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 .
DETAILED ACTION
Claims 1-6, 12-15, 18, 21-25, 28-31 and 34-82 are pending in the application. Claims 1-6, 12-15, 18, 21-25, 29-31, 34-47, 49, 56, 59-62, 66 and 71-82 are rejected. Claims 28, 48, 50-55, 57, 58, 63-65 and 67-70 are objected to.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on April 21st, 2025.
Claim Objections
Claim 24 has an extraneous backslash after the period that should be deleted.
In claim 30, the word “wherein” should be added before “Q8”.
Claim 35 does not end in a period.
In claim 40, “R1” should be replaced with “R1”.
Claim Rejections - 35 USC § 112(a)
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 73-81 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 (marked relative to claim 73) a “method of treating an FGFR-associated disease or disorder in a subject having said FGFR-associated disease or disorder”, does not reasonably provide enablement for treating the full scope of disease or disorders embraced by instant claim 73 or for preventing the full scope of diseases or disorders embraced by instant claim 73. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. (See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
The above factors, regarding the present invention, are summarized as follows:
(a) Breadth of the claims - The breadth of the claims is drawn to the treatment of (in claim 73) “a disease or disorder” where the nature of the disease or disorder is not particularly limited.
Regarding the scope of “treating”, the specification provides the following definition on pages 11 and 12:
[0030] The terms “treatment,” “treating,” “treat” and the like shall be given its ordinary meaning and shall also include herein to generally refer to obtaining a desired pharmacologic and/or physiologic effect. The effect may be prophylactic in terms of completely or partially preventing a disease or symptom thereof and/or may be therapeutic in terms of a partial or complete stabilization or cure for a disease and/or adverse effect attributable to the disease. “Treatment” as used herein shall be given its ordinary meaning and shall also cover any treatment of a disease in a mammal, particularly a human, and includes: (a) preventing the disease or symptom from occurring in a subject which may be predisposed to the disease or symptom but has not yet been diagnosed as having it; (b) inhibiting the disease symptom, e.g., arresting its development; and/or (c) relieving the disease symptom, e.g., causing regression of the disease or symptom.
The specification broadly defines “treating” as including preventing where administration of a claimed compound prevents the disease from occurring in a subject.
(b) Nature of the invention - The nature of the invention is drawn to the treatment of diseases or disorders using compounds that are disclosed as FGFR inhibitors.
(c,e) State of the prior art and predictability in the art - The state of the prior art is that the pharmacological art involves screening in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can treat which specific disease by what mechanism). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
While a full discussion of each disease which is encompassed by Applicant’s claim language will not be given, the start of the prior art with respect FGFR inhibition has not advanced to the point of being predictive of the treatment of the breadth of diseases instantly claimed.
Xie et al. (Signal Transduction and Targeted Therapy 2020, 5, 181, pages 1-38) provide a detailed review of the involvement of FGFRs in various pathways including the following general introduction:
Fibroblast growth factors (FGFs) are broad-spectrum mitogens and regulate a wide range of cellular functions, including migration, proliferation, differentiation, and survival. It is well documented that FGF signaling plays essential roles in development, metabolism, and tissue homeostasis. The malfunction of FGF/FGF receptor (FGFR) signaling axis is observed in a variety of human diseases,
such as congenital craniosynostosis and dwarfism syndromes, as well as chronic kidney disease (CKD), obesity, insulin resistance, and various tumors (Fig. 1).
While FGFRs possess different roles, the state of the art fails to demonstrate that FGFR inhibition is a panacea that can be used to treat any type of condition as embraced by the instant claims.
Applicant’s claims are drawn to the treatment of various types of cancer. The state of the art with respect to cancer is that despite the common result of uncontrolled cell growth and replication, the various types of cancers have widely varied causes. Luo et al. (Cell, 2009, 136, pages 823-837) teach that (p. 823):
[I]t is clear that there is tremendous complexity and heterogeneity in the patterns of mutations in tumors of different origins.
Accordingly, despite the common phenotypic traits of tumors brought upon by genetic alterations, the underlying causes result in a significant complexity in treating cancer generally. There is no known target that can be activated/inhibited that would be expected to result in the treatment of all types of cancer generally. Furthermore, despite that particular therapies, such as, radiation and chemotherapy, are used for a variety of cancers, these therapies are still not fully understood. Luo et al. teach that (p. 824):
[W]e still do not have a clear molecular understanding of why these agents work to selectively kill tumor cells and, conversely, why they eventually fail.
