DETAILED ACTION
This is an initial Office action for non-provisional application 18/966838 filed December 3, 2024 which is a continuation of PCT/US2023/068119 filed June 8, 2023, which claims priority to provisional application 63/350332 filed June 8, 2022.
Claim Status: Claims 1, 3, 6-17, 23-26, 32 and 35 are pending. Claims 2, 4-5, 18-22, 27-31, 33-34 and 36-37 are cancelled.
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 . 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.
Claim Objections
Claim 1 is objected to because of the following informalities:
The last line of claim 1 should recite “….”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) – Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 6-17, 23-26, 32 and 35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...”) Regents of the University of California v. Eli Lilly & Co., 438 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include level of skill
and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In this case, the claims of the instant application embrace Compound A of the following structure:
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or a pharmaceutically acceptable salt, tautomer, stereoisomer, enantiomer isotopologue, solvate or prodrug thereof. Particularly, the term “prodrug” recited in claims 1, 17 and 23-25 invoke the 35 U.S.C. 112(a) rejection. Even a cursory calculation of the number of compounds embraced in the instant claims would result in thousands of compounds.
The level of skill and knowledge in the art is high. Compounds of the above structure have been disclosed and are known in the prior art. However, as to the claimed prodrugs, no specific examples are given that would demonstrate possession or put the public in possession of all the claimed prodrugs of the structure. It is generally accepted in the art that prodrugs may vary by chemical formulae and may also differ in properties and the arrangement of atoms in the molecule.
Compound A recited in instant claim 1 is administered to treat cancer in subjects. Although the art recognizes generally accepted definitions, the terms are not explicitly defined by the specification in such a way as to demonstrate that the inventor had possession of the prodrugs of Compound A recited in claim 1.
A review of the prior art identifies the reference Najjar (Najjar, A. & Karaman, R. Expert Opinion on Drug Discovery, 2018, 14(3), 199-220), which discloses successes and failures of prodrugs of known pharmaceuticals, one example of which is an ester (abstract and page 212, section 3). Najjar teaches hetacillin, an ester prodrug of ampicillin, which was withdrawn since it did not have a superior advantage when compared to ampicillin. In light of Najjar, it is unknown which of the prodrugs of Compound A recited in claim 1 by Applicant will be active or inactive. Further, one of ordinary skill in the art would not be able to predict which compounds, of the vast number that are claimed, will be active or inactive absent evidence. There is no structure/function correlation in the specification showing which prodrugs would or would not be active.
Since Applicant has not set forth compounds or substituents on the compound recited in claim 1 in the specification which Applicant considers prodrugs. Applicant has not described prodrugs that have the ability to treat cancer and which do not. Stated differently, there is no structure/function correlation and no representative number of specific examples of prodrugs that demonstrate which compounds retain activity. Further, one of ordinary skill in the art would not be able to predict the biological activity of the prodrugs of the compound recited in claim 1.
Medicinal chemistry is an experimental science with a low predictability level. Small changes in the structure of a compound can lead to large differences in their pharmacological activity. Predicting if a certain claimed compound retains the activity and function of the original drug is filled with experimental uncertainty because prodrugs contain variation by chemical and physical properties of the molecules.
Although the specification provides a method for making Compound A recited in claim 1, no method for making all of the compounds, including the prodrugs, encompassed by the instant claims has been disclosed. Methods of synthesizing compounds are, in general, known to a person of ordinary skill; however, methods of making the myriad of compounds encompassed by the instant claims is beyond the skill of the artisan, particularly when certain elements, such as prodrugs are merely described partially.
As such, the instant specification and instant claims do not provide sufficient description such that one could anticipate what additional elements may be present in the prodrugs of Compound A recited in claim 1 because the examples illustrated in the experimental section are limited to only Compound A.
