DETAILED ACTION
All rejections and objections not mentioned below are withdrawn.
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
Acknowledgment is made of applicant’s claim for priority. The certified copy has been filed in parent Application No. 62/854,823, filed on 05/30/2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/25/2025 and 03/01/2022 are being considered by the examiner.
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.
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) 15, 17-18, and 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over HERGENROTHER (HERGENROTHER et al., WO2016197129A1, 2016-12-08, previously provided) in view of Chowdhury (Chowdhury et al., Journal of Internal Medicine, 2018, 283; 110–120, previously provided) further in view of Wang (Wang et al., The role of CTLA-4 and PD-1 in anti-tumor immune response and their potential efficacy against osteosarcoma. / International Immunopharmacology 38 (2016) 81–89).
PNG
media_image1.png
273
727
media_image1.png
Greyscale
The reference HERGENROTHER teaches (reference claim 21 and 24-27):
PNG
media_image2.png
364
730
media_image2.png
Greyscale
This helps to teach claim 15 and 24.
The reference HERGENROTHER teaches (reference claim 31):
PNG
media_image3.png
111
691
media_image3.png
Greyscale
This helps to teach claim 23.
The reference HERGENROTHER teaches (page 12):
PNG
media_image4.png
237
752
media_image4.png
Greyscale
This helps to teach all claims.
The reference HERGENROTHER teaches (page 2):
PNG
media_image5.png
295
733
media_image5.png
Greyscale
This helps to teach all claims.
The reference HERGENROTHER teaches (pages 21-22, and page 28):
PNG
media_image6.png
166
719
media_image6.png
Greyscale
PNG
media_image7.png
366
695
media_image7.png
Greyscale
PNG
media_image8.png
388
720
media_image8.png
Greyscale
The reference HERGENROTHER teaches “Accordingly, PAC-1 can be used in combination with the second active agent for cancer treatment. PAC-1 may precede or follow the second active agent administration by intervals ranging from minutes to weeks. In embodiments where the second active agent and PAC-1 are applied separately to the cell, one would generally ensure that a significant period of time did not elapse between each delivery, such that the agent and PAC-1 would still be able to exert an advantageously combined effect on the cell. For example, in such instances, it is contemplated that one may contact the cell, tissue or organism with the two modalities substantially simultaneously (i.e., within less than about a few minutes). In other aspects, the second active agent of the combination may be administered within about 1 minute, about 5 minutes, about 10 minutes, about 20 minutes about 30 minutes, about 45 minutes, about 60 minutes, about 2 hours, about 3 hours, about 4 hours, about 6 hours, about 8 hours, about 9 hours, about 12 hours, about 15 hours, about 18 hours, about 21 hours, about 24 hours, about 28 hours, about 31 hours, about 35 hours, about 38 hours, about 42 hours, about 45 hours, or at about 48 hours or more, prior to and/or after administering PAC-1. In certain other embodiments, the second active agent may be administered within about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 8 days, about 9 days, about 12 days, about 15 days, about 16 days, about 18 days, about 20 days, or about 21 days, prior to and/or after administering PAC-1. In some situations, it may be desirable to extend the time period for treatment significantly, however, where several weeks (e.g., about 1 , about 2, about 3, about 4, about 6, or about 8 weeks or more) lapse between the respective administrations”(page 24-25) and “Long term treatment with PAC-1 prevents cell regrowth, and addition of PAC-1 to vemurafenib delays the onset of cell regrowth. The Emax of vemurafenib (the percent cell death induced by high concentrations of compound) in A375 cells is 96.8±0.3% after 5 days (Fig. 5A), indicating that -3% of A375 cells are insensitive to vemurafenib. Under the same conditions, PAC-1 has an Emax of 99.4±0.7% (Fig. 5A), indicating that PAC-1 kills A375 cells quantitatively, with very few insensitive cells. We therefore hypothesized that long term treatment with vemurafenib would lead to re-growth of cancer cells, while treatment with PAC-1 should prevent re-growth. To investigate this hypothesis, A375 and SK-MEL-5 cells were plated at low densities and treated continuously with PAC-1 (4 μΜ) or vemurafenib (10 μΜ) for up to 30 days. In A375 and SK-MEL-5 cells treated with vemurafenib, regrowth of cells was observed in as early as 20 days (Fig. 5B). However, in wells treated with PAC-1, no regrowth was observed even after 30 days (Fig. 5B). Thus, consistent with the higher Emax value, PAC-1 is able to quantitatively kill cells thereby preventing regrowth”(page 35).
