DETAILED ACTION
This office action is in response to applicant’s filing dated February 6, 2026.
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 Claims
Claims 46, 51, 54, and 55 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed February 6, 2026. Acknowledgement is made of Applicant's cancelation of claims 1-45, 47-50, 52, and 53; and addition of new claim 55.
The Examiner notes that propane-1-sulfonic acid {3-[5- (4-chlorophenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl]-2,4-difluoro-phenyl}-amide is the chemical name of vemurafenib as evidenced by Bray et al (WO 2014/027056 A1, cited in the IDS filed June 28, 2024). Bray teaches vemurafenib has the chemical name propane-1-sulfonic acid {3-[5-(4-chlorophenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl]-2,4-difluoro-phenyl}-amide [00153]. Similarly, the Examiner notes that (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl][3-hydroxy-3-(piperidin-2-yl)azetidin-1-yl]methanone is the chemical name for cobimetinib as evidenced by Bray. Bray teaches GDC-0973 is also termed “cobimetinib” and has the chemical name [3,4-difluoro-2-[(2-fluoro-4-iodophenyl)amino]phenyl][3-hydroxy-3-[(2S)-2-piperidinyl]-1-azetidinyl]methanone [00155].
Priority
The present application is a continuation of U.S. Application No. 16/683,032, filed November 13, 2019, which is a continuation of U.S. Application No. 15/984,06, filed May 18, 2018, which is a continuation of PCT/US2016/062859 filed on November 18, 2016, which claims benefit of US Provisional Application No. 62/257,645 filed on November 19, 2015. The effective filing date of the instant application is November 19, 2015.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 6, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Objections and/or Rejections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
New Objections and/or Rejections
Necessitated by Claim Amendment
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 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.
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 46, 51, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Bray et al (WO 2014/027056 A1, cited in the IDS filed June 28, 2024) in view of Genentech, Inc. (https://clinicaltrials.gov/ct2/history/NCT01656642?V_1=View#StudyPageTop, August 1, 2012 (v1), obtained from the internet May 8, 2019, cited in the IDS filed June 28, 2024); Sharma et al (Drugs, 2012; 72(17): 2207-2222, cited in the IDS filed June 28, 2024); Maecker et al (WO 2013/019906 A1, cited in the IDS filed June 28, 2024); and Hamid et al. (ASCO Annual Meeting Abstract, J Clin Onc, 2013; 31(15 suppl):9010-9010, cited in the IDS filed June 28, 2024).
Regarding claim 46, Bray teaches a method of treating BRAF-V600 mutation-positive unresectable or metastatic melanoma comprising administering compositions comprising cobimetinib, the elected MEK inhibitor, and vemurafenib, the elected B-RAF inhibitor (abstract). Bray further teaches vemurafenib is also termed “Compound I” and has the chemical name propane-1-sulfonic acid {3-[5-( 4-chlorophenyl)-1H-pyrrolo[2,3-b ]pyridine-3-carbonyl]-2,4-difluoro-phenyl}-amide [00153]; and GDC-0973 is also termed “cobimetinib” or “Compound II” and has the chemical name [3,4-difluoro-2-[(2-fluoro-4-iodophenyl)amino]phenyl][3-hydroxy-3-[(2S)-2-piperidinyl]-1-azetidinyl]methanone [00155].
Bray does not teach a method of treating melanoma comprising first administering to the individual an effective amount of vemurafenib and cobimetinib, and second administering vemurafenib, cobimetinib, and atezolizumab.
However, Bray does teach the combination therapy of the invention can additionally comprise treatment with one or more therapeutic agent(s); in some embodiments, the one or more therapeutic agent is one or more cancer medicament(s); the combined administration includes concurrent administration, using separate formulations or a single pharmaceutical formulation, and sequential administration in either order, wherein preferably there is a time period while both ( or all) active agents simultaneously exert their biological activities [00157].
