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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 5 and 9, the phrase "about" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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(s) 2-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lurie (US Patent Application Publication 20160128899) in view of Kroupa (US Patent Application Publication 20080053445) further in view of Wilson (US Patent Application Publication 20110205061).
Regarding claim 2, A patient support system for use during cardiopulmonary resuscitation (CPR) comprising: a platform (Figure 1; 106) configured to receive a patient thereon; a tilt adjuster (Figure 3; motor under 310 as shown) mechanically coupled to the platform and configured to elevate a head portion of the platform relative to a horizontal axis (Figure 1b; as shown at 106); a user interface comprising a display (Paragraph 88 “the elevation mechanism 514 may be electrically controlled such that a user may select a desired angle and/or height of the second portion 504 using a control interface”), and after commencement of CPR, repositioning the patient after a predetermined period of time (Paragraph 122). Lurie does not specifically teach a timer comprising a timing circuit, the timer configured to initiate in response to an input corresponding to commencement of CPR and generate an alert to reposition the patient after a predetermined period of time, for initiating elevation of the head portion, wherein the display is configured to present an elevation indicator comprising at least one element that illuminates to indicate lifting and lowering of the head portion. Kroupa teaches a timer comprising a timing circuit (Figure 4; 206, see also Figure 3), the timer configured to initiate in response to an input corresponding to commencement of CPR (Figure 4; 200, turning the system on would correspond to an input commencing CPR) and generate an alert for a CPR related action (Figure 4; 207) after a predetermined period of time (Paragraph 44). Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Lurie (directed to a CPR support system) and Kroupa (directed to a CPR timer) and arrived at a CPR support system with a timer. One of ordinary skill in the art would have been motivated to make such a combination because doing so “provides a visual cue to the user to begin providing breaths and/or chest compressions to a patient.” as taught in Kroupa (Paragraph 7). Lurie and Kroupa do not teach the CPR related action is to reposition the patient, for initiating elevation of the head portion, and wherein the display is configured to present an elevation indicator comprising at least one element that illuminates to indicate lifting and lowering of the head portion. Wilson teaches the CPR related action alert is to reposition the patient, for initiating elevation of the head portion (Paragraphs 77 and 83 discuss a head of bed angle alert system where the display generates an alert when the angle of the bed needs to be adjusted. Examiner notes that Lurie teaches adjusting an angle of the support as a step during CPR, Kroupa teaches a timer which indicates CPR steps, and Wilson teaches indicating bed angle adjustment is needed, thus taken together they form a system which indicates to the user to adjust an angle of the support as a step during CPR), and wherein the display is configured to present an elevation indicator comprising at least one element that illuminates to indicate lifting and lowering of the head portion (Paragraph 97). Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Lurie (directed to a CPR support system including an angle adjustment step during cpr) and Kroupa (directed to a CPR timer which indicates CPR steps) and Wilson (directed to a bed angle adjustment alert) and arrived at a CPR support system with a timer which indicates a bed angle adjustment step during CPR. One of ordinary skill in the art would have been motivated to make such a combination so that “The system may determine one or more actions to be performed by a caregiver or other staff person of the healthcare facility… The actions to be performed may be electronically communicated to the bed, to one or more remote displays, and/or to communication devices associated with staff persons of the healthcare facility.” (Wilson Abstract).
Regarding claim 3, Lurie does not teach the alert comprises a visual or auditory signal. Kroupa teaches the alert comprises a visual or auditory signal (Figure 2; 22, 24, 26, 28). Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Lurie (directed to a cpr support system) and Kroupa (directed to a CPR timer) and arrived at a CPR support system with a timer. One of ordinary skill in the art would have been motivated to make such a combination because doing so “provides a visual cue to the user to begin providing breaths and/or chest compressions to a patient.” as taught in Kroupa (Paragraph 7).
Regarding claim 4, Lurie does not teach the input is user-activated. Kroupa teaches the input is user-activated (Figure 2; 14). Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Lurie (directed to a cpr support system) and Kroupa (directed to a CPR timer) and arrived at a CPR support system with a timer. One of ordinary skill in the art would have been motivated to make such a combination because doing so “provides a visual cue to the user to begin providing breaths and/or chest compressions to a patient.” as taught in Kroupa (Paragraph 7).
Regarding claim 5, Lurie teaches the tilt adjuster comprises a bi- directional motor (Paragraph 91) configured to tilt the head portion to an angle between about 0 and 40 degrees (Paragraph 91).
Regarding claim 6, Lurie teaches the cardiopulmonary resuscitation comprises automated chest compressions of the patient (Figure 9b; 920).
Regarding claim 7, Lurie teaches the platform comprises a multi- section articulated structure including a plurality of sections, each section configured to tilt independently about a transverse axis (Figure 9a; 908 and 904).