Substantial and undue experimentation would be needed to practice Applicant’s invention because the specification lacks sufficient detail to show how to use the prodrugs of the instant invention. Further, there is no guarantee that all of the prodrugs embraced by the scope of the claims would be for use in treatment of cancer.
Even with the undue burden of experimentation, there is no guarantee that one would obtain the product of a desired prodrugs of Compound A recited in claim 1. Although some functional characteristics are disclosed or would be known to a person of ordinary skill in the art, in the absence of a disclosed structure, there can be no correlation between the function and structure of the claimed prodrugs in the instant application.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claim(s) are broad and generic with respect to all possible compounds encompassed by the claims. In the instant case, however, the specification does not disclose a sufficient variety of species to reflect this variance in the genus. Specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims such as prodrugs of Compound A recited in claim 1.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Dependent claims do not resolve the 112(a) written description rejections raised in independent claim 1, since those claims do not further limit or provide further structure of the prodrugs of Compound A recited in claim 1. Accordingly, these claims are also rejected. This rejection would be overcome by amending the claims to remove the limitation “prodrugs thereof”.
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.
Claims 1, 3, 6-8, 11, 16-17, 23-26, 32 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (US 2022/0105033; cited in the PTO-892 attached herein).
Regarding claim 1, Zhang et al teach physically stable solid dispersions comprising the BRAF kinase dimer inhibitor according to the following structure recited in claim 1:
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(abstract; paragraph 0023, whole document). Zhang et al further teach this BRAF kinase dimer inhibitor is administered to treat subjects with cancer selected from lung cancer, ovarian cancer, and melanoma (paragraphs 0159-0160). More specifically, the cancer is a BRAF (V600E) or NRAS or KRAS mutant cancer selected from lung cancer, ovarian cancer and melanoma (paragraph 00161). The administered dosage of the BRAF kinase dimer inhibitor is 2.5-100 mg/day and the administration frequency is 1-3 times a day (paragraph 0163).
Thus, Zhang et al teach treating cancer in a subject in need thereof by administering the compound recited in instant claim 1, wherein the cancer is lung cancer, melanoma and ovarian cancer. However, Zhang et al do not explicitly teach the dosages per day recited in instant claim 1.
Instead, Zhang et al teach a dosage range (2.5-100 mg/day) at a frequency of 1-3 times a day that overlaps with the dosages recited in claim 1. According to MPEP 2144.05, “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). It also would have been obvious to an artisan of ordinary skill to manipulate and optimize the dosage of the BRAF kinase dimer inhibitor. Optimization of parameters is a routine practice that would be obvious to a person of ordinary skill in the art to employ and reasonably expect success. One would have been motivated with a reasonable expectation of success to determine the optimal dosage depending on the patient’s weight, symptoms, and desired outcomes of treatment. Dosage is a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
Regarding claims 3, 6-8, 11, and 16, Zhang et al teach its BRAF kinase dimer inhibitor is administered to treat subjects with cancer including BRAF (V600E) or NRAS or KRAS mutant cancer selected from lung cancer, ovarian cancer and melanoma (paragraph 00161).
Regarding claim 17, Zhang et al teach its BRAF kinase dimer inhibitor is administered 1-3 times a day (paragraph 0163).
Regarding claims 23-25, Zhang et al teach a dosage (2.5-100 mg/day) at a frequency of 1-3 times a day that overlaps with the dosages recited in claims 23-25. According to MPEP 2144.05, “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). It also would have been obvious to an artisan of ordinary skill to manipulate and optimize the dosage of the BRAF kinase dimer inhibitor. Optimization of parameters is a routine practice that would be obvious to a person of ordinary skill in the art to employ and reasonably expect success. One would have been motivated with a reasonable expectation of success to determine the optimal dosage depending on the patient’s weight, symptoms, and desired outcomes of treatment. Dosage is a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
Regarding claim 26, it is acknowledged that Zhang et al do not teach the AUC8H values recited in claim 26. However, since Zhang et al teach the administration of the same BRAF kinase dimer inhibitor at the suggested dosages recited in the instant claims for the treatment of cancer, the AUC8H values would naturally result from the teachings of Zhang et al. See MPEP 2112.02. Claim scope is not limited by claim language that does not require further steps to be performed, or by claim language that does not limit a claim to a particular structure. Such language is not considered limiting when it simply expresses the intended result of a process step positively recited. See, e.g., Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329 (Fed. Cir. 2005), quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003).
