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 .
Priority
This application repeats a substantial portion of prior Application No. 17/047,658, filed 10/14/2020, and adds disclosure not presented in the prior application (specifically it adds “sequentially folding” see claim 1). Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: There is no mention of “sequentially folding”.
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 1-13 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.
The phrase “sequentially folding” in claim 1 is a relative term which renders the claim indefinite. The term “sequentially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In particular the specification does not describe the steps of “sequentially” folding rather only disclose that edges are folded.
The phrase “prior to, simultaneous with and/or after” in claim 7 is a relative term which renders the claim indefinite. The term “sequentially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In particular the specification does not describe these steps.
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.
Claim 1-3 rejected on the ground of non-statutory double patenting as being unpatentable over claims 17-29 of U.S. Patent No. 11,0823,564 (hereafter ‘564). Although the claims at issue are not identical, they are not patentably distinct from each other. For example current claim 1 recites:
“1. A method for delivering a filled prosthetic bladder into a surgical cavity, comprising:
placing a filled prosthetic bladder onto a first surface of a sheet, the sheet having a second surface on an opposite side of the sheet from the first surface and further including at least a pair of opposed lateral edges, bottom edge and a top edge,
sequentially folding the top edge and the pair of lateral edges over the filled prostheses
bladder such that a folded sheet with a single opening is defined at the bottom edge; and manipulating the folded sheet to direct the filled prosthetic bladder out the single opening and into a surgical cavity.”
Patent ‘564 claims 17, 23 and 27 recites :
“17. A method for delivering a filled prostheses bladder into a surgical cavity, the method comprising: placing the filled prostheses bladder onto a first surface of a delivery sheet as directed by a plurality of positioning indicia visible on the first surface, the positioning indicia corresponding to a volume of the filled prosthetic bladder; folding the delivery sheet so as to enclose the filled prostheses bladder, wherein the filled prostheses bladder remains in contact with the first surface of the delivery sheet and a second surface of the delivery sheet is exposed on the exterior of the delivery sheet; forming a delivery nozzle having an opening from a delivery tab defined on a bottom edge of the delivery sheet as the delivery sheet is folded; inserting the delivery nozzle through an incision such that the opening is in communication with a surgical cavity; and applying manual pressure to the second surface so as to direct the filled prosthesis bladder though the delivery nozzle and out the opening such that the filled prosthesis resides in the surgical cavity.”
“23. The method of claim 22, wherein the delivery sheet includes a first lateral edge and a second lateral edge and wherein the step of folding the delivery sheet further comprises: folding the second lateral edge over the first lateral edge to form the delivery nozzle”
“27. A method for delivering a filled prostheses bladder into a surgical cavity, the method comprising: placing the filled prostheses bladder onto a first surface of a delivery sheet folding a top edge of the delivery sheet toward a bottom edge of the delivery sheet such that the top edge extends past the filled prosthesis bladder; folding a first lateral edge of the delivery sheet toward a second lateral edge of the delivery sheet such that the first lateral extends past the filled prosthesis bladder; and folding the second lateral edge toward the first lateral edge such that the second lateral edge extends past the filled prosthesis bladder, whereby the filled prosthesis bladder is enclosed by the delivery sheet, wherein the filled prostheses bladder remains in contact with the first surface of the delivery sheet and a second surface of the delivery sheet is exposed on the exterior of the delivery sheet forming a delivery nozzle having an opening from a delivery tab defined on the bottom edge as the delivery sheet is folded; inserting the delivery nozzle through an incision such that the opening is in communication with a surgical cavity; and applying manual pressure to the second surface so as to direct the filled prosthesis bladder though the delivery nozzle and out the opening such that the filled prosthesis resides in the surgical cavity.”
It is obvious to one having ordinary skill in the art that the subject matter of the current claim is recited in a varied manner. However, pat. ‘564 does not recite sequentially folding. As best interpreted it would have been obvious to one having ordinary skill in the art to sequentially fold the sheet of pat. ‘564 in order to form the delivery apparatus quickly for insertion of the prosthetic bladder.
Regarding claims 2-3 see pat. ‘564 claims 17, 23 and 27. Regarding claim 4, see pat. ‘564 claim 17. Regarding claim 6 see pat. ‘564 claim 18. Regarding claim 7 pat. ‘564 does not limit when the lubricant may be applied to the surface thus could obviously be applied prior to, simultaneous with and/or after placing the filled prosthetic bladder. Regarding claim 8, see pat. ‘564 claim 17. Regarding claim 9 see pat. claim 19 where it is obvious that the step of moistening can activate the lubricant. Regarding claims 11-12 pat. ‘564 does not recites a “breast implant” or a breast cavity” however it is obvious that the term a filled prostheses bladder into a surgical cavity as recited in claim 17 of ‘564 is broad and could encompass a breast prosthesis and a breast cavity.
Allowable Subject Matter
10. Claims 5, 10 and 13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 May 29, 2026
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