DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Terminal Disclaimer, Amendments to the Claims and Arguments/Remarks filed 02 February 2026, in response to the Office Correspondence dated 05 November 2025, are acknowledged.
The listing of Claims filed 02 February 2026, have been examined. Claims 1-14 and 16-19 are pending. Claims 1, 2, 4-7, 9, and 14 are amended and are supported by the originally-filed disclosure. Claim 15 is canceled and new claims 16-19 have been added.
Response to Amendment
The amendments are acknowledged and entered. However, for the reasons set forth below, the rejections are maintained in part and new rejections are made.
The objection to claim 1 regarding the duplicated “a)” has been overcome by amendment. Accordingly, this objection is withdrawn. The prior rejection under 35 U.S.C. § 101, 35 USC § 112(b), 35 U.S.C. § 103, nonstatutory double patenting, and provisional nonstatutory double patenting of claim 15 is moot, as to claim 15 has been canceled.
Regarding the rejection of claims 1-14 under 35 USC § 112(b), the applicant's amendments have cured the identified informalities, including removal of the duplicate "a)" designation, deletion of "preferably" limitations, correction of antecedent basis issues, and amendment of claim 14 to proper dependent form. However, the rejection of claims 1-14 under 35 USC § 112(b) related to the process versus product characterization and concerning overlap between components is maintained for the reasons set forth below in the Response to Arguments.
The rejection of claims 1, 4-7, and 9, as indefinite under 35 USC § 112(b) or using the term “preferably” in the claim and claim 1 for the use “comprising or consisting of” are withdrawn as issues have been removed from the claims by amendment. The rejections of claims 2, 12 and 14 base on the lack of antecedent basis are withdrawn as the issues have been corrected by amendment to the claims.
The applicant's traversing arguments have been considered but found unpersuasive. The rejection of claims 1-14 under 35 U.S.C. § 103 over Guha in view of Wang is maintained and new grounds of rejection under 35 U.S.C. § 103 for newly added claims 16-19 have been made for the reasons set forth below.
The nonstatutory double patenting rejections of claims 1-14 over claims 1-8 of US Patent No. 11,980,692 and claims 1, 2, 5, 6, 19, 20, 23 and 24 of US Patent No. 9,844,511 B2 are maintained, as the applicant's request for withdrawal based on traversing the underlying obviousness rejection is not persuasive. The terminal disclaimer filed with respect to claims 1-4 and 7-16 of co-pending US Application No. 18/563,327 and claims 1-9, 12, and 14-16 of co-pending US Application No. 18/577,357 is acknowledged, and the provisional rejections of claims 1-14 are accordingly withdrawn.
New grounds of objection to amended claims 4 and 6, and new grounds of rejection under 35 U.S.C. § 112(b) are for newly added claims 16-19 are made as set forth below, in addition to the previously mentioned new grounds of rejection under 35 U.S.C. § 103 for newly added claims 16-19.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 05 November 2025, since the art which was previously cited continues to read on the amended/newly cited limitations.
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 Applicant regards as his invention.
Claims 1-14 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, regards as the invention.
Claim 1 is not understood because it is directed towards a process of forming a coated capsule however, the claims detail a composition and structure defined primarily by its components (a product) without sufficient recitation of concrete process steps or any specific processing conditions (e.g., solvent ratios, drying conditions, coating method) or any physical manipulation of the capsule that is necessary to transform the raw materials into a finished capsule coating. The "pre-locked state" is a condition of use of the conventional capsule, not a transformation imparted by the process itself. Thus, the claim is not "directed to" a method of manufacture/process, rather a product/composition which renders the claim and dependent claims 2-15 ambiguous as well since they fail to cure the defect. To overcome this rejection, the Applicant may amend the claims to include specific process steps that effect a transformation of a physical article and demonstrate a practical application (e.g., “wherein the coating is applied by fluidized bed coating at a temperature of X °C and dried to yield a film with Y% weight gain”) or amend the claims to be consistent with product claims.
