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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/02/18 has been entered.
Response to Arguments
Applicant's amendment and arguments filed 7/30/2026 overcame the rejection under 35 U.S.C. 102(a)(1) as being anticipated by Korman (9,814,528).
Regarding the double patenting rejections, applicant requested these rejections be held in abeyance.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following from claim 1 must be shown or the feature(s) canceled from the claim(s):
(c) a portable carrier is a bra adapted to be worn by the user and shaped to mimic natural breasts, wherein the bra holds configured to hold one or more of the source of inflation medium, and wherein the source of inflation medium comprises an outward facing surface mimicking a natural appearance of a normal, healthy breast.
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The examiner does not accept applicant’s figure 9A wherein the inflation medium mimics the natural appearance of a normal, healthy breast. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-23, 26-37 and 39 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.
Claim 1 claims, “(c) a portable carrier is a bra adapted to be worn by the user and shaped to mimic natural breasts, wherein the bra holds the source of inflation medium, and wherein the source of inflation medium comprises an outward facing surface mimicking a natural appearance of a normal, healthy breast”. The scope and demarcation of wherein the inflation medium mimics the natural appearance of a normal, healthy breast and where it does not mimic, in light of figure 9A and claim 33, makes the language indefinite. Note applicant’s claim 33 claims the portable carrier for the inflation medium is located on a lateral side.
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.
Claims 1-17, 26-33 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Korman (9,814,528) in view of Lee et al (2014/0196189) or Shailer (6,241,575).
Korman teaches a system for expanding tissue of a user, said system comprising:
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(a) an expandable bladder 16 adapted to be located beneath a region of skin of the user to be expanded;
(b) a pump 12 (adapted to be connected to a source of inflation medium and to deliver said inflation medium to the expandable bladder (functional language, fully capable of)); and
(c) a portable carrier (30, see 3:65 et seq.) configured to hold one or more of the source of inflation medium and the pump, wherein the portable carrier is adapted to be worn by the user, wherein the portable carrier comprises a bra-like jacket, vest, a backpack, or a belt; see 3:65-4:4.
However, the portable carrier is not interpreted as being a bra adapted to be worn by the user and shaped to mimic natural breasts, wherein the bra holds the source of inflation medium, and wherein the source of inflation medium comprises an outward facing surface mimicking a natural appearance of a normal, healthy breast”.
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Figure 3 of Lee teaches a portable carrier having a pouch 34 (see reference number 35 above) which is fully capable of being worn on the lateral side of the breast. Applicant’s claim 33 teaches that this mimics the natural appearance of a normal healthy breast.
It would have been obvious to one having ordinary skill in the art to have substituted the portable carrier which is a bra of Lee et al for the portable carrier of Korman to obtain predictable results; see MPEP 2143. Additional benefits include the bra of Korman is capable of holding at least the inflation medium closer to the wear’s body for a more natural appearance and less swinging and striking the wearer’s body.
Also, it would have been obvious to one having ordinary skill in the art to have included the bra of Lee et al as an additional component of the system of Korman as a more complete post breast mastectomy system.
Shailer also teaches a portable carrier which is a bra 10 adapted (functional language) to be worn and shaped to mimic natural breast, wherein the bra holds a source of a source of inflation medium 18 which comprises an outward facing surface mimicking a natural appearance of a normal healthy breast.
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It would have been obvious to one having ordinary skill in the art to have substituted or tried the portable carrier which is a bra of Shailer for the portable carrier of Korman to obtain predictable results and/or with a reasonable expectation of success; MPEP 2143. Additional benefits include the bra of Shailer is capable of keeping at least the inflation medium closer to the wear’s body for a more natural appearance and less swinging and striking the wearer’s body.
Also, it would have been obvious to one having ordinary skill in the art to have included the bra of Lee et al as an additional component of the system of Korman as a more complete post breast mastectomy system wherein it could be used including to estimate desired cup size.
Claims 2-3, Lee et al teaches many pouches 34 configured to hold the source of inflation medium 22 and the pump 12. Shailer teaches pouches 18 and a pump can be hung/attached to a strap.
Claim 4, Korman teaches: (a) a pressure sensor 20 adapted to monitor a pressure within the expandable bladder on a substantially continuous basis (see at least the abstract); and (b) a controller (14) which receives pressure data from the pressure sensor.
Claim 5, Korman teaches wherein the controller is configured to control the pump to deliver the inflation medium to the expandable bladder when the pressure within the expandable bladder falls below a lower threshold value; see at least the abstract.
Claim 6, Korman teaches wherein the controller is configured to control the pump to deliver the inflation medium to the expandable bladder until a predetermined volume of the inflation medium is delivered to the expandable bladder; see at least the abstract teaching “reaches a predetermined maximum volume”.
Claim 7, Korman teaches wherein the controller is programmable; see at least 4:5-19.
Claim 8, Korman teaches wherein the controller is configured to control the pump to deliver the inflation medium, terminate delivery of the inflation medium, and/or resume delivery of the inflation medium after a predetermined interval; see claim 1.
Claim 9, claim 10 of Korman teaches the predetermined interval is at least one hour.
Claim 10, Korman teaches wherein the controller is programmed to deliver the inflation medium until the pressure within the expandable bladder reaches an upper threshold value; see claim 3.
