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 .
Please note that the instant application has been transferred to examiner Ganapathirama Raghu (571-272-4533), Art Unit: 1652, and all future correspondence regarding this application must be addressed to said examiner.
Detailed Action
Applicant’s election of Group I, corresponding to claims 22-30 and 32-43 without traverse in the reply filed on 10/22/2025 is acknowledged. Thus, claims 22-30 and 32-43 are pending in this application and is now under consideration for examination.
Priority
This application claims the benefit of priority under 35 U.S.C. 119(e) to the US Provisional applications: 63/126,294 filed on 12/16/2020; 63/168,414 filed on 03/31/2021; and 63/170,805 filed on 04/05/2021. However, not that the support for the instant claims are only found in 63/168,414 filed on 03/31/2021 and therefore the granted priority of the instant claims is deemed to be 03/31/2021.
Information disclosure statement
The information disclosure statements (IDS) submitted on 01/22/2024, 02/12/2024, 04/17/2024, 05/15/2024, 07/08/2024, 11/08/2024 and 10/22/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statements are considered and initialed by the examiner.
Claim Rejections: 35 USC § 112(b)
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.
I. Claim 22 and claims 23-30 and 32-43 depending therefrom are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 22, 32 and 43 recites the phrase “substantially devoid of…” is considered to be a relative term which renders the claim indefinite. Claims 22, 32 and 43 do not recite the specific diet/pharmaceutical composition and the concentration of the recited amino acids in the claimed diet/pharmaceutical composition. In the art what is considered “substantially devoid of…” varies widely depending on the individual situation as well as the person making the determination. It is not clear to the examiner as to “substantially devoid of…” is measured and encompassed in the above phrase. Thus, the scope of the claim is unclear, as written does not recite the specific conditions/specific ration of amino acids in the claimed pharmaceutical composition the applicants' intend to encompass. As such it is unclear what “substantially devoid of…” of interest must be to be included within the scope of the claims; examiner also would like to point out: “Although the claims are examined in the light of the specification, specification cannot be read into the claims, i.e., the limitations of the specification cannot be read into the claims (see MPEP 2111 R-5)”). Clarification and correction is required.
II. Furthermore, the term “about” in claims 29 and 33-37 is a relative term which extends the metes and bounds of the claimed range, however, the disclosure does not recite the requisite degree or how one would objectively determine a radiation therapy and percentage as being “about” (or not about) a certain value, for example 80% may by broadly and reasonably be interpreted above or below 80%, as “‘about” 70% and thereby rendering the claims indefinite. Clarification and correction is required. Examiner suggests amending the phrase to recite “…at least …”. See MPEP § 2173.05(c).
Claim Rejections: 35 USC § 112(a)
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.
Enablement
Claims 22-30 and 32-43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the following reasons. The specification teaches the following. The specification is enabling for characterization of a few species in vitro assays and in vitro cell culture models, said in vitro treatment of cultured cancer cell lines and in vivo animal models transplanted with said cancer cell lines and a method for the inhibition of Phosphoglycerate Dehydrogenase (PHGDH), the first step in the de novo serine synthesis pathway (SSP) enzymes, in combination with specific compositions devoid of serine and/or glycine (for details see Fig. 1-78; and Examples 1-15, pages 38-77 of specification). However, the specification does not reasonably provide enablement for treating any cancer in a subject in need thereof, the method comprising: a) administering to the subject in need thereof a therapeutically-effective amount of any undefined pharmaceutical composition for a first amount of time, wherein the pharmaceutical composition is substantially devoid of at least two amino acids and the at least two amino acids are serine and glycine; b) administering to the subject in need thereof a radiation therapy for a second amount of time; and c) after the first amount of time and the second amount of time, waiting a third amount of wherein the subject in need thereof is not administered the pharmaceutical composition or the radiotherapy during the third amount of time (also see rejection under 35 U.S.C. 112(b) for claims interpretation). Based thereon, it is not expected that any cancer irrespective of etiology or pathogenesis or pathobiology treated by the claimed method comprising: a) administering to any subject in need thereof a therapeutically-effective amount of any undefined pharmaceutical composition for a first amount of time, wherein the pharmaceutical composition is substantially devoid of at least two amino acids and the at least two amino acids are serine and glycine; b) administering to the subject in need thereof a radiation therapy for a second amount of time. 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 and use the invention commensurate in scope with these claims.
