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 .
DETAILED ACTION
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claims 8(second occurrence), 9, 10, 11, 12, 13 and 14 been renumbered 9, 10, 11, 12, 13, 14 and 15, consecutively. Renumbered claim 12 now depends on claim 11 and renumbered claim 14 now depends on claim 13.
Claim Rejections - 35 USC § 112
Re-numbered claims 13-15 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.
Re-numbered claims 13-15 are indefinite because claim 1 lacks antecedent basis for a wearable device. It appears re-numbered claims 13-15 are intended to depend from re-numbered claim 11. For examination purposes, the examiner is interpreting re-numbered claims 13 and 15 to depend from re-numbered claim 11.
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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,819,334. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims contain the same essential elements and features of monitoring body position over time and issuing an alert when time thresholds are met as claimed in claims 1-15 of U.S. Patent No. 11,819,334.
Re-numbered claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12 and 17 of U.S. Patent No. 10,849,549. Although the claims at issue are not identical, they are not patentably distinct from each other because the present re-numbered claim 11 with the alert, supine, and threshold features is an obvious broadening of claims 12 and 17 of U.S. Patent No. 10,849,549.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,918,673. Although the claims at issue are not identical, they are not patentably distinct from each other because present claim 6 is an obvious broadening of a system having a body orientation sensor to record a time series and an alert system as claimed in claim 1 of U.S. Patent No. 9,918,673.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21 and 22 of U.S. Patent No. 9,585,614. Although the claims at issue are not identical, they are not patentably distinct from each other because present claim 1 is directed to an obvious broadening with the claimed features of body position over time and issuing an alert compared to features of abdomen orientations and warnings as claimed in claims 21 and 22 of U.S. Patent No. 9,585,614.
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.
Claims 1, 2, 4-7, 9 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Klap (US 2014/0005502).
Regarding claim 1, Klap discloses a method of preventing supine sleep in patients in need thereof, comprising:
providing a device 10 that monitors body position;
monitoring patient body position over time, see paragraph [0107]; and
Klap teaches system 10 includes a posture change identification algorithm that identifies whether a patient has changed his position on a bed. The objective is to identify whether the patient moved between 1 of the 4 positions: supine, on stomach, on left side, or on right side, since such a change every 2-4 hours to prevent pressure ulcer formation in high risk patients, see paragraph [0150].
A supine alert is issued when the monitored patient body position is supine for more than about five minutes, see paragraph [0152].
Regarding claim 2, Klap discloses issuing a lateral alert when the monitored body position is lateral for more than about two hours, see paragraphs [0150] and [0152].
Regarding claim 4, Klap discloses providing a monitoring station 120.
Regarding claim 5, Klap discloses the monitoring station comprises an alarm configured to issue a supine alert when the monitored patient body position is supine for more than about five minutes, see paragraph [0199].
Regarding claim 6, Klap discloses system for monitoring patients, comprising:
a device 10 comprising a body orientation sensor configured to record a time series of body position data comprising position and time, see paragraph [0107].
Klap teaches system 10 includes a posture change identification algorithm that identifies whether a patient has changed his position on a bed. The objective is to identify whether the patient moved between 1 of the 4 positions: supine, on stomach, on left side, or on right side, since such a change every 2-4 hours to prevent pressure ulcer formation in high risk patients, see paragraph [0150].
Klap teaches setting a defined time threshold for generating alerts, see paragraph [0199]. In addition, system 10 displays a counter of time since the last time a clinician turned the patient and hen the time reaches the above threshold, the system alerts the clinician to turn the patient.
b) an alert system, wherein the alert system is configured to generate alerts when the time series of body position data exceeds a defined time threshold, see paragraph [0152].
Regarding claim 7, Klap discloses the alert system is configured to issue supine alerts and lateral alerts, see paragraphs [0150] and [0152].
Regarding claim 9, Klap discloses the supine alerts are issued after about five minutes and the lateral alerts are issued after about one hour, see paragraphs [0150] and [0152]. The examiner is interpreting an alert after two hours to meet the claim limitations of an alert after five minutes and after about one hour.
Regarding claim 11, Klap discloses wearable device 30, see paragraph [0122] to promote certain body positions in patients comprising an alert system configured to issue an alert if a recorded body position is supine and a time series of data exceeds a supine threshold, see paragraphs [0150], [0152] and [0199].
Regarding claim 12, the examiner is interpreting the patients having a condition selected from the group consisting of COVID-19, ARDS, asthma and lung cancer to be intended use limitations which are met by the device 10 and system disclosed in Klap.
Regarding claim 13, Klap discloses the wearable device 30 in combination with the device 10 is configured to detect coughing, see paragraph [0134].
Regarding claim 14, Klap discloses the device is further configured to analyze detected coughing for respiratory pathology, see paragraphs [0313].
Regarding claim 15, Klap discloses the device is configured to generate alerts to promote body position in respiratory patients, see paragraphs [0313].
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.
Claims 3, 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over by Klap (US 2014/0005502).
Klap teaches system 10 displays a counter of time since the last time a clinician turned the patient and when the time reaches predetermined threshold, the system alerts the clinician to turn the patient, see paragraph [0152].
Regarding claim 3, one of ordinary skill in the art would have found it obvious to alert the clinician using an alert with different parameters so the clinician can have additional assistance in turning the patient for the supine alert and without the additional assistance for the lateral alert because these two transitions require differing amounts of effort to turn the patient.
Regarding claim 8, one of ordinary skill in the art would have found it obvious to differ numbers of vibrational pulses for the supine alerts and lateral alerts because hospital settings have quiet areas and times where noise and light are not permitted and it is common and well known to use vibrational pulses to indicate alarms in these areas and times.
Regarding claim 10, one of ordinary skill in the art would have found it obvious to promote certain body positions in a user comprising an alert system, wherein the device is configured to issue an alert if the user has not shifted positions within a certain threshold time unless the user is in a prone position because this position is well known to include medical treatments where the patient should not be moved.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Klap( US-2011/0046498) and Halperin (US-2013/0267791) disclose related medical orientation and activity prevention systems.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Manuel whose telephone number is (571) 272-4952.
The examiner can normally be reached on regular business days.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached on (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George Manuel/
Primary Examiner
Art Unit: 3792
2/3/2026