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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 28 January 2026 has been entered. Claims 1, 12, and 19 are currently amended. Claims 1-20 are pending in the application. Applicant’s amendments to the claims, specification have overcome the objections previously set forth in the Final Office Action mailed 28 October 2025.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 10-14, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Nazeri et al. (US PGPub No. 2005/0113661), hereinafter Nazeri, in view of Jones (US PGPub No. 2021/0153837) and Levy et al. (WO 2020/047607), hereinafter Levy, and further in view of Gopinathan et al. (US PGPub No. 2020/0054238), hereinafter Gopinathan.
Regarding claims 1-2 and 12-13, Nazeri teaches an alignment tool (Abstract: “a precordial pad for positioning EKG electrodes on a patient”) comprising:
a sensor connector releasably engaged with a sensor device having multiple sensors to capture measurement data indicative of cardiopulmonary health of a subject (Figs. 2 and 7: positioning extension 26, precordial pad body 12, multiple electrodes 52-62; par. 0045: “a positioning extension 26 that is detachable […] to the pad body 12;” examiner notes that a connector is implicit between the detachable positioning extension and the pad body),
with the sensor device including a frame configured to be removably placed on the chest of the subject (Fig. 16: EKG pads placed on the chest of the subject; par. 0019: “The pad is disposable so that it will be used for only one patient”),
and having an elongated section configured to be aligned with a midline of the body of the subject (Fig. 16: umbilical extension 112; par. 0066: “The umbilical extension 112 extends in the same vertical line as the manubrium notch 28, and it is either placed over or in line with the umbilicus 102 of the patient. By aligning the precordial pad 10 of the invention between the supra sternal notch 96 and the umbilicus 102, the EKG pad of the invention is guaranteed that it is aligned with the medial line 120 of a patient”),
the sensor connector assembled to controllably transition between a first arrangement engaged with the sensor device and a second arrangement disengaged from the sensor device (since the positioning extension 26 is detachable from the pad body 12, the connector between these two elements is necessarily capable of transitioning between engagement and disengagement from the sensor device, that is, the pad body);
and a strap or at least one arm comprising: a first portion comprising an alignment mechanism to fit into a suprasternal notch of the subject (Fig. 1: positioning extension 26 and suprasternal notch 28; par. 0046: “The positioning extension 26 includes a supra sternal notch 28. The supra sternal notch 28 is meant to be placed adjacent the manubrium, which is the bone adjacent to the jugular notch directly above the ribcage and at a patient's throat”);
and a second portion engaged with the sensor connector (Fig. 7: bottom half of positioning extension 26).
Nazeri does not explicitly teach wherein the sensor connector is separate from the sensor device while also being assembled to controllably transition between engagement and disengagement. However, in an analogous art, Jones teaches an alignment tool with a sensor connector separate from a sensor device (Fig. 1: main body 10, bracket mechanism 70, microphone 60; par. 0022: “main body 10 may allow microphone(s) 60 and/or bracket mechanism(s) to be added or removed as desired”). In light of Jones’ teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the sensor connector of Nazeri as a separate element that can controllably transition between engagement and disengagement, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Nazeri does not explicitly teach wherein the alignment mechanism comprises a hollow portion on one side corresponding to a protruding region on an opposite side, as recited in claims 1-2 and 13. However, in an analogous art, Jones teaches an alignment tool with an alignment mechanism that can be shaped as a dip, depression, notch, the like, or combinations thereof (par. 0020). In light of Jones’ teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to shape the alignment mechanism of Nazeri with a protruding region on one side and corresponding hollow portion on an opposite side, since Applicant has not disclosed that the particular shape of the protruding region and corresponding hollow portion solves any stated problem, and it appears that the invention would perform equally as well with Nazeri’s alignment notch or any of the alignment mechanisms suggested by Jones.