In regards to this enablement rejection, the application disclosure and claims are compared per the factors indicated in the decision In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). These factors are considered when determining whether there is sufficient evidence to support a description that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. The factors include but are not limited to: (1) the nature of the invention; (2) the breath of the claims; (3) the predictability or unpredictability of the art; (4) the amount of direction or guidance presented; (5) the presence or absence of working examples; (6) the quantity of experimentation necessary; (7) the relative skill of those skilled in the art. Each factor is here addressed on the basis of a comparison of the disclosure, the claims, and the state of the prior art in the assessment of undue experimentation.
Claims 22-30 and 32-43 are so broad as to encompass treating any cancer in a subject in need thereof, the method comprising: a) administering to the subject in need thereof a therapeutically-effective amount of any undefined pharmaceutical composition for a first amount of time, wherein the pharmaceutical composition is substantially devoid of at least two amino acids and the at least two amino acids are serine and glycine; b) administering to the subject in need thereof a radiation therapy for a second amount of time; and c) after the first amount of time and the second amount of time, waiting a third amount of wherein the subject in need thereof is not administered the pharmaceutical composition or the radiotherapy during the third amount of time (also see rejection under 35 U.S.C. 112(b) for claims interpretation). The scope of each of these claims is not commensurate with the enablement provided by the disclosure with regard to the extremely large number of diet/pharmaceutical compositions broadly encompassed by the claims in the claimed method.
The specific diet/pharmaceutical compositions, drug, doses, formulations, routes of administration, and patient population to be treated determines the success of any treatment. Predictability of which diet/pharmaceutical, drug, doses, formulations, routes of administration, can be used to obtain the desired effect in any patient population requires a knowledge of, and guidance with regard to how said diet/pharmaceutical, drug, doses, formulations, routes of administration, relate to the desired outcome in any patient population. However, in this case the disclosure is limited to characterization of a few species in vitro assays and in vitro cell culture models, said in vitro treatment of cultured cancer cell lines and in vivo animal models transplanted with said cancer cell lines and a method for the inhibition of Phosphoglycerate Dehydrogenase (PHGDH), the first step in the de novo serine synthesis pathway (SSP) enzymes, in combination with specific compositions devoid of serine and/or glycine (for details see Fig. 1-78; and Examples 1-15, pages 38-77 of specification). While some model systems and methods for testing the effect of diet/pharmaceutical on some proliferative diseases/disorders in vivo are known, it is not routine in the art to screen an essentially unlimited number of diet/pharmaceutical compositions, drug, doses, formulations, routes of administration, for successful treatment of any proliferative disease/disorder and any cancer in any patient population. Furthermore, the specific diet/pharmaceutical compositions, drug, doses, formulations, routes of administration, to be used with a reasonable expectation of success in obtaining the desired treatment are limited and remain unpredictable. In addition, one skilled in the art would expect any tolerance to modification of any successful method to diminish with each further and additional modification of steps and diet/pharmaceutical, drug, doses, formulations used, as cancer is not a single disease, or cluster of closely related disorders. There are hundreds of cancers, which have in common only some loss of controlled cell growth. Cancers are highly heterogeneous at both the molecular and clinical level, something seen especially in, for example, the cancers of the breast.
Examiner’s position is supported by the following references:
Dioguardi et al., (Int. J. Mol. Sci., 2018, Vol. 19, 3631, pages 1-17) clearly provide evidence that there are complexities regarding amino acid biology and links to cancer metabolism (see Abstract; Fig. 1, page 9; Conclusions; and entire document); and
Macintyre B., (PhD., Thesis, Univ. College of London, 2021, pages 1-195), provide evidence that the importance of understanding and evaluating context-specific roles of deregulated metabolic pathways to the design and implementation of novel therapeutic strategies in the treatment of cancer (see Introduction, pages 5-6; Metabolism in cancer, pages 29-50; Discussion, perturbation in serine metabolism, pages 157-164; and entire document).
