DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/01/2026 has been entered.
Claims 1, 3-7, 9, and 11 are pending and are currently under consideration.
Claim 1 is currently amended.
Maintained Rejections
Double Patenting
Claims 1, 3-7, 9, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent 11,147,767 (Pilgaonkar) in view of US 2007/0196396 (Pilgaonkar et al).
Both instant claims and the patented claims are directed to gastroretentive dosage forms comprising active agents and a swelling agent, in a bilayer tablet (instant claim 5). Instant claims recite multilayered and further claim 5 is directed to a bilayer tablet of patented claims. Patented bi-layered tablet meets instant claimed multi-layered tablet. The above patent claims carbidopa, levodopa or a combination thereof as the active agent as well as recite the swelling agent, polyethylene oxide, of instant claims 6 and 7. Instant claim 1 also recites a release retardant agent, whereas the patented claims recite a swelling retardant agent, ethyl cellulose. Therefore, the dosage form of the patented claims provides the same swelling index as claimed in the instant claim 11. The above patented claims lack the additional excipients of claim 9. Instant claims recite release retardant whereas patented claims state swelling retardant.
Pilgaonkar teaches controlled release oral composition comprising one or more active agents having low bioavailability, one or more solubilizers, one or more swelling agents, which in combination with a swelling enhancer, swells in the presence of water in the gastric fluid, so as to provide retention of the dosage form in the stomach and gradually erodes within the gastrointestinal tract over a prolonged period of time (abstract; [0001], [0020-0025], 0035& 0050). Pilgaonkar teaches additional excipients such as lubricants, disintegrants etc [0057] in the tablet. Pilgaonkar teaches a multi-layered tablet having either an instant release layer and a gastroretentive sustained release layer, or one or more gastroretentive sustained release layers [0026]. Pilgaonkar teaches a number of active agents [0064]. Pilgaonkar teaches surfactants as solubilizers [0065]-[0070]. For the swelling agent, Pilgaonkar teaches the instant claimed polyethylene oxide, hydroxypropyl methyl cellulose, of instant claim 7 [0072-0076]. For the swelling enhancers, Pilgaonkar also teaches instant claimed low-substituted hydroxypropyl cellulose, crosslinked PVP, crosslinked polyacrylic acid etc [0078], and states that the swelling enhancer allows a rapid and dramatic increase in the size of the tablets [0080]. Pilgaonkar teaches that a synergistic combination of a swelling agent and a swelling enhancer allows rapid swelling and maintenance of integrity by polymeric network formed by swelling of the polymers [0081]. Pilgaonkar also teaches additional excipients such as fillers, disintegrants, binders, lubricants etc [0053-0056]. Pilgaonkar teaches that the solid composition can be in the form of a multi-layer system in which the first layer releases the drug immediately and the second layer provides an expanding nature of the dosage system, thereby making the system to have a greater retention in the stomach [0057].
Thus, both Pilgaonkar and patented claims are directed to gastroretentive compositions and therefore one of an ordinary skill in the art would have expected that the swelling ethylcellulose of the patented claims also acts as a release retardant and further polyethylene oxide acts as a swelling property, as described by Pilgaonkar. While Pilgaonkar does not use the term release retardant, Pilgaonkar teaches swellable properties of various polymers i.e., polyethylene oxide, HPMC of different viscosities such K4M and K100M (table 1), which also acts to control or retard the release of the active agent upon swelling. It is noted that while the reference teaches Methocel K4M as a swelling polymer, instant specification describes the same as a release retardant (see page 6, 1st full paragraph). Hence, one of an ordinary skill in the art would have expected that the swelling enhancer of Pilgaonkar also act as a release retardant and the swelling index of the instant claim 11. Further, one of an ordinary skill in the art would have been able to choose the optimum excipients such as lubricants, fillers, disintegrants as in the tablet of the patented claims depending on the desired effect.
