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 arguments regarding the 35 USC 112(a) written description rejection have been considered and are not persuasive. Applicant argues on page 5 under Remarks, “While the HOT ZONES database and map and the Safety Circle are innovative concepts, anyone of skill in the art of AI training would know how to feed location data and data on elevated body temperature of individuals together with their location into an AI unit and how to prompt an AI unit to output a database and map tying together the location data and the body temperature data.” This is not found persuasive as “It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015)”, MPEP §2161.01. This is not an enablement rejection and the Examiner has not asserted one of ordinary skill in the art could not write such a program. Instead, the Examiner has noted that Applicant’s “specification does not sufficiently describe how the function is performed or the result is achieved.”(MPEP §2161.01) . The rejection now applies to Claim 11 in that claim 11 now requires an “artificial intelligence unit including neural network circuitry, at least the deep learning module, a search tree-based decision-making system…the artificial intelligence unit storing, recording and analyzing the vital signs data.” Applicant has set forth a functional result of analyzing vital signs data without setting forth any particular steps or algorithms indicating how that data is particularly analyzed with the AI unit having a deep learning module and a search tree-based decision-making system. Applicant is claiming a blackbox algorithm.
Applicant's amendment and arguments filed 7/15/2025 with respect to the rejection of Claim 1 as being anticipated by Landgraf et al. (2018/0256061) have been fully considered but they are not persuasive. Applicant has amended claim 1 to require a press-and-hold button that must be held down to measure vital sign data. The Examiner contends Landgraf likewise discloses this feature. Specifically, Landgraf discloses constructing a button on the back surface of the sensing device so that, when pressed, the sensors have improved contact with the user’s body for signal measurement (par. [0005]). Landgraf also states “…force applied by a user pressing button 120 during a measurement serves to press electrodes 110 and sensor 112 directly against the user's skin, thereby improving quality of contact with the user's skin. This configuration may be particularly helpful for applications in which a person is using wireless cardiac sensor 100 on themselves, in a one-handed mode of operation.” (par. [0022]). This clearly indicates that the measurement is taken when the user presses and holds the button. If a user lets go of the button, contact with the body is thereby reduced which would result in an inaccurate reading which is expressly counter to the disclosure of Landgraf.
The rejection of Claim 1 with respect to Heneghan has been made into a 103 rejection relying on Landgraf for the push-and-hold measurement configuration.
Applicant’s amendment to Claim 11, Applicant has amended claim 11 to include the limitations of Claim 12. The “wherein” statement added to Claim 11 is simply the traditional framework of a deep learning network. Heneghan et al. (US Patent 11,191,466) discloses this feature in col. 17, lines 1-5). The Examiner also notes Chauhan, “A Review on Conventional Machine Learning vs Deep Learning” provides the basic architecture of a Deep Learning network in Fig. 6 in which an input layer and output layer are separated by multiple hidden layers.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11, 13-17 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As noted in MPEP §2161.01, computer implemented functional limitations “may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.”
Claim 11 states “ the artificial intelligence unit including neural network circuitry, at least the deep learning module, a search tree-based decision-making system…the artificial intelligence unit storing, recording and analyzing the vital signs data.”.
Applicant’s specification fails to provide the details/functional steps necessary to illustrate how the AI/deep learning model/ search tree-based decision-making system actually analyzes the vital signs data. There is not any discussion on the particular training of the model; construction of the model; or any other details that would allow one of ordinary skill in the art to understand how the deep learning model produces the claimed results of vital sign analysis. Fig. 11A, B show a box saying deep learning model but again does not provide any of the necessary details described above. Par. [0062] of PGPUB 2023/0255484 (which is the publication of the present application) states “A deep learning network secures, controls, and updates the world's thermal map database 68 in real time to provide global, thermal, HOT ZONES alerts. The device and system define a “Safety Circle” to alert the user via audible and visual alerts about getting close to a region with high temperature people. Exemplary embodiments allow the user to define his or her “Safety Circle” perimeter as well. The user can define a proximity safe zone via the mobile app or work with the system defaults. The “Safety Circle” is a proximity alert to notify and alert users in case they are getting closer to a “HOT ZONE”, meaning people with high body temperature, i.e., potentially ill individuals. Advantageously, the proximity alerts enable users to avoid HOT ZONES, which contain many potentially ill people and should be avoided to combat viruses.” This is the most detailed description in the specification and only defines the deep learning model in terms of functional results and not how the model is constructed and/or produces these results. The same applies to the search tree-based decision-making system and the control logic claimed. These are essentially “black box” algorithms that are not explained or described sufficiently to meet the written description requirement for computer-implemented functional limitations.
