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 1-26 are pending.
The prior art does not reasonably teach a pharmaceutical dosage form as claimed particularly with a sufficient motivation to select the thickness value instantly claimed with regard to thin structural elements within the range of 5 micrometers to 2.5 millimeters in particular in further combination with the additional elements claimed and particularly with at least an absorptive polymer excipient being mutually soluble with a physiological fluid as claimed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 20, the phrase "e.g., poly(methacrylic acid, ethyl acrylate)” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Similarly, it is unclear how the 1:1 ratio relates to the required polymethacrylates referenced outside parentheses in the same claim.
Appropriate clarification is required.
Double Patenting, Non-Provisional
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 1-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 11129798B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a pharmaceutical dosage form comprising a drug-containing solid having an outer surface and an internal 3D structural framework contiguous with and terminating at an outer surface wherein the structural elements or fibers are present in an overlapping thickness range and comprise at least one active pharmaceutical ingredient and at least one excipient. Both claim sets further encompass a spacing structure which includes free spaces to form an interconnected pore network type structure, and both claim sets include the same or substantially the same excipient solubility parameters. Both claim sets encompass thin structural elements having segments, free spaces, an open pore network, and corresponding functionality as claimed and as detailed in claims 2-16 and additional throughout claims 17-38 as issued.
The instant claims further include the requirement that the at least an absorptive polymeric excipient has a molecular weight greater than 50 kg/mol as well as an additional overlapping solubility characteristic. Issued claim 17 teaches an overlapping molecular weight range.
The instant claims further include the requirement that at least a hydrophilic surface composition is included. The issued claims specify an outer surface (issued claim 1) which is further detailed in issued claim 31 and understood from the issued claims to dissolve or disintegrate in physiological conditions which overlap with the instantly claimed “hydrophilic surface composition” feature.
As to the viscosity, expansion, and release characteristics described in claims 2-6, these functions appear to result from the structure addressed above, which overlaps and therefore are rendered obvious based on the structure and therefore function of the issued claims.
As to the free spacing; 3D structural framework parameters; segments; fibers; fiber size, shape, and arrangement components of instant claims 7-16, the same or substantially the same components are described throughout issued claims 1-10, 19-21, 23-29, 31, 32, and 34-38 of the issued claims
Because the issued claims teach the structural components and the inseparable functions thereof, the issued claims render obvious the instant claims.
Further regarding resulting functional characteristics and effects upon use, including percolation time, penetration, diffusivity, and effects upon combination with a physiological fluid as in claims 17-19, 21, 24, 25, and 26, see the same or substantially the same features described in issued claims 3, 4, 13-16, 19, 22, and 24-38
As to instant claim 20 pertaining to the excipient, see issued claim 18 noted to include at least overlapping hydroxyethyl cellulose and polyacrylic acid.
As to instant claims 22 and 23 pertaining to the active ingredient itself, see issued claim 1.
Claims 1-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11478427B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a pharmaceutical dosage form comprising a drug-containing solid having an outer surface and an internal 3D structural framework contiguous with and terminating at an outer surface wherein the structural elements Both claim sets further encompass a spacing structure which includes free spaces to form an interconnected pore network type structure.
Both claim sets are drawn to a pharmaceutical dosage form comprising a drug-containing solid having an outer surface and an internal 3D structural framework contiguous with and terminating at an outer surface wherein the structural elements or fibers are present in an overlapping thickness range and comprise at least one active pharmaceutical ingredient and at least one excipient. Both claim sets further encompass a spacing structure which includes free spaces to form an interconnected pore network type structure, and both claim sets include the same or substantially the same excipient solubility parameters. Both claim sets encompass thin structural elements having segments, free spaces, an open pore network, and corresponding functionality as described throughout claims 2-22 as issued.
The main difference in the claims is that the framework in the instant claims is made of “one or more thin structural elements whereas the analogous skeleton elements in the issued claims are made of stacked sheets. The specification as filed for the issued application defines the structural framework elements as having a specified and overlapping thickness and comprising sheets, fibers, and/or bead elements.
Accordingly, it would have been prima facie obvious to combine any of these structural elements, beads, fibers, or sheets, as thin structural elements in a framework as claimed, with a reasonable expectation of success. One would have been motivated to do so since the instant specification as filed defines these elements as analogous and/or equivalent structural framework elements functioning to define interconnected free spaces across or through which drug-containing solid or gas is filled and with terminal elements as further defined in the issued claims. The issued claims encompass the gas filling feature at the end of issued claim 1.
The instant claims further include the requirement that the at least an absorptive polymeric excipient has a molecular weight greater than 50 kg/mol as well as an additional overlapping solubility characteristic, and the excipient is further specified in instant claims 20-21. Issued claims 15 and 16 teach overlapping materials, and the corresponding disclosure of the application for the issued claims defines the same features including average molecular weight of the excipient as well as the identity and viscosity features of the excipient.
The instant claims further include the requirement that at least a hydrophilic surface composition is included. The issued claims specify an outer surface the same or substantially the same as detailed in issued claim 22 and describes it as including a water-soluble polymeric excipient, which renders obvious the instant claim language of “hydrophilic” (see description of FIG. 8 of issued claims for definition).
As to the viscosity, expansion, and release characteristics described in claims 2-6, these functions appear to result from the structure addressed above, which overlaps and therefore are rendered obvious based on the structure and therefore function of the issued claims.
As to the free spacing; 3D structural framework parameters; segments; fibers; fiber size, shape, and arrangement components of instant claims 7-16, the same or substantially the same components are described throughout issued claims 1-22. Because the issued claims teach the structural components and the inseparable functions thereof, the issued claims render obvious the instant claims.
Further regarding resulting functional characteristics and effects upon use, including percolation time, penetration, diffusivity, and effects upon combination with a physiological fluid as in claims 17-19, 21, 24, 25, and 26, see the same or substantially the same features described in issued claims 4-12, 14, 21, and 22 in particular.
As to instant claim 20 pertaining to the excipient, see issued claims 13-16 noted to include at least overlapping hydroxyethyl cellulose and polyacrylic acid.
As to instant claims 22 and 23 pertaining to the active ingredient itself, see issued claim 1.
Because the claims issued are structured differently, this rejection is made using obviousness rationale. It is the examiner’s position that it would have been obvious to combine elements from the issued claims and arrive at the instant claims or a product having the functional features further instantly claimed since a product as in the issued claims and its properties are inseparable.
Claims 1-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23 and 24 of U.S. Patent No. 11285116 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a pharmaceutical dosage form comprising a drug-containing solid having an outer surface and an internal 3D fiber or thin structural element network further specified in the claims, with overlapping thickness characteristic, having active agent and excipients with the same or similar properties as those instantly claimed and a scaffold/segment/free space/pore network structure the same or substantially the same. Both sets of claims are described to function similarly in terms of wetting, dissolution, drug release, and viscosity characteristics which are considered inseparable from the structural components outlined in the claims.
The instant claims differ from the issued claims in the recitation of overlapping structure (i.e, structural or fiber element thickness) and in the structuring of the claims, however both claim sets are drawn to the same or substantially the same dosage form. It would have been prima facie obvious to select fiber components and characteristics thereof as well as additional features including free space / open cell network structure, excipient identity, and drug inclusion as detailed in the issued claims and arrive at the instant claims, with a reasonable expectation of success. One would have been motivated to do so to achieve desirable drug storage and controlled release properties as is routine in the art.
It is noted that the specification as filed corresponding to the issued claims offers definitions of excipient components such as hydroxypropyl methylcellulose excipient, free space structure filled with gas or solid for instance, viscosity characteristics, thickness ranges, free space sizes and network/ framework/ segment ordering, sheet/bead/fiber structural elements, coating shell feature, excipient identity and molecular weight and consequential functional characteristics, and additional properties inseparable from the product described.
Claims 1-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 12/251465. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a pharmaceutical dosage form comprising a drug-containing solid having an outer surface and an internal 3D fiber or thin structural element network further specified in the claims, with overlapping thickness characteristic, having active agent and excipients with the same or similar properties as those instantly claimed and a scaffold/segment/free space/pore network structure the same or substantially the same. Both sets of claims are described to function similarly in terms of wetting, dissolution, drug release, and viscosity characteristics which are considered inseparable from the structural components outlined in the claims.
The instant claims differ from the issued claims in the recitation of overlapping structure (i.e, structural or fiber element thickness) and in the structuring of the claims, however both claim sets are drawn to the same or substantially the same dosage form. It would have been prima facie obvious to select fiber components and characteristics thereof as well as additional features including free space / open cell network structure, excipient identity, and drug inclusion as detailed in the issued claims and arrive at the instant claims, with a reasonable expectation of success. One would have been motivated to do so to achieve desirable drug storage and controlled release properties as is routine in the art.
Like the instant claims, the issued claims detail excipient solubility parameters functioning as further specified in the claims with regard to behavior in physiological or body fluid conditions; a product and its properties are inseparable, and the issued claims are directed to a product having the same or substantially the same components and intended functions as in the instant claims.
