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 .
Claim of Foreign Priority
Applicant’s claim of foreign priority to application KR-10-2021-0078801 and Certified Copy of Foreign Priority are acknowledged. The Office has not received an English translation of those documents. As such, foreign priority has not yet been perfected.
Status of the Claims
Claims 1-9 are pending and examined.
Claim Objection
Claim 2 recites: “and a the dissolution” which appears intended to recite “and the dissolution.” Clarification is requested.
Specification
The use of the term Starcap 1500® in Table 2, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 2 and 3 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the claimed dependent limitations below are purely functional recitation with no additional limitation of structure for a further limiting claim. For example, these claims recite:
Claim 2:
“has a dissolution rate at 15 minutes is 65% or more, a dissolution rate at 30 minutes is 80% or more, and a the dissolution rate at 60 minutes is 90% or more, as measured using 900 ml of pH 6.8 buffer as a dissolution medium, and a paddle with a rotation speed of 50 rpm.”; and
Claim 3:
“does not have a dissolution at 60 minutes, when a pH 1.2 buffer or a pH 4.5 buffer is used as a dissolution medium, and a paddle with a rotation speed of 50 rpm is used.”
The above examples are the dependent limitations, which are required to be further limiting, although there are no further limiting structural limitations or steps. A functional result is merely claimed.
These functional recitations therefore include any and all possible structures (composition ingredients and formulation techniques) to achieve the result/function. This type of claiming results in a single means claim, i.e., where a means recitation does not appear in combination with another recited element of means, is subject to an enablement rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714-715, 218 USPQ 195, 197 (Fed. Cir. 1983) (A single means claim which covered every conceivable means for achieving the stated purpose was held nonenabling for the scope of the claim because the specification disclosed at most only those means known to the inventor.). When claims depend on a recited property, a fact situation comparable to Hyatt is possible, where the claim covers every conceivable structure (means) for achieving the stated property (result) while the specification discloses at most only those known to the inventor.
Applicant is reminded that 35 U.S.C. § 112, sixth paragraph, when enacted, was a statutory response to the Supreme Court’s decision in Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946); and was a way to use to limit the scope to what the inventor described in the specification.
This general prohibition against the use of “purely functional claim language” (and the more specific Halliburton rule) has not been completely eliminated. Rather, “purely functional claim language” is now permissible but only under the conditions of 35 U.S.C. § 112, sixth paragraph, i.e., if its scope is limited to the corresponding structure, material, or act disclosed in the specification and equivalents thereof.
In the absence of such limited construction, the concerns expressed by the Court in Halliburton are still applicable to prohibit the use of “purely functional” claim language. Hence, any claim that includes purely functional claim language, and which is not subject to the limited construction under 35 U.S.C. § 112, sixth paragraph, fails to meet the requirements of 35 U.S.C. § 112, first paragraph, according to reasoning in Halliburton and thus is unpatentable.
While the particular claim language involved in the Supreme Court's Halliburton decision uses the word “means,” the issue was claiming in a purely functional manner, a practice condemned by pre-existing case law, and not any particular problem associated uniquely with the word “means” as distinguished from other purely functional words and phrases. With regard to pre-existing case law around the time of the Supreme Court's Halliburton decision, see In re Fuetterer, 319 F.2d 259, 263 (CCPA 1963), wherein the Court of Customs and Patent Appeals explained:
In the Fullam case [In re Fullam, 161 F.2d 247 (CCPA 1947)], this court stated that some claims were properly rejected as “functional in claiming merely the desired result well known to and sought after by workers skilled in the art.” Claims directed merely to a “desired result” have long been considered objectionable primarily because they cover any means which anyone may ever discover of producing the result. See, e.g., O'Reilly v. Morse, 15 How. 62; Heidbrink v. McKesson, 290 F. 665.