Claims 1, 3-7, 9 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 11-14 of copending Application No. 16/943851 (US 20210121398) in view of US 20070196396 (Pilgaonkar et al).
Both instant claims and the copending claims are directed to gastroretentive dosage forms comprising active agents and a swelling agent, in a bilayer tablet (instant claim 5). Instant claims recite multilayered and further claim 5 is directed to a bilayer tablet of copending claims. Thus, copending bi-layered tablet meets instant claimed multi-layered tablet. The above copending claims carbidopa, levodopa or a combination thereof as the active agent and hence meet instant combination. Copending claims recite the swelling agent, polyethylene oxide, of instant claims 6 and 7.
Instant claim 1 also recites a release retardant agent, whereas the copending claims recite a swelling retardant agent, ethyl cellulose. Further instant claim 8 recites hydroxypropyl methyl cellulose, lower viscosity, not recited by the copending claims. Copending claims lack the instant release retardant agent (claim 1) and the additional excipients of claim 9. Therefore, the dosage form of the patented claims provides the same swelling index as claimed in the instant claim 11. The above copending claims lack the additional excipients of claim 9. Instant claims recite release retardant whereas copending claims state swelling retardant.
In this regard, Pilgaonkar teaches controlled release oral composition comprising one or more active agents having low bioavailability, one or more solubilizers, one or more swelling agents, which in combination with a swelling enhancer, swells in the presence of water in the gastric fluid, so as to provide retention of the dosage form in the stomach and gradually erodes within the gastrointestinal tract over a prolonged period of time (abstract; [0001], [0020-0025], 0035& 0050). Pilgaonkar teaches a multi-layered tablet having either an instant release layer and a gastroretentive sustained release layer, or one or more gastroretentive sustained release layers [0026]. Pilgaonkar teaches a number of active agents [0064]. Pilgaonkar teaches surfactants as solubilizers [0065]-[0070]. For the swelling agent, Pilgaonkar teaches the instant claimed polyethylene oxide, hydroxypropyl methyl cellulose, of instant claim 7 [0072-0076]. For the swelling enhancers, Pilgaonkar also teaches instant claimed low-substituted hydroxypropyl cellulose, crosslinked PVP, crosslinked polyacrylic acid etc [0078], and states that the swelling enhancer allows a rapid and dramatic increase in the size of the tablets [0080]. Pilgaonkar teaches that a synergistic combination of a swelling agent and a swelling enhancer allows rapid swelling and maintenance of integrity by polymeric network formed by swelling of the polymers [0081]. Pilgaonkar also teaches additional excipients such as fillers, disintegrants, binders, lubricants etc [0053-0056]. Pilgaonkar teaches that the solid composition can be in the form of a multi-layer system in which the first layer releases the drug immediately and the second layer provides an expanding nature of the dosage system, thereby making the system to have a greater retention in the stomach [0057].
Thus, both Pilgaonkar and patented claims are directed to gastroretentive compositions and therefore one of an ordinary skill in the art would have expected that the swelling ethylcellulose of the copending claims also acts as a release retardant and further polyethylene oxide acts as a swelling property, as described by Pilgaonkar. While Pilgaonkar does not use the term release retardant, Pilgaonkar teaches swellable properties of various polymers i.e., polyethylene oxide, HPMC of different viscosities such K4M and K100M (table 1), which also acts to control or retard the release of the active agent upon swelling. It is noted that while the reference teaches Methocel K4M as a swelling polymer, instant specification describes the same as a release retardant (see page 6, 1st full paragraph). Hence, one of an ordinary skill in the art would have expected that the swelling enhancer of Pilgaonkar also act as a release retardant and the swelling index of the instant claim 11. Further, one of an ordinary skill in the art would have been able to choose the optimum excipients such as lubricants, fillers, disintegrants as in the tablet of the patented claims depending on the desired effect.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant argues in the Remarks filed 04/01/2026 that the double patenting rejections should be held in abeyance. Applicant’s argument is not found persuasive, and the rejections are therefore maintained.
