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 .
Status of the Claims
Claims 1, 4-5, 10, and 12-13 are pending.
Priority
Instant application 16/276,004, filed 02/14/2019 claims priority as follows:
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Response to Amendment/Arguments
The amendment filed 12/24/2025 has been entered. Applicant has amended claim 1.
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, 4-5, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over AlMansoori (Biology Theses, Nov. 2018) in view of Nair et al. (Journal of Basic and Clinical Pharmacy, vol. 7, no. 2, Mar. 2016, pp. 27–31; cited in IDS).
With respect to claim 1, AlMansoori is drawn to an in vivo assessment of safranal’s therapeutic effects on chemically induced hepatic neoplasia and notes “This study highlights safranal’s therapeutic potential against HCC and introduces it as a novel natural therapeutic and adjuvant agent against HCC” (page vii, Abstract).
AlMansoori teaches administering safranal to an HCC rat model at a dose of 200 mg/kg per day, either alone or in combination with sorafenib (pages 9-10, “experimental design”). Further, AlMansoori teaches that treatments of HCC rats with safranal and safranal + sorafenib “reduced lesions comparing to HCC animals, safranal also dramatically decreased lesions comparing to treatment with sorafenib alone” (page 15, “Anti-tumorigenic and Anti-proliferative activities of safranal on DEN induced rat liver tumors”; see also Figs. 5-6).
Additionally, AlMansoori teaches that safranal causes cell cycle arrest of induced hepatic neoplasia and induces apoptosis (pages 21-25). Particularly, AlMansoori teaches that CDC25B expression was significantly increased in HCC animals as compared to control animals, and treatment with safranal or safranal + sorafenib significantly decreased levels of expression in comparison to control animals (page 22, first paragraph, and Figure 11):
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The only difference between the method taught in AlMansoori and the instant claims is that AlMansoori administers safranal + sorafenib to rats at a dose of 200 mg/kg per day rather than to humans at a dose of 25 mg/day to 45 mg/day per kg body weight.
However, the person having ordinary skill would have recognized that AlMansoori’s teachings were applicable to human subjects, and would have converted the dose for rats to a suitable dose for humans.
For example, Nair teaches a simple practical guide for dose conversion between animals and humans. According to Nair’s Table 1, the 200 mg/kg dose in rats disclosed by AlMansoori converts to (200 / 6.2) = 32 mg/kg, which reads on the recited range of 25 to 45 mg/kg.
Finding of prima facie obviousness
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (G), it would have been prima facie obvious to administer safranal and a second therapeutic agent (e.g., sorafenib) to a human subject that overexpresses CDC25B to treat HCC, resulting in a decrease in expression of CDC25B protein, wherein the HCC comprises a malignant tumor. The skilled artisan would have been motivated by AlMansoori’s teachings that safranal alone or safranal + sorafenib in combination exhibit therapeutic effects on hepatic neoplasms.
With respect to claims 4 and 5, AlMansoori teaches administering safranal or safranal + sorafenib by oral gavage. However, parenteral administration is also known to the skilled artisan and is routinely employed in the administration of therapeutics. Nair teaches guidelines to convert mg/kg doses to doses for parenteral administration (see Table 3). Accordingly, claims 4-5 are prima facie obvious over AlMansoori in view of Nair.
With respect to claim 12, AlMansoori is silent about a decrease of 65% within 48 hours of administration. However, the limitation of claim 12 is being interpreted as an intended result of a method step positively recited. As noted in MPEP 2111.04, “a ‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited’”. In the instant case, the results (decreasing CDC25B expression by 65% within 48 hours of administration) are the intended result of the step of administering a composition including safranal in the amount of 25 to 45 mg/kg per day, and these claims do not add any additional active steps to the method of claim 1. Accordingly, claim 12 is prima facie obvious over AlMansoori in view of Nair.
With respect to claim 13, AlMansoori discloses administering safranal as a solution in phosphate buffered saline. No other active agents are present in the composition. The composition taught by AlMansoori is therefore being interpreted as “consisting essentially of” safranal. Accordingly, claim 13 is prima facie obvious over AlMansoori in view of Nair.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over AlMansoori (Biology Theses, Nov. 2018) in view of Nair et al. (Journal of Basic and Clinical Pharmacy, Mar. 2016; cited in IDS) as applied to claims 1, 4-5, and 12-13 above, and further in view of Borch et al. (US 5,233,031; previously cited) and Platzek et al. (US 6,180,113; previously cited).
