DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/26/2026 has been entered. Claims 66-78 are and are under examination pending in the instant application.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 66-78 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Finn et al., in view of Giovinazzo et al.:
Applicants have traversed the rejection asserting that the Giovinazzo et al. 61/186,445 (provisional filing) has filing date of June 12, 2009, but this provisional application does not contain any information on pH (e.g., the importance of local pH and what would be appropriate for film delivery) and any subject matter that was not present in Giovinazzo 61/186,445 cannot be afforded the filing date of June 12, 2009. Applicants assert these details were added in the actual ‘475 application, which was filed after Applicants’ priority date of 8/7/2009.
In response, this is not found persuasive because the teachings of Giovinazzo et al. that are relevant to this rejection do have the EFD of 06/12/2009. Giovinazzo et al. was relied upon in the rejection only for curing the deficiency of Finn et al. for the teachings of that the apomorphine agonist is contained in the first region and the buffer is contained in the second region. Specifically, it was used for the teachings that the film includes a first layer and a second layer, wherein the first layer that contains the apomorphine is acidic and the second layer that contains the neutralizing agent, which is comparable to the claimed buffer in the second region, is basic (specifically, claim 22 of the provisional application filed on 06/12/2009). This information was filed in the provisional application on 06/12/2009 (please see the details of the maintained rejection below). Applicants argue that this argument distinguishing Giovinazzo '475 was made in Applicants' parent application App. No. 16/048243, which resulted in that application being granted and issued as U.S. Patent 10,821,074 and a different result in this case would be inconsistent with the MPEP, the case law, and the previous decisions of the USPTO. However, as previously stated, Giovinazzo et al. was not relied upon for the claimed limitation that said film dosage provides a local pH of between about 5 to about 9 like in the rejection of App. No. 16/048243, but for the claimed limitation that the buffer is contained in the second region of the film. The claimed limitation that said film dosage provides a local pH of between about 5 to about 9 was actually addressed using the primary reference Fin et al. (US9597288) (please see claims 1 and 15 of Fin et al.).
Furthermore, applicants argue that Finn et al. does not contain any teaching regarding the selection of apomorphine among all possible medicaments, opioids or and their derivatives, let alone that the agonist is contained in the first region and the buffer is contained in the second region. This is not persuasive because although Finn et al. fails to specifically teach selecting apomorphine as an agonist, it is noted that Finn et al. does actually teach to use apomorphine as a suitable opioid (See claim 20 and Column 10, lines 5-7 of Fin et al.). Thus, the argument that Finn et al Finn does not teach apomorphine as the agonist is not persuasive for those claims that recites apomorphine as the agonist. MPEP 2123(II) states that "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.").
Additionally, applicants argue that neither Finn et al. nor Giovinazzo et al. teach or suggest a self-supporting film dosage that disperses in an oral cavity in about 30 minutes or less.
This is not persuasive because this limitation is addressed in the teachings of Giovinazzo et al. that specifically teaches that following sublingual administration to a subject the unit dosage form produces an average circulating concentration of at least 3 ng/mL within a period of from 5 to 15 minutes following the administration (please see Giovinazzo et al.’s teachings on col. 5, lines 19-25). This reads on “a self-supporting film dosage that disperses in an oral cavity in about 30 minutes or less”.
Applicant's arguments filed on 02/26/2026 have been fully considered but they are not persuasive for the reasons set forth in detail above. The rejection is therefore maintained.
RE: Rejection of claims 66-78 on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 10,034,833.
Applicants have traversed the rection asserting that Examiner's remarks refer to old claim language (e.g., "at least a first region" ...) that is no longer present. This is not persuasive because the instant claims differ from the issued claims only to the extent that instant claims recite wherein the self-supporting film dosage composition comprises a first region and a second region… wherein the first region and the second region are arranged in a film dosage, the agonist is contained in the first region and the buffer is contained in the second region, all other limitations describing the characteristics of the claimed invention are recited in the issued claims. This difference regarding the “first region and a second region” recited in the instant claims is an obvious variation of the issued claims. This difference is obvious because the issued claims recite wherein the claimed self-supporting layered film dosage comprises “at least a first region,”. This limitation is interpreted as encompassing multiple regions, including a first and a second region comprising a polymeric carrier matrix, apomorphine or pharmaceutically acceptable salt thereof, and a buffer, as recited in the instant claims.