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.
Claim(s) 1, 3-7, 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Chase et al (US 11033521), Pilgaonkar et al (US 2011/0229569) (herein “Pilgaonkar”), and Pilgaonkar et al (US 20070196396) (herein “Pilgaonkar ‘396”).
Chase teaches treatment of Parkinson’s disease by administration of a combination of levodopa (LD) and carbidopa (CD) in the form of a multi-score bilayered tablet, the tablet comprising a pharmaceutical composition comprising an admixture of CD/LD and a pharmaceutical carrier (see entire document, for instance, col. 1, l 20-34 & col. 6, l 57-63). The multiscore tablet is a bilayered tablet consisting of two-score or three-score top layer comprising CD/LD, and a bottom layer comprising a pharmaceutical carrier without active ingredient, and wherein each score of said top layer penetrates said bottom layer without cutting it (see entire document, for instance, col. 2, l 18-24 & col. 9, l 47-58). The pharmaceutical carriers include cellulose, polyalkylene glycols, alginates etc. (see entire document, for instance, col. 10, l 22-45). Example 1 of Chase is directed to a bilayer tablet with carbidopa and levodopa in a single layer and a second layer comprising a pharmaceutical excipient.
Chase teaches a second layer comprising a carrier material but does not explicitly teach the instant claimed swelling or gastroretentive agent.
Pilgaonkar teaches an oral gastrointestinal dosage form comprising fenugreek fibers that have excellent swelling property (see entire document, for instance, 0014-0019). The composition further includes other swelling and mucoadhesive polymers for gastroretention and include the instant claimed (see entire document, for instance, claims 6 and 7) polyalkylene oxide and hydroxypropyl methyl cellulose (see entire document, for instance, 0050-0051). Pilgaonkar teaches retardant polymers (see entire document, for instance, 0055-0056). The gastroretentive composition is in the form of a bi-layered or trilayered solid dosage form. In particular, the bilayered system is adapted to deliver a pharmaceutical agent from the first layer, a second agent from the second layer, the second agent may be same or different from the first layer (see entire document, for instance, 0059). In a particular embodiment, Pilgaonkar teaches a solid pharmaceutical composition for oral administration contains two layers: one comprising of active ingredient along with a suitable release retardant and the other layer comprising fenugreek fibers in combination with other excipients (see entire document, for instance, 0060). Pilgaonkar teaches several active agents to delivered from the bilayered tablet, and suggests the instant claimed levodopa (see entire document, for instance, 0044). Even though Pilgaonkar fails to exemplify or teach levodopa with sufficient specificity, levodopa is taught as a suitable active agent in the multilayer composition.
