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 .
Priority
This application is a division of U.S. Application No. 17/548,755 filed on December 13, 2021, now U.S. Patent No. 12,109,218 B2, which is a continuation of U.S. Application No. 15/144,609 filed on May 2, 2016, now abandoned, which is a division of U.S. Application No. 14/639,898 filed on March 5, 2015, now U.S. Patent No. 11,369,621 B2 which claims priority to U.S. Provisional Application No. 62/089,713 filed on December 9, 2014.
Please note that Applicants have designated this application as a divisional application of U.S. Application No. 17/548,755, however this application is directed to the same invention as that of U.S. Application No. 17/548,755 and as such should be designated as a continuation application. A later application for an independent or distinct invention, carved out of a non-provisional application, an international application designating the United States, or an international design application designating the United States and disclosing and claiming only subject matter disclosed in the earlier or parent application, is known as a divisional application. A divisional application is often filed as a result of a restriction requirement made by the examiner. See MPEP 201.06
Please note that in order to obtain the benefit of the prohibition of nonstatutory double patenting rejection under 35 U.S.C. 121, claims must be formally entered, restricted in, and removed from an earlier application and filed in divisional application only.
The U.S. Court of Appeals for the Federal Circuit has concluded that the protection of 35 U.S.C. 121 does not extend to all types of continuing applications, stating that "the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications." Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1362, 86 USPQ2d 1001, 1007-1008 (Fed. Cir. 2008). In this case, since this application should be designated as a continuation application, prohibition of nonstatutory double patenting rejection under 35 U.S.C. 121 does not apply.
Appropriate correction is required.
Drawings Objection
The drawings filed on September 17, 2024 are objected to because the figure legends of figures 7-15 are incomplete. In addition, the figures are objected to because they are of low resolution and poor clarity. Thus the figures appear blurry, unclear and less detailed which significantly hinders proper evaluation of the content on the figures. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 2 is objected to because of the following informalities: Claims 2 recites Tax in line 2 instead of Tmax. Appropriate correction is required.
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not). In the instant case, the claims submitted on 9/17/2024 include claims 1-11 and 13-16 and are missing claim 12.
Misnumbered claims 13-16 have been renumbered 12-15.
Thus claims 1-15 are currently pending.
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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,109,218. Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the cited claims of ‘218 are drawn to a method for treating pain and inflammation in a cat or dog, the method comprising administering to the cat or dog an oral pharmaceutical composition comprising a therapeutically effective amount of grapiprant and one or more excipients; wherein the therapeutically effective amount of grapiprant is administered at a dosage rate of 2 mg per kilogram bodyweight of the dog once per day.
Although the claims of ‘218 do not specifically claim the composition is formulated as a solution, suspension, or a viscous liquid formulation as claimed in the instant claims, since ‘218 broadly claims administration of an oral pharmaceutical composition, any suitable oral form including solids, liquids, suspensions and solutions are contemplated. Thus the cited claims of the instant application are rendered obvious over the cited claims of ‘218.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-49 of U.S. Patent No. 11,369,621 B2 (Provided on IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the cited claims of ‘621 are drawn to a method for treating pain and inflammation in a cat or a dog, the method comprising administering to the cat or dog an oral pharmaceutical composition comprising a therapeutically effective amount of grapiprant and one or more excipients; wherein the therapeutically effective amount of grapiprant is administered at a dosage rate of 2 mg per kilogram bodyweight of the dog once per day.
Although the claims of ‘621 do not specifically claim the composition is formulated as a solution, suspension, or a viscous liquid formulation as claimed in the instant claims, since ‘621 broadly claims administration of an oral pharmaceutical composition, any suitable oral form including solids, liquids, suspensions and solutions are contemplated. Thus the cited claims of the instant application are rendered obvious over the cited claims of ‘621.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,478,633. Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the cited claims of ‘633 are drawn to a method for treating pain and inflammation in a dog, the method comprising administering to the dog an oral pharmaceutical composition comprising a therapeutically effective amount of grapiprant and one or more excipients; wherein the therapeutically effective amount of grapiprant is administered at a dosage rate of 2 mg per kilogram bodyweight of the dog per day.
