DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Pursuant to the amendment dated 12/02/2025, claims 35 and 43 have been cancelled. Claims 1-33, 37, 39, 41, 47, and 49 had been cancelled in a previous correspondence. Claims 50-57 stand withdrawn without traverse.
Claims 34, 36, 38, 40, 42, 44-46, 48, and 50-57 are pending. Claims 50-57 are withdrawn.
Claims 34, 36, 38, 40, 42, 44-46, and 48 are under current examination.
All rejections not reiterated have been withdrawn.
With regard to the rejection of claims 34-36, 38, 40, 42-46, and 48 under 35 USC 112(a), Applicant’s arguments, see pages 8-11, were found persuasive.
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 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 34, 36, 38, 40, 42, 44-46, and 48 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dow et al. (US 5,506,229; issue date: 04/09/1996; of record) in view of Gant et al. (US2008/0312247; publication date: 12/18/2008; of record) and Venkatesh (US 2006/0246134; publication date: 11/02/2006; of record).
With respect to claims 34 and 42, Dow discloses a controlled release formulation of ranolazine base (col 11-12). The formulation is formed by dry mixing (i.e. blending a powder; therefore the examiner considers both the ranolazine and the polymer both to be powders) 90 parts by weight ranolazine with 10 parts by weight (i.e. a 9:1 weight ratio) microcrystalline cellulose (i.e. a drug binding polymer) followed by extrusion spheronization to form microspheres (i.e. a plurality of drug cores) of size ranging from 0.5 to 1.4 mm, which are then coated with an appropriate release rate-controlling polymer and put into a hard shell capsule. The weight ratio of ranolazine to drug binding polymer (microcrystalline cellulose) falls within the range recited in the instant claims and the particle size range disclosed by Dow overlaps with the particle size recited in the instant claims (see MPEP 2144.05). With regard to the limitation requiring the ranolazine/pharmaceutically active substance to be in reversible association with the drug-binding polymer, the examiner considers this feature to be inherent because both the drug and the polymer are identical to those used in the instant invention (see e.g. page 1 of the instant specification which indicates that microcrystalline cellulose is a “drug binding polymer” according the instant invention). Moreover, “reversible association” reads on weak intermolecular forces that exist between any combination of substances that are physically in contact with one another and therefore inherently are present between the ranolazine and microcrystalline cellulose in Dow’s cores. The formulation is a controlled release formulation and there are release coating polymers therefore the examiner considers the invention to embrace methods of extending duration between doses of ranolazine, as recited in instant claim 42. With regard to the limitation of instant claim 34 and 42 requiring the particulate composition to be in the form of a powder or granulation, the examiner considers the coated particles disclosed
Dow does not disclose the solubility or permeability or the identity of the release rate controlling polymers, nor the ranolazine release profile.
Gant discloses that ranolazine has a half-life of less than two hours and must be taken frequently (0090).
Venkatesh discloses a multiparticulate dosage form for delivering one or more basic active pharmaceutical ingredients (API) to achieve a target pharmacokinetic (PK) profile (abstract). The composition is suitable for once or twice daily dosing and contains one or more bead populations that can provide a sustained release profile (0008). These bead populations contain an active core that is coated with a release rate controlling polymer that includes a water-insoluble polymer to control release (0008 and 0017) and are therefore structurally very similar to the particulate composition disclosed by Dow. Claimed water-insoluble polymers for Venkatesh’s invention include ethylcellulose, which the instant specification indicates to be water permeable.
With regard to the extended release profiles required by instant claims 34 and 42, it would have been prima facie obvious to optimize the formulation disclosed by Dow with the understanding of how to extend PK profile in coated core particulate compositions provided by Venkatesh. The skilled artisan would have been motivated to extend release of ranolazine because this substance has a very short half-life and an extended release formulation could reduce the number of doses required to maintain an effective plasma concentration of the drug. This, in turn, is more convenient for patients and increases patient compliance. The skilled artisan would have had a reasonable expectation of success because Venkatesh discloses details as to how to optimize polymer coated core multiparticulates such as those disclosed for controlled release by Dow to achieve an extended release profile. With regard to the specific pharmacokinetic parameters recited in instant claims 34 and 42, it would have been merely a matter of routine testing for one of ordinary skill to optimize the parameters disclosed in the prior art to achieve the claimed drug release kinetics.