When an applicant has not given notice to the public that his or her purely functional claim element is to be limited by the application of 35 U.S.C. § 112, sixth paragraph, a first USPTO concern is that the claim is indefinite under 35 U.S.C. § 112, second paragraph. A second USPTO concern is that such unlimited purely functional claiming may reasonably be construed to encompass any and all structures for performing the recited function, including those which are not what the applicant invented. Thus, it is doubly critical that the USPTO be in possession of such public notice when making a determination to grant a patent. That is, when the limitation encompasses any and all structures or acts for performing a recited function, including those which were not what the applicant had invented, the disclosure fails to provide a scope of enablement commensurate with the scope of the claim and the claim would violate the prohibition of Halliburton.
The Supreme Court’s Halliburton case remains viable for claims having purely functional claim language which is unlimited either by (1) the application of 35 U.S.C. § 112, sixth paragraph, or (2) the additional recitation of structure.
In the present case, these claim limitations violate the rule set forth in Halliburton, because the claims are not limited by the application of 35 U.S.C. § 112, sixth paragraph, and they do not contain any additional recitation of structure. As such, these claims are unpatentable under 35 U.S.C. § 112, first paragraph, for lack of an enabling disclosure commensurate with the scope of the claims.
Without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim. Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc). See also Datamize LLC v. Plumtree Software Inc., 75 USPQ2d 1801 (Fed. Cir. 2005) where a claim directed to a software based system for creating a customized computer interface screen recited that the screen be "aesthetically pleasing," which is an intended result and does not provide a clear cut indication of scope because it imposed no structural limits on the screen. Unlimited functional claim limitations that extend to all means or methods of resolving a problem may not be adequately supported by the written description or may not be commensurate in scope with the enabling disclosure, both of which are required by 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714, 218 USPQ 195, 197 (Fed. Cir. 1983); Ariad, 598 F.3d at 1340, 94 USPQ2d at 1167. For instance, a single means claim covering every conceivable means for achieving the stated result was held to be invalid under 35 U.S.C. 112, first paragraph because the court recognized that the specification, which disclosed only those means known to the inventor, was not commensurate in scope with the claim. Hyatt, 708 F.2d at 714-715, 218 USPQ at 197. For more information regarding the written description requirement and enablement requirement under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, see MPEP §§ 2161-2164.08(c). Examiners should keep in mind that whether or not the functional limitation complies with 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is a different issue from whether the limitation is properly supported under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, or is distinguished over the prior art.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 4-6 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Song et al., U.S. Pat. No. 8,729,273.
Song teaches compounds used as an API in a pharmaceutical composition. Preferred compounds include the claimed agent listed as the first example 1. See col. 10, lines 66-67. The composition can be administered orally with a variety of potential excipients. See col. 15, lines 44-47. Excipients that can be used for oral preparations include fillers, binders, and lubricants, e.g. All compositions include a suitable amount of active agent. See col. 16, lines 1-10. Enteric coating can be sued for tablets and pills. However, capsules are also a form for oral administration. See col. 15, lines 49-54. Compounds typically include 1 to 1,000 mg per day.
As such, claims 1 and 4-6 are anticipated by the prior art.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al., U.S. Pat. No. 8,729,273, in view of Gunawardhana et al., (US2014/0357683).
Song teaches compounds used as an API in a pharmaceutical composition. They are xanthine oxidate inhibitors for treating gout, e.g. See col. 1. Preferred compounds include the claimed agent listed as the first example 1. See col. 10, lines 66-67. The composition can be administered orally with a variety of potential excipients. See col. 15, lines 44-47. Excipients that can be used for oral preparations include fillers, binders, and lubricants, e.g. All compositions include a suitable amount of active agent. See col. 16, lines 1-10. Enteric coating can be sued for tablets and pills. However, capsules are also a form for oral administration. See col. 15, lines 49-54. Compounds typically include 1 to 1,000 mg per day.
With further regard to claim 9, the unit dosage is an amount not a method of administration. A unit dosage of 200 mg can be administered once or multiple times daily. The dosages claimed fall within the up to 1000 mg oral dosage taught by the prior art. In view of the known result-effective nature of the claimed API, it would be obvious to optimize a dosage to arrive at a desired effect. See M.P.E.P. § 2144.05.
