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 .
Election/Restrictions
Applicant's election without traverse of Group I (claims 1-23) in the reply filed on 1/27/26 is acknowledged. The examiner acknowledges the response dated 1/27/26 and agrees that:
Group I claims 1-23 are drawn to “Breast Implants” classified in A61F 2/12
Group II claims 24-29 are drawn to “Methods of Manufacture/Assembly” classified in A61F 2250/0062.
Claims 24-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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: In particular claim 11 recites “The apparatus of claim 1, wherein the plurality of extensions includes a first pair of extensions having a longitudinal axis along a first axis and a second pair of extensions having a longitudinal axis along a second axis perpendicular to the first axis.”
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 1-2, 4-8, 10, 12, 14, 16-20, 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-39 of U.S. Patent No. 12/364,590 (hereafter ‘590). Although the claims at issue are not identical, they are not patentably distinct from each other.
Independent claims 1 and 12 recite:
“1. (Original) An apparatus, comprising: a body formed of a matrix material, the body configured to be positioned around a breast prosthesis to support a breast prosthesis within a patient, the body having a shape including: a central region configured to cover a central portion of an anterior side of a breast prosthesis; and a plurality of extensions extending from the central region, each of the plurality of extensions including: a first section configured to cover a portion of the anterior side of the breast prosthesis; a second section extending from the first section and having a narrower width than the first section, the second section configured to wrap around a side of the breast prosthesis; and a third section extending from the second section and increasing to a
greater width than the second section before tapering to an apex, the third section
configured to cover at least a portion of a posterior side of the breast prosthesis,
the apex of each of the plurality of extensions configured to be coupled to one
another at a posterior side of the breast prosthesis to secure the body to the breast
prosthesis.”
“12. (Original) An apparatus, comprising: a body formed of a matrix material, the body configured to be positioned around a breast prosthesis to support a breast prosthesis within a patient, the body having a shape including: a central region configured to cover a central portion of a first side of a breast prosthesis; and a plurality of extensions extending from the central region, each of the plurality of extensions including: a first section configured to cover a portion of the first side of the breast prosthesis and having a first maximum width; a second section extending from the first section; a third section extending from the second section and configured to cover at least a portion of a second side of the breast prosthesis opposite the first side, the third section having a second maximum width smaller than the first maximum width and tapering to an apex, the plurality of extensions configured to be coupled to one another to secure the body to the breast prosthesis.”
Patent ‘590 claims 16 and 17 recite:
“16. A kit, comprising: at least one pre-shaped matrix material, the at least one pre-shaped matrix material including: a central region configured to cover a central portion of an anterior side of a breast prosthesis, and a plurality of extensions extending from the central region, each of the plurality of extensions configured to wrap around a portion of the breast prosthesis, the plurality of extensions configured to be affixed to surrounding tissue to secure the breast prosthesis in place; and a foldable sheet configured to be folded into an envelope form that is configured to enclose around the at least one pre-shaped matrix material to maintain at least one pre-shaped matrix material in a sterile environment therein.
17. The kit of claim 16, wherein each extension from the plurality of extensions includes: a first section configured to cover a portion of the anterior side of the breast prosthesis; a second section extending from the first section and having a narrower width than the first section, the second section configured to wrap around a side of the breast prosthesis; and a third section extending from the second section and increasing to a greater width than the second section before tapering to an apex, the third section configured to cover at least a portion of a posterior side of the breast prosthesis.
19. The kit of claim 17, wherein a maximum width of the third section is smaller than a maximum width of the first section of each of the plurality of extensions.
It is obvious to one having ordinary skill in the art that the patent recites the limitations of the current application claims in a varied manner and includes additional limitations such an envelope. The patent recites the imitations in independent and independent form.
Regarding claim 2 see pat. ‘590 claim 19.
Regarding claim 4 see pat. ‘590 claim 20.
Regarding claim 5, 8, 17 these limitations are considered to be intended use. It is obvious that because the structural limitations of the patent are equivalent that it is capable of performing the functions as claimed.
Regarding claim 6, see pat. ‘590 claim 21.
Regarding claims 7 and 19, see pat. ‘590 claim 25.
Regarding claims 10 and 22, pat. ‘590 claim 36 recites the limitations of a foldable matrix sheet that includes at least one slot and at least one tab configured to fit through the slot.
Regarding claim 14 see claim pat. ‘590 claim 17.
Regarding claim 16, see ‘590 claim 20.
Regarding claim 18, see pat. ‘590 claim 21.
Regarding claim 20, pat. ‘590 recites the use of pharmaceutical (see claim 21). It is obvious to one having ordinary skill in the art that antibacterial agents are pharmaceutical agents.
Allowable Subject Matter
Claims 3, 9, 11, 13, 15, 21, and 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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 February 11, 2026