Nazeri teaches providing different sizes of the sensor device and strap or arm to accommodate for variation in patient anatomy (par. 0014: “Depending on the size of the patient's test area, a size of precordial pad is selected based on the testing system of the invention. For instance, sizes 1, 2, 3 and 4 may be available for various sizes of patients”) but does not explicitly teach wherein the sensor connector and the first portion of the strap are separated by a distance having a configurable length within a defined range centered along the midline of the body of the subject. However, Jones further teaches providing a configurable length from the alignment mechanism for a heart monitoring device as an alternative to providing different sizes of the device and wherein the defined range for the configurable length is centered along the midline of the body of the subject (par. 0020: “Embodiments of the main body may include different sizes (e.g. infant, child, adult, and tall). However, other embodiments may provide an adjustable main body that allows adjustment of the length and/or microphone 60 positions. Main body 10 provides an alignment mechanism 10-1, such as notch, depression, and/or the like, facilitation proper placement of the system;” examiner notes that adjusting the length as disclosed is within a defined range centered along the midline of the body of the subject). It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the device of Nazeri with a configurable length on the positioning extension instead of providing different sizes of the device, as suggested by Jones, since Jones teaches both options as explicit alternatives of one another.
The combination is silent with respect to the particular structure of the sensor connector and does not explicitly teach wherein the sensor connector includes a locking mechanism to fixedly set the sensor connector at a position along the second portion. However, in an analogous art, Leyv teaches a sensor harness with a sensor connector releasably engaged with a sensor device (Figs. 1A-1B and par. 0088: “the sensor device 150 may be inserted (or removed) from elongated aperture 103”) with a locking mechanism to set the sensor connector at a desired position relative to the user’s anatomy, which permits optimal positioning of the sensor device (par. 0088: “Sensor devices 150 further comprise releasable engagement formations 155 adapted to engage with retaining apertures 103 of harness 100 such that when formations 155 are engaged, sensor device is locked in a desired position within the associated retaining aperture 103, and when formations 155 are disengaged, sensor device is able to slide within retaining aperture 103 to permit optimal positioning of the sensor device with respect to the user’s abdomen or anatomical features”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the tool of the combined reference by providing a locking mechanism on the sensor connector, as taught by Levy, in order to permit optimal positioning of the sensor device, as taught by Levy.
The combination further does not explicitly teach wherein the multiple sensors capture measurement data according to multiple measurement modes. However, in an analogous art, Gopinathan teaches a sensor device with multiple sensors to capture measurement data according to multiple measurement modes (par. 0013: “systems, apparatus, and methods are disclosed for non-invasively detecting and monitoring medical or health conditions such as congestive heart failure (CHF) conditions in human subjects using multiple modalities of sensing”), which increases the accuracy of detecting potential cardiopulmonary health problems (par. 0013: “By non-invasively gathering and analyzing data from multiple modalities of sensing to detect the onset of CHF and/or monitor its severity in human subjects, the disclosed systems, apparatus, and methods can increase the positive detection of potentially problematic CHF conditions while decreasing false positives, which can reduce the number of unnecessary hospital readmissions, shorten hospital stays, and reduce hospital costs”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the sensor device of the combined reference by configuring the multiple sensors to capture measurement data according to multiple measurement modes, as taught by Gopinathan, in order to increase the accuracy of detecting potential cardiopulmonary health problems, as taught by Gopinathan.
Regarding claims 3 and 14, the combination teaches the alignment tools of claims 1 and 12 as described previously. The combination is silent with respect to the particular structure of the sensor connector and does not teach the sensor connector comprising an insertable pin for engaging a corresponding receptacle on the sensor. However, Levy teaches a sensor harness with a sensor connector comprising a receptacle for engaging a corresponding insertable pin on the sensor (par. 0088: “Sensor devices 150 further comprise releasable engagement formations 155 adapted to engage with retaining apertures 103 of harness 100 such that when formations 155 are engaged, sensor device is locked in a desired position within the associated retaining aperture 103”), which allows the sensor to be inserted or removed from the sensor connector (par. 0088: “formations 155 may be spring-loaded such that when opposing formations 155 are depressed inward towards each other, the sensor device 150 may be inserted (or removed) from elongated aperture 103”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the sensor connector and sensor engagement configuration of Levy for the bracket mechanism of Jones, so that the sensor can be inserted or removed from the sensor connector.