Moreover, Genentech, Inc. teaches an open-label, multicenter, Phase Ib, dose-escalation and cohort-expansion study of MPDL3280A in combination with Vemurafenib (Zelboraf®) in previously untreated patients with BRAFV600-mutation positive metastatic melanoma (page 5, Study Description, Brief Summary). MPDL3280A is equivalent to the elected immune checkpoint inhibitor, atezolizumab.
Sharma teaches vemurafenib is the first molecularly targeted therapy to be licensed in the US and Europe for treatment of advanced melanoma; vemurafenib is generally well tolerated, but its use can be associated with development of cutaneous neoplasms such as squamous cell carcinoma (SCC) and keratoacanthoma (KA); these lesions can be excised safely without the need for withholding the drug or reducing its dose; mechanisms of resistance to vemurafenib do not involve development of secondary mutations in the BRAF kinase domain, but may be related to BRAF V600E over-amplification, bypassing mechanisms via upregulation and overexpression of other components in the MAPK signaling cascade or activation of alternative pathways with potential to enhance cell growth, proliferation and survival; clinical trials to test the efficacy of vemurafenib in combination with immunomodulatory agents, such as ipilimumab, and MAPK kinase (MEK) inhibitors, such as GDC-0973, in the treatment of advanced melanoma are currently underway (abstract).
Maecker teaches a method for treating cancer in an individual comprising to the individual an effective amount of a PD-1 axis binding antagonist and a MEK inhibitor (claim 1), wherein the PD-1 axis binding antagonists is a PD-L1 binding antagonist (claims 2 and 13), wherein the PD-L1 binding antagonist is an antibody (claim 17), wherein the PD-L1 binding antagonist is MPDL3280A (claim 18), wherein the MEK inhibitor is GDC-0973, and wherein the individual has melanoma (claim 42). MPDL3280A is equivalent to the elected anti-PD-L1 antibody, atezolizumab. GDC-0973 is methanone, [3,4-difluoro-2-[(2-fluoro-4-iodophenyl)amino]phenyl][3-hydroxy-3-(2S)-2-piperidinyl-1-azetidinyl]- [0203], which is equivalent to the elected MEK inhibitor, cobimetinib.
As such, since Bray teaches method of treating BRAF-V600 mutation-positive unresectable or metastatic melanoma comprising administering compositions comprising cobimetinib and vemurafenib and that the combination can further comprise an additional chemotherapeutic agent; Genentech, Inc. teaches a method of treating melanoma comprising administering vemurafenib and MPDL3280A (atezolizumab); since Sharma teaches a method of treating melanoma comprising administering vemurafenib, resistance to vemurafenib develops but does not involve development of secondary mutations in the BRAF kinase domain, and that clinical trials to test vemurafenib in combination with immunomodulatory agents for the treatment melanoma are underway; and since Maecker teaches a method for treating melanoma comprising administering to the individual an effective amount of atezolizumab, cobimetinib, and vemurafenib; it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the prior art to arrive at a method of treating melanoma comprising first administering vemurafenib in combination with cobimetinib and second administering the combination of vemurafenib, cobimetinib and MPDL3280A (atezolizumab) with an expectation of success, since the prior art establishes that vemurafenib alone and in combination with MPDL3280A (atezolizumab) are useful in a method of treating advanced melanoma; that cobimetinib in combination with vemurafenib and cobimetinib in combination with MPDL3280A (atezolizumab) are useful in a method of treating melanoma.
Regarding the amounts and dosing cycle of vemurafenib, cobimetinib, and atezolizumab of instant claim 46, Bray teaches patients received vemurafenib at 720 mg or 960 mg BID (twice daily) each day of a 28-day cycle [00223] and these dose levels were deemed safe and tolerable [00222]. Moreover, Bray teaches administering vemurafenib and GDC-0973/cobimetinib in two 28-day cycles (Fig. 2).
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Moreover, Bray teaches GDC-0973 is an orally available, potent and highly selective inhibitor of MEK1 and MEK2 [00155]; GDC-0973 is supplied as 20 mg tablets for oral use [00250]; and GDC-0973 was administered at doses of 60 mg, 80 mg or 100 mg QD (once daily) 21 d on/7 d off (21/7) [00223].