Therefore, any claim to the treatment of cancer, in general, requires the support of extensive studies to demonstrate that the particular mode of treatment applies to treating all types of cancer since there is no mode of action that can reliably lead to the treatment of all types of cancer.
Regarding prevention, the same general rationale applies; however, the instant claims are generic to the prevention of conditions with no known manner of prevention irrespective of the targeted system. For instance, the instant claims embrace generally the prevention of cancer and developmental disorders, which are not known to be generally preventable using any approach.
(d) Level of one of ordinary skill in the art - The artisans making and using applicant’s pharmaceutical compositions would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience. The level of skill in the art is high; however, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro or in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
(f-g) Amount of direction provided by the inventor and existence of working examples - The only direction or guidance present in the instant specification is directed to inhibitions of FGFRs and associated diseases thereof. There are no working examples present for the treatment of any disease or disorder by administering compounds of the instant formula.
Test assays and procedures are provided in the specification on pages 355-376 for FGFR inhibition and cell viability; however, the disclosure does not provide how the in vitro data correlates to the treatment of the assorted disorders of the instant claims.
Regarding prevention, there is no evidence of record, which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with the numerous diseases/disorders or conditions claimed herein. That a single compound can be used to treat or prevent all diseases/disorders and conditions embraced by the claim is an incredible finding for which Applicant has not provided supporting evidence. Applicant has not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use for treating or preventing any or all of the diseases/disorders or conditions by administering the instant claimed compound.
Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
(h) Quantity of experimentation needed to make or use the invention based on the content of the disclosure - The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what diseases, disorders, or conditions out of all diseases, disorders, or conditions would be benefited by FGFR inhibition and would furthermore then have to determine which of the claimed compounds in the instant invention would provide treatment of the diseases. Furthermore regarding prevention, a person having ordinary skill in the art would need to determine which diseases or disorders are actually preventable, including developing methods to reliably determine which subjects not currently possessing a disorder would otherwise develop a disorder, and determine whether it is possible to effect prevention using a compound instantly claimed.
With particular respect to the treatment any type of cancer, as instantly claimed, an undue amount of experimentation is required. Luo et al. teach that the majority of cancer therapies fail when applied generally in that (p. 833):
It is very likely that the oncogenes and non-oncogenes to which tumors are addicted will serve as the targets of successful cancer therapies in the future. However, it is already clear that each of even the best therapies applied alone eventually fail in the majority of cases.
Therefore, the sum of the entire efforts in the field of cancer research has resulted in treatment methods that are not broadly applicable; however, Applicant claims that the instant compounds are the first and only broadly applicable cancer treatment despite the fact that Applicant has merely shown activity in assays where other prior compounds have shown activity and then failed to provide a broad treatment ability.
In fact, Luo et al. teach that even the best individual therapies can only be considered as filters to remove particular subsets of cancer cells with particular properties. Therefore, the most likely broadly applicable cancer treatment will be through a series of treatments with differing targets. Applicant has not provided sufficient teaching in the instant specification to allow a person of ordinary skill in the art to treat all types of cancer using either the instant compounds alone or in an orthogonal therapy approach. Rather, in order to practice the full scope the instant invention, a person of ordinary skill in the art would need to develop a treatment method that has eluded the entire field of cancer research.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. {In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which diseases can be treated by the compound encompassed in the instant claims, with no assurance of success.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 25, 35-41, 43, 62, 66, 75 and 81 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 25 recites the limitation "the R5a" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. Parent claim 24 provides a definition for R5a that applies to an instance of R5a within Q4; however, grandparent claim 1 is still generic to additional instances of R5a and it is unclear if claim 25 is limiting only the instance as it applies to Q4 or all instances of R5a. It is suggested that Applicant amend claim 25 to refer to “the R5a of Q4”.
Regarding claims 35-41, 43 and 66, the phrase "such as" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 43 is further rejected as indefinite since multiple lists recite alkyl substituted by groups where the last two options are not separated with a conjugation. Accordingly, it is unclear if the alkyl group in these embodiments is only substituted by one or all of the recited groups. See the eighth, tenth and eleventh embodiments.
