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 Claims
1. This Office Action is in response to the filing of the application on 04/29/2024. Since the initial filing, no claims have been amended, added, or cancelled. Thus, claims 1-11 are currently pending.
Drawings
2. The drawings are objected to because some of the reference numerals in figs. 3-4 are illegible. See 37 CFR 1.84(p)(1).
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.
3. Figure 3, 4, 6, 7, 8, 9, and 10 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See paragraph [0054], [0057], [0070], [0073], [0074], and [0075] of the specification which states the figures above are a recreation of the figures in US Patent No. 7,048,702. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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
4. 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.
5. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
6. Claim(s) 1-5 and 7-10 is/are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Hui (US 2003/0233118).
Regarding claim 1, Hui discloses a system comprising:
at least one pressure device configured to inflate and deflate ([0037] states that an external counterpulsation (ECP) apparatus includes one or more pressure devices which are meant to inflate and deflate);
at least one hardware processor ([0049] states a microprocessor controls the timing of the ECP apparatus); and
software that is configured to, when executed by the at least one hardware processor,
receive information related to a subject’s specific medical conditions (fig. 3, computer 51 receives inputs from temperature and pressure sensors, ECG, patient call, a finger pleth, and a CPU 52, further [0043] states that the computer monitors and records information associated with treatment) and automatically initiate inflation and deflation of the at least one pressure devices based on the subject specific information as part of a treatment ([0049] states that during an initiation stage the inflation/deflation times are set up automatically, see fig. 5 which shows that these are based on the ECG signal, see [0051]),
receive ECG and pressure data (fig. 3, computer 51 receives inputs from pressure sensors and ECG),
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 ([0045] states that the inflation and deflation is in synchrony with the subject’s cardiac cycle which is done by synchronizing the signals from opening and closing valves, which have associated pressure sensors according to [0040], with the treated subject’s ECG), 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 ([0045] states that the controller manages the inflation and deflation to be in synchrony with the subject’s cardiac cycle, and [0049] states that the inflation and deflation times are set up and adjusted automatically, see fig. 5).
Regarding claim 2, Hui discloses the system of claim 1 and further discloses 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 ([0045] recites the same language), and wherein the inflation volume and timing is automatically adjusted ([0049] states that inflation times are automatically set thereby also controlling the volume entering the ECP apparatus) to achieve synchrony with the subject's cardiac cycle ([0049] states the controller syncs the inflation/deflation with the subject’s cardiac cycle).
Regarding claim 3, Hui discloses the system of claim 1 and further discloses 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 ([0045] states the controller initiates inflation/deflation in synchrony with the subject’s cardiac cycle, and [0023] states that the synchrony between the repeated inflation/deflation and the cardiac cycle is done in a substantially continuous manner).
Regarding claim 4, Hui discloses the system of claim 1 and further discloses wherein the at least one hardware processor is remote from the at least one pressure device ([0043] states that the computer may be located remotely from the remainder of the apparatus).
Regarding claim 5, Hui discloses the system of claim 1 and further discloses 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 ([0043] states that the computer monitors and records information associated with the treatment of the patient, where the system is meant to facilitate treatment of heart failure [0007]).
Regarding claim 7, Hui discloses a method comprising:
receiving information related to a subject’s specific medical conditions (fig. 3, computer 51 receives inputs from temperature and pressure sensors, ECG, patient call, a finger pleth, and a CPU 52, further [0043] states that the computer monitors and records information associated with treatment) and automatically initiating inflation and deflation of the at least one pressure devices based on the subject specific information as part of a treatment ([0049] states that during an initiation stage the inflation/deflation times are set up automatically, see fig. 5 which shows that these are based on the ECG signal, see [0051]),
receiving ECG and pressure data (fig. 3, computer 51 receives inputs from pressure sensors and ECG),
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 ([0045] states that the inflation and deflation is in synchrony with the subject’s cardiac cycle which is done by synchronizing the signals from opening and closing valves, which have associated pressure sensors according to [0040], with the treated subject’s ECG), 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 ([0045] states that the controller manages the inflation and deflation to be in synchrony with the subject’s cardiac cycle, and [0049] states that the inflation and deflation times are set up and adjusted automatically, see fig. 5).
Regarding claim 8, Hui discloses the method of claim 7 and further discloses 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 ([0045] recites the same language), and wherein the inflation volume and timing is automatically adjusted to achieve synchrony with the subject's cardiac cycle ([0049] states that inflation times are automatically set thereby also controlling the volume entering the ECP apparatus).
Regarding claim 9, Hui discloses the method of claim 7 and further discloses 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 ([0045] states the controller initiates inflation/deflation in synchrony with the subject’s cardiac cycle, and [0023] states that the synchrony between the repeated inflation/deflation and the cardiac cycle is done in a substantially continuous manner).
Regarding claim 10, Hui discloses the method of claim 7 and further discloses receiving information related to the treatment and update the information related to the subject’s specific medical conditions ([0043] states that the computer monitors and records information associated with the treatment of the patient, where the system is meant to facilitate treatment of heart failure [0007]).
Claim Rejections - 35 USC § 103
7. 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.
8. Claim(s) 6 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hui as applied to claims 1 and 7 above, and further in view of Mallon et al. (US 2012/0259649).
Regarding claim 6, Hui discloses the system of claim 5, but does not disclose the software is further configured to, when executed by the at least one hardware processor, automatically bill the subject for the treatment.
