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 .
Response to Amendment and
Status of the Claims
2. Applicant's amendment and response, filed September 26, 2025 has been reviewed by the examiner and entered of record in the file.
3. Claims 1 and 3-5 are amended, and claim 2 is cancelled.
4. Applicant previously elected to pursue the following species:
(1) “AKT inhibitor’ as the anticancer agent in claim 1;
(2) “PI3K inhibitor” as the at least one additional agent as recited in claim 2;
(3) “Ipatasertib” as the sub-species of AKT inhibitor in claim 3;
(4) “Ipatasertib and Rapamycin and Pictilisib” as the combination in claim 5;
(5) “A further therapeutic agent” in claim 11 as the further therapeutic intervention;
(6) “CDK 4/6 inhibitor” as the further therapeutic agent in claim 12; and
(8) “breast cancer” as the species of cancer, claim 15.
5. Claims 17 and 18 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim 13 remains withdrawn from consideration as directed to non-elected species.
6. Claims 1, 3-12, 14-16, 19 and 20 are under examination with the elected species and are the subject of this office action.
Information Disclosure Statement
7. The information disclosure statement (IDS) submitted on October 16, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner, please refer to the signed copy of Applicant’s PTO-1449 form, attached herewith.
Response to Amendment
8. The Declaration under 37 CFR 1.132 filed September is insufficient to overcome the rejection of claims 1, 4, 6, 7, 9 and 14-16 based upon Longo and Di Biase, in view of Sarker et al. under 35 USC 103 as set forth in the last Office action because:
The Declaration submitted by Dr. Valter D. Longo under 37 CFR 1.132 (the “Longo Declaration”), presents additional experimental results demonstrating that treating malignant melanoma in a murine model with the combination of a Fasting-Mimicking Diet (FMD) and administering both Rapamycin and Pictilisib resulted in a synergistic effect on percentage of surviving mice (in days) and against tumor progression (see Declaration, paragraphs 8 through 13; and figures labeled as "A375 xenograft” at page 3).
The Longo Declaration alleges that the metabolic effects of FMD + Rapa + Pictilisib on melanoma tumors are plausibly translatable to triple negative breast cancer (TNBC) because both melanoma and TNBC are dependent on PI3K/AKT/mTOR signaling and “frequently exhibit hyperactive PI3K/AKT/mTOR pathways” (referencing Salvadori et al. and Raffaghello et al. in paragraph 14). The Longo Declaration alleges that TNBC and melanoma are both highly glycolytic and dependent on nutrient availability (referencing Wang et al. in paragraph 15), suggesting that FMD mimics caloric restriction, creating a metabolic environment less favorable for tumor proliferation, such that “it is scientifically reasonable to expect similar synergistic effects in TNBC or clinical models” (paragraph 16).
9. However, it is well settled that a showing of unexpected results is generally sufficient to overcome a prima facie case of obviousness. In re Albrecht, 514 F.2d 1389 (CCPA 1975). In the instant case, Applicant has appropriately compared the claimed invention (the combined effects of the administration of FMD + Rapa + Pictilisib) with that of a FMD alone, and with the administration of Rapa + Pictilisib alone, and provided factual evidence which establishes unexpected results of the claimed invention for the treatment of malignant melanoma. However, although the evidence establishes unexpected results, Applicant is reminded that “the objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support” (In re Clemens, 622 F.2d 1029 (CCPA 1980)). Thus, in In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003), factual evidence demonstrating a greater than expected result from the addition of 2% of an ingredient did not evidence unexpected results for the entire claimed range of about 1-3% of the ingredient. Rather, the nonobviousness of a broader range or genus can only be established by evidence based on unexpected results of a narrower range or genus when one of ordinary skill in the art would be able to determine a trend in the exemplified data allowing said artisan to reasonably extend the probative value thereof. In re Kollman, 595 F.2d 48 (CCPA 1979).
10. In the instant case, the claims are not drafted commensurate in scope with the results demonstrated in the Longo Declaration to overcome the prima facie case of obviousness, i.e., the unexpected synergistic effects of the combination of a FMD with the administration of both Pictilisib at a dose of 100 mg/kg and Rapamycin at a dose of 2 mg/kg to a patient in need thereof for the treatment of melanoma. That is, the amended claims presently embrace the treatment of any patient affected by any cancer comprising administering any therapeutically effective dose(s) of any PI3K inhibitor, and any CDK4/6 inhibitor, OR any therapeutically effective dose(s) of any mTOR inhibitor and any P13 inhibitor.
