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 .
Response to Arguments
Applicant’s amended Specification dated 8/22/2024 is accepted and appears to overcome the objections to the specification from the Non-Final Rejection.
Applicant’s amendments to the claims have overcome previous grounds for rejection under 35 U.S.C. § 112(b) and merit new grounds for rejection under 35 U.S.C. § 112(b) and (d), § 101, and § 103 in view of a new combination of references.
Applicant’s arguments with respect to claim(s) 1, 5-10, 12, 14-15, and 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1, 5-10, 12, 14-15, and 17 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 1, 8-9, and 15, the term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of Examination, “about” will be interpreted as +/- 3cm.
Regarding claim 12, the limitation “when dependent on claim 2” renders the claim indefinite. A contingent or conditional dependency is indefinite and should be removed. For the purposes of Examination, this phrase will be considered a typographical error and is removed for interpreting the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 9 appears identical to subject matter already incorporated into pending claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 15 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). In claim 15, the claim includes “the navel” in lines 13-14 of the claim that when construed under BRI, can be interpreted to positively claim the human body. To overcome this rejection, the Examiner suggests amending lines 13-14 to “…such that, in use, at least one electrode is configured to lie above the navel and at least one electrode is configured to lie below the navel…”
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, and 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shennib (U.S. Patent Application Publication No. 2007/0255184) hereinafter referred to as Shennib; in view of Meyer (U.S. Patent Application Publication No. 2010/0022865) hereinafter referred to as Meyer; in view of Faarbaek et al. (U.S. Patent Application Publication No. 2014/0288381) hereinafter referred to as Faarbaek; in view of Hayes-Gill et al. (U.S. Patent Application Publication No. 2012/0150010) hereinafter referred to as Hayes-Gill.
Regarding claims 1 and 9, Shennib teaches an apparatus for acquiring signals from a pregnant subject (Abstract), the apparatus including a flexible portion that is conformable to an abdomen of the subject (¶[0026]), the flexible portion including a plurality of signal acquisition points (¶[0028], ¶[0046]) each signal acquisition point comprising a contact adapted to electrically couple to a respective electrode and signal acquisition circuitry (¶[0055]), wherein the flexible portion includes:
a first linear section that is generally aligned along a first axis (Fig. 10, Em1 to Em2 defines the first axis); and
a second linear section extending from the first linear section, the second linear section being aligned along a second axis that is perpendicular to the first axis (Fig. 10, midpoint of Em1 to Em2 and ER define second axis extending from first axis, the middle segment of the H shape);
wherein a first group of the signal acquisition points is located along the first axis (Fig. 1, Em1 and Em2) and a signal acquisition point is located along the second axis (Fig. 10, ER), where the signal acquisition points are coupled with disposable adhesive (¶[0047]) electrodes (¶[0026] the patch is disposable, therefore the electrodes are disposable) for collecting information of cardiac function of the pregnant subject, a fetus in, and uterine muscle of, the pregnant subject (¶[0051], maternal and fetal ECG, EMG),
wherein one of the signal acquisition points located along the second axis is a reference signal acquisition point to acquire reference signals (¶[0055] and Fig. 10, ER).
Shennib does not teach a second group of the signal acquisition points along the second axis, or the apparatus further comprising a chamfered channel defined therethrough for aligning the apparatus with a navel of the subject, the channel being positioned along the second axis, wherein two signal acquisition points of the second group of signal acquisition points are located on opposite sides of the channel along on the second axis, and two signal acquisition points of the first group of signal acquisition points are located on opposite side of the channel along the first axis, wherein one of the signal acquisition points located along the second axis is a uterine activity signal acquisition point, wherein the uterine activity signal acquisition point is spaced about 8 cm from an intersection between the first axis and the second axis, or wherein the reference signal acquisition point is spaced about 18 cm from the intersection between the first axis and the second axis.