The teachings of AlMansoori in view of Nair are disclosed above and at least those
teachings are incorporated herein by reference. AlMansoori in view of Nier teaches the method of instant claim 1.
With respect to claim 10, AlMansoori fails to teach a second therapeutic agent selected from the group consisting of carboplatin, cisplatin, methotrexate, fluorouracil, gemcitabine, goserelin, leuprolide, tamoxifen, taxanes, aldesleukin, interleukin-2, etoposide, interferon alpha, tretinoin, bleomycin, dactinomycin, daunorubicin, doxorubicin, mitomycin, vinblastine, vincristine, and combinations thereof.
However, other anticancer agents such as cisplatin, fluorouracil, doxorubicin, etc. (see for example, Borch, col. 2, lines 55-61; Plaztek, col. 74, lines 61-63) are taught in the prior art for treating hepatocellular carcinoma.
Finding of prima facie obviousness
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results.
Moreover, as recognized by MPEP § 2144.06(I):
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, 279 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, 1378-79, 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).
Therefore, applying KSR example rationale (A), it would have been prima facie obvious to add other anticancer agents taught in the prior art such as cisplatin, fluorouracil, doxorubicin, etc. to the composition administered in the method of treatment taught by AlMansoori in view of Nair. As noted above, the motivation to combine flows logically from their having been individually taught in the prior art for treatment of the same disorder(s).
Accordingly, claim 10 is prima facie obvious over AlMansoori in view of Nair, further in view of Borch and Plaztek.
Response to Arguments
Applicant asserts that the AlMansoori reference “constitutes and inventor pre-filing publication subject to a one-year grace period that does not qualify as prior art based on the effective filing date of the instant application” (Remarks 12/24/2025, page 2). Applicant stated in their Remarks that “The AlMansoori thesis was authored by Ameera Ali Mohammed AlMansoori in partial fulfillment of the requirements for receiving a Masters degree from the College of Sciences of United Arab Emirates University ("University"), the sole Applicant of the instant Application. AlMansoori was a graduate student at the University whose studies were conducted under the direction and supervision of Professor Amr Amin, the named inventor of the subject matter disclosed and claimed in the instant Application.”
Applicant's arguments filed 12/24/2025 have been fully considered but they are not persuasive. Applicant’s argument that AlMansoori does not qualify as prior art due to the 102(b)(1)(A) exception is not supported by objective evidence. Applicant is reminded of MPEP 716.01(c), which states:
Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor.
Applicant is invited to file the appropriate affidavit or declaration to disqualify the AlMansoori disclosure as prior art by establishing that the disclosure was made by the inventor, or that the subject matter disclosed was obtained directly or indirectly from the inventor. See MPEP 717.01(a) which discusses declarations or affidavits under 37 CFR 1.130(a) – Attribution. In particular, note the following factor which will be considered in evaluating the affidavit or declaration:
(1) Where the authorship of the prior art disclosure includes the inventor or a joint inventor named in the application, an "unequivocal" statement from the inventor or a joint inventor that he/she (or some specific combination of named joint inventors) invented the subject matter of the disclosure, accompanied by a reasonable explanation of the presence of additional authors, may be acceptable in the absence of evidence to the contrary. See In re DeBaun, 687 F.2d 459, 463, 214 USPQ 933, 936 (CCPA 1982).
Applicant is invited to provide an explanation for the listing of AlMansoori as the author of the prior art disclosure, particularly taking into account the following passage on page ii of AlMansoori:
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Applicant additionally argues that safranal decreasing the expression of CDC25B protein by 65% within 48 hours of administration is the threshold by which the claimed dosage of safranal is therapeutically effective. Applicant argues that no measurements were made in tissue samples within 48-hours of safranal administration commencing. Applicant argues that AlMansoori is silent with respect to what constitutes an amount of safranal that is therapeutically effective against HCC cells in a human subject.
Applicant's arguments have been fully considered but they are not persuasive. Applicant cannot convincingly argue that AlMansoori’s disclosure fails to teach a therapeutically effective amount in humans because it only provides rat data when the instant application also only provides rat data as support for claims drawn to human subjects. Stated differently, the instant application’s primary evidentiary basis for human dosage claims consists of a rat study, which consists of dosing at 200 mg/kg, the same dosage used by AlMansoori (see Specification, para. [00165]; and AlMansoori, pages 9-10, “experimental design”). See also para. [00107] of the instant application, which states:
The data obtained from the cell culture assays and animal studies may be used in formulating a range of dosage for use in humans. For example, effective dosages achieved in one animal species may be extrapolated for use in another animal, including humans, as illustrated in the conversion table of FIG. 22 where human equivalent dose (HED) dosage factors based on body surface area of other species are reported.