Claim 1 is rejected because there is an overlap between the features, wherein some components can fall within the scope of other components (e.g., component (c) can fall within the scope of component (d); see Guha et al. (WO2019096833A1; referenced below, page 23, lines 33 and 34). There is no requirement in the present claims that a particular component must be different to a different component (e.g., component (c) vs. (d)), thus the scope of the claim is unclear. There remains no requirement that these components be distinct, resulting in potential double counting of the same material and ambiguous compositional boundaries. A relevant overlap between the feature in claim 1 (b) of an alkali or ammonium salt of a saturated aliphatic monocarboxylic acid having 10 to 30 carbon atoms, which preferably is sodium stearate (claim 4), and the additional glidant of claim 6, which may be a stearate salt.
For these reasons, the metes and bounds of the claimed subject matter cannot be determined with reasonable certainty, as required by MPEP §2173.02. Dependent claims 2-14 are included in this rejection because they do not cure the defect noted above. Applicant may overcome these rejections by amending the claims to clarify the claim language.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. § 102 and 103 (or as subject to pre-AIA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-14 are rejected under 35 U.S.C. § 103 as being unpatentable over Guha et al. (WO2019096833A1; published 23 May 2019, hereinafter referred to as “Guha”) in view of Wang et al. (Lubrication in tablet formulations, European Journal of Pharmaceutics and Biopharmaceutics, Volume 75, Issue 1, 2010, Pages 1-15; published May 2010, hereinafter referred to as "Wang").
Guha discloses a process for preparing a polymer-coated hard shell capsule, suitable as container for pharmaceutical or nutraceutical biologically active ingredients, wherein the hard shell capsule comprises a body and a cap, wherein in the closed state the cap overlaps the body either in a pre-locked state or in a final-locked state, wherein the hard shell capsule is provided in the pre-locked state and coated with a coating solution, suspension or dispersion (claim 1; Example 2 and C4 Vcaps®) wherein in Example 2, Vcaps® Plus hydroxypropyl methyl cellulose (HMPC; see claim 4) capsules were coated in the pre-locked state with a colon targeting coating dispersions comprising a mix of 4 mg/cm2 Eudragit® FS 30 D (236 g) and 1 mg/cm2 Eudragit® L 30 D-55 (59 g), with 7.55 g glyceryl monostearate (3.2% the weight of the (meth)acrylate copolymer Eudragit® FS 30 D), 27.81 g polysorbate 80 non-ionic emulsifier (11.78% the weight of the (meth)acrylate copolymer Eudragit® FS 30 D, 9.46 g triethyl citrate plasticizer (4.0% the weight of the (meth)acrylate copolymer Eudragit® FS 30 D), and 425.34 g water (page 37, Example 2). See also Example C4 (page 43).
Eudragit® FS 30 D is a dispersion of 30% by weight Eudragit® FS which is a (meth)acrylate copolymer comprising polymerized units of 25% by weight methyl methacrylate C1-to C4-alkylesters of acrylic acid and 65% by weight methyl acrylate C1-to-C4 alkyl ester of acrylic acid for a total of 90% and 10% by weight methacrylic acid. Eudragit® L 30 D-55 is a dispersion of 30% by weight Eudragit® L 100-55 which is a copolymer polymerized from 50% by weight ethyl acrylate and 50% by weight methacrylic acid (page 32, lines 5-11). Thus, the instant claimed ranges substantially overlap with that of what is taught by Guha and optimizing the content within a known range to achieve desired release properties is obvious and routine for one skilled in the art.
Guha also teaches wherein the body and the cap are comprising encircling notches or dimples in the area where the cap overlaps the body, that allow the capsule to be closed by a snap-into-place mechanism either in the pre-locked state or in the final-locked state (claim 11), wherein the body comprises a tapered rim (claim 12) and the coating layer is applied in an amount of about 0.7 to 20 mg/cm2 (claim 13), wherein a polymer-coated hard-shell capsule is obtained from a process (claim 14) wherein the invention is preferably used for enteric [delayed] or sustained release formulated pharmaceutical or nutraceutical dosage forms (page 21, lines 15-17).