Maecker teaches Group 6 received 10 mg/kg anti-PD-L1 antibody PRO314483, LOT#5944.96 intraperitoneally 3 times per week and the anti-PD-L1 antibody PRO314483, LOT#5944.96 was a reverse chimera, containing the human variable region of MPDL3280A [0217].
Hamid teaches clinical activity, safety, and biomarkers of MPDL3280A, an engineered PD-L1 antibody in patients with locally advanced or metastatic melanoma (mM) (title); patients with mM received MPDL3280A administered IV q3w for up to 1 year (Methods); and 45 mM pts were treated at ≤1 (n=4), 10 (n=10), 25 (n=20) and 20 mg/kg (n=11) and evaluable for safety. Thus, Hamid teaches administering MPDL3280A (atezolizumab) at doses of 1-25 mg/kg intravenously 3qw. Assuming an average weight of a human is 70 kg, a 1-25 mg/kg dose of atezolizumab is equivalent to about 70 mg-1750 mg dose of atezolizumab. The cited art does not teach administering atezolizumab q2w. It would have been prima facie obvious to one of ordinary skill in the art to start with the 28-day cycle treatments taught by Bray to determine tolerability of the patient before adding additional chemotherapeutic agents. Moreover, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the treatment regimens of MPDL3280A taught by Maecker and Hamid as a starting point for optimizing the dosing regimen of MPDL3280A to arrive at a method of treating melanoma comprising first administering vemurafenib and cobimetinib and second administering vemurafenib, cobimetinib, and atezolizumab.
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Regarding claim 51, Hamid teaches administering MPDL3280A (atezolizumab) intravenously.
Regarding claim 54, Bray teaches in some embodiments, BRAF mutation is BRAF V600E mutation or V600K ([00194-00195]).
Regarding claim 55, Bray teaches an "effective response" of a patient or a patient's "responsiveness" to treatment with a medicament and similar wording refers to the clinical or therapeutic benefit imparted to a patient at risk for, or suffering from, cancer (e.g., BRAFv60o mutation-positive unresectable or metastatic melanoma) upon administration of the cancer medicament; such benefit includes any one or more of extending survival (including overall survival and progression free survival) [00129].
Taken together, all this would result in the practice of the method of claims 46, 51, 54, and 55 with a reasonable expectation of success.
Response to Arguments
Applicant argues:
With respect to the run-in period required by each of the pending claims, Bray does not teach or suggest a vemurafenib split dosing regimen in general much less a vemurafenib split dosing regimen of 960 mg twice a day for 21 days of a 28 day dosing schedule followed by 720 mg twice a day for 7 days of the 28 day schedule as presently claimed. With respect to the one or more subsequent cycles required by each of the pending claims, Bray does not teach or suggest the combination of vemurafenib, cobimetinib, and atezolizumab. Bray fails to disclose treating a patient with vemurafenib + cobimetinib in a first treatment cycle followed by treating that patient with vemurafenib + cobimetinib + any third active in a second treatment cycle. Applicant notes that the Bray disclosure of an additional chemotherapeutic agent is open ended and no chemotherapeutic agent in particular nor any agents defined by mechanism of action are disclosed, therefore resulting in said disclosure encompassing any conceivable therapeutic agent without limitation.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
Applicants are reminded that it must be remembered that the references are relied upon in combination and are not meant to be considered separately as in a vacuum. It is the combination of all of the cited and relied upon references, which make up the state of the art with regard to the claimed invention. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference and it is not that the claimed invention must be expressly suggested in any one or all of the references; but rather the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
As set forth above, Bray teaches patients received vemurafenib at 720 mg or 960 mg BID (twice daily) each day of a 28-day cycle [00223] and these dose levels were deemed safe and tolerable. Moreover, Bray teaches administering vemurafenib and GDC-0973/cobimetinib in two 28-day cycles (Fig. 2).
