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 .
Claim Objections
Claims 1-2, 6, 8, 10, 13, 17-18, and 20 are objected to because of the following informalities:
In claim 1, line 1, “the method comprising the steps of…” should read “the method comprising steps of…”
In claim 2, line 2, “a frequency in a range of from about 50 kHz…” should read “a frequency in a range of about 50 kHz…”
In claim 6, line 1, “further comprising the step of…” should read “further comprising a step of…”
In claim 8, line 1, “further comprising the step of…” should read “further comprising a step of…”
In claim 10, line 1, “the method comprising the steps of…” should read “the method comprising steps of…”
In claim 13, line 2, “a frequency in a range of from about 50 kHz…” should read “a frequency in a range of about 50 kHz…”
In claim 17, line 1, “further comprising the step of…” should read “further comprising a step of…”
In claim 18, line 1, “further comprising the step of…” should read “further comprising a step of…”
In claim 20, line 3, “the method comprising the steps of…” should read “the method comprising steps of…”
Appropriate correction is required.
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.
Claim 13 is 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 the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites the limitation "the cancer cells" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the period of time" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Herrera (EP 4043071) in view of Beardsley et al. (U.S. PGPub No. 2019/0151331).
Regarding claim 1, Herrera teaches a method of reducing viability of cancer cells (Fig. 11, Paragraph 0077, line 1 and Paragraph 0002, lines 2-3), the method comprising the steps of: (1) administering at least one composition to the cancer cells (Fig. 11, Paragraph 0080, line 1, Step S3 or Paragraph 0095, line 1, Step S4), wherein the at least one composition comprises at least one anti-carcinogenic compound (Fig. 11, Paragraph 0080, line 1, Step S3) and/or at least one glutathione inhibitor (Fig. 11, Paragraph 0095, line 1, Step S4 and Paragraph 0096, lines 8-9 and 71, Buthionine sulfoximine); and (2)
applying an alternating electric field1 to the cancer cells (Fig. 11, Paragraph 0078, lines 1-2, Step S1) for a period of time (Paragraph 0112, lines 3-4).
Furthermore, Herrera teaches that the anti-carcinogenic composition refers to a “composition that comprises an agent that at least partially inhibits the development or progression of cancer” (Paragraph 0081, lines 1-2). Herrera does not explicitly teach that the anti-carcinogenic composition is a thioredoxin reductase inhibitor.
Beardsley, however, teaches a combination therapy for cancer treatment that includes administering at least one active agent that is at least one of a thioredoxin reductase inhibitor and a glutathione depleting agent (Fig. 11A-11B, Paragraph 0103, lines 1-4). Beardsley teaches that both thioredoxin reductase inhibitors and glutathione depleting agents may result in increased H2O2 levels in cancer cells, which leads to increased cytotoxicity (Paragraph 0101, lines 1-7).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the anti-carcinogenic composition of Herrera for the thioredoxin reductase inhibitor of Beardsley. Thus, the simple substitution of one known element for another producing the predictable result of inhibiting the development or progression of cancer renders the claim obvious.
Regarding claim 2, Herrera teaches the method (Fig. 11, Paragraph 0077, line 1
and Paragraph 0002, lines 2-3) of claim 1, wherein at least one of: the alternating electric field has a field strength of at least about 1 V/cm in at least a portion of the cancer cells
(Paragraph 0112, lines 2-3); and the period of time that the alternating electric field is applied is at least about 50% of at least about a 24 consecutive hour time period (Paragraph 0112, lines 3-4).
Herrera does not teach that the alternating electric field is applied at a frequency in a range of from about 50 kHz to about 1 MHz. Herrera does teach that the alternating electric field may have a frequency of between 10 kHz to 500 kHz (Paragraph 0112, lines 1-2). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 3, Herrera teaches the method (Fig. 11, Paragraph 0077, line 1 and Paragraph 0002, lines 2-3) of claim 1 that comprises administering at least one composition that comprises an anti-carcinogenic composition (Fig. 11, Paragraph 0080, line 1, Step S3).
Herrera teaches that the anti-carcinogenic composition refers to a “composition that comprises an agent that at least partially inhibits the development or progression of cancer” (Paragraph 0081, lines 1-2). Herrera does not explicitly teach that the anti-carcinogenic composition is a thioredoxin reductase inhibitor that comprises auranofin.
