DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Claims 40-65 are newly added and under consideration in this action. Claims 1-39 are cancelled.
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.
Claim 56 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 56 recites the limitation “the glidant is co-spray dried with the at least three co-processed carbohydrates”. While the application as filed provides support for the inclusion of glidant in the solid dosage form, there is no support in the application as filed for co-spray drying the glidant with the co-processed carbohydrates.
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.
Claims 45-51, 55, 56, and 58 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With regards to Claims 45-50, each of the claims claim a hardness of the solid dosage form when the dosage form is made into a tablet in a particular way. These limitations are unclear because they merely state a property for the solid dosage form when made into a tablet in a particular weight without any indication about how the property is provided structurally. The recited property do not appear to follow from (i.e., is not an inherent property of) the structure recited in the instant claims. It is noted that for each of the claims, claim 40 is the only claim that recites the structural components. Thus, it is unclear whether the claims require some other structure (e.g., binder, lubricants, particular moisture level, coating, etc.), or other non-structural factors, such as processing parameters (e.g., compression force) to provide the claimed properties. Thus, the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
With regards to Claim 51, the claim recites a limitation regarding the tensile strength of the solid dosage form. This limitation is unclear because it mere states a property for the solid dosage form without any indication about how the property is provided structurally. The recited property does not appear to follow from (i.e., is not an inherent property of) the structure recited in the claim claims. It is noted that for claim 51, claim 40 is the only claim that recites the structural components. Thus, it is unclear whether the claims require some other structural component (e.g., binder, coating, porosity, lubricant etc.) or other non-structural factors, such as processing parameters (e.g., compaction pressure) to provide the claimed property. Thus, the resulting claim does not clearly set forth the metes and bounds of the patent protection desired.
Claims 55, 56, and 58 recite the limitation "the at least three co-processed carbohydrates". There is insufficient antecedent basis for this limitation in each claim because each claim depends from claim 40, which recites “three co-processed carbohydrates”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 55, 56 and 58 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 55, 56, and 58 recite the limitation "the at least three co-processed carbohydrates". Each claim, however, depends from claim 40, which recites “three co-processed carbohydrates.” Thus, claims 55 and 58 each fail to further limit the subject matter of the claim upon which they depend because they each widen the scope of claim 40 by allowing an open upper limit on the amount of co-processed carbohydrates.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 40-44, 52, and 54-65 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Norman et al. (Norman) (US 2003/0118642 A1; published Jun. 26, 2003) and Schwarz et al. (Schwarz) (US 6,165,511; published Dec. 26, 2000).
With regards to Claims 40, 41, 55, Norman discloses a co-processed carbohydrate system, and formulations produced therefrom, which formulations are directly compressible into solid dosage forms, some of which, when placed in the oral cavity, shall dissolve or disintegrate, preferably within about 60 seconds (abstract). The formulations are compressible into a tablet, which is robust enough to withstand stress of handling during production, packaging and transportation, without special processing or handling, while retaining rapid disintegration or dissolution properties, in the oral cavity (para.0069).
Norman defines the term “co-processed carbohydrate system” to include a co-processed carbohydrate plus a disintegrant and a glidant (para.0065). The term “co-processed carbohydrate” means the processing of at least two polyols together to make a single product (para.0064).
The co-spray dried carbohydrate system was shown to achieve a much lower friability percent as compared with the same ingredients prepared as dry-blends (par.0168).
In an embodiment, the composition further includes one or more disintegrating agents (para.0027). In an embodiment, Norman discloses a quick-dissolving composition having at least co-spray-dried mannitol and sorbitol and a disintegrant (para.0024).
Norman discloses that the tablets produced from the invention preferably have a tablet hardness in the range of about 10 newtons to about 100 newtons (about 1.02 to 10.2 kP) and a friability in the range of about 0.0% to about 5% (para.0140).
With regards to Claim 42, in an embodiment, the composition further includes at least one active ingredient (para.0026).
With regards to Claim 43, in an embodiment, the active ingredient is coated (para.0026).