With regard to claims 35 and 43, Venkatesh indicates that drug release profiles can be determined in a type 2 apparatus rotating at 50 rpm. This method is routinely used in the pharmaceutical arts to estimate drug release in the body. See MPEP 2144.07 regarding obviousness of art-recognized suitability.
With regard to claims 36 and 44, Dow discloses spheres which falls within the scope of “spheroidal”.
With regard to claims 40 and 45, as noted above, Venkatesh discloses ethylcellulose.
With regard to claims 38 and 46, Venkatesh discloses adding the plasticizers triacetin, tributyl citrate, triethyl citrate, acetyl tri-n-butyl citrate (0044). It would have been prima facie obvious to add these plasticizers the polymer coating. The skilled artisan would have been motivated to do so in order to reduce brittleness and thereby increase durability of the coating. The artisan of ordinary skill would have had reasonable expectation of success because Venkatesh indicates that these substances are suitable plasticizers for pharmaceutical coatings.
Claims 42, 44-46 and 48 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Venkatesh (US 2006/0246134; publication date: 11/02/2006; of record in view of Boghani et al. (US 2006/0263480; publication date: 11/23/2006).
With regard to claim 42, Venkatesh discloses a particulate composition (abstract: “[a] unit multiparticulate dosage form”) comprising one or more basic active pharmaceutical ingredients designed to achieve target pharmacokinetic (PK) profiles comprising coated particles (i.e. coated cores; abstract). Venkatesh discloses a group of parameters that can be adjusted to achieve target PK profiles suitable for once or twice daily dosing (abstract). Venkatesh describes the formulation as providing a single targeted sustained-release profile over several hours after oral administration, with or without an immediate release pulse (0037). The active containing core may be prepared by, inter alia, granulation into micro/minitablets (i.e. particles) with a binder and an optional dissolution rate controlling polymer, followed by coating the micro/minitablets (i.e. particles). Thus, the resulting particles are a granulation as required by instant claim 42. The binders disclosed are polymers (e.g. PVP, HPMC, hydroxypropylcellulose, carboxyalkyl celluloses, PEO, polysaccharides; 0040). The examiner considers the phrase “reversible association” to read on weak intermolecular forces that exist between any combination of substances that are physically in contact with one another and therefore inherently are present in embodiments of Venkatesh having a binder and optional release rate controlling polymer and a drug within matrix core. The examiner considers the limitation requiring “combining particles of a pharmaceutically active compound and particles of one or more drug binding polymers to form a homogeneous powder drug-polymer blend” to read on or be an obvious variation of the granulation process disclosed by Venkatesh because the drug and binder must be combined, and if solid must be in particle form in order to be mixed to homogeneity by the step “blended together in a high-shear granulator or a fluid bed granulator. The active core that is coated with a release rate controlling polymer that includes a water-insoluble polymer to control release (0008 and 0017). Claimed water-insoluble polymers for Venkatesh’s invention include ethylcellulose, which the instant specification indicates to be water permeable. Once the particulates are formed they may be filled into a capsule (Venkatesh: claim 18). With regard to the weight ratio of drug to drug-binding polymer (i.e. Venkatesh’s binder or release rate controlling polymer), the quantity would depend upon the identity of the drug and binder/release controlling polymer and desired dose and release profile. The examiner considers the relative proportions of the drug, binder, and release controlling polymer to be optimizable parameter that one having ordinary skill would have tested as a matter of course during design of a controlled release formulation of any given drug (see MPEP 2144.05).
Venkatesh discloses microtablets having diameter in the range of about 1 mm (0021) and therefore does not disclose the claimed range for particle diameter, although the examiner remarks that about 1 mm is close to the upper limit of the range recited in the instant claims.