Regarding claim 8, Lurie does not teach the elevation indicator illuminates according to a tilt angle adjustment. Wilson teaches the elevation indicator illuminates according to a tilt angle adjustment (Paragraph 97 discusses illuminating the display to allow viewing of the head of bed angle). Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Lurie (directed to a cpr support system including an angle adjustment step during cpr) and Kroupa (directed to a CPR timer which indicates CPR steps) and Wilson (directed to a bed angle adjustment alert) and arrived at a CPR support system with a timer which indicates a bed angle adjustment step during CPR. One of ordinary skill in the art would have been motivated to make such a combination so that “The system may determine one or more actions to be performed by a caregiver or other staff person of the healthcare facility… The actions to be performed may be electronically communicated to the bed, to one or more remote displays, and/or to communication devices associated with staff persons of the healthcare facility.” (Wilson Abstract).
Regarding claim 9, Lurie does not teach the predetermined period of time for initiating elevation of the head portion is about 2 minutes, however the optimization of proportions in a prior art device is a design consideration within the skill of the art. In re Reese, 290 F.2d 839, 129 USPQ 402 (CCPA 1961). Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have modified Lurie (directed to a cpr support system which adjusts the angle of the head section a predetermined period of time (at least the period of time described in Paragraph 122 to get the head section to the first height) after starting cpr) to begin the adjustment after 2 minutes, because the optimization of proportions in a prior art device is a design consideration within the skill of the art. In re Reese, 290 F.2d 839, 129 USPQ 402 (CCPA 1961), and using a slower elevation would impart less stress on the patients body.
Regarding claim 10, Lurie teaches a tilt controller that includes a processor configured to generate a tilt initiation signal after the predetermined time from when chest compressions are commenced (Paragraph 122 describes initiating tilting at a predetermined time after chest compressions begin, and Paragraph 93 describes a processor to control the motor and angle of the supports based on input).
Regarding claim 11, Lurie does not teach the input corresponds to commencement of manual chest compressions. Kroupa teaches the input corresponds to commencement of manual chest compressions (Figure 2; 14, the on/off switch would be pressed when beginning cpr to start the timer). Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Lurie (directed to a cpr support system) and Kroupa (directed to a CPR timer) and arrived at a CPR support system with a timer. One of ordinary skill in the art would have been motivated to make such a combination because doing so “provides a visual cue to the user to begin providing breaths and/or chest compressions to a patient.” as taught in Kroupa (Paragraph 7).
Regarding claim 12, Lurie teaches the tilt angle when resuscitation treatment commences is approximately zero degrees (Paragraph 122).
Regarding claim 13, Lurie does not teach an interface for a user to input a signal to change the tilt angle to a target tilt angle after receiving the alert signal. Wilson teaches an interface for a user to input a signal to change the tilt angle to a target tilt angle after receiving the alert signal (Paragraph 152 describes the head of bed angle indicator as well as the monitoring alarm mode, and also describes head up/down controls so a user can change the angle after receiving a head of bed alert or alarm). Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Lurie (directed to a cpr support system including an angle adjustment step during cpr) and Kroupa (directed to a CPR timer which indicates CPR steps) and Wilson (directed to a bed angle adjustment alert) and arrived at a CPR support system with a timer which indicates a bed angle adjustment step during CPR. One of ordinary skill in the art would have been motivated to make such a combination so that “The system may determine one or more actions to be performed by a caregiver or other staff person of the healthcare facility… The actions to be performed may be electronically communicated to the bed, to one or more remote displays, and/or to communication devices associated with staff persons of the healthcare facility.” (Wilson Abstract).
Regarding claim 14, Lurie teaches the platform is configured to be coupled to a stretcher (Paragraph 107).
Regarding claim 15, Lurie teaches the tilt adjuster is positional between the stretcher and platform to maintain the platform at a tilt angle during transport (Paragraph 107 and Figure 9a, the tilt adjuster at 912 would be positioned between the platform at 904/908 and the stretcher at 916).
Regarding claim 16, Lurie teaches the elevation of the head portion comprises a distance of the platform from the horizontal axis, ranging between 0 cm and 50 cm (Paragraph 122).
Regarding claim 17, Lurie teaches the elevation of the head portion comprises a distance of the platform from the horizonal axis, ranging between 2 cm and 20 cm (Paragraph 122).
Regarding claim 18, Lurie teaches elevation of the head portion is based on physiological signals from physiological sensors (Paragraph 77).
Regarding claim 19, Lurie teaches the physiological signals include cerebral oxygenation, blood pressure, and blood flow (Paragraph 93).
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 2-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-8, 10-16, 18-23, 34-35, 39, 42-53, and 55 of copending Application No. 16031354 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets relate to a CPR system including a timer configured to notify the user of a time for repositioning of the patients head.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MORGAN J MCCLURE whose telephone number is (571)270-0362. The examiner can normally be reached Tuesdays 12pm-10pm and Thursdays 12pm-10pm.
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/MORGAN J MCCLURE/Examiner, Art Unit 3673