In addition, glidants or releasing agents may be added to prevent agglomeration including talc, Mg- or Ca-stearate, ground silica, kaolin or nonionic emulsifiers (HLB value of between 2 and 8) with standard proportions for use in the inventive coating and binding agents ranging between 0.5-100 % by weight relative to polymer (page 24, lines 21-24). Example embodiments include preferably 30-70% by weight of the inventive polymer of talc (page 24, lines 30-31), within the range of instant claim 6. In other embodiments 5-30% (w/w) solid content glidants or releasing agents [such as the disclosed Mg- or Ca-stearate] can be applied (page 24, lines 26-27), strongly overlapping with the range of instant claim one for the alkali or ammonium salt of a saturated aliphatic monocarboxylic acid having 10 to 30 carbon atoms, such as sodium stearate recited in instant claim 4. However, Guha does not explicitly teach the use of at least one alkali or ammonium salt of a saturated aliphatic monocarboxylic acid having 10 to 30 carbon atoms, such as sodium stearate.
Wang teaches, “Mg stearate, aluminum stearate, calcium stearate, sodium stearate, and zinc stearate are a few examples in this group of lubricants…Mg stearate can be replaced with sodium stearate or calcium stearate if Mg stearate cannot be used in the formulation due to chemical stability concerns.” (page 3, paragraph 2). Thus, it was known at the time of the invention that common lubricants used in pharmaceutical excipient formulations such as magnesium or calcium stearate can be substituted with sodium stearate to optimize formulations. The instant specification experimental data do not show that the release at pH value 7.2 for hard shell capsules can only be obtained by the specific coating composition containing saturated aliphatic monocarboxylic acid alkali or ammonium salts or that the salts would bring about an unexpected effect.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to substitute the Mg- or Ca-stearate in the invention of Guha for sodium stearate, a known alternative in pharmaceutical formulation to the invention (as evidence by Wang), with a reasonable expectation of success. Adjusting the relative percentages of the formulation ingredients, including the carboxylic salt, would be a matter of routine experimental optimization for a person skilled in the art. One would be motivated to make the change because it is known to be used for the same purpose and may be used to avoid formulation incompatibilities with magnesium or calcium leading to stability or performance issues, to optimize processing management or to improve dissolution wettability (more hydrophilic) or bioavailability of an active agent.
The other features claimed in the dependent claims are rendered obvious by the cited prior art directly or represent matters of common practice to a skilled person (e.g., represent mere known alternative embodiments to the process). No further technical effect or unexpected results were demonstrated to be obtained by these features. The instant claimed capsule itself, defined only by its process of manufacture, does not possess any unexpected or distinguishing properties over a capsule that would be produced by the teachings of Guha particularity in light of Wang.
Further, evidentiary reference Schwarz (US-20050037073-A1; published 17 February 2005) teaches the use of sodium stearate in compositions for pharmaceutical dosage forms to modify release properties (claim 24) and evidentiary reference Holzer et al. (US-20040058001-A1; published 25 March 2004) teaches the use of sodium stearyl fumarate, which is chemically very similar to sodium stearate and functions as a lubricant/anti-tacking agent in coatings, in film coating composition for pharmaceutical formulations that comprises an acrylic polymer dispersion (e.g., an ethylacrylate/methylmethacrylate copolymer such as Eudragit® NE30D) in a water-containing liquid to achieve controlled/modified release properties (Abstract).
Regarding the hard-shell capsule base materials of instant claim 2 (i.e., HPMC, starch, gelatin, pullulan), evidentiary reference Cade et al. (US-20070087939-A1; published 19 April 2007) further teaches the use of pullulan (claim 3), starch derivatives (claim 5), and cellulose derivatives (claim 5, including HPMC ¶[0012]) as replacements for gelatin in hard capsule shells. The application explicitly discusses gelatin as the conventional material for forming hard capsule shells (¶[0003]) and then teaches HPMC, pullulan, and starch derivatives as alternatives.
Evidentiary reference Ohira et al. (JP-S5949840-A; published 22 March 1984) further teaches the glidants of claim 6 as a sticking preventive agent selected from a group that includes talc, magnesium stearate, and both forms of silica (hydrous silicic acid or light silicic anhydride; Abstract), while applied to granules for pharmaceuticals, it would have been obvious to use these agents taught by Ohira for the same purpose of preventing sticking in methacrylate copolymer coatings for pharmaceutical dosage forms.