Note that the conversion table of FIG. 22 is identical, and appears to be directly copied from, Table 1 of the Nair reference which discloses dose conversion between animals and humans.
Additionally, there is no evidence in the instant application that the 65% decrease is a distinguishing “threshold value” for therapeutic effectiveness. The number 65% appears to be taken from Fig. 2B, which is a western blot analysis of cell cycle regulatory proteins in HepG2 cells post treatment with safranal at a concentration of 500 uM, not from a study in humans being dosed at 25 mg/day to 45 mg/day. AlMansoori provides equivalent data to FIG. 2B in Figures 11 and 12. In particular, note that AlMansoori’s Figure 12 appears to show a ~65% – 70% decrease in CDC25B expression in cells treated with safranal (SF) or safranal and sorafenib (SF + SB), relative to untreated cells (HCC):
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HCC + SF: (1.0-0.35)/1.0 = ~65%
HCC + SF + SB: (1.0-0.30)/1.0 = ~70%
Therefore, the rejection is maintained.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
US 12,521,425
Claims 1, 4-5, 10, and 12-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,521,425.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent recites treating, suppressing, or reducing the severity of hepatocellular carcinoma in a subject comprising administering safranal (10 mg/day to 1000 mg/day per kg) or prodrug thereof in combination with topotecan, wherein the safranal induces an increased sensitivity of the cells to topotecan. Dependent claims recite administering safranal orally or parenterally. Dependent claim 7 recites wherein the safranal inhibits an expression of CDC25B.
The difference between the reference claims and the instant claims is that the reference claims do not recite administering a second therapeutic agent selected from those recited in instant claim 10.
However, the portions of the specification in the reference patent that provide support for the reference claims include:
para. [00122] and [00140], which disclose that safranal was found to inhibit CDC25B expression and induced cell cycle arrest at the G2 phase;
para. [0009], which discloses that safranal increases the cytotoxic effect of a second therapeutic agent (TOP1 inhibitor, topotecan) and teaches administering safranal with other therapeutic agents including carboplatin, cisplatin, fluorouracil, gemcitabine, etc.
Therefore, the instant claims are prima facie obvious in view of U.S. Patent No. 12,521,425.
This rejection is proper according to MPEP 804(II)(B)(1):
Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
US 12,576,122
Claims 1, 4-5, 10, and 12-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,576,122. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent recites treating, suppressing, or reducing the severity of hepatocellular carcinoma in a subject comprising administering safranal or prodrug thereof in combination with topotecan, wherein the safranal induces an increased sensitivity of the cells to topotecan.
The differences between the instant claims and the reference patent are that the reference patent does not recite:
a patient population that overexpresses CDC25B;
administering safranal in an amount from 25 mg/day to 45 mg/day per kg body weight;
administering safranal orally or parenterally;
a second therapeutic agent selected from those recited in instant claim 10.
However, the portions of the specification in the reference patent that provide support for the reference claims include:
para. [00122] and [00140], which disclose that safranal was found to inhibit CDC25B expression and induced cell cycle arrest at the G2 phase;
para. [00110], which discloses exemplary doses of safranal and discloses dose ranges of from 25 mg/day to 45 mg/day per kg;
para. [0009], which discloses that safranal may be administered orally or parenterally, or to a hepatic artery;
para. [0009], which discloses that safranal increases the cytotoxic effect of a second therapeutic agent (TOP1 inhibitor, topotecan) and teaches administering safranal with other therapeutic agents including carboplatin, cisplatin, fluorouracil, gemcitabine, etc.
Therefore, the instant claims are prima facie obvious in view of U.S. Patent No. 12,576,122.
This rejection is proper according to MPEP 804(II)(B)(1); note the relevant sections cited earlier in the rejection over US 12,521,425.
US Patent No. 10,568,873
Claims 1, 4-5, and 12-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,568,873 (“the ‘873 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘873 patent recites a method of treating, suppressing, or reducing the severity of hepatocellular carcinoma in a subject comprising administering safranal or prodrug thereof (10 mg/day to 1000 mg/day per kg) in combination with sorafenib.