Regarding claim 32, since Zhang et al teach the administration of the same BRAF kinase dimer inhibitor at the suggested dosages recited in the instant claims for the treatment of cancer, the subject’s response including stable disease, a partial response or a complete response would naturally result from the teachings of Zhang et al. See MPEP 2112.02. Claim scope is not limited by claim language that does not require further steps to be performed, or by claim language that does not limit a claim to a particular structure. Such language is not considered limiting when it simply expresses the intended result of a process step positively recited. See, e.g., Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329 (Fed. Cir. 2005), quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003).
Regarding claim 35, since Zhang et al teach the administration of the same BRAF kinase dimer inhibitor at the suggested dosages recited in the instant claims for the treatment of cancer, the subject experiencing a progressive disease would naturally result from the teachings of Zhang et al. See MPEP 2112.02. Claim scope is not limited by claim language that does not require further steps to be performed, or by claim language that does not limit a claim to a particular structure. Such language is not considered limiting when it simply expresses the intended result of a process step positively recited. See, e.g., Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329 (Fed. Cir. 2005), quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (US 2022/0105033; cited in the PTO-892 attached herein) as applied to claims 1, 3, 6-8, 11, 16-17, 23-26, 32 and 35 above and in further view of Bleam et al (US 2013/0231347; cited in the PTO-892 attached herein).
Regarding claim 9, the disclosure of Zhang et al is discussed above and incorporated herein.
Zhang et al do not explicitly teach its BRAF kinase dimer inhibitor treats cancer characterized by a mutation selected from NRAS Q61R, NRAS Q61K, NRAS Q61L, KRAS G12D, KRAS G12V and combinations thereof.
Bleam et al disclose methods of cancer treatment comprising a BRAF inhibitor (abstract) wherein the cancer was characterized by a mutation NRAS Q61R (paragraph 0007).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to administer Zhang’s BRAF kinase dimer inhibitor to treat cancer characterized by NRAS Q61R mutation as discussed in Bleam et al. An ordinary skilled artisan would have been motivated to do so with a reasonable expectation of success to develop improved methods of treatment and because Bleam et al teach similar BRAF inhibitors are effective at treating cancer with NRAS Q61R mutation.
Claims 10 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (US 2022/0105033; cited in the PTO-892 attached herein) as applied to claims 1, 3, 6-8, 11, 16-17, 23-26, 32 and 35 above and in further view of Leonardi et al (International Journal of Oncology 52: 1071-1080, 2018).
Regarding claims 10 and 12-13, the disclosure of Zhang et al is discussed above and incorporated herein.
Zhang et al do not explicitly teach administering its BRAF kinase dimer inhibitor to treat cancer characterized by a MAPK pathway genomic aberration, cutaneous melanoma or metastatic melanoma.
