DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of (i) a hydroxyl methyl cellulose acetate succinate salt of 1-((1S,1aS,6bS)-5-((7-oxo- 5,6,7,8-tetrahydro-1,8-naphthyridin-4-yl)oxy)-la,6b-dihydro-1H-cyclopropa[b]benzofuran-1-yl)- 3-(2,4,5-trifluorophenyl)urea; (ii) non-small cell lung cancer as the solid tumor, and (iii) BRAF as the patient mutation as the elected species, in the reply filed on 10/23/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 17-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Priority
The present application claims priority to U.S. Provisional Application No. 63/379,617 filed October 14, 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/16/2023 and 01/30/2024 has been considered by the examiner.
Status of Claims
Claims 1-25 are pending. Claims 17-21 are withdrawn. Claims 1-16 and 22-25 are examined in accordance to the elected species.
Claim Rejections - 35 USC § 112
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 1-13 and 22-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for enabling for treating cutaneous melanoma harboring NRAS and non-small cell lung cancer harboring BRAF and KRAS, does not reasonably provide enablement for treating all solid tumors including claim 13 or preventing a solid cancer where treating encompassed by the claim to also mean preventing because the term “treat” or “treating” or “treating” is defined in the specification at paragraph [0024] to include treatment and prophylactic or preventive measures wherein the object is to prevent or slow down (lessen) an undesired physiological condition, disorder, or disease, or obtain beneficial or desired clinical results. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
There are several guidelines when determining if the specification of an application allows the skilled artisan to practice the invention without undue experimentation. The factors to be considered in determining what constitutes undue experimentation were affirmed by the court in re Wands (8 USPQ2d 1400 (CAFC 1986)). These factors are (1) nature of the invention; (2) state of the prior art; (3) level of one of ordinary skill in the art; (4) level of predictability in the art; (5) amount of direction and guidance provided by the inventor; (6) existence of working examples; (7) breadth of claims; and (8) quantity of experimentation needed to make or use the invention based on the content of the disclosure.
(1) Nature of the invention
The claims are directed to treatment of all solid tumors and preventing of a solid tumor to the extent treatment encompasses prevention.
(2) State of the prior art
The state of the art is that both mirdametinib, or a pharmaceutically acceptable salt thereof, and 1-((1S,1aS,6bS)-5-((7-oxo-5,6,7,8-tetrahydro-1,8-naphthyridin-4-yl) oxy)-1a,6b-dihydro-1H-cyclopropa[b]benzofuran-1-yl)-3-(2,4,5-trifluorophenyl) urea, or a pharmaceutically acceptable salt thereof can be expected to treat non-small cell lung cancer harboring BRAF mutation. (See Zhou et al (WO2014/206343 A1) and Luo et al (WO2020/202981 A1), both are cited in the IDS dated 10/16/2023 and 01/30/2024.) However, Eduardo Bruera (BMJ 2024;384) teaches new systemic anticancer treatments, such as targeted therapy and immunotherapy, have made treating incurable solid cancer more successful but also more challenging and unpredictable. (See What you need to know Section.) Thus, one cannot ascertain whether the instant invention is of use to treat all solid tumor.
(3) Level of one of ordinary skill in the art
The level of skill in the art is deemed to be high, generally that of a medical Doctor specializing in the field of oncology.
(4) Level of predictability in the art
The art pertaining to mirdametinib, or a pharmaceutically acceptable salt thereof, and 1-((1S,1aS,6bS)-5-((7-oxo-5,6,7,8-tetrahydro-1,8-naphthyridin-4-yl) oxy)-1a,6b-dihydro-1H-cyclopropa[b]benzofuran-1-yl)-3-(2,4,5-trifluorophenyl) urea, or a pharmaceutically acceptable salt thereof for treating all solid tumor or cancer or preventing a solid tumor is highly unpredictable. Specifically, namely Pestana et al (Lancet Reg Health Am. 2024 Jan 4;30:100671) teaches sarcomas are a heterogeneous group of mesenchymal malignancies of the soft tissue and bone, represented by more than 80 subtypes, the majority of which are categorized as rare cancers based on their incidence. Rare cancers—defined as those with an incidence of less than 6 per 100,000 persons per year—can be particularly challenging to diagnose and treat, therefore depending heavily on well-structured networks and timely referral to high-volume centres. (See right column of page 1.)