Gunawardhana teaches xanthine oxidase inhibitors for treating gout and other conditions taught by Song to be treatable with the claimed xanthine oxidase inhibitor. The composition can be administered once, twice, or more daily depending on need and can be delayed, sustained or controlled release. See par. 140-144. The formulations can be designed to release independent of pH and avoid a dose dump after oral administration. See par. 144. Dosages forms include oral unit dosages of 80 mg, 120 mg, 240 mg, among others. See par. 149. Release profiles can include releasing 20% after 30 minutes or releasing 100% after 60 minutes. See par. 164. In examples, the concentration of xanthine oxidase inhibitors includes a concentration relative to the overall composition that is as much as 35%.
The examiner notes that an optimal percentage of API can be used in a tablet that can be controlled release. Further, there is no requirement that an enteric coating be used. Formulations that can have their released profiles controlled without regard to pH are taught. As such, it would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to combine the teachings of Song and Gunawardhana to arrive at a desired and optimizable release profile with a known API that is taught to be administered orally without a pH modifier. Utilizing a typical dosage and/or weight ratio of a known result effective API is obvious in light of the prior art.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al., U.S. Pat. No. 8,729,273, in view of Reiland Wakeman et al., (US2018/0360761).
Song teaches compounds used as an API in a pharmaceutical composition. They are xanthine oxidate inhibitors for treating gout, e.g. See col. 1. Preferred compounds include the claimed agent listed as the first example 1. See col. 10, lines 66-67. The composition can be administered orally with a variety of potential excipients. See col. 15, lines 44-47. Excipients that can be used for oral preparations include fillers, binders, and lubricants, e.g. All compositions include a suitable amount of active agent. See col. 16, lines 1-10. While an enteric coating can be used for tablets and pills, pH independent polymer coatings are also described, and thus, an enteric coating is not required. See par. 164. However, capsules are also a form for oral administration. See col. 15, lines 49-54. Compounds typically include 1 to 1,000 mg per day.
With further regard to claim 9, the unit dosage is an amount not a method of administration. A unit dosage of 200 mg can be administered once or multiple times daily. The dosages claimed fall within the up to 1000 mg oral dosage taught by the prior art. In view of the known result-effective nature of the claimed API, it would be obvious to optimize a dosage to arrive at a desired effect. See M.P.E.P. § 2144.05.
Reiland Wakeman teaches compositions comprising a xanthine oxidate inhibitors, such as febuxostat, e.g. See par. 126. It can be used to treat gout. See par.’s 126-127. The composition can be orally deliverable. See Abstract. Typically, the agent will be effective in a range of up to about 0.21 to 700 mg/day and the agent will be present in a composition in a range from 0.5 to 50% by weight of the composition. See par. 49.
The examiner notes that an optimal percentage of API can be used in a tablet that can be controlled release. Further, there is no requirement that an enteric coating be used. Formulations that can have their released profiles controlled without regard to pH are taught. As such, it would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to combine the teachings of Song and Gunawardhana to arrive at a desired and optimizable release profile with a known API that is taught to be administered orally without a pH modifier. Utilizing a typical dosage and/or weight ratio of a known result effective API is obvious in light of the prior art.
