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.
Claim 14 is 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.
Claim 14 recites that the slug is configured for placement within a slot of the phone device, but in claim 1 the slug is positioned within a slot of the protective case. As such, it is indefinite because it is not clear whether the slug is place within the phone or the case. Amendment required.
Claims not listed are rejected by virtue of claim dependency.
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.
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.
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 1-2, 4-5, 7, 10-11, 14-18, 23 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Tyrrell (US 20160077091- previously cited) and further in view of Erickson et al. (US 20150359458- previously cited), hereinafter Erickson, Soller et al. (US 6006119), hereinafter Soller, Heikenfeld et al. (US 20180153451 A1 – previously cited) referred to as Heikenfeld hereinafter, and Cronin (US 20180011089 – previously cited).
Regarding claim 1, Tyrrell discloses a system for correlating bodily fluids to health aspects, comprising:
a slug (fig. 1, slug 103b) comprising a passive chemical sensor (101),
a receiving channel for wicking (¶[0145,0182,0191] and fig. 6A, elements 611 are the receiving channels) the bodily fluids from a body to the passive chemical sensor (¶[0064,0185,0191], indicator/test result determination regions), a first light source (¶[0145], digital camera hardware comprising light).
and an interface for interfacing the passive chemical sensor to an imaging system device (fig. 1 and ¶[0059], the slug 103b comprises an interface to attach the slug on position 102a to obtain the image of the sensor). Tyrrell fails to teach a second light source, however, the first light source is of the mobile phone device. Therefore, Tyrell does not teach a second light source.
Erickson teaches a smartphone capable of obtaining analyte samples via a chemical sensor strip (abstract). The invention requires two light sources, a flash from the phone and an LED for diffusing light behind the test strip to aid in uniformly lighting the test strip in a slug housing (see fig. 4 and para. [0071]).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tyrrell, such that the system comprises a second light source, as taught by Erickson, to aid in uniformly illuminating the test strip, thereby providing a better image of the chemical sensor.
It follows Tyrrell-Erickson teach that the slug of Tyrell comprises a first light source (LED array of Erickson, ¶[0071], and fig. 4) wherein the passive chemical sensor is positioned between the receiving channel and interface of the slug (¶[0145, 0182,0191] of Tyrrell,the analyte system comprises a phone (102) and slug (103) configured to receive a chemical sensor strip (101) (see fig. 1). The chemical sensor strip comprises a receiving channel (612), a chemical sensor (613,607), and an interface (609) that encapsulates the sensors and interfaces with the slug (103b) The configuration is therefore one where the passive chemical sensor is positioned between the receiving channel and interface of the slug)
wherein the slug positions the receiving channel over the imaging system and second light source of the mobile device (¶[0059-62,0142] of Tyrrell, “wherein the electronic device can be at least partially or fully enclosed in a case that serves to provide for optimal positioning of the testing device in front of a photographic or digital camera that is included or can be provided with the electronic device and/or optionally providing optimal lighting for image capture,” “in order to help ensure that the test device is correctly positioned under the digital camera, a case can optionally have a slot that when the case is open, the test device can be inserted into the slot and/or the fixturing on the inside of the case can ensure the proper positioning of the device under the camera lens,” and “taking a digital image of the sample conditioned and run on each test strip with the digital camera positioned, optionally, via the tester, case and/or housing.” Therefore the test strip slug 103b is positioned adjacent the camera, the strip/receiving channel being fully within the slug and therefore positioned under the imaging and light system. For clarity, the second light source is considered that of the mobile device of Tyrrell and the first light source is arrived with the combination of Erickson),
wherein the slug is positioned within a slot of a protective case associated with the mobile phone device (case housing 103), such that the interface is firmly lodged against both the imaging system and the second light source (¶[0059-62,0142] of Tyrrell, “wherein the electronic device can be at least partially or fully enclosed in a case that serves to provide for optimal positioning of the testing device in front of a photographic or digital camera that is included or can be provided with the electronic device and/or optionally providing optimal lighting for image capture,” “in order to help ensure that the test device is correctly positioned under the digital camera, a case can optionally have a slot that when the case is open, the test device can be inserted into the slot and/or the fixturing on the inside of the case can ensure the proper positioning of the device under the camera lens”). Since the disclosed teaching is in a separated embodiment, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tyrell-Erickson, such that the slug is positioned within a slot of a protective case associated with the mobile phone device, as taught by Tyrrell, to aid in ensuing that the device if correctly positioned under the camera to obtain proper image of the test strip (¶[0059-62] of Tyrell).