Regarding the capsule structural features of claims 10 and 11 (i.e., notches, dimples, tapered rim), evidentiary reference Graham et al. (US-3664495-A; published 23 May 1972) further teaches a hard-shell pharmaceutical capsule with joinable cap and body parts that can be joined in a first pre-locking position (partial assembly) and optionally in another more completely joined (final-locked; complete assembly) position (Abstract), wherein the "encircling notches and dimples" correspond to what the patent calls "capsule indents" in the cap with specific slopes of about 8°-12° that interact with the body to provide the two locking states (claim 1). The patent also notes that this construction prevents the parts from popping apart (snap-into-place mechanism via elastic distortion and air release) during assembly, avoiding any tendency for the cap and body to separate inadvertently. In addition, evidentiary reference Wang et al. (US-20110097397-A1; published 28 April 2011) further teaches a tapered rim on the capsule body (claim 1; claim 9 including a bevel angle of from about 4° to 10°; and claim 10 including a bevel length from 0.5-1.5 mm) configured to prevent contact with the cap portion in the closed position, thereby reducing breakage and damage during closing.
Claim Rejections – Nonstatutory 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).
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of Patent No. US 11,980,692 and claims 1, 2, 5, 6, 19, 20, 23 and 24 of Patent No. US 9,844,511 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
The WO-2019096833-A1 PCT (Guha reference cited above) disclosure corresponds to the US 11,980,692 B2 disclosure and as such, it is obvious for the same reasons as described above for Guha. Claim 1 of US 11,980,692 B2 discloses a method of preparing a polymer-coated hard-shell capsule by providing a pre-locked hard-shell capsule and applying a coating comprising (meth)acrylate copolymer, plasticizer, and additives, then drying and optionally filling in final locking. The key differences between the instant application and US 11,980,692 B2 include the instant application’s limitation as to the co-polymer percentages restricting meth)acrylate copolymer to 5–25 % methacrylic acid and 75–95 % (meth)acrylic esters. As noted above, Guha discloses examples using overlapping ranges of these methacrylic/ester proportions (e.g. 10–30 % methacrylic acid, 50–70 % methyl acrylate, 5–15 % methacrylic acid) in its specification.
The selection of a specific alkali salt of a saturated aliphatic acid (e.g. sodium stearate) in 1–25 wt % is a further narrowing. The salts of long chain fatty acids (e.g. stearate) are well known glidants or surfactant additives in coatings, and substituting a known salt is within routine optimization. Inclusion of glycerol monostearate/distearate is similarly a known excipient in coating formulations and use is disclosed in the US 11,980,692 B2 Formulation Example 2, 3, C4 and 5. The use of glidants such as silica, talc, stearate salts, etc., is conventional in coatings and use is disclosed in the US 11,980,692 B2 Formulation Example 10. The step of applying ~0.7 to 20 mg/cm² is a subrange within the broader range of 1 to 8 mg/cm² in claim 8 of US 11,980,692 B2 and thus is obvious to a formulator. The optional features notches/dimples, tapered rim are structural capsule modifications known in the art of capsule design and could be combined with the coating process without inventive effort.
Because the instant claims recite only narrower subranges, conventional additives or structural modifications over the earlier claimed invention of US 11,980,692 B2, the differences would have been obvious to a skilled artisan and hence are not patentably distinct from claims 1-8 of US 11,980,692 B2.
US 9,844,511 B2 relates to coating of pharmaceutical dosage forms and includes processes of applying methacrylate copolymers coatings to drug forms for modified release or enteric protection.
The coating step of instant claim 1 including the polymer, salt, plasticizer and optional additive is mapped to US 9,844,511 B2 coating claims 1, 2, 5, 6, 19, 20, 23 and 24. The use of methacrylic acid/alkyl ester copolymer is conventional. The explicit structural context of a hard-shell capsule and pre-locked overlap is not recited in US 9,844,511, but applying known coatings to a new substrate (i.e., hard shell capsule) is a mere adaptation of known coating techniques to a known substrate that is obvious to a formulator. The specific subranges of monomer ratios, salt percentages, plasticizer percentages, etc. routine optimizations within the known ranges of US 9,844,511 or common coating art.