It would further have been obvious to one of ordinary skill in the art to modify the device of the combined reference by placing the insertable pin on the sensor connector and the corresponding receptacle on the sensor to arrive at the invention of claims 3 and 14, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Regarding claim 10, the combination teaches the alignment tool of claim 1 as described previously. Levy further teaches the sensor connector comprising a receptacle for inserting the second portion of the strap, namely, the end of the strap (par. 0037: “Each strap connection arm may be adapted to securably receive an end of a retaining strap”), and Jones further teaches the second portion of the strap having a length according to a selected distance between the first portion and the sensor connector (par. 0020: “an adjustable main body that allows adjustment of the length”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the alignment tool of the combined reference with a receptacle for inserting the second portion of the strap, as taught by Levy, since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art, that is, an alignment tool with a strap with end configured to be inserted into a receptacle in the sensor connector, which is configured to receive an end of a strap.
Regarding claims 11 and 18, the combination teaches the alignment tools of claims 1 and 12 as described previously. The combination does not explicitly teach the sensor connector comprising an opening for the second portion of the strap or the at least one arm to slide through, the second portion of the strap or the at least one arm configured to slide within the opening to a position according to a selected distance between the first portion and the sensor connector. Jones teaches a length-adjustable strap (par. 0020: “an adjustable main body that allows adjustment of the length”) but is silent with respect to the specific length adjustment mechanism.
However, Levy teaches a sensor connector (Figs. 1A-1B: arm 101 with sensor retaining aperture 103) comprising an opening for a length-adjustable strap to slide through (Fig. 1B: strap retaining portion 109; par 0078: “each strap 102b is formed from an elastomeric material which conforms to the user’s body shape in use and the length of the strap engaged with the user may be adjusted by the strap receiving portions e.g. the straps 102b may be pulled through the strap retaining portions 109 or complementary arms 101 to either lengthen or shorten the strap length to suit”).
To provide the alignment tool of the combined reference with an opening in the sensor connector for the strap or arm to slide through for length adjustment, as taught by Levy, would have been obvious to one of ordinary skill in the art for the following reasons:
Nazeri in view of Jones, Levy, and Gopinathan teaches a prior art alignment tool upon which the claimed invention (comprising an opening in the sensor connector for the strap or arm to slide through) may be seen as an improvement (Jones teaches length adjustability but is silent with respect to the mechanism for adjusting length). Levy teaches a prior art sensor connector using a known length adjustment technique that is applicable to the alignment tool and sensor connector of Jones, namely, the technique of providing an opening through which a strap or arm can slide for lengthening or shortening the strap or arm. It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that applying the known length adjustment technique of Levy to the alignment tool of the combined reference would have yielded predictable results and resulted in an improved system, namely, a system capable of length adjustment via an opening in the sensor connector through which a strap or arm can slide for lengthening or shortening the strap or arm.
Regarding claim 19, Nazeri teaches a sensor system comprising: a chest sensor (Figs. 1-2: precordial pad 10), comprising:
multiple sensors to capture measurement data indicative of cardiopulmonary health of a subject (Fig. 2: multiple electrodes 52-62);
and a frame configured to be removably placed on the chest of the subject (Fig. 16: EKG pads placed on the chest of the subject; par. 0019: “The pad is disposable so that it will be used for only one patient”),
and having an elongated section configured to be aligned with a midline of the body of the subject (Fig. 16: umbilical extension 112; par. 0066: “The umbilical extension 112 extends in the same vertical line as the manubrium notch 28, and it is either placed over or in line with the umbilicus 102 of the patient. By aligning the precordial pad 10 of the invention between the supra sternal notch 96 and the umbilicus 102, the EKG pad of the invention is guaranteed that it is aligned with the medial line 120 of a patient”),
and an alignment tool comprising: a sensor connector releasably engaged with the chest sensor (Figs. 2 and 7: positioning extension 26, precordial pad body 12, multiple electrodes 52-62; par. 0045: “a positioning extension 26 that is detachable […] to the pad body 12;” examiner notes that a connector is implicit between the detachable positioning extension and the pad body);
the sensor connector assembled to controllably transition between a first arrangement engaged with the chest sensor and a second arrangement disengaged from the chest sensor (since the positioning extension 26 is detachable from the pad body 12, the connector between these two elements is necessarily capable of transitioning between engagement and disengagement from the sensor device, that is, the pad body);
a strap comprising: a first portion comprising an alignment mechanism to fit into a suprasternal notch of the subject (Fig. 1: positioning extension 26 and suprasternal notch 28; par. 0046: “The positioning extension 26 includes a supra sternal notch 28. The supra sternal notch 28 is meant to be placed adjacent the manubrium, which is the bone adjacent to the jugular notch directly above the ribcage and at a patient's throat”);
and a second portion to engage with the sensor connector (Fig. 7: bottom half of positioning extension 26).
