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 .
Status of the Application
Claims 1-20 have been examined in this application. This communication is the first action on the merits.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/28/2024 and 12/29/2025 are being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-21 of copending Application No. 18/758,661 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims require the following limitations:
a plurality of surface electrodes configured to be disposed on an abdomen of a maternal patient;
a stimulator connected to at least two of the plurality of surface electrodes and configured to generate stimulation pulses between at least two of the plurality of surface electrodes; and
a control system configured to obtain electromyography (EMG) data via the plurality of surface electrodes; detect at least one indicator of insufficient uterine activity (below a threshold) based on the EMG data; and, in response to detecting the at least one indicator of insufficient uterine activity, control the stimulator to deliver a plurality of stimulation pulses via the plurality of surface electrodes to the maternal abdomen to stimulate the uterine muscle of the maternal patient, wherein the control system is further configured to detect the at least one indicator of insufficient uterine activity based on a current labor phase of the maternal patient.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 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 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garfield et al. (US 2014/0058473 A1) (IDS of 12/29/2025).
Claim 1. Garfield et al. (Garfield) discloses a system for stimulating a uterine muscle of a maternal patient after childbirth, the system comprising:
a plurality of surface electrodes configured to be disposed on an abdomen of a maternal patient; [0007]; [0047]; [0048]
a stimulator connected to at least two of the plurality of surface electrodes and configured to generate stimulation pulses between at least two of the plurality of surface electrodes; Fig. 10; [0036], and
a control system configured to control the stimulator to deliver a plurality of stimulation pulses via the plurality of surface electrodes to the maternal abdomen to stimulate the uterine muscle of the maternal patient. [0036]; [0040]
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 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 2-20 are rejected under 35 U.S.C. 103 as being unpatentable over Garfield in view of Ben-David et al. (US 2014/0012190 A1).
Claim 2. While Garfield discloses a monitor configured to obtain EMG data from the plurality of surface electrodes, wherein the control system is configured to, before controlling the stimulator to deliver the plurality of stimulation pulses, detect that uterine shrinkage has not occurred in the maternal patient based on the stimulation results, wherein the plurality of stimulation pulses are configured to stimulate the uterine muscle of the maternal patient to cause uterine shrinkage, Figs. 3 and 5-9, Garfield does not specifically teach the use of an EMG monitor, which is disclosed in Ben-David et al. (Ben-David). Ben-David further discloses a plurality of surface electrodes configured to be disposed on an abdomen of a maternal patient. [0012]; [0023]; [0024]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Garfield to include the recited limitations, as disclosed in Ben-David, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson's-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Claim 3. The system of claim 2, wherein the control system is configured to detect that the uterine shrinkage has not occurred based on a comparison of a response amplitude of the uterine muscle to at least one threshold. Garfield, [0027]; [0044]; Ben-David, [0012]. Same rationale as applied to claim 2.
Claim 4. The system of claim 2, wherein the at least one threshold is based on an amplitude of the EMG data recorded while the maternal patient was in labor. Ben-David, [0012]; [0015]. Same rationale as applied to claim 2.
Claim 5. The system of claim 1, further comprising an EMG monitor configured to obtain EMG data from the plurality of surface electrodes; wherein the control system is configured to determine a response of the uterine muscle to the plurality of stimulation pulses based on the EMG data. Ben-David, [0012]. Same rationale as applied to claim 2.
Claim 6. The system of claim 5, wherein the control system is further configured to: compare the response of the uterine muscle to at least one threshold; control at least one of a stimulation amplitude, a stimulation frequency, and a stimulation pulse width of the stimulation pulses based on the comparison. Garfield, [0027]; [0035]-[0037]; [0044]; Ben-David, [0012]; [0015]. Same rationale as applied to claim 2.
Claim 7. The system of claim 6, wherein the control system is further configured to determine at least one of the at least one threshold based on the EMG data obtained from the patient. Garfield, [0027]; [0044]; Ben-David, [0012]; [0015]. Same rationale as applied to claim 2.
Claim 8. The system of claim 6, wherein the control system is further configured to: determine that the response of the uterine muscle is less than the at least one threshold; in response to determining that the response of the uterine muscle is less than the at least one threshold, increase the at least one of the stimulation amplitude, the stimulation frequency, and the stimulation pulse width of the stimulation pulses by an increase amount. Garfield, [0027]; [0044]; Ben-David, [0012]; [0015]. Same rationale as applied to claim 2.
Claim 9. The system of claim 8, wherein the increase amount is based on a user input. Garfield, [0027]; [0044]; Ben-David, [0012]; [0015] Same rationale as applied to claim 2.
Claim 10. Garfield teaches a method of monitoring a maternal patient after childbirth, the method comprising:
controlling a stimulator to deliver a first plurality of stimulation pulses via a plurality of surface electrodes configured to be disposed on an abdomen of a maternal patient, wherein the first plurality of stimulation pulses are configured to stimulate a uterine muscle of the maternal patient; [0007]; [0036]; [0040]; [0047]; [0048]
obtaining stimulation data from the maternal patient via the plurality of surface electrodes; [0036]; [0040]; [0047]; [0048].
Garfield does not specifically teach the use of an EMG monitor, which is disclosed in Ben-David. Ben-David further discloses a plurality of surface electrodes configured to be disposed on an abdomen of a maternal patient. [0012]; [0023]; [0024]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Garfield to include the recited limitations, as disclosed in Ben-David, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson's-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Garfield, as modified by Ben-David, further teaches:
determining a response of the uterine muscle to the plurality of stimulation pulses based on the EMG data. Garfield, [0036]; [0040]; [0047]; [0048]; Ben-David, [0012]; [0023]; [0024].
Claim 11. The method of claim 10, further comprising controlling the stimulator to deliver a second plurality of pulses via the plurality of surface electrodes, wherein the second plurality of stimulation pulses are configured to stimulate the uterine muscle of the maternal patient; and wherein the second plurality of pulses have at least one of an increased amplitude, an increased frequency, and an increased pulse width compared to the first plurality of pulses. Garfield, [0027]; [0044]; Ben-David, [0012]; [0015]. Same rationale as applied to claim 8.
Claim 12. The method of claim 11, further comprising comparing the response of the uterine muscle to at least one threshold prior to delivering the second plurality of stimulation pulses, and selecting the at least one of the increased amplitude, the increased frequency, and the increased pulse width based on the comparison. Garfield, [0027]; [0044]; Ben-David, [0012]; [0015]. Same rationale as applied to claim 8.
Claim 13. The method of claim 12, further comprising determining the at least one threshold based on the EMG data obtained from the patient. Garfield, [0027]; [0044]; Ben-David, 0012]; [0023]; [0024]. Same rationale as applied to claim 8.
Claim 14. The method of claim 10, further comprising, prior to controlling the stimulator to deliver the plurality of stimulation pulses: obtaining the EMG data from the maternal patient via the plurality of surface electrodes following childbirth by the maternal patient; detecting that uterine shrinkage has not occurred in the maternal patient based on the EMG data; wherein the plurality of stimulation pulses are configured to stimulate the uterine muscle of the maternal patient to cause uterine shrinkage. Garfield, [0027]; [0044]; Ben-David, [0012]; [0023]; [0024]. Same rationale as applied to claim 8.
Claim 15. The method of claim 14, further comprising detecting that the uterine shrinkage has not occurred in the maternal patient based on a comparison of a response amplitude of the uterine muscle to at least one threshold, wherein the at least one threshold is based on an amplitude of the EMG data recorded while the maternal patient was in labor. Garfield, [0027]; [0044]; Ben-David, [0012]; [0023]; [0024]. Same rationale as applied to claim 8.
Claim 16. Garfield discloses a method of monitoring a maternal patient after childbirth, the method comprising:
obtaining stimulation data from the maternal patient via a plurality of surface electrodes following childbirth by the maternal patient, wherein the plurality of surface electrodes are configured to be disposed on an abdomen of a maternal patient; [0007]; [0036]; [0040]; [0047]; [0048]
Garfield does not specifically teach the use of an EMG monitor, which is disclosed in Ben-David. Ben-David further discloses a plurality of surface electrodes configured to be disposed on an abdomen of a maternal patient. [0012]; [0023]; [0024]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Garfield to include the recited limitations, as disclosed in Ben-David, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson's-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Garfield, as modified by Ben-David, further teaches:
detecting that uterine shrinkage has not occurred in the maternal patient based on the EMG data; Garfield, [0027]; [0044]; Ben-David, [0012]; [0023]; [0024]
controlling a stimulator to deliver a plurality of stimulation pulses via the plurality of surface electrodes, wherein the plurality of stimulation pulses are configured to stimulate a uterine muscle of the maternal patient to cause uterine shrinkage; Garfield, [0007]; [0036]; [0040]; [0047]; [0048]
reobtaining EMG data from the maternal patient via the plurality of surface electrodes; Ben-David, [0012], and
determining a response of the uterine muscle to the plurality of stimulation pulses based on the reobtained EMG data. Garfield, [0027]; [0044]; Ben-David, [0012]; [0023]; [0024]
Claim 17. The method of claim 16, further comprising comparing the response of the uterine muscle to at least one threshold to detect whether uterine shrinkage has occurred in the maternal patient; and continuing to deliver the plurality of stimulation pulses and determining a response of the uterine muscle until a threshold change in the EMG data is detected indicating that uterine shrinkage has occurred. Garfield, [0027]; [0044]; Ben-David, [0012]; [0023]; [0024]. Same rationale as applied to claim 16.
Claim 18. The method of claim 17, further comprising increasing at least one of an amplitude, a frequency, and a pulse width of the plurality of stimulation pulses until the threshold change in the EMG data is detected indicating that uterine shrinkage has occurred. Garfield, [0027]; [0035]-[0037]; [0044]; Ben-David, [0012]; [0023]; [0024]. Same rationale as applied to claim 16.
Claim 19. The method of claim 16, wherein detecting the uterine shrinkage in the maternal patient includes comparing the EMG data to at least one amplitude threshold. Garfield, [0027]; [0044]; Ben-David, [0012]. Same rationale as applied to claim 16.
Claim 20. The method of claim 19, further comprising determining the at least one amplitude threshold based on an amplitude of EMG data recorded from the maternal patient while the maternal patient was in labor. Ben-David, [0012]; [0015]. Same rationale as applied to claim 16.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Igor Borissov whose telephone number is 571-272-6801. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor Kambiz Abdi can be reached on 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IGOR N BORISSOV/Primary Examiner, Art Unit 3685 2/20/2026