Tyrell-Erickson fail to teach wherein the first light source included in the slug comprises a plurality of secondary lenses comprising a series of collimating lenses.
Soller teaches a method and device for measuring constituents in bodily fluids (abstract and col. 18-19, lines [65-67; 1-7], hematocrit (analyte) concentration).
Therefore, it would have it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Tyrell-Erickson, such that the first light source included in the slug comprises a plurality of secondary lenses comprising a series of collimating lenses, as taught by Soller, to aid in non-invasively measuring bodily fluid constituents.
Tyrrell-Erickson-Soller fail to teach wherein the first light source is actuatable by the mobile phone device. In a separate embodiment of Tyrrell, it is disclosed that “Illumination can optionally be provided by . . . a separate illumination source.” (¶0178] of Tyrrell) In this case, that would be the external LED of Erickson, as modified above, that illuminates the back of the test strip (see fig. 4b of Erickson). Tyrrell discloses that such external illumination would be actuatable by the mobile phone device (¶[0178], “A system software can perform one or more of several distinct functions. These functions include one or more of the following, but are not limited to: 1) controlling the illumination”). Therefore, the teaching arrives to the claimed invention because the light sources are capable of being controlled by the mobile phone device.
As such it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tyrrell-Erickson-Soller, such that the first light source is actuatable by the mobile phone device, as taught by Tyrrell, as it would merely be applying a known technique (external light source controlled by mobile phone) to a known device (analyte detecting systems) ready for improvement to yield predictable results. In Erickson, the external LED is controlled by a light switch (fig. 8a), by making the LED controllable by the phone, the invention is simplified in both physical structure and manufacturing.
It follows that Tyrrell-Erickson-Soller teach, at least one indicator associated with the passive chemical sensor, wherein the at least one indicator changes based on features of the wicked bodily fluids (¶[0052,0154,0161,0178] of Tyrrell, “test strip or casing can be provided with markings or color coding or changes that indicate one or more of sufficient sample volume or run time, positive or negative result, or one or more threshold drug test concentrations met or not met”);
at least one secondary sensor integrated into the protective case associated with the mobile phone device, comprising a humidity sensor (¶[0025,0163] of Tyrrell, “portable lateral flow drug test strip system can optionally provide wherein the environmental conditions are selected from humidity”);and
at least one computing memory device associated with the mobile phone device comprising at least comparative lookup of an application, and wherein the at least one indicator is compared to the comparative lookup (¶[0055] of Tyrrell, “color coding can be matched to a lookup table”) to produce a user display on the application of the health aspects indicated by the at least one indicator (¶[0101] of Tyrrell, “A displayed image is derived from the data received by the input port of the computer device from the interface”).
Tyrell-Erickson-Soller fail to teach at least one secondary sensor comprising a hydration sensor, a skin temperature sensor, and a heart rate sensor.
Heikenfeld teaches a device for measuring the user’s hydration state via bodily fluid analyte detection comprising a hydration sensor (see ABSTRACT and para. [0034]). Additionally, skin temperature measurements are obtained to improve the predictive capability of the sweat measurement device (¶[0038,0096] and fig. 1, “sweat sensing device might include a plurality of sensors.” That is, the slug (sweat sensing device) comprises the plurality of sensors).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Tyrrell-Erickson-Soller, such that the secondary sensor comprises a hydration sensor, skin temperature, and heart rate sensors integrated into a protective case, as taught by Heikenfeld, to aid in relaying crucial data, to a connected phone, about the health levels of a person and improving the predictive capability of the device (see para. [0003,011,0053,0096] of Heikenfeld). It is further noted that Tyrrell discloses that the system can incorporate a plurality of physiological sensors (¶[0177], of Tyrrell).
Cronin teaches a sensor strip analyte detecting system that is configured to measure heart rate (¶[0068]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tyrrell-Erickson-Soller-Heikenfeld, such that the at least one secondary sensor further comprises a heartrate sensor, as taught by Cronin, because Tyrrell requires additional physiologic sensors, and Cronin teaches that additional sensors can include heart rate. The combination is merely combining prior art elements (analyte detecting systems comprising sensor strips) according to known methods (comprising additional sensors, such as heart rate) to yield predictable results.
