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 .
Status of the Claims
Pursuant to the amendment dated 02/26/2026, claim 2 has been cancelled. Claims 3-9, 11-30, 32, 36, 39, 42-45, 49, 50, 53, 54, 56, 58-81, 83-89, and 91-100 have been cancelled previously.
Claims 1, 10, 31, 33-35, 37, 38, 40, 41, 46-48, 51, 52, 55, 57, 82, and 90 are pending and under current examination.
Withdrawn Rejections
Applicant’s amendment to the claims has overcome the indefiniteness rejections under 35 USC 112(b).
Applicant’s arguments that the limitation requiring a filament circumferentially connecting the distal tips of the arms patentably defines over the cited prior art are found persuasive to overcome the obviousness rejection under 35 USC 103, see response filed 02/26/2026, pages 17-21.
Double patenting rejections citing patents or applications that do not embrace the limitation requiring a filament circumferentially connecting the distal tips have been withdrawn for the same reason.
The provisional nonstatutory double patenting rejection over US Serial No. 17774445 is withdrawn in view of the abandonment of this application.
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 1, 10, 31, 33-35, 37, 38, 40, 41, 46-48, 51, 52, 55, 57, 82, and 90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 10, 31, 33-35, 37, 38, 40, 41, 46-48, 51, 52, 55, 57, 70, and 80 of copending Application No. 18729705 in view of Bellinger et al. (US 2019/0262265; publication date: 08/29/2019).
The claims of the copending application are identical to the instant claims except that the copending application recites a limitation requiring the agent not to be risperidone, whereas the instant claims require risperidone.
Bellinger discloses a nearly identical stellate gastroretentive system for extended drug delivery to the stomach and indicates that the drug may be risperidone or the system can be formulated to deliver a multitude of active agents other than risperidone (0270).
The claims of the copending application are considered an obvious variant of the instant claims because, in view of the prior art, the inventive elements relate to the gastroretentive structure itself rather than the particular agent being delivered.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 10, 31, 33-35, 37, 38, 40, 41, 46-48, 51, 52, 55, 57, 82, and 90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-19, 36, 40, 41, 63, 64, 68-74, 97, 101, and 102 of copending Application No. 18289331 in view of Bellinger et al. (US 2019/0262265; publication date: 08/29/2019).
Inter alia, the claims of the copending application embrace a stellate gastroretentive dosage form for drug delivery comprising: a plurality of arms affixed to a central elastomer, wherein at least one arm comprises a drug-eluting component; each arm comprising a proximal end, a distal end, and an outer surface therebetween; wherein the proximal end of each arm is attached to the elastomer component and projects radially from the elastomer component, each arm having its distal end not attached to the elastomer component and located at a larger radial distance from the elastomer component than the proximal end; wherein the at least one arm comprising a drug eluting component comprises: a polymeric linker segment; a first disintegrating matrix segment attached to the polymeric linker segment; a first inert segment attached to the first disintegrating matrix segment; a second disintegrating matrix segment attached to the first inert segment; a second inert segment attached to the second disintegrating matrix segment ;the drug-eluting component attached to the second inert segment, wherein the drug eluting component comprises a carrier polymer, buprenorphine or a salt thereof, and naloxone or a salt thereof, and wherein the drug eluting component further comprises a coating comprising a release rate-modulating polymer film; a third inert segment attached to the drug-eluting component; a third disintegrating matrix segment attached to the third inert segment; and a filament circumferentially connecting each arm. The active agent may be present in less than all of the arms.
The scope of the structural elements falls within or overlaps with the scope of the structural elements recited in instant claims 1, 2, 10, 31, and 57.
The claims of the copending application differ from the instant claims in that the drug to be delivered is buprenorphine and naloxone, whereas the instant claims require risperidone.
Bellinger discloses a nearly identical stellate gastroretentive system for extended drug delivery to the stomach and indicates that the drug may be risperidone or the system can be formulated to deliver a multitude of active agents other than risperidone (0270).
The claims of the copending application are considered an obvious variant of the instant claims because, in view of the prior art, the inventive elements relate to the gastroretentive structure itself rather than the particular agent being delivered.
Regarding the instant dependent claims, Bellinger provides further guidance as to structural design of the segments, linkers, and arms/elongate members:
With regard to claim 40, as noted above, Bellinger ‘265 discloses that the linkers can be time-dependent (0007).
With regard to claim 41, the ratio of HPMCAS to polycaprolactone in the linkers can be between about 80% HPMCAS:20% PCL to about 20% HPMCAS:80% PCL (0009). This range embraces the range recited in the instant claims. See MPEP 2144.05.
