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
Claims 1-14 and 16-21 are pending and under current examination.
Withdrawn Claim Objections and Rejections
All objections pertaining to claim 5 are withdrawn in view of the amendments to the claims filed 11/10/2025.
All rejections under 35 U.S.C 112 (b) are withdrawn in view of the amendments to the claims filed 11/10/2025.
All double patenting rejections over Application No. 18/272,441 and Application No. 18/272,189 are withdrawn in view of the arguments filed 11/10/2025.
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.
Claims 1-14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Von Falkenhausen (U.S. Patent No. 7,988,997, issue date: 8/2/2011, of record) in view of Pathare et. al. (International Journal of Pharmaceutical Sciences Review and Research, pg. 169-178, publication year: 2013, of record).
Applicant’s Invention
Applicant’s claim 1 is drawn to an oral thin film comprising a polymer matrix in the form of a solidified foam having voids, wherein the polymer matrix contains at least one active pharmaceutical ingredient, at least one first polymer which comprises a water-soluble polymer and at least one second polymer which comprises a mucoadhesive polymer having a number-average molecular weight of equal to or greater than 100,000 g/mol.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1- 5, Von Falkenhausen teaches an oral dosage form in the form of a solidified foam (col. 3 line 7). The matrix of the dosage forms comprises as base substances a water-soluble polymer or mixtures of such polymers. The polymers may include cellulose derivatives, polyvinyl alcohol, polyacrylates, and polyvinylpyrrolidone. Particularly preferred cellulose derivatives are hydroxypropylmethylcellulose, carboxymethylcellulose, hydroxypropylcellulose, hydroxymethylcellulose, methylcellulose, and other substituted cellulose derivatives. Likewise preferred are water-soluble polysaccharides of vegetable, microbial or synthetic origin, in particular those polysaccharides which are not cellulose derivatives, Such as, for example, pullulan, Xanthan, alginates, dextrans, agar-agar, pectins and carrageenan. (col. 3 lines 42-63). The oral dosage form contains therapeutically active compounds as active ingredients (col. 4 lines 4-5). Spaces or cavities are present in the polymeric matrix of the dosage form (col. 2 lines 22-23).
Regarding claims 6 and 7, Von Falkenhausen teaches the relevant limitations of claim 1 as described above.
Regarding claim 8, Von Falkenhausen teaches that the active ingredient content per dose unit is up to 50mg (col. 4 lines 28-29).
Regarding claim 9, Von Falkenhausen teaches the spaces or cavities may be isolated from one another in the polymeric matrix or preferably in the form of solidified bubbles (col. 2 lines 66-67 and col. 3 line 1).
Regarding claim 10, Von Falkenhausen teaches that the spaces or cavities may be connected to one another, preferably forming a connected channel system penetrating through the matrix (col. 3 lines 2-4).
Regarding claims 11 and 20, Von Falkenhausen teaches that the total volume of the spaces or cavities is from 5 to 98% as a proportion of the total volume of the dosage form (col. 3 line 17-19).
Regarding claims 12 and 14, Von Falkenhausen teaches that the oral dosage form may be produced by preparing a solution of at least one water-soluble film-forming polymer and at least one active ingredient followed by foaming by introducing gas or gas mixture (col. 5 lines 29-38). A foam stabilizing agent may be added before or during the production of the foam (col. 5 lines 39-42). The foam is spread as film or layer on a suitable substrate and is dried . Removal of solvent during the drying causes the foam to solidify to an aerogel (col. 5 lines 44-47).
Regarding claim 13, Van Falkenhausen teaches that the polymer matrix may be initially produced in the form of a block. The required sheet-like dosage forms are then removed from the latter by cutting (col. 6 lines 33-36).
Regarding claim 16, Von Falkenhausen teaches that the dosage forms are advantageously suitable for administering medicaments in the oral cavity and can be employed in human medicine and in veterinary medicine (col. 6 lines 37-50).
Regarding claim 17, Von Falkenhausen (U.S. Patent No. 7,988,997, issue date: 8/2/2011) teaches an oral dosage form in the form of a solidified foam (col. 3 line 7). The matrix of the dosage forms comprises as base substances a water-soluble polymer or mixtures of such polymers. The polymers may include cellulose derivatives, polyvinyl alcohol, polyacrylates, and polyvinylpyrrolidone (col. 3 lines 42-63).