Nazeri not explicitly teach wherein the sensor connector is separate from the sensor device while also being assembled to controllably transition between engagement and disengagement; or wherein the alignment mechanism comprises a protruding region; or wherein the first portion and the sensor connector are separated by a distance having a configurable length within a defined range centered along the midline of the body of the subject; or wherein the system comprises a locking mechanism to fixedly set the sensor connector at a position along the second portion; wherein the multiple sensors capture measurement data according to multiple measurement modes. However, these limitations are taught by Jones, Levy, and Gopinathan, and would have been an obvious modification to one of ordinary skill in the art for the same reasons laid out previously in the rejection for claims 1 and 12.
Nazeri further does not explicitly wherein the chest sensor comprises a housing and wherein the sensor connector is configured to releasably engage with the housing. However, Levy further teaches a sensor comprising a housing (Fig. 9: portion of sensor device 150 surrounding microphone 157) configured to releasably engage with a connector (par. 0088: “sensor device is able to slide within retaining aperture 103 to permit optimal positioning of the sensor device with respect to the user’s abdomen or anatomical features. This could be facilitated by a notched or serrated edge 119 to the elongated aperture 103 of arms 101 and complementary notched edges 156 comprised in each of formations 155 of each of the sensor devices 150”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the chest sensor of Nazeri with a housing configured to releasably engage with the sensor connector, as taught by Levy, in order to facilitate optimal positioning of the sensor using complementary notched edges, as taught by Levy.
Regarding claim 20, the combination teaches the system of claim 19 as described previously. Levy further teaches a sensor connector comprising at least one receptacle and a sensor comprising at least one retractable pin for engaging the at least one receptacle of the sensor connector (par. 0088: “Sensor devices 150 further comprise releasable engagement formations 155 adapted to engage with retaining apertures 103 of harness 100 such that when formations 155 are engaged, sensor device is locked in a desired position within the associated retaining aperture 103”), which allows the sensor to be inserted or removed from the sensor connector (par. 0088: “formations 155 may be spring-loaded such that when opposing formations 155 are depressed inward towards each other, the sensor device 150 may be inserted (or removed) from elongated aperture 103”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the sensor connector and sensor engagement configuration of Levy for the bracket mechanism of the combined reference, so that the sensor can be inserted or removed from the sensor connector.
It would further have been obvious to one of ordinary skill in the art to modify the device of the combined reference by placing the at least one retractable pin on the sensor connector and the at least one receptacle on the sensor to arrive at the invention of claim 20, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Claims 4-6, 8, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Nazeri in view of Jones, Levy, and Gopinathan, and further in view of Vasavada et al. (US PGPub No. 2021/0333759), hereinafter Vasavada.
Regarding claims 4-5 and 15, Nazeri in view of Jones, Levy, and Gopinathan teaches the alignment tools of claims 3 and 14 as described previously. The combination does not explicitly teach the sensor connector further comprising a button to retract the insertable pin of the sensor connector and disengage the sensor connector from the sensor, or wherein the insertable pin is actuable by a single hand of the subject.