The inclusion of glidant/excipient blends, stearic salts, silica, etc., is well known in coating formulations; substituting or adding those is obvious. The step of specifying a coating thickness in mg/cm² is a standard measure in coating art, and the particular amounts would be within the predictable range of the art. The capsule-specific structural features (e.g., notches, dimples, tapered rim) are independent of the coating chemistry and are obvious modifications from capsule art. Combining known capsule features with a known coating method is routine.
The instant claims differ from the US 9,844,511 coating claims 1, 2, 5, 6, 19, 20, 23 and 24 only by routine optimization, substrate substitution, and minor structural details known in the art, and thus are not patentably distinct. A person of ordinary skill, seeking to provide an enteric release function to the capsule of the patent US 9,844,511 B2, would have found it obvious to use the standard capsules with the structural features detailed in the instant claims.
To overcome this rejection, Applicant may file a Terminal Disclaimer to obviate the rejections or claims must be amended to be patentably distinct over all cited references that is not an obvious variant of what is claimed in the cited references.
New Rejections
The following new rejections are made from the previous Office Correspondence dated 05 November 2025, as the Applicant's amendment necessitated the new grounds of rejection presented below based on the amended/newly cited limitations.
Claim Objections
Claims 4 and 6 are objected to because of the following informalities:
Claim 4 is objected to for scientific inaccuracy. Claim 4 recites “hexadecenoic acid (palmitic acid, C16)", wherein hexadecenoic acid is an unsaturated fatty acid, while palmitic acid, C16 is hexadecanoic acid (saturated), rendering the claim internally inconsistent. Claim 4 recites "heneicosanoic acid (behenic acid, C22)", wherein heneicosanoic acid has 21 carbon atoms (C21), while docosanoic acid has 22 carbon atoms and is behenic acid, C22. The spelling of "ceratic acid" should be "cerotic acid”. Appropriate correction is required.
Claim 6 recites "kaolin calcium silicate" and is missing comma between "kaolin" and "calcium silicate". Claim 6 also recites "colloidal silicone dioxide", which should be "colloidal silicon dioxide”. Appropriate correction is required.
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 Applicant regards as his invention.
Claims 16-19 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, regards as the invention.
Claims 16-19 are rejected as indefinite for incorporating functional release limitations without resolving the ambiguity of the underlying process and overlap between components of claim 1 in which they directly or indirectly depend from (see maintained 35 U.S.C. § 112(b) rejections of claim 1 outlined above).
In addition, 16 and 18 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention.
Claims 16 and 18 each recite "the main portion of the pharmaceutical or nutraceutical biologically active ingredient is released within about 1h after the pH value of 7.2 has been reached". The term "main portion" is indefinite because it fails to provide an objective boundary for a person of ordinary skill in the art to determine with reasonable certainty what percentage of the active ingredient constitutes the "main portion". For example, it is unclear whether "main portion" means greater than 50%, greater than 75%, greater than 90%, or some other percentage. Claims 17 and 19 attempt to define "main portion" by requiring "at least about 81%", but claims 16 and 18 do not incorporate this limitation, leaving the scope of claims 16 and 18 uncertain. A person of ordinary skill in the art cannot determine whether a formulation releasing 60% of the active ingredient within one hour falls within or outside the scope of claims 16 or 18 (see Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014)). This indefiniteness is not cured by reference to the specification, as the specification at page 1, lines 34-36 and the tables on pages 31-32 do not define the term "main portion".
Claims 16-19 are further rejected under 35 U.S.C. § 112(b) because the phrase "within about 1h after the pH value of 7.2 has been reached" is indefinite. The claims do not specify whether the pH value of 7.2 is measured in vitro (e.g., in a dissolution apparatus) or in vivo (e.g., in the human colon). Moreover, the claims do not specify the conditions under which the pH value is reached or maintained (e.g., buffer composition, temperature, agitation). Without such parameters, a person of ordinary skill in the art cannot determine with reasonable certainty when the "pH value of 7.2 has been reached" for purposes of measuring the release time (see MPEP § 2173.05(g), wherein functional limitations must be based on reliable and well-established parameters).
To overcome these rejections the applicant may consider amending the claims to define the testing conditions (e.g., media composition, agitation, apparatus, temperature) and define what constitutes “main portion”.