The specification does not support the broad scope of claims 22-30 and 32-43, which encompasses treating any cancer in a subject in need thereof, the method comprising: a) administering to the subject in need thereof a therapeutically-effective amount of any undefined pharmaceutical composition for a first amount of time, wherein the pharmaceutical composition is substantially devoid of at least two amino acids and the at least two amino acids are serine and glycine; b) administering to the subject in need thereof a radiation therapy for a second amount of time; and c) after the first amount of time and the second amount of time, waiting a third amount of wherein the subject in need thereof is not administered the pharmaceutical composition or the radiotherapy during the third amount of time (also see rejection under 35 U.S.C. 112(b) for claims interpretation). The specification does not support the broad scope of claims 22-30 and 32-43 because the specification does not establish: (A) any successful method of treating any specific cancer disease/disorder; (B) the specific diseases/disorders that can be treated successfully; (C) diet/pharmaceutical compositions, drug, doses, formulations to be used with a reasonable expectation of success; and (D) the specification provides insufficient guidance as to which of the essentially infinite possible choices of steps and reagents is likely to be successful in treating any specific cancer disease/disorder.
Thus, applicants’ have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims broadly including any number of methods for treating any cancer in a subject in need thereof, the method comprising: a) administering to the subject in need thereof a therapeutically-effective amount of any undefined pharmaceutical composition for a first amount of time, wherein the pharmaceutical composition is substantially devoid of at least two amino acids and the at least two amino acids are serine and glycine; b) administering to the subject in need thereof a radiation therapy for a second amount of time; and c) after the first amount of time and the second amount of time, waiting a third amount of wherein the subject in need thereof is not administered the pharmaceutical composition or the radiotherapy during the third amount of time (also see rejection under 35 U.S.C. 112(b) for claims interpretation). The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of the identity of methods having the desired biological characteristics is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Liebel-Flarsheim Co. v. Medrad, Inc. 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
Therefore, the instant claims 22-30 and 32-43 are not enabled for the full scope of the claims.
Double patenting 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 22-30 and 32-43 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-9, 12 and 19 of reference patent US 12,109,184 B2 (Maddocks O.D.K., in IDS) in view of Hagihara et al., (US 10,675,262 B2) and Ashraf et al., (Int. J. Cancer Therapy and Oncology, 2014, Vol. 2(3): 1-9). An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claims are not patentably distinct from the reference claims, because the examined claims are either anticipated by, or would have been obvious over reference claims. 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).
Although the conflicting claims are not identical, they are not patentably distinct from each other. Claims 22-30 and 32-43 of the instant application are directed to treating any cancer in a subject in need thereof, the method comprising: a) administering to the subject in need thereof a therapeutically-effective amount of any undefined pharmaceutical composition for a first amount of time, wherein the pharmaceutical composition is substantially devoid of at least two amino acids and the at least two amino acids are serine and glycine; b) administering to the subject in need thereof a radiation therapy for a second amount of time; and c) after the first amount of time and the second amount of time, waiting a third amount of wherein the subject in need thereof is not administered the pharmaceutical composition or the radiotherapy during the third amount of time (also see rejection under 35 U.S.C. 112(b) for claims interpretation).
Claims 1-9, 12 and 19 of reference patent US 12,109,184 B2 (Maddocks O.D.K., in IDS) in view of Hagihara et al., (US 10,675,262 B2) and Ashraf et al., (Int. J. Cancer Therapy and Oncology, 2014, Vol. 2(3): 1-9) are also directed to a method for treating a cancer having dysregulated polyamine metabolism in a subject in need thereof, wherein the cancer having dysregulated polyamine metabolism is breast cancer, colorectal cancer, pancreatic cancer, or brain cancer, the method comprising administering to the subject a therapeutically effective amount of a dietary product, wherein: the dietary product comprises at most about 0.5% (w/w) of cysteine or cystine; the dietary product comprises at least about 7.5% (w/w) of methionine; the therapeutically effective amount of the dietary product is from about 0.5 g/kg/day to about 1 g/kg/day; and the subject is undergoing a cancer therapy for the cancer having dysregulated polyamine metabolism; wherein the cancer having dysregulated polyamine metabolism is breast cancer; wherein the cancer having dysregulated polyamine metabolism is colorectal cancer;… wherein the dietary product is devoid of cysteine or cystine, serine, and glycine; wherein the cancer therapy is radiotherapy.