Previous Claim Rejections - 35 USC § 103
11. Claims 1, 4, 6, 7, 9 and 14-16 remain rejected under 35 U.S.C. 103 as being unpatentable over Longo and Di Biase, WO 2015134837 A2, in view of Sarker et al., (Clinical Cancer Research 2014).
Instant claim 1 is directed to a method for treating a patient affected by cancer, (more specifically, breast cancer (claim 15), i.e., a solid cancer (claim 14) resistant to treatment (claim 16)),
comprising subjecting the patient to a reduced caloric intake cycle and
administering therapeutically effective doses of a PI3K inhibitor and CDK inhibitor, OR
administering therapeutically effective doses of an mTOR inhibitor and a P13 inhibitor, (more specifically the combination of the PI3K inhibitor Pictilisib, with the mTOR inhibitor Rapamycin), and
wherein said reduced caloric intake cycle provides at most 2100 Kcal per day and consists of a first and a second part,
wherein the first part has a regular caloric intake reduced by 30% to 70%, and the second part has a regular caloric intake reduced by 40 to 97%, and
wherein said first part and/or said second part lasts for a period of 24 to 120 hours (claims 6 and 7), wherein the at least one reduced caloric intake cycle is repeated from 1 to 30 times after respective periods of from 5 to 60 days (claim 9).
12. Longo specifically teaches a murine breast cancer model (4T1) comprising multi-cycle treatment (for a total of three cycles), wherein in each cycle, the mice were subjected to a reduced caloric diet for 48 to 72h (comprising either a short-term starvation (“STS”) or a fasting mimicking diet (“FMD”)), and the mice received a daily injection of the anti-cancer agent rapamycin (an mTOR inhibitor), followed by a standard chow diet for 10 days between cycles to recover the bodyweight lost see paragraph [0061]). A cycle of 48 to 72h reads on the limitation of a period of 24 to 120 hours required by claims 6 and 7. Longo teaches that “the steps of administering the reduced caloric diet… and administering of the kinase inhibitor constitute a treatment cycle that can be repeated a plurality of times,” which embraces the recited “first part” and “second part,” required by claim 1 (see paragraph [0043]). The standard diet for 10 days between cycles to recover the bodyweight lost, taught by Longo in paragraph [0061]) reads on the limitation of a respective period of from 5 to 60 days between cycles, required by claim 9.
13. Longo demonstrates the additive effects of the combination of STS and rapamycin, i.e.,
“[i]n a murine breast cancer (4T1) and murine melanoma (B16) mouse allograft models, it is demonstrated that STS and rapamycin have an additive effect in reducing tumor progression, which confirms that STS potentiates the effects of the mTOR kinase inhibitor rapamycin on cancer cells,” (paragraph [0061], first sentence).
14. Regarding the limitation of a reduction in regular caloric intake of 30%-70% of the first part, and a reduction of 40%-97% in the second part, Longo teaches that “the diet provides no more than 1000 kcal per day, and in particular, no more than 813-957 kcal per day. In a variation, the reduced caloric diet provides from about 100 to 1000 kcal per day to the subject,” (paragraph [0046]). Assuming a 2000 kcal per day regular caloric intake, 1000 kcal per day is a 50% reduction in calories, which meets the limitation of a 30-70% reduction, as well as a 40-97% reduction required by claim 1.
15. As such, Longo teaches the treatment of a patient affected by breast cancer comprising subjecting said patient to a reduced calorie diet (STS) and administering an mTOR inhibitor, but does not teach the administration of a PI3K inhibitor.
16. Yet, Sarker et al. teach the administration of the PI3k inhibitor pictilisib to patients affected by breast cancer (see Table 1, page 79), wherein pictilisib was well- tolerated and successfully achieved antitumor activity (page 84, right column, second full paragraph).
17. Thus, one of skill in the art before the effective filing date of the claimed invention would have been motivated to subject a patient affected by breast cancer to a reduced calorie diet, and administer to said patient a combination of the known mTOR inhibitor rapamycin with the PI3k inhibitor pictilisib, each having previously demonstrated antitumor activity in breast cancer, in order to achieve an additive effect for the treatment of breast cancer in said patient. The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law, please see In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings).Furthermore, MPEP 2144 teaches that the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.