Also, applicants assert that they will address this rejection when the claims are deemed allowable. Given that the claims are still rejected, the rejection is maintained.
RE: Rejection of claims 66-68, and 70-78 on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,821,074 in view of Finn et al. (US 9597288).
Applicants have traversed the rejection asserting that Finn has been distinguished above and the claims are patentably distinct from Finn et al. for the reasons set forth above. This is not persuasive because applicants argue that Finn et al. does not contain any teaching regarding the selection of apomorphine among all possible medicaments, opioids or and their derivatives, let alone that the agonist is contained in the first region and the buffer is contained in the second region. However, Finn et al. was only relied upon in this rejection for the teaching that the self-supporting film dosage is a layered film dosage, such that Finn et al. teaches that the delivery device is a film comprising a multi-layer structure, wherein one layer comprises an opioid, and another layer that facilitates unidirectional delivery of the opioid (please see Finn et al.’s teachings on col. 2, paragraph 4).
Also, applicants argue that neither Finn et al. does not teach or suggest a self-supporting film dosage that disperses in an oral cavity in about 30 minutes or less. Although this is true, issued claim 11 of U.S. Patent No. 10,821,074 recite wherein said self-supporting film dosage composition disperses in an oral cavity in about 30 minutes or less. The rejection is therefore maintained.
New/Maintained Grounds of Rejection
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.
Claims 66-78 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Finn et al. (US9597288), in view of Giovinazzo et al. (US9044475B2).
Regarding claim 66, Finn et al. describes a transmucosal delivery device for enhanced uptake of a medicament (Abstract). Fin et al. specifically teaches that the device comprises a biodegradable mucoadhesive layer comprising fentanyl disposed in a polymeric diffusion environment, wherein the polymeric diffusion environment has a pH of between about 6 and about 8.5 and a polymeric barrier environment disposed adjacent to the mucoadhesive layer (claims 1 and 15 of Fin et al.). The pH range of about 6- 8.5 falls within the claimed pH range of about 5 to about 9. The entire transmucosal delivery device reads on a self-supporting film dosage. The biodegradable mucoadhesive layer comprising a polymeric diffusion environment reads on a first region. The polymeric barrier layer reads on a second region. Finn et al. further teaches that the polymeric diffusion environment comprises at least one film-forming water-erodible adhesive polymer and that the polymeric barrier environment comprises at least one film-forming water-erodible polymer (claims 3 and 4 of Finn et al.) This reads on that the first region and the second region are arranged in a film dosage. Finn et al. further teaches that the biodegradable mucoadhesive layer disposed in a polymeric diffusion environment further comprises an opioid antagonist (claim 13 of Finn et al.) Finn et al. teaches that opioids antagonists suitable for use include apomorphine (Column 10, lines 5-7). Finn et al. also teaches that the bioadhesive polymer of the water-erodible mucoadhesive polymeric diffusion environment can include any water erodible substituted cellulosic polymer and examples include hydroxypropylmethyl cellulose (HPMC), hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC), polyvinyl pyrrolidone, carboxymethyl cellulose (Column 13, lines 57-60 and column 14, lines 1-24). Finn et al. teaches that the device further comprises plasticizers, such as triacetin, polysorbate, cetyl alcohol, sorbitol (column 17, lines 8-10 and 22-25), propylene glycol (column 16, lines 36-40). Finn et al. further teaches that the device comprises a pH buffering agent, such that the pH of the mucoadhesive polymeric diffusion environment can be adjusted and/or maintained by methods including, but not limited to, the use of buffering agents (column 12, lines 34-37).
However, Finn et al. fails to specifically teach wherein the ratio of buffer to apomorphine is from about 2:1 to about 1:5 by weight, within the self-supporting film dosage as recited in the instant claims.
However, it would have been prima facie obvious to one of the ordinary skills in the art before the effective filing date of the claimed invention to have optimized the ratio of the buffering agent to the apomorphine agonist in Finn et al.’s device, such that the ratio of the buffering agent to the apomorphine agonist is from about 2:1 to about 1:5 by weight with a reasonable expectation of success. One would have been motivated to have done so to control the release from the film and/or the absorption into the body of the film components such as the apomorphine agonist and to enable unidirectional delivery of an opioid in a self-supporting film device since Fin et al. establishes that the ratio of the components in the device would have required only routine experimentation.
