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 .
Application Status
The amendment filed on 8/25/2026 in response to the non-final rejection of 3/25/2026 is acknowledged and has been entered.
Claims 1-5, 9-13, 17, 21 and 31-33 are currently pending.
Applicant’s election without traverse of Group 1, claims 1-13 and 15-17 in the reply filed on 9/30/2025. Applicants further election of selenocystine as the Category 1 or Category 2 compound and diphenyl diselenide as the Category 3, 4 or 5 compound is acknowledged.
In view of the claim amendments filed on 8/25/2026, the examiner is interpreting the original election to encompass selenocystine as the cytotoxic agent and diphenyl diselenide as the cytotoxic enhancing agent (e.g. species of Formula I). After a review of the prior art, the species election for the cytotoxic agent has been expanded to include a selenite anion such as calcium selenite or sodium selenite, a selenide anion such as potassium selenide. The species election for the cytotoxicity enhancing agent has been expanded to include sulphoraphane (e.g. sulforaphane), dimethyl selenide, and dibenzyl diselenide.
Accordingly, claims 1-5, 9-12 and 17 read on the elected species/invention.
Claims 21 and 31-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/30/2025.
Claim 13 is withdrawn from consideration as being drawn to nonelected species.
Response to the Declaration submitted on 2/27/2026
The Declaration filed under 1.132 on 2/27/2026 was considered and not found persuasive for the reasons set forth in the Non-final Rejection of 3/25/2026 and incorporated herein. Of note: The Examiner acknowledged and was impressed with the fold increase in many of the cancer cells in Table 2 which is the combination of sodium selenite or selenocystine and diphenyl diselenide (DPPS). However, the Examiner was less impressed with the combination of sodium selenite or selenocystine and the other asserted cytotoxic enhancing agents as there seems to be many instances where they did not appear to work, e.g. enhance cytotoxicity (blank spaces for the combination). Moreover, it is unclear how much of the “other compounds” were given and their impact alone on the cell lines. Assuming, arguendo, that Applicants have shown unexpected results, the claims do not appear to be commensurate in scope with the results presented. First, the claims are broad (see below). Secondly, the claims do not require any molar ratio which as noted by the Declarant is an important factor to achieve better cancer cell killing effect.
Rejections Withdrawn:
Any rejection set forth in the previous office action which is not set forth below has been withdrawn in view of Applicants amendments.
Claim Objections based on amendment:
Claim Objections
Claims 9-12 are objected to because of the following informalities: Claims 9-12 recite “comprises” followed by the recitation of a number of compounds or only one. It is suggested that Application replace “comprising” with either “selected from the group consisting of” or “is” with respect to claim 10. Appropriate correction is required.
Rejections Maintained, but amended in view of Applicants amendments:
Claim Rejections - 35 USC § 112
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.
Claim 1 remains 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. THIS IS A NEW MATTER REJECTION.
Claim 1 has been amended to recite a pharmaceutical composition comprising one or more cytotoxic agent(s), wherein the one or more cytotoxic agent(s) are selected from a selenite anion, a selenide anion, selenocystine, precursors thereof …. Applicants contend that support for the amendment can be found throughout the application as originally filed at least on page 19, lines 14-18 and page 20, lines 14-16. A careful review of the specification and claims as originally filed, in particular, page 20, lines 14-16, does not appear to lend support for wherein the cytotoxic compound is a selenide anion or a precursor of a selenide anion or precursor of selenocystine. For example, the specification, page 20, lines 14-16, teaches “In some embodiments, the compound of category 1 is sodium selenite, potassium selenite, selenium dioxide, sodium selenide, potassium selenide, selenious acid, elemental selenium, selenite anion, any precursor molecules that give rise to selenite anion or hydrogen selenide, or a combination thereof. Thus, while the specification provides support for a selenite anion, the specification does not appear to provide support for a selenide anion or a precursor of a selenide anion or precursor of selenocystine.
In response to this rejection, Applicants contend that they have amended the claim to remove the “precursor” language. Thus, while Examiner recognizes that the deletion addresses the “precursor” issue of the above rejection, Applicants have not provided any support for where a “selenide anion” can be found. In the instant case, a selenide anion is considered to be a genus. Accordingly, the rejection is maintained.