Leonardi et al teach cutaneous melanoma is one of the most aggressive forms of skin cancer and one of the leading causes of cancer-related mortality due to its metastatic power (pg. 1072, 3. Melanoma biology). According to Leonardi et al, up to 90% of melanomas exhibit an aberrant MAPK pathway activation, which is a central step in melanoma development, being responsible for cell cycle deregulation and apoptosis inhibition (pg. 1073, 3. Melanoma biology). Leonardi et al further teach BRAF inhibitors are common methods of treatment used for treating melanoma with different mutations and MAPK pathway genomic aberration (pg. 1075, 4. Principles of medical treatment).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date of the claimed invention to administer Zhang’s BRAF kinase dimer inhibitor to treat cutaneous melanoma, metastatic melanoma or cancer characterized by a MAPK pathway genomic aberration. A skilled artisan would have been motivated to do so since Zhang’s BRAF kinase dimer inhibitor are administered to treat melanoma and genomic aberrations in MAPK pathways are common pathways for melanoma to develop, and cutaneous and metastatic melanoma are aggressive forms of skin cancer that often lead to mortality according to Leonardi et al. It would have been obvious for a skilled artisan to develop improved methods of treatment for similar conditions.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (US 2022/0105033; cited in the PTO-892 attached herein) as applied to claims 1, 3, 6-8, 11, 16-17, 23-26, 32 and 35 above and in further view of Zhou et al (US 2019/0144446; cited in the PTO-892 attached herein).
Regarding claims 14-15, the disclosure of Zhang et al is discussed above and incorporated herein.
Zhang et al do not explicitly teach administering its BRAF kinase dimer inhibitor to treat non-small cell lung cancer or colorectal cancer.
Zhou et al further disclose various compounds including
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(paragraph 0145, Compound 1.49) for treatment of conditions including colorectal cancer and non-small cell lung cancer (paragraph 0150).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to administer Zhang’s BRAF kinase dimer inhibitor to treat non-small cell lung cancer or colorectal cancer as suggested in Zhou et al. One would have been motivated to do so with a reasonable expectation of success since Zhou et al teach compounds including Zhang’s BRAF kinase dimer inhibitor can be used to treat other cancers including colorectal cancer and non-small cell lung cancer.
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 1, 3, 6-17, 23-26, 32 and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9, 16-17, 20-21, 24-25, 28-29, 31 and 33 of copending Application No. 19/089489 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, all of the limitations therein are substantially recited and anticipated by claims 9, 20 and 31 of US ‘489.
Regarding claim 3 and 6-9, all of the limitations therein are substantially recited and anticipated by claims 17, 21 and 24-25 of US ‘489.
Regarding claim 10, all of the limitations therein are substantially recited and anticipated by claim 28 of US ‘489.
Regarding claims 11-15, all of the limitations therein are substantially recited and anticipated by claims 17 and 20 of US ‘489.
Regarding claim 16, all of the limitations therein are substantially recited and anticipated by claim 20 of US ‘489.
Regarding claim 17, all of the limitations therein are substantially recited and anticipated by claim 29 of US ‘489.
Regarding claims 23-25, all of the limitations therein are substantially recited and anticipated by claim 31 of US ‘489.
Regarding claim 26, all of the limitations therein are substantially recited and anticipated by claim 33 of US ‘489.
Regarding claim 32, since the copending claims recite the administration of the same BRAF kinase dimer inhibitor at the suggested dosages recited in the instant claims for the treatment of cancer, the subject’s response including stable disease, a partial response or a complete response would naturally result from the copending claims. See MPEP 2112.02. See MPEP 2112.02. Claim scope is not limited by claim language that does not require further steps to be performed, or by claim language that does not limit a claim to a particular structure. Such language is not considered limiting when it simply expresses the intended result of a process step positively recited. See, e.g., Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329 (Fed. Cir. 2005), quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003).
Regarding claim 35, since the copending claims recite the administration of the same BRAF kinase dimer inhibitor at the suggested dosages recited in the instant claims for the treatment of cancer, the subject not experiencing a progressive disease would naturally result from the copending claims. See MPEP 2112.02. Claim scope is not limited by claim language that does not require further steps to be performed, or by claim language that does not limit a claim to a particular structure. Such language is not considered limiting when it simply expresses the intended result of a process step positively recited. See, e.g., Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329 (Fed. Cir. 2005), quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 3, 6-17, 23-26, 32 and 35 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL E BREDEFELD whose telephone number is (571)270-5237. The examiner can normally be reached 8:00-5:00 Monday-Friday.
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/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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