With regards to Claim 44, among the suitable disintegration agents include crospovidone, croscarmellose, and sodium starch glycolate (para.0027).
With regards to Claim 56, the composition further includes a glidant (para.0025). With regards to the limitation in the instant claim that “the glidant is co-spray dried with the at least three co-processed carbohydrates,” the limitation is a product-by-process limitation. Note MPEP 2113: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The MPEP also indicates that “the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979).
With regards to Claim 57, among the suitable glidants include colloidal silica, silica gel, and precipitated silica (para.0025).
With regards to Claim 58, carbohydrates useful in Norman’s invention include polyols (para.0072).
With regards to Claim 59, preferably, the polyols include sorbitol, mannitol, erythritol, maltitol, lactitol, isomalt, and mixtures thereof (para.0072).
With regards to Claims 61 and 62, Norman exemplifies co-spray drying mannitol and sorbitol (para.0064, 0147).
With regards to Claims 52, 63, and 64, in an embodiment, the solid dosage form completely disintegrates into an easily swallowable form within about 25 to 50 seconds after placing the tablet in the oral cavity (para.0139, 0170; Fig.3). Further, as discussed above, Norman discloses that the tablets produced from the invention preferably have a tablet hardness in the range of about 10 newtons to about 100 newtons (about 1.02 to 10.2 kP) and a friability in the range of about 0.0% to about 5% (para.0140).
With regards to Claim 65, the co-processed carbohydrate formulation is directly compressed into a solid dosage form (e.g., a tablet), which interacts with saliva in the oral cavity of a patient and completely disintegrates in the oral cavity into an easily swallowable form (reading on a swallow tablet) (para.0138, 0139).
To prepare a co-processed carbohydrate system formulation using mannitol and sorbitol as the carbohydrates, mannitol and sorbitol powders are dissolved in hot water to form a solution, and the temperature of the solution is maintained at about 80 to 85 degrees C. The ratio of mannitol can vary. In an embodiment, the mannitol:sorbitol ratio ranges from about 99.5:0.5 to 60:40. The polyol composition is then spray-dried (para.0073-0075). The moisture content of the resulting co-processed polyol particle is less than 1% (para.0079, 0181).
Norman exemplifies the production of a mannitol:sorbitol composition (“feed”). The mannitol:sorbitol composition (“feed”) was prepared in a steam jacketed tank with deionized water at 85oC. 220 kg of mannitol powder and 30 kg of sorbitol were dissolved in hot water. The inlet temperature varied between 190 and 210oC, and the outlet temperature was varied between 90 and 92oC (para.0184, Table 3).
Norman does not appear to explicitly disclose a combination of at least three polyols and the solid dispersion having a microcrystalline plate structure. Schwarz is relied upon for this disclosure. The teachings of Schwarz are set forth herein below.
Schwarz discloses a polyol composition useful as a tableting aid for the production of tablets for consumption. The composition is obtained by co-spray drying at least two polyols. An active medicament may be present (abstract; col.1, lines 5-10). Schwarz discloses that a known combination of polyols is mannitol, sorbitol, and lactitol, which may be in a ratio of mannitol:sorbitol:lactitol of 90:1:9 or within the range of 90:9:1 and 98:1:1 (col.2, lines 38-44; Schwarz claim 6).
In particularly preferred embodiment, the polyol composition comprises 85-99% by weight of mannitol, and 5 to 15% by weight of one or two polyols selected from lactitol and sorbitol (col.3, lines 1-6).