Claim 1-5, 9-12 and 17 remain 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. THIS IS A WRITTEN DESCRIPTION REJECTION
Claim 1 recites a pharmaceutical composition comprising one or more cytotoxic agent(s), wherein the one or more cytotoxic agents are selected from a selenite anion, a selenide anion, a selenocystine, or any combination thereof;
one or more cytotoxicity enhancing agent(s), wherein the one or more cytotoxicity enhancing agent(s) are selected from sulphorane, curcumin, tert-butyl hydroxyquinone, tumicamycin, a compound of formula I: R3-X-Y-R2 or a pharmaceutically acceptable salt thereof
wherein the presence of the cytotoxicity enhancing agent increases the cytotoxicity of the composition by at least 1.5-fold compared to in the absence of the cytotoxicity enhancing agent. Thus, the claims encompass a genus of cytotoxicity enhancing agents characterized by different functional language, wherein the presence of the cytotoxicity enhancing agent increases the cytotoxicity of the composition by at least 1.5-fold compared to in the absence of the cytotoxicity enhancing agent.
The specification teaches a variety of different compounds the majority of which contain either Selenium, sulfur or tellurium and groups these into different categories 1-5, wherein categories 1 and 2 appear to encompass the cytotoxic agents of claim 1 and categories 3-5 encompass the cytotoxicity enhancing agent, although category 3 is noted as being a hybrid molecule that serves as both a cytotoxic agent and a cytoxicity enhancing agent (see for example, pages 20 to page 48). For the category 4 and 5 compounds, the specification teaches that one common characteristics of this class of molecules, with certain exceptions, is that these molecules alter the redox potential of the microenvironment of cancer or normal cells or blood at a systemic level by effluxing endogenous thiols in human normal and cancer cells, wherein similar properties are exhibited by some of the category 3 molecules as well, since these contain one of the building blocks or functional groups that is implicated in the observed effects of Category 4 molecules on modulating the redox potential of the microenvironment of cancer or normal cells (page 26, lines 11-19).
Regarding the cytotoxicity enhancing agents and the claimed functional language, the specification provides a number of examples testing various compounds. In particular, the specification teaches a number of cytotoxicity tests wherein sodium selenite or selenocysteine are used alone or in combination with diphenyl selenide, tert-butyl hydroxyquinone, phenyl selenide, sulforaphen, dimethyl fumarate, curcumin and tunicamycin in a variety of tumor cell lines. For example, Table 3 is reproduced below:
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and Table 4 is reproduced below:
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Thus, while the specification provides specific instances where there appears to be a lower IC50 value in the combination compared to the single agent alone, these results appear to be directly related to the specific cytotoxic agent and the “second agent” and cell line. In other words, there does not appear to be a predictable pattern in view of these results. Moreover, it is unclear what the IC50 value for the 2nd agent was alone and whether it actually “enhanced” the cytotoxic activity of the 1st agent.
At the time the invention was filed, the state of the art regarding at least some of the organoselenium compounds such as diphenyl diselenide recognizes that there are differences in activity depending on the structure. For example, Zhang et al. (Chemical Research in Toxicology 2013; 26:456-464) found that organoselenium compounds modulate extracellular redox by induction of extracellular cysteine and cell surface thioredoxin reductase (Title). Specifically, Zhang et al. tested a number of selenium compounds:
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and
found that arylselenium compounds benzeneselenol (PhSeH), dibenzyl diselenide (DBDSe), diphenyl diselenide (DPDSe) and ebselen were capable of inducing extracellular cysteine accumulation via a cystin- and glucose-dependent processes but, sodium selenite, selenomethionine, seleno-l-cystine and Se-methylselenocysteine did not have these effects on macrophages under the same treatment conditions (abstract). Zhang et al. further teach that the order of effectiveness and relative magnitude of effect among the organoselenium compounds in stimulating cellular export of cysteine were DPDSe>PhSeH<ebselen>DBDSe (page 459, 2nd column, 1st full paragraph).
Thus, while the specification provides numerous compounds, the specification does not appear to be provide a structure function correlation which would allow one of skill in the art to determine which agent increases the cytotoxicity of the composition by at least 1.5-fold compared to in the absence of the cytotoxicity enhancing agent.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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.
Claim(s) 1-5, 9, 11-13 and 17 remain rejected under 35 U.S.C. 103 as being unpatentable over Pomeranian Academy of Medicine (WO2005/013951A2, 2005-02-17) referred to herein as Pomeranian, in view of Barbosa et al. (Arch Toxicol (2008) 82: 655-663).