Claims 13-17 and 21 inherit the same issues from Claim 11. There are not any details indicating how these results are achieved or generated.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Landgraf et al. (2018/0256061).
Regarding Claim 1, Landgraf discloses a device having a housing with front and back sides, wherein the front side has a circular portion 120 with a pressable button in the center (Fig. 2; par. [0022]); an electronic circuit within the housing for measuring ECG data (Abstract; Fig. 4, ref. 144) to derive heart rate (par. [0039]). Regarding taking measurements while the button is pressed and held, Landgraf discloses constructing the button on the back surface of the sensing device so that, when pressed, the sensors have improved contact with the user’s body for signal measurement (par. [0005]). Landgraf also states “…force applied by a user pressing button 120 during a measurement serves to press electrodes 110 and sensor 112 directly against the user's skin, thereby improving quality of contact with the user's skin. This configuration may be particularly helpful for applications in which a person is using wireless cardiac sensor 100 on themselves, in a one-handed mode of operation.” (par. [0022]). This clearly indicates that the measurement is taken when the user presses and holds the button. If a user lets go of the button, contact with the body is thereby reduced which would result in an inaccurate reading which is expressly counter to the disclosure and intent of Landgraf.
Regarding Claim 8, Landgraf discloses wireless telemetry 136 for communicating the vital signs to another device 400 (Fig. 4).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Stivoric et al. (2008/0171919) in view of Heneghan et al. (US Patent 11,191,466), further in view of Landgraf et al. (2018/0256061).
Regarding Claim 1, Stivoric discloses a device for measuring vital signs having a housing with front and back sides and a push button 1020 on the front side inside of a circular area (Fig. 28; par. [0172]). Stivoric also discloses electronic sensing circuitry for detecting heart rate, body temperature, blood oxygenation and blood pressure (par. [0067]). Stivoric is silent regarding centering the button in the center of the circular portion and is silent regarding measuring and recording vital signs while the button is being held. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to place the button wherever is desired or expedient from a design standpoint, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Alternatively, Heneghan provides equivalents to a push button on a watch structure such as a touch screen (col. 19, lines 60-63). Therefore, because push buttons and touchscreen buttons were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute the touch screen button for the manual push button. This modification would place the touch input in the center of the circular portion (or close thereto), wherein any such positional changes would again be a matter of obvious design choice.
Additionally, regarding the press-and-hold feature of signal measurement, Landgraf discloses constructing a button on the back surface of the sensing device so that, when pressed, the sensors have improved contact with the user’s body for signal measurement (par. [0005]). Landgraf also states “…force applied by a user pressing button 120 during a measurement serves to press electrodes 110 and sensor 112 directly against the user's skin, thereby improving quality of contact with the user's skin. This configuration may be particularly helpful for applications in which a person is using wireless cardiac sensor 100 on themselves, in a one-handed mode of operation.” (par. [0022]).” Stivoric has the same feature of having the pressable button (such as button 470) on the opposite site of the sensing surface contacting the skin (Fig. 12) and therefore would clearly benefit from taking measurements only while improved skin contact is effectuated through pressing of the button. Therefore 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 device in the Stivoric and Heneghan combination to include measuring during the pressing and holding of a button, as taught and suggested by Landgraf, for the purpose of improving quality of contact with the user's skin during measurement.