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Bray teaches GDC-0973 is an orally available, potent and highly selective inhibitor of MEK1 and MEK2; GDC-0973 is supplied as 20 mg tablets for oral use; and GDC-0973 was administered at doses of 60 mg, 80 mg or 100 mg QD (once daily) 21 d on/7 d off (21/7). Moreover, as set forth above, Maecker teaches Group 6 received 10 mg/kg anti-PD-L1 antibody PRO314483, LOT#5944.96 intraperitoneally 3 times per week and the anti-PD-L1 antibody PRO314483, LOT#5944.96 was a reverse chimera, containing the human variable region of MPDL3280A. As set forth above, Hamid teaches administering MPDL3280A (atezolizumab) at doses of 1-25 mg/kg intravenously 3qw. Assuming an average weight of a human is 70 kg, a 1-25 mg/kg dose of atezolizumab is equivalent to about 70 mg-1750 mg dose of atezolizumab. As set forth above, it would have been prima facie obvious to one of ordinary skill in the art to start with the 28-day cycle treatments taught by Bray to determine tolerability of the patient before adding additional chemotherapeutic agents. Moreover, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the treatment regimens of MPDL3280A taught by Maecker and Hamid as a starting point for optimizing the dosing regimen of MPDL3280A to arrive at a method of treating melanoma comprising first administering vemurafenib and cobimetinib and second administering vemurafenib, cobimetinib, and atezolizumab.
With regard to the argument that Bray disclosure of an additional chemotherapeutic agent is open ended and no chemotherapeutic agent in particular nor any agents defined by mechanism of action are disclosed, therefore resulting in said disclosure encompassing any conceivable therapeutic agent without limitation, the Examiner acknowledges that Bray does not explicitly teach the additional chemotherapeutic agent is atezolizumab. However, as set forth above, Bray does teach a method of treating BRAF-V600 mutation-positive unresectable or metastatic melanoma comprising administering compositions comprising cobimetinib and vemurafenib and that the combination can further comprise an additional chemotherapeutic agent. As set forth above, Genentech, Inc. teaches a method of treating melanoma comprising administering vemurafenib and MPDL3280A (atezolizumab). As set forth above, Maecker teaches a method for treating melanoma comprising administering to the individual an effective amount of atezolizumab, cobimetinib, and vemurafenib. As set forth above, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the prior art to arrive at a method of treating melanoma comprising first administering vemurafenib in combination with cobimetinib and second administering the combination of vemurafenib, cobimetinib and MPDL3280A (atezolizumab) with an expectation of success, since the prior art establishes that vemurafenib alone and in combination with MPDL3280A (atezolizumab) are useful in a method of treating advanced melanoma; that cobimetinib in combination with vemurafenib and cobimetinib in combination with MPDL3280A (atezolizumab) are useful in a method of treating melanoma.
Applicant argues:
NCT01656642 does not disclose vemurafenib and cobimetinib doses, and such doses were first disclosed in an update to NCT01656642 dated 4 April 2016 which is after the present priority date of 19 November 2015. Clinical trial results were not posted. NCT01656642 further fails to disclose treating a patient with vemurafenib + cobimetinib in a first treatment cycle followed by treating that patient with vemurafenib + cobimetinib + atezolizumab in a second treatment cycle. NCT01656642 therefore fails to teach or suggest the presently claimed run in period and the presently claimed vemurafenib and cobimetinib dosing schedules required by the subsequent 28 day cycle, and further fails to establish a reasonable expectation of success.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
Applicants are reminded that it must be remembered that the references are relied upon in combination and are not meant to be considered separately as in a vacuum. Arguments regarding the teachings of vemurafenib + cobimetinib in a first treatment cycle followed by treating that patient with vemurafenib + cobimetinib + atezolizumab in a second treatment cycle have been addressed above and will not be reiterated here. The Examiner acknowledges that Genetech, Inc. does not explicitly teach the claimed amounts. However, the teachings of Genentech, Inc. were relied upon to establish that it was known in the art that atezolizumab in combination with vemurafenib was useful in a method of treating patients with BRAFV600-mutation positive metastatic melanoma.
