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 .
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.
Claims 7-8 are 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.
Claims 7-8 recite the limitation "the second permeation rate" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sowden (US 2006/0233881 A1; published 19 October 2006).
Sowden discloses a medicinal (i.e., drug) dosage form (10) with two cores (11, 12) (i.e., first and second compartments) enclosed by a shell (13) (i.e., a substrate, a wall) wherein each core has an aperture therefrom on the top of the dosage form having fill material therein (16) (i.e., plugs) sealing each aperture (claim 1; Figure 1); wherein fill material is soluble and/or erodible (claims 13, 14); wherein the cores are physically separated from one another (i.e., disconnected) (claim 6); wherein the cores contain active ingredients (claim 11), i.e., drugs (paragraphs [0002]-[0003]); wherein each core may have different active ingredient for combination therapy (paragraph [0057]) wherein cores may or may not have the same composition as desired (i.e., first drug content same as second drug content) (paragraph [0084]); fill material 16a and 16b can be level with and/or lower than the exterior surface of the shell and be compositionally different (paragraph [0028]) such as having different size (i.e., one longer and one shorter) (paragraph [0056]); wherein each fill material and sections of the shell may have the same or different release rates and can be permeable and/or impermeable (i.e., plugs and/or shell sections can have the same or different permeation/permeability/erosion/dissolution rates) (claim 13; paragraph [0058]); wherein release rates are controlled by diffusion/erosion/permeation (paragraphs [0016], [0066]) wherein apertures are circular and fill material is rod-shaped (Figs. 1-4); wherein the cores may have a variety of different shapes (paragraphs [0036]-[0038]) such as a polygonal prism shape (Figs. 3-4); wherein fill material may comprise pH dependent polymers (i.e., water-soluble or erodible or dissolvable polymer) (paragraph [0060]); wherein first and second cores may have first and second shell portions with varying shell thickness (paragraph [0116]); wherein the dosage form may have three disconnected cores (Fig. 4); wherein the core may comprise a flowable component such as a plurality of granules or particles (paragraph [0034]); wherein beads of active ingredient may be filled as loosely separated beads into a core cavity (paragraph [0050]); wherein two or more cores are provided adjacent to one another or connected via a fill material (paragraph [0031]) wherein the shell is made of thermoplastic material (paragraph [0119]).
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 1-3, 12-13, and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-16 of U.S. Patent No. 10,143,626.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘626 claims merely recite additional elements.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,363,220.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘220 claims merely recite additional elements.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,278,499.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘499 claims merely recite additional elements.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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