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-AlA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AlA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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, 14, and 16-19 are rejected under 35 U.S.C. § 103 as being unpatentable over Guha et al. (WO2019096833A1; published 23 May 2019, hereinafter referred to as “Guha”) in view of Wang et al. (Lubrication in tablet formulations, European Journal of Pharmaceutics and Biopharmaceutics, Volume 75, Issue 1, 2010, Pages 1-15; published May 2010, hereinafter referred to as "Wang"), and in further view of Beckert et al. (US-20020192282-A1; published 19 December 2002, hereinafter referred to as “Beckert”) and Singh (Modified-release solid formulations for colonic delivery. Recent Pat Drug Deliv Formul. 2007;1(1):53-63).
Guha and Wang teach the limitations of instant claims 1 and 14, as discussed above, from which instant claims 16 and 17 and 18 and 19 depend, respectively.
Guha teaches colon-targeted release formulations using Eudragit® FS 30 D, a copolymer that dissolves at pH 7.0 or above. A person of ordinary skill in the art would recognize that the dissolution rate of such coatings at pH 7.2 is a function of coating thickness, copolymer composition, and plasticizer content, which are all variables taught by Guha. Optimizing these variables to achieve a particular dissolution profile (e.g., >80% release within 1 hour at a target pH) is a routine matter of experimental optimization, not an inventive step (see In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012), wherein optimizing a result-effective variable is a matter of routine experimentation.
The applicant's reliance on the data from Examples 2 and 4-6 (specification pages 31-32) does not confer patentability. Example 6 shows 81-100% release within 1 hour at pH 7.2, but the applicant has not demonstrated that this result is unexpected or that the claimed ranges are critical. A person of ordinary skill in the art seeking to achieve rapid release at pH 7.2 would simply adjust the coating formulation parameters within the ranges already taught by Guha, with a reasonable expectation of success. The claimed release profile is a predictable result of adjusting known formulation variables.
Additionally, Beckert teaches colon-targeted release with a defined release profile at pH 7.0 specifically using a multilayer system with an outer coating of an anionic (meth)acrylate copolymer coating (Abstract; similar to EUDRAGIT® S or L) that dissolves at higher pH. The patent explicitly aims to release the drug "shortly before or only in the colonic region" (¶[0006]). The patent teaches that in the USP quantitative release test specification (i.e., 2 hours at pH 1.2 followed by a buffer change to pH 7.0), the release should be less than 5% up to 2.0 hours (gastric protection) and 30 to 80% at 8 hours after the start of the test (¶[0006]), covering pH 7.0-triggered release (similar pH 7.2 target) using methacrylate copolymers, however it does not explicitly teach “main portion” or ≥ about 81% active ingredient release within about 1h after a pH value of 7.2 has been reached.
Singh teaches that pH-controlled systems are standard for colon targeting (page 2), wherein the final pH value in the colon is 7.0 ± 0.7 (page 2 paragraph 2) and optimal pH for dissolution of methacrylic acid copolymer Type B (EUDRAGIT® S-100 and EUDRAGIT® S12,5) is ≥7.0 (page 3, Table 1). Singh shows in Figure 3 that dissolution profiles of active ingredients (acetaminophen) from HPMC capsules can be tuned to release faster or slower by modifying the various quantity of methacrylic acid copolymer, wherein >95% release occurred within 10 minutes of reaching the higher pH (pH 6.8 buffer) when using a 7 mg/cm2 coating, having a faster release with less coating of 5 mg/cm2 and a slower release with more coating of 10 mg/cm2 (page 8). The pH buffer at 6.8 is intended to simulate colon pH wherein it is previously stated that this may vary ± 0.7, which would reasonably translate to encompass the instant claimed 7.2 pH and wherein the optimal pH of dissolution can be modified by methacrylic acid copolymer selection (see page 3, Table 1).
Collectively, these references teach that it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to tune the invention taught by Guha to arrive at the instant claimed main portion or ≥ 81% active ingredient release at pH 7.2, tuned for dissolution at this specific pH by methacrylic acid copolymer type/proportions as taught by Singh and tuned to release the main portion or ≥ 81% active ingredient in less than 1 hour once reaching a pH of 7.2 by adjusting the amount (mg/cm2) of coating applied as taught by Singh with a reasonable expectation of success.