Applicant argues:
Sharma fails to overcome the deficiencies of Bray and Genentech in combination. Sharma adds nothing to the teaching of Bray. Sharma discloses that vemurafenib monotherapy is efficacious for the treatment of melanomas carrying the BRAF V600E mutation. Maecker fails to overcome the deficiencies of Bray, Genentech and Sharma in combination. Hamid fails to overcome the deficiencies of Bray, Genentech, Sharma, and Maecker in combination.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
Applicant has not independently argued the merits of this rejection. Arguments regarding Bray and Genentech have been addressed above. Therefore, the rejection is maintained for the reasons set forth on the record and for those set forth in the response to the arguments above.
Applicant argues:
Applicant notes that, due to the inherent in vivo unpredictability of drugs and drug combinations, rigorous clinical trials are required to demonstrate safety and efficacy. Even in view of positive pre-clinical trial evaluation, about 90% of drugs fail clinical trials. Clearly as of the present priority date, it was common general knowledge that combination drug therapy is highly unpredictable. Further, the pharmacokinetic and pharmacodynamic relationship, as measured in terms of safety and/or efficacy in clinical trials, between the combination of vemurafenib + cobimetinib + atezolizumab was unknown as of the present priority date; therefore, the effect of a co-therapy directed to the presently claimed drug combination would have been unpredictable. A statement of an expected benefit of a clinical trial in the absence of any test results does not establish a reasonable expectation of success. A statement of an expected benefit of a clinical trial, such as taught by the cited references Genentech Phase lb Study (NCT01656642) and Sharma, does not establish a reasonable expectation of success.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
MPEP 2143.02.I. states:
Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that the expectation of success need only be reasonable, not absolute")). In the instant case, as set forth above, Bray teaches a method of treating BRAF-V600 mutation-positive unresectable or metastatic melanoma comprising administering compositions comprising cobimetinib and vemurafenib and that the combination can further comprise an additional chemotherapeutic agent. As set forth above, Genentech, Inc. teaches a method of treating melanoma comprising administering vemurafenib and MPDL3280A (atezolizumab). As set forth above, Maecker teaches a method for treating melanoma comprising administering to the individual an effective amount of atezolizumab, cobimetinib, and vemurafenib. As set forth above, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the prior art to arrive at a method of treating melanoma comprising first administering vemurafenib in combination with cobimetinib and second administering the combination of vemurafenib, cobimetinib and MPDL3280A (atezolizumab) with an expectation of success, since the prior art establishes that vemurafenib alone and in combination with MPDL3280A (atezolizumab) are useful in a method of treating advanced melanoma; that cobimetinib in combination with vemurafenib and cobimetinib in combination with MPDL3280A (atezolizumab) are useful in a method of treating melanoma.
Applicant argues:
In Sanofi v. Watson Laboratories, 875 F.3d 636, 647-49, 124 U.S.P.Q. 2d 1601 (Fed. Cir. 2017), the court held that a prior art reference stating an "expected" benefit of a clinical trial does not establish a reasonable expectation of success. In Coalition for Affordable Drugs VLLC v. Biogen, Case IPR2015-01136, Patent 8,399,514 B2, the Patent Trial and Appeals Board denied a petition to institute inter partes review over evidence that was an internet posting of a clinical trial on the ClinicalTrials.gov site . The PTAB's holding is therefore consistent with Sanofi. In In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063 (Fed. Cir. 2012), a district court holding that U.S. Patent Nos. 7,387,793 and 7,544,372 were invalid as obvious was reversed by the federal circuit. "The district court misapprehended the importance of the lack of a known PK/PD relationship...Because all experts and parties agree, however, that skilled artisans did not know the PK/PD relationship even for the immediate-release formulation, there was no way to match the dosage for the extended-release formulation to achieve a known therapeutic effect....While it may have been obvious to experiment with the use of the same PK profile when contemplating an extended-release formulation, there is nothing to indicate that a skilled artisan would have had a reasonable expectation that such an experiment would succeed in being therapeutically effective. Id., at 1070.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
It is possible that the cited cases are correct as to their statements of the law. However,
because they are not precedential, they have no binding effect on examination. Thus, they do not lend strong support to the position being advanced in the attorney’s response.
Conclusion
Claims 46, 51, 54, and 55 are rejected.
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
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