However, in an analogous art, Vasavada teaches wearable sensor device with a sensor connector comprising a button to retract an insertable pin and disengage the sensor connector from the sensor (Fig. 4: pins 402, buttons 403; par. 0079: “When spring-loaded buttons 403 are pressed inward, pins 402 may retract from an indentation in watch band 412 such that a retaining force exerted by pins 402 on watch body 404 is removed. The removal of the retaining force allows watch body 404 to be easily decoupled from watch band 412”), which is actuable by a single hand of the user (par. 0062: “Wristband system 200 may include a single release mechanism 220 or multiple release mechanisms 220 (e.g., two release mechanisms 220 positioned on opposing sides of wristband system 200 such as spring-loaded buttons 403 of FIG. 4);” examiner notes that a single release button is inherently actuable by a single hand of the user). Vasavada further teaches that a button is one of various equivalent alternative release mechanisms for coupling and decoupling a sensor from a sensor connector (par. 0061: “watch body 204 may be decoupled from watch band 212 by actuation of release mechanism 220. Release mechanism 220 may include, without limitation, a button, a knob, a plunger, a handle, a lever, a fastener, a clasp, a dial, a latch, or a combination thereof”).
Vasavada is considered analogous to the claimed invention because the disclosure is reasonably pertinent to the problem solved by the claimed invention, that is, providing a coupling mechanism for connecting a sensor to a sensor connector. It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the alignment tool of the combined reference by providing a button to retract the insertable pin of the sensor connector and disengage the sensor connector from the sensor, the button actuable by a single hand of the subject, as taught by Vasavada, since Vasavada teaches that a button is one of various equivalent alternative release mechanisms known in the art for coupling and decoupling a sensor from a sensor connector, and one of ordinary skill in the art could have performed the substitution with predictable results.
Regarding claims 6 and 17, Nazeri in view of Jones, Levy, and Gopinathan teaches the alignment tools of claims 1 and 12 as described previously. The combined reference does not teach wherein the second portion of the strap or the at least one arm comprises at least one series of holes positioned lengthwise along the strap or the arm, and the sensor connector comprises at least one pin for insertion into a selected one of the holes to set a selected length between the sensor connector and the alignment mechanism. Jones teaches a length-adjustable strap or arm between the sensor connector and the alignment mechanism (par. 0020: “an adjustable main body that allows adjustment of the length”) but is silent with respect to the specific length adjustment mechanism.
However, Vasavada further teaches a series of holes and a corresponding pin for insertion into a selected one of the holes as a length adjustment mechanism that is known in the art (Figs. 1A and 2A: length-adjustable watch band 112/212 with series of holes and corresponding pin for insertion into a selected one of the holes). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the alignment tool of Jones by providing a series of holes lengthwise along the strap or arm and a corresponding pin for insertion into a selected one of the holes, as taught by Vasavada, since Vasavada teaches the hole-and-pin configuration as a known length adjustment mechanism, and one of ordinary skill in the art could have substituted this length adjustment mechanism in the alignment tool of Jones with predictable results, namely, a length-adjustable main body with a series of holes lengthwise along the body and a corresponding pin in the sensor connector for insertion into one of the holes in order to adjust the length between the sensor connector and the alignment mechanism.
Regarding claim 8, the combination teaches the alignment tool of claim 6 as described previously. The combination does not explicitly teach wherein the series of holes is a first series of holes, the strap further comprising a second series of holes positioned lengthwise along the strap, and the sensor connector further comprising a second pin for insertion into a selected one of the second series of holes. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the invention of the combined reference by providing a second series of holes and a second pin for insertion into a selected one of the second series of holes, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Nazeri in view of Jones, Levy, Gopinathan, and Vasavada, and further in view of Mordecai et al. (US PGPub No. 2014/0352023), hereinafter Mordecai.
Nazeri in view of Jones, Levy, Gopinathan, and Vasavada teaches the alignment tool of claim 6 as described previously. The combination does not explicitly teach wherein the pin is configured to be fixedly inserted into the selected hole such that a user cannot adjust the distance between the sensor connector and the first portion of the strap after the distance is set.
