DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 22, 24, 27-28 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Shfaram 2006/0167338.
PNG
media_image1.png
210
336
media_image1.png
Greyscale
Noting figures 3B-3C Shfaram discloses the invention as claimed comprising: A method for elevating a lower pole of a breast, comprising: providing a lower pole support (this may be interpreted as element 48 cradling member) and a positioning tool (“45”; see [0062] which states “tool 45, a passage 46 is formed between the incisions and using that tool a cradling member 48 is yarned through the passage 46), loading a tubular distal section of the positioning tool with the lower pole support (see illustration supra and distal end of tool), delivering at least a portion of the lower pole support (48) through an access incision (42) with the positioning tool, and anchoring the lower pole support around breast parenchyma to retain the breast in place (See figure. 3H).
Regarding claim 24 see body pocket (46). Regarding claims 27-28 limitations of attaching a plurality of straps (70) extending from the lower pole support to an upper pole suspension struts (see fig. 3H); and to support parenchyma (which is breast tissue).
Regarding claim 30 Shfaram does not specifically state that the pole support is wrapped around the positioning tool. It would have been obvious to one having ordinary skill in the art to modify Shraram and wrap the pole support 48 around the tool 45 because fig. 3d utilizes an additional tool which illustrates supports wrapped around that tool and would thus help secure 48 to the device while being passed through passage 46.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 23-24 and 30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shfaram 2006/0167338.
Regarding claim 23, Shfaram has been disclosed however does not specifically state that the withdrawing the positioning tool through the access incision. It would have been obvious (if not inherent) to remove the tool through the incision because the incision is where access is initially gained and Shfaram states in [0066] that the tool is removed.
Double Patenting
9. 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.
10. Claims 22-23 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 8,858,629 (hereafter ‘629). Although the claims at issue are not identical, they are not patentably distinct from each other.
Current claim 22 recites:
“22. A method for elevating a lower pole of a breast, comprising: providing a lower pole support and a positioning tool, loading a tubular distal section of the positioning tool with the lower pole support, delivering at least a portion of the lower pole support through an access incision with the positioning tool, and anchoring the lower pole support around breast parenchyma to retain the breast in place.”
Pat. ‘629 claim 1 recites”
“1. A mastopexy system, comprising: a lower pole support comprising a body region and a plurality of upper and lower straps, and wherein each of said upper and lower straps being a continuous extension and integral with the body region of said lower pole support, and a first positioning tool comprising a tubular distal section loaded with the lower pole support, wherein the first positioning tool facilitates placement of the lower pole support within a breast through an incision, and wherein the lower pole support holds the breast in place when anchored by the upper and lower straps to a support tissue structure and the body region is around breast parenchyma and wherein the lower pole support is positioned within the tubular distal section of the positioning tool.”
It is obvious to one having ordinary skill in the art that current method claims as currently recited are fully recited as functional intended use claims within the patent the patent. It is also obvious that “facilitating placement” is equivalent to “delivering’.
11. Regarding claim 23, pat. 629 does not specifically state that the withdrawing the positioning tool through the access incision. It would have been obvious to remove the tool through the incision because the incision is where access is initially gained and the tool does not remain in the body.
12. Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 8,858,629 (hereafter ‘629) in view of Moses et al. claims 1-22 of U.S. Pat. 10,765,507 (hereafter ‘507) has been disclosed however does not recite positioning the pole support within a body pocket formed through the access incision.
13. Regarding claim 25, pat. ‘629 does not recite delivering the lower pole support through a periareolar incision. Pat. ‘507 claim 1 and 16 recite that at least one access incision is made in the vicinity of the NAR (nipple areola complex). It is obvious to one having skill in the art that this is equivalent to inserting through a periareolar incision.