Regarding claim 2, Tyrrell discloses wherein the passive chemical sensor comprises a sensor strip (fig. 6A).
Regarding claim 4, Tyrell teaches wherein the slug is integrated into an exercise device (¶[0142-45], the mobile phone device is capable of being used during exercise and placed in 103).
Regarding claim 5, Tyrell teaches wherein the exercise device further comprises a holder for the mobile phone device (fig. 1, holder 103c holds the smart phone).
Regarding claim 7, Tyrrell discloses wherein the holder comprises a pocket (fig. 1, pocket/dock 103d-e).
Regarding claim 10, Tyrrell discloses wherein the application further comprises an algorithmic analytics platform (¶[0168]) for particular types of the bodily fluid images pertaining to the immunoassay region being analyzed (¶[0115], “biological fluid sample such as blood, serum, saliva, or urine, or a fluid derived from a biological sample, such as a throat or genital swab”).
Regarding claim 11, Tyrrell fails to teach wherein the features comprise at least one of pH. Erickson teaches that a chemical test strip can measure pH (¶[0030-31]). As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tyrrell-Erickson-Heikenfeld, such that the features comprise at least one of pH, as taught by Erickson, because Tyrrell requires measuring pH (¶[0163]), but fails to provide details, and Heikelfeld teaches it can be performed with a senor strip.
Regarding claim 14, Tyrrell teaches wherein the slug is configured for placement into a slot of the mobile phone device (see fig. 1 and ¶[0012], slug is positioned on the back of the mobile phone device holder).
Regarding claim 15, Tyrrell teaches wherein the slug is configured for placement into a slot of a protective case associated with the mobile phone device (see fig. 1 and ¶[0012], slug is positioned on the back of the mobile phone device slot, the slot part of the protective case 103).
Regarding claim 16, Tyrrell teaches wherein the passive chemical sensor is single-use (fig. 6a, sensor strip can be disposed after a single use).
Regarding claim 17, Tyrrell teaches wherein the at least one indicator is a color (¶[0064]).
Regarding claim 18, Tyrrell teaches wherein the bodily fluids is one of sweat (¶[0007]).
Regarding claim 23, Tyrrell teaches wherein the change of the at least one indicator corresponds to a light intensity of the at least one indicator (¶[0054-55], “A software can include library algorithms for each analyte, used to determine whether a result is positive or negative based on the relative intensities”).
Regarding claims 28, Soller teach wherein the secondary lenses are configured to direct light to the imaging system of the mobile phone device (col. 18-19, lines [65-67; 1-7] and fig. 13B, “ Lens array 820 contains a series of molded lenses 825 used to collimate output light from LEDs”).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tyrrell in view of Erickson, Soller, Heikenfeld, and Cronin, as applied to claim 4, further in view of Connor (US 9536449 B2 – previously cited).
Regarding claim 6, the sections of Tyrrell-Erickson-Soller-Heikenfeld-Cronin cited above disclose all the elements of the invention as described but fails to recite wherein the exercise device comprises an armband. Connor teaches a wearable device that helps a person monitor/manage nutritional intake (See Column 30, line 35-47 ), track exercise patterns, and track health goals (See Column 37, lines 50-52 and lines 58-67; Column 38, line 1) wherein the exercise device comprises an armband (See Column 82, lines 17-19, the device can be embodied in a smart arm band). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Tyrrell-Erickson-Heikenfeld, to comprise an armband, as taught by Connor, to provide a single wireless device that can monitor food consumption, food nutrients, caloric expenditure and types of calorie-expending activities (See Column 30, lines 62-67; Column 31, line 3) by using a chemical sensor (See Column 51, line 42) to measure saliva (See Column 45, lines 4-6) .
Claims 25-26 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Tyrrell in view of Erickson, Soller, Heikenfeld, and Cronin, as applied to claim 1, and further in view of Depa et al. (US 20170234858 A1 - previously cited), hereinafter Depa.
Regarding claim 25 and 26, Tyrrell-Erickson-Soller-Heikenfeld-Cronin fail to teach wherein the second light source comprises a second LED array configured to emit light at varying emission bandwidths to detect a feature of the bodily fluids, wherein the light of the second LED array is configured to be modulated and wherein a change of the at least one indicator is determined based on the modulated light of the LED array.
