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 .
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) 1-5 and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hui U.S. Publication No. (2003/0233118 A1).
With respect to claim 1, Hui discloses a system comprising:
at least one pressure device configured to inflate and deflate (an external counterpulsation apparatus 'ECP' comprising one or more pressure devices that are applied to an extremity of the subject to inflate and deflate; paragraph [0037]);
at least one hardware processor (microprocessor; paragraph [0049]); 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 [0043, the computer (51) monitors and records information associated with the treatment of the patient] and [0088, monitoring the subject being treated with ECP for one or more indicia of safety or efficacy. Such indicia include those pertaining to blood oxygen level, respiration rate, heart rate, and diagnostic indicators of heart failure including evaluation of symptoms such as dyspnea, orthonea, paroxysmal nocturnal dyspnea, chronic fatigue, peripheral edema, ascites, tachycardia, "galloping" heart rhythm, rales, jugular venous distention, and oliguria; chest x-ray to assess the size of the heart; electrocardiogram, preferably with Doppler interrogation; radionuclide ventriculogram; coronary angiography; and magnetic resonance imaging], automatically initiate inflation and deflation of the at least one pressure devices as part of a treatment (automatic inflation/deflation timing control logic of the ECP apparatus; paragraph [0049]),
receive ECG and pressure data (receive ECG and pressure data; paragraphs [0043]-[0045]),
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 (analyze the ECG and pressure data to determine inflation/deflation timing in synchrony with the subject's cardiac cycle; paragraphs [0043]-[0045]), 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 (automatically adjust the timing and pressure of the inflation/deflation to achieve synchrony with the subject's cardiac cycle; paragraphs [0045], [0049]).
With respect to claim 2, Hui discloses 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 (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; paragraph [0045]), and the inflation volume and timing is automatically adjusted to achieve synchrony with the subject's cardiac cycle (the inflation timing and inflation pressure and thus inflation volume of the pressure device is automatically adjusted to achieve synchrony with the subject's cardiac cycle; paragraphs [0045]).
With respect to claim 3, Hui discloses 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; (analyze the ECG and pressure data to determine inflation/deflation timing in synchrony with the subject's cardiac cycle in a continuous manner; paragraphs [0028], [0043]-[0045]).
With respect to claim 4, Hui discloses the at least one hardware processor is remote from the at least one pressure device (the computer located remotely from the remainder of the equipment; paragraph [0043]).
With respect to claim 5, Hui discloses 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 (the computer 51 monitors and records information associated with the treatment of the patient; paragraph [0043]).
With respect to claim 7, Hui discloses a method comprising: reviewing subject information for a plurality of subjects in electronic medical records [0043], automatically identifying subjects of the plurality of subjects that are candidates for treatment [0044] and [0102], 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 [0043-0045] and [0049].
With respect to claim 8, Hui discloses 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 (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; paragraph [0045]), and wherein the inflation volume and timing is automatically adjusted to achieve synchrony with the subject's cardiac cycle (the inflation timing and inflation pressure and thus inflation volume of the pressure device is automatically adjusted to achieve synchrony with the subject's cardiac cycle; paragraphs [0045]).
With respect to claim 9, Hui 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 (analyze the ECG and pressure data to determine inflation/deflation timing in synchrony with the subject's cardiac cycle in a continuous manner; paragraphs [0028], [0043]-[0045]).
With respect to claim 10, Hui discloses receiving information related to the treatment and update the information related to the subject's specific medical conditions (the computer 51 monitors and records information associated with the treatment of the patient; paragraph [0043]).
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.
Claim(s) 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Hui as applied to claims 5 and 7 above, and further in view of Mallon et al. U.S. Publication No. (2012/0259649 A1).
With respect to claim 6, Hui substantially discloses the invention as claimed except the software is further configured to, when executed by the at least one hardware processor, automatically bill the subject for the treatment.