Boghani, in the analogous art of delivery systems for edible compositions (abstract), discloses that particle size of a delivery system can be selected based on the desired rate of release (00099).
It would have been prima facie obvious to adjust particle size of the multiparticulate formulation as a variable that influences drug release profile because this was an art-recognized result-effective variable at the time of the instant invention (see MPEP 2144.05).
With regard to the specific pharmacokinetic parameters recited in instant claim 42, it would have been merely a matter of routine testing for one of ordinary skill to optimize the parameters disclosed in the prior art to achieve the claimed drug release kinetics dependent upon the identity of the drug and the desired PK profile.
With regard to claim 43, Venkatesh indicates that drug release profiles can be determined in a type 2 apparatus rotating at 50 rpm. This method is routinely used in the pharmaceutical arts to estimate drug release in the body. See MPEP 2144.07 regarding obviousness of art-recognized suitability.
With regard to claim 44, Venkatesh discloses pellets which falls within the scope of “spheroidal”.
With regard to claim 45, as noted above, Venkatesh discloses ethylcellulose.
With regard to claim 46, Venkatesh discloses adding the plasticizers triacetin, tributyl citrate, triethyl citrate, acetyl tri-n-butyl citrate (0044). It would have been prima facie obvious to add these plasticizers the polymer coating. The skilled artisan would have been motivated to do so in order to reduce brittleness and thereby increase durability of the coating. The artisan of ordinary skill would have had reasonable expectation of success because Venkatesh indicates that these substances are suitable plasticizers for pharmaceutical coatings.
Response to Arguments
Applicant's arguments filed 12/02/2025 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 13-18 of the response traversing the obviousness rejection over Dow, Gant, and Venkatesh are cumulative and have been fully addressed in the previous Office action. For convenience, the examiner’s response to these arguments is replicated below exactly as it appeared in pages 14-17 the Office action mailed 07/13/2025:
Previous Response to Arguments:
On page 15, Applicant argues that Dow does not teach any release-controlling polymers or materials for providing a controlled or extended release and fails to enable one of ordinary skill in the art to make and use an extended release formulation, let alone one of ranolazine having the claimed release profile.
This argument does not accurately characterize Dow. As noted in the rejection, Dow discloses a controlled release formulation comprising a plurality of drug-polymer cores that is coated with “appropriate release-controlling polymers” (col 11). The term “controlled release” was known at the time of filing to refer to, inter alia, extended release, and one having ordinary skill would have understood “appropriate release-controlling polymers” to indicate that a polymer coating could be selected in order to achieve a desired release profile. Dow does disclose modified release multiparticulate formulation having a drug/polymer core and a coating that contributes to the release profile of the formulation. Dow simply does not identify the polymer and instead leaves its selection to one of ordinary skill. Gant provides a motivation to formulate ranolazine as an extended release formulation and Venkatesh provides detailed guidance as to how to achieve any target drug release profile by selecting the coating for drug cores that are the same type of core disclosed by Dow. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On page 16, Applicant argues that Gant does not teach methods of preparing a particulate composition as presently claimed.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On pages 17-18, Applicant argues that Venkatesh teaches a pulsatile release system suitable for twice daily dosing of a specific therapeutic agent depending on its acidity/alkalinity, solubility in gastrointestinal fluids and its elimination half-life. Applicant argues that the pulsatile release compositions include immediate release populations and asserts that Venkatesh fails to teach methods and related compositions as claimed in the instant invention. On page 18, Applicant asserts that Venkatesh teaches away from the presently claimed invention. Specifically that Venkatesh explains the drawbacks of formulations having extended release profiles and acknowledges the pH-dependent solubility of the therapeutic agents and that their acidity/alkalinity have a significant effect on the lag-time that can be achieved. Applicant argues that in view of Venkatesh’s teaching of a pulsatile release formulation one of ordinary skill would have been discouraged from particulate compositions having the claimed extended release profile and would have been led in a direction divergent from the path taken by applicant.
