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 .
Double Patenting
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 3 and 6 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of the claims below of copending Applications No. 18/649,943 and 18/649,923 (reference applications). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Regarding claim 3, of the instant application the subject matter may be found in claim 1 of ‘943 and claim 1 of ‘923.
Regarding claim 6, of the instant application the subject matter may be found in claim 5 of ‘943 and claim 5 of ‘923.
Non-Statutory 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 1-2, 4-5, and 7-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Applications No. 18/649,943 and 18/649,923 (reference applications), hereinafter ‘943 and ‘923 for simplicity in writing. Although the claims at issue are not identical, they are not patentably distinct from each other since, if allowed, it would improperly extend the “right to exclude” already granted in the patent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The subject matter claimed in the instant application is fully disclosed in the copending Applications ‘943 and ‘923, and is covered by the copending Applications since the copending Applications and the instant Application are claiming common subject matter, as follows:
Regarding claim 1, of the instant application the subject matter may be found in claim 1 of ‘943 and claim 1 of ‘923.
Regarding claim 2, of the instant application the subject matter may be found in claim 2 of ‘943 and claim 2 of ‘923.
Regarding claim 4, of the instant application the subject matter may be found in claim 3 of ‘943 and claim 3 of ‘923.
Regarding claim 5, of the instant application the subject matter may be found in claim 4 of ‘943 and claim 4 of ‘923.
Regarding claim 7, of the instant application the subject matter may be found in claim 7 of ‘943 and claim 7 of ‘923.
Regarding claim 8, of the instant application the subject matter may be found in claim 8 of ‘943 and claim 8 of ‘923.
Regarding claim 9, of the instant application the subject matter may be found in claim 7 of ‘943 and claim 7 of ‘923.
Regarding claim 10, of the instant application the subject matter may be found in claim 9 of ‘943 and claim 9 of ‘923.
Regarding claim 11, of the instant application the subject matter may be found in claim 10 of ‘943 and claim 10 of ‘923.
Claim Objections
Claims 8-11 are objected to because of the following informalities:
Claim 8 recites “the method of claim 6”, where claim 6 is directed towards the system of claim 1, claim 8 should read ---the method of claim 7---, in order for proper dependency off of the independent method claim 7. For the purposes of examination, the preamble of claim 8 is interpreted as ---the method of claim 7---.
Claim 9 recites “further comprising receiving information”, but should read ---further configured to receive information--- to avoid reciting method steps in a system claim. Additionally, the claim is dependent off of claim 6, but includes the subject matter available in claim 1, thereby failing to further limit, but it is understood that this might be a typo
Claim 10 recites “further comprising monitoring the ECG and pressure data and continually adjust the timing”, but should read ---further configured to monitor the ECG and pressure data and continually adjust the timing--- to avoid reciting method steps in a system claim.
Claim 11 recites “further comprising receiving information”, but should read ---further configured to receive information--- to avoid reciting method steps in a system claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 1-4, and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hui (US 20030233118 A1).
Regarding claim 1, Hui discloses a system comprising: at least one pressure device configured to inflate and deflate (Hui [0037]; where there is a pressure device ‘12’ that is configured to inflate and deflate);
at least one hardware processor (Hui [0049]; microprocessor – hardware processor);
and software that is configured to, when executed by the at least one hardware processor, automatically initiate inflation and deflation of the at least one pressure devices as part of a treatment (Hui [0049]; automatic inflation/ deflation control logic (software) of the ECP apparatus executed by microprocessor);
receive ECG and pressure data (Hui [0043-0045]; the system receives the patient’s ECG signal and identifies the R peak, the R peak is used to monitor the cardiac cycle of a patient, to facilitated monitoring as well as effect of the counter pulsation waves, the controller initiates inflation and deflation of the pressure devices ‘12’ in synchrony with the patient’s cardiac cycle (receiving pressure data));
analyze the ECG and pressure data and determine timing and pressure required to achieve inflation and deflation of the at least one pressure device in synchrony with the subject's cardiac cycle (Hui [0043-0045]; the system reads the patient’s ECG, to determine timing of the cardiac cycle, by measuring the R peak, the computer decides when to inflate/deflate the pressure device, the user interface can be used to operate the system of inflation/deflation relative to a user’s cardiac cycle);
and automatically adjust at least one of timing and pressure of the inflation and deflation of the at least one pressure device to achieve synchrony with the subject's cardiac cycle (Hui [0045,0049]; where the system can adjust and initiate inflation and deflation of the pressure device with the patient’s cardiac cycle, the pressure device is inflated sequentially based on the pressure waveforms, the inflation and deflation times can be automatically set or adjusted manually).