Beardsley, however, teaches a combination therapy for cancer treatment that includes administering at least one active agent that is at least one of a thioredoxin reductase inhibitor and a glutathione depleting agent (Fig. 11A-11B, Paragraph 0103, lines 1-4). Beardsley teaches that both thioredoxin reductase inhibitors and glutathione depleting agents may result in increased H2O2 levels in cancer cells, which leads to increased cytotoxicity (Paragraph 0101, lines 1-7). Furthermore, Beardsley teaches that the thioredoxin reductase inhibitor comprises auranofin (Paragraph 0103, lines 13-14).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the anti-carcinogenic composition of Herrera for the thioredoxin reductase inhibitor that comprises auranofin of Beardsley. Thus, the simple substitution of one known element for another producing the predictable result of inhibiting the development or progression of cancer renders the claim obvious.
Regarding claim 4, Herrera in view of Beardsley discloses the claimed invention of claim 1. Herrera further discloses the method (Fig. 11, Paragraph 0077, line 1 and Paragraph 0002, lines 2-3) of claim 1, wherein steps (1) and (2) are performed wholly or partially sequentially (Paragraph 0095, lines 3-4), and wherein the at least one composition is administered before or after the application of the alternating electric field has begun (Paragraph 0095, lines 3-4).
Regarding claim 5, Herrera in view of Beardsley discloses the claimed invention of claim 1. Herrera further discloses the method (Fig. 11, Paragraph 0077, line 1 and Paragraph 0002, lines 2-3) of claim 1, wherein the cancer cells are selected from the group consisting of hepatocellular carcinoma cells (Paragraph 0085, line 5), glioblastoma cells (Paragraph 0085, line 2), pleural mesothelioma cells (Paragraph 0085, line 5), differentiated thyroid cancer cells (Paragraph 0085, line 11), advanced renal cell carcinoma cells (Paragraph 0085, lines 7 and 12), ovarian cancers (Paragraph 0085, line 6), breast cancers (Paragraph 0085, line 1), pancreatic cancers (Paragraph 0085, line 7), lung cancers (Paragraph 0085, line 5), and combinations thereof.
Regarding claim 6, Herrera teaches the method (Fig. 11, Paragraph 0077, line 1 and Paragraph 0002, lines 2-3) of claim 1. Herrera does not teach that the method further comprises the step of exposing the cancer cells to radiation therapy, wherein the radiation therapy is applied before step (1), after step (1), before step (2), and/or after step (2).
Beardsley, however, teaches a combination therapy for cancer treatment that includes administering at least one active agent that is at least one of a thioredoxin reductase inhibitor and a glutathione depleting agent (Fig. 11A-11B, Paragraph 0103, lines 1-4). Beardsley teaches that both thioredoxin reductase inhibitors and glutathione depleting agents may result in increased H2O2 levels in cancer cells, which leads to increased cytotoxicity (Paragraph 0101, lines 1-7).
Furthermore, Beardsley teaches in a further embodiment that radiation therapy can be administered to a subject prior to, concomitantly with, or after administration of one or more of at least one of the thioredoxin reductase inhibitor and glutathione depleting agent (Paragraph 0237, lines 1-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Herrera to incorporate the teachings of Beardsley to specify that the method further includes exposing the cancer cells to radiation therapy before step (1), after step (1), before step (2), and/or after step (2). Doing so would improve the efficacy of both the active agent and the radiation in killing cancer cells (Paragraph 0100, lines 6-12), as recognized by Beardsley.
Regarding claim 7, Herrera teaches the method (Fig. 11, Paragraph 0077, line 1 and Paragraph 0002, lines 2-3) of claim 1, that further includes a step of providing direct heat to the cancer cells (Fig. 11, Paragraph 0079, line 1, Step S2). The present embodiment does not teach that the at least one composition further comprises at least one chemotherapeutic agent.
