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 CON of 17/199,506 (03/12/2021 ABN)
17/199,506 is a CON of 16/945,996 (08/03/2020 ABN)
16/945,996 is a CON of 16/705,655 (12/06/2019 ABN)
16/705,655 is a CON of 16/391,425 (04/23/2019 ABN)
16/391,425 is a CON of 16/042,003 (07/23/2018 PAT 10307404)
16/042,003 is a CON of 14/775,357 (09/11/2015 PAT 10092549)
14/775,357 is a 371 of PCT/US2014/027589 (03/14/2014)
PCT/US2014/027589 has PRO 61/784,681 (03/14/2013).
Status
Claims 1, 4, 6, 10-17, 20-28 are pending.
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.
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, 4, 6, 10-17, 20-28 are rejected under 35 U.S.C. 103 as being unpatentable over Gant et al. (US20020151573) in view of Chong et al. (US20100010082).
Gant teaches “a pharmaceutical composition for treating a disease related to vasculogenesis or angiogenesis” ([0046]) including treating “diabetic retinopathy” with compounds including that of Example 2 ([0085]) “hydrochloride salt of 3-(4-Bromo-2,6-difluoro-benzyloxy)-5-[3-(4-pyrrolidin-1-yl-butyl)-ureido]-isothiazole-4-carboxylic Acid Amide” having the following structure:
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Gant teaches the compound for treatment of ocular diseases such as, diabetic retinopathy, age-related macular degeneration, intraocular melanoma, etc. ([0046], [0051], [0053]). Gant teaches various routes of administration, including topical ([0074]), solution or suspension ([0077]-[0079]); the amount of the compound will be dependent on the subject treated, the severity of the disorder or condition, the rate of administration and the judgement of the physician and an effective dose in the range of about 0.001 to about 100 mg/kg per day ([0074]-[0075]). Gant teaches that one of ordinary skill in the art would know how to formulate the compound in a pharmaceutical composition and cites Remington ([0080]: “For examples, see Remington's Pharmaceutical Sciences, Mack Publishing Company”).
Gant does not teach the particular formulation of the claims.
Chong teaches formulations for treating eye/ocular disorders with ophthalmic solutions (Title, Abstract). Chong teaches ocular solutions comprising tromethamine, glycerin (Examples 1-2, [0059]-[0067]; claims 12-14) and carboxymethylcellulose (CMC) ([0036], [0039]; claims 12, 13, 15, 16) and poloxamer ([0036], [0038]; claims 12, 15) with the active agent, sodium mycophenolic acid (NaMPA), present at 0.1 to 2.0 w/v% (claim 5; Example 2, Table 2, [0066]) at a pH including “about 6.0” ([0030]; claim 1). Chong also teaches treating conditions including “diabetic retinal edema” ([0008], claim 24) “macular degeneration” ([0046], claim 24), “vascular diseases (e.g., retinal ischemia, retinal vasculitis, choroidal vascular insufficiency, choroidal thrombosis)” ([0008], claim 24).
One of ordinary skill in the art following the teaching of Gant would have considered using known formulations useful for treating the same conditions such as taught by Chong. One of ordinary skill in the art would have considered routine substituting Chong’s active agent of NaMPA for Gant’s compound as they are in the same field of endeavor and for the same therapeutic use. One of ordinary skill in the art would have also had a reasonable expectation of success in the combination because Gant and Chong are in the same field of endeavor and for the same therapeutic use.
As taught by Gant, one of ordinary skill in the art would have known how to formulate the composition using well-known techniques and routine optimization. In addition, the optimization of particular ratios of ingredients of formulations are results effective variables and the modification of which are typically made by one of ordinary skill in the art to improve efficacy and stability. Generally, such differences will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such a difference 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); MPEP 2144.05. Furthermore, as per MPEP 2144.05:
[A] prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. “The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.”). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); 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%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Becket, 88 F.2d 684 (CCPA 1937) (“Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys.”); In re Dreyfus, 73 F.2d 931, 934, 24 USPQ 52, 55 (CCPA 1934)(the prior art, which taught about 0.7:1 of alkali to water, renders unpatentable a claim that increased the proportion to at least 1:1 because there was no showing that the claimed proportions were critical); In re Lilienfeld, 67 F.2d 920, 924, 20 USPQ 53, 57 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an alkali cellulose with varying higher ranges of water (e.g., “not substantially less than 13%,” “not substantially below 17%,” and “between about 13[%] and 20%”); K-Swiss Inc. v. Glide N Lock GmbH, 567 Fed. App'x 906 (Fed. Cir. 2014)(reversing the Board's decision, in an appeal of an inter partes reexamination proceeding, that certain claims were not prima facie obvious due to non-overlapping ranges); In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of “less than 6 pounds per cubic feet” and the prior art range of “between 6 lbs./ft3 and 25 lbs./ft3” were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.).