Claim 62 is rejected as indefinite based on the option “-CH2CHOCH3”. It is unclear which groups are bound to the middle carbon atom. If the carbon is sp2 hybridized, it would appear that it must be doubly bound to oxygen leaving hydrogen and methyl to form five total bonds to carbon. If the carbon is sp3 hybridized, the carbon would only have three bonds if “HO” is a hydroxy group or the oxygen atom would have a dangling valence if each of hydrogen, oxygen and methyl is bound to the middle carbon atom.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 75 recites the broad recitation “head and neck”, and the claim also recites “(squamous)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 81 recites the broad recitation “Achondroplasia (Ach) and related chondropysplasia syndromes”, and the claim also recites “including Hypochondroplasia (Hch), severe achondroplasia with developmental delay and Acanthosis Nigricans (SADDAN), and Thanatophoric dysplasia (TD)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-6, 12-15, 18, 21-25, 29-31, 34, 35, 38, 42-47, 49, 56, 59-62 and 71-82 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,264,149. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite compounds embraced by the instant claims. For instance, claim 20 of the patent recites 1-[5-[5-[(1R)-1-(3,5-dichloro- 2-methyl-4-pyridyl)ethoxy]-6- methoxy-1H-indazol-3-yl]-2- pyridyl]azetidin-3-ol as the two hundred eighth compound, which has the following structure:
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334
340
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.
The compound above is embraced by instant formula (I) where X is O, R6 is C1 alkyl, Q1 and Q3 are each CR5a where R5a is H, one of Q2 and Q4 is N and the other is CR5a where R5a is H, n and m are each 1, R9 is H, R1 is H, R2 is -OR4a where R4a is H, R7 is C1 alkoxyl, R8 is H, Q5 and Q9 are CR5 where R5 is halogen, one of Q6 and Q8 is CR5 where R5 is H and the other is CR5 where R5 is C1 alkyl and Q7 is N. The compound is embraced by instant claims 1, 2, 3, 4, 5, 6 (formula IA-4-1), 14, 15, 18, 21, 22, 29, 31, 34, 45, 46 and 49. Regarding instant claim 72, claim 16 of the patent recites analogous compositions. Regarding instant claims 73-82, the patent discloses these various utilities, beginning in column 94 and continuing through column 100. With respect to the fact that the cited claim 20 of the patent is drawn to compounds while the instant claims are drawn to methods of treating, Applicant is directed to Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. 95 USPQ2d 1797, Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 [68 USPQ2d 1865] (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008) for analogous situations.
Regarding instant claim 12, claim 4 of the patent recites that the corresponding positions (on the ring bearing the instant variable R5a can each be carbon or nitrogen). At least in the interest of preparing additional compounds must closely structurally related to exemplary compounds, a person having ordinary skill in the art would have been motivated to test the permissible ring member options of the claims of the patent.
Regarding additional claims not addressed above, claim 20 of the patent recites 3-[6-(2-azaspiro[3.3]-heptan-2-yl)-3-pyridyl]-5-[(1R)-1-(3,5-dichloro-2-methyl-4-pyridyl)ethoxy]-1H-indazole that possesses a ring where R1 and R2 are taken together to form a C4 ring as embraced by instant claim 71.
Regarding additional claims not addressed above, claim 20 of the patent recites (R)-1-(5-(6-chloro-5-(1-(3,5-dichloropyridin-4-yl)ethoxy)-1H-indazol-3-yl)-3-(methylsulfonyl)pyridin-2-yl)-N,N,3-trimethylazetidin-3-amine that possesses a structure where R1 is C1 alkyl and R2 is -NR3R4 where R3 and R4 are C1 alkyl and where Q2 is N and Q4 is CR5a where R5a is -SO2CH3 as embraced by instant claims 24, 25, 56, 60 and 62.
Regarding additional claims not addressed above, claim 20 of the patent recites (R)-2-(3-amino-3-methylazetidin-1-yl)-5-(5-(1-(3,5-dichloropyridin-4-yl)ethoxy)-1H-indazol-3-yl)nicotinonitrile that possesses a structure where R1 is C1 alkyl and R2 is -NR3R4 where R3 and R4 are hydrogen and where (in formula (IA) of claim 5) R5 is H as embraced by instant claims 13, 59 and 61.
Regarding additional claims not addressed above, claim 20 of the patent recites 5-[(1R)-1-(3,5-dichloro-2-methyl-4-pyridyl)ethoxy]-3-[6-(3-methoxy-3-methyl-azetidin-1-yl)-3-pyridyl]-1H-indazole that possesses a structure where R1 is C1 alkyl and R2 is -OR4a where R4a is C1 alkyl as embraced by instant claim 47.