However, in an alternative embodiment, Herrera teaches that the apparatus used to perform the method disclosed in Figure 11 includes an electromagnetic emitter (Fig. 7, Paragraph 0062, line 1, 10) and a heat source (Fig. 7, Paragraph 0062, line 1, 700) for heating a target site (Fig. 7, Paragraph 0062, line 2, 30). In the embodiment of Figure 7, Herrera teaches that the heat source (700) further includes a fluidic loop that heats a fluid that is then delivered to the target site (Paragraph 0063, lines 5-8). Herrera teaches that the fluid may comprise a chemotherapeutic composition or anti-cancer drug (Paragraph 0063, line 10 and Paragraph 0091).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the direct heating step disclosed by Herrera in Figure 11 with the heat source that includes the fluidic pump disclosed by Herrera in Figure 7, as doing so would provide a means of killing fast-growing cancer cells while also applying the alternating electric fields to the cancer cells (Paragraph 0079, lines 1-3).
Regarding claim 8, Herrera in view of Beardsley discloses the claimed invention of claim 1. Herrera further discloses the method (Fig. 11, Paragraph 0077, line 1 and Paragraph 0002, lines 2-3) of claim 1, further comprising the step of administering a second composition to the cancer cells (Fig. 11, Paragraph 0080, line 1, Step S3), wherein the first and second compositions are administered substantially simultaneously or wholly or partially sequentially (Paragraph 0080, lines 2-4).
Regarding claim 9, Herrera teaches the method (Fig. 11, Paragraph 0077, line 1 and Paragraph 0002, lines 2-3) of claim 8, wherein at least one of: the first composition comprises at least one anti-carcinogenic composition (Fig. 11, Paragraph 0080, line 1, Step S3), and the second composition comprises at least one glutathione inhibitor (Fig. 11, Paragraph 0095, line 1, Step S4 and Paragraph 0096, lines 8-9 and 71, Buthionine sulfoximine); the first composition comprises at least one glutathione inhibitor (Fig. 11, Paragraph 0095, line 1, Step S4 and Paragraph 0096, lines 8-9 and 71, Buthionine sulfoximine), and the second composition comprises at least one anti-carcinogenic composition (Fig. 11, Paragraph 0080, line 1, Step S3).
Herrera teaches in the present embodiment that Step S3 may be performed either before or after Step S4 (Paragraph 0080, lines 2-4). Furthermore, Herrera teaches that the anti-carcinogenic composition refers to a “composition that comprises an agent that at least partially inhibits the development or progression of cancer” (Paragraph 0081, lines 1-2). Herrera does not explicitly teach that the anti-carcinogenic composition is a thioredoxin reductase inhibitor.
Beardsley, however, teaches a combination therapy for cancer treatment that includes administering at least one active agent that is at least one of a thioredoxin reductase inhibitor and a glutathione depleting agent (Fig. 11A-11B, Paragraph 0103, lines 1-4). Beardsley teaches that both thioredoxin reductase inhibitors and glutathione depleting agents may result in increased H2O2 levels in cancer cells, which leads to increased cytotoxicity (Paragraph 0101, lines 1-7).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the anti-carcinogenic composition of Herrera for the thioredoxin reductase inhibitor of Beardsley. Thus, the simple substitution of one known element for another producing the predictable result of inhibiting the development or progression of cancer renders the claim obvious.
Furthermore, Herrera teaches that the method further includes a step of providing direct heat to the cancer cells (Fig. 11, Paragraph 0079, line 1, Step S2). Herrera teaches that Step S3 can be performed before Step S2 (Paragraph 0080, lines 2-3). The present embodiment in Figure 11 does not explicitly teach that Step S2 involves delivering a second composition that comprises at least one chemotherapeutic agent.
However, in an alternative embodiment, Herrera teaches that the apparatus used to perform the method disclosed in Figure 11 includes an electromagnetic emitter (Fig. 7, Paragraph 0062, line 1, 10) and a heat source (Fig. 7, Paragraph 0062, line 1, 700) for heating a target site (Fig. 7, Paragraph 0062, line 2, 30). In the embodiment of Figure 7,
Herrera teaches that the heat source (700) further includes a fluidic loop that heats a fluid that is then delivered to the target site (Paragraph 0063, lines 5-8). Herrera teaches that the fluid may comprise a chemotherapeutic composition or anti-cancer drug (Paragraph
0063, line 10 and Paragraph 0091).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the direct heating step disclosed by Herrera
in Figure 11 with the heat source that includes the fluidic pump disclosed by Herrera in Figure 7 in order to specify that the second composition can comprise at least one chemotherapeutic agent. Doing so would provide a means of killing fast-growing cancer cells before administering the anti-carcinogenic compound (Paragraph 0080, lines 2-3).
