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 .
Priority
This is a 35 U.S.C. 371 National Stage filing of International Application No. PCT/US2020/041204 filed July 8th, 2020, which claims to U.S. provisional application 62/872,149 filed July 9th, 2019.
Status of Claims
Claims 1-2, 4, 6, 8-9, 15-23 and 79-82 are pending in the instant application. Claims 1, 4, 9 and 23 are amended, claims 3, 5, 7, 10-14 and 24-77 are cancelled and claims 78-82 are new via the amendment filed February 12th, 2026.
Restriction/Election
Search and examination has been limited as previously discussed in the Office action dated February 20th, 2025. Examination is limited to the extent that the claims are readable on elected group I and elected compound of instant claim 8. Since the elected species is not allowable, subject matter not embraced by the elected embodiment is therefore withdrawn from further consideration.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 12th, 2026 has been entered.
Maintained Rejections
Applicant’s arguments, filed February 12th, 2026, with respect to 35 USC 103 rejections have been fully considered but they are not persuasive. See response to remarks.
Applicant’s arguments, filed February 12th, 2026, with respect to double patenting rejection have been fully considered but they are not persuasive. See response to remarks.
Response to Remarks
Firstly, Applicant argues that by amending claim 1 to replace “treating cancer” with “reducing growth or proliferation of a cancer cell”, that the claims have now overcome the previous rejection.
In response, Applicant has relied on the use of a synonym to overcome the rejection, however, it fails to change the scope of the invention. Additionally, the examiner assigns the broadest reasonable interpretation to claim language, meaning a synonym that is substantially identical in meaning to the rejected term would be rejected for the same reason. By definition, treating cancer involves using a therapeutic intervention to control or reduce the growth of malignant cells, and as such, the prior claim definition and the currently amended claim limitation are synonymous.
On p. 8 of the response, Applicant argues that independent claim 1, as amended, is within the scope of the present disclosure.
However, the results remain not commensurate in scope with the scope of the claims. The results provided do not occur over the entire claimed range (an effective concentration a compound of formula (I)). In the instant Figures 2-5, an amount of 0.01 nM to 10 μM of PTX was tested, however, the present claims do not require a specific dosage amount and are generic to a compound of Formula (I).
Applicant then argues that Callmann does not teach cells overexpressing one or more fatty acid uptake proteins, however, this deficiency is resolved in view of the prior art below and evidentiary references cited.
On p. 8-9 of the response, Applicant argues that Satsangi does not teach or suggest wherein X1 is a C12-22 hydrocarbylene, nor does Satsangi teach or suggest a cancer cell overexpressing one or more fatty acid uptake proteins.
However, Satsangi is cited as teaching that paclitaxel conjugates are useful in treating breast cancer. As the compound taught by Callmann is a conjugate of paclitaxel, one of ordinary skill in the art would recognize that the compound will also be useful in treating breast cancer.
On p.9-10 of the response, Applicant argues that Qiu does not mention or evaluate compounds comprising a taxane moiety.
However, Qiu teaches modifications of cisplatin, that included adding a long hydrocarbon tail and a carboxylic acid head, exhibited a high toxicity against CD36-overexpressing cancer cells. As such, one of ordinary skill in the art would have recognized that modifying paclitaxel, the compound of the instant claims, would expect to have the same results.
In view of the above, the 103 rejection presented in the previous Office action is maintained. Further, an additional 103 rejection over new prior art is also presented below.
On p.11 of the response, Applicant argues that the double patenting rejection is overcome for the same reasons as presented in the argument against the 103 rejection. However, for the reasons stated above, the double patenting rejection is maintained. Applicant also argues that the written description of the reference patent may not be used in the double patenting rejection. However, Callmann is cited as a reference as it qualifies to be used as prior art under 35 USC 102/103.
In view of the above, the double patenting rejection presented in the previous Office action is maintained. Further, an additional double patenting rejection over new prior art is also presented below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 6, 8-9, 15-18 and 23 stand rejected under 35 U.S.C. 103 as being unpatentable over Callmann et al (WO 2017/053391 A1, as cited on the IDS) in view of Satsangi et al (Mol. Pharmaceutics 2014, 11, 1906−1918), Li et al (Cell Metabolism 25, February 7, 2017)
and Qiu et al (Fatty-Acid like Pt(IV) Prodrugs harnessing CD36 to target Chemo resistant Ovarian Cancer Cells, May. 2019, as cited on the IDS).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Callmann teaches a method of treating cancer, comprising administering to a subject the following the following compound (claim 34):
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This compound is Applicant’s elected species, the compound of instant claim 8, in which A1 is a carboxylic acid group, X1 is a C16 hydrocarbylene, X2 is an organic group (C(=O)) and A2 is a paclitaxel moiety.