The differences between the instant claims and the ‘873 patent are that the ‘873 patent does not recite:
a patient population that overexpresses CDC25B;
administering safranal in an amount from 25 mg/day to 45 mg/day per kg body weight;
administering safranal orally or parenterally;
However, the portions of the specification in the reference application that provide support for the reference claims include:
col. 14, line 60-col. 15, line10, which discloses that CDC2B expression was increased in HCC animals and that safranal was found to significantly decrease CDC25B expression and induced cell cycle arrest at the G2 phase;
col. 8, lines 27-52, which discloses exemplary doses of safranal and discloses dose ranges of from 25 mg/day to 45 mg/day per kg;
col. 5, which discloses that safranal may be administered orally or parenterally;
Therefore, the instant claims are prima facie obvious in view of US 10,568,873.
This rejection is proper according to MPEP 804(II)(B)(1); note the relevant sections cited earlier in the rejection over Application No. 16/272,426.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,568,873 (“the ‘873 patent) in view of Borch et al. (US 5,233,031) and Platzek et al. (US 6,180,113).
The recitations of the ‘873 patent are disclosed above and at least those recitations are incorporated herein by reference.
The difference between instant claim 10 and the ‘873 patent is that the ‘873 patent does not recite or disclose administering safranal in combination with one of the second therapeutic agents recited in instant claim 10.
However, other anticancer agents such as cisplatin, fluorouracil, doxorubicin, etc. (see for example, Borch, col. 2, lines 55-61; Plaztek, col. 74, lines 61-63) are taught in the prior art for treating hepatocellular carcinoma.
Therefore, applying KSR example rationale (A), it would have been prima facie obvious to administer other anticancer agents taught in the prior art such as cisplatin, fluorouracil, doxorubicin, etc. with the safranal composition administered in the method of treatment of the ‘873 patent. As noted above, the motivation to combine flows logically from their having been individually taught in the prior art for treatment of the same disorder(s).
Therefore, instant claim 10 is prima facie obvious over US 10,568,873 in view of Borch and Platzek.
US Patent No. 10,912,741
Claims 1, 4-5, and 12-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,912,741 (“the ‘741 patent) in view of Yan et al. (Molecular Cancer, vol. 7, Feb. 2008, p. 19), and further in view of in view of Borch et al. (US 5,233,031) and Platzek et al. (US 6,180,113).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘741 patent recites a method of treating, suppressing, or reducing the severity of hepatocellular carcinoma in a subject comprising administering safranal (25 mg/day to 45 mg/day per kg).
The differences between the instant claims and the ‘741 patent are that the ‘741 patent does not recite:
administering safranal orally or parenterally;
a patient population that overexpresses CDC25B;
administering safranal in combination with a second therapeutic agent, or a specific second therapeutic agent selected from those recited in claim 10.
However, the portions of the specification in the reference application that provide support for the reference claims include col. 6, which discloses that safranal may be administered orally or parenterally.
Therefore, it would have been prima facie obvious to administer safranal orally or parenterally.
With respect to the patient population that overexpresses CDC25B, Yan teaches that CDC25B was known to be “significantly highly expressed” in hepatocellular carcinoma compared to non-tumor liver.
Therefore, applying KSR example rationale (G), it would have been prima facie obvious to administer safranal to patient populations having overexpression of CDC25B. A skilled artisan would have been motivated to administer to such a patient population in view of Yan’s teaching that overexpression of CDC25B is an indicator of HCC.
With respect to the administration of safranal in combination with a second therapeutic agent, such as those recited in claim 10, other anticancer agents such as cisplatin, fluorouracil, doxorubicin, etc. (see for example, Borch, col. 2, lines 55-61; Plaztek, col. 74, lines 61-63) are taught in the prior art for treating HCC.
Therefore, applying KSR example rationale (A), it would have been prima facie obvious to administer other anticancer agents taught in the prior art such as cisplatin, fluorouracil, doxorubicin, etc. with the safranal composition administered in the method of treatment of the ‘741 patent. As noted above, the motivation to combine flows logically from their having been individually taught in the prior art for treatment of the same disorder(s).
Therefore, the instant claims are prima facie obvious in view of US 10,912,741.
Conclusion
Claims 1, 4-5, 10, and 12-13 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 8:30 am - 5:30 pm.
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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621