With regard to claim 46, as noted above the segments may be formed from PCL. Bellinger ‘265 also discloses that the segments may contain radiopaque substances such as bismuth subcarbonate (i.e. (BiO2)CO3; 0209).
With regard to claim 47, as noted above Bellinger ‘265 teaches enteric linkers (i.e. enteric disintegrating matrix).
With regard to claim 48, as noted above, Bellinger ‘265 teaches combining PCL with HPMCAS to form an enteric linker having optimized stability in the different regions of the gastrointestinal tract. Bellinger also teaches including poloxamers (i.e. PEG-PPG-PEG block copolymers) in the enteric linkers (0009).
With regard to claim 51, as discussed supra, Bellinger teaches that the carrier polymer-drug (i.e. drug-eluting) comprises PCL and can be formulated to deliver risperidone. This segment can also contain colloidal silicon dioxide (0230).
With regard to claim 52, as discussed in detail above, any segment of the stellate arms disclosed by Bellinger ‘265 may be formed from PCL.
It would have been prima facie obvious to follow the specific formulation guidance provided by Bellinger to manufacture the stellate gastroretentive dosage form of the copending application because this would have been merely combining prior art elements according to known methods to yield predictable results (see MPEP 2143(I)(A)).
Claims 82 and 90 require various pharmacodynamic properties of the formulation for risperidone delivery, in the alternative. The examiner considers optimizing risperidone release to have been a matter of routine testing for one of ordinary skill in view of the teachings provided by Bellinger on how to achieve steady state extended release of any drug, including risperidone, and for this reason the examiner does not consider the functional language of claims 82 and 90 to patentably define over the cited prior art.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 10, 31, 33-35, 37, 38, 40, 41, 46-48, 51, 52, 55, 57, 82, and 90 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1, 2, 5, 7, 8, 10, 11, 13, 14, 17, 20, 22-24, 29, 31-33, 35, and 70 of copending Application No. 17774126;
claims 1-14 and 25-30 of copending Application No. 19082659
in view of Bellinger (US 2019/0254966; publication date: 08/22/2019) and Kanasty et al. (Journal of Controlled Release vol 303 pages 34-41; publication year: 2019).
Inter alia the claims of the copending applications embrace a gastric residence system comprising: one or more arms extending radially, wherein the one or more arms comprises a first segment comprising a first polymer composition and a second segment comprising a second polymer composition, a core, and a core and a plurality of arms connected to the core and extending radially from the core, i.e. a stellate gastric retentive system. The arms contain segments within them. The system contains a filament circumferentially connecting each arm of the plurality of arms.
The claims of the copending applications do not require the gastric residence system to contain risperidone.
Bellinger discloses a nearly identical stellate gastroretentive system for extended drug delivery to the stomach and indicates that the drug may be risperidone or the system can be formulated to deliver a multitude of active agents other than risperidone (0196).
The claims of the copending application are considered an obvious variant of the instant claims because, in view of the prior art, the inventive elements relate to the gastroretentive structure itself rather than the particular agent being delivered.
The copending applications do not expressly require a coating over the drug eluting segment comprising a release rate-modulating polymer film.
Kanasty discloses a stellate gastroretentive dosage form (figure 1, page 35) wherein coating the drug releasing polymer matrix leads to near linear drug release for a memantine formulation (abstract, title, figure 1, and figure 3). The coating is formed from a polymer (section 4.1, page 40), which as can be seen from figure 3 modulates the release rate of the drug from the polymer matrix.
It would have been prima facie obvious to coat the drug eluting segment with a release rate modulating polymer film. The skilled artisan would have been motivated to do so in order to provide steady consistent release of drug, and in turn consistent plasma profiles, after administration. The skilled artisan would have had a reasonable expectation of success because this had been achieved with a different drug, as demonstrated by Kanasty.
The claims of the ‘659 application recite further detail regarding the arrangement of the arms and segments within in a manner identical to or falling within the scope of instant claims 1, 2, 10, 31, and 57.
The claims of the ‘126 and ‘445 applications do not describe the number and location of segments within the arms/elongate members of the stellate system having the arrangement of instant claims 1, 2, 10, and 31.