Regarding claims 18 and 19, Von Falkenhausen teaches that the gases suitable for formation of the foam include inert gases such as nitrogen, carbon dioxide or helium, or mixtures thereof (col. 5 lines 36-38).
Regarding claim 21, Von Falkenhausen teaches that a foam stabilizing agent may be added before or during the production of the foam (col. 5 lines 39-42). The foam stabilizing agent may be added prior to foaming a melt by decompression of a dissolved gas (Claim 5).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 1, 2, 4, 5, and 17 Von Falkenhausen does not teach a single embodiment or example meeting all limitation of the invention of claims 1, 2, 4, 5, and 17.
Regarding claims 1 and 3, Von Falkenhausen does not teach an average molecular weight of polymers present in the dosage form. However, this deficiency is cured by Pathare.
Pathare teaches that the disintegration rate of polymers present in fast dissolving oral films is decreased by increasing the molecular weight of polymer film bases (pg. 170, Introduction).
Regarding claims 6 and 7, Von Falkenhausen does not teach a weight percentage of polymers present in the oral dosage form. However, this deficiency is cured by Pathare.
Pathare teaches that the disintegration rate of polymers present in fast dissolving oral films is decreased by increasing the molecular weight of polymer film bases (pg. 170, Introduction).
Regarding claim 8, Von Falkenhausen does not teach a weight percentage of active ingredient present in the dosage form relative to the total weight of the oral dosage form.
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 1, 2, 4, 5, and 17, within the broader scope of Von Falkenhausen all of the limitations of the invention of claims 1, 2, 4, 5, and 17 are met. It would have been prima facie obvious for one having ordinary skill in the art to choose the limitations in the instant claims from those disclosed by Von Falkenhausen and arrive at this conclusion because such was contemplated by Von Falkenhausen.
With regards to the “mucoadhesive” limitations of instant claims 1, 2, and 5, the prior art teaches the same polymers as claimed and therefore, the mucoadhesive properties are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Regarding claims 1 and 3, the average molecular weight of polymers present in the oral dosage form is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal average molecular weight of the polymers in order to best achieve the desired results as such would provide advantageous dissolution effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Pathare teaches that the disintegration rate of polymers present in fast dissolving oral films is decreased by increasing the molecular weight of polymer film bases (pg. 170, Introduction). The Examiner considers it prima facie obvious to optimize the average molecular weight of polymers present in the dosage form, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the molecular weight of polymers present in the oral dosage form would affect the dissolution rate of the active ingredient and therefore be an optimizable variable.
Regarding claims 6 and 7, the weight percentage of polymers in the oral dosage form is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal weight percentage of first and second polymers in order to best achieve the desired results as such would provide advantageous dissolution effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Pathare teaches that the disintegration rate of polymers present in fast dissolving oral films is decreased by increasing the molecular weight of polymer film bases (pg. 170, Introduction). The Examiner considers it prima facie obvious to optimize the weight percentage of polymers present in the oral dosage form, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that varying the weight percentages of polymers present in the film would vary the total molecular weight of polymers present in the film and thereby affect the dissolution rate of the oral dosage form. Therefore, the weight percentage of polymers present in the oral dosage form is an optimizable variable.
Regarding the weight percentage of active ingredient as specified in claim 8, MPEP 2144.05 states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Furthermore, Von Falkenhausen teaches that the active ingredient content per dose unit is up to 50mg (col. 4 lines 28-29). The Applicants' specification provides no evidence that the selected weight percentage of active ingredient in claim 8 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to the wide range of active ingredients that may be included in the dosage form as claimed, it would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to combine these teachings and alter the weight percentage of the active ingredient present in the dosage form. One of ordinary skill in the art would have been motivated to change the weight percentage as this could be expected to be advantageous for the desired dose at the desired dissolution rate of the oral dosage form.
Response to Arguments
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive.