Depa teaches a bodily fluid testing system comprising a mobile device-based multi-analyte testing analyzer integrated with a chemical test strip reader (see ABSTRACT and para. [0001]). The mobile device-based analyzer has a plurality of integrated LED light sources that are configured to be modulated and detect analytes of the bodily fluid at different wavelengths/bandwidths (see para. [0047,0053,0060-62], “Since test strip reader 10 can contain a plurality of light sources 62 that can have different central wavelengths, it is particularly suitable for the analysis of multiple types of analytes” and “Following each blink in the blinking sequence, at 606, test strip reader 10 can send “COLOR SENSOR DATA” which it measured during that blink. This “COLOR SENSOR DATA” can contain the sensor data values”).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system Tyrrell-Erickson-Soller-Heikenfeld-Cronin, such that a second LED array is integrated in the mobile phone device and emits modulated light at varying emission bandwidths and detect analytes, as taught by Depa, because Tyrrell-Erickson-Soller-Heikenfeld-Cronin requires a second light source, but fails to disclose details, and Depa teaches an LED capable of emitting modulated light at different wavelengths can be used to analyze analytes in bodily fluids.
Therefore, the combination of Tyrrell-Erickson-Soller-Heikenfeld-Cronin-Depa, teaches wherein the change of the at least one indicator is determined based on the modified modulated light of the LED array of Tyrrell-Erickson-Soller-Heikenfeld-Cronin-Depa.
Regarding claim 30, Tyrrell teaches recording a light intensity of the at least one indicator (¶[0054-55,0169-172], “Intensities or values of these lines can optionally be determined from these regions” and “The average pixel intensity is determined”), but fails to teach wherein the mobile phone is configured to modulate light from the second light source.
Depa teaches a bodily fluid testing system comprising a mobile device-based multi-analyte testing analyzer integrated with a chemical test strip reader (see ABSTRACT and para. [0001]). The mobile device-based analyzer has a plurality of integrated LED light sources that are configured to be modulated and detect analytes of the bodily fluid at different wavelengths/bandwidths (see para. [0047,0053,0060-62], “Since test strip reader 10 can contain a plurality of light sources 62 that can have different central wavelengths, it is particularly suitable for the analysis of multiple types of analytes” and “Following each blink in the blinking sequence, at 606, test strip reader 10 can send “COLOR SENSOR DATA” which it measured during that blink. This “COLOR SENSOR DATA” can contain the sensor data values”).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system Tyrrell-Erickson-Soller-Heikenfeld-Cronin, such the mobile phone is configured to modulate light from the second light source, as taught by Depa, because Tyrrell-Erickson-Soller-Heikenfeld-Cronin requires a second light source but fails to disclose details, and Depa teaches an LED capable of emitting modulated light at different wavelengths can be used to analyze analytes in bodily fluids.
Response to Arguments
Applicant's arguments filed 05/19/2026 have been fully considered but they are not fully persuasive.
Applicant’s arguments with respect to rejection of claims under 35 U.S.C. 103 have been considered but are moot because amendment requires new ground of rejection in view of Soller.
Applicant argues that no reference cited teaches at least one secondary sensor integrated with the protective case comprising a hydration sensor, skin temperature sensor, humidity sensor, and a heart rate sensor, on page 6 of the Remarks. Examiner disagrees. Heikenfield teaches the use of hydration and skin temperature sensors, within the protective housing of the device, to improve predictions (¶[0038, 0096]). Additionally, Tyrrell teaches collection of additional data through the GPS device/sensor (fig. 1 and ¶[0145]). Moreover, in Tyrrell, since the GPS element is within the smart phone and the smart phone is within the protective case, then the GPS element is necessarily integrated with the protective case (fig. 1 and ¶[0145] of Tyrrell). Lastly, Cronin teaches a sensor strip analyte detecting system that is configured to measure heart rate (¶[0068]).
Therefore, Applicant’s arguments are unpersuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hall teaches a non-invasive device for continuously monitoring concentration levels of blood and tissue constituents has a polychromatic light source. The light source can emit light over a very wide bandwidth including light in the near infrared spectrum. The light from the light source passes first through a collimator, which is a collection of lenses that concentrate the light into a narrow parallel beam directed at the receptor. The receptor is shaped to receive within it that part of the subject, for example, a finger or ear of a human. US 5361758
Hwang teaches Apparatus and method for measuring concentration of a component of target material including a collimating unit that may be realized by connecting a plurality of lenses in series. US 20020169368
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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