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 .
Response to Arguments
Applicant’s arguments in combination with amendments, see Remarks and Claims, filed 11/28/2025, with respect to the rejection(s) of claim(s) 1, 3, 8, 18, 34, 65-78 under 35 USC 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the following:
Claim(s) 1, 3, 18, , 65, 71, 74, 78 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pat Pub No. 20140371811A1 to Lian et al.
Claim(s) 8, 66, 68-70, 72, 75-77 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20140371811A1 to Lian et al. in view of US Pat Pub No. 20180185642 to Lu (previously presented).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20140371811A1 to Lian et al. (hereinafter “Lian”) in view of US Pat Pub No. 20060020299 to Shalev (previously presented).
Claim(s) 73 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20140371811A1 to Lian et al. in view of US Pat Pub No. 20180361148 to Meyyappan et al.
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.
Claim(s) 1, 3, 18, , 65, 71, 74, 78 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pat Pub No. 20140371811A1 to Lian et al. (hereinafter “Lian”).
Regarding claims 1 and 71. (Currently Amended) Lian discloses a method and system for conditioning respiratory muscles in a patient (para 0067 “method for respiration synchronized spinal cord stimulation”), the method including steps comprising:
(a) measuring a plurality of physiological parameters (para 0068 “detect respiration signals”)
(b) detecting an inspiratory phase of the patient from one or more sensors (para 0068 “respiration signal can be extracted [] By identifying the peaks and nadirs of the extracted respiration signal, different phases of the respiration cycle can be determined, such as, for example, inspiration, [], as illustrated in FIG. 4.”);
(c)phase to activate one or more respiratory muscles of the patient, beginning administering a stimulation signal to one or more-portions of a spinal cord of the patient (para 0069 “dynamically adjusts the stimulation intensity [] in synchronization with the detected respiration phases”. Para 0070 “higher intensity spinal cord stimulation is delivered during the inspiration phase”);
(d)detecting an expiratory phase of the patient from the one or more sensors (para 0068 “respiration signal can be extracted [] By identifying the peaks and nadirs of the extracted respiration signal, different phases of the respiration cycle can be determined, such as, for example, [], expiration, [], as illustrated in FIG. 4.”); and
(e)_removing the stimulation signal in response to detecting the expiratory phase (para 0070 “no spinal cord stimulation is delivered”, 0071 “The spinal cord stimulation intensity during the expiration phase, Iexp, is preferably lower than, or equal to, Iip and/or Iep. In one embodiment, Iexp is set to zero, i.e., spinal cord stimulation is turned off during the expiration phase.” see fig 4),
(f) measuring the plurality of physiological parameters upon removal of the stimulation signal (para 0068 “detect respiration signals”): and[,]
repeating steps (a) through (f) to augment or sustain activation of one or more respiratory muscles in the patient and improve respiration of the patient after the method for conditioning respiratory muscles is completed (fig. 4, illustrates repeating the steps above to dynamically adjust the stimulation intensity).
Regarding claim 3. (Previously Presented) Lian discloses the method of claim 1, wherein the one or more portions of the spinal cord comprises a dorsal column of a thoracic spinal cord (para 0020, 0047, 0048, 0063-0064, etc.; it is noted that as recited the claim only requires the dorsal column to be one of the portions of the spinal column; it is understood that ).
Regarding claim 18. (Previously Presented) Lian discloses the method of claim 1, further comprising: administering a second stimulation signal to the one or more portions of the spinal cord of the patient during the detected inspiratory phase (fig. 4).
Regarding claim 65. (Previously Presented) Lian discloses the method of claim 1, further comprising: activating, via the stimulation signal, a plurality of motor neurons corresponding to the one or more portions of the spinal cord (para 0066 “cardiomotor neurons are inhibited during inspiration and are mildly activated during expiration”).
Regarding claim 74. (Previously Presented) Lian discloses the system of claim 71, wherein the stimulation signal is administered to a dorsal column of the thoracic spinal cord (para 0020, 0047, 0048, 0063-0064, etc.; it is noted that as recited the claim only requires the dorsal column to be one of the portions of the spinal column; it is understood that ).