Chua et al (“Advanced Ovarian Cancer: What You Need to Know” December, 29, 2025) teaches ovarian cancer is not one single disease — it’s a type of gynecologic cancer (cancer of the female reproductive system). Cancers that fall under this umbrella include tumors that grow in the ovaries, fallopian tubes, and peritoneum (tissue that lines the inside of your abdomen). Some ovarian cancers are caught early, when the tumor is still small. Others are more advanced, meaning the tumors have grown larger or spread to other organs. Advanced ovarian cancer is usually harder to treat and has a worse outlook. (See first and second paragraphs.)
Cleveland clinic (https://my.clevelandclinic.org/health/diseases/21881-tumor) accessed on 02/02/2025 teaches Most tumors occur for no known reason, so you can’t always prevent them. Still, you can potentially reduce your risk if you:
Quit smoking.
Drink alcohol moderately or avoid it altogether.
Eat balanced meals that contain nutrient-rich foods.
Stay physically active.
Maintain a weight that’s healthy for you.
Reduce your risk of HPV by getting the vaccine and practicing safer sex. (See Prevention
Section.)
Emory Winship Cancer Institute (https://winshipcancer.emory.edu/cancer-types-and-treatments/sarcoma/prevention.php#:~:text=Ways%20to%20Prevent%20Sarcoma,these%20patients%20may%20be%20warranted%2C) Accessed on 02/02/2025 teaches sarcoma prevention does not yet exist. According to experts, there are no lifestyle-related or environmental causes of sarcoma, which means that there is no determined way to prevent these tumors from forming. In addition, the genetic conditions that may increase a person’s risk cannot be changed, however screening in these patients may be warranted. (See Ways to prevent Sarcoma Section.)
Mak et al (Am J Transl Res. 2014 Jan 15;6(2):1/14–118) teaches the average rate of successful translation from animal models to clinical ca/ncer trials is less than 8%. Animal models are limited in their ability to mimic the extremely complex process of human carcinogenesis, physiology and progression. Therefore, the safety and efficacy identified in animal studies is generally not translated to human trials. (See Abstract.)
Agadjanian et al (Sci Rep 15, 34969 (2025)) teaches ovarian cancer is a heterogeneous disease characterized by late-stage diagnosis and poor survival rates. Research efforts are hindered by the complexity of the tumor microenvironment and the lack of suitable preclinical models. While immortal human cell lines and patient-derived xenograft (PDX) models have contributed significantly to understanding tumor biology, they are limited by their immunodeficient nature, which precludes the study of immune-mediated mechanisms. Genetically modified mouse models of ovarian cancer address this limitation but the long and unpredictable tumor latency is impractical for testing therapies. (See second paragraph of page 1.) Moreover, Agadjianian teaches with the plethora of syngeneic ovarian cancer cell lines to choose from, is there a need for additional cell lines? The effectiveness of currently available therapies for treating ovarian carcinomas remains limited, largely due to the heterogeneous nature of these tumors. Ovarian carcinomas encompass a variety of distinct mutant genotypes, each of which exerts diverse and often poorly understood influences on tumor phenotypes. These influences extend to critical factors such as the tumor’s microenvironment and its response to treatment. This complexity poses significant challenges, particularly in developing and evaluating new immunotherapies. Our limited understanding of the mechanisms by which cancer genotypes shape both immunophenotypes and therapeutic responses further complicates efforts to improve outcomes in this disease. (See fifth paragraph of page 2.)
(5) Amount of direction and guidance provided by the inventor
The claims encompass a vast number of solid tumors. Applicant’s limited guidance does not enable the public to use the claimed combination for treating all solid tumors or preventing a solid tumor. There is no directional guidance for the treatment of all solid tumors or prevention of a solid tumor with the claimed combination. Hence, there is no enablement for the claimed combination to effectively treat ovarian cancer and sarcomas and prevent a solid tumor.
