DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/18/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Status of the Claims
The response and amendment filed 09/18/2025 is acknowledged.
Claims 1-2, 4-5, 7-12, 14, 16, 18-19, 21-24, 26, and 39 are pending.
Applicant’s election without traverse of Group I, claims 1-2, 4-5, 7-12, 14, 16 in the reply filed on 09/18/2025 is acknowledged.
Claims 18-19, 21-24, 26, and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/18/2025.
Claims 1-2, 4-5, 7-12, 14, and 16 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 2 includes the term preferably at least in lines 3 and 4. The term "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The limitations following preferably are construed as optional. However, the term "preferably" should be deleted.
Clarification is required.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 12 includes the limitation that wherein the particles of a sugar, a sugar alcohol, or any mixture thereof are from 5 to 1000 times smaller in diameter than the core, and/or wherein the diameter of the granule is up to five times greater than the diameter of the core. The core is not structurally defined, and no core diameter is given, and therefore the diameter of the core cannot be determined. Neither the claim, nor the specification, defines what in particular makes up the core. Therefore, the diameter at which the core ends and the rest of the granule begins is arbitrary. Since it is not clear what structures, in particular, make up the “core,” the diameter of the core is indefinite. Since the diameter of the core is indefinite, the relative sizes recited in the claim are also indefinite.
Clarification is required.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 14 includes the term preferably at least in lines 5 and 7. The term "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The limitations following preferably are construed as optional. However, the term "preferably" should be deleted.
Clarification is required.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 5 includes the term preferably at least in line 4. The term "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The limitations following preferably are construed as optional. However, the term “preferably” should be deleted.
Clarification is required.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
1. Claim 4 includes the term such as at least in line 10. The term "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The limitations following preferably are construed as optional. However, the term “such as” should be deleted.
2. Claim 4 contains the trademark/trade name Kollidon® VA 64. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112, second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a vinylpyrrolidone- vinyl acetate copolymer and, accordingly, the identification/description is indefinite.
Claim 16 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
The terms “smooth” and “rough” in claim 16 are relative terms which renders the claim indefinite. The terms “smooth” and “rough” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The skilled artisan cannot determine how smooth or rough the coatings need to appear in order to meet the limitations of claim 16, particularly where there is no required degree of magnification for each layer. It is suggested to recite particle sizes for the particles in the “rough” coating layer to remedy this rejection.
Clarification is required.
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 1-2, 4-5, 7-12, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Fujii, WO 2019013310 A1.
Fujii teaches granules comprising a substantially spherical core containing an active pharmaceutical agent (API) and comprising multiple coatings, e.g. first and second coating layers. See Fujii, entire document, e.g., 0084, pp. 97-99, example 25. First coating layer reads on, compound A coating (Fujii, entire document, e.g., pg. 97:29-pg.98:3), and/or e.g., organic acid coating layer comprising a polymethacrylate copolymer (Fujii, entire document, e.g., pg. 98:5-11). See also additional coating layer obtained by water-insoluble polymer coating liquid (Fujii, e.g., pg. 98:23-29), i.e., first coating layer comprises two or more discrete sublayers. Polymer binders are found in ¶ spanning pp. 15-16.
Sugar alcohol outer coating layer is taught as a coagulation inhibiting substance (Fujii, e.g., 0025-0027, 0069, e.g., Table 1-2, 0071, e.g., Table 1-4, claims). Coagulation inhibiting substance may be saccharides or sugar alcohol, e.g., mannitol erythritol, trehalose, maltitol (Fujii, e.g., 0025, e.g., pg. 14:26-pg. 15:3, tables 1-2 and 1-4). Coagulation inhibiting substance may be applied as a suspension, i.e., resulting in particles on the outer layer, i.e., rough surface (Fujii, e.g., ¶ spanning pp. 19-20). Thus, the skilled artisan would have at once envisaged API granules having multiple polymeric subcoatings and an outer coagulating inhibiting substance coating containing saccharides or sugar alcohol in the form of particles. Even if applied as a solution, particles of mannitol having some size will be present, particularly after the coating is dried. Coagulation inhibiting substance may be applied with a binder (Fujii, e.g., 0025-0027, 0069, e.g., Table 1-2, 0071, e.g., Table 1-4, claims). Coagulation inhibiting substance is effective for taste masking (Fujii, e.g., 0095, experimental example 7, pg. 106).