Additionally the following references of prior art: (i) Hagihara et al., (US 10,675,262 B2; see Abstract; Fig. 1-19; and entire document) provides teaching, suggestion and motivation for dietary therapy in cancer for administering a high fat diet to the subject in need thereof, and further comprising administering a low carbohydrate diet to the subject in need thereof, including in breast cancer and rectal cancer patients (col. 12, lines 38-63) and in patients receiving radiation therapy (col. 14, lines 7-38); and
(ii) Ashraf et al., (Int. J. Cancer Therapy and Oncology, 2014, Vol. 2(3): 1-9) provides teaching, suggestion and motivation for optimization of radiotherapy in cancer treatment including breast cancer wherein the radiation therapy is an external beam therapy; wherein the external beam therapy is three dimensional conformal radiation therapy (3D-CRT); wherein the external beam therapy is intensity-modulated radiation therapy (IMRT); wherein the radiation therapy comprises administering about 50 Grays (Gy) (see Abstract; col. 1, ¶ 2, page 3; and entire document).
Therefore, claims 22-30 and 32-43 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-9, 12 and 19 of reference patent US 12,109,184 B2 (Maddocks O.D.K., in IDS) in view of Hagihara et al., (US 10,675,262 B2) and Ashraf et al., (Int. J. Cancer Therapy and Oncology, 2014, Vol. 2(3): 1-9), when there is specifically disclosed embodiments in the reference patent that supports reference claims of that patent and falls within the scope of the claims 22-30 and 32-43 herein i.e., treating any cancer in a subject in need thereof, the method comprising: a) administering to the subject in need thereof a therapeutically-effective amount of any undefined pharmaceutical composition for a first amount of time, wherein the pharmaceutical composition is substantially devoid of at least two amino acids and the at least two amino acids are serine and glycine; b) administering to the subject in need thereof a radiation therapy for a second amount of time; and c) after the first amount of time and the second amount of time, waiting a third amount of wherein the subject in need thereof is not administered the pharmaceutical composition or the radiotherapy during the third amount of time (also see rejection under 35 U.S.C. 112(b) for claims interpretation), because it would have been obvious to one having ordinary skill in the art to modify claims of cited reference patent by selecting a specifically disclosed embodiment that supports those claims 1-9, 12 and 19 of reference patent. One of ordinary skill in the art would have been motivated to do this because that embodiment is disclosed as being preferred embodiment within claims of cited reference patent US 12,109,184 B2 (Maddocks O.D.K., in IDS) in view of Hagihara et al., (US 10,675,262 B2) and Ashraf et al., (Int. J. Cancer Therapy and Oncology, 2014, Vol. 2(3): 1-9).
Claim Rejections: 35 USC § 102 (AIA )
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claims 22-26, 30, 32 and 36-43 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Maddocks et al., (WO 2017/144877 A1, in IDS) when given the broadest reasonable interpretation.
Maddocks et al., (WO 2017/144877 A1, in IDS) disclose a dietary product devoid of at least two essential amino acids including devoid of serine, glycine, cysteine and proline and said dietary product and reference method utilized in the treatment of rectal and breast cancer (see Abstract; Fig. 1-40; page 2, lines 22-33 to page 3, lines 1-9; page 21, lines 29-35 to page 22, lines 1-12); in combination with radiotherapy/beam therapy, separate or sequential (page 32, lines 31-33 to page 33, lines 1-2; page 37, lines 1-23); dosing, time and days of administration (page 63, lines 1-25; Claims; and entire document) .
Therefore, the reference of Maddocks et al., (WO 2017/144877 A1, in IDS) is deemed to anticipate claims 22-26, 30, 32 and 36-43 is written and when given the broadest reasonable interpretation.
Since the Office does not have the facilities for examining and comparing applicants’ method with the method of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed method and the method of the prior art (i.e., that the method of the prior art does not possess the same material structural and functional characteristics of the method of the instant invention). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Claim Rejections: 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 22-30 and 32-43 are rejected under 35 U.S.C. 103(a) as being unpatentable over Maddocks et al., (WO 2017/144877 A1, in IDS) as applied to claims 22-26, 30, 32 and 36-43 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Ashraf et al., (Int. J. Cancer Therapy and Oncology, 2014, Vol. 2(3): 1-9) and Hagihara et al., (US 10,675,262 B2).
The disclosure of Maddocks et al., (WO 2017/144877 A1, in IDS) as applied to claims 22-26, 30, 32 and 36-43 is described above. However, Maddocks et al., are silent regarding wherein the external beam therapy is three dimensional conformal radiation therapy (3D-CRT); wherein the external beam therapy is intensity-modulated radiation therapy (IMRT); wherein the radiation therapy comprises administering about 5 Grays (Gy) to about 50 Gy of radiation to the subject in need thereof (as in claims 27-29); and further comprising administering a high fat diet to the subject in need thereof and further comprising administering a low carbohydrate diet to the subject in need thereof (as in claims 33-35).