As an initial matter, Applicant’s characterization of Venkatesh as disclosing formulations for twice daily administration is incomplete. Venkatesh discloses that the formulation can be designed for once or twice daily administration, as noted in the rejection . Applicant’s arguments that the combined references do not render obvious the instant claims are not persuasive for the reasons set forth in the rejection. Venkatesh also discloses that their formulation may be optimized to achieve any target PK profile (abstract). The argument that one having ordinary skill would not have been able to decide upon a target of once daily administration in view of Dow and Gant and optimize a multiparticulate formulation that allows for such a release profile in view of the detailed description of how to do so provided by Venkatesh is not convincing. Also, Venkatesh describes the formulation as providing a single targeted sustained-release profile over several hours after oral administration, with or without an immediate release pulse (0037). Finally, Applicant appears to distinguish between the pulsatile release formulation of Venkatesh and the instant release profile; however, the instant release profile does not exclude a pulsatile release pattern, it merely dictates the total quantity of drug released after given time points under the recited test conditions. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., exclusion of a pulsatile release formulation) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Finally, the examiner does not consider Venkatesh to teach away from the instant invention because Venkatesh provides choices for components of their formulation that would allow one of ordinary skill to tailor the release profile as desired, as stated by Venkatesh in the abstract.
Response to Newly Presented Arguments:
On page 18, Applicant traverses an obvious to try rationale; however, these arguments do not pertain to the reasoning underlying the obviousness conclusion above, as the examiner has not relied on an “obvious to try” rationale. On page 19, Applicant argues that disclosure of a genus does not render obvious a species.
Insomuch as Applicant may be arguing that Dow’s disclosure of the release-controlling polymers genus does not render obvious any particular species within that genus, the examiner points out that Gant provides motivation to develop an extended release profile for ranolazine due to it’s short half-life in the body and Venkatesh provides a detailed methodology and lists well known release rate polymers that one could use as coatings. Venkatesh describes how to achieve immediate, delayed, and extended release profiles and how to combine particulates having various of the above features to achieve a target drug release profile. As optimization of drug release from multiparticulate formulations using the particular polymers recited in dependent claims of the instant application was routine as of the instant effective filing date, the functional language describing release rate and the release rate controlling polymers recited in the claims do not patentably define over the cited prior art, absent a persuasive showing of unexpected results.
Regarding the obviousness rejection of claims 42, 44-46, and 48 over Venkatesh in view of Boghani, on page 20 Applicant argues that the combination fails to achieve independent claim 42 because they do not teach the claimed dissolution pattern and Boghani does not “cure the teaching away of Venkatesh” discussed in the preceding pages or that the genus of possible release characteristics is so broad as to encompass numerous possible distinct combinations.
These arguments regarding Venkatesh have been addressed above. On pages 20-21, Applicant asserts that one would not have been motivated to select the claimed release profile over any other release profile nor do the references lead the skilled artisan to the claimed release profile.
The examiner respectfully disagrees for the reasons detailed in the rejection.
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 42, 44-46, and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,463,611 (of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the instant claims.
Inter alia, the claims of the ‘611 patent embrace a particulate composition, wherein the particulate composition comprises:
(a) a biologically active core, said biologically active core comprising (i) naproxen, a pharmaceutically acceptable salt of said naproxen, or a combination thereof and (ii) a drug binding polymer comprising a silicified high density microcrystalline B cellulose composed of 98% microcrystalline cellulose and 2% colloidal silicon dioxide, wherein said naproxen, said pharmaceutically acceptable salt of said naproxen, or said combination thereof is in reversible association with said drug binding polymer and in a weight ratio therewith of from about 20:1 to about 1:2; and
(b) a coat, said coat comprising a membrane-forming polymer, said membrane-forming polymer comprising ethylcellulose and surrounding said biologically active core, wherein the particulate composition comprises microparticles/microparticulates having average diameter of from about 100 μm to about 900 μm.