Regarding claim 78. (Previously Presented) Lian discloses the system of claim 71, wherein the controller has further instructions stored thereon that, when executed cause the processor to: analyze the respiratory data to detect an expiratory phase of the patient; and cease administration of the stimulation signal (para 0068 “respiration signal can be extracted [] By identifying the peaks and nadirs of the extracted respiration signal, different phases of the respiration cycle can be determined, such as, for example, [], expiration, [], as illustrated in FIG. 4.” para 0070 “no spinal cord stimulation is delivered”, 0071 “The spinal cord stimulation intensity during the expiration phase, Iexp, is preferably lower than, or equal to, Iip and/or Iep. In one embodiment, Iexp is set to zero, i.e., spinal cord stimulation is turned off during the expiration phase.” see fig 4)
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 8, 66, 68-70, 72, 75-77 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20140371811A1 to Lian et al. (hereinafter “Lian”) in view of US Pat Pub No. 20180185642 to Lu.
Regarding claim 8. (Previously Presented) Lian discloses the method of claims 1, but fails to disclose wherein the stimulation signal is superimposed on a high frequency carrier signal.
Lu, from a similar field of endeavor, teaches a spinal cord stimulation system and method and teaches that it is known for the system to be configured to deliver the transcutaneous stimulation signal superimposed on a high frequency carrier signal (para 0025, 0182). It would have been obvious to one of ordinary skill in the art to modify the disclosure of Lian with the known teachings of Lu to superimpose the stimulation on a high frequency carrier signal to provide the predictable result of delivering stimulation using the known method of Lu.
Regarding claim 66. (Previously Presented) Lian discloses the method of claims 1, Lian discloses the spinal cord stimulation device is integrated into an implantable cardiac stimulation device (para 0038) but fails to explicitly disclose wherein administering the stimulation signal comprises at least one of a transcutaneous administration, an epidural delivery, a percutaneous delivery, or a magnetic induction.
Lu, from a similar field of endeavor, shows that it is known for the stimulation to be transcutaneous stimulation, percutaneous insertion, to provide stimulation (abstract, para 0008, 0014, 0128, etc.). It would have been obvious to one of ordinary skill in the art to modify the disclosure of Lian with the known teachings of Lu to provide the predictable result of providing stimulation to the spinal cord.
Regarding claim 68. (Previously Presented) Lian as modified by Lu renders obvious the method of claim 66, wherein: the first pulse is a 10 kHz pulse with a first pulse width of 1 ms; and the second pulse is a 30 Hz burst pulse with a second pulse width of 1ms (Lu, para 0161-0162, 0178-0179, etc.). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Also MPEP 2143 (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Regarding claim 69. (Previously Presented) Lian discloses the system of claim 36, wherein the stimulation signal comprises a plurality of monophasic pulses (Lian, para 0003) but fails to disclose at 5 Hz with a 500 s pulse width at an intensity between 3 mA and 5 mA.
Lu, from a similar field of endeavor, teaches providing transcutaneous stimulation (para 0059, stimulation is monophasic) at 5 Hz with a 500 s pulse width at an intensity between 3 mA and 5 mA (para 0021-0023, 0178-0179). It would have been obvious to one of ordinary skill in the art to modify the disclosure of Lian with the known teachings of Lu to provide the predictable result of providing stimulation therapy to the spinal cord. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Also MPEP 2143 (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Regarding claim 70. (Previously Presented) Lian discloses the system of claim 36, wherein the stimulation signal comprises a plurality of monophasic pulses (Lian, para 0003) but fails to disclose at 30 Hz with a 500 s pulse width at an intensity between 3 mA and 5 mA.
Lu, from a similar field of endeavor, teaches providing transcutaneous stimulation (para 0059, stimulation is monophasic) at 30 Hz with a 500 s pulse width at an intensity between 3 mA and 5 mA (para 0021-0023, 0178-0179). It would have been obvious to one of ordinary skill in the art to modify the disclosure of Lian with the known teachings of Lu to provide the predictable result of providing stimulation therapy to the spinal cord. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Also MPEP 2143 (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Regarding claim 72. (Previously Presented) Lian discloses the system of claim 71, but fails to disclose wherein the one or more sensors comprises a sensor configured to detect chest wall expansion.
Lu, from a similar field of endeavor teaches having a sensor to monitor chest wall expansion/movement so that the controller/stimulator adjust the stimulation pattern in response to the sensor output (para 0245). It would have been obvious to one of ordinary skill in the art to modify the disclosure of Lian with the teachings of Lu to provide the predictable result of adjusting the stimulation pattern in response to the sensor output.
Regarding claim 75. (Previously Presented) Lian discloses the system of claim 71, Lian discloses the spinal cord stimulation device is integrated into an implantable cardiac stimulation device (para 0038) but fails to explicitly disclose wherein the stimulator is configured to administer at least one of a transcutaneous stimulation, an epidural stimulation, a percutaneous stimulation, or a magnetic stimulation.