(6) Existence of working examples
The claims encompass a vast number of solid tumors. Applicant’s limited working examples do not enable the public to treat all solid tumors or to prevent a solid tumor with the claimed combination. While Applicant’s claims encompass a plethora of possible solid tumors, the specification only provides guidance of a particular clinical trial for treating cutaneous melanoma harboring NRAS and non-small cell lung cancer harboring BRAF and KRAS or for preventing a solid tumor. The specification appears to be silent on extrapolating the claimed examples of treatment of NSCLC and cutaneous melanoma to all treat all solid tumors or prevent a solid tumor.
(7) Breadth of claims
The claims are extremely broad due to the vast number of possible solid tumors.
(8) Quantity of experimentation needed to make or use the invention based on the content of the disclosure
The specification does not enable any person skilled in the art to which it pertains to make and use the invention commensurate in scope with the claims because using the claimed combination for treating all solid tumors including ovarian cancer and sarcomas and for preventing a solid tumor. The specification fails to enable the skilled artisan to practice the invention without undue experimentation to treating all solid tumors. Furthermore, based on the unpredictable nature of the invention, the state of the prior art, and the extreme breadth of the claims, one skilled in the art could not perform the claimed invention without undue experimentation.
In order to overcome the 112(a) rejection with respect to the "treatment" to include prevention, the claims need to be amended to indicate that it is a therapeutic treatment, as it is not enabled for the full scope of the term.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 8-16, and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al (WO2014/206343 A1) in view of Luo et al (WO2020/202981 A1)
Zhou teaches a method of treating cancer responsive to inhibition of Raf kinase and/or Raf kinase dimer comprising administering to a subject in recognized need thereof at least one compound of the formula (I)
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, or a pharmaceutically acceptable salt in an amount effective to inhibit said Raf kinase and/or Raf kinase dimer. (See claim 36 and claim 1.) Moreover, Zhou teaches one of the preferred compounds of the formula (I) includes compound 1.40
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. (See page 27.) Moreover, Zhou teaches the dosage administered is a preferred daily dose of 10-500 mg once or multiple times per day. (See lines 33-35 of page 42 bridging lines 1-2 of page 43.) Zhou teaches the compound of the formula (I) can be administered as the sole active ingredient or in combination with at least one second active ingredient useful for treating cancer and can be administered concomitantly, sequentially. (See lines 1-9 of page 45.) Zhou teaches when administered as a separate dosage form, the at least one other therapeutic agent may be administered prior to, at the same time as, or following administration of the at least one compound and /or at least one pharmaceutically acceptable salt thereof. (See lines 1-3 of page 38.) The separate administration contemplated both the same or different dosage forms. Zhou teaches the composition can be administered orally in the form of a tablet. (See lines 23-29 of page 41 Compounds 1.1-1.87 and 2.1-2.16 inhibited B-Raf (wild type, V60OE)/C-Raf with IC50 values ranging from 0.1 nM to 10 µM. (See lines 32-33 of page 114.) Furthermore, Zhou teaches the cancer can be non-small cell lung cancer. (See claim 37.)
Zhou does not teach mirdametinib administered twice a day in the amount claimed and two equal doses. Moreover, Zhou does not teach 28-day dosing cycle that is repeated up to a total of 24 consecutive 28-day dosing cycles.
Luo teaches a method of treating a patient having a solid tumor comprising administering twice daily 4 mg Compound A as free base and once d acceptable salt thereof. (See claim 292.) Compound A is mirdametinib. (See paragraph [0002].) Moreover, Luo teaches compound A is administered before, concomitantly, or subsequently to the administering of Compound B, or a pharmaceutically acceptable salt form thereof. (See claim 304.) The dosage form of compound A is an oral capsule. (See claims 306 and 307.) Luo also teaches the patient has a confirmed mutation of BRAF and has non-small cell lung cancer. (See claims 309 and 313.) BRAF encompasses BRAF Class II/III fusion mutation. Additionally, Luo teaches the amount of Compound A, or a pharmaceutically acceptable salt thereof, administered in the lead-in period is the same as the amount of Compound A, or a pharmaceutically acceptable salt thereof, administered during the first 28-day dosing cycle. (See claim 195.) Luo teaches
the 28-day dosing cycle is repeated up to a total of 24 consecutive 28-day dosing cycles. (See paragraph [0535].) Furthermore, Luo teaches compound A free based is divided over two doses per day. (See paragraph [0144].) Two divided doses contemplate two equal doses.