Although the claims of ‘633 do not specifically claim the composition is formulated as a solution, suspension, or a viscous liquid formulation as claimed in the instant claims, since ‘633 broadly claims administration of an oral pharmaceutical composition, any suitable oral form including solids, liquids, suspensions and solutions are contemplated. Thus the cited claims of the instant application are rendered obvious over the cited claims of ‘633.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Application No. 19/374,274 (U.S. Publication No. 2026/0053822 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the cited claims of copending ‘274 are drawn to a method for treating pain and inflammation in a dog, the method comprising administering to the dog an oral pharmaceutical composition comprising a therapeutically effective amount of grapiprant and one or more excipients; wherein the therapeutically effective amount of grapiprant is administered at a dosage rate of 2 mg per kilogram bodyweight of the dog per day.
Although the claims of copending ‘274 do not specifically claim the composition is formulated as a solution, suspension, or a viscous liquid formulation as claimed in the instant claims, since copending ‘274 broadly claims administration of an oral pharmaceutical composition, any suitable oral form including solids, liquids, suspensions and solutions are contemplated. Thus the cited claims of the instant application are rendered obvious over the cited claims of copending ‘274.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Haruta et al. U.S. Patent No. 7,960,407 B2 (Provided on IDS).
Claims 1-15 of the instant application claim a method for treating pain and inflammation in a cat or a dog, the method comprising administering to the cat or dog an oral pharmaceutical composition comprising a therapeutically effective amount of grapiprant and one or more excipients; wherein the therapeutically effective amount of grapiprant is administered at a dosage rate of 2 mg per kilogram bodyweight of the dog once per day; and wherein the oral pharmaceutical composition is administered with or without food and wherein the oral pharmaceutical composition is formulated as a solution, suspension, or a viscous liquid formulation. Claims 2-6 further claim that the administering achieves a Cmax of grapiprant between 375 ng/ml to 10,000 ng/ml and a Tmax between 0.4 to 3.4 hours.
Claims 3 and 7 of Haruta et al. claim a pharmaceutical composition comprising N-(((2-(4-(2-ethyl-4,6-dimethyl-1H-imidazo[4,5-c]pyridin-1-yl)phenyl)ethyl)amino)carbonyl)-4-methylbenzenesulfonamide which is grapiprant together with one or more pharmaceutically acceptable excipients. Haruta et al. further teach that grapiprant is for the treatment of pain or inflammation, as well as osteoarthritis or rheumatoid arthritis (column 3 lines 33-40 and 50-53). Haruta et al. teaches a method for the treatment of pain, inflammation, osteoarthritis or rheumatoid arthritis comprising the administration of grapiprant to a mammal in need of such treatment (column 3 lines 41-49). Haruta et al. teaches that the composition can be administered presurgery (column 6 line 64).
Haruta et al. specifically teaches a pharmaceutical composition including grapiprant and one or more suitable excipients for the treatment of pain or inflammation (column 8 lines 1-7). Haruta et al. teaches the treatment of non-human animals or veterinary use (column 8 lines 11-12).