Fujii does not expressly teach wherein at least 90% of the granules by number have a diameter of greater than 200 µm and in which at least 90% of the granules by number have a diameter of less than 1400 µm
However, Fujii teaches particle sizes which substantially overlap with the range recited in claim 11, e.g., about 75 micron to about 750 micron (Fujii, e.g., claim 7). Further, Fujii teaches 350 micron sieved particles which is a clearly disclosed value within the claimed range and specifically points to particles sized within the claimed range. The degree of overlap and additional guidance offers sufficient specificity to anticipate the range recited in claim 11. Inert cores are found in Fujii, e.g., 0036, pp. 21-22.
Separately, and applicable to claim 1, Fujii teaches granules comprising cellulose and hydroxypropylcellulose (food supplements) which granules also contain solid mannitol (particles of a sugar alcohol) and a mannitol binder. The process appears to result in a granule core which would contain mannitol particles in at least one coating layer surrounding the granule core. Since the binder liquid is sprayed over a period of time, the coating grows as particles agglomerate and further binder is applied. Thus, it can be said that the coating comprises many layers, e.g., first and second and so forth. See Fujii, e.g., pg. 99:16-30. This embodiment applies to claims 1-2, 5, 7-10, 12, 14, and 16.
Product by process limitations “in a high shear mixer” and “wet coating method,” and “fluid bed coating or high shear melt coating” do not imply any structural limitations beyond those expressly recited in the claims. Further, the prior art teaches wet coating methods including spraying of a binder solution on the granules.
Fujii anticipates the subject matter of instant claims 1-2, 4-5, 7-12, 14, and 16.
Claims 1-2, 4-5, 7, 9-10, 12, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Ecseri, WO 2015028829 A1 (cited on IDS dated 09/18/2025).
Ecseri teaches granules having a core containing an active ingredient (Ecseri, entire document, e.g., Abstract, claims). The granules further comprise a coating containing a polymer and particles of a sugar, e.g., sugar powder with dextrose and starch (Ecseri, e.g., claims 18-22 and example 1, pg. 9). The coating process results in multiple coatings, i.e., syrup and powder were progressively fed into the pan such that the granules were allowed to grow. Thus, the granules appear to have a first and second coating layer including discrete sublayers as claimed.
Product by process limitations “in a high shear mixer” and “wet coating method,” and “fluid bed coating or high shear melt coating” do not imply any structural limitations beyond those expressly recited in the claims. Further, the prior art teaches wet coating methods including addition of a binder solution to the granules.
Ecseri anticipates the subject matter of instant claims 1-2, 4-5, 7, 9-10, 12, 14, and 16.
Claims 1-2, 4-5, 7-12, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Kurasawa, US 20150037423.
Kurasawa teaches granules comprising a core and API, which granules also comprise a mannitol (water soluble sugar alcohol) outer coating covering a core containing a drug layer and two additional polymer coatings, and wherein the particle size range is entirely within the claimed range, e.g., 250-425 microns (Kurasawa, entire document, e.g., examples, e.g., 0308-0314, production examples 28-34 and claims). Since the particle size is entirely within the claimed range, the limitation of wherein at least 90% of the granules by number have a diameter of greater than 200 µm and in which at least 90% of the granules by number have a diameter of less than 1400 µm is met. The water soluble sugar alcohol may be mannitol, erythritol, maltitol and combinations may be used in particle form as the outer coating layer (Kurasawa, e.g., 0228). The water soluble sugar alcohol outer layer prevents coagulation of the granules (Kurasawa, e.g., 0179). Particles of the coagulation inhibiting water soluble sugar alcohol, e.g., mannitol, would appear to be present, particularly after the coating is dried.
Further with respect to the claimed second coating layer, Kurasawa teaches the mannitol coated API granules are further mixed with outer layer granules containing solid mannitol particles to give a solid preparation containing mannitol coated API granules further comprising an outer layer of granules containing solid mannitol particles. See Kurasawa, e.g., 0275 and 0315.