It would have been prima facie obvious for a person of ordinary skill in the art at the time of the invention was made to combine the method disclosed by Zhou that includes the claimed effective amount with the method set forth by Luo because each is taught by the prior art to be useful for the same purpose (i.e., treating non-small cell lung cancer harboring BRAF). See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Further, a person of ordinary skill in the art would reasonably have expected to be successful because both compositions were shown to be useful separately for the exact same purpose and thus would be expected to be similarly useful when used together.
Claims 1-16, and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al (WO2014/206343 A1) in view of Luo et al (WO2020/202981 A1), as applied to claims 1-6, 8-16, and 22-25, in further view of Ueda et al (Journal of Pharmaceutical Sciences 109 (2020) 2464-2473.
The teachings of Zhou and Luo have been discussed supra.
Zhou and Luo collectively do not teach hydroxypropyl methyl cellulose acetate succinate salt of compound I.40 as claimed in claim 7.)
Ueda evaluates the effect of polymer substituent type on drug amorphous solubility as well as drug membrane transport rate. Two grades of hypromellose acetate succinate (HPMCAS), AS-LF and AS-HF, were studied with 4 model drugs. (See Abstract.) Moreover, Ueda teaches these polymers can improve the transport of drug to the vicinity of the epithelial cells, resulting in further enhancements in drug absorption. (See Conclusion Section and last paragraph of the right column of page 2464.) While Ueda does not teach HPMCAS is a pharmaceutically acceptable salt, the instant specification and the election of HPMCAS as the elected pharmaceutically acceptable salt are taken as evidentiary that HPMCAS as the elected pharmaceutically acceptable salt. A chemical compound and its properties are considered inseparable because a specific chemical structure inherently possesses its physical and chemical properties. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to modify the method taught by Zhou and Luo to include the HPMCAS as taught by Ueda to give Applicant’s claimed invention. One would have been motivated to do so, because Ueda teaches HPMCAS can improve the transport of drug to the vicinity of the epithelial cells, resulting in further enhancements in drug absorption. One would reasonably expect the inclusion of HPMCAS to improve the transport of the drugs taught by Zhou and Luo in order to effectively treat NSCLC harboring BRAF mutation.
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 1-16 and 22-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 30, 31, and of copending Application No. 17/995,002 in view of Zhou et al (WO2014/206343 A1), Luo et al (WO2020/202981 A1), and Ueda et al (Journal of Pharmaceutical Sciences 109 (2020) 2464-2473.
The copending claims teach a method of treating a patient having a solid tumor comprising administering a therapeutically effective amount of mirdametinib and a therapeutically effective amount of lifirafenib. (See claim 2) Moreover, the copending claims teach mirdametinib is the amount of 1 mg to about 5 mg per day and administered once per day. (See claims 30 and 31.) The solid tumor can include non-small cell lung cancer. (See claim 37.)
The copending claims do not teach 1-((1S,1aS,6bS)-5-((7-oxo-5,6,7,8-tetrahydro-1,8-naphthyridin-4-yl) oxy)-1a,6b-dihydro-1H-cyclopropa[b]benzofuran-1-yl)-3-(2,4,5-trifluorophenyl) urea, or a pharmaceutically acceptable salt thereof in the amount claimed, oral capsule administration. Moreover, the copending claims do not teach 28-day dosing cycle that is repeated up to a total of 24 consecutive 28-day dosing cycles.
