any p53-deficient cancer, and the unpredictability for preventing and/or curing any p53-deficient cancer using the claimed method, undue experimentation would have been required for one skilled in the art to practice the claimed method.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 5-6, 13, 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lieberman et al. (US2018010583A1; IDS ref.)
Regarding claims 5-6, Lieberman et al. teach a method of treating a cancer and a tumor using a combination of histone deacetylase inhibitor and glycolysis inhibitors (para. 9 and 133). Lieberman et al. teach that the cancer or the tumor includes BL-BT (basal-like breast cancer), lung cancer (e.g. small-cell lung cancer, non-small cell lung cancer, adenocarcinoma of the lung and squamous carcinoma of the lung), squamous cell cancer and a cancer of the head and neck (para. 135, 165 and 453-454). Lieberman et al. teach that BL-BT has loss of function of p53, i.e. p53-deficient (para. 453-454 and 466).
Regarding claim 6, while Lieberman et al. do not teach the cancer types discussed above, e.g. lung cancer, being p53-deficient, however, as the claim discloses lung cancer as p53-deficient cancer, the method of Lieberman et al. treating lung cancer would meet the limitation.
Regarding claim 13, the claim requires only the step of administering a glycolysis inhibitor to the subject in need of increasing the sensitivity of a p53-deficient cancer in the subject, and does not require any additional step of administering HDACi therapy. Lieberman et al. teach the limitation as discussed above. Even if the method is interpreted such that the subject being administered with both HDACi and a glycolysis inhibitor, Lieberman et al. would meet the limitation as well as discussed above.
Regarding the intended purpose in the preamble of claim 13, i.e. increasing the sensitivity of a cancer in a subject to HDACi therapy, this limitation does not require any other active step than administering to the subject a HDACi therapy and a glycolysis inhibitor. The method of Nezami in view of Lichenstein et al. and Galloway et al. would inherently meet the preamble as the method steps are identical.
Regarding claim 15, the wherein clause is directed to the result of the administration of the glycolysis inhibitor. As Lieberman et al. teach the administration of the glycolysis inhibitor in addition to the HDACi, it is expected that the same result as claimed method would be expected by the method of Lieberman et al.
Regarding claim 16, the limitation is interpreted as a method of administering to the subject a combination of a glycolysis inhibitor and a HDACi in order to increase the sensitivity of a p53-deficient cancer to radiation therapy. Under this interpretation, the radiation therapy is not required as an active step of the claimed method. Thus, the combined teaching of Lieberman et al. would meet the limitation.
Thus, the reference anticipates the claimed invention.
Claim(s) 12 and 29-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Depinho et al. (US 2011/0030074; of record)
Regarding claim 12, the step (iii) is directed to a contingent limitation. MPEP2111.04(II) states “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B.”
As the step (iii) of claim 12 requiring the administering a combination therapy comprising a glycolysis inhibitor and a HDACi if Fbxw7 expression is present as a result of the step (ii), under the broadest reasonable interpretation, the administering step of (iii) falls into the contingent limitations and thus is not required as a part of the claimed step. Thus, claim 12 is interpreted as a method of isolating a cancerous tissue sample from the subject and detecting Fxbw7 expression in the cancerous sample.
Depinho et al. teach a step of detecting the expression or activity of FBXW7 in a tumor cell from the subject (para. 19). Depinho et al. teach that a cancer patient is screened based on the expression level of FBXW7 in a cancer cell sample (para. 113). These teachings would meet the limitation of steps (i) and (ii).
Regarding the wherein clause of step (a), the limitation does not provide any active step to be carried out and thus, it does not provide patentable weight in determining the patentability of the method.
Regarding claims 29-30, these claims are directed to the contingent limitations of claim 12. As discussed above, the step of administering in the step (iii) of claim 12 does not limit the claim, and thus, the subject matter of claims 29-30 which further limit the step (iii) of claim 12 also does not provide any patentable weight. Therefore, claims 29-30 are interpreted the same as claim 12, and Depinho et al. would meet the limitations.
Thus, the reference anticipates the claimed invention.