18. Please refer to MPEP 2144.06 “I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE” wherein Kerkhoven is specifically referenced:
“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.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
19. And, as stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976); see also: Merck v. Biocraft (874 F.2d 804, 807 (Fed. Cir. 1989), indicating that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands; Sundance, Inc. v. DeMonte Fabricated, Ltd., 550 F.3d 1356 (Fed. Cir. 2008): a claimed invention is obvious is it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they had been combined.
20. Therefore, it would have been obvious to one skilled in the art before the effective filing date of the claimed invention to treat a patient affected by breast cancer to the reduced calorie diet “STS,” and administer to said patient a combination of the known mTOR inhibitor rapamycin with the PI3k inhibitor pictilisib, each having previously demonstrated antitumor activity in breast cancer, with a reasonable expectation of success.
As such, claims 1, 4, 6, 7, 9 and 14-16 are prima facie obvious.
Claim 8 is drawn to claim 6, wherein said first part and/or or said second part lasts for approximately 120 hours.
21. Longo additionally teaches wherein a reduced caloric diet, in particular FMD, for mammal subjects and in particular humans, substitutes the normal diet of a cancer patient for a period of 5 to 21 days with a 17 day maximum for most patients with frequency to be determined based on the frequency and efficacy of other treatments, with more frequent use needed when other treatments are not effective in cancer treatment (paragraph [0053]). Thus, the period of 5 days, embraced by the range taught by Longo (i.e., 5 to 21 days) meets the limitation of 120 hours (equivalent to 5 days), required by claim 8.
22. And, since the recited process is a well-known process, optimization of result-effective variables of said process, such as duration of reduced caloric intake, would be obvious to one skilled in the art. Changing the weight, purity or other characteristic (i.e., temperature, pressure, etc) of an old process does not render the newer claimed form patentable where the difference in weight, purity or characteristic was inherent, please see In re Cofer (CCPA 1966) 354 F2d 664, 148 USPA 268. Therefore, it would have been obvious to one skilled in the art before the effective filing date of the claimed invention to treat a patient affected by breast cancer to the reduced calorie diet “STS,” wherein the STS cycle comprises a first part and a second part, wherein said first part and/or or said second part lasts for approximately 120 hours, and also administer to said patient a combination of the known mTOR inhibitor rapamycin with the PI3k inhibitor pictilisib, each having previously demonstrated antitumor activity in breast cancer, with a reasonable expectation of success.
As such, claim 8 is prima facie obvious.
23. Claims 3, 5, 19 and 20 remain rejected under 35 U.S.C. 103 as being unpatentable over Longo and Di Biase, in view of Sarker et al, as applied to claims 1, 4, 6, 7, 9 and 14-16, above, further in view of Costa et al., Breast Cancer Research and Treatment (2018).
Claim 1 is addressed in detail, above.
Claim 3 is drawn to claim 1, and limits wherein an AKT inhibitor is administered in combination with the PI3K inhibitor and the mTOR inhibitor, (more specifically, Ipatasertib and Rapamycin and Pictilisib (claim 5)).
Claim 19 is drawn to a method for treating a patient affected by cancer, comprising subjecting the patient to a reduced caloric intake cycle and a combination of anticancer agents:
wherein the anticancer agent is a combination of an AKT inhibitor, an mTOR inhibitor and a PI3K inhibitor (more specifically, Ipatasertib and Rapamycin and Pictilisib (claim 20));
and wherein the reduced caloric intake cycle provides at most 2100 Kcal per day and consists of a first and a second part, wherein the first part has a regular caloric intake reduced by 30% to 70% and the second part has a regular caloric intake reduced by 40 to 97%.
24. Longo in view of Sarker et al. teach the treatment of a patient affected by breast cancer comprising subjecting said patient to a reduced calorie diet (in the form of STS) and administering an mTOR inhibitor and a PI3K inhibitor, but do not teach the combined administration with an AKT inhibitor.
25. However, Longo teaches that the combination of a reduced calorie diet (STS/ FMD) with kinase inhibitors provides a synergistic pro-death role with inhibitors of kinases (paragraph [0043]), and suggest that the potentiating effect of STS/FMD observed with rapamycin is expected to apply to many different kinase inhibitors used in cancer treatment inhibitors of signaling pathways, including AKT-mTOR (paragraph [0062]).