Regarding claim 2, Hui further discloses the system of claim 1, wherein inflation and deflation are affected so as to create a retrograde pulse of arterial blood that arrives at the heart at approximately the end of the ejection phase of the left ventricle at the time of aortic valve closure (Hui [0045]; where the inflation and deflation is effected so as to create a retrograde pulse of arterial blood that arrives at the heart at approximately the end of the ejection phase of the left ventricle at the time of aortic valve closure – verbatim);
and wherein the inflation volume and timing is automatically adjusted to achieve synchrony with the subject's cardiac cycle (Hui [0049]; where the inflation volume and timing can be set/ initiated automatically and [0045]; where the system initiates inflation and deflation of the pressure device in synchrony with the subject’s cardiac cycle).
Regarding claim 3, Hui further discloses the system of claim 1, wherein the software is further configured to, when executed by the at least one hardware processor, receive information related to the subject’s specific medical conditions and initiate inflation and deflation of the at least one pressure devices based on the subject specific information (Hui [0007,0047]; where the system is configured to receive information relating to systolic or diastolic heart failure (receiving information related to subject specific medical conditions) and initiate inflation and deflation based on the systolic or diastolic heart failure (initiating based on the subject specific information, [0049]; inflation/ deflation control (software) of the ECP apparatus executed by microprocessor).
Regarding claim 4, Hui further discloses the system of claim 1, wherein the software is further configured to, when executed by the at least one hardware processor, monitor the ECG and pressure data and continually adjust the timing and or pressure to achieve inflation and deflation of the at least one pressure device in synchrony with the subject's cardiac cycle (Hui [0028]; repeated inflation and deflation of pressure devices in synchrony with the cardiac cycle of the subject in a substantially continuous manner, [0044]; monitoring the ECG for the cardiac cycle of a patient, [0006]; timing of the inflation and deflation is adjusted so that the flow of blood from the extremities reaches the heart at the onset of diastole, which gives an increased venous return, [0043]; the user interface is used for monitoring of patient treatment status, treatment parameters, other relevant data, and provides capability to control operation, [0049]; inflation/ deflation control (software) of the ECP apparatus executed by microprocessor).
Regarding claim 7, Hui discloses a method comprising: automatically initiating inflation and deflation of the at least one pressure devices as part of a treatment (Hui [0037]; where there is a pressure device ‘12’ that is configured to inflate and deflate, [0049]; automatic inflation/ deflation control logic (software) of the ECP apparatus executed by microprocessor);
receiving ECG and pressure data (Hui [0043-0045]; the system receives the patient’s ECG signal and identifies the R peak, the R peak is used to monitor the cardiac cycle of a patient, to facilitated monitoring as well as effect of the counter pulsation waves, the controller initiates inflation and deflation of the pressure devices ‘12’ in synchrony with the patient’s cardiac cycle (receiving pressure data));
analyzing the ECG and pressure data and determine timing and pressure required to achieve inflation and deflation of the at least one pressure device in synchrony with the subject's cardiac cycle (Hui [0043-0045]; the system reads the patient’s ECG, to determine timing of the cardiac cycle, by measuring the R peak, the computer decides when to inflate/deflate the pressure device, the user interface can be used to operate the system of inflation/deflation relative to a user’s cardiac cycle);
and automatically adjusting at least one of timing and pressure of the inflation and deflation of the at least one pressure device to achieve synchrony with the subject's cardiac cycle (Hui [0045,0049]; where the system can adjust and initiate inflation and deflation of the pressure device with the patient’s cardiac cycle, the pressure device is inflated sequentially based on the pressure waveforms, the inflation and deflation times can be automatically set or adjusted manually).
Regarding claim 8, Hui further discloses the method of claim 6, wherein inflation and deflation are affected so as to create a retrograde pulse of arterial blood that arrives at the heart at approximately the end of the ejection phase of the left ventricle at the time of aortic valve closure (Hui [0045]; where the inflation and deflation is effected so as to create a retrograde pulse of arterial blood that arrives at the heart at approximately the end of the ejection phase of the left ventricle at the time of aortic valve closure – verbatim);
and wherein the inflation volume and timing is automatically adjusted to achieve synchrony with the subject's cardiac cycle (Hui [0049]; where the inflation volume and timing can be set/ initiated automatically and [0045]; where the system initiates inflation and deflation of the pressure device in synchrony with the subject’s cardiac cycle).