Claim Rejections - 35 USC § 103 (New)
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) 11 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lieberman et al. (supra) as applied to claims 5-6, 13 and 15-16 above, and further in view of Nezami (supra).
Lieberman et al. anticipate the subject matter of claims 5-6, 13 and 15-16, and thus, render them obvious (see above).
Regarding claim 11 directed to the radiation therapy as additional to the combination of the glycolysis inhibitor and HDACi, Lieberman et al. do not teach the limitation.
Nezami teaches that the method of treating a cancer by using a pharmaceutical formulation comprising a histone deacetylase inhibitor and one or more glycolytic inhibitors can be used in combination with radiation (para. 10).
It would have been obvious to a person skilled in the art to use the radiation therapy in addition the treatment method of Lieberman et al. with a reasonable expectation of success.
Regarding claim 16, as discussed above, the radiation therapy is not required by the method. However, even if the radiation therapy is required in addition to the combination of glycolysis inhibitor and HDACi, the combined teaching of Lieberman et al. in view of Nezami would meet the limitation as discussed above.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 14, 17 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lieberman et al. (supra) as applied to claims 5-6, 13 and 15-16 above, and further in view of Venkatanarayan et al. (supra) and Bannister et al. (US2014/0199296; of record)
Regarding claims 14, 17 and 27 directed to the glycolysis inhibitor being pramlintide, Lieberman et al. do not teach the limitation.
Venkatanarayan et al. teach the use of pramlintide, a synthetic analogue of amylin that is currently used to treat type 1 and type 2 diabetes, caused rapid tumor
regression in p53-deficient thymic lymphomas (abstract). Venkatanarayan et al. teach that amylin functions through the calcitonin receptor (Calcar) and receptor activity modifying protein 3 (RAMP3) to inhibit glycolysis and induce reactive oxygen species
and apoptosis, and pramlintide, a synthetic analogue of amylin (Abstract).
It would have been obvious to a person skilled in the art to use pramlintide taught by Venkatanarayan et al. as a glycolysis inhibitor in the method of Lieberman et al. with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because pramlintide is already known in the art as a cancer therapeutic according to Bannister et al. (para. 34), and it is shown to inhibit glycolysis taught by Venkatanarayan et al. Thus, one skilled in the art would recognize that pramlintide is a suitable glycolysis inhibitor for the method of Lieberman et al.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 28 and 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lieberman et al. as applied to claims 5-6, 13 and 15-16 above, and further in view of Crisanti et al. (2009, Mol. Cancer Ther.)
Regarding claims 28 and 31-32 directed to the HDACi comprising panobinostat, Lieberman et al. do not teach the limitation.
However, it is well known in the art that panobinostat is one of HDACi according to Crisanti et al. Crisanti et al. teach that the HDAC inhibitor panobinostat inhibits lung cancer cells in vitro and in vivo (see entire document).
It would have been obvious to a person skilled in the art to use panobinostat taught by Crisanti et al. for the methos of Lieberman et al. with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because panobinostat of Crisanti et al. is one of HDACi known in the art and Cristanti et al. show that panobinostat is capable of inhibiting lung cancer cells as intended by the method of Lieberman et al.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 5-6, 11, 13 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nezami (US 2013/0011488; of record) in view of Lichenstein et al. (US2008/0213399) and Galloway et al. (supra).
Regarding claim 5, Nezami teaches a method of treating a cancer by administering a pharmaceutical formulation comprising a histone deacetylase inhibitor and one or more glycolytic inhibitors (para. 4-5). As the pharmaceutical formulation comprises both a histone deacetylase inhibitor and a glycolytic inhibitor, the method of Nezami is considered as a combination therapy.
Nezami does not teach the cancer being p53-deficient cancer (claim 5) or selected from cutaneous squamous cell carcinoma, head and neck squamous cell carcinoma or lung cancer (claim 6).
Lichenstein et al. teach a method for treating cancer such as lung cancer by administering a histone deacetylase (HDAC) inhibitor (Abstract).
Galloway et al. teach that inhibitor of HDAC in combination with chemoradiation as a treatment for head and neck squamous cell carcinoma (HNSCC) (see entire document).