Lu, from a similar field of endeavor, shows that it is known for the stimulation to be transcutaneous stimulation, percutaneous insertion, to provide stimulation (abstract, para 0008, 0014, 0128, etc.). It would have been obvious to one of ordinary skill in the art to modify the disclosure of Lian with the known teachings of Lu to provide the predictable result of providing stimulation to the spinal cord.
Regarding claim 76. (Previously Presented) Lian discloses the system of claim 71, but fails to disclose wherein the stimulator comprises one or more adhesive stimulators.
Lu, from a similar field of endeavor teaches a similar method and system having a neuromodulation of respiration device configured as an adhesive patch having at least one electrode (para 0266).
It would have been obvious to one of ordinary skill in the art to modify the disclosure of Lian with the teachings of Lu, to provide the predictable result of attaching electrodes/sensors to the body.
Regarding claim 77. (Previously Presented) Lian discloses the system of claims 71, but fails to disclose further comprising: a second stimulator, wherein the controller has further instructions stored thereon that, when executed cause the processor to: administer, via the second stimulator, a second stimulation signal during the inspiratory phase to activate respiratory drive in the patient.
Lu, from a similar field of endeavor teaches the stimulator configured to induce epidural and transcutaneous electrical stimulation and magnetic stimulation (para 0096). It would have been obvious to one of ordinary skill in the art to modify the disclosure of Lian with the teachings of Lu to provide the predictable result of providing required stimulation. Furthermore, it is noted that the court has held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20140371811A1 to Lian et al. (hereinafter “Lian”) in view of US 20060020299 to Shalev.
Regarding claim 34. (Previously Presented) The method of claim 1, but fails to disclose further comprising administering a glutamatergic agent to the patient.
Shalev, from a similar field of endeavor, teaches that it is known to provide pharmaceutical agent (i.e., a glutamate receptor antagonist), where configuring the stimulation comprises configuring the stimulation to cause the increase in the passage of the glutamate receptor antagonist, NMDA receptor blocker, stimulant of nerve regeneration, microglial activation modulator, antioxidant, inhibitor of protein tyrosine phosphatases or a medium chain triglyceride.
It would have been obvious to one of ordinary skill in the art to modify the disclosure of Lian with the teachings of Shalev to provide the predictable result of causing an increase in the passage of the glutamate receptor antagonist.
Claim(s) 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20140371811A1 to Lian et al. (hereinafter “Lian”) in view of US Pat Pub No. 20100030299 to Covalin.
Regarding claim 67. (Previously Presented) Lian discloses the method of claim 1, but fails to disclose further comprising: determining a delay based on a desired biphasic pulse waveform, and wherein administering the stimulation signal comprises: administering a first pulse; waiting the delay; and administering a second pulse, the second pulse having an opposite polarity of the first pulse.
Covalin, from a similar field of endeavor, teaches that it is known to use pulses of opposite polarity and implementing a delay in order to give the first pulse time to take effect before the charge-balancing second pulse is sent (para 0070).
It would have been obvious to one of ordinary skill in the art to modify the disclosure of Lian with the teachings of Covalin to provide the predictable result of using pulses of opposite polarity and implementing a delay in order to give the first pulse time to take effect before the charge-balancing second pulse is sent.
Claim(s) 73 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20140371811A1 to Lian et al. (hereinafter “Lian”) in view of US Pat Pub No. 20180361148 to Meyyappan et al. (hereinafter “Meyyappan”).
Regarding claim 73. (Previously Presented) Lian discloses the system of claim 71, but fails to disclose wherein the one or more sensors comprises a sensor coupled to a mechanical ventilator treating the patient.
Meyyappan, from a similar field of endeavor teaches a similar pacing system and method to provide respiratory assistance from a mechanical ventilator (para 0016, etc.) having one or more sensors to sense diaphragm data (para 0032, 0114 “the system 20 operates in conjunction with a positive pressure mechanical ventilator 32 (“ventilator 32”) in order to satisfy the respiratory needs of the patient. In some embodiments, signals sensed from a breath sensor 50 that monitors the breath cycle of the ventilator 32 can be employed to synchronize the delivery of the stimulation signals with the ventilator breath cycle”). It would have been obvious to one of ordinary skill in the art to modify the disclosure of Lian with the teachings of Meyyappan to provide the predictable result of providing respiratory needs of the patient while also synchronizing the delivery of the stimulation signal with the ventilator breathing cycle.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SANA SAHAND/Examiner, Art Unit 3796