In regard to Claim 3, Stivoric discloses including artificial intelligence in the device (par. [0232]).
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Stivoric et al. (2008/0171919) in view of Heneghan et al. (US Patent 11,191,466), further in view of Chauhan, “A Review on Conventional Machine Learning vs Deep Learning”.
Regarding Claims 11 and 13, Stivoric discloses a device for measuring vital signs having a housing with front and back sides and a push button 1020 on the front side inside of a circular area (Fig. 28; par. [0172]). Stivoric also discloses electronic sensing circuitry for detecting heart rate, body temperature, blood oxygenation and blood pressure (par. [0067]). Stivoric further discloses including artificial intelligence in the device wherein the AI can use decision tree models among others (par. [0232]). Stivoric is silent regarding centering the button in the center of the circular portion and is silent regarding a deep learning network having and input layer, output layer and hidden layers therebetween. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to place the button wherever is desired or expedient from a design standpoint, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Alternatively, Heneghan provides equivalent alternatives to a push button on a watch structure such as a touch screen (col. 19, lines 60-63). Therefore, because push buttons and touchscreen buttons were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute the touch screen button for the manual push button. This modification would place the touch input in the center of the circular portion (or close thereto), wherein any such positional changes would again be a matter of obvious design choice.
Furthermore, Chauhan discloses utilizing deep learning models instead of conventional models to provide the benefit of allowing data to be processed in its original form and simplifying finding the solution of complex and non-linear functions (see p. 349, “III. Deep Learning”). Therefore 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 device in the Stivoric and Heneghan combination to include deep learning as part of the AI unit, as taught and suggested by Chauhan, for the purpose of allowing data to be processed in its original form and simplifying finding the solution of complex and non-linear functions.
Claim(s) 1-3, 5-10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Heneghan et al. (US Patent 11,191,466) in view of Landgraf et al. (2018/0256061).
Regarding Claims 1, 6 and 7, Heneghan discloses a vital signs monitoring device having a housing with front (Fig. 1A) and back sides (Fig. 1B) and a button on the front surface of the housing, specifically in the form of a capacitive touch screen sensor integrated into the display (col. 4, lines 20-25; see also ref. 508 in Fig. 5; col. 19, lines 60-63). Heneghan further discloses an electronic circuit for sensing body temperature, heart rate and blood oxygenation (col. 15, lines 1-30; see also sensors 516 in Fig. 5; col. 20, line 27 – col. 23, line 20, wherein the various derived parameters from the sensors are discussed). While Heneghan discloses a button on the touchscreen can be used to initiate measurements, Heneghan is silent regarding measuring and recording vital signs while the button is being held and the button being centered on a circular portion (such as a circle that is displayed on the touchscreen).
However, regarding the press-and-hold feature of signal measurement, Landgraf discloses constructing a button on the back surface of the sensing device so that, when pressed, the sensors have improved contact with the user’s body for signal measurement (par. [0005]). Landgraf also states “…force applied by a user pressing button 120 during a measurement serves to press electrodes 110 and sensor 112 directly against the user's skin, thereby improving quality of contact with the user's skin. This configuration may be particularly helpful for applications in which a person is using wireless cardiac sensor 100 on themselves, in a one-handed mode of operation.” (par. [0022]).” Heneghan has the same feature of having the pressable button on the opposite site of the sensing surface contacting the skin and therefore would clearly benefit from taking measurements only while improved skin contact is effectuated through pressing of the button. Therefore 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 device in the Heneghan reference to include measuring during the pressing and holding of a button, as taught and suggested by Landgraf, for the purpose of improving quality of contact with the user's skin during measurement.
Additionally, it would have been an obvious matter of design choice to make the different portions of the touchscreen button of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. A pressable button centered on a square, oval, ellipse, etc. on the display screen would provide the predictable result of allowing the button to actuate monitoring. The shape of the interactive component on the screen is a matter of design preference and does not change the operation of the button.