Regarding claim 2, as seen in the compound above, A1 is a carboxylic acid group.
Regarding claims 4 and 6, as seen in the compound above, the cytotoxic drug moiety is a taxane moiety, specifically a paclitaxel moiety of the formula:
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Callmann also teaches a method of treating cancer comprising administering a pharmaceutical composition comprising the compound above.
Regarding claim 9, Callmann teaches that the pharmaceutical composition is suitable for administration to a human (claim 32).
Regarding claims 15 and 18, Callmann teaches that the pharmaceutical composition comprises a carrier, which comprises water (claim 27).
Regarding claims 16-17, Callmann teaches that the pharmaceutical composition comprises a protein, specifically human serum albumin (claim 29).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not teach a method of treating cancer specifically, wherein the cancer comprises cells that overexpress one or more fatty acid uptake proteins.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Satsangi teaches paclitaxel prodrug conjugates for active targeting of an enzyme upregulated in breast cancer cells (abstract). Satsangi teaches that paclitaxel is the first-line therapy for breast cancer for its metastatic form. Satsangi also teaches that anticancer treatment involving paclitaxel faces several limitations. The limitations include poor aqueous solubility and slow dissolution rate in bodily fluids (page 1906, right column). Satsangi then goes on to explain that paclitaxel lacks ionizable functional groups, which otherwise would have allowed for possible solubilization with moderation in pH and formation of salts and charged complexes (page 1906, right column). Satsangi then proposes an approach to counter the current challenges of cancer treatments that involve paclitaxel. Satsangi teaches that by designing a conjugate of paclitaxel with a hydrophilic macromolecule with a biocleavable linker, the paclitaxel drug would be improved in anticancer treatment (abstract).
Li teaches that CD36 is expressed at high levels in many metastatic tumors, include breast cancers (page 229). Li also teaches that CD36 promotes fatty acid uptake (page 229). Also, the instant specification recites that CD36 is a fatty acid uptake protein, on page 1.
Further, Qiu teaches that prodrugs that include a long hydrocarbon tail and a carboxylic acid head group use CD36 to facilitate their entry to cancer cells (page 4). Qiu specifically teaches a prodrug of the cytotoxic drug, cisplatin, with a long hydrocarbon tail and a carboxylic acid head. This is similar to Applicant’s elected species as the species is a cytotoxic drug moiety, paclitaxel, with a hydrocarbon chain and a carboxylic acid group. Qiu then teaches that upon upregulation of CD36, the uptake of the cisplatin prodrug was increased and also that the prodrug exhibited a high toxicity against CD36-overexpressing cancer cells in comparison with cisplatin alone (page 15).
Thus, Applicant’s elected species is a conjugate of paclitaxel, Callmann teaches the elected species as having applicability to cancer, Satsangi teaches paclitaxel and its conjugations are useful in the treatment of breast cancer, Li teaches that breast cancer cells overexpress CD36, a fatty acid uptake protein and Qiu teaches specific conjugations of drugs that are useful in the treatment of cancer cells that overexpress CD36. One of ordinary skill in the art would have been motivated by the teachings of Satsangi, Li and Qiu to alter the method of administering Applicant’s elected species in a method of treating cancer to apply the paclitaxel conjugates in utilities where paclitaxel and it conjugates have already been demonstrated to be therapeutically useful, specifically in cancers wherein the cancer cells overexpress CD36.