It should also be noted that the limitation "within about 1h after the pH value of 7.2 has been reached" is a intended result of the process, not a structural or procedural limitation that distinguishes the claimed process from the prior art processes. Merely claiming a desired outcome without claiming the specific means by which that outcome is achieved does not render an otherwise obvious process non-obvious (see In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)).
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 02 February 2026, have been fully considered.
With regards to the 35 U.S.C. § 112(b) rejection of claims 1-14 related to the process versus product characterization, the applicant asserts that the addition of the step of providing the hard-shell capsule in the pre-locked state and coating resolves the issue. This is not persuasive. Claim 1 remains predominantly directed to a composition/product defined by its components, rather than a series of affirmative process steps that effect a transformation. Specifically, the claim does not recite how the coating is applied (e.g., spray-coating, dip-coating, fluidized bed coating). The claim does not recite processing parameters, which are necessary to define a manufacturing process that would enable a person of ordinary skill in the art to perform the claimed process with reasonable certainty. The “pre-locked state” remains a condition of the starting state of the capsule, but does not recite any physical transformation steps or conditions that distinguish the process from merely providing a capsule and a coating composition. Thus, the metes and bounds between a method claim and a product-by-process claim remain unclear (MPEP §2173.05(p)). The rejection of claim 1 and dependent claims 2-14 is maintained and extended to included new dependent claim 16-19.
Regarding the prior 35 U.S.C. § 112(b) rejection of claims 1-14 concerning overlap/ambiguity between components is maintained. The applicant argues that glycerol (component d) does not overlap with glycerol monostearate/distearate (component c). This is persuasive only with respect to that specific overlap, and the rejection is withdrawn to that extent. However, the following ambiguity remains, in respect to claim 1(b) alkali/ammonium salts of fatty acids (e.g., sodium stearate) and claim 6 glidants including stearate salts. There remains no requirement that these components be distinct, resulting in potential double counting of the same material and ambiguous compositional boundaries. Thus, the claims remain indefinite on this basis. Claims dependent therefrom are also held as indefinite as they do not cure the defects in claim 1. This deficiency extends to claims 16-19, which rely on an indefinite base claim.
Regarding the prior 35 U.S.C. § 103 rejection of claims 1-14, Guha teaches a process for coating pre-locked hard-shell capsules (HPMC Vcaps® Plus capsules coated in pre-locked state; Example 2), an aqueous dispersion coating solution, (meth)acrylate copolymer composition as Eudragit® FS 30 D (10% methacrylic acid, 65% methyl acrylate, 25% methyl methacrylate) with overlapping monomer ratios (5-25% methacrylic acid, 75-95% C1-C4 alkyl esters), glyceryl monostearate (Example 2), triethyl citrate as a plasticizer (Example 2), an optional emulsifier additive as polysorbate 80 (Example 2), and pH-dependent colon-targeted release. Guha teaches an application coating amount range of 0.7-20 mg/cm² for hard shell capsules (claim 13). Additionally, the Guha’s specification refers to a coating amount range of about 2-12 mg/cm² for enteric coatings (page 2, lines 4-10; citing WO 2015/177028 as a reference). Wang teaches the only major limitation missing from Guha, the alkali/ammonium salt of a saturated aliphatic monocarboxylic acid (C10-30) as sodium stearate, calcium stearate, magnesium stearate, and zinc stearate lubricants in pharmaceutical formulations, wherein magnesium stearate can be replaced with sodium stearate or calcium stearate.
The applicant argues that Guha does not identify problems that would motivate substitution of Mg/Ca stearate with alkali salts. This argument is not persuasive. The motivation to substitute lubricants in pharmaceutical formulations does not need to arise from a problem explicitly identified in Guha. Wang teaches that sodium stearate is a direct substitute for magnesium or calcium stearate "if Mg stearate cannot be used in the formulation due to chemical stability concerns" (page 3), thus, sodium stearate and related salts are interchangeable lubricants. A person of ordinary skill in the art would be motivated to consider alternative lubricants for any number of routine reasons (e.g., cost, availability, batch-to-batch consistency, compatibility with other excipients, wettability, dissolution performance, or regulatory preferences). The absence of an explicit problem in Guha does not negate obviousness. It is sufficient that the substitution is known in the art, and it would have yielded predictable results.