Attention is brought to the Meyer reference, which teaches a second group of the signal acquisition points along a second axis (Fig. 4B, second axis defined by points electrodes E6 and E3, first axis defined by points electrodes E1 and E5), or the apparatus further comprising a channel (Fig. 4B, element 499b elongated reference aperture) defined therethrough for aligning the apparatus with a navel of the subject (¶[0049], the “body structure” is defined as the umbilicus of the patient ¶[0044], Figs. 5A-B), the channel being positioned along the second axis (Fig. 4B), wherein two signal acquisition points of the second group of signal acquisition points are located on opposite sides of the channel along on the second axis (Fig. 4B, electrodes E6 and E3 are on opposite sides of channel 499b), and two signal acquisition points of the first group of signal acquisition points are located on opposite side of the channel along the first axis (Fig. 4B, electrodes E1 and E5 are on opposite sides of channel 499b), wherein one of the signal acquisition points located along the second axis is a uterine activity signal acquisition point (¶[0007]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the monitor of Shennib to include a reference channel, and additional signal acquisition points, as taught by Meyer, because the reference channel ensures proper and consistent placement of the sensor array, and all electrodes are properly placed relative to the body (Meyer ¶[0045]) and the addition of more signal acquisition points disposed at the ends of the projected substrate provides for accurate and consistent electrode placement on curved skin surface, enhancing reliability and accuracy of clinical data acquired during monitoring (Meyer ¶[0007], ¶[0034]).
Shennib as modified does not teach the channel with chamfered edges, or wherein the uterine activity signal acquisition point is spaced about 8 cm from an intersection between the first axis and the second axis, or wherein the reference signal acquisition point is spaced about 18 cm from the intersection between the first axis and the second axis.
Attention is drawn to the Faarbaek reference, which teaches an adhesive monitoring patch with chamfered edges (¶[0068]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the edges of the patch of Shennib as modified to include a chamfered edge, as taught by Faarbaek, because Faarbaek teaches that a smooth edge is critical, otherwise fabric will stick to the edges and cause rolling of the patch (Faarbaek ¶[0270]). It is the Examiner’s position that it would have been obvious to apply this teaching to all of the edges of Shennib as modified, thereby including the edges of the channel, because Faarbaek teaches it provides a smooth interface with the skin (Faarbaek ¶[0068]) and the edges of the channel would further obtain this benefit.
Shennib as modified does not teach wherein the uterine activity signal acquisition point is spaced about 8 cm from an intersection between the first axis and the second axis, or wherein the reference signal acquisition point is spaced about 18 cm from the intersection between the first axis and the second axis.
Notably, Shennib as modified teaches two acquisition points on opposite ends of the first axis, and a reference electrode point at the furthest end of the second axis (Fig. 10)
Attention is brought to the Hayes-Gill reference, which teaches that the electrodes for uterine signal acquisition should be spaced apart from each other between 5cm and 15cm (¶[0094]), therefore in combination with Shennib’s configuration, teaches wherein the uterine activity signal acquisition point is spaced about 8 cm from an intersection between the first axis and the second axis (when the electrodes are 15cm apart, this corresponds to 7.5cm from the midline, or intersection between the axes which is “about” 8cm), or wherein the reference signal acquisition point is spaced about 18 cm from the intersection between the first axis and the second axis (15cm corresponds to “about” 18cm).
Notably, Hayes-Gill teaches that the spacing of the acquisition electrodes is results effective (¶[0094], ¶[0108])
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the size of the monitoring system of Shennib as modified to use a distance between an electrode and the axis intersection of about 8cm, and a distance between a reference electrode and the axis intersection of about 18cm, because the spacing the electrode separation determines the strength of uterine contraction signals, therefore correct spacing improves signal strength according to known calibrations (Hayes-Gill ¶[0108]) and because “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 5, Shennib as modified teaches the apparatus of claim 1.
Meyers further teaches wherein the channel defines a longitudinal axis that is mutually orthogonal to the first axis and the second axis (Fig. 4B, element 499b; reference aperture is through a substrate which has a thickness, and the axis is defined by the channel insofar as it is parallel to this thickness, orthogonal to the skin surface of the patient).
Regarding claim 6, Shennib as modified teaches the apparatus of claim 1.
Meyer further teaches wherein the channel is shaped to allow a user to align the channel to the navel of the subject by visual and/or tactile means (¶[0045], ¶[0048], ¶[0050], each embodiment the reference aperture is for aligning the monitoring array with the umbilicus/navel, however, allowing for a user to position the device is an intended use and given limited patentable weight) and for receiving a finger of the user (the channel of Meyer, Fig. 4B, element 499b is shaped for receiving a finger, but the reception of a finger in the channel is not required as it is an intended use).
Regarding claim 7, Shennib as modified teaches the apparatus of claim 1.
Faarbaek further teaches wherein the channel comprises a chamfered entry portion (¶[0068], as applied in the rejection of claim 1) to facilitate gripping by a user (this is considered an intended use, and the device of Shennib as modified is capable of this use; it is further noted that the claim does not include what is being gripped and is therefore broadly interpreted).
Regarding claim 8, Shennib as modified teaches the apparatus of claim 1.
Shennib as modified does not teach wherein the uterine activity signal acquisition point along the second axis is spaced about 8 cm from an intersection between the first axis and the second axis.
Notably, Shennib as modified teaches two acquisition points on opposite ends of the first axis, and a reference electrode point at the furthest end of the second axis (Fig. 10).
Meyer is relied upon to teach additional signal acquisition points along the second axis.
Attention is brought to the Hayes-Gill reference, which teaches that the electrodes for uterine signal acquisition should be spaced apart from each other between 5cm and 15cm (¶[0094]), encompassing 8cm within this range.
Notably, Hayes-Gill teaches that the spacing of the acquisition electrodes is results effective (¶[0094], ¶[0108])
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the size of the monitoring system of Shennib as modified to use a distance between an electrode and the axis intersection of about 8cm, and a distance between a reference electrode and the axis intersection of about 18cm, because the spacing the electrode separation determines the strength of uterine contraction signals, therefore correct spacing improves signal strength according to known calibrations (Hayes-Gill ¶[0108]) and because “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shennib, Meyer, Faarbaek, and Hayes-Gill as applied to claim 1 above, and further in view of Hayes-Gill et al. (U.S. Patent Application Publication No. 2016/0262649) hereinafter referred to as Hayes-Gill 2.
Regarding claim 10, Shennib as modified teaches the apparatus of claim 1.
Shennib as modified does not teach a cable hub attached to the flexible portion for feeding signals from the signal acquisition points to the signal acquisition circuitry and/or to signal processing circuitry.
Attention is brought to the Hayes-Gill 2 reference, which teaches a cable hub (element 200, readout device) attached to the flexible portion (¶[0134], connected electrical module, Fig. 7 element 204) for feeding signals from the signal acquisition points to the signal acquisition circuitry and/or to signal processing circuitry (¶[0137] readout device transmits signals and is included in the system for this purpose).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the apparatus of claim 1 to include a cable hub as taught by Hayes-Gill 2, because integrating the cable hub with a patch allows a subject to move freely (Hayes-Gill 2 ¶[0155]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shennib, Meyer, Faarbaek, Hayes-Gill, and Hayes-Gill 2 as applied to claim 10 above, and further in view of Cline et al. (U.S. Patent Application Publication No. 2016/0331299) hereinafter referred to as Cline.
Regarding claim 12, Shennib as modified teaches the apparatus of claim 10.
Shennib as modified teaches the channel extending through the flexible portion. Shennib as modified does not teach wherein a channel extends through the cable hub.
Attention is brought to the Cline reference, which teaches a rigid body (¶[0116] outer housing) that is connected to the flexible portion (¶[0116] extending over device, which is otherwise flexible ¶[0038]) including a channel through both (alignment portion of the device in Figs. 6-7, element 603).
It would have been obvious to one of ordinary skill in the art to modify the monitoring system of Shennib as modified to include a channel through a rigid housing, as taught by Cline, because it promotes positioning of the patch-based data acquisition device at a desired location (Cline ¶[0040]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shennib, Meyer, Faarbaek, and Hayes-Gill as applied to claim 1 above, and further in view of Frei et al. (U.S. Patent Application Publication No. 2007/0100278) hereinafter referred to as Frei.
Regarding claim 14, Shennib as modified teaches the apparatus of claim 1.
Shennib as modified does not teach circuitry that is configured to determine a signal quality index (SQI) for each of plurality of signals acquired at the signal acquisition points; and to generate an alert for any signal acquisition points for which the SQI falls below a predetermined threshold.
Attention is drawn to the Frei reference, which teaches circuitry that is configured to determine a signal quality index (SQI) for each of a plurality of signals acquired at the signal acquisition points (¶[0011]); and to generate an alert (¶[0085] notifies user of the existence of degraded signal, including in the form of alarm ¶[0087]) for any signal acquisition points for which the SQI falls below a predetermined threshold (¶[0101] multiple criterion).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the monitoring device of Shennib as modified to include signal quality monitoring, as taught by Frei, because Frei teaches that detecting signal degradation is desirable in the art (Frei ¶[0009]).
Claim(s) 15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shennib (U.S. Patent Application Publication No. 20070255184) hereinafter referred to as Shennib; in view of Meyer (U.S. Patent Application Publication No. 2010/0022865) hereinafter referred to as Meyer; in view of Faarbaek et al. (U.S. Patent Application Publication No. 2014/0288381) hereinafter referred to as Faarbaek; in view of Hayes-Gill et al. (U.S. Patent Application Publication No. 2012/0150010) hereinafter referred to as Hayes-Gill; in view of Cline et al. (U.S. Patent Application Publication No. 2016/0331299) hereinafter referred to as Cline.
Regarding claims 15 and 17, Shennib teaches a system for acquiring signals from a pregnant subject (Abstract), comprising:
a plurality of electrodes (¶[0055]) disposed on a flexible portion that is conformable to an abdomen of the subject (¶[0026]), the plurality of electrodes being arranged in a T-shaped pattern (Fig. 10, the electrodes Em1 to Em2 and ER shape corresponds to a T) in which a first group of electrodes is aligned along a first axis (Fig. 10, Em1 to Em2 defines the first axis) and an electrode is aligned along a second axis that is perpendicular to the first axis (Fig. 10, midpoint of Em1 to Em2 and ER define second axis extending from first axis, the middle segment of the overall H shape);
signal acquisition circuitry electrically coupled to said electrodes (¶[0028], ¶[0046]) for acquiring electrocardiographic and/or electromyographic signals from the signals (¶[0051], maternal and fetal ECG, EMG);
wherein the signal acquisition circuitry comprises signal acquisition points connected to the electrodes (¶[0028], ¶[0046], ¶[0055]);
wherein one of the signal acquisition points located along the second axis is a reference signal acquisition point to acquire reference signals (¶[0055] and Fig. 10, ER).
Shennib does not teach a second group of the signal acquisition points along the second axis, a rigid body that is connected to the flexible portion for alignment of the flexible position on the abdomen of the subject, or the system further comprising a channel along the second axis comprising a chamfered entry portion, wherein two electrodes of the second group of electrodes are located on opposite sides of the channel such that, in use, at least one electrode lies above the navel and at least one electrode lies below the navel, and two electrodes of the first group of electrodes are located on opposite sides of the channel along the first axis; one of the signal acquisition points located along the second axis is a uterine activity signal acquisition point, wherein the uterine activity signal acquisition point is spaced about 8 cm from an intersection between the first axis and the second axis, or wherein the reference signal acquisition point is spaced about 18 cm from the intersection between the first axis and the second axis.
Attention is brought to the Meyer reference, which teaches a second group of the signal acquisition points along a second axis (Fig. 4B, second axis defined by points electrodes E6 and E3, first axis defined by points electrodes E1 and E5), and a channel along the second axis (Fig. 4B, element 499b elongated reference aperture), wherein two electrodes of the second group of electrodes are located on opposite sides of the channel such that, in use, at least one electrode lies above the navel (¶[0049], the “body structure” is defined as the umbilicus of the patient ¶[0044], Figs. 5A-B) and at least one electrode lies below the navel (Fig. 4B, electrodes E6 and E3 are on opposite sides of channel 499b), and two electrodes of the first group of electrodes are located on opposite sides of the channel along the first axis (Fig. 4B, electrodes E1 and E5 are on opposite sides of channel 499b), wherein one of the signal acquisition points located along the second axis is a uterine activity signal acquisition point (¶[0007]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the monitor of Shennib to include a reference channel, and additional signal acquisition points, as taught by Meyer, because the reference channel ensures proper and consistent placement of the sensor array, and all electrodes are properly placed relative to the body (Meyer ¶[0045]) and the addition of more signal acquisition points disposed at the ends of the projected substrate provides for accurate and consistent electrode placement on curved skin surface, enhancing reliability and accuracy of clinical data acquired during monitoring (Meyer ¶[0007], ¶[0034]).
Shennib as modified does not teach the channel comprises a chamfered entry portion to facilitate gripping by a user; a rigid body that is connected to the flexible portion for alignment of the flexible position on the abdomen of the subject, or wherein the uterine activity signal acquisition point is spaced about 8 cm from an intersection between the first axis and the second axis, or wherein the reference signal acquisition point is spaced about 18 cm from the intersection between the first axis and the second axis.
Attention is drawn to the Faarbaek reference, which teaches an adhesive monitoring patch with chamfered edges (¶[0068]) to facilitate gripping by a user (this is considered an intended use, and the device of Shennib as modified is capable of this use; it is further noted that the claim does not include what is being gripped and is therefore broadly interpreted).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the edges of the patch of Shennib as modified to include a chamfered edge, as taught by Faarbaek, because Faarbaek teaches that a smooth edge is critical, otherwise fabric will stick to the edges and cause rolling of the patch (Faarbaek ¶[0270]). It is the Examiner’s position that it would have been obvious to apply this teaching to all of the edges of Shennib as modified, thereby including the edges of the channel, because Faarbaek teaches it provides a smooth interface with the skin (Faarbaek ¶[0068]) and the edges of the channel would further obtain this benefit.
Shennib as modified does not teach wherein the uterine activity signal acquisition point is spaced about 8 cm from an intersection between the first axis and the second axis, or wherein the reference signal acquisition point is spaced about 18 cm from the intersection between the first axis and the second axis.
Notably, Shennib as modified teaches two acquisition points on opposite ends of the first axis, and a reference electrode point at the furthest end of the second axis (Fig. 10)
Attention is brought to the Hayes-Gill reference, which teaches that the electrodes for uterine signal acquisition should be spaced apart from each other between 5cm and 15cm (¶[0094]), therefore in combination with Shennib’s configuration, teaches wherein the uterine activity signal acquisition point is spaced about 8 cm from an intersection between the first axis and the second axis (when the electrodes are 15cm apart, this corresponds to 7.5cm from the midline, or intersection between the axes which is “about” 8cm), or wherein the reference signal acquisition point is spaced about 18 cm from the intersection between the first axis and the second axis (15cm corresponds to “about” 18cm).
Notably, Hayes-Gill teaches that the spacing of the acquisition electrodes is results effective (¶[0094], ¶[0108])
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the size of the monitoring system of Shennib as modified to use a distance between an electrode and the axis intersection of about 8cm, and a distance between a reference electrode and the axis intersection of about 18cm, because the spacing the electrode separation determines the strength of uterine contraction signals, therefore correct spacing improves signal strength according to known calibrations (Hayes-Gill ¶[0108]) and because “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Shennib as modified does not teach a rigid body that is connected to the flexible portion for alignment of the flexible position on the abdomen of the subject.
Attention is brought to the Cline reference, which teaches a rigid body (¶[0116] outer housing) that is connected to the flexible portion (¶[0116] extending over device, which is otherwise flexible ¶[0038]) for alignment of the flexible position on the abdomen of the subject (this is an intended use, nevertheless, Cline teaches an alignment portion of the device in Figs. 6-7, element 603).
It would have been obvious to one of ordinary skill in the art to modify the monitoring system of Shennib as modified to include a rigid outer housing, as taught by Cline, because it waterproofs the device (Cline ¶[0116]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792