Claims 1-2, 6, 8-9, 15-20 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Callmann et al (WO 2017/053391 A1, as cited on the IDS) in view of Satsangi et al (Mol. Pharmaceutics 2014, 11, 1906−1918), Li et al (Cell Metabolism 25, February 7, 2017)
and Qiu et al (Fatty-Acid like Pt(IV) Prodrugs harnessing CD36 to target Chemo resistant Ovarian Cancer Cells, May. 2019, as cited on the IDS), as applied to claims 1-2, 6, 8-9, 15-18 and 23 and in further view of Yu et al (J Biol Chem. 2016 Jun 29;291(33):16977–16989).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Neither Callmann, Satsangi, Li nor Qiu disclose a method of treating cancer, wherein the cancer comprises cells that overexpress one or more fatty acid uptake proteins, the method comprising administering Applicant’s elected species in combination with one or more additional chemotherapeutic agents.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
There is not a single embodiment of the method of treating cancer with Applicant’s elected species along with an additional chemotherapeutic agent.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Yu teaches that tamoxifen, an anti-breast cancer medicine inhibits CD36 protein expression (abstract). Tamoxifen is a kinase inhibitor, as evidenced by Corbel et al (2015, Chemistry & Biology 22, 472–482 April 23, 2015). Corbel discloses that tamoxifen inhibits CDK5 kinase activity (summary).
Because both Applicant’s elected species and tamoxifen, a chemotherapeutic agent and kinase inhibitor, are known to treat breast cancer, there would be a reasonable expectation that their combined use would also effectively treat breast cancer. When elements are combined for the same known purpose, in this case, treating breast cancer, the combination would have been reasonably expected to succeed.
There is no indication in the prior art or in the claimed invention that administration of the elected species with an additional chemotherapeutic agent results in any unexpected or surprising results, beyond what would be anticipated from their individual use. The combination achieves the same therapeutic effect that is already known for each compound individually.
Considering the above, the administration of Applicant’s elected species with tamoxifen for the treatment of breast cancer would have been obvious to a person of ordinary skill in the art, at the time of invention. The motivation to combine the two compounds is that there would be a reasonable expectation of success in achieving the desired therapeutic effect.
Claims 1-2, 6, 8-9, 15-18 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Callmann et al (WO 2017/053391 A1, as cited on the IDS) in view of Satsangi et al (Mol. Pharmaceutics 2014, 11, 1906−1918), Li et al (Cell Metabolism 25, February 7, 2017)
and Qiu et al (Fatty-Acid like Pt(IV) Prodrugs harnessing CD36 to target Chemo resistant Ovarian Cancer Cells, May. 2019), as applied to claims 1-2, 6, 8-9, 15-18 and 23 and in further view of Emens et al (Clin Cancer Res; 24(3) February 1, 2018).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Neither Callmann, Satsangi, Li nor Qiu disclose a method of treating cancer, wherein the cancer comprises cells that overexpress one or more fatty acid uptake proteins, the method comprising administering Applicant’s elected species in combination with one or more immunomodulating agents.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
There is not a single embodiment of the method of treating cancer with Applicant’s elected species along with an immunomodulating agent.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Emens teaches that ipilimumab, an immunomodulating agent, aids in the treatment of breast cancer (page 513, left column).
Because both Applicant’s elected species and ipilimumab, an immunomodulating agent treat breast cancer, there would be a reasonable expectation that their combined use would also effectively treat cancer. When elements are combined for the same known purpose, in this case, treating breast cancer, the combination would have been reasonably expected to succeed.
There is no indication in the prior art or in the claimed invention that administration of the elected species with an additional immunomodulating agent results in any unexpected or surprising results, beyond what would be anticipated from their individual use. The combination achieves the same therapeutic effect that is already known for each compound individually.
Considering the above, the administration of Applicant’s elected species with ipilimumab for the treatment of breast cancer would have been obvious to a person of ordinary skill in the art, at the time of invention. The motivation to combine the two compounds is that there would be a reasonable expectation of success in achieving the desired therapeutic effect.
Claim(s) 1-2, 4, 6, 8-9, 15-18, 23 and 78-82 are newly rejected under 35 U.S.C. 103 as being unpatentable over Callmann et al (US 2017/0080094 A1) in view of Yang et al (Cancer Letters 438 (2018) 76-85), as evidenced by Xiao et al (Cancer Cell International (2015) 15:53) and Mehdi et al (Nature Medicine, (6)1, 2000).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Callmann teaches a method of inhibiting proliferation of a cancerous tumor, including contacting the cancerous tumor with a compound such as the following (paragraph [0102] and claim 16):
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This compound is Applicant’s elected species, the compound of instant claim 8, in which A1 is a carboxylic acid group, X1 is a C16 hydrocarbylene, X2 is an organic group (C(=O)) and A2 is a paclitaxel moiety.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Callmann does not explicitly teach that the cells overexpress a fatty acid uptake protein.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Callmann further teaches the administration of the above compound to HeLa cells, at various concentrations including 64.42 nM (Table 8).