This helps to teach claims 17-18 and 25-26.
The reference HERGENROTHER teaches “In another embodiment, cancer cells can be osteosarcoma cells and the cancer treated is bone cancer”(page 5). This helps to teach claims 15, 17-18, and 24-26 .
The reference HERGENROTHER does not teach “wherein the second active agent is an immunotherapeutic, wherein the effect of the immunotherapeutic is enhanced by the administration of the procaspase-3 activator PAC-1” (all claims) and the second active agents of all claims, or the specific treatment of claim 26.
The reference Chowdhury teaches “The discovery of PD-1 molecule and understanding of PD-1 function as an immune regulator have created a new concept of killing tumour cells by unleashing the immune system. Extensive studies in cancer immunotherapy, in particular immune checkpoint blockade such as PD-1 signalling inhibitors, over the past decade have shaped the direction of cancer treatment. We have summa-rized the growing body of evidence for the use ofPD-1 blockade in the basic and clinical studies, suggesting its impact on drug discovery of cancer treatment. Although many researchers have worked on the most important issue that a subset of patients is still unresponsive to this therapy, it is not yet solved. Therefore, further research to decode this unresponsiveness is necessary. Scientists and clinicians have come up with the concept of combining various existing cancer treatments with PD-1 blockade to fulfil the medical demand. We have documented current advances of PD-1blockade-based combination therapies and also discussed the concept of modulating T-cell meta-bolism to boost PD-1 blockade efficacy. The mod-ern immune cancer research is expanding with the discovery of new fields and technologies. A deeper understanding of the PD-1 blockade unresponsive mechanism from various multidisciplinary aspects will still be necessary to identify new therapeutic targets to combine with PD-1 blockade”(Summery) and “The rationale of combining immune checkpoint inhibitors with PD-1 blockade is based on the assumption that unresponsive tumours utilize immunosuppressive pathways other than the PD-1–PD-L1 interaction. The first combination therapy with the blockade of CTLA-4 improved the efficacy[70] and was approved in 2016 for melanoma treatment, even though the rate of the adverse effects was higher than in the individual therapies(NCT01024231) [71] (Table 2). Clinical trials of combination therapy of PD-1 blockade with the inhibition of other negative co-receptors such asLag3 (NCT02658981) and Tim3 (NCT02608268)are ongoing”(page 114). Table 1, shown below, teaches pembrolizumab as a PD-1 inhibitor. This helps to teach claims 15, 17-21, and 23-25.
PNG
media_image9.png
328
991
media_image9.png
Greyscale
The reference Wang teaches “The role of CTLA-4 and PD-1 in anti-tumor immune response and their potential efficacy against osteosarcoma” (title) and “Osteosarcoma (OS) is the most common primary bone malignancy mainly affecting childhood and adolescence, which has a tendency for regional invasion and early pulmonary metastasis”(page 82). The reference also teaches “Recently, it has been shown that PD-L1 is expressed on the OS patient samples and correlated with the tumor-infiltrating T-lymphocytes (TILs)”(age 82) and “Study showed that PD-1 expression was significantly up-regulated in OS patients, especially those with metastasis and pathological fracture [105]. And some researchers also found that human metastatic OS highly expressed PD-L1 and the tumor infiltrating-CTLs highly expressed PD-1 [131]. In this study, blockade of PD-1/PD-L1 dramatically enhanced the activity of OS reactive CTLs in vitro and in vivo and inhibit the tumor growth as well as increase the survival rate in the mouse model of metastatic OS [131]. However, further study indicated that anti-PD-L1 treatment against metastatic OS cells down-regulated PDL1 expression and produced resistance to further blockade treatment [132]. Tumor immune resistance appeared to be associated with upregulation of additional negative receptors, notably CTLA-4, which Table 2 Clinical trials of CTLA-4 and PD-1/PD-L1 blocking antibodies in human malignancies… Based on these results, combination therapy of anti-CTLA-4 and anti-PD-1 were tested in the treatment of metastatic OS in the mouse model and resulted in completely control of tumors [132]. The effect of this combination therapy seemed to be synergistic while there was no impact on tumor controlled by CTLA-4 blockade alone. Thus the combinational blockade of CTLA-4 and PD-1 appears to be an attractive immunotherapy to treat the patients with resistant or metastatic OS. In addition to combination of the antibodies of these “immune checkpoints”, combinational therapy of PD-1 or CTLA-4 blockade with other agents may also show some synergistic effects”(pages 86-87). The reference also teaches “CTLA-4 and PD-1 represent the two major inhibitory immune receptors, the level of which show great correlation of malignant disease progression, and mAbs blocking the PD-1 and CTLA-4 pathway have present strong anti-tumor immune responses. Ipilimumab and pembrolizumab, the antibody targeting CTLA-4 and PD-1 respectively, have been granted FDA approval and have been tested in many preclinical and clinical trials on some tumors, such as melanoma, NSCLC, breast cancer, renal cell carcinoma and so on. Further studies have revealed that CTLA-4 and PD-1 function in distinct mechanisms, indicating the potential therapeutic effect of combination therapy. PD-1 and CTLA-4 are found to be highly expressed in OS patients, and are demonstrated to be correlated with the prognosis. Researches revealed that mAbs blocking PD-1/PD-L1 or CTLA-4 increased the efficacy of immune response against OS but not satisfactory enough. Combination therapy showed further improvement of anti-tumor immune activity and better control of tumor progression [132]. Currently, multiple agents blocking inhibitory receptors are under development, and combination therapy of PD-1/PD-L1 and CTLA-4, or other types of therapies are present as a novel potential therapeutic route for OS in the future”(page 87). This helps to teach 15, 17-18, and 24-26.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified HERGENROTHER with Chowdhury and Wang because HERGENROTHER teaches that “Because PAC-1 acts late in the apoptotic cascade, it is uniquely capable of synergizing with a wide range of chemotherapeutic active agents, as described herein” (page 12) as well as PAC-1 for OS treatment, and Wang teaches combination therapy with PD-1 inhibitors for treatment of OS that are unresponsive to single compound therapy and Chowdhury teaches “Although many researchers have worked on the most important issue that a subset of patients is still unresponsive to this therapy, it is not yet solved. Therefore, further research to decode this unresponsiveness is necessary. Scientists and clinicians have come up with the concept of combining various existing cancer treatments with PD-1 blockade to fulfil the medical demand”(summery) thus all references teach combination therapy using at least one of the cited compounds for the same purpose and motivation of improved cancer treatment. "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). Additionally, "[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.) One would have a reasonable expectation of success because both are taught separately to treat cancer and are suggested for combination therapy for cancer treatment.
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.
Claims 15, 17-18, and 24-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11510919 B2, over claims 1-13 of U.S. Patent No. 12168006 B2, over claims 1-21 of U.S. Patent No. 12090153 B2, over claims 1-4 of U.S. Patent No. 10350207 B2, over claims 1-18 of U.S. Patent No. 11129830 B2, over claims 1-18 of U.S. Patent No. 10085977 B2, over claims 1-10 of U.S. Patent No. 10888560 B2, over claims 1-10 of U.S. Patent No. 10085978 B2, over claims 1-12 of U.S. Patent No. 10874666 B2, over claims 1-6 of U.S. Patent No. 11844798 B2, over claims 1-20 of U.S. Patent No. 9421202 B2, over claims 1-23 of U.S. Patent No. 10166229 B2, over claims 1 of U.S. Patent No. 8592584 B2, over claims 1-20 of U.S. Patent No. 9522901 B2, over claims 1-6 of U.S. Patent No. 11833147 B2, and over claims 1-6 of U.S. Patent No. 9399035 B2 in view of HERGENROTHER (HERGENROTHER et al., WO2016197129A1, 2016-12-08) in view of Chowdhury (Chowdhury et al., Journal of Internal Medicine, 2018, 283; 110–120) further in view of Wang (Wang et al., The role of CTLA-4 and PD-1 in anti-tumor immune response and their potential efficacy against osteosarcoma. / International Immunopharmacology 38 (2016) 81–89)..