Mallon et al. however, teaches in [0016, a movement monitoring and management system, comprises a communication interface; a database configured to store treatment information, sensor data, subject information, reporting, and billing information for a plurality of subjects; a server coupled with the database and the communication interface, the server configured to: receive sensor data via the communication interface, the sensor data including data related to certain activities, exercises or movements performed by the subject according to a treatment plan, analyze the sensor data to assess performance with the treatment plan, and automatically determine whether the treatment plan is being complied with or not, whether the treatment plan needs to be altered, and whether the subject is progressing or regressing based on the analysis]; Mallon et al. further teaches in [0031, the server can be configured with payment guidelines that can allow the server to automatically bill the proper payor for properly performed exercises, completed treatment plans, and successful or intended outcomes for both reimbursement and non-reimbursement purposes].
In view of the teachings of Mallon et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the software of Hui by configuring the software such that when executed by the at least one hardware processor, automatically bill the subject for the treatment in order to reduce cost and minimize human errors.
With respect to claim 11, Hui substantially discloses the invention as claimed except automatically billing the subject for the treatment.
Mallon et al. however, teaches in [0016, a movement monitoring and management system, comprises a communication interface; a database configured to store treatment information, sensor data, subject information, reporting, and billing information for a plurality of subjects; a server coupled with the database and the communication interface, the server configured to: receive sensor data via the communication interface, the sensor data including data related to certain activities, exercises or movements performed by the subject according to a treatment plan, analyze the sensor data to assess performance with the treatment plan, and automatically determine whether the treatment plan is being complied with or not, whether the treatment plan needs to be altered, and whether the subject is progressing or regressing based on the analysis]; Mallon et al. further teaches in [0031, the server can be configured with payment guidelines that can allow the server to automatically bill the proper payor for properly performed exercises, completed treatment plans, and successful or intended outcomes for both reimbursement and non-reimbursement purposes].
In view of the teachings of Mallon et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the software of Hui by configuring the software such that when executed by the at least one hardware processor, automatically bill the subject for the treatment in order to reduce cost and minimize human errors.
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 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. (11,649,923) (reference application). 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.
Claim 1 of the instant application recites: 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 1 of Co-pending application no. (11,649,923) recites: 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.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 1 of the current application and claim 1 of Co-pending application no. (11,649,923) lies in the fact that the instant application claims include many more elements and is thus much more specific. Thus, the invention of claim 1 of the instant application is in effect a “species” of the “generic” invention of Co-pending application no. (11,649,923) claim 1. It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of Co-pending application no. (11,649,923) is anticipated by claim 1 of the instant invention, it is not patentably distinct from claim 1 of the instant application.
All of the limitation of claims 2-11 of the instant application can be found in claims 2-11 of Co-pending application no. (11,649,923).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5 and 7-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-8 and 10-11 of copending Application No. (11,649,898) (reference application). 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.
Claim 1 of the instant application recites: 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 1 of Co-pending application no. (11,649,898) recites: 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.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 1 of the current application and claim 1 of Co-pending application no. (11,649,898) lies in the fact that the instant application claims include many more elements and is thus much more specific. Thus, the invention of claim 1 of the instant application is in effect a “species” of the “generic” invention of Co-pending application no. (11,649,898) claim 1. It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of Co-pending application no. (11,649,898) is anticipated by claim 1 of the instant invention, it is not patentably distinct from claim 1 of the instant application.
All of the limitation of claim 2 of the instant application can be found in claim 2 of Co-pending application no. (11,649,898).
All of the limitation of claim 3 of the instant application can be found in claim 3 of Co-pending application no. (11,649,898).
All of the limitation of claim 4 of the instant application can be found in claim 5 of Co-pending application no. (11,649,898).
All of the limitation of claim 5 of the instant application can be found in claim 6 of Co-pending application no. (11,649,898).
All of the limitation of claim 7 of the instant application can be found in claim 7 of Co-pending application no. (11,649,898).
All of the limitation of claim 8 of the instant application can be found in claim 8 of Co-pending application no. (11,649,898).
All of the limitation of claim 9 of the instant application can be found in claim 10 of Co-pending application no. (11,649,898).
All of the limitation of claim 10 of the instant application can be found in claim 11 of Co-pending application no. (11,649,898).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/OPHELIA A HAWTHORNE/ Primary Examiner, Art Unit 3786
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