Pomeranian teach pharmaceutical compositions of selenium (or its salts or derivatives or any other selenium comprising compound) and a method of using said pharmaceutical composition for the prevention of breast /ovarian cancers (abstract). With regards to the selenium, Pomeranian teach selenium or its salts or derivatives refers to any known selenium comprising compound including, but not limited to, elemental selenium, selenium dioxide, selenoic acid, potassium selenide, calcium selenite, selenomethinine and dimethyl selenide, wherein the selenium or its salts or derivates can be used in conjunction with other selenium containing compounds (page 5, last paragraph bridging page 6). Pomeranian further teach that the pharmaceutical composition comprises a pharmaceutically acceptable carrier in in addition to the compound(s) of the invention (page 7, 1st full paragraph). Moreover, Pomeranian teach that the compounds of the invention may be administered in conjunction with one or more other known antineoplastic and/or cancer preventative agents either together or sequentially page 7, last paragraph bridging page 8).
While Pomeranian contemplates treating cancer using a selenium compound with other selenium compounds and/or anti-neoplastic agents either together or sequentially, Pomeranian does not explicitly teach that the second selenium compound is diphenyl diselenide or the ratio’s present within the composition.
Barbosa et al. teach that diphenyl diselenide is a synthetic organoselenium compound that possess glutathione peroxidase-like activity and exhibits antioxidant, anti-hyperglycemic and anti-inflammatory properties, wherein when used in pharmacological doses it has low toxicity in rodents (page 656, 1st column, 2nd full paragraph). Moreover, Barbosa et al. teach that diphenyl diselenide can retard cancer development and may be considered as a potential chemopreventitive agent (page 661, 2nd column, last paragraph bridging page 662).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the pharmaceutical composition taught by Pomeranian to include diphenyl diselenide as the another selenium compound or anti-neoplastic agent/chemo-preventative agent for treatment of cancer in view of Barboasa. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Barbosa et al. teach that diphenyl diselenide can retard cancer development and may be considered as a potential chemopreventitive agent.
- "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.).
Moreover, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to optimize the ratio’s of selenium compound to the other agents within the pharmaceutical composition for the treatment of cancer. One of ordinary skill in the art would have been motivated to make such an optimization, with a reasonable expectation of success, because:
- Generally, differences in concentration or temperature 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
While the prior art does not specifically teach the results obtained of administering the pharmaceutical composition as recited in claim 2-4, the claimed limitation does not appear to result in a manipulative difference in the optimization of the amounts or ratios as set forth above for the treatment of cancer. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
In response to this rejection, Applicants contend that Pomeranian fails to disclose or suggest the combination as claimed and that Barbosa does not cure the deficiencies of Pomeranian because it does not disclose or suggest the combination. Moreover, Applicants point to the information submitted in the Declaration under 1.132 which shows that the claimed combination of cytotoxic agent(s) and cytotoxic enhancing agent(s) resulted in a synergistic cytotoxic effect that was unexpected.
These arguments have been carefully considered, but are not found persuasive.
In response to applicant's arguments against the references individually, the Examiner recognizes that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As set forth above, Pomeranian teaches the use of selenium compounds for treating cancer and contemplates the addition of a second selenium containing compound. Barbosa et al. teach that diphenyl diselenide can retard cancer development and may be considered as a potential chemopreventitive agent. Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the pharmaceutical composition taught by Pomeranian to include diphenyl diselenide as the another selenium compound or anti-neoplastic agent/chemo-preventative agent for treatment of cancer in view of the teachings of Barbosa. Regarding the alleged unexpected results submitted in the Declaration under 1.132 on 2/26/2026, as noted above, the Examiner acknowledged and was impressed with the fold increase in many of the cancer cells in Table 2 which is the combination of sodium selenite or selenocystine and diphenyl diselenide (DPPS). However, the Examiner was less impressed with the combination of sodium selenite or selenocystine and the other asserted cytotoxic enhancing agents as there seems to be many instances where they did not appear to work, e.g. enhance cytotoxicity (blank spaces for the combination). Moreover, it is unclear how much of the “other compounds” were given and their impact alone on the cell lines. Assuming, arguendo, that Applicants have shown unexpected results, the claims do not appear to be commensurate in scope with the results presented. First, the claims are broad (see below). Secondly, the claims do not require any molar ratio which as noted by the Declarant is an important factor to achieve better cancer cell killing effect.
Claim(s) 1-5, 9, 11 and 17 remain rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (Chemical Research in Toxicology 2013; 26:456-464).