Regarding claim 10, Herrera teaches a method of treating cancer (Fig. 11, Paragraph 0077, line 1) in a subject (Paragraph 0077, line 3, “patient”), the method comprising the steps of: (1) administering at least one composition to the subject (Fig. 11, Paragraph 0080, line 1, Step S3 or Paragraph 0095, line 1, Step S4), wherein the at least one composition comprises at least one anti-carcinogenic compound (Fig. 11, Paragraph 0080, line 1, Step S3) and/or at least one glutathione inhibitor (Fig. 11, Paragraph 0095, line 1, Step S4 and Paragraph 0096, lines 8-9 and 71, Buthionine sulfoximine); and (2) applying an alternating electric field1 to a target region of the subject (Fig. 11, Paragraph 0078, lines 1-2, Step S1).
Furthermore, Herrera teaches that the anti-carcinogenic composition refers to a “composition that comprises an agent that at least partially inhibits the development or,
progression of cancer” (Paragraph 0081, lines 1-2). Herrera does not explicitly teach that the anti-carcinogenic composition is a thioredoxin reductase inhibitor.
Beardsley, however, teaches a combination therapy for cancer treatment that includes administering at least one active agent that is at least one of a thioredoxin reductase inhibitor and a glutathione depleting agent (Fig. 11A-11B, Paragraph 0103,
lines 1-4). Beardsley teaches that both thioredoxin reductase inhibitors and glutathione
depleting agents may result in increased H2O2 levels in cancer cells, which leads to increased cytotoxicity (Paragraph 0101, lines 1-7).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the anti-carcinogenic composition of Herrera for the thioredoxin reductase inhibitor of Beardsley. Thus, the simple substitution of one known element for another producing the predictable result of inhibiting the development or progression of cancer renders the claim obvious.
Regarding claim 11, Herrera teaches the method (Fig. 11, Paragraph 0077, line 1) of claim 10 that comprises administering at least one composition that comprises an anti-carcinogenic composition (Fig. 11, Paragraph 0080, line 1, Step S3).
Herrera teaches that the anti-carcinogenic composition refers to a “composition that comprises an agent that at least partially inhibits the development or progression of cancer” (Paragraph 0081, lines 1-2). Herrera does not explicitly teach that the anti-carcinogenic composition is a thioredoxin reductase inhibitor that comprises auranofin.
Beardsley, however, teaches a combination therapy for cancer treatment that includes administering at least one active agent that is at least one of a thioredoxin reductase inhibitor and a glutathione depleting agent (Fig. 11A-11B, Paragraph 0103, lines 1-4). Beardsley teaches that both thioredoxin reductase inhibitors and glutathione depleting agents may result in increased H2O2 levels in cancer cells, which leads to increased cytotoxicity (Paragraph 0101, lines 1-7). Furthermore, Beardsley teaches that the thioredoxin reductase inhibitor comprises auranofin (Paragraph 0103, lines 13-14).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the anti-carcinogenic composition of Herrera for the thioredoxin reductase inhibitor that comprises auranofin of Beardsley. Thus, the simple substitution of one known element for another producing the predictable result of inhibiting the development or progression of cancer renders the claim obvious.
Regarding claim 12, Herrera in view of Beardsley discloses the claimed invention of claim 10. Herrera further discloses the method (Fig. 11, Paragraph 0077, line 1) of claim 10, wherein the at least one composition is orally or intravenously administered to the subject (Paragraph 0080, lines 1-2 and Paragraph 0095, lines 2-3).
Regarding claim 13, Herrera teaches the method (Fig. 11, Paragraph 0077, line 1)
of claim 10, wherein at least one of: the alternating electric field has a field strength of at least about 1 V/cm in at least a portion of the cancer cells (Paragraph 0112, lines 2-3); and the period of time that the alternating electric field is applied is at least about 50% of at least about a 24 consecutive hour time period (Paragraph 0112, lines 3-4).
Herrera does not teach that the alternating electric field is applied at a frequency in a range of from about 50 kHz to about 1 MHz. Herrera does teach that the alternating electric field may have a frequency of between 10 kHz to 500 kHz (Paragraph 0112, lines 1-2). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 14, Herrera in view of Beardsley discloses the claimed invention of claim 10. Herrera further discloses the method (Fig. 11, Paragraph 0077, line 1) of claim 10, wherein steps (1) and (2) are performed substantially simultaneously (Paragraph 0080, lines 2-3 and Paragraph 0095, line 3).