The applicant argues lack of reasonable expectation of success. This argument is not persuasive. Both references are within pharmaceutical formulation art and both relate to coating compositions and excipient functionality. Wang explicitly teaches that sodium stearate functions as a lubricant in tablet formulations, and Guha already teaches the use of stearate salts (Mg, Ca) in coating compositions for hard shell capsules. Substituting one known stearate salt for another, both having similar physicochemical properties (long-chain fatty acid salts), is a routine, predictable substitution. When the prior art teaches a genus (stearate salts) and a person of ordinary skill in the art knows that species within that genus are interchangeable for lubricant/glidant functions, thus substituting sodium for magnesium or calcium is predictable and this routine optimization would have a reasonable expectation of success. Thus, a person of ordinary skill in the art would reasonably expect comparable lubrication and dispersion effects and modifiable release characteristics through routine optimization.
The applicant argues that Examples 2 and 4-6 demonstrate unexpected accelerated release at pH 7.2, whereas Guha's Examples show release at pH 7.4 after about 25 minutes. This argument is not persuasive, Guha's release data at pH 7.4 is not directly comparable to applicant's data at pH 7.2. More critically, the applicant has not provided comparative data using the identical Guha formulation (without the alkali/ammonium salt) tested under identical conditions (pH 7.2). Without such a direct comparison, the applicant cannot establish that the inclusion of component (b) produces an unexpected effect. The specification demonstrates that certain formulations achieve release at pH 7.2, but it does not demonstrate that the claimed composition is superior to or qualitatively different from what a person of ordinary skill in the art would have expected from modifying Guha's teaching.
Furthermore, the fact that Guha's coatings release at pH 7.4 rather than 7.2 is a minor variation in dissolution threshold that a person of ordinary skill in the art would expect to be tunable by adjusting the methacrylic acid content of the copolymer (e.g., adding Eudragit® L 30 D-55 as Guha does) to shift the dissolution pH threshold, a routine optimization. Guha already teaches enteric/colon-targeted release behavior using Eudragit® FS 30 D, which is known to dissolve at pH 7.0 or above. The claimed pH 7.2 release is well within the predictable range for such copolymers. Small differences in release timing (e.g., 25 min vs. 1h window) are optimization of result-effective variables. No evidence of criticality across the full claimed scope (C10-C30 acids, 1-25 wt%; see In re Grasselli, 713 F.2d 731, Fed. Cir. (1983), wherein the data is limited to specific embodiments and does not demonstrate commensurate scope therefore provides no unexpected results sufficient to overcome prima facie obviousness).
Regarding the newly recited release profile limitations of new claims 16-19, these properties of the coating composition would be optimized through routine experimentation. Release pH thresholds (e.g., 6.8-7.5) are tunable via polymer blends and additives and fatty acid salts influence film permeability and erosion. Thus, tailoring release to pH 7.2 within ~1 hour represents routine fine-tuning of known enteric systems. Where the prior art teaches similar compositions, discovering an optimum release profile is obvious (see In re Aller, 220 F.2d 454, CCPA (1955)). Accordingly, claims 16-19 are also obvious.
The nonstatutory double patenting rejection over U.S. Patent No. 11,980,692 is maintained. The applicant’s arguments mirror those presented for §103 and are not persuasive for the same reasons. The claims differ only by narrowed ranges, inclusion of known excipients, and routine optimization. Thus, the claims are not patentably distinct. In addition, the nonstatutory double patenting rejection over U.S. Patent No. 9,844,511 is maintained. The applicant’s reliance on release profile differences is unpersuasive because functional results do not confer patentable distinction absent structural differences. The compositions remain obvious variants. The applicant's request for withdrawal based on traversing the underlying obviousness rejection is denied for the reasons stated above. The terminal disclaimer filed with respect to US Application Nos. 18/563,327 and 18/577,357 is acknowledged, and those provisional rejections are withdrawn as moot.
Conclusion
No claims are allowed.
The applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (87 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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