Additionally, Finn et al. further fails to teach that the apomorphine agonist is contained in the first region and the buffering agent is contained in the second region. Also, Finn et al. fails to teach that the self-supporting film dosage composition disperses in an oral cavity in about 30 minutes or less.
However, Giovinazzo et al. teaches a pharmaceutical composition in unit dosage form formulated for sublingual administration, wherein said unit dosage form is a film or a strip having a first layer and a second layer, said first layer comprising apomorphine particles and said second layer comprising a pH neutralizing agent (claim 1 of Giovinazzo et al.). The pH neutralizing agent is comparable to the claimed buffer in the second region. Giovinazzo et al. specifically teaches that the first portion of the unit dosage form is separated from the second portion of the unit dosage form by a barrier (e.g., a film separating an acidic layer from a basic layer in a multi-layered film, or a coating on a particulate base or apomorphine particle contained within the unit dosage form) (Column 9, lines 1-6). Additionally, Giovinazzo et al. teaches that following sublingual administration to a subject the unit dosage form produces an average circulating concentration of at least 3 ng/mL within a period of from 5 to 15 minutes following the administration (column 5, lines 19-25). This reads on that the self-supporting film dosage composition disperses in an oral cavity in about 30 minutes or less.
Therefore, it would have been prima facie obvious to one of the ordinary skills in the art before the effective filing date of the claimed invention to have modified the device of Finn et al., such that the apomorphine agonist is contained in a first layer and the buffering agent is contained in a second layer with a reasonable expectation of success. One would have been motivated to have done so to separate the acidic first portion from the basic second portion of the unit dosage form, based on the suggestion of Giovinazzo et al.
Regarding claim 67: Following discussion of claim 66 above, Finn et al. fails to teach that apomorphine is from about 2 to about 16 mg.
However, Giovinazzo et al. teaches that the unit dosage form comprises from 12 to 30 mg of an acid addition salt of apomorphine (claim 12). Giovinazzo et al. specifically teaches that the unit dosage form includes from 2 to 50 mg of an apomorphine prodrug (e.g., from 2 to 15 mg, 10 to 50 mg, 12 to 30 mg, 20 to 50 mg, 15 to 30 mg, or 35 to 50 mg of an apomorphine prodrug) (column 4, lines 59-64).
Therefore, it would have been prima facie obvious to one of the ordinary skills in the art before the effective filing date of the claimed invention to have modified the device of Finn et al., such that the apomorphine dosage
is from about 2 to about 16 mg with a reasonable expectation of success. One would have been motivated to have done so as the amount of apomorphine taught by Giovinazzo et al. would have been optimizable by a person of ordinary skill in the art by routine experimentation.
Regarding claim 68: Following discussion of claim 66 above, Giovinazzo et al. teaches that following sublingual administration to a subject the unit dosage form produces an average circulating concentration of at least 3 ng/mL within a period of from 5 to 15 minutes following the administration (column 5, lines 19-25).
Although Giovinazzo et al. does not explicitly teach that the apomorphine disperses in an oral cavity in about 1-3 minutes; however, it would have been prima facie obvious to one of the ordinary skills in the art before the effective filing date of the claimed invention to have optimized the dispersing time of the apomorphine dosage in an oral cavity, such that the apomorphine dosage disperses in an oral cavity when administered in about 1-3 minutes with a reasonable expectation of success. One would have been motivated to accelerate dispersing or dissolving the apomorphine agonist in the oral cavity since Giovinazzo et al. establishes that the dispersing time of the agonist would have required only routine experimentation.
Regarding claim 69: Following discussion of claim 66 above, Finn et al. teaches that the device comprises a biodegradable mucoadhesive layer comprising fentanyl disposed in a polymeric diffusion environment, wherein the polymeric diffusion environment has a pH of between about 6 and about 8.5 and a polymeric barrier environment disposed adjacent to the mucoadhesive layer (claims 1 and 15 of Fin et al.). This reads on the claimed layered film dosage.
Regarding claim 70: Following discussion of claim 66 above, Finn et al. further teaches that the device further comprises a pharmaceutically acceptable coloring agent (e.g., FD&C Blue #1) (Column 16, lines 62-64).