An improvement in the art would have been obvious if “it is likely the product not of innovation but of ordinary skill and common sense.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Finding workable or optimal ranges is generally understood as within the capabilities of the ordinary artisan. See Pfizer Inc. v. Apotex Inc., 82 USPQ2d 1321 (Fed. Cir. 2007) (discovery of an optimum value of a variable in a known process is usually obvious.). The idea that optimizing an ordinary variable does not by itself constitute a patentable advance was also stated in In re Geisler, 43 USPQ2d 1362: “…“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). Only if the “results of optimizing a variable” are “unexpectedly good” can a patent be obtained for the claimed critical range. In re Antonie, 559 F.2d 618, 620, 195 USPQ 6, 8 (CCPA 1977); see also In re Dillon , 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed.Cir. 1990) (in banc).” Note MPEP §2144.05(II)(A) on this issue. Likewise, optimization of a range or other variable within the claims flows from the “normal desire of scientists or artisans to improve upon what is already generally known.” In re Peterson, 65 USPQ2d 1379, 1382. See also In re Boesch, 617 F.2d 272, 276 (C.C.P.A. 1980): “[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.”; In re Esterhoy, 440 F.2d 1386, 1389 (C.C.P.A. 1971): “The conditions recited in the claims appear to us to be only optimum and easily ascertained by routine experimentation.”; In re Swentzel, 219 F.2d 216, 219 (C.C.P.A. 1955): “the determination of that desired size under the present circumstances involves nothing more than routine experimentation and exercise of the judgment of one skilled in the art.”; In re Swain, 156 F.2d 246, 247-48 (C.C.P.A. 1946): “In the absence of a proper showing of an unexpected and superior result over the disclosure of the prior art, no invention is involved in a result obtained by experimentation.” See also In re Kulling, 14 USPQ2d 1056 and In re Malagari, 182 USPQ 549, 553.
Moreover, In re Huang, 40 USPQ2d 1685, 1688 states that even if the “modification results in great improvement and utility over the prior art, it may still not be patentable if the modification was within the capabilities of one skilled in the art, unless the claimed ranges “produce a new and unexpected result which is different in kind and not merely in degree from the results of the prior art.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (C.C.P.A. 1955); see In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (Fed.Cir. 1990).” Note similar language in In re Waymouth and Koury, 182 USPQ 290 (“a difference in kind, rather than in degree.”).
In this case the prior art teaches the same elements in similar amounts that are within a scope that one of ordinary skill in the art would consider in routine optimization such that a prima facie case of obviousness has been established. Thus, claims 1, 4, 6, 10-13, 21-28 are rejected.
Regarding claims 14-17 and 20, Gant teaches “treating a disease related to vasculogenesis” including “diabetic retinopathy” and “age-related macular degeneration” ([0046]) and Chong teaches macular edema, macular degeneration, and ), “vascular diseases (e.g., retinal ischemia, retinal vasculitis, choroidal vascular insufficiency, choroidal thrombosis)” ([0008], claim 24) in the context of neovascular diseases such that one of ordinary skill in the art would at once envisage the claimed invention. See MPEP 2131.02.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
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, 4, 6, 10-17, 20-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent Nos. 9,446,026; 9,623,011; 9,814,702; 10,092,549; 10,183,014 and 10,307,404 in view of Gant et al. (US20020151573) and Chong et al. (US20100010082) as detailed supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and those of the reference patents are drawn to the same formulations comprising the same active agent and excipients or obvious variations thereof. The methods of use instantly claimed are also set forth in the reference disclosures (see for example, ‘011, ‘014, ‘404, col. 3, lines 10-36; ‘026, ‘702, ‘549, col. 3, lines 6-32).
Claims 1, 4, 6, 10-17, 20-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19062440 in view of Gant et al. (US20020151573) and Chong et al. (US20100010082) as detailed supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and those of the reference patents are drawn to the same formulations comprising the same active agent and excipients or obvious variations thereof.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626