Regarding claim 15, Herrera in view of Beardsley discloses the claimed invention of claim 10. Herrera further discloses the method (Fig. 11, Paragraph 0077, line 1) of claim 10, wherein steps (1) and (2) are performed wholly or partially sequentially (Paragraph 0095, lines 3-4), and wherein the at least one composition is administered before or after the application of the alternating electric field has begun (Paragraph 0095, lines 3-4).
Regarding claim 16, Herrera in view of Beardsley discloses the claimed invention of claim 10. Herrera further discloses the method (Fig. 11, Paragraph 0077, line 1) of claim 10, wherein the cancer cells are selected from the group consisting of hepatocellular carcinoma cells (Paragraph 0085, line 5), glioblastoma cells (Paragraph 0085, line 2), pleural mesothelioma cells (Paragraph 0085, line 5), differentiated thyroid cancer cells (Paragraph 0085, line 11), advanced renal cell carcinoma cells (Paragraph 0085, lines 7 and 12), ovarian cancers (Paragraph 0085, line 6), breast cancers (Paragraph 0085, line 1), pancreatic cancers (Paragraph 0085, line 7), lung cancers (Paragraph 0085, line 5), and combinations thereof.
Regarding claim 17, Herrera teaches the method (Fig. 11, Paragraph 0077, line 1) of claim 10. Herrera does not teach that the method further comprises the step of exposing the cancer cells to radiation therapy, wherein the radiation therapy is applied before step (1), after step (1), before step (2), and/or after step (2).
Beardsley, however, teaches a combination therapy for cancer treatment that includes administering at least one active agent that is at least one of a thioredoxin reductase inhibitor and a glutathione depleting agent (Fig. 11A-11B, Paragraph 0103, lines 1-4). Beardsley teaches that both thioredoxin reductase inhibitors and glutathione depleting agents may result in increased H2O2 levels in cancer cells, which leads to increased cytotoxicity (Paragraph 0101, lines 1-7).
Furthermore, Beardsley teaches in a further embodiment that radiation therapy can be administered to a subject prior to, concomitantly with, or after administration of one or more of at least one of the thioredoxin reductase inhibitor and glutathione depleting agent (Paragraph 0237, lines 1-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Herrera to incorporate the teachings of Beardsley to specify that the method further includes exposing the cancer cells to radiation therapy before step (1), after step (1), before step (2), and/or after step (2). Doing so would improve the efficacy of both the active agent and the radiation in killing cancer cells (Paragraph 0100, lines 6-12), as recognized by Beardsley.
Regarding claim 18, Herrera in view of Beardsley discloses the claimed invention of claim 10. Herrera further discloses the method (Fig. 11, Paragraph 0077, line 1) of claim 10, further comprising the step of administering a second composition to the cancer cells (Fig. 11, Paragraph 0080, line 1, Step S3), wherein the first and second compositions are administered substantially simultaneously or wholly or partially sequentially (Paragraph 0080, lines 2-4).
Regarding claim 19, Herrera teaches the method (Fig. 11, Paragraph 0077, line 1) of claim 18, wherein at least one of: the first composition comprises at least one anti-carcinogenic composition (Fig. 11, Paragraph 0080, line 1, Step S3), and the second composition comprises at least one glutathione inhibitor (Fig. 11, Paragraph 0095, line 1, Step S4 and Paragraph 0096, lines 8-9 and 71, Buthionine sulfoximine); the first composition comprises at least one glutathione inhibitor (Fig. 11, Paragraph 0095, line 1, Step S4 and Paragraph 0096, lines 8-9 and 71, Buthionine sulfoximine), and the second composition comprises at least one anti-carcinogenic composition (Fig. 11, Paragraph 0080, line 1, Step S3).
Herrera teaches in the present embodiment that Step S3 may be performed either before or after Step S4 (Paragraph 0080, lines 2-4). Furthermore, Herrera teaches that the anti-carcinogenic composition refers to a “composition that comprises an agent that at least partially inhibits the development or progression of cancer” (Paragraph 0081, lines 1-2). Herrera does not explicitly teach that the anti-carcinogenic composition is a thioredoxin reductase inhibitor.