Claims 1-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 11865216. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a pharmaceutical dosage form comprising a drug-containing solid having an outer surface and an internal 3D fiber or thin structural element network further specified in the claims, with overlapping thickness characteristic, having active agent and excipients with the same or similar properties as those instantly claimed and a scaffold/segment/free space/pore network structure the same or substantially the same. Both sets of claims are described to function similarly in terms of wetting, dissolution, drug release, and viscosity characteristics which are considered inseparable from the structural components outlined in the claims.
The instant claims differ from the issued claims in the recitation of overlapping structure (i.e, structural or fiber element thickness) and in the structuring of the claims, however both claim sets are drawn to the same or substantially the same dosage form. It would have been prima facie obvious to select fiber components and characteristics thereof as well as additional features including free space / open cell network structure, excipient identity, and drug inclusion as detailed in the issued claims and arrive at the instant claims, with a reasonable expectation of success. One would have been motivated to do so to achieve desirable drug storage and controlled release properties as is routine in the art.
Like the instant claims, the issued claims detail excipient solubility parameters functioning as further specified in the claims with regard to behavior in physiological or body fluid conditions; a product and its properties are inseparable, and the issued claims are directed to a product having the same or substantially the same components and intended functions as in the instant claims, including the particular excipient which is hydroxypropyl methyl cellulose for instance.
Double Patenting, Provisional
Claims 1-26 provisionally are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of copending Application No. 18908569 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a pharmaceutical dosage form comprising a drug-containing solid having an outer surface and an internal 3D fiber or thin structural element network further specified in the claims, with overlapping thickness characteristic, having active agent and excipients with the same or similar properties as those instantly claimed and a scaffold/segment/free space/pore network structure the same or substantially the same. Both sets of claims are described to function similarly in terms of wetting, dissolution, drug release, and viscosity characteristics which are considered inseparable from the structural components outlined in the claims.
The instant claims differ from the copending claims in the recitation of overlapping structure (i.e, structural or fiber element thickness) and in the structuring of the claims, however both claim sets are drawn to the same or substantially the same dosage form. It would have been prima facie obvious to select fiber components and characteristics thereof as well as additional features including free space / open cell network structure, excipient identity, and drug inclusion as detailed in the copending claims and arrive at the instant claims, with a reasonable expectation of success. One would have been motivated to do so to achieve desirable drug storage and controlled release properties as is routine in the art. Like the instant claims, the copending claims detail excipient solubility parameters functioning as further specified in the claims with regard to behavior in physiological or body fluid conditions; a product and its properties are inseparable, and the copending claims are directed to a product having the same or substantially the same components and intended functions as in the instant claims.
Additionally, the copending claims teach overlapping thickness ranges, excipient identities, and structural elements including structural network of fibers, expandability, attachment structure, drug component, excipient component, and free space occupied by a gas for instance.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-26 provisionally are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19301977 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a pharmaceutical dosage form comprising a drug-containing solid having an outer surface and an internal 3D fiber or thin structural element network further specified in the claims, with overlapping thickness characteristic, having active agent and excipients with the same or similar properties (hydrophilicity) as those instantly claimed and a scaffold/segment/free space/pore network structure the same or substantially the same. Both sets of claims are described to function similarly in terms of wetting, dissolution, drug release, and viscosity characteristics which are considered inseparable from the structural components outlined in the claims.
The instant claims differ from the copending claims in the recitation of overlapping structure (i.e, structural or fiber element thickness) and in the structuring of the claims, however both claim sets are drawn to the same or substantially the same dosage form. It would have been prima facie obvious to select fiber components and characteristics thereof as well as additional features including free space / open cell network structure, excipient identity, and drug inclusion as detailed in the copending claims and arrive at the instant claims, with a reasonable expectation of success. One would have been motivated to do so to achieve desirable drug storage and controlled release properties as is routine in the art. Like the instant claims, the copending claims detail excipient solubility parameters functioning as further specified in the claims with regard to behavior in physiological or body fluid conditions; a product and its properties are inseparable, and the copending claims are directed to a product having the same or substantially the same components and intended functions as in the instant claims.
Additionally, the copending claims teach overlapping thickness ranges, excipient identities, and structural elements including structural network of fibers, expandability, attachment structure, drug component, excipient component, and free space occupied by a gas for instance as well as overlapping functional elements including percolation and dissolution properties under physiological conditions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/AUDREA B CONIGLIO/Primary Examiner, Art Unit 1617
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