Further, HeLa cells are derived from the cervical cancer immortal cell line, as evidenced by Xiao et al (Cancer Cell International (2015) 15:53). Yang teaches that in a clinical setting, CD36 expression is positively correlated with tumor progression and poor prognosis in patients with cervical cancer (abstract). Yang also teaches that CD36 expression is markedly increased in cervical cancer patients with an advanced tumor clinical stage (page 78, left column).
Regarding claim 1, as Callmann teaches a method of inhibiting proliferation of a cancerous tumor, including contacting the cancerous tumor with a compound of instant formula (I) and the administration of the compound to HeLa cells at an effective concentration, one of ordinary skill in the art would have been motivated to administer the same compound to cancerous cells overexpressing CD36, as Callmann teaches that the compound is effective regarding cervical cancer cells and Yang teaches that CD36 is overexpressed in cervical cancer cells.
Regarding claim 2, as seen in the compound above, A1 is a carboxylic acid group.
Regarding claims 4 and 6, as seen in the compound above, the cytotoxic drug moiety is a taxane moiety, specifically a paclitaxel moiety of the formula:
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Callmann also teaches a method of treating cancer comprising administering a pharmaceutical composition comprising the compound above.
Regarding claim 9, Callmann teaches that the pharmaceutical composition is suitable for administration to a human (claim 32).
Regarding claims 15 and 18, Callmann teaches that the pharmaceutical composition comprises a carrier, which comprises water (claim 27).
Regarding claims 16-17, Callmann teaches that the pharmaceutical composition comprises a protein, specifically human serum albumin (claim 29).
Regarding claim 23,
Regarding claim 78, as seen above, HeLa cells overexpress CD36.
Regarding claims 79-80, Callmann also teaches compounds such as the one above and it’s in vivo efficacy in treating HT-1080 tumor burdened mice (Example 15). HT-1080s are metastatic human cells derived from a fibrosarcoma, as evidenced by Mehdi et al (Nature Medicine, (6)1, 2000). As the method of reducing growth or proliferation of a cancer cell overexpressing CD36 has been made obvious above, one of ordinary skill in the art would have been motivated to have the cell be a fibrosarcoma cell as Callmann teaches that the compound of instant formula (I) shows in vivo efficacy against fibrosarcoma cells. Regarding claim 23, as seen above, HT-1080 cells are metastatic cells.
Regarding claim 81, Callmann teaches the administration of the above compound to HeLa cells, at various concentrations including an effective concentration of 64.42 nM (Table 8). Regarding claim 82, one of ordinary skill in the art would have been motivated by these teachings of Callmann to optimize the effective concentration of the compound. See MPEP 2144.05:
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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was “unexpectedly good”); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
Claim(s) 1-2, 4, 6, 8-9, 15-20, 23 and 78-82 is/are rejected under 35 U.S.C. 103 as being unpatentable over Callmann et al (US 2017/0080094 A1) in view of Yang et al (Cancer Letters 438 (2018) 76-85), as evidenced by Xiao et al (Cancer Cell International (2015) 15:53) and Mehdi et al (Nature Medicine, (6)1, 2000) as applied to claims 1-2, 4, 6, 8-9, 15-18, 23 and 78-82 above, and in further view of Schwab et al (Anticancer Drugs. 2014 May ; 25(5): 522–535).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Neither Callmann nor Yang disclose a method of reducing growth or proliferation of a cancer cell, wherein the cancer cell overexpresses one or more fatty acid uptake proteins, the method comprising administering Applicant’s elected species in combination with one or more additional chemotherapeutic agents. However, Callmann does teach the elected species utility in treating cervical cancer.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
There is not a single embodiment of the method with Applicant’s elected species along with an additional chemotherapeutic agent.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Further, Schwab teaches that the taxane, paclitaxel treats cervical cancer (page 12, paragraph 3). As both the compound of instant formula (I) and the taxane, paclitaxel have utility in treating cervical cancer, it would have been prima facie obvious to combine the two for the same utility.
Because both Applicant’s elected species and paclitaxel, a chemotherapeutic agent and a taxane, are known to treat cervical cancer, there would be a reasonable expectation that their combined use would also effectively treat cervical cancer. When elements are combined for the same known purpose, in this case, treating cervical cancer, the combination would have been reasonably expected to succeed.
There is no indication in the prior art or in the claimed invention that administration of the elected species with an additional chemotherapeutic agent results in any unexpected or surprising results, beyond what would be anticipated from their individual use. The combination achieves the same therapeutic effect that is already known for each compound individually.
See MPEP 2144.06: "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.). See also In re Crockett, 278 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-78, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Claim(s) 1-2, 4, 6, 8-9, 15-18, 21-23 and 78-82 is/are newly rejected under 35 U.S.C. 103 as being unpatentable over Callmann et al (US 2017/0080094 A1) in view of Yang et al (Cancer Letters 438 (2018) 76-85), as evidenced by Xiao et al (Cancer Cell International (2015) 15:53) and Mehdi et al (Nature Medicine, (6)1, 2000) as applied to claims 1-2, 4, 6, 8-9, 15-18, 23 and 78-82 above, and in further view of Borcoman et al (Therapeutic Advances in Medical Oncology 9(6)).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Neither Callmann nor Yang disclose a method of reducing growth or proliferation of a cancer cell, wherein the cancer cell overexpresses one or more fatty acid uptake proteins, the method comprising administering Applicant’s elected species in combination with one or more additional chemotherapeutic agents. However, Callmann does teach the elected species utility in treating cervical cancer.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
There is not a single embodiment of the method with Applicant’s elected species along with an additional chemotherapeutic agent.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Borcoman teaches that pembrolizumab, an anti-PD-1 antibody is known to treat cervical cancer (conclusion).
Because both Applicant’s elected species and pembrolizumab, an anti-PD-1 antibody, are known to treat cervical cancer, there would be a reasonable expectation that their combined use would also effectively treat cervical cancer. When elements are combined for the same known purpose, in this case, treating cervical cancer, the combination would have been reasonably expected to succeed.
There is no indication in the prior art or in the claimed invention that administration of the elected species with an additional chemotherapeutic agent results in any unexpected or surprising results, beyond what would be anticipated from their individual use. The combination achieves the same therapeutic effect that is already known for each compound individually.
See MPEP 2144.06: "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.). See also In re Crockett, 278 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-78, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-2, 4, 6, 8-9 and 15-23 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,023,581 in view of Callmann et al (WO 2017/053391 A1, as cited on the IDS), Satsangi et al (Mol. Pharmaceutics 2014, 11, 1906−1918), Li et al (Cell Metabolism 25, February 7, 2017), Qiu et al (Fatty-Acid like Pt(IV) Prodrugs harnessing CD36 to target Chemo resistant Ovarian Cancer Cells, May. 2019, as cited on the IDS), Yu et al (J Biol Chem. 2016 Jun 29;291(33):16977–16989) and Emens et al (Clin Cancer Res; 24(3) February 1, 2018).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patent claims a method of treating cancer, comprising administering to a subject a pharmaceutical composition comprising the following compound:
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along with a protein wherein the protein is human serum albumin (claim 21).
The patent does not claim that the cancer comprises cells that overexpress one or more fatty acid uptake proteins.
However, the claims of the patent are directed to the compound of Callmann et al. and methods of use thereof that serve as the basis for the rationales under 35 USC 103. The rejections under 35 USC 103 are incorporated here by reference. For the same reasons the instant claims are deemed obvious in view of the prior art, the instant claims are deemed obvious variants of the claims of the patent.
Claims 1-2,4,6,8-9,15-23 and 79-82 are newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No.10, 023, 581 in view of Callmann et al (US 2017/0080094 A1) in view of Yang et al (Cancer Letters 438 (2018) 76-85), as evidenced by Xiao et al (Cancer Cell International (2015) 15:53), Mehdi et al (Nature Medicine, (6)1, 2000), Schwab et al (Anticancer Drugs. 2014 May ; 25(5): 522–535) and Borcoman et al (Therapeutic Advances in Medical Oncology 9(6)).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patent claims a method of treating cancer, comprising administering to a subject a pharmaceutical composition comprising the following compound:
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286
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along with a protein wherein the protein is human serum albumin (claim 21).
The patent does not claim explicitly a method of reducing growth of a cancer cell expressing CD36.
However, the claims of the patent are directed to the compound of Callmann et al. and methods of use thereof that serve as the basis for the rationales under 35 USC 103. The rejections under 35 USC 103 are incorporated here by reference. For the same reasons the instant claims are deemed obvious in view of the prior art, the instant claims are deemed obvious variants of the claims of the patent.
Correspondence
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699