It would have been obvious to a person skilled in the art to use the pharmaceutical formulation comprising a histone deacetylase inhibitor and one or more glycolytic inhibitors taught by Nezami for treating lung cancer taught by Lichenstein et al. or HNSCC taught by Galloway et al. A person of ordinary skilled in the art would have been motivated to do so because Lichenstein et al. teach that HDAC inhibitors can be used for treating lung cancer, and Galloway et al. teach the inhibitors of HDAC for treating HNSCC. Thus, one skilled in the art would reasonably expect that the pharmaceutical formulation of Nezami would be effective in treating lung cancer because the formulation comprises HDACi, and by doing so, the combined teachings of Nezami in view of Lichenstein et al. and Galloway et al. would inherently meet the limitation directed to the p53-deficient cancer.
Regarding claim 11, Nezami teaches that the method of treating a cancer by using a pharmaceutical formulation comprising a histone deacetylase inhibitor and one or more glycolytic inhibitors can be used in combination with radiation (para. 10). The teachings of Nezami et al. in view of Lichenstein et al. and Galloway et al. as discussed for claim 11 would be also applicable to the limitation of claim 16.
Claim 16 is interpreted as a method of administering to the subject a combination of a glycolysis inhibitor and a HDACi in order to increase the sensitivity of a p53-deficient cancer to radiation therapy. Under this interpretation, the radiation therapy is not required as an active step of the claimed method. Thus, the combined teaching of Nezami in view of Lichenstein et al. and Galloway et al. would meet the limitation. Even if the claimed method is interpreted to require all three (i.e. glycolysis inhibitor, HDACi, and radiation therapy), as Nezami teaches radiation therapy as discussed above, the combined teachings of Nezami in view of Lichenstein et al. and Galloway et al. would also meet the method requiring all three components.
Regarding claim 13, the claim requires only the step of administering a glycolysis inhibitor to the subject in need of increasing the sensitivity of a p53-deficient cancer in the subject, and does not require any additional step of administering HDACi therapy. Nezami in view of Lichenstein et al. and Galloway et al. teach the limitation as discussed above. Even if the method is interpreted such that the subject being administered with both HDACi and a glycolysis inhibitor, the combined teachings of Nezami in view of Lichenstein et al. and Galloway et al. as discussed above would meet the limitation as well.
Regarding the intended purpose in the preamble of claim 13, i.e. increasing the sensitivity of a cancer in a subject to HDACi therapy, this limitation does not require any other active step than administering to the subject a HDACi therapy and a glycolysis inhibitor. The method of Nezami in view of Lichenstein et al. and Galloway et al. would inherently meet the preamble as the method steps are identical.
Regarding claim 15, the wherein clause is directed to the result of the administration of the glycolysis inhibitor. As Nezami in view of Lichenstein et al. and Galloway et al. teach the administration of the glycolysis inhibitor in addition to the HDACi, it is expected that the same result as claimed method would be expected by the method of Nezami in view of Lichenstein et al. and Galloway et al.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 14, 17 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nezami in view of Lichenstein et al. and Galloway et al. as applied to claims 5-6, 11, 13 and 15-16 above, and further in view of Venkatanarayan et al. (supra) and Bannister et al. (US2014/0199296; of record)
Regarding claims 14, 17 and 27 directed to the glycolysis inhibitor being pramlintide, Nezami in view of Lichenstein et al. and Galloway et al. do not teach the limitation.
Venkatanarayan et al. teach the use of pramlintide, a synthetic analogue of amylin that is currently used to treat type 1 and type 2 diabetes, caused rapid tumor
regression in p53-deficient thymic lymphomas (abstract). Venkatanarayan et al. teach that amylin functions through the calcitonin receptor (Calcar) and receptor activity modifying protein 3 (RAMP3) to inhibit glycolysis and induce reactive oxygen species
and apoptosis, and pramlintide, a synthetic analogue of amylin (Abstract).