In regard to Claim 2, Heneghan discloses a button integrated into the touch screen but does not provide any particular size for the button It would have been an obvious matter of design choice to make the button cover half of the touch screen (i.e. the front side), since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
With regard to Claim 3, Heneghan discloses including an artificial intelligence unit (col. 11, lines 24-46; col. 16, lines 50-65).
Regarding Claim 5, Heneghan disclose a battery 512 within housing for powering all components, such as the button (Fig. 5; col. 19, lines 53-55).
In regard to Claim 8, Heneghan discloses wireless communication capability 518 to another device 520 (Fig. 5).
With regard to Claim 9, Heneghan discloses location detection (col. 15, lines 19-20; col. 19, lines 18-20).
Regarding Claim 10, Heneghan discloses the system can run an application on a mobile device and use web-based capabilities to send and receive data over a network (col. 7, line 55 – col. 8, line 5).
Regarding Claim 20, Heneghan discloses the screen can be a touch screen, see col. 18, lines 65-67 (the entire front face of the wearable device is a screen (see Fig. 1D)). Therefore, the entire front face can be a pressable button a user can interact with. Alternatively, it would have been an obvious matter of design choice to make the button of whatever size is desired or expedient, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Applicant likewise provides various options of button size and does not assert any criticality or unexpected results with an embodiment having a button the size of the entire front face. It is just one of a myriad of obvious options (see par. [0046] of PGPUB 2023/0255484, which is the publication of the present application.)
Claim(s) 11, 14-17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Heneghan et al. (US Patent 11,191,466) in view of Landgraf et al. (2018/0256061) further in view of Chauhan, “A Review on Conventional Machine Learning vs Deep Learning”.
Regarding Claims 11, 15 and 16, Heneghan discloses a vital signs monitoring device (in the form of a wrist-worn device which can be considered a bracelet) having a housing with front (Fig. 1A) and back sides (Fig. 1B) and a button on the front surface of the housing, specifically in the form of a capacitive touch screen sensor integrated into the display (col. 4, lines 20-25; see also ref. 508 in Fig. 5; col. 19, lines 60-63). Heneghan further discloses an electronic circuit for sensing body temperature, heart rate and blood oxygenation (col. 15, lines 1-30; see also sensors 516 in Fig. 5; col. 20, line 27 – col. 23, line 20, wherein the various derived parameters from the sensors are discussed). Furthermore, Heneghan discloses including an artificial intelligence unit which could include a deep learning network (col. 11, lines 24-46; col. 16, lines 50-65; col. 17, lines 1-4). The Examiner notes a deep learning network is typically constructed of an input layer, output layer and multiple hidden layers therebetween, as evidenced by Chauhan, see Fig. 6.
While Heneghan discloses a button on the touchscreen can be used to initiate measurements, Heneghan is silent regarding the button being centered on a circular potion (such as a circle that is displayed on the touchscreen). It would have been an obvious matter of design choice to make the different portions of the touchscreen button of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. A pressable button centered on a square, oval, ellipse, etc. on the display screen would provide the predictable result of allowing the button to actuate monitoring. The shape of the interactive component on the screen is a matter of design preference and does not change the operation of the button.
Regarding Claim 14, Heneghan discloses memory 504 for storing vital signs data (Fig. 5; col. 21, line 60-col. 22, line 14).
In regards to Claim 17, Heneghan discloses the battery can be recharge wirelessly (Fig. 5; col. 19, lines 53-57). and that data collection can be activated via a button (col. 4, lines 20-25; see also ref. 508 in Fig. 5; col. 19, lines 60-63), therefore meeting the power management requirement where the sensing components are not active (in sleep mode) unless activated by the button.
With regard to Claim 21, the Examiner notes the claims are device claims whereas Applicant is claiming an intended use of said device without further defining any particular structure of the claim. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The device of Heneghan has a display and is capable of connecting to a remote server and receiving data form said server (see Fig. 5). Therefore it is capable of receiving data and displaying data form a remote server which is all that would be required structurally to enact the functional limitations of the claim.
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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/ALLEN PORTER/Primary Examiner, Art Unit 3796