Zang et al. found that organoselenium compounds modulate extracellular redox by induction of extracellular cysteine and cell surface thioredoxin reductase (Title). Specifically, Zhang et al. found that arylselenium compounds benzeneselenol (PhSeH), dibenzyl diselenide (DBDSe), diphenyl diselenide (DPDSe) and ebselen were capable of inducing extracellular cysteine accumulation via a cystin- and glucose-dependent processes, wherein extracellular cysteine production was dose-dependently inhibited by glutamate, an inhibitor of cystine/glutamate antiporter (Xc- transporter) supporting the involvement of Xc- transporter for cystine uptake in the above process (abstract). Note: Xc- transporter appears to be also referred to as SLC7A11 in the art. Moreover, Zhang et al. also found that coadministration of 1.25-2.5mM sodium selenite and 2.5-5mM DPDSe synergistically inhibited cell proliferation in Hepa Iclc7 (hepatoma cells) and RAW 264.7 cells (mouse tumor induced by Abelson murine leukemia virus) and suggests that this cotreatment may extend to the combination of other organoselenium compounds with sodium selenite (page 461, 2nd column, 1st full paragraph and page 462, 2nd column 2, 2nd full paragraph).
Thus, while Zang et al. teach coadministration of sodium selenite and DBDSe, Zhang et al. do not specifically teach that the compounds together in one pharmaceutical composition.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by Zhang et al. to include both agents within one pharmaceutical composition. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-combining the two agents into one composition would eliminate the need to formulate each separately and administer each separately.
In response to this rejection, Applicants contend that Claim 1 has been amended to recite” when one or more of the cytotoxic agents is the selenite anion, then the cytotoxicity enhancing agent is not a compound of formula I, wherein X and Y are Se and R2 and R3 are unsubstituted aryl. Thus, Applicants contend that claim 1 excludes a composition where the one or more cytotoxic agent is sodium selenite and the cytotoxicity enhancing agent is diphenyldiselenide or dibenzyldiselenide.
These arguments have been carefully considered, but are not found persuasive.
In response to these arguments, the Examiner acknowledges that the current claims proviso out a composition where the one or more cytotoxic agent is sodium selenite and the cytotoxicity enhancing agent is diphenyldiselenide. However, dibenzyldiselenide
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reads on a compound of formula I, wherein X and Y are Se, and R2 and R3 are a substituted alkyl, wherein the substitution is an aryl.
Claim(s) 10 remains rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (Chemical Research in Toxicology 2013; 26:456-464), as applied above to claims 1-5, 9, 11 and 17 above, in view of Olm et al. (PNAS 2009; 106(27): 11400-11405).
Zang et al. found that organoselenium compounds modulate extracellular redox by induction of extracellular cysteine and cell surface thioredoxin reductase (Title). Specifically, Zhang et al. found that arylselenium compounds benzeneselenol (PhSeH), dibenzyl diselenide (DBDSe), diphenyl diselenide (DPDSe) and ebselen were capable of inducing extracellular cysteine accumulation via a cystin- and glucose-dependent processes, wherein extracellular cysteine production was dose-dependently inhibited by glutamate, an inhibitor of cystine/glutamate antiporter (Xc- transporter) supporting the involvement of Xc- transporter for cystine uptake in the above process (abstract). Note: Xc- transporter appears to be also referred to as SLC7A11 in the art. Moreover, Zhang et al. also found that coadministration of 1.25-2.5mM sodium selenite and 2.5-5mM DPDSe synergistically inhibited cell proliferation in Hepa Iclc7 (hepatoma cells) and RAW 264.7 cells (mouse tumor induced by Abelson murine leukemia virus) and suggests that this cotreatment may extend to the combination of other organoselenium compounds with sodium selenite (page 461, 2nd column, 1st full paragraph and page 462, 2nd column 2, 2nd full paragraph). Zhang et al. further teach that sodium selenite cytotoxicity has been shown to be greatly enhanced with extracellular thiols via a potential mechanism in which SeO32- is reduced by thiols (page 462, 2nd column, 2nd full paragraph).
Zhang et al. does not specifically teach that the combination of selenocystine and diphenyl diselenide.
Olm et al. found that the extracellular thiol-assisted selenium uptake dependent on the Xc- cystine transporter explains the cancer-specific cytotoxicity of selenite (Title). In particular, Olm et al. teach that control experiments revealed that the redox active selenium compounds selenocystine and GSSeSG are also dependent on extracellular thiols for cytotoxicity.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to sodium selenite taught by Zhang et al. for selenocystine in view of the teachings of Olm et al. . One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Zhang et al. teach that sodium selenite cytotoxicity has been shown to be greatly enhanced with extracellular thiols; and
- Olm et al. teach that selenocystine and GSSeSG are also dependent on extracellular thiols for cytotoxicity.