Bellinger ‘966, describing a very similar gastrorententive dosage form (see: title, abstract, figures), teaches that use of multiple linker sections permits the gastric residence system to break into relatively small pieces after desired residence time for easier passage through the gastrointestinal tract (0090). Bellinger ‘966 teaches further advantages of multi-segment stellate gastroretentive systems including protection against undesired passage of the system into the small intestine, and easy removal if such is required prior to the designed residence time by consumption of an alkaline solution (0087). Bellinger also teaches that curved ends allow the system to fit more snugly into the capsule prior to administration (0097). Finally, Bellinger ‘966 teaches that the ability to construct precise architectures for the systems provides excellent control over drug release, in vivo stability, and residence time of the system (abstract).
In view of the teachings set forth above, one having ordinary skill in the art would have understood that stellate gastroretentive systems can be designed to deliver risperidone with arms sufficiently long that the system does not pass out of the stomach, wherein the arms are comprised of multiple segments, some of which are degradable such that the arms break apart over time into pieces small enough to pass out of the stomach, where they are subsequently excreted, and that an additional curved cap segment would allow for longer arms, while permitting the folded system to fit snugly within a smaller capsule for easy swallowing.
Claims 1, 2, 10, and 31 as well as claims 33, 35, and 37 are considered prima facie obvious, although the specific arrangement is not recited in the ‘126 and ‘445 applications, because one having ordinary skill would have predicted the above benefits from the claimed arrangement of segments. Absent evidence of unexpectedly superior performance for the claimed arrangement of prior art segments within the arm, the examiner considers this to have been combining prior art elements according to known methods to yield predictable results (see MPEP 2143(I)(A)).
With regard to claim 40, as noted above, Bellinger discloses that the linkers can be time-dependent (0110).
With regard to claim 41, Bellinger discloses forming segments from HPMCAS (0157 or PCL (0122) in a variety of rations (0184) and it would have been prima facie obvious to one of ordinary skill to optimize dissolution of the segments based on quantity of each polymer. See MPEP 2144.05.
With regard to claim 46, as noted above the segments may be formed from PCL. Bellinger also discloses that the segments may contain radiopaque substances such as bismuth subcarbonate (i.e. (BiO2)CO3; 0209).
With regard to claim 47, as noted above Bellinger teaches enteric linkers (i.e. enteric disintegrating matrix).
With regard to claim 48, as noted above, Bellinger teaches combining PCL with HPMCAS to form an enteric linker having optimized stability in the different regions of the gastrointestinal tract. Bellinger also teaches including poloxamers (i.e. PEG-PPG-PEG block copolymers) in the enteric linkers (e.g. claim 9).
With regard to claim 51, as discussed supra, Bellinger teaches that the carrier polymer-drug (i.e. drug-eluting) comprises PCL and can be formulated to deliver risperidone. This segment can also contain colloidal silicon dioxide (0170).
With regard to claim 52, as discussed in detail above, any segment of the stellate arms disclosed by Bellinger may be formed from PCL.
With regard to claim 55, as discussed in the rejection of claim 57 above, it would have been prima facie obvious to coat the drug eluting segment because this results in nearly zero-order drug release, which would in turn provide constant plasma drug concentrations during the drug release period.
Claims 82 and 90 require various pharmacodynamic properties of the formulation for risperidone delivery, in the alternative. The examiner considers optimizing risperidone release to have been a matter of routine testing for one of ordinary skill in view of the teachings provided by Bellinger on how to achieve steady state extended release of any drug, including risperidone, and for this reason the examiner does not consider the functional language of claims 82 and 90 to patentably define over the cited prior art.
This is a provisional nonstatutory double patenting rejection.
Claims 57, 82, and 90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 25, 40, 60, 127-129, 131, 132, 135, 136, 143-147, 218, and 224 of copending Application No. 17774132 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the copending application embrace a gastric residence system, comprising an elastomer core; a plurality of arms (i.e. a number of arms that overlaps with the number required by the instant claims) connected to the core at a proximal end through a plurality of linker components, one linker component of the plurality of the plurality of linker components corresponding to each arm of the plurality of arms, and the plurality of arms extending radially from the proximal end; and a filament circumferentially connecting each arm of the plurality of arms, wherein one or more first arms comprises a carrier polymer and an agent, the one or more first arms attached to a second arm through a polymeric linker, the arm comprising a carrier polymer-agent further comprises a release rate-modulating film coated on the arm; wherein the agent is risperidone.