The patents ‘919, ‘006, ’153, ‘207, ‘830, ‘977 , ‘560, ‘978, ‘666, ‘798, ‘202, ‘229, ‘584, ‘901, ‘147, and ‘035 all claim the same PAC-1 as the instant application for the method or composition for treating cancer in combination with one other active agent. ‘207 teaches “The invention provides compositions and methods for the induction of cancer cell death. The compositions and methods of using them include use of compositions in therapy for the treatment of cancer and for the selective induction of apoptosis in cancer cells. The drug combinations described herein can be synergistic and can have lower neurotoxicity effects than the same amounts of other compounds and combinations of compounds, and can be effective when a particular cancer has become resistant to previously administered therapies”(abstract). A compound claim can be used to reject a method claim if the utility is disclosed in the specification. See Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F. 3d 1381, 1385 (CAFC 2010). See also MPEP § 804(II)(B)(2)(a).
The patents ‘919, ‘006, ’153, ‘207, ‘830, ‘977, ‘560, ‘978, ‘666, ‘798, ‘202, ‘229, ‘584, ‘901, ‘147, and ‘035 do not teach wherein the second active agent is a specific immunotherapeutic (all claims), the specific doses of claims (17-18), the specific cancer (all claims), or the method of dosing (claim 24, 25, 26).
The secondary references further teaches that all needed changes would be obvious as outlined in the 103 rejection (which is incorporated herein by reference).
It would have been prima facie obvious to one of ordinary skill in the art to have modified patents ‘919, ‘006, ’153, ‘207, ‘830, ‘977, ‘560, ‘978, ‘666, ‘798, ‘202, ‘229, ‘584, ‘901, ‘147, and ‘035 with HERGENROTHER with Chowdhury and Wang because HERGENROTHER teaches that “Because PAC-1 acts late in the apoptotic cascade, it is uniquely capable of synergizing with a wide range of chemotherapeutic active agents, as described herein” (page 12) as well as PAC-1 for OS treatment, and Wang teaches combination therapy with PD-1 inhibitors for treatment of OS that are unresponsive to single compound therapy and Chowdhury teaches “Although many researchers have worked on the most important issue that a subset of patients is still unresponsive to this therapy, it is not yet solved. Therefore, further research to decode this unresponsiveness is necessary. Scientists and clinicians have come up with the concept of combining various existing cancer treatments with PD-1 blockade to fulfil the medical demand”(summery) thus all references teach combination therapy using at least one of the cited compounds for the same purpose and motivation of improved cancer treatment. "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). Additionally, "[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.) One would have a reasonable expectation of success because both are taught separately to treat cancer and are suggested for combination therapy for cancer treatment.
Response to Arguments
Applicant's arguments filed 09/26/2025 have been fully considered but they are not persuasive.
The applicant argues the following:
Initially, Applicant notes that claims 15 and 26 are presently amended to recite a method of treating osteosarcoma using the combination of PAC-1 and an anti-PD-1 antibody selected from the group consisting of RMP1-14 and pembrolizumab. The combination of cited art fails to teach or suggest these features of Applicant's claimed subject matter. The combination of Hergenrother in view of Chowdhury in no way teaches or suggests the use of PAC-1 in combination with the anti-PD-1antibodies RMP1-14 or pembrolizumab to treat osteosarcoma.
This argument was not found persuasive as the modified rejection due to the amendments recites each of these new limitations. For example the reference HERGENROTHER teaches PAC-1 and “In another embodiment, cancer cells can be osteosarcoma cells and the cancer treated is bone cancer”(page 5). This helps to teach claims 15, 17-18, and 24-26 . It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified HERGENROTHER with Chowdhury because HERGENROTHER teaches that “Because PAC-1 acts late in the apoptotic cascade, it is uniquely capable of synergizing with a wide range of chemotherapeutic active agents, as described herein” (page 12) and Chowdhury teaches “Although many researchers have worked on the most important issue that a subset of patients is still unresponsive to this therapy, it is not yet solved. Therefore, further research to decode this unresponsiveness is necessary. Scientists and clinicians have come up with the concept of combining various existing cancer treatments with PD-1 blockade to fulfil the medical demand”(summery) thus both reference teach combination therapy of the cited compounds for the same purpose and motivation of improved cancer treatment. The reference also teaches pembrolizumab as a PD-1 inhibitor. Wang teaches combination therapy with PD-1 inhibitors for treatment of OS that are unresponsive to single compound therapy. Thus the combination of these three references do suggest the use of PAC-1 in combination with the anti-PD-1 antibodies pembrolizumab to treat osteosarcoma because HERGENROTHER teaches PAC-1 for OS and Chowdhury and Wang teach pembrolizumab as a PD-1 for combination therapy and Wang suggest it for OS.