14. Regarding claim 26, see pat. ‘629 claims 2-5. Regarding claims 27, see pat. ‘629 claim 1. Regarding claim 28 see claims 1 which recites attaching to tissue. Regarding claim 29, see pat. ‘629 last sentence of claim1. Regarding claim 30, see pat. ‘629 claim 7. Regarding claim 31, see pat. ‘629 claim 8.
15. Claims 32, 48-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,765,507 (hereafter ‘507) in view of U.S. Pat. 8,858,629 (hereafter ‘629). Although the claims at issue are not identical, they are not patentably distinct from each other.
16. Current claim 32 recites:
“32. A minimally invasive method for placing a device to lift a breast and NAC of a patient from a first position to a second position comprising: making a first incision in a side of the breast; creating a subcutaneous body pocket in an inferior portion of the breast; advancing a lower pole support positioning tool though the first incision and into the body pocket; deploying a lower pole support in the body pocket; manipulating the body of the lower pole support to span the body pocket; manipulating tissue of the breast and the NAC to the second position; and attaching the lower pole support to supportive tissue to secure the breast and the NAC in the second position.”
Pat. ‘507 claims 1 and 17 recites:
“1. A method for elevating a lower pole of a breast from a first position to an elevated target position, the breast comprising a superficial, inferior half, and a NAC, the method comprising the steps of: creating at least one access incision in the vicinity of the NAC; dissecting in the superficial, inferior half of the breast through the at least one incision to create a space; positioning a lower pole support into the space; adjusting the position of the breast from the first position to the elevated target position; and affixing the lower pole support after the breast is positioned in the elevated target position and wherein the affixing is performed by securing a plurality of straps radially extending from a body of the lower pole support to supportive tissue.”
“17. The method of claim 1, wherein the dissecting the space comprises creating a triangular shaped pocket.”
However ‘507 does not recite the positioning tool. Pat. ‘629 claims recite the use of a positioning tool (see claims 1 and 7-9). Pat. ‘623 also recites that the pole support may have a canoe shape.
It would have been obvious to one having ordinary skill in the art to utilize a “tool” for positioning the support member in order to ensure accurate placement of the implant. It is further obvious that the “second” position as claimed can equate to the limitation of “a first position to an elevated position” where the elevated position is the “second position”. It further would have been obvious to have the implant “span” the lower pole because of it being claimed to have a canoe shaped.
17. Regarding claims 48-49, pat. ‘507 does not specifically state “wherein the step of manipulating the breast and NAC to the second position is performed by manipulating the mesh”. It is obvious that this step is performed because pat. ‘507 claim 20 states cutting and folding a mesh structure and positioning it into the space.
Allowable Subject Matter
18. Claims 33-47, 50-52 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.
19. The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is considered to be Shfaram 2006/0167338, however Shfaram does not disclose the methods of:
“A minimally invasive method for placing a device to lift a breast and NAC of a patient from a first position to a second position comprising: making a first incision in a side of the breast; creating a subcutaneous body pocket in an inferior portion of the breast; advancing a lower pole support positioning tool though the first incision and into the body pocket; deploying a lower pole support in the body pocket; manipulating the body of the lower pole support to span the body pocket; manipulating tissue of the breast and the NAC to the second position; and attaching the lower pole support to supportive tissue to secure the breast and the NAC in the second position then creating a second incision on the side of the breast opposite to the first incision; and wherein the deploying step comprises deploying a lower pole support in the body pocket from the lower pole support positioning tool, the lower pole support comprising a body and plurality of upper straps and a plurality of lower straps. Shfaram further does not disclose the step of removing skin above the NAC to for the second position for the NAC in conjunction with the limitations of claim 32. Shfaram further does not disclose the steps of “creating at least one channel pocket extending from the body pocket to the support tissue, and wherein manipulating the upper straps comprises manipulating at least one upper strap through the channel pocket to the support tissue.
Conclusion
20. 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https:/Awww.uspto.gov/patents/apply/patent- center for more information about Patent Center and https:/Awww.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197.
/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 February 19, 2026