Zhou teaches a method of treating cancer responsive to inhibition of Raf kinase and/or Raf kinase dimer comprising administering to a subject in recognized need thereof at least one compound of the formula (I)
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, or a pharmaceutically acceptable salt in an amount effective to inhibit said Raf kinase and/or Raf kinase dimer. (See claim 36 and claim 1.) Moreover, Zhou teaches one of the preferred compounds of the formula (I) includes compound 1.40
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. (See page 27.) Moreover, Zhou teaches the dosage administered is a preferred daily dose of 10-500 mg once or multiple times per day. (See lines 33-35 of page 42 bridging lines 1-2 of page 43.) Zhou teaches the compound of the formula (I) can be administered as the sole active ingredient or in combination with at least one second active ingredient useful for treating cancer and can be administered concomitantly, sequentially. (See lines 1-9 of page 45.) Zhou teaches when administered as a separate dosage form, the at least one other therapeutic agent may be administered prior to, at the same time as, or following administration of the at least one compound and /or at least one pharmaceutically acceptable salt thereof. (See lines 1-3 of page 38.) The separate administration contemplated both the same or different dosage forms. Zhou teaches the composition can be administered orally in the form of a tablet. (See lines 23-29 of page 41 Compounds 1.1-1.87 and 2.1-2.16 inhibited B-Raf (wild type, V60OE)/C-Raf with IC50 values ranging from 0.1 nM to 10 µM. (See lines 32-33 of page 114.) Furthermore, Zhou teaches the cancer can be non-small cell lung cancer. (See claim 37.)
Luo teaches a method of treating a patient having a solid tumor comprising administering twice daily 4 mg Compound A as free base and once d acceptable salt thereof. (See claim 292.) Compound A is mirdametinib. (See paragraph [0002].) Moreover, Luo teaches compound A is administered before, concomitantly, or subsequently to the administering of Compound B, or a pharmaceutically acceptable salt form thereof. (See claim 304.) The dosage form of compound A is an oral capsule. (See claims 306 and 307.) Luo also teaches the patient has a confirmed mutation of BRAF and has non-small cell lung cancer. (See claims 309 and 313.) BRAF encompasses BRAF Class II/III fusion mutation. Additionally, Luo teaches the amount of Compound A, or a pharmaceutically acceptable salt thereof, administered in the lead-in period is the same as the amount of Compound A, or a pharmaceutically acceptable salt thereof, administered during the first 28-day dosing cycle. (See claim 195.) Luo teaches
the 28-day dosing cycle is repeated up to a total of 24 consecutive 28-day dosing cycles. (See paragraph [0535].) Furthermore, Luo teaches compound A free based is divided over two doses per day. (See paragraph [0144].) Two divided doses contemplate two equal doses.
It would have been prima facie obvious for a person of ordinary skill in the art at the time of the invention was made to combine the method disclosed by Luo and the copending claims that includes the claimed effective amount with the method set forth by Zhou because each is taught by the prior art to be useful for the same purpose (i.e., treating non-small cell lung cancer harboring BRAF). See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Further, a person of ordinary skill in the art would reasonably have expected to be successful because both compositions were shown to be useful separately for the exact same purpose and thus would be expected to be similarly useful when used together.
The copending claims do not further teach hydroxypropyl methyl cellulose acetate succinate salt of compound I.40 as claimed in claim 7.)
Ueda evaluates the effect of polymer substituent type on drug amorphous solubility as well as drug membrane transport rate. Two grades of hypromellose acetate succinate (HPMCAS), AS-LF and AS-HF, were studied with 4 model drugs. (See Abstract.) Moreover, Ueda teaches these polymers can improve the transport of drug to the vicinity of the epithelial cells, resulting in further enhancements in drug absorption. (See Conclusion Section and last paragraph of the right column of page 2464.) While Ueda does not teach HPMCAS is a pharmaceutically acceptable salt, the instant specification and the election of HPMCAS as the elected pharmaceutically acceptable salt are taken as evidentiary that HPMCAS as the elected pharmaceutically acceptable salt. A chemical compound and its properties are considered inseparable because a specific chemical structure inherently possesses its physical and chemical properties. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to modify the method taught by the copending claims, Zhou and Luo to include the HPMCAS as taught by Ueda to give Applicant’s claimed invention. One would have been motivated to do so, because Ueda teaches HPMCAS can improve the transport of drug to the vicinity of the epithelial cells, resulting in further enhancements in drug absorption. One would reasonably expect the inclusion of HPMCAS to improve the transport of the drugs taught by Zhou and Luo in order to effectively treat NSCLC harboring BRAF mutation.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-16 and 22-25 are not allowed.
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/JEAN P CORNET/Primary Examiner, Art Unit 1628