Regarding claims 27-29, the following reference, provides teaching, suggestion and motivation for wherein the external beam therapy is three dimensional conformal radiation therapy (3D-CRT); wherein the external beam therapy is intensity-modulated radiation therapy (IMRT); wherein the radiation therapy comprises administering about 5 Grays (Gy) to about 50 Gy of radiation to the subject in need thereof: Ashraf et al., (Int. J. Cancer Therapy and Oncology, 2014, Vol. 2(3): 1-9) provides teaching, suggestion and motivation for optimization of radiotherapy in cancer treatment including breast cancer wherein the radiation therapy is an external beam therapy; wherein the external beam therapy is three dimensional conformal radiation therapy (3D-CRT); wherein the external beam therapy is intensity-modulated radiation therapy (IMRT); wherein the radiation therapy comprises administering about 50 Grays (Gy) (see Abstract; col. 1, ¶ 2, page 3; and entire document).
Regarding claims 33-35, further comprising administering a high fat diet to the subject in need thereof and further comprising administering a low carbohydrate diet to the subject in need thereof, the following reference Hagihara et al., (US 10,675,262 B2; see Abstract; Fig. 1-19; and entire document) provides teaching, suggestion and motivation for dietary therapy in cancer for administering a high fat diet to the subject in need thereof, and further comprising administering a low carbohydrate diet to the subject in need thereof, including in breast cancer and rectal cancer patients (col. 12, lines 38-63) and in patients receiving radiation therapy (col. 14, lines 7-38).
As such, disclosure of strategy, methods and advantages for “optimization of radiotherapy in cancer treatment including breast cancer wherein the radiation therapy is an external beam therapy; wherein the external beam therapy is three dimensional conformal radiation therapy (3D-CRT); wherein the external beam therapy is intensity-modulated radiation therapy (IMRT); wherein the radiation therapy comprises administering about 50 Grays (Gy) and further comprising administering a high fat diet to the subject in need thereof and further comprising administering a low carbohydrate diet to the subject in need thereof”; as in claims 27-29 and 33-35 of the instant invention, such as that of references of Ashraf et al., and Hagihara et al., teaching the advantages of said modifications, clearly suggests to a skilled artisan to modify the teachings of Maddocks et al., and incorporate the structural and functional elements of Ashraf et al., and Hagihara et al., in the claimed method for the treatment of cancer as claimed in the instant invention. One of ordinary skill in the art would have a reasonable expectation of success, since treatment of cancer and the optimization of radiotherapy in cancer treatment and the use of high fat diet to the subject in need thereof, and further comprising administering a low carbohydrate diet to the subject in need thereof are well known in the art.
Regarding specific choice of radiation therapy, compositions of high fat diet and low carbohydrate diet and their administration are also provided/suggested in the combination of references, and examiner also takes the position the following position; optimization of known variables, and the examiner finds support in: MPEP 2144.05 [R-5]: A. Optimization Within Prior Art Conditions or Through Routine Experimentation Generally, differences in radiation therapy, compositions of high fat diet and low carbohydrate diet and their administration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation". As to optimization results, a patent will not be granted based upon the optimization of result effective variables when the optimization is obtained through routine experimentation unless there is a showing of unexpected results which properly rebuts the prima facie case of obviousness. See In re Boesch, 617 F.2d 272,276,205 USPQ 215,219 (CCPA 1980). See also In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (Fed. Cir. 1990), and In re Aller, 220 F2d 454,456,105 USPQ 233,235 (CCPA 1955). Furthermore, "it is prima facie obvious to combine two or more methods each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition or third method 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)”. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Therefore, claims 22-30 and 32-43 are rejected under 35 U.S.C. 103(a) as being unpatentable over Maddocks et al., (WO 2017/144877 A1, in IDS) as applied to claims 22-26, 30, 32 and 36-43 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Ashraf et al., (Int. J. Cancer Therapy and Oncology, 2014, Vol. 2(3): 1-9) and Hagihara et al., (US 10,675,262 B2)).
Allowable Subject Matter/Conclusion
None of the claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHIRAMA RAGHU whose telephone number is (571)272-4533. The examiner can normally be reached on M-F 8:30am-5pm EST.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652