However, Mallon teaches of a management system that is configured to receive sensor data related to activities performed by the subject according to a treatment plan ([0016]) and a server that is configured with payment guidelines that allow the server to automatically bill the proper payor for completed treatment plans ([0031]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the system of Hui with the program for automatically billing the subject in order to allow the payor to not be dependent on the healthcare provider to access report information and determine whether the payment should be approved (Mallon [0046]).
Regarding claim 11, Hui discloses the method of claim 7, but does not disclose automatically billing the subject for the treatment.
However, Mallon teaches of a management system that is configured to receive sensor data related to activities performed by the subject according to a treatment plan ([0016]) and a server that is configured with payment guidelines that allow the server to automatically bill the proper payor for completed treatment plans ([0031]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the system of Hui with the program for automatically billing the subject in order to allow the payor to not be dependent on the healthcare provider to access report information and determine whether the payment should be approved (Mallon [0046]).
Double Patenting
9. 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.
10. Claim 1-11 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-11 of copending Application No. 18/649,943 (reference application) hereinafter ‘943. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are broader in at least on aspect.
Regarding the broadening aspect of the application claims, see the following highlights (underlined features in ‘943) for elements that have been excluded.
Instant Application 18/649,923
Copending Application 18/649,943
Claim 1
Claim 1
A system comprising: at least one pressure device configured to inflate and deflate; at least one hardware processor; and software that is configured to, when executed by the at least one hardware processor, receive information related to a subject’s specific medical conditions and automatically initiate inflation and deflation of the at least one pressure devices based on the subject specific information as part of a treatment, receive ECG and 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, 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.
A system comprising: at least one pressure device configured to inflate and deflate; at least one hardware processor; and software that is configured to, when executed by the at least one hardware processor, review subject information for a plurality of subjects in electronic medical records, automatically identify subjects of the plurality of subjects that are candidates for treatment, receive information related to a subject’s specific medical conditions and automatically initiate inflation and deflation of the at least one pressure devices based on the subject specific information as part of a treatment, receive ECG and 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, 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.
Claim 7
Claim 7
A method comprising: receiving information related to a subject’s specific medical conditions and automatically initiating inflation and deflation of the at least one pressure devices based on the subject specific information as part of a treatment, receiving ECG and 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, 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.
A method comprising: reviewing subject information for a plurality of subjects in electronic medical records, automatically identifying subjects of the plurality of subjects that are candidates for treatment, receiving information related to a subject’s specific medical conditions and automatically initiating inflation and deflation of the at least one pressure devices based on the subject specific information as part of a treatment, receiving ECG and 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, 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.
Thus, it is apparent, for the broadening aspect, that ‘943 claims 1 and 7 includes features that are not in application claim 1 or 7 respectively. Following the rational in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Since application claim 1 and 7 are anticipated by ‘943 claim 1 and 7 respectively, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then application claims 1 and 7 is obvious over ‘943 claim 1 and 7 respectively with respect to the broadening aspect.
Regarding dependent claims 2-6 and 8-11, in view of the rationale above, the claims are obvious over claims 2-6 and 8-11 of ‘943 due to having the same claim language.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
11. Claims 1-5 and 7-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-8, and 10-11 of copending Application No. 18/649,898 (reference application) hereinafter ‘898. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are a narrower recitation of the invention than that of the Co-pending application.
Regarding the narrowing aspect of the application claims, see the following highlights (underlined features in ‘898) for elements that have been excluded.
Instant Application 18/649,923
Copending Application 18/649,898
Claim 1
Claim 1
A system comprising: at least one pressure device configured to inflate and deflate; at least one hardware processor; and software that is configured to, when executed by the at least one hardware processor, receive information related to a subject’s specific medical conditions and automatically initiate inflation and deflation of the at least one pressure devices based on the subject specific information as part of a treatment, receive ECG and 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, 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.
A system comprising: at least one pressure device configured to inflate and deflate; at least one 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, receive ECG and 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, 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.
Claim 7
Claim 7
A method comprising: receiving information related to a subject’s specific medical conditions and automatically initiating inflation and deflation of the at least one pressure devices based on the subject specific information as part of a treatment, receiving ECG and 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, 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.
A method comprising: automatically initiating inflation and deflation of the at least one pressure devices as part of a treatment, receiving ECG and 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, 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.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claims 1 and 7 of the current application and claims 1 and 7 respectively of Co-pending application ‘898 lies in the fact that the instant application claims include more elements are is thus more specific. Thus, the invention of claims 1 and 7 of the instant application is in effect a “species” of the “generic” invention of Co-pending application ‘898. It has been held that the generic invention is anticipated by the species. See In re Goodman, cited above. Since claims 1 and 7 of Co-pending application ‘898 is anticipated by claims 1 and 7 respectively of the instant invention, it is not patentably distinct from claims 1 and 7 of the instant application.
Regarding dependent claims 2-5 and 8-10, in view of the rationale above, the following claims are obvious over claims 2, 4-6, 8, and 10-11 of ‘898 due to having the same claim language.
Instant Application 18/649,923
Copending Application 18/649,898
Claim 2
Claim 2
Claim 3
Claim 4
Claim 4
Claim 5
Claim 5
Claim 6
Claim 8
Claim 8
Claim 9
Claim 10
Claim 10
Claim 11
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
12. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hui et al. (US 2006/0058717) discloses a ECP for digitally adjusting the preset reservoir pressure.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS Z CHANG whose telephone number is (571)272-0432. The examiner can normally be reached Monday-Friday 9:00 am-5:00 pm.
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, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS Z CHANG/ Examiner, Art Unit 3785
/TIMOTHY A STANIS/ Supervisory Patent Examiner, Art Unit 3785
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