Beardsley, however, teaches a combination therapy for cancer treatment that includes administering at least one active agent that is at least one of a thioredoxin reductase inhibitor and a glutathione depleting agent (Fig. 11A-11B, Paragraph 0103, lines 1-4). Beardsley teaches that both thioredoxin reductase inhibitors and glutathione depleting agents may result in increased H2O2 levels in cancer cells, which leads to increased cytotoxicity (Paragraph 0101, lines 1-7).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the anti-carcinogenic composition of Herrera for the thioredoxin reductase inhibitor of Beardsley. Thus, the simple substitution of one known element for another producing the predictable result of inhibiting the development or progression of cancer renders the claim obvious.
Furthermore, Herrera teaches that the method further includes a step of providing direct heat to the cancer cells (Fig. 11, Paragraph 0079, line 1, Step S2). Herrera teaches that Step S3 can be performed before Step S2 (Paragraph 0080, lines 2-3). The present embodiment in Figure 11 does not explicitly teach that Step S2 involves delivering a second composition that comprises at least one chemotherapeutic agent.
However, in an alternative embodiment, Herrera teaches that the apparatus used to perform the method disclosed in Figure 11 includes an electromagnetic emitter (Fig. 7, Paragraph 0062, line 1, 10) and a heat source (Fig. 7, Paragraph 0062, line 1, 700) for heating a target site (Fig. 7, Paragraph 0062, line 2, 30). In the embodiment of Figure 7, Herrera teaches that the heat source (700) further includes a fluidic loop that heats a fluid that is then delivered to the target site (Paragraph 0063, lines 5-8). Herrera teaches that the fluid may comprise a chemotherapeutic composition or anti-cancer drug (Paragraph 0063, line 10 and Paragraph 0091).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the direct heating step disclosed by Herrera in Figure 11 with the heat source that includes the fluidic pump disclosed by Herrera in Figure 7 in order to specify that the second composition can comprise at least one chemotherapeutic agent. Doing so would provide a means of killing fast-growing cancer cells before administering the anti-carcinogenic compound (Paragraph 0080, lines 2-3).
Regarding claim 20, Herrera teaches a method of reducing a volume of a tumor and/or preventing an increase in volume of the tumor (Fig. 11, Paragraph 0077, line 1 and Paragraph 0002, lines 2-3), wherein the tumor is present in a body of a living subject
(Paragraph 0077, line 3, “patient”) and includes a plurality of cancer cells (Paragraph 0083, lines 1-2), the method comprising the steps of: (1) administering at least one composition to the subject (Fig. 11, Paragraph 0080, line 1, Step S3 or Paragraph 0095, line 1, Step S4), wherein the at least one composition comprises at least one anti-carcinogenic compound (Fig. 11, Paragraph 0080, line 1, Step S3) and/or at least one glutathione inhibitor (Fig. 11, Paragraph 0095, line 1, Step S4 and Paragraph 0096, lines 8-9 and 71, Buthionine sulfoximine); and (2) applying an alternating electric field1 to a target region of the subject (Fig. 11, Paragraph 0078, lines 1-2, Step S1).
Furthermore, Herrera teaches that the anti-carcinogenic composition refers to a “composition that comprises an agent that at least partially inhibits the development or progression of cancer” (Paragraph 0081, lines 1-2). Herrera does not explicitly teach that the anti-carcinogenic composition is a thioredoxin reductase inhibitor.
Beardsley, however, teaches a combination therapy for cancer treatment that includes administering at least one active agent that is at least one of a thioredoxin reductase inhibitor and a glutathione depleting agent (Fig. 11A-11B, Paragraph 0103, lines 1-4). Beardsley teaches that both thioredoxin reductase inhibitors and glutathione
depleting agents may result in increased H2O2 levels in cancer cells, which leads to increased cytotoxicity (Paragraph 0101, lines 1-7).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the anti-carcinogenic composition of Herrera for the
thioredoxin reductase inhibitor of Beardsley. Thus, the simple substitution of one known element for another producing the predictable result of inhibiting the development or progression of cancer renders the claim obvious.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Orwar et al. (U.S. PGPub No. 2022/0168273) teaches a pharmaceutical combination for treating cancer that comprises a CDK inhibitor and at least one antioxidant enzyme inhibitor (Abstract).
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/H.A.H./Patent Examiner , Art Unit 3796
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights