DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This action is in response to the remarks filed on 12/09/2025.
The amendments filed on 12/09/2025 have been entered. Accordingly claims 1-1-5, 7-12 and 14-20 remain pending. Claims 6, and 13 are cancelled. Claims 10, and 15-20 were prevouisly withdrawn pursuant to the restriction requirement.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-5, 7-9, 11-12 and 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Saroka et al (WO2009031149A2 the citations below are from the equivalent of US20110160549) in view of Turnquist et al (US20120053445A1) and Bouton et al (US 20070123770).
Regarding claim 1, Saroka teaches an adhesive patch for attaching at least one EM probe to a subject's body (“wearable monitoring apparatus for monitoring … comprises at least one transducer configured for delivering electromagnetic (EM) radiation to said internal tissue and intercepting a reflection of said EM radiation” abst; “wearable monitoring apparatus 100 that is attached to the body of a user” [0098]), the adhesive patch (“ the monitoring apparatus may be wearable, as shown at 100, and/or designed …for allowing the replacement and/or fixing of a component due to wearing-off of the package, an adhering material used for attaching the monitoring apparatus or a portion thereof to the body” [0235]) comprising:
an EM probe having a cup shaped cavity with an opening and an interior volume, and at least one EM element located in said interior volume (“housing, which is designed to contain all the integral parts of the monitoring apparatus 400, including a processing unit and one or more EM transducers which are designed to implement monitoring methods” [0103]; the housing interpreted as “cup shaped” since no specifics are claimed and due to the fact that the housing designed to contain all the integral parts of the monitoring apparatus shown in e.g., figs 1, 4, 7 and 8);
wherein the cup shaped cavity is made of a conductive material (“electrically conductive material, such as metal and electrically conductive polymeric resins. Optionally, the rounded biconic slot 355 forms two round cones which are connected with two strips, such as extended strips, which may be supported by the dielectric substrate” [0162]);
a flexible planar member that dissipates EM energy, wherein said flexible planar member is configured to conform to a contour of the subject's body (“a dielectric substrate 354, which is optionally made of a flexible material and supports the construction of these components. The dielectric substrate 354 contains any flexible or non-flexible composite material, such as a polymeric film, paper, a fabric band, a rubber band, and a leather band” [0161]) and comprising at least one layer of radiation absorbing material (“EM radiation and an arrangement of at least one lumped absorbing element” [0076]);
that dissipates EM energy and at least one opening formed within the at least one layer of said radiation absorbing material and said planar member, wherein said EM probe is positioned above said at least one opening of planar member (“arrangement having a minimal absorption area absorbing at least 75% of the energy absorbed by the arrangement. The first distance is the smallest distance between a geometric center of the printed metallic field transducer and a perimeter encircling a transmission area of the printed metallic field transducer required for transmitting 50% of the energy of the EM radiation in the lowest end of a used frequency band with respect to infinite size transducer. The distance of each point within the minimal absorption area from the geometric center is at least the first distance.” [0076]); and
at least one layer of an adhesive attached directly over at least part of a bottom surface of the planar member for adhering the planar member to the subject's skin (“the monitoring apparatus is designed as disposable device which is designed to replace and/or being replaced by a similar monitoring apparatus and/or with a placement unit that allows repositioning it after performing a maintenance activity…the monitoring apparatus may be wearable, as shown at 100, and/or designed to be taken off intermittently, for example, for convenience reasons …an adhering material used for attaching the monitoring apparatus or a portion thereof to the body,” [0235]),
wherein said at least one EM element is adapted to emit EM radiation via said interior volume and via said at least one opening formed within the at least one layer of said radiation absorbing material and said planar member to allow the propagation of EM radiation originated from the at least one EM element via the at least one opening from one side of the planar member to the other (“The electromagnetic energy that is not emitted from the EM antenna 350 is absorbed by the dielectric substrate 354” [0164]), and
wherein the EM radiation is selected from a group consisting of radiofrequency (RF) radiation and microwave (MW) radiation (“the EM transducer is designed to transmit one or more stable frequency continuous wave (CW) radio signals and then to receive the reflection thereof from internal tissues and/or objects. The one or more CW radio signals may be transmitted, simultaneously or sequentially. For example, the CW radio signals may be transmitted in frequencies such as 900 MHz and 2.5 GHz” [0145]; “beaming the microwave from one transducer and capturing the reflections from another transducer” [0245]);
wherein the planar member is structurally distinct from the EM probe and is configured to receive the EM probe (“EM antenna 350 comprises resistors 351, which are optionally discrete resistors, a field transducer 352, a matching construction 353 and a dielectric substrate 354, which is optionally made of a flexible material and supports the construction of these components. The dielectric substrate 354 contains any flexible or non-flexible composite material, such as a polymeric film, paper, a fabric band, a rubber band, and a leather band” [0161]).
Although it is apparent that Saroka teaches all the broad claimed invention as shown above, if one argues that the housing of Saroka is not a “cup shaped cavity” (which the office does not concede), in an effort to provide compact prosecution, the Turnquist reference is brought in to show particularly “cup shaped cavity” as detailed below.
In the same field of endeavor, Turnquist teaches, as shown in throughout the reference and in particular, antenna the that is shielded within an enclosure, which can have an open end to receive signals from a patient via a matching layer that is positioned at the open end of the enclosure. A rim of shielding material encompasses the open end of the enclosure so as to reduce stray electromagnetic interference, such as when the assembly is used to monitor a deep tissue temperature (abst).
FIG. 5 illustrates a radiometer 302 positioned within a cavity 304 of a case, cup, enclosure, or shield 306 to the shielding 167 discussed above to receive signals from the antenna 204 and can be used to sense or otherwise obtain a temperature reading based on the signals. The shield 306 can encompass at least a portion of the radiometer 302 so as to shield the radiometer 302 from stray electromagnetic radiation at an exterior of the patient. The shield 306 can comprise any suitable conductive material or materials, such as a metal (e.g., copper), and may be formed in any suitable manner (e.g., stamped, deep drawn) [0126].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with cup shaped cavity as taught by Turnquist because it helps to provide a diagnosing or treating diseases with thermal energy which does not burn or otherwise discomfort patients would also be desirable ([0010] of Turnquist).
Further, the above combination does not point out the specifics of flexible planar member formed entirely through the at least one layer; and receive the EM probe above the at least one opening.
However, in the same field of endeavor, Bouton teaches the sensor device includes an RF cable assembly, at least one flexible circuit board assembly for transmission of energy to and from the antenna elements such that electromagnetic energy can be transmitted and electromagnetic energy can be received from at least two of the plurality of antenna elements and carried by a single transmission trace within the flexible circuit board [0023]. The sensor device can further include an attachment mechanism to operably attach the sensor device to the tissue of the body. The attachment mechanism can include an adhesive portion defining a cutout region generally coextensive with the opening of the housing. The adhesive portion has one side thereof coated with a first adhesive adapted to removably attach to the tissue and an opposite side thereof coated with a second adhesive adapted to attach to a bottom surface of the housing. The attachment mechanism can further include a release band affixed to a perimeter of the adhesive portion. In one embodiment, the first adhesive is adapted to facilitate removal of the attachment mechanism from the patient. For example, the first adhesive can provide less adhesion than the second adhesive [0024]. The tape can, however, contain, for example, a material such as a ceramic material that yields a thin structure with low electromagnetic loss and an impedance that matches the surface tissue. This embodiment can provide better coupling of the microwave energy between the antennas and the tissue to increase detection sensitivity while decreasing leaked energy and thereby decreasing any palpation/motion artifact [0084].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with as taught by Bouton because it is desirable to develop improved devices, systems and methods for detecting changes in fluid levels in tissue, and particularly, for detecting elevated or otherwise abnormal levels of fluids in living tissue for example, as a result of edema, hematoma or extravasation ([0020] of Bouton).
Regarding claim 3, Saroka teaches all the claimed limitations except for one or more layers (104) of a material for absorbing EM radiation covering the external sides of the cup shaped cavity (103) which do not face the interior volume.
However, in the same field of endeavor, Turnquist teaches, as shown in throughout the reference and in particular, antenna the that is shielded within an enclosure, which can have an open end to receive signals from a patient via a matching layer that is positioned at the open end of the enclosure. A rim of shielding material encompasses the open end of the enclosure so as to reduce stray electromagnetic interference, such as when the assembly is used to monitor a deep tissue temperature (abst).
PNG
media_image1.png
387
613
media_image1.png
Greyscale
As shown in figs. 5-7 and also re-produced exemplary FIG. 5 illustrates above layers of a material for absorbing EM radiation covering the external sides of the cup shaped cavity which do not face the interior volume along with a radiometer 302 positioned within a cavity 304 of a case, cup, enclosure, or shield 306 to the shielding 167 discussed above to receive signals from the antenna 204 and can be used to sense or otherwise obtain a temperature reading based on the signals. The shield 306 can encompass at least a portion of the radiometer 302 so as to shield the radiometer 302 from stray electromagnetic radiation at an exterior of the patient. The shield 306 can comprise any suitable conductive material or materials, such as a metal (e.g., copper), and may be formed in any suitable manner (e.g., stamped, deep drawn) [0126].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with layers of a material for absorbing EM radiation covering the external sides of the cup shaped cavity which do not face the interior volume as taught by Turnquist because it helps to provide a diagnosing or treating diseases with thermal energy which does not burn or otherwise discomfort patients would also be desirable ([0010] of Turnquist).
Regarding claim 4, Saroka teaches all the claimed limitations except for mechanical connector for securing at least one EM probe to the planar member at a position overlapping the at least one opening.
PNG
media_image2.png
367
693
media_image2.png
Greyscale
However, in the same field of endeavor, Turnquist teaches, as shown in throughout the reference and in particular, as shown in re-produced exemplary FIG. 8 illustrates above the connection system 650 comprises a connection interface 651 of the reusable unit 610 that includes a lower end of the shield 606, which has a different configuration than the lower end of the shield 306. In particular, in the illustrated embodiment, the lower end of the shield 606 does not include a flange. Rather, the outer surface of the shield 606 can be substantially cylindrically shaped, and may be smooth. The connection interface 652 of the disposable unit 612 includes the resilient fingers 641, which define a substantially cylindrical shape that has a slightly smaller diameter than the outer diameter of the lower end of the shield 606. Accordingly, advancement of the lower end of the shield 606 into contact with the resilient fingers 641 forces the fingers 641 outward, which gives rise to a restorative force in the fingers 641 that tends to grip the shield 606 and hold it in fixed relation relative to the disposable unit 612. The connection interfaces 651, 652 can readily disengage from each other upon application of suitable separation forces on the reusable and disposable units 610, 612. [0152].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with mechanical connector for connecting at least one EM probe to the planar member at a position overlapping the opening as taught by Turnquist because it helps to provide a diagnosing or treating diseases with thermal energy which does not burn or otherwise discomfort patients would also be desirable ([0010] of Turnquist).
Regarding claim 5, Saroka teaches all the claimed limitations except for wherein the at least one mechanical connector is configured for detachably connecting the at least one EM probe to the planar member at a position overlapping the at least one opening of the planar member.
PNG
media_image2.png
367
693
media_image2.png
Greyscale
However, in the same field of endeavor, Turnquist teaches, as shown in throughout the reference and in particular, as shown in re-produced exemplary FIG. 8 illustrates above the connection system 650 comprises a connection interface 651 of the reusable unit 610 that includes a lower end of the shield 606, which has a different configuration than the lower end of the shield 306. In particular, in the illustrated embodiment, the lower end of the shield 606 does not include a flange. Rather, the outer surface of the shield 606 can be substantially cylindrically shaped, and may be smooth. The connection interface 652 of the disposable unit 612 includes the resilient fingers 641, which define a substantially cylindrical shape that has a slightly smaller diameter than the outer diameter of the lower end of the shield 606. Accordingly, advancement of the lower end of the shield 606 into contact with the resilient fingers 641 forces the fingers 641 outward, which gives rise to a restorative force in the fingers 641 that tends to grip the shield 606 and hold it in fixed relation relative to the disposable unit 612. The connection interfaces 651, 652 can readily disengage from each other upon application of suitable separation forces on the reusable and disposable units 610, 612. [0152].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with wherein at least one of the at least one mechanical connector is configured for detachably connecting the at least one EM probe to the planar member at a position overlapping the at least one opening of the planar member as taught by Turnquist because it helps to provide a diagnosing or treating diseases with thermal energy which does not burn or otherwise discomfort patients would also be desirable ([0010] of Turnquist).
Regarding claim 7, Saroka teaches the at least one layer of adhesive extends below at least one of the at least one opening of the planar member (“the monitoring apparatus may be wearable, as shown at 100, and/or designed to be taken off intermittently, for example, for convenience reasons and/or for allowing the replacement and/or fixing of a component due to wearing-off of the package, an adhering material used for attaching the monitoring apparatus or a portion thereof to the body” [0235]).
Further Turnquist also teaches positioner 166 may include an adhesive portion for temporarily affixing positioner 166 to an individual being treated [0085]. a fixture 121 may be adhesively applied to the body 70. With reasonable placement, normal contours of the body may direct the focused antenna 162 to the correct anatomic regions [0087]. Quick and/or easy attach-and-release mechanisms may be used, such as snap-fit, magnetic, hook-and-pile, temporary adhesive, or other suitable fastening arrangements [0129].
Regarding claim 8, Saroka teaches a plurality of openings formed within the at least one layer of radiation absorbing material to allow the propagation of EM radiation via at least a plurality of the plurality of openings from one side of the planar member to the other (“The wearable monitoring apparatus comprises at least one transducer configured for delivering electromagnetic (EM) radiation to an internal tissue and intercepting a reflection of the EM radiation” [0055]).
Further Turnquist also teaches the shield 306 and other components of the assembly 300 are substantially cylindrical, or circularly symmetrical about a vertical axis, but other suitable arrangements are also possible (e.g., rectangular). The shield 306 can define an opening 307 at a lower end thereof through which electromagnetic energy can enter or exit the shield 306 [0126]. An opening is provided in the adhesive layer 334 to permit direct contact between the skin of the patient and at least a portion of the impedance matching layer 330. In other or further embodiments, one or more openings or spaces in the adhesive layer 334 are present at which the shield extension 320 may be in direct contact with the skin of the patient, or at which the patient's skin may be exposed to the matching element and/or shield extension without an intervening adhesive layer [0138].
Regarding claim 9, Saroka teaches at least one connector for connecting one EM probe to the planar member at a position overlapping at least two of the plurality of openings (“The wearable monitoring apparatus comprises at least one transducer configured for delivering electromagnetic (EM) radiation to an internal tissue and intercepting a reflection of the EM radiation” [0055]).
Further Turnquist also teaches the shield 306 and other components of the assembly 300 are substantially cylindrical, or circularly symmetrical about a vertical axis, but other suitable arrangements are also possible (e.g., rectangular). The shield 306 can define an opening 307 at a lower end thereof through which electromagnetic energy can enter or exit the shield 306 [0126]. An opening is provided in the adhesive layer 334 to permit direct contact between the skin of the patient and at least a portion of the impedance matching layer 330. In other or further embodiments, one or more openings or spaces in the adhesive layer 334 are present at which the shield extension 320 may be in direct contact with the skin of the patient, or at which the patient's skin may be exposed to the matching element and/or shield extension without an intervening adhesive layer [0138].
Regarding claim 11, Saroka teaches the adhesive is attached over at least part of a surface covering 70% or less of the patch contact surface (“an adhering material used for attaching the monitoring apparatus or a portion thereof to the body” [0235]).
Further Turnquist also teaches the shield 306 and other components of the assembly 300 are substantially cylindrical, or circularly symmetrical about a vertical axis, but other suitable arrangements are also possible (e.g., rectangular). The shield 306 can define an opening 307 at a lower end thereof through which electromagnetic energy can enter or exit the shield 306 [0126]. An opening is provided in the adhesive layer 334 to permit direct contact between the skin of the patient and at least a portion of the impedance matching layer 330. In other or further embodiments, one or more openings or spaces in the adhesive layer 334 are present at which the shield extension 320 may be in direct contact with the skin of the patient, or at which the patient's skin may be exposed to the matching element and/or shield extension without an intervening adhesive layer [0138].
In addition, it would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with adhesive surface covering fort desired amount since it is within knowledge of the skilled artisan as a design choice.
Regarding claim 12, Saroka teaches wherein at least part of the surface of the planar member is an adhesive-free portion, and wherein at least part of the adhesive-free portion is covered by a skin soothing agent (“monitoring apparatus 100 is used for improving a titration and/or a prognosis process. For example, angio-genesis medication, chemotherapy and/or irradiation treatments may be titrated optimized according to readings of the wearable monitoring apparatus 100.” [0121]; “wearable monitoring apparatus 100 comprises multiple front end sensors which are used for monitoring, optionally dynamically, the spreading of the inflammation in one or more areas, optionally in response to an antibiotic medication treatment.” [0123]).
Further Turnquist also teaches the bolus 436 may comprise any suitable material, such as, for example, a liquid, gel, or compressible foam. The bolus 436 may be capable of readily changing shape so as to maintain good contact between the skin on one side [0146]. matching material 731 can be used with the assembly 700. In the illustrated embodiment, the matching material 731 comprises one or more of a gel, jelly, or semi-gelatin material that can coat, cover, or otherwise contact a bottom end of the radiometer system 705 and can further coat, cover, or otherwise cover a portion of the skin of a patient that is encompassed by the conducting ring 740 [0156].
Regarding claim 14, Saroka teaches wherein the patch is configured to be worn for a period of time of 24 hours or longer (“ the wearable monitoring apparatus 100 may be used for performing such monitoring for hospitalized and non hospitalized users during a monitoring period which is longer than 1, 2, 4, 8, 12, 16, 20 and 24 hours, days, weeks, mouths, and/or years” [0105] “The wearable monitoring apparatus 100 may function as an independent monitoring device, as a sensing unit of a monitoring system, and/or as a monitoring device that communicates with a central computing unit, such as the user management unit 102, during a period which is longer than 1, 2, 4, 8, 12, 16, 20 and 24 hours, days, weeks, mouths, and/or years, in an intermittent or continuous measurement manner” [0109]).
Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Saroka in view of Turnquist and Bouton as applied to claim 1 above and further in view of Hoppe et al (WO2011076871).
Regarding claim 2, the above noted combination teaches all the claimed limitations except for volumetric resistivity is 10^-3 Ohm meter.
However, in the same field of endeavor, Hoppe teaches radiation absorbing
material is volumetric resistivity greater than 10-3 Ohm meter [0034].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and device of above noted combination in view of Hoppe with radiation absorbing material is volumetric resistivity greater than 10-3 Ohm meter as taught by Hoppe because it would provide an improved sensor for monitoring of an individual ([0007] of Hoppe).
Response to Arguments
Applicant’s arguments 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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERKAN AKAR whose telephone number is (571)270-5338. The examiner can normally be reached 9am-5pm M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at 571-272 7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SERKAN AKAR/ Primary Examiner, Art Unit 3797