Separately, and applicable to claim 1, Kurasawa teaches granules comprising cellulose and hydroxypropylcellulose (food supplements) which granules also contain solid mannitol (particles of a sugar alcohol) and a mannitol binder. The process appears to result in a granule core which would contain mannitol particles in at least one coating layer surrounding the granule core. Since the binder liquid is sprayed over a period of time, the coating grows as particles agglomerate and further binder is applied. Thus, it can be said that the coating comprises many layers, e.g., first and second and so forth. See Fujii, e.g., pg. 99:16-30. This embodiment applies to claims 1-2, 5, 7-10, 12, 14, and 16.
Product by process limitations “in a high shear mixer” and “wet coating method,” and “fluid bed coating or high shear melt coating” do not imply any structural limitations beyond those expressly recited in the claims. Further, the prior art teaches wet coating methods including spraying of a binder solution on the granules.
Kurasawa anticipates the subject matter of instant claims 1-2, 4-5, 7-12, 14, and 16.
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-5, 7-12, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Fujii, WO 2019013310 A1.
All of the teachings of Fujii enumerated above apply here.
This rejection is made in the alternative in the event the disclosure of Fujii is found insufficient to allow the skilled artisan to at once envisage a granule containing a core with a pharmaceutically active ingredient (API), additional layers, and a coagulating inhibiting substance coating containing saccharides or sugar alcohol in the form of particles.
Fujii clearly teaches coagulation inhibiting substance, e.g., sugar alcohols, may be applied as a solution or a suspension (Fujii, e.g., ¶ spanning pp. 19-20). Applying a suspension will necessarily result in particles on the outer layer, i.e., rough surface. Fujii also clearly teaches water soluble sugar alcohols may have a particle size of less than 50 mesh (Fujii, e.g., ¶ spanning pp. 23-24).
Thus, to the extent that Fujii may not clearly disclose sugar or sugar alcohol particles in the outer layer on a granule core containing a pharmaceutically active ingredient, these teachings in Fujii represents express teachings which would have prompted the skilled artisan to configure the coagulation inhibiting substance, specifically saccharide and/or sugar alcohols as particles in the outer coating corresponding to the second coating layer as claimed with a reasonable expectation of success. Fujii teaches applying a suspension of coagulation inhibiting substance (Fujii, e.g., pg. 77:14-19).
It would have been obvious before the effective filing date of the presently claimed invention to modify any of the saccharide and/or sugar alcohol coatings exemplified in Fujii on granule core containing a pharmaceutically active ingredient by formulating the saccharide and/or sugar alcohol in the outer layer as particles with a reasonable expectation of success. Since Fujii teaches the outer layer containing sugar and/or sugar alcohol may be applied as a suspension, the skilled artisan understood from Fujii that the outer layer may contain sugar and/or sugar alcohol particles which protrude from the surface to achieve coagulation inhibiting effect and taste masking. The skilled artisan would have had a reasonable expectation of success because Fujii also clearly teaches applying a suspension of coagulation inhibiting substance.
This rejection is also made in the alternative in the event it is determined that Fujii does not describe the claimed range with sufficient specificity to anticipate the subject matter of claim 11.
Acknowledging that Fujii does not expressly teach wherein at least 90% of the granules by number have a diameter of greater than 200 µm and in which at least 90% of the granules by number have a diameter of less than 1400 µm, it is noted that Fujii does teach a general particle size range which overlaps significantly with the claimed range. For example, Fujii teaches granules having a size ranging from 50 µm to 1000 µm preferably about 75 μm - about 750 μm, more preferably about 80 μm - about 500 μm, further preferably about 100 μm - about 400 μm (Fuji, e.g., pg. 6:25-30). Further, Fujii exemplifies a number of granules having a size overlapping significantly with the claimed range, e.g., 132 µm – 355 µm (Fujii, e.g., pg. 99:2-14).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
It would have been obvious before the effective filing date of the presently claimed invention to optimize the size of the granules taught by Fujii within the general range, e.g., a size ranging from 50 µm to 1000 µm suggested therein with a reasonable expectation of success since the reference suggests sizes in this range are effective for rapid pharmacological effect.
Accordingly, the subject matter of claims 1-2, 4-5, 7-12, 14, and 16 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615