However, in the same field of endeavor, Mordecai teaches a wearable sensor retaining device with a length-adjustable strap that remains fixed after the length is set (par. 0034: “the wearable sensor retaining device may pass through one or more channels in the garment and may include a fixed loop at one end of the strap. A "fixed" loop is one in which the loop (e.g. a length adjustment loop) is designed to retain its size once a size has been set by the user. The strap can be disconnected and reconnected without altering the size of the connected strap”), which provides a reproducible, customizable fit for each user (par. 0048: “Once the strap has been adjusted to fit a particular user, the loop 300 can remain at the same fixed length whether the fastening mechanism 290 is connected or disconnected, providing a reproducible, customizable fit for each wearer”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the alignment tool of Jones and Vasavada by configuring the pin to be fixedly inserted into the hole such that a user cannot adjust the distance between the sensor connector and the first portion of the strap after the distance is set, since Mordecai teaches that keeping an adjustable strap at a fixed length after adjustment provides a reproducible, customizable fit for each user.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Nazeri in view of Jones, Levy, Gopinathan, and Vasavada, and further in view of Riekkinen et al. (WO 2021/110937), hereinafter Riekkinen.
Nazeri in view of Jones, Levy, Gopinathan, and Vasavada teaches the alignment tool of claim 8 as described previously. The combination does not explicitly teach wherein consecutive holes in the first series of holes and the second series of holes are separated by approximately 1 centimeter.
However, in the same field of endeavor, Riekkinen teaches a method for determining proper positioning of ECG electrodes for precordial leads on a human subject relative to the suprasternal notch (Fig. 3 and page 15, lines 24-26: “the device of the present disclosure (302) is aligned with its sternal midline mark ‘ML’ on the upper short side (304) to the subject’s sternal notch (301)”), wherein the device and measurements are marked in units of centimeters.
In light of Riekkinen’s teaching that it is known in the art to determine placement of sensors relative to the suprasternal notch using units of centimeters, it would have been obvious matter of design choice to one of ordinary skill in the art, before the effective filing date of the claimed invention, to choose units of approximately 1 centimeter for the separation distance between consecutive length adjustment holes in the alignment tool of the combined reference, since Applicant has not disclosed that the distance of 1 centimeter solves any stated problem or is for any particular purpose, and it appears that the invention would perform equally as well with any selected distance between consecutive length adjustment holes, as appropriate for the particular application.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Nazeri in view of Jones, Levy, and Gopinathan, and further in view of Mordecai.
Nazeri in view of Jones, Levy, and Gopinathan teaches the alignment tool of claim 12 as described previously. The combination does not explicitly teach wherein the locking mechanism comprises a clamp, and the sensor connector comprises the clamp to set a selected length between the sensor connector and the suprasternal notch indent. Jones teaches a length-adjustable arm between the sensor connector and the alignment mechanism (par. 0020: “an adjustable main body that allows adjustment of the length”) but is silent with respect to the specific length adjustment mechanism.
However, Mordecai teaches that clamps are known in the art for adjusting the length of straps and related structures (par. 0038: “the length can be adjusted when the wearable sensor retaining device is not fastened, typically with adjustable buckles, clips, clamps, or other such suitable mechanisms for adjusting straps and the like”). It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by choosing a clamp for the length-adjustment mechanism, since Mordecai teaches that clamps are known in the art for adjusting the length of straps or related structures, such as arms, and one of ordinary skill in the art could have performed such a substitution with predictable results.
Response to Arguments
Applicant's arguments filed 28 January 2026 have been fully considered but they are not persuasive.
In response to applicant’s argument that Nazeri teaches an embodiment wherein the positioning extension is not attached to the pad body and thus does not teach a connector between the two elements, it is noted that all embodiments, although obvious variants of one another, are not relied upon equally in the rejection of the claims. In this case, since Nazeri teaches that the positioning extension can be detachable from the pad body, the positioning extension and pad body must necessarily include a connecting structure that can controllably transition from engagement to disengagement (as broadly recited in each of the independent claims).
In response to applicant's other arguments that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a chronological order of steps requiring the joining of the sensor connector and the sensor device before detaching the sensor connector) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794