The coating polymers may be water insoluble and water permeable.
The release profile required by the ‘611 patent narrowly embraces the drug release profile recited in the instant claims.
The examiner considers the invention of the ‘611 patent to be a multiparticulate dosage form for extended release drug delivery.
Claims 34, 36, 38, 40, 42, 44-46, and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,463,611 (of record) in view of Gant et al. (US2008/0312247; publication date: 12/18/2008) and Venkatesh (US 2006/0246134; publication date: 11/02/2006).
Inter alia, the claims of the ‘611 patent embrace a particulate composition, wherein the particulate composition comprises:
(a) a biologically active core, said biologically active core comprising (i) naproxen, a pharmaceutically acceptable salt of said naproxen, or a combination thereof and (ii) a drug binding polymer comprising a silicified high density microcrystalline B cellulose composed of 98% microcrystalline cellulose and 2% colloidal silicon dioxide, wherein said naproxen, said pharmaceutically acceptable salt of said naproxen, or said combination thereof is in reversible association with said drug binding polymer and in a weight ratio therewith of from about 20:1 to about 1:2; and
(b) a coat, said coat comprising a membrane-forming polymer, said membrane-forming polymer comprising ethylcellulose and surrounding said biologically active core, wherein the particulate composition comprises microparticles/microparticulates having average diameter of from about 100 μm to about 900 μm.
The examiner considers the invention of the ‘611 patent to be a multiparticulate dosage form for extended release drug delivery.
Gant discloses that ranolazine has a half-life of less than two hours and must be taken frequently (0090).
Venkatesh discloses a multiparticulate dosage form for delivering one or more basic active pharmaceutical ingredients (API) to achieve a target pharmacokinetic (PK) profile (abstract). The composition is suitable for once or twice daily dosing and contains one or more bead populations that can provide a sustained release profile (0008). These bead populations contain an active core that is coated with a release rate controlling polymer that includes a water-insoluble polymer to control release (0008 and 0017). Claimed water-insoluble polymers include ethylcellulose, which the instant specification indicates to be water permeable.
It would have been prima facie obvious to formulate the invention of the ‘611 patent to deliver ranolazine rather than naproxen. The artisan of ordinary skill would have been motivated to do so in order to extend the release of this agent in view of its short half-life, thereby reducing the number of doses that must be administered to achieve prolonged therapeutic plasma levels. The skilled artisan would have had reasonable expectation of success because Venkatesh indicates that the structure of multiparticulate formulations having polymer coated polymer/drug cores was known for providing extended release of drugs at the time of the instant invention.
With regard to the specific pharmacokinetic parameters recited in the instant claims, it would have been merely a matter of routine testing for one of ordinary skill to optimize the parameters disclosed in the prior art to achieve the claimed drug release kinetics.
With regard to claims 35 and 43, Venkatesh indicates that drug release profiles can be determined in a type 2 apparatus rotating at 50 rpm. This method is routinely used in the pharmaceutical arts to estimate drug release in the body. See MPEP 2144.07 regarding obviousness of art-recognized suitability.
With regard to claims 36 and 44, Venkatesh discloses that the multiparticulates can come in many shapes such as spherical beads (0008).
With regard to claims 38 and 46, Venkatesh discloses adding the plasticizers triacetin, tributyl citrate, triethyl citrate, acetyl tri-n-butyl citrate (0044). It would have been prima facie obvious to add these plasticizers the polymer coating. The skilled artisan would have been motivated to do so in order to reduce brittleness and thereby increase durability of the coating. The artisan of ordinary skill would have had reasonable expectation of success because Venkatesh indicates that these substances are suitable plasticizers for pharmaceutical coatings.
Response to Arguments
Applicant's arguments filed 12/02/2025 have been fully considered but they are not persuasive. Applicant’s comment on page 21 that they will consider filing a terminal disclaimer upon an indication that the claims are otherwise in condition for allowance is noted.
Conclusion
No claims are allowed.
Applicant's amendment necessitated any 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 (37 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617