And even if the combination of Hergenrother in view of Chowdhury taught the use of PAC1 in combination with the anti-PD-1 antibodies RMP1-14 or pembrolizumab to treat osteosarcoma, which it clearly does not, there is nothing in the cited art that teaches or suggests the unexpected synergistic effects of using PAC-1 in combination with the anti-PD-1 antibodies RMP1-14 or pembrolizumab to treat osteosarcoma.
This argument was not found persuasive because there is a reasonable expectation of success of synergistic effects because both Wang “In addition to combination of the antibodies of these “immune checkpoints”, combinational therapy of PD-1 or CTLA-4 blockade with other agents may also show some synergistic effects”(pages 86-87) and HERGENROTHER “Because PAC-1 acts late in the apoptotic cascade, it is uniquely capable of synergizing with a wide range of chemotherapeutic active agents, as described herein” (page 12) suggest synergistic effects with other combinations. "Obviousness does not require absolute predictability of success.” Id. at 903, 7 USPQ2d at 1681".
Additionally, this argument was not found persuasive because the synergistic effects were found over a specific range of concentrations (not found in claim 15 and 26) and specific compounds (not found in claim 26, claim 26 is independent and thus PAC-1 may have any structure, not necessarily the structure of claim 15). Thus the unexpected results are not commensurate in scope with the claims. Conclusory statements that results were "unexpected," unsupported by objective factual evidence, were considered but were not found to be of substantial evidentiary value. Although an affidavit or declaration which states only conclusions may have some probative value, such an affidavit or declaration may have little weight when considered in light of all the evidence of record in the application. In re Brandstadter, 484 F.2d 1395, 179 USPQ 286 (CCPA 1973). The objective evidence of nonobviousness is not sufficient to outweigh the evidence of obviousness. Newell Cos. v. Kenney Mfg. Co., 864 F.2d 757, 769, 9 USPQ2d 1417, 1427 (Fed. Cir. 1988). In the instant case, Applicants have not provided any evidence the unexpected results would be achieved in the same manner at any concentrations/amounts administered. The argument that it would also work in other amounts is a conclusory statement not supported by objective factual evidence.
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100C). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F .2d 731,741,218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.). To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
MPEP 716.02(d) states “The nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range if one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof. In re Kollman, 595 F.2d 48, 201 USPQ 193 (CCPA 1979) (Claims directed to mixtures of an herbicide known as "FENAC" with a diphenyl ether herbicide in certain relative proportions were rejected as prima facie obvious. Applicant presented evidence alleging unexpected results testing three species of diphenyl ether herbicides over limited relative proportion ranges. The court held that the limited number of species exemplified did not provide an adequate basis for concluding that similar results would be obtained for the other diphenyl ether herbicides within the scope of the generic claims. Claims 6-8 recited a FENAC:diphenyl ether ratio of 1:1 to 4:1 for the three specific ethers tested. For two of the claimed ethers, unexpected results were demonstrated over a ratio of 16:1 to 2:1, and the effectiveness increased as the ratio approached the untested region of the claimed range. The court held these tests were commensurate in scope with the claims and supported the nonobviousness thereof. However, for a third ether, data was only provided over the range of 1:1 to 2:1 where the effectiveness decreased to the "expected level" as it approached the untested region. This evidence was not sufficient to overcome the obviousness rejection.); In re Lindner, 457 F.2d 506, 509, 173 USPQ 356, 359 (CCPA 1972) (Evidence of nonobviousness consisted of comparing a single composition within the broad scope of the claims with the prior art. The court did not find the evidence sufficient to rebut the prima facie case of obviousness because there was "no adequate basis for reasonably concluding that the great number and variety of compositions included in the claims would behave in the same manner as the tested composition.").”
Conclusion
Claims 15, 17-18, and 24-26 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR SALAMATIAN whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.A.S./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
Prosecution Insights