Claims 82 and 90 require various pharmacodynamic properties of the formulation for risperidone delivery, in the alternative. The examiner considers optimizing risperidone release to have been a matter of routine testing for one of ordinary skill in view of the parameters on how to achieve steady state extended release of any drug, including risperidone, and for this reason the examiner does not consider the functional language of claims 82 and 90 to patentably define over the cited prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 10, 31, 33-35, 37, 38, 40, 41, 46-48, 51, 52, and 55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 25, 40, 60, 127-129, 131, 132, 135, 136, 143-147, 218, and 224 of copending Application No. 17774,132 (reference application) as applied to claims 57, 82, and 90 above, and further in view of Bellinger (US 2019/0254966; publication date: 08/22/2019).
The relevant limitations of the copending application are set forth above.
The application does not recite a limitation regarding the number and location of segments within the arms/elongate members of the stellate system having the arrangement of instant claims 1, 2, 10, and 31.
Bellinger ‘966, describing a very similar gastrorententive dosage form (see: title, abstract, figures), teaches that use of multiple linker sections permits the gastric residence system to break into relatively small pieces after desired residence time for easier passage through the gastrointestinal tract (0090). Bellinger ‘966 teaches further advantages of multi-segment stellate gastroretentive systems including protection against undesired passage of the system into the small intestine, and easy removal if such is required prior to the designed residence time by consumption of an alkaline solution (0087). Bellinger also teaches that curved ends allow the system to fit more snugly into the capsule prior to administration (0097). Finally, Bellinger ‘966 teaches that the ability to construct precise architectures for the systems provides excellent control over drug release, in vivo stability, and residence time of the system (abstract).
In view of the teachings set forth above, one having ordinary skill in the art would have understood that stellate gastroretentive systems can be designed to deliver risperidone with arms sufficiently long that the system does not pass out of the stomach, wherein the arms are comprised of multiple segments, some of which are degradable such that the arms break apart over time into pieces small enough to pass out of the stomach, where they are subsequently excreted, and that an additional curved cap segment would allow for longer arms, while permitting the folded system to fit snugly within a smaller capsule for easy swallowing.
Claims 1, 2, 10, and 31 as well as claims 33, 35, and 37 are considered prima facie obvious, although the specific arrangement is not recited in the copending application, because one having ordinary skill would have predicted the above benefits from the claimed arrangement of segments. Absent evidence of unexpectedly superior performance for the claimed arrangement of prior art segments within the arm, the examiner considers this to have been combining prior art elements according to known methods to yield predictable results (see MPEP 2143(I)(A)).
With regard to claim 40, Bellinger discloses that the linkers can be time-dependent (0110).
With regard to claim 41, Bellinger discloses forming segments from HPMCAS (0157) or PCL (0122) in a variety of rations (0184) and it would have been prima facie obvious to one of ordinary skill to optimize dissolution of the segments based on quantity of each polymer. See MPEP 2144.05.
With regard to claim 46, as noted above the segments may be formed from PCL. Bellinger also discloses that the segments may contain radiopaque substances such as bismuth subcarbonate (i.e. (BiO2)CO3; 0209).
With regard to claim 47, as noted above Bellinger teaches enteric linkers (i.e. enteric disintegrating matrix).
With regard to claim 48, as noted above, Bellinger teaches combining PCL with HPMCAS to form an enteric linker having optimized stability in the different regions of the gastrointestinal tract. Bellinger also teaches including poloxamers (i.e. PEG-PPG-PEG block copolymers) in the enteric linkers (e.g. claim 9).
With regard to claim 51, as discussed supra, Bellinger teaches that the carrier polymer-drug (i.e. drug-eluting) comprises PCL and can be formulated to deliver risperidone. This segment can also contain colloidal silicon dioxide (0170).
With regard to claim 52, as discussed in detail above, any segment of the stellate arms disclosed by Bellinger may be formed from PCL.
With regard to claim 55, as discussed in the rejection of claim 57 above, it would have been prima facie obvious to coat the drug eluting segment because this results in nearly zero-order drug release, which would in turn provide constant plasma drug concentrations during the drug release period.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 02/26/2026 have been fully considered but they are not persuasive.
On page 26, Applicant traverses the double patenting rejection over the ‘705 application for the element of the filament circumferentially connecting the distal tips of the arms.
This is not persuasive because the ‘705 application embraces a stellate gastroretentive system falling within the scope of the instant claims, including the claimed filament.
On page 26, Applicant points out that the ‘331 application is later filed and requests withdrawal of this rejection because the instant application is the earlier filed application, in accordance with MPEP 804(I)(B)(1).
This argument is not persuasive because the provisional nonstatutory double patenting rejection over the ‘331 application is not the only rejection remaining in the instant application.
Applicant’s comment that the double patenting rejection over the ‘126, ‘659, and ‘132 applications will be addressed upon indication of allowable subject matter is noted.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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