26. And, Costa et al. discuss targeting the PI3K/AKT/mTOR pathway in the treatment of breast cancer, specifically naming the PI3K inhibitor Pictilisib, the AKT inhibitor ipatasertib and the mTOR inhibitor rapamycin (page 399, right column, second paragraph; page 400, left column, second paragraph; and page 400, left column, last paragraph). While Costa et al. do not disclose a single embodiment comprising the administration of pictilisib, ipatasertib and rapamycin, in this case, when each species is clearly named, the species claim is anticipated no matter how many other species are additionally named. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter.1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that "the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is described' as that term is used in 35 U.S.C. § 102(a), in that publication."). Id. at 1718. See also In re Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982). As such, one of skill in the art before the effective filing date of the claimed invention would have been motivated to treat a patient having breast cancer with a reduced calorie diet and the administration of the combination of kinase inhibitors pictilisib, ipatasertib, and rapamycin in said patient, and would have expected that in combination, each element merely would perform the same function as it did separately, with a reasonable expectation of success.
As such, claims 3, 5, 19 and 20 are prima facie obvious.
27. Claims 10-12 remain rejected under 35 U.S.C. 103 as being unpatentable over Longo and Di Biase, in view of Sarker et al., as applied to claims 1, 4, 6, 7, 9 and 14-16 above, further in view of Dong et al., Frontiers in Pharmacology, (published March 15, 2021).
Claim 1 is addressed in detail, above.
Claim 10 is drawn to claim 1, additionally comprising administering a further therapeutic intervention to said patient, (more specifically, a further therapeutic agent (claim 11) that is a CDK4/6 inhibitor (claim 12)).
28. Longo in view of Sarker et al. teach the treatment of a patient affected by breast cancer comprising subjecting said patient to a reduced calorie diet (in the form of STS) and administering an mTOR inhibitor and a PI3K inhibitor, but do not teach the combined administration with a CDK4/6 inhibitor.
29. Yet, Dong et al. teach that CDK4/6 inhibitors, such as ribociclib, abemaciclib and palbociclib, have been approved for HR+/ HER2− breast cancer treatment, and additionally teach that,
“combining PI3K inhibitors with CDK4/6i has been confirmed to have a synergistic effect to overcome intrinsic and adaptive resistance in multiple studies (Voraetal., 2014; Herrera-Abreuetal., 2016). CDK4/6 and PI3K inhibitors together have been shown to induce breast cancer cell apoptosis in vitro and suppress tumor growth in patient-derived tumor xenograft models (Herrera-Abreuetal., 2016). Additionally, mTORC1/2 inhibition has been shown to inhibit Rb phosphorylation, cyclin D1 expression and E2F-mediated transcription in CDK4/6i-resistant cells (Michaloglou et al., 2018),” (page 9, right column, last two paragraphs- page 10, left column, lines 4-14).
30. As such, one skilled in the art before the effective filing date of the claimed invention would have been motivated to combine a reduced calorie diet with the administration of a CDK4/6 inhibitor and the PI3K, AKT, and mTOR pathway inhibitors taught by Longo and Costa et al. to achieve a greater than additive effect in the treatment of breast cancer in a patient in need thereof. It would have been obvious to one of skill in the art before the effective filing date of the claimed invention to combine a reduced calorie diet with the administration of a CDK4/6 inhibitor and the PI3K, AKT, and mTOR pathway inhibitors in the treatment of breast cancer in a patient in need thereof, with a reasonable expectation of success.
Thus, claims 10-12 are prima facie obvious.
Response to Arguments
31. Applicant traverses the previous obviousness rejection of claims 1, 4, 6, 7, 9 and 14-16 over Longo and Di Biase, in view of Sarker et al., and claims 3, 5, 19, and 20 further in view of Costa et al., and claims 10-12 further rejected in view of Dong et al. Applicant argues that the instant inventors have clearly demonstrated that FMD treatment, when combined with PI3K and TOR inhibitors, yields statistically superior results compared to the benefits resulting from administering each of the inhibitors taken alone, resulting in an unexpected synergistic effect.
