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 .
Claims and Previous Objections/Rejections Status
Claims 17,22,27-29,61,62 and 64-70 are pending in the application. Claim 63 is cancelled in the amendment filed 8/25/25.
Any objections and/or rejections from previous office actions that have not been reiterated in this office action are obviated.
Response to Arguments
Applicant's arguments filed 8/25/25 have been fully considered but they are not persuasive.
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.
Claim(s) 17,22,27-29,61,62 and 64-70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sadek et al. (US 6,482,516B1) in view of Kessel et al. (US 2004/0161527A1) as stated in the office action mailed 2/25/25.
Applicant asserts that the Examiner appears to raise Kessel as teaching the elements of claim 29 which appears to contradict the Examiner’s assertions that Sadek teaches the reinforcing coating layer of claim 29.
The reference of Kessel was used to teach of a reinforcing coating layer coupled to the edges of the coating layer.
The reference of Sadek et al. teaches of a thickening of the coating along the seam line.
Sadek et al. was used to teach of a medicine tablet that comprises a solid core and a polymer (e.g. gelatin, PVA, etc.) coating. The solid core encompasses the substrate of the instant claims and the gelatin coating encompasses the coating layer of the instant claims.
The polymer films (first and second films) are applied to opposite sides of the core and are sealed together in an essentially edge-to-edge manner along a seal line.
The first film and/or second film encompass a primary portion covering a substantial surface area of the substrate of the instant claims.
The sealed portion of the film encompasses the sealing area covering a remainder of the surface area of the substrate of the instant claims.
The reference of Sadek et al. does not explicitly disclose the sealing area comprises excess film of a single piece of polymer laminated to the substrate or polymer film forming the coating layer.
The reference of Sadek et al. further teaches that there is a thickening of the coating along the seam line and therefore, it would have been obvious to one of ordinary skill in the art that the thickening of the coating along the seam line indicates an excess film from one and/or both of the two polymer film layers overlapping during the sealing process to provide the variation in thickness at the
seal line of the tablet.
The excess from one of the polymer film layers encompasses the excess film of a single piece of polymer of the instant claims.
The reference of Kessel was used to teach that an adhesive material or glue may be used between the overlapping film coating surface to ensure formation of an effective seal and to make the enrobed tablet tamper-evident.
The extra adhesive added to the seal line that is used for providing a tamper-evident medicinal tablet encompasses a reinforcing coating layer coupled to the edges of the coating layer of the instant claim 29.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize an adhesive material or glue as a reinforcing coating layer for the seal line of the polymer coated tablets of Sadek et al. for the advantages of forming an effective seal and/or to make the enrobed tablet tamper-evident.
Applicant asserts that the Examiner has not mentioned any teaching in Kessel when addressing claim 63.
The reference of Kessel was not explicitly used to teach of a sealing area comprising excess film of a single piece of polymer laminated to the substrate or polymer film forming the coating layer but teaches of an ingestible medicament tablet that is enrobed in a polymer film, such as PVA.
Although, the reference of Kessel further teaches that polymer coating involves forming two separate, overlapping part (generally half) coatings on the tablet. The two coatings are sealed together to provide a sealed complete enclosure for the tablet.
The reference of Kessel was explicitly used to teach that an adhesive material or glue may be used to cover the overlapping film coating surface to ensure formation of an effective seal and to make the enrobed tablet tamper-evident.
Therefore, the overlapping film indicates that at least one of the polymer film ends has excess of
polymer available for overlapping the other polymer film end at the location of where the seal is formed.
Applicant asserts that the sealing area and the primary portion are made from a same unitary piece of polymer film. This is in contrast to Sadek as Sadek teaches that layers 13 and 14 of soft elastic gelatin film are applied to opposite sides of the core and which are sealed together, in an essentially edge-to-edge manner.
The instant claims do not state that the entire film coating must comprise a single unitary piece of polymer that is sealed at a sealing area but does state that the polymer piece having an excess of film is a single unitary piece. Therefore, the instant claims do no exclude two single unitary polymer film pieces that are sealed at a sealing area where one or both of the polymer films has/have an excess of film.
The instant claims states that the primary portion (of the coating layer) covers a substantial surface area of a substrate.
The reference of Sadek teaches that a first and a second film cover opposite sides of the solid core and therefore, the each of the first and second film cover a substantial surface area of the solid core individually.
The instant claims states that the primary portion comprising the single unitary piece of polymer has edges sealed at the sealing area.
The reference of Sadek teaches that both a first and/or second film have edges that are sealed at the sealing area.
The instant claims states that the sealing area comprises excess film from a single unitary piece of polymer film.
The thickening of the coating along the seam line of Sadek indicates excess film from one and/or
both of the two polymer film layers overlapping during sealing to provide a variation in thickness at the
seal line of the tablet. Therefore, the first and/or second polymer film having an excess of film for
sealing are each single unitary piece of polymer film.
Applicant asserts that Kessel does not teach or suggest “a sealing area covering a remainder of the surface area of the substrate, the sealing area comprising excess film of a single unitary piece of polymer film laminated to at least one of the substrate or the polymer film forming the coating layer, the primary portion comprising the single unitary piece of polymer film and having edges sealed at the sealing area.”
The reference of Kessel teaches of an ingestible medicament tablet that is enrobed in a polymer
film, such as PVA as well as that stated above.
Although Kessel was not explicitly used to teach of a sealing area comprising excess film of a single piece of polymer laminated to the substrate or polymer film forming the coating layer, Kessel does teach that polymer coating involves forming two separate, overlapping part (generally half) coatings on the tablet wherein the overlapping film indicates that at least one of the polymer film ends has excess of polymer available for overlapping the other polymer film end at the location of where the seal is formed.
The two separate polymer films with overlapping parts, each individually, encompass a single unitary piece of polymer film having excess film at the sealing area.
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 17,22,27-29,61,62,64,66 and 70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6,8-10 and 13-16 of U.S. Patent No. 11,591,276 as stated in the office action mailed 2/25/25.
Applicant requests that the filing of a terminal disclaimer be held in abeyance until such time as all other outstanding rejections in this matter have been resolved.
The rejection is maintained and not held in abeyance.
Conclusion
No claims are allowed at this time.
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 MELISSA JEAN PERREIRA whose telephone number is (571)272-1354. The
examiner can normally be reached M9-3, T9-3, W9-3, Th9-2, F9-2.
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, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA J PERREIRA/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618