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 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. No. 8,729,273, in view of Gunawardhana et al., (US2014/0357683) and independently in view of Reiland Wakeman et al., (US2018/0360761) (as applied above). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘273 patent teaches compounds used as an API in a pharmaceutical composition. Preferred compounds include the claimed agent listed as the first example 1. See col. 10, lines 66-67. The composition can be administered orally with a variety of potential excipients. See col. 15, lines 44-47. Excipients that can be used for oral preparations include fillers, binders, and lubricants, e.g. All compositions include a suitable amount of active agent. See col. 16, lines 1-10. Enteric coating can be sued for tablets and pills. However, capsules are also a form for oral administration. See col. 15, lines 49-54. Compounds typically include 1 to 1,000 mg per day. The secondary references as described above teach percentage of API claimed which is optimizable and the tunability of release profile. As such it would have been prima facie obvious to arrive at the instant claims in view of those of the ‘273 patent.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/255,212. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘212 application are directed towards an oral formulation of claimed API with a percent API that overlaps that claimed and includes a dosage that overlaps the claimed dosages. There is no requirement that pH modifier be used. Further, any deviation in percentage of components and/or release profile would appear to be optimizable.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 18/555,226. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘226 application are directed towards an oral formulation of claimed API with a percent API that overlaps that claimed and includes a dosage that overlaps the claimed dosages. There is no requirement that pH modifier be used. Further, any deviation in percentage of components and/or release profile would appear to be optimizable. The claims of the ‘226 patent are narrower in a respect because they require a particle size distribution for the API. The instant application includes claims that are broader and encompasses the claims of the ‘226 application.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18/557,276, in view of Song et al., U.S. Pat. No. 8,729,273, in view of Gunawardhana et al., (US2014/0357683), and in view of Reiland Wakeman et al., (US2018/0360761). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘276 application are directed towards preparing the claimed API. In view of the cited secondary references, arriving at an oral dosage form at the claimed dosage amounts and an API with percentage of API relative to the weight of the composition as a whole are obvious. Further, any deviation in percentage of components and/or release profile would appear to be optimizable.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15-17, 20, 23-37 of copending Application No. 18/569,568, in view of Song et al., U.S. Pat. No. 8,729,273, in view of Gunawardhana et al., (US2014/0357683), and in view of Reiland Wakeman et al., (US2018/0360761). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘568 application are directed towards a product and/or a method that requires an oral form of claimed API to be administered at dosage that per day that falls within the claimed amount. In view of the cited secondary references, arriving at an oral dosage form at the claimed dosage amounts and an API with percentage of API relative to the weight of the composition as a whole are obvious. Further, any deviation in percentage of components and/or release profile would appear to be optimizable.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/818,183, in view of Song et al., U.S. Pat. No. 8,729,273, in view of Gunawardhana et al., (US2014/0357683), and in view of Reiland Wakeman et al., (US2018/0360761). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘183 application are directed towards a method that requires an oral form of claimed API to be administered at dosage that per day that falls within the claimed amount. In view of the cited secondary references, arriving at an oral dosage form at the claimed dosage amounts and an API with percentage of API relative to the weight of the composition as a whole are obvious. Further, any deviation in percentage of components and/or release profile would appear to be optimizable. The subject in the claimed co-pending method does not alter the fact that the product used can be the same and/or an obvious variant.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13-31 of copending Application No. 18/569,571, in view of Song et al., U.S. Pat. No. 8,729,273, in view of Gunawardhana et al., (US2014/0357683), and in view of Reiland Wakeman et al., (US2018/0360761). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘571 application are directed towards a method that requires an oral form of claimed API to be administered at dosage that per day that falls within the claimed amount. In view of the cited secondary references, arriving at an oral dosage form at the claimed dosage amounts and an API with percentage of API relative to the weight of the composition as a whole are obvious. Further, any deviation in percentage of components and/or release profile would appear to be optimizable. The subject in the claimed co-pending method does not alter the fact that the product used can be the same and/or an obvious variant.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/575,570, in view of Song et al., U.S. Pat. No. 8,729,273, in view of Gunawardhana et al., (US2014/0357683), and in view of Reiland Wakeman et al., (US2018/0360761). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘570 application are directed towards preparing the claimed API. In view of the cited secondary references, arriving at an oral dosage form at the claimed dosage amounts and an API with percentage of API relative to the weight of the composition as a whole are obvious. Further, any deviation in percentage of components and/or release profile would appear to be optimizable.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/575,630, in view of Song et al., U.S. Pat. No. 8,729,273, in view of Gunawardhana et al., (US2014/0357683), and in view of Reiland Wakeman et al., (US2018/0360761). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘630 application are directed towards preparing the claimed API. In view of the cited secondary references, arriving at an oral dosage form at the claimed dosage amounts and an API with percentage of API relative to the weight of the composition as a whole are obvious. Further, any deviation in percentage of components and/or release profile would appear to be optimizable.
The above rejections over patent applications are provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
As such, no claim is allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628