With regards to the limitation regarding co-processed carbohydrates with different solubilities and/or concentration as recited in Claims 40, 60, and 62, as discussed above, Norman discloses co-processing (e.g. co-spray drying) at least two polyols together, exemplifying a combination of mannitol and sorbitol, wherein the resulting product is used to form orally administered tablets. In light of Schwarz’s disclosure that a combination of mannitol, sorbitol, and lactitol in a ratio within the range of 90:9:1 and 98:1:1 is known to be co-spray dried to form a tableting aid, one of ordinary skill in the art would have found it prima facie obvious at the time the instant invention was made to combine the teachings of Norman with the teachings of Schwarz and use a combination of mannitol, sorbitol, and lactitol in ratios within the range disclosed by Schwarz as the combination of polyols to co-process in Norman’s compositions and methods. One of ordinary skill in the art would have been motivated with a reasonable expectation of success in doing so as Schwartz discloses that such a combination of polyols is known to be co-processed to form a tableting aid, and mannitol, sorbitol, and lactitol are among the preferred polyols disclosed by Norman for use in their compositions. Furthermore, the ratio of mannitol:sorbitol disclosed by Schwarz is within the range for mannitol:sorbitol disclosed by Norman.
With regards to the amounts and ranges disclosed by the prior art references, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
With regards to the limitation in the Claim 40 wherein the solid dispersion has a microcrystalline plate structure, and Claim 54, these limitations appear to follow from using a combination of polyols as claimed and the particular processing steps and parameters used. Example 1 in the instant Specification co-processes a mixture of mannitol, maltitol, and sorbitol in a mannitol:maltitol:sorbitol ratio of about 96:2:2 to form Solid Dispersion A. Water is heated to 78-90oC, and the mannitol, maltitol, and sorbitol are dissolved into the water. When the polyols are in solution and at temperature, the solution is spray dried. The spray dryer parameters are as follows: dryer inlet temperature 195-200oC; fluid bed inlet temperature 74-112oC (for monitoring purposes only); dryer outlet temperature 80-95oC (target 89-92oC). The solution is sprayed into a drier outlet air temperature of 85-90oC. The moisture content of the discharged product should be less than 0.3% (para.00178-00180). The instant Specification discloses that Solid Dispersion A demonstrated the microcrystalline structure wherein the plates are less than 1 micron in thickness. The instant Specification discloses that it is believed that the microcrystalline plate structure is due to differences in solubilities and concentrations of the polyols (para.00181). Because the combined teachings of Norman and Schwarz disclose using a similar mixture of polyols in overlapping ratios (it is noted that maltitol and lactitol have similar water solubilities (Spec., Table 1)), and a substantially similar method using parameters that are within or substantially overlapping with those used in the instant Specification’s Example 1 (e.g. solubilizing the polyols in water at about 80-85oC; co-spray drying using a dryer outlet temperature between 90-92oC), absent evidence to the contrary, the combined teachings of Norman and Schwarz as discussed above will also produce a solid dispersion having a microcrystalline plate structure, wherein the plates are less than 1 micron in thickness.
With regards to Claim 61, as discussed above, Norman discloses co-spray drying at least two carbohydrates, exemplifying co-spray drying mannitol and sorbitol. Norman also discloses that suitable polyols include sorbitol, mannitol, erythritol, maltitol, lactitol, isomalt, and mixtures thereof. Schwarz also discloses co-spray drying at least two polyols, and notes that preferred combinations comprising 85-99% by weight of mannitol, and 5 to 15% by weight one or two polyols selected from lactitol and sorbitol. In light of Norman’s disclosure that maltitol is also a suitable polyol for combining with mannitol and sorbitol, one of ordinary skill in the art would have found it prima facie obvious at the time the invention was made to combine the teachings of Norman and Schwarz and try maltitol as the third polyol (in an amount ranging from 5-15% by weight) with mannitol and sorbitol as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007). One of ordinary skill in the art would have been motivated with a reasonable expectation of success in doing so as both Norman and Schwarz are directed to solid dispersions used in oral tablets, and Norman discloses that maltitol is suitable for use with mannitol and sorbitol.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Claim 53 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Norman et al. (Norman) (US 2003/0118642 A1; published Jun. 26, 2003) and Schwarz et al. (Schwarz) (US 6,165,511; published Dec. 26, 2000) as applied to Claims 40-44, 52, and 54-65 set forth above, further in view of Kigoshi et al. (Kigoshi) (US 6,254,889 B1; published Jul. 3, 2001).
The teachings of Norman and Schwarz and the motivation for their combination as they apply to Claims 40-44, 52, and 54-65 are set forth above and incorporated herein.