Claim Rejections - 35 USC § 103
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hui (US 20030233118 A1).
Regarding claim 5, Hui further discloses the system of claim 1, wherein the at least one hardware processor is remote from the at least one pressure device (Hui [0043]; where the computer can be located remotely from the remainder of the equipment).
Although Hui doesn’t explicitly disclose wherein the at least one hardware processor is remote from the at least one pressure device, Hui also does disclose that the computer may be remotely located from the rest of the equipment (including the at least one pressure device). Hui does not explicitly disclose the location of the microprocessor (hardware processor) disclosed first in [0049]. It would have been readily understood by one of ordinary skill in the art that the microprocessor would be readily available within or in conjunction with the computer, such that the hardware processor and the computer work together to monitor, record, and analyze data from the system.
Claims 6 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hui (US 20030233118 A1) in view of Mallon (US 20120259649 A1).
Regarding claim 6, Hui further discloses the system of claim 3.
Hui is silent to the hardware processor updating the information related to the subject’s specific medical conditions.
Mallon discloses a remote system comprising:
wherein the software is further configured to, when executed by the at least one hardware processor, to receive information related to the treatment and update the information related to the subject’s specific medical conditions (Mallon [0122]; where the algorithms (software) can compare current data to past data, the server can determine whether progress is being made over time and whether the treatment plan needs to be updated (updating the information relative to the patient’s specific medical condition, adjusted, or optimized, and analysis performed by the algorithm can be received from sensors (receiving information related to treatment) and can be related to the patient (subject’s specific medical conditions), [0042]; where there is a processor as required, and the server can comprise the processor and all the hardware/ software to perform needed processes).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Hui by including receiving and updating the information related to the subject’s specific medical condition as taught by Mallon, since, it allows for the healthcare provider to optimize and adjust the treatment plan of a subject needing treatment (Mallon [0122]).
Regarding claim 9, modified Hui further discloses the system of claim 6, further comprising receiving information related to the subject’s specific medical conditions and initiate inflation and deflation of the at least one pressure devices based on the subject specific information (Hui [0007,0047]; where the system is configured to receive information relating to systolic or diastolic heart failure (receiving information related to subject specific medical conditions) and initiate inflation and deflation based on the systolic or diastolic heart failure (initiating based on the subject specific information, [0049]; inflation/ deflation control (software) of the ECP apparatus executed by microprocessor).
Regarding claim 10, modified Hui further discloses the system of claim 6, further comprising monitoring the ECG and pressure data and continually adjust the timing and or pressure to achieve inflation and deflation of the at least one pressure device in synchrony with the subject's cardiac cycle (Hui [0028]; repeated inflation and deflation of pressure devices in synchrony with the cardiac cycle of the subject in a substantially continuous manner, [0044]; monitoring the ECG for the cardiac cycle of a patient, [0006]; timing of the inflation and deflation is adjusted so that the flow of blood from the extremities reaches the heart at the onset of diastole, which gives an increased venous return, [0043]; the user interface is used for monitoring of patient treatment status, treatment parameters, other relevant data, and provides capability to control operation, [0049]; inflation/ deflation control (software) of the ECP apparatus executed by microprocessor).
Regarding claim 11, Hui further discloses the system of claim 9.
Hui is silent to the hardware processor updating the information related to the subject’s specific medical conditions.
Mallon discloses a remote system comprising:
further comprising receiving information related to the treatment and update the information related to the subject’s specific medical conditions (Mallon [0122]; where the algorithms (software) can compare current data to past data, the server can determine whether progress is being made over time and whether the treatment plan needs to be updated (updating the information relative to the patient’s specific medical condition, adjusted, or optimized, and analysis performed by the algorithm can be received from sensors (receiving information related to treatment) and can be related to the patient (subject’s specific medical conditions), [0042]; where there is a processor as required, and the server can comprise the processor and all the hardware/ software to perform needed processes).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kwok (US 20170312171 A1): methods and models to analyze ECG signals.
Zheng (US 4753226 A): combination device for external counter pulsation and cardiac massage.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AISLINN MOIRA JONES whose telephone number is (571)272-3835. The examiner can normally be reached Monday-Friday 7:30-5, EO Friday 7:30-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 5712707410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AISLINN M JONES/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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