Pilgaonkar ‘396 teaches controlled release oral composition comprising one or more active agents having low bioavailability, one or more solubilizers, one or more swelling agents, which in combination with a swelling enhancer, swells in the presence of water in the gastric fluid, so as to provide retention of the dosage form in the stomach and gradual erodes within the gastrointestinal tract over a prolonged period of time (see entire document, for instance, abstract; [0001], [0020-0025], 0035 & 0050). Pilgaonkar ‘396 teaches that a synergistic combination of a swelling agent and a swelling enhancer allows rapid swelling and maintenance of integrity by polymeric network formed by swelling of the polymers (see entire document, for instance, 0081). Pilgaonkar ‘396 teaches a multi-layered tablet having either an instant release layer and a gastroretentive sustained release layer, or one or more gastroretentive sustained release layers (see entire document, for instance, 0026). Pilgaonkar ‘396 teaches that the solid composition can be in the form of a multi-layer system in which the first layer releases the drug immediately and the second layer provides an expanding nature of the dosage system, thereby making the system to have a greater retention in the stomach see entire document, for instance, 0057). In paragraph 0058, Pilgaonkar ‘396 teaches that the controlled release layer includes one or more solubilizers, one or more biocompatible swelling agent and a swelling enhancer (see entire document, for instance, 0058). For the swelling agent, Pilgaonkar ‘396 teaches the instant claimed polyethylene oxide, hydroxypropyl methyl cellulose, and combinations thereof of instant claims 6 and 7 (see entire document, for instance, 0072-0076). While the reference does not use the term release retardant, Pilgaonkar ‘396 teaches swellable properties of various polymers i.e., polyethylene oxide, HPMC of different viscosities such K4M and K100M (see entire document, for instance, table 1). For claim 9, Pilgaonkar ‘396 also teaches additional excipients such as fillers, disintegrants, binders, lubricants etc (see entire document, for instance, 0053-0056). Pilgaonkar ‘396 does not specify the claimed swelling index of instant claims 4 and 11. However, a product and its properties are inseparable. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Pilgaonkar teaches the same swelling agents [0075] of instant claims and hence the property of claims 4 and 11 is inherent. Pilgaonkar ‘396 teaches a number of active agents such as levodopa (see entire document, for instance, 0064) but exemplifies actives such as simvastatin, azithromycin etc. Even though Pilgaonkar ‘396 fails to exemplify or teach levodopa with sufficient specificity, the reference levodopa as a suitable active agent in the multilayer composition. It would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare the bilayered composition of Chase comprising carbidopa and levodopa and further modify the composition by including a swelling polymer, such as polyethylene oxide or hydroxypropyl methyl cellulose, and a gastroretentive polymer such as fenugreek fiber in the same or second layers of the composition, so as to arrive at the instant claimed composition. One of an ordinary skill in the art would have modified the bilayered tablet composition of Chase because both Pilgaonkar and Pilgaonkar ‘396 references teach that the inclusion of swelling polymers and gastroretentive polymers enables the retention of the dosage form in the stomach, which gradually erodes within the gastrointestinal tract over a prolonged time period, enables the release of the drug near absorption site to ensure better absorption of the drug resulting in increased bioavailability, which further reduces the dose and the frequency needed ([0045-0048] in Pilgaonkar ‘396 & [0014 & 0042] of Pilgaonkar). One of an ordinary skill in the art would have employed the swelling polymer and gastroretentive polymer (meets the instant release retardant) in the same or different layers of the bilayered tablet of Chase with an expectation to optimize the rate or speed of release of the drug from the drug containing layer. Pilgaonkar ‘396 teaches that a synergistic combination of a swelling agent and a swelling enhancer allows rapid swelling and maintenance of integrity by polymeric network formed by swelling of the polymers.
Response to Arguments
Applicant argues in the Remarks filed 04/01/2026 that Chase teaches away from extended release. Applicant’s argument is not persuasive against the ground of rejection set forth above. First, it is noted that the portion of Chase that references any issue with extended or slow release is that LD can only be absorbed in a very short segment of the duodenum. This does not teach away from any and all modified release, rather, the teaching merely indicates that the LD needs to be delivered in the duodenum. Notably, Pilgaokar expressly teaches that composition can be delivered to the duodenum (see entire document for instance, 0036). Second, it is noted that the addition of a bottom layer, as well as the addition of excipients, both as taught by Chase, limit the surface area of exposed LD. It is noted that by limiting the surface area of exposed LD, the release of LD is necessarily modified. It is noted that there is no indication as to the extent of modification necessary.
Applicant further argues that the Pilgaokar references do not teach the instantly claimed carbidopa. Applicant’s argument is not found persuasive against the ground of rejection set forth above. Specifically, Chase teaches the combination of LD and CD, wherein the rejection is based on the combination of the references. It is noted that MPEP 2145 states: “One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR M LOVE whose telephone number is (571)270-5259. The examiner can normally be reached M-F typically 6:30-3.
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/TREVOR LOVE/Primary Examiner, Art Unit 1611
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