In response to this rejection, Applicants contend that as demonstrated by Tables 2, 4 and 5 of the Specification, as filed and the data submitted in the Declaration under 1.132 on 2/26/2026, the claimed combination of a cytotoxic agent and a cytotoxic enhancing agent resulted in a synergistic effect that was unexpected.
These arguments have been carefully considered, but are not found persuasive.
Regarding the unexpected results Regarding the alleged unexpected results submitted in the Declaration under 1.132 on 2/26/2026, as noted above, the Examiner acknowledged and was impressed with the fold increase in many of the cancer cells in Table 2 which is the combination of sodium selenite or selenocystine and diphenyl diselenide (DPPS). However, the Examiner was less impressed with the combination of sodium selenite or selenocystine and the other asserted cytotoxic enhancing agents as there seems to be many instances where they did not appear to work, e.g. enhance cytotoxicity (blank spaces for the combination). Moreover, it is unclear how much of the “other compounds” were given and their impact alone on the cell lines. Assuming, arguendo, that Applicants have shown unexpected results, the claims do not appear to be commensurate in scope with the results presented. First, the claims are broad (see below). Secondly, the claims do not require any molar ratio which as noted by the Declarant is an important factor to achieve better cancer cell killing effect.
Claim(s) 1-5, 9 and 12 remain rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (Nutrition Research 2015; 35: 610-617).
Wang et al. teaches synergy between sulforaphane and selenium (Sodium Selenite) in protection against oxidative damage in colonic CCD841 cells (normal colon cells) (Title and Abstract). Specifically, Wang et al. teach exposing the cells to 2.5mM sulforaphane and/or 0.1mM sodium selenite for 24 hrs (page 611, 2nd column, Section 2.3).
Thus, while Wang et al. teach coadministration of sodium selenite and sulforaphane, Wang et al. do not specifically teach that the compounds together in one pharmaceutical composition.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by Wang et al. to include both agents within one pharmaceutical composition. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-combining the two agents into one composition would eliminate the need to formulate each separately and administer each separately.
In response to this rejection, Applicants contend that Wang describes synergy between sulforaphane and selenium in protection against oxidative damage in normal colonic CCD841 cells. However, Wang is silent regarding the cytotoxicity effect in cancer cells.
These arguments have been carefully considered, but are not found persuasive.
In response to these arguments, the Examiner acknowledges and does not dispute Applicants assert that Wang describes synergy between sulforaphane and selenium in protection against oxidative damage in normal colonic CCD841 cells and not cancer cells. However, the Examiner recognizes that the instant rejected claims encompass a pharmaceutical composition, wherein the cytotoxic activity in cancer cells can be interpreted as an intended use. During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963). See MPEP 2111.02. In the instant case, all the composition requires is two compounds and it does not appear that the recited purpose of the compositions use results in a structural different between the claimed invention and the prior art.
New Rejections Necessitated by Amendment:
Claim Rejections - 35 USC § 112
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.
Claim 9 is 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. THIS IS A NEW MATTER REJECTION.
Claim 9 has been amended to recite “wherein the selenite anion, the selenide anion or any combination thereof comprises sodium selenite, potassium selenite, sodium selenide, potassium selenide or a combination thereof”. Thus, the claims appear to insinuate that the selenite anion and selenide anion is the genus and sodium selenite, potassium selenite, sodium selenide and potassium selenide are the species. In the instant case, Applicants have not provided any support from the specification or claims as originally filed that support this type of genus/species relationship. For example, the specification, page 20, lines 14-16, teaches “In some embodiments, the compound of category 1 is sodium selenite, potassium selenite, selenium dioxide, sodium selenide, potassium selenide, selenious acid, elemental selenium, selenite anion, any precursor molecules that give rise to selenite anion or hydrogen selenide, or a combination thereof”. Thus, it appears that these recitations are distinct and different. While it is acknowledged that sodium selenite or potassium selenite can be considered as a precusor molecule that give rise to a selenite anion, the specification does not specifically equate the two, nor does the specification or claims teach that sodium selenide and potassium selenide equate to selenide anion.
Conclusion
Therefore, No claim is 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.
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/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
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