On page 7, Applicant argues that the technical effect achieved by the claimed invention is opposed to the objective of Von Falkenhausen because Von Falkenhausen is directed to rapidly disintegrating dosage forms that have a reduced tendency to stick or adhere to the oral mucosa. This is not found persuasive. The Examiner respectfully draws attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” Von Falkenhausen teaches the same polyvinyl alcohol, polyacrylates, and pectins as the instantly claimed composition, therefore the mucoadhesive properties must be present despite Von Falkenhausen’s teachings of reduced mucoadhesion. Therefore, the argument is not persuasive and the rejection is maintained. In response to applicant's argument that Von Falkenhausen is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Von Falkenhausen is directed to oral dosage forms in the form of solidified foams (col. 3 line 7). The instant invention is directed to oral dosage forms in the form of solidified foams, therefore Von Falkenhausen is from the same field of endeavor as the claimed invention.
On pages 8 and 9, Applicant argues that Pathare provides no teaching or motivation to modify the foam-based, non-adhesive system of Von Falkenhausen by introducing a high-molecular weight mucoadhesive polymer. This is not found persuasive. In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Von Falkenhausen is directed to a rapidly disintegrating dosage form (Abstract) that may contain polyvinyl alcohol as a constituent polymer (col. 3 line 49). Pathare teaches that the disintegration rate of polymers present in fast dissolving oral films is decreased by increasing the molecular weight of polymer film bases (pg. 170, Introduction). While the Examiner agrees that the Pathare provides no teaching regarding mucoadhesion, Pathare does teach that the molecular weight of the polymer present in a dissolving oral film has a direct effect on the disintegration rate of the film. Because Von Falkenhausen is directed to a rapidly disintegrating dosage form, the molecular weight of the polymer present in the dosage form is clearly a results effective parameter in view of the teachings of Pathare. Therefore, the argument is not persuasive and the rejection is maintained.
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 1-9, 11-14, 16, 17, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-54 of U.S. Patent No. 7,988,997 in view of Pathare et. al. (International Journal of Pharmaceutical Sciences Review and Research, pg. 169-178, publication year: 2013, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims.
Inter alia, the claims of the ‘997 patent embrace a sheet-shaped, rapidly disintegrating dosage form for rapid release of active ingredients in an oral cavity. The dosage form comprises a solidified foam matrix which comprises one or more film forming water-soluble polymers selected from cellulose derivatives, polyacrylates, polyvinyl pyrrolidone, hydroxypropylmethylcellulose, hydroxymethylcellulose, carboxymethylcellulose, hydroxypropylcellulose, methyl-cellulose, water soluble polysaccharides of vegetable or microbial origin, pullulan, Xanthan, alginates, dextrans, agar-agar, pectins, carrageenan, proteins, gelatin, caseinates, other gel-forming proteins, and protein hydrolysates. The active ingredient is nicotine. The dosage form is provided with spaces or cavities which are present in the polymeric matrix and whose contents are gaseous. The cavities may be isolated from one another or in the form of bubbles and may account for 50 to 80% of the total volume of the dosage form. With regards to the “mucoadhesive” limitations of instant claims 1, 2, and 5, the claims of the ‘977 patent embrace the same polymers as claimed and therefore, the mucoadhesive properties are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
The claims of the ‘997 patent also embrace a method for preparation of the dosage form in which a hot melt comprising at least one water-soluble polymer and the active ingredient is foamed by introducing a gas mixture. The foamed melt is spread on a coating substrate and solidified by cooling. The foamed melt may also be produced in the form of a block the block may be cut in order to obtain sheet-shaped forms. The claims of the ‘997 patent also embrace a method for administration of active pharmaceutical ingredients which comprises applying the dosage form in an oral cavity.
The claims of the ‘997 patent do not embrace an average molecular weight or weight percentage of polymers present in the dosage form. However, this deficiency is cured by Pathare. Pathare teaches that the disintegration rate of polymers present in fast dissolving oral films is decreased by increasing the molecular weight of polymer film bases (pg. 170, Introduction).
The average molecular weight of polymers present in the oral dosage form is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal average molecular weight of the polymers in order to best achieve the desired results as such would provide advantageous dissolution effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Pathare teaches that the disintegration rate of polymers present in fast dissolving oral films is decreased by increasing the molecular weight of polymer film bases (pg. 170, Introduction). The Examiner considers it prima facie obvious to optimize the average molecular weight of polymers present in the dosage form, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the molecular weight of polymers present in the oral dosage form would affect the dissolution rate of the active ingredient and therefore be an optimizable variable.
