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 .
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 SIM card must be shown or the feature(s) canceled from the claim(s). 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 § 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.
Claims 1-15, 17, 24-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Korman (9,814,528).
Korman teaches a system for expanding tissue, said system comprising:
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(a) an expandable bladder 16 adapted to be located beneath a region of skin 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 a patient.
Claim 2, see figure 2, above, wherein the portable carrier 30 is configured to hold both the source of inflation medium 22 and the pump 12.
Claim 3, carrier 30 can be a backpack which inherently has one or more pouches for holding the one or more of the source of inflation medium and the pump.
Claim 4, further comprising: (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, 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, 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, wherein the controller is programmable; see at least 4:5-19.
Claim 8, 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, see claim 10 teaching the predetermined interval is at least one hour.
Claim 10, 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, wherein the upper threshold level is in the range from about 5 mmHg to about 35 mmHg; see claim 4.
Claim 12, wherein the controller is programmed to stop delivering the inflation medium after a target total volume of inflation medium has been delivered to the patient; see the last paragraph of claim 1.
Claim 13, 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, 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, wherein the portable carrier comprises a pouch for holding the controller. Portable carrier 30 can be a backpack which inherently has one or more pouches for holding the pouch.
Claim 17, the controller 14 is configured to receive an activation device (pressure sensor or memory) for activating operation of the pump”.
Claim 24, wherein the portable carrier comprises a bra-like jacket, vest, a backpack, or a belt; see 3:65-4:4 teaching at least a vest.
Claim 25 depends from claim 24, “wherein the bra-like jacket is shaped to mimic natural breasts” which is not needed to fulfill claims 24-25.
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, see the source of the inflation medium 22.
Claim 29, wherein the source of the inflation medium is housed within the portable carrier such as a backpack.
Claim 34, the controller 14 or the pressure sensor is considered “an activation device for activating operation of the pump”.
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 15-16, 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Korman (9,814,528) in view of LaBove et al (4,087,864).
Korman teaches a system for expanding tissue as explained above including the portable carrier vest, however, fails to teach the vest has a pouch located on a lateral side.
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LaBove et al also teaches a system comprising a portable carrier vest/bra-like jacket having a lateral pouch(es) (at least 14) to carry a source of fluid 16.
It would have been obvious to one have substituted the vest of LaBove et al having a lateral pouch for the vest of Korman to hold the source of inflation medium.
Regarding claim 31, Korman is unclear if the source of inflation medium at least partially shaped to mimic the shape of one or more natural breasts. LaBove et al teaches using bag 16 to hold a fluid source which is inherently flexible.
It would have been obvious to one having ordinary skill in the art to have used a bag as taught by LaBove et al for the source to contain the inflation medium of Korman which conforms to the body as positioned and at least partially shaped to mimic the shape of one or more natural breasts. Note that this is a different rejection for claim 15.
Claim 32, the examiner takes the position that bag 16 is a pouch and is on the lateral side of the portable carrier.
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Korman (9,814,528). Evidenced by Korman (2016/0242865) or Logan et al (A Control Unit for Maximal-Rate Continuous Tissue Expansion (CTE)).
Korman ‘528 teaches a system for expanding tissue as explained above, however, fails to teach:
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 Shalon et al (2010/0010531).
Korman teaches 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.
Claim 17, 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 37: wherein the activation device is configured to enable operation of the pump for a prescribed duration after being received by the controller. As stated above, 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.
Claims 19 and 36 claim “wherein the activation device is configured to enable operation of the pump for a prescribed duration after being received by the controller”, inherently the activation device must be received by the controller to enable operation of the pump.
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.
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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