32. Applicant submitted a Declaration Under 37 C.F.R. 1.132 by Dr. Valter D. Longo (the “Longo Declaration”) on September 26, 2025. The Longo Declaration presents additional experimental results demonstrating that treating malignant melanoma in a murine model with the combination of a Fasting-Mimicking Diet (FMD) and administering both Rapamycin and Pictilisib resulted in (a) a synergistic effect on the percentage of surviving mice (in days), and (b) a synergistic effect against the progression of melanoma tumors (see Declaration, paragraphs 8 through 13; and figures labeled as "A375 xenograft” at page 3).
33. Additionally, the Longo Declaration alleges that the metabolic effects of FMD + Rapa + Pictilisib on melanoma tumors are plausibly translatable to triple negative breast cancer (TNBC), because both melanoma and TNBC are dependent on PI3K/AKT/mTOR signaling and “frequently exhibit hyperactive PI3K/AKT/mTOR pathways” (referencing Salvadori et al. and Raffaghello et al. in paragraph 14). The Longo Declaration alleges that TNBC and melanoma are both highly glycolytic and dependent on nutrient availability (referencing Wang et al. in paragraph 15), suggesting that FMD mimics caloric restriction, creating a metabolic environment less favorable for tumor proliferation, such that “it is scientifically reasonable to expect similar synergistic effects in TNBC or clinical models” (paragraph 16).
34. Applicant's arguments have been fully considered but they are not persuasive. In response to Applicant's argument that combining the administration of both an mTOR kinase inhibitor and a PI3K inhibitor with a reduced caloric intake provides unexpectedly superior results, it is well settled that a showing of unexpected results is generally sufficient to overcome a prima facie case of obviousness. In re Albrecht, 514 F.2d 1389 (CCPA 1975). In the instant case, Applicant has appropriately compared the claimed invention (the combined effects of the administration of FMD + Rapa + Pictilisib) with that of a FMD alone, and with the administration of Rapa + Pictilisib alone, and provided factual evidence which establishes unexpected results of the claimed invention for the treatment of malignant melanoma. However, although the evidence establishes unexpected results, Applicant is reminded that “the objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support” (In re Clemens, 622 F.2d 1029 (CCPA 1980)). Thus, in In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003), factual evidence demonstrating a greater than expected result from the addition of 2% of an ingredient did not evidence unexpected results for the entire claimed range of about 1-3% of the ingredient. Rather, the nonobviousness of a broader range or genus can only be established by evidence based on unexpected results of a narrower range or genus when one of ordinary skill in the art would be able to determine a trend in the exemplified data allowing said artisan to reasonably extend the probative value thereof. In re Kollman, 595 F.2d 48 (CCPA 1979).
35. In the instant case, the claims are not drafted commensurate in scope with the results demonstrated in the Longo Declaration to overcome the prima facie case of obviousness, i.e., the unexpected synergistic effects of the combination of a FMD with the administration of both Pictilisib at a dose of 100 mg/kg and Rapamycin at a dose of 2 mg/kg to a patient in need thereof for the treatment of melanoma. That is, the amended claims presently embrace the treatment of any patient affected by any cancer comprising administering any therapeutically effective dose(s) of any PI3K inhibitor, and any CDK4/6 inhibitor, OR any therapeutically effective dose(s) of any mTOR inhibitor and any PI3 inhibitor.
36. According to MPEP 716.02(d), the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." The instant claims do not capture Applicant’s unexpected results of the administration of the combination of PI3K, AKT and mTOR inhibitors under fasting conditions. Furthermore, it is noted that Applicant demonstrates in the Specification that the most potent results were actually obtained when combining three drugs: Pictilisib, Ipatasertib, and Rapamycin, selective inhibitors of PI3K, AKT and mTOR, with FMD cycles induced cell death in SUM159 cells (i.e., triple negative breast cancer cell line), (see Figures 4b, 4c, 4e, 10c, 10d, 11a, 11b).
37. Thus, the examiner recommends inserting criticality from the synergistic effects as a result of the combination of a FMD with the administration of at least Pictilisib at a dose of 100 mg/kg and Rapamycin at a dose of 2 mg/kg.
Conclusion
38. In conclusion, claims 1 and 3-20 are present in the application. Claims 13, 17 and 18 are presently withdrawn from consideration. Claims 1, 3-12, 14-16, 19 and 20 are rejected. No claim is currently allowed.
39. 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.
40. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
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