The weight percentage of polymers in the oral dosage form is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal weight percentage of first and second polymers in order to best achieve the desired results as such would provide advantageous dissolution effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Pathare teaches that the disintegration rate of polymers present in fast dissolving oral films is decreased by increasing the molecular weight of polymer film bases (pg. 170, Introduction). The Examiner considers it prima facie obvious to optimize the weight percentage of polymers present in the oral dosage form, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that varying the weight percentages of polymers present in the film would vary the total molecular weight of polymers present in the film and thereby affect the dissolution rate of the oral dosage form. Therefore, the weight percentage of polymers present in the oral dosage form is an optimizable variable.
Regarding the weight percentage of active ingredient as specified in the instant claim 8, MPEP 2144.05 states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Furthermore, the Applicants' specification provides no evidence that the selected weight percentage of active ingredient in the instant claim 8 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to the wide range of active ingredients that may be included in the dosage form as claimed, it would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to combine these teachings and alter the weight percentage of the active ingredient present in the dosage form. One of ordinary skill in the art would have been motivated to change the weight percentage as this could be expected to be advantageous for the desired dose at the desired dissolution rate of the oral dosage form.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-54 of U.S. Patent No. 7,988,997 in view of Pathare et. al. (International Journal of Pharmaceutical Sciences Review and Research, pg. 169-178, publication year: 2013, of record) as applied to claims 1-9, 11-14, 16, 17, and 20 above, and further in view of Hsu et. al. (Journal of Biomedical Materials Research, pg. 107-116, publication year: 1997, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims.
Inter alia, the claims of the ‘997 patent embrace the relevant limitations as described above. The claims of the ‘997 patent do not embrace a foam in which the voids are connected to one another and form a channel system penetrating the polymer matrix. However, this deficiency is cured by Hsu. Hsu teaches that the use of open polymeric foams in the preparation of release systems has been shown to minimize the initial burst and yield slower release rates (pg. 107, Introduction). It would have been prima facie obvious to one of ordinary skill in the art of filing that to use an open polymeric foam in the dosage form embraced by the claims of the ‘997 patent. One would have understood in view of Hsu that an open polymeric foam slows the release rate of drug from a polymeric foam. One of ordinary skill in the art of filing would have been motivated to use an open polymeric foam in the dosage form embraced by the claims of the ’997 patent in order to better control the release rate of the active ingredient. The artisan of ordinary skill would have had reasonable expectation of success because Hsu teaches that open polymeric foams may be used in controlled-release drug systems.
Claims 18 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-54 of U.S. Patent No. 7,988,997 in view of Pathare et. al. (International Journal of Pharmaceutical Sciences Review and Research, pg. 169-178, publication year: 2013, of record) as applied to claims 1-9, 11-14, 16, 17, and 20 above, and further in view of Coste et. al. (European Polymer Journal, pg. 110029, publication year: 2020, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims.
Inter alia, the claims of the ‘997 patent embrace the relevant limitations as described above. The claims of the ‘997 patent do not embrace an inert gas used to form the bubbles present in the dosage form. However, this deficiency is cured by Coste. Coste teaches that compressed carbon dioxide may be dissolved in polymer melt. A foam structure is obtained by then reducing pressure (pg. 2, Introduction). The idea for combining compounds each of which is known to be useful for the same purpose, in order to form a composition which is to be used for the same purpose, flows logically from their having been used individually in the prior art. See In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As shown by the recited teachings, the instant claims define nothing more than the concomitant use of conventional inert gases used in the formation of foams from polymer melt. It would follow that the recited instant claims define prima facie obvious subject matter. See MPEP 2144.06.
Response to Arguments
Applicant’s arguments, see pg. 10, filed 11/10/2025, with respect to the double patenting rejection over Application No. 18/272,441 Application No. 18/272,189 have been fully considered and are persuasive. The double patenting rejection of claims 1-14 and 16-21 over Application No. 18/272,441 and Application No. 18/272,189 has been withdrawn.
With respect to the double patenting rejection over U.S. Patent No. 7,988,997, the double patenting rejection over U.S. Patent No. 7,988,977 in the office action dated 8/8/2025 is a typographical error. The double patenting rejection is issued over U.S. Patent No. 7,988,997, the same patent relied upon in the obviousness rejections. The double patenting rejection in the instant office action is correct to read U.S. Patent No. 7,988,997.
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.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614