It would have been obvious to a person skilled in the art to use pramlintide taught by Venkatanarayan et al. as a glycolysis inhibitor in the method of Nezami in view of Lichenstein et al. and Galloway et al. with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because pramlintide is already known in the art as a cancer therapeutic according to Bannister et al. (para. 34), and it is shown to inhibit glycolysis taught by Venkatanarayan et al. Thus, one skilled in the art would recognize that pramlintide is a suitable glycolysis inhibitor for the method of Nezami in view of Lichenstein et al. and Galloway et al.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 28 and 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nezami in view of Lichenstein et al. and Galloway et al. as applied to claims 5-6, 11, 13 and 15-16 above, and further in view of Crisanti et al. (2009, Mol. Cancer Ther.)
Regarding claims 28 and 31-32 directed to the HDACi comprising panobinostat, Nezami in view of Lichenstein et al. and Galloway et al. do not teach the limitation.
However, it is well known in the art that panobinostat is one of HDACi according to Crisanti et al. Crisanti et al. teach that the HDAC inhibitor panobinostat inhibits lung cancer cells in vitro and in vivo (see entire document).
It would have been obvious to a person skilled in the art to use panobinostat taught by Crisanti et al. for the methos of Nezami in view of Lichenstein et al. and Galloway et al. with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because panobinostat of Crisanti et al. is one of HDACi known in the art and Cristanti et al. show that panobinostat is capable of inhibiting lung cancer cells as intended by the method of Nezami in view of Lichenstein et al. and Galloway et al.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Arguments
Applicant’s arguments with respect to the 102 and 103 rejection(s) in view of the instant amendment have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made as discussed above.
Regarding the 35 U.S.C. 112(a) WD rejection, the main issue of this rejection is the scope of “treating” which encompasses preventing or curing. Applicant has amended the specification to delete “preventing” and “curing”. Furthermore, the claims have been amended to disclose the type of cancer being p53-deficient cancer. These amendments do not overcome the rejection. First, the specification does not particularly provide a definition to the term “treating”, rather the scope would include all the listed terms in paragraph 41. Even if the term “preventing” and “curing” are deleted from the paragraph, the scope of “treating” still encompasses “preventing” or “curing” in addition to various terms utilized in the paragraphs because the term is not particularly defined. Furthermore, the paragraph 41 discloses the treatments according to the invention may be applied preventatively, prophylactically, and prophylactic treatment is disclosed in the same way as “preventing”. As discussed in the rejection, at most, the specification provides written description for regression of tumor, i.e. alleviating, relieving, ameliorating, etc. but not preventing or curing any p53-deficient cancer. Applicant is advised to replace the term “treating” with, for example, alleviating, ameliorating or reducing one or more symptoms of p53-deficient cancer.
It is noted that the applicant’s argument directed to the p53-deficient cancer as introduced by the instant amendment, it is moot as the new limitation has been addressed in the new claim rejections above.
Regarding the 103 rejection based on Nezami in view of Lichenstein et al. and Galloway et al., applicant argued that Nezami teaches two or more epigenetic modifiers, and thus, at a minimum, 3 separate agents are required whereas the instant application includes only two. The Examiner respectfully disagrees with this argument. The instant claims dose not exclude other agents present in addition to the glycolysis inhibitor and the HDACi. The claims disclose a transitional phrase of “comprising” and this term does not exclude additional agents or elements in the claim. See MPEP2111.03(I).
Applicant stated that it was unexpectedly found that the combination of pramlintide and panobinostat was far superior to either agent along referring paragraph [0058], and the combination cooperatively suppresses DNp63 expression. It appears that applicant alleges unexpected results based on the synergism of the two factors utilized in the claimed treatment. It appears that the data for the alleged superior effect is shown Fig. 18 and 19. The data shown in the Fig. 18 are not clear what the lines are referring to as there is no legend for the figure. Fig. 19 does not provide any quantification to support whether there is any synergism for the combination of pramlintide and panobinostat. Applicant is advised to provide a factual data to support that there is indeed a synergism for the claimed method compared to an individual treatment. It is noted that such evidence would be submitted in the form of a declaration (MPEP716.01(C); 716.02(a)). However, it is noted that unexpected results and/or synergism do not overcome the 102 rejection.
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 TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631