Claim 11, Korman teaches wherein the upper threshold level is in the range from about 5 mmHg to about 35 mmHg; see claim 4.
Claim 12, Korman teaches wherein the controller is programmed to stop delivering the inflation medium after a target total volume of inflation medium has been delivered to the user; see the last paragraph of claim 1.
Claim 13, Korman teaches wherein the target total volume of inflation medium is in the range from about 150 cc to about 800 cc; see claim 5.
Claim 14, Korman teaches wherein the target total volume of inflation medium is in the range from about 200 cc to about 600 cc; see claim 6.
Claim 15, rejection in view of Lee et al only. Lee teaches many pouches 34 for/capable of holding the controller.
Claims 16 and 33, both Lee et al and Shailer teach the pouch on the lateral side.
Claim 17, the controller 14 of Korman is configured to receive an activation device (pressure sensor or memory) for activating operation of the pump”.
Claim 26, wherein the expandable bladder is configured and fully capable of being placed in a subpectoral pocket of the patient following a mastectomy. See 3:29-49 and claim 1.
Claim 27, wherein the expandable bladder is fully capable of being initially inflated with a volume of saline in the range from about 50 cc to about 100 cc; see claim 8 teaching this limitation.
Claim 28, wherein the inflation medium comprises saline, see claim 11.
Claim 29 and 31, see the source of the inflation medium 22 or Korman or 30 of Shailer. Claim 31, an inflation medium has any shape.
Claim 30, wherein the source of the inflation medium is housed within the portable carrier 22 or Korman or 30 of Shailer.
Claim 32, see claims 2-3 above.
Claim 34, the controller 14 or the pressure sensor is considered “an activation device for activating operation of the pump”.
Claim 39 describes the inflation fluid which is not positively claimed.
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Korman (9,814,528) in view of Lee et al (2014/0196189) or Shailer (6,241,575). Evidenced by Korman (2016/0242865) or Logan et al (A Control Unit for Maximal-Rate Continuous Tissue Expansion (CTE)).
Korman (9,814,528) in view of Lee et al (2014/0196189) or Shailer (6,241,575) teach the system as described above, however, fail to teach claims 21-23:
Claim 21, the pump and the controller are disposed with the same housing.
Claim 22, wherein the pump comprises a syringe pump.
Claim 23, wherein the pump comprises a peristaltic pump.
Korman ‘865 teaches a syringe pump 16 wherein the pump and controller 14 are disposed with the same housing 12. See at least figure 1.
Logan et al teaches a peristaltic pump 16 wherein the pump and controller are disposed with the same housing. See diagram 2.
It would have been obvious to one having ordinary skill in the art to have disposed the pump and controller in the same housing as evidenced for simplicity and to have used either a syringe pump or peristaltic pump which meet the needed parameters of the system as evidenced.
Claims 17-20 and 34-37 are rejected under 35 U.S.C. 103 as being unpatentable over Korman (9,814,528) in view of Lee et al (2014/0196189) or Shailer (6,24.,575) and further in view of LaBove et al (4,087,864).
Korman in view of Lee et al or Shailer teach a system for expanding tissue, as described above, comprising an activation device (controller 14) which is programmable including predetermined intervals of a least one hour. See claims 9-10. Said controller (digital microprocessor, see 4:55) inherently has a memory.
Regarding claim 17-18 and 35, Korman fails to teach the memory is a SIM card (activation device).
Shalon et al also teaches a system for expanding tissue comprising a controller 350 which can use various memory types such as a SIM card; see par. 0292.
It would have been obvious to one having ordinary skill in the art to have tried a SIM card, as taught by Shalon et al, for the memory of Korman with a reasonable expectation of success.
Claims 17-18, the combination places the SIM card as part of the controller, therefore, the controller is configured to receive the SIM card (activation device).
Claims 19-20 and 36-37: wherein the activation device is configured to enable operation of the pump for a prescribed duration after being received by the controller is inherent. As stated above and claim 10, Korman teaches a prescribed duration of at least hour which meets all claimed prescribed duration of about 1 day, about 2 days, about 1 week, about 2 weeks, about 1 month, or about 3 months.
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 1-15, 17, 24-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over all claims of U.S. Patent No. Korman (9,814,528). Although the claims at issue are not identical, they are not patentably distinct from each other both claim a system for expanding tissue. Current claim is much broader. See the description under 35 U.S.C. 102(a)(1) above.
Claims 1-15, 17, 24-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over all claims of U.S. Patent No. Korman (9,814,528). Although the claims at issue are not identical, they are not patentably distinct from each other both claim a system for expanding tissue. Current claim is much broader. See the description under 35 U.S.C. 102(a)(1) above.
Claims 1, 4-16, 24-30, 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/186,070. Although the claims at issue are not identical, they are not patentably distinct from each other and are self-evident. Current claim 1 is much broader than claim 1 of copending Application No. 18/186,070.
Claim 15, a backpack inherently has a pouch.
Claims 24-25, a vest is interpreted as bra-like.
All other claims are self-evident.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mori (2005/0261805) with SIM card 32.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
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, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRUCE E SNOW/Primary Examiner, Art Unit 3774
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