Regarding claim 71: Following discussion of claim 66 above, Giovinazzo et al. further teaches that the pharmaceutical composition further comprises glycerol (column 9, lines 63-65).
Regarding claims 72-73: Following discussion of claim 66 above, Giovinazzo et al. further teaches that the pharmaceutical composition further comprises sucralose (column 18, Examples 7 and 8).
Regarding claim 74: Following discussion of claim 66 above, Finn et al. further teaches that the device has a thickness such that it exhibits minimal mouth feel. In some embodiments, the device has a thickness of about 0.25 mm. 0.25mm falls within the claimed range of about 0.1-10 mm.
Regarding claim 75: Following discussion of claim 66 above, Finn et al. further teaches that the dissolution characteristics (kinetics) may be adjusted to modify the residence time and the release profile of a drug when included in each layer. This reads on the differing dissolution rates in the two layers (see also Figures 4A-4C).
Regarding claim 76: Following discussion of claim 66 above, Finn et al. teaches that that the device comprises a biodegradable mucoadhesive layer comprising fentanyl disposed in a polymeric diffusion environment, wherein the polymeric diffusion environment has a pH of between about 6 and about 8.5 and a polymeric barrier environment disposed adjacent to the mucoadhesive layer (claims 1 and 15 of Fin et al. and Figures 4A-4C). This reads on the claimed dual region within the composition.
Regarding claims 77-78: Following discussion of claim 66 above, Finn et al. further teaches a single buffering agent, e.g., a dibasic buffering agent is used. In another embodiment, a combination of buffering agents is employed, e.g., a combination of a tri-basic buffering agent and a monobasic buffering agent. This is comparable to both the claimed first buffering system in instant claim 77 and the claimed second buffering system in instant claim 78.
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 66-78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 10,034,833.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the issued claims and the instant claims are drawn to a self-supporting layered film dosage composition comprising a first region and a second region wherein the first region includes: a polymeric carrier matrix, apomorphine or a pharmaceutically acceptable salt thereof, and a buffer. The instant claims differ from the issued claims only to the extent that instant claims recite wherein the self-supporting film dosage composition comprises a first region and a second region… wherein the first region and the second region are arranged in a film dosage, the agonist is contained in the first region and the buffer is contained in the second region, all other limitations describing the characteristics of the claimed invention are recited in the issued claims. This difference regarding the “first region and a second region” recited in the instant claims is an obvious variation of the issued claims. This difference is obvious because the issued claims recite wherein the claimed self-supporting layered film dosage comprises “at least a first region,”. This limitation is interpreted as encompassing multiple regions, including a first and a second region comprising a polymeric carrier matrix, apomorphine or pharmaceutically acceptable salt thereof, and a buffer, as recited in the instant claims.
Claims 66-68, and 70-78 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,821,074 in view of Finn et al. (US 9597288).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the issued claims recite a self-supporting film dosage composition. Issued claim 1 differs from instant claim 66 only to the extent that the polymeric carrier matrix is not limited to wherein the polymeric carrier matrix comprises polyethylene oxide, pullulan, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch, gelatin. However, this limitation is recited in issued claim 4.
The limitations of instant claim 67 are recited in issued claim 2.
The limitations of instant claim 68 are recited in issued claim 3.
The limitations of instant claims 70-78 are recited in instant claims 6-19.
Regarding claim 69, the issued claims do not recite wherein the self-supporting film dosage is a layered film dosage. However, this limitation is obvious over Finn et al. Finn et al. also teaches wherein the delivery device is a film comprising a multi-layer structure, wherein one layer comprises an opioid, and another layer that facilitates unidirectional delivery of the opioid, see col. 2, 4th ¶.
It would have been prima facie obvious for the person of ordinary skill in the art, at the effective filing date of the instant invention, to have modified the self-supporting film dosage recited in the instant claims to comprise a layered structure. This modification would have been obvious because Finn et al. teaches that a layered structure would enable unidirectional delivery of an opioid in a self-supporting film device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANAN ISAM ABUZEINEH whose telephone number is (571)272-9596. The examiner can normally be reached Mon- Fri 8:30-5:00.
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Hanan Isam Abuzeineh
/H.I.A./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633