Regarding additional claims not addressed above, claim 20 of the patent recites (R)-5-(1-(3,5-dichloropyridin-4-yl)ethoxy)-3-(6-(3,3-dimethylazetidin-1-yl)-5-fluoropyridin-3-yl)-6-methoxy-1H-indazole that possesses a structure where R1 is C1 alkyl and R2 is C1 alkyl as embraced by instant claims 35, 43 and 44.
Regarding additional claims not addressed above, claim 20 of the patent recites 2-[5-[5-[(1R)-1-(3,5-dichloro-4-pyridyl)ethoxy]-1H-indazol-3-yl]pyrimidin-2-yl]-6λ6-thia-2-azaspiro[3.4]octane 6,6-dioxide that possesses a structure where R1 is heterocycloalkyl and R2 is hydrogen as embraced by instant claims 38 and 42.
Regarding additional claims not addressed above, claim 20 of the patent recites (R)-3-(6-(azetidin-1-yl)-5-fluoropyridin-3-yl)-5-(1-(3,5-dichloropyridin-4-yl)ethoxy)-6-methoxy-1H-indazole that possesses a structure where Q6 and Q8 are CH as embraced by instant claim 30.
Regarding additional claims not addressed above, claim 20 of the patent recites (R)-1-(5-(5-(1-(3,5-dichloropyridin-4-yl)ethoxy)-6-methoxy-1H-indazol-3-yl)-3-fluoropyridin-2-yl)-N,N,3-trimethylazetidin-3-amine that possesses a structure where Q2 is N and Q4 is CR5a where R5a is F.
Claims 1-6, 13-15, 18, 21-25, 29-31, 34, 35, 42-44, 56, 59, 61 and 72-82 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 18, 19, 29, 30, 33, 39, 40, 42, 44, 46, 53-55, 57, 58, 61, 62 and 64 of copending Application No. 19/140,498 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending case recite compounds that anticipate instant claims. Claim 53 of the copending case recites the following compounds:
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204
258
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,
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212
510
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218
224
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and
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208
212
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.
The compounds above are embraced by instant formula (I) where X is O, R6 is C1 alkyl, Q1 and Q3 are each CR5a where R5a is H, one of Q2 and Q4 is N and the other is CR5a where R5a is halogen or -CN, n and m are each 1, R9 is H,
R1 is H, R2 is -OR4a where R4a is H, R7 is H or C1 alkoxyl, R8 is H, Q5 and Q9 are CR5 where R5 is halogen, Q6 and Q8 are CR5 where R5 is H and Q7 is N, and (for the first two compounds) R1 is C1 alkyl and R2 is -NR3R4 where R3 is H and R4 is substituted C2 alkyl, (for the third compound) R1 and R2 are optionally substituted C1 alkyl and (for the fourth and fifth compounds) R1 is substituted C1 alkyl and R2 is -NR3R4 where R3 and R4 are H. At least one compound is embraced by instant claims 1, 2, 3, 4, 5, 6 (formulas (IA-1-1) and (IA-3-1)), 13, 15, 18, 21, 23, 24, 25, 29, 30, 31, 35, 43, 44, 56, 59 and 61.
Regarding instant claim 12, claim 1 of the copending recites that the corresponding positions (on the ring bearing the instant variable R5a can each be carbon or nitrogen). At least in the interest of preparing additional compounds must closely structurally related to exemplary compounds, a person having ordinary skill in the art would have been motivated to test the permissible ring member options of the claims of the copending case.
Regarding instant claims 14, 22, 34 and 42, the same rationale applies to the additional dependent that recite permutations of variables embraced by the parent claim of the copending case where various positions can be hydrogen, alkyl, halogen, etc.
Regarding instant claim 72, claim 54 of the copending case recites analogous compositions. Regarding instant claims 73-82, the copending case discloses these various utilities, beginning on page 49 and continuing through page 61. With respect to the fact that the cited claim 20 of the patent is drawn to compounds while the instant claims are drawn to methods of treating, Applicant is directed to Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. 95 USPQ2d 1797, Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 [68 USPQ2d 1865] (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008) for analogous situations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 28, 48, 50-55, 57, 58, 63-65 and 67-70 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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