Haruta et al. specifically teaches formulations suitable for oral administration comprising grapiprant and pharmaceutically acceptable excipients (column 8 lines 20-57). Haruta et al. further teaches formulations suitable for oral administration include solid, semi-solid and liquid systems such as tablets; soft or hard capsules containing multi- or nano-particulates, liquids, or powders; lozenges (including liquid-filled); chews; gels; fast dispersing dosage forms; films; ovules; sprays; and buccal/mucoadhesive patches (column 8 lines 26-31). Liquid formulations include suspensions, solutions, syrups and elixirs (column 8 lines 32-38). Haruta et al. teaches that such liquid formulations may be employed as fillers in soft or hard capsules (made, for example, from gelatin or hydroxypropylmethylcellulose) and typically comprise a carrier, for example, water, ethanol, polyethylene glycol, propylene glycol, methylcellulose, or a suitable oil, and one or more emulsifying agents and/or suspending agents (column 8 lines 33-38). Liquid formulations may also be prepared by the reconstitution of a solid, for example, from a sachet (column 8 lines 38-40). Haruta et al. teaches examples of emulsifiers including sodium lauryl sulfate and polysorbate 80 (column 9 line 2).
Haruta et al. teaches that other possible ingredients include flavoring agents and taste-masking agents (column 9 lines 13-15).
Haruta et al. teaches that the total daily dose may be administered in a single or divided doses and preferably the total daily dose is in the range of 0.1 mg to 500 mg (column 12 lines 64-67).
Haruta et al. does not specifically teach administering the grapiprant formulation to cats or dogs at a dosage rate of 2 mg/kg. Haruta et al. does not specifically teach that the administering achieves the pharmacokinetic profile as claimed in claims 2-6.
However, Haruta et al. teaches the treatment of non-human animals or veterinary use which includes companion animals such as a dog (column 8 lines 11-12). Accordingly, prior to the effective filing date of the instant application, based on the teachings of Haruta et al., a person of ordinary skill in the art would have been motivated to treat non-human animals for veterinary use including companion animals such as cats or dogs with a reasonable expectation of success. With respect to the dosage of 2 mg/kg, which is about 20 mg for a 10 kg animal, or about 100 mg for a 50 kg animal, or about 10 mg for a 5 kg animal, Haruta et al. teaches that the total daily dose may be administered in a single or divided doses and preferably the total daily dose is in the range of 0.1 mg to 500 mg (column 12 lines 64-67). Therefore, a dosage of 2 mg/kg as claimed is within the range taught in the prior art.
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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.").
Furthermore, it is obvious to vary and/or optimize the amount of a drug, according to the guidance provided by the prior art in order to provide optimal treatment results. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
With respect to the claimed limitation that the administration achieves the pharmacokinetic profile as claimed in claims 2-6, Haruta et al. teaches administering a formulation comprising the same grapiprant compound in overlapping amounts as claimed. Thus, administering the same compound in the same amount will necessarily achieve the same pharmacokinetic properties as claimed in instant claims 2-6. Thus, achieving the same Cmax, Tmax and half-life as claimed in the instant claims as well as causing no clinically significant adverse gastrointestinal effect or changes in liver, kidney and coagulation parameter in the dog as claimed in claim 14 of the instant application are rendered obvious in view of the cited prior art teachings.
Although Haruta et al. does not teach the amount of the flavorant to add as claimed in claims 7-8 of the instant application, it is obvious and within the skill of an ordinary artisan to vary and/or optimize the amount of components in a composition such that a composition having the desired properties is achieved. A person of ordinary skill in the art would have been motivated to add an amount of flavorant such that the flavor of the composition is palatable to the subject treated. It is noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, it has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980).
With respect to the claimed limitation that the composition is administered with or without food, said limitation is rendered obvious since the composition can only be administered with or without food because there would be no other option.
Claims 9-11 are rendered obvious since it would have been obvious to a person of ordinary skill in the art to administer the composition for as long as necessary in order to treat pain and inflammation. Thus, in the absence of secondary considerations such as a demonstration of criticality, claims 9-11 are rendered obvious.
Claim 12 is rendered obvious since Haruta et al. specifically teaches that the composition can be administered presurgery and it would have been within the skill of an ordinary skilled artisan to determine the time in which to administer the composition such that optimal results are achieved. Thus, in the absence of secondary considerations such as a demonstration of criticality, claim 12 is rendered obvious.
Thus, the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 1-15 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached on (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
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