The combined teachings of Norman and Schwarz do not appear to explicitly disclose wherein the solid dispersion is coated. Kigoshi is relied upon for this disclosure. The teachings of Kigoshi are set forth herein below.
Kigoshi discloses a solid dispersion and a solid dispersion dosage form, which comprises an active ingredient (abstract; col.1, ln.5-10; Kigoshi claim 1). Kigoshi discloses that the solid dispersion may be coated with an enteric-coating polymer (Kigoshi claim 1; col.6, ln.4-9).
With regards to Claim 53, one of ordinary skill in the art would have found it prima facie obvious at the time the instant invention was made to further combine the teachings of Norman and Schwarz with the teachings of Kigoshi and add a coating (e.g., enteric-coating polymer) to the solid dispersion of the combined teachings of Norman and Schwarz. One of ordinary skill in the art would have been motivated to do so in order to obtain additional art recognized functionalities for the dosage form, such as controlled release or controlling where the active ingredient is released, or taste masking. One of ordinary skill in the art would have had a reasonable expectation of success in doing so Norman, Schwarz, and Kigoshi are directed to orally administered solid dispersions, and Kigoshi discloses that solid dispersions are known to be coated.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
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 40-44 and 52-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-31 of U.S. Patent No. 8,617,588 B2 (USPN 588).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims claim a substantially similar and overlapping solid dosage forms comprising a solid dispersion comprising three co-processed carbohydrates with different solubilities and/or concentration, the solid dispersion having a microcrystalline plate structure; and a disintegrant; wherein the solid dosage form has a friability of 1.0% or less. Both sets of claims also claim substantially similar and overlapping polyols used as the three co-processed carbohydrates and ratios of the three polyols. Both sets of claims also claim overlapping disintegration times and tablet hardness values.
Claim 40-44 and 52-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-20 of U.S. Patent No. 9,358,212 B2 (USPN 212).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims claim a substantially similar and overlapping solid dosage forms comprising a solid dispersion comprising three co-processed carbohydrates with different solubilities and/or concentration, the solid dispersion having a microcrystalline plate structure; and a disintegrant; wherein the solid dosage form has a friability of 1.0% or less. Both sets of claims also claim substantially similar and overlapping polyols used as the three co-processed carbohydrates and ratios of the three polyols. Both sets of claims also claim overlapping disintegration times and tablet hardness values.
Claim 40-44 and 52-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-19 of U.S. Patent No. 11,672,763 B2 (USPN 763) and Kigoshi et al. (Kigoshi) (US 6,254,889 B1; published Jul. 3, 2001).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims claim a substantially similar and overlapping solid dosage forms comprising a solid dispersion comprising three co-processed carbohydrates with different solubilities and/or concentration, the solid dispersion having a microcrystalline plate structure; and a disintegrant; wherein the solid dosage form has a friability of 1.0% or less. Both sets of claims also claim substantially similar and overlapping polyols used as the three co-processed carbohydrates and ratios of the three polyols. Both sets of claims also claim overlapping disintegration times and tablet hardness values.
The primary difference is that the claims of USPN 763 do not explicitly claim wherein the solid dispersion is coated. Kigoshi is relied upon for this disclosure. The teachings of Kigoshi are set forth above and incorporated herein.
One of ordinary skill in the art would have found it prima facie obvious at the time the instant invention was made to combine the claims of USPN 763 with the teachings of Kigoshi and add a coating (e.g., enteric-coating polymer) to the solid dispersion of USPN 763. One of ordinary skill in the art would have been motivated to do so in order to obtain additional art recognized functionalities for the dosage form, such as controlled release or controlling where the active ingredient is released, or taste masking. One of ordinary skill in the art would have had a reasonable expectation of success in doing so both USPN 763 and Kigoshi are directed to orally administered solid dispersions, and Kigoshi discloses that solid dispersions are known to be coated.
Conclusion
Claims 40-65 are rejected. No claims are allowed.
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/MONICA A SHIN/Primary Examiner, Art Unit 1616