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 filed 12/16/2025 have been fully considered but are not persuasive.
Applicant argues, “Jones does not teach or suggest the three discrete functional layers required by the claims. Jones discloses only a single LED PCB with optional surface coverings or interface materials. None of these structures correspond to a separate resistive heating mesh or a distinct thermal insulation module.”
Examiner respectfully disagrees. Jones discloses a device [0045] for transferring heat and infrared energy [0045] with dynamic temperature control [0032, 0093] and homogeneous heat distribution [0195], comprising:
a first layer [0101] comprising a PCB [0101]
a second layer comprising a heating module ([0101-0102]: combination of LED array, heat-conductive material around each LED, and heatsink are interpreted as a second layer comprising a heating module because LED array generates heat [0046] and then the head-conductive material and heatsink transfer heat) comprising a resistance mesh ([0085]: mesh baseplate may be connected to the LEDs as part of the baseplate structure)
a third layer ([0089]: LED array) comprising a thermal insulation module ([0089]: LED array acts as an insulator between heat producing LED arrays) formed of a heat-directing material ([0089]: contains silicone and has a heat sink to direct heat; [0084, 0086-0087]); and
a core (fig. 2: entire portion of soft silicone lip) that
comprises the elastomer ([0089]: core would include the vertical silicon polymer) and
encapsulates the first layer, the second layer, and the third layer (fig. 2: core would contain the first layer of the PCB, and then the heating module on top, and then the LED array, see above).
Furthermore, although Jones discloses a single LED PCB, under broadest reasonable interpretation, the limitations “a first layer”, “a second layer”, and “a third layer” are interpreted as different layers of the LED PCB. It is not required that each of the layers comprise their own LED PCB.
Additionally, Jones teaches a second layer comprising a resistance mesh and a third layer comprising a thermal insulation module, as discussed above.
Applicant argues “None of the references cited for the prior rejection teach or suggest manufacturing these three layers, placing them in this sequence into a mold, or encapsulating them together to form a core.”
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding the limitations,
“components comprising:
a first layer comprising a PCB with an LED light module;
a second layer comprising a heating module comprising a resistance mesh configured to receive electrical energy to generate heat; and
a third layer comprising a thermal insulation module (130)”,
see above, where it’s inherent that components part of the core would be manufactured.
Although Jones fails to disclose “a manufacturing process of a device to transfer heat and infrared energy with dynamic temperature control and homogeneous heat distribution
b) preparing a core mold configured to receive the components for forming the core of the applicator module;
c) preparing a pad mold;
d) placing the PCB with the LED light module (110) into the core mold;
e) subsequently placing the heating module (120) into the core mold;
f) then placing the thermal insulation module (130) into the core mold;
g) pouring an amount of elastomer into the core mold sufficient to encapsulate the components to form the core (140);
h) waiting for vulcanization and removing the core (140) from the core mold;
i) placing the core into the pad mold;
j) pouring the amount of elastomer into the pad mold sufficient to form the applicator module; and
k) waiting for vulcanization and removing the applicator module from the pad mold”,
Alemany Negrete teaches a manufacturing process [0008, 0021], comprising the following stages
b) preparing a core mold [0008-0009] configured to receive components ([0046]: inner portions of the mold) for a core of an applicator module ([0009]: upper mould is the applicator module), which contains structural elements to secure each component in place ([0009]: fasteners secure mould parts together which would secure the components (i.e. inner portions of the mold [0046]) in the mould),
wherein the mold contains a series of fastening elements (which can be magnets or presses) [0009] strategically placed to secure and compact the components in the vulcanization process ([0009-0010]: vulcanized silicone mould includes fasteners to secure the two mould parts together and would also be secured during the vulcanization process),
said structural elements separable from the core once an elastomer is vulcanized ([0009]: vulcanized silicon mould is separated into two parts);
c) preparing a pad mold [0012], which will receive the core ([0014]: distribution chamber i.e. core is part of the upper mould [0044]);
d) opening the core mold to place the components ([0044]: melted material inlet receives injected material);
h) secure and compact all components ([0046]: fasteners used to secure the inner components of the mold; fig. 6: 2);
i) preparing the elastomer and submitting it to a vacuum chamber for air removal ([0025-0027]: air is removed while elastomer (inner part of mould) is being prepared);
j) pouring an exact amount of elastomer necessary to form a core ([0020]: elastomer can be used as the injected material; inherent that the exact amount of elastomer would be used);
k) waiting for vulcanization and disassembling the core ([0048]: vulcanized silicone mould is used and then the injection is inserted afterwards, and then the mould is separated after being filled and cooled so there core would be disassembled after vulcanization)
l) assembling the core in the pad mold ([0020-0021]: pouring the injected material into the mould is considered as assembling the core in the pad mold);
m) preparing the elastomer and submitting it to the vacuum chamber for air removal [0026];
n) pour the exact amount of elastomer needed to form the pad ([0048]: pad is considered to be one of the items generated in the cavities which would inherently require the exact amount of elastomer to be formed);
o) waiting for vulcanization and removing the pad ([0048]: pad i.e. part of the items generated in the cavities occurs after the silicone mould is vulcanized).
Alemany Negrete further teaches that the disclosed manufacturing process allows for economical and fast production of flexible moulds [0006], and that is it valid for moulding any component such as electrical components [0006].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the device taught by Jones, to provide wherein a manufacturing process of a device to transfer heat and infrared energy with dynamic temperature control and homogeneous heat distribution b) preparing a core mold configured to receive the components for forming the core of the applicator module; c) preparing a pad mold; d) placing the PCB with the LED light module (110) into the core mold; e) subsequently placing the heating module (120) into the core mold; f) then placing the thermal insulation module (130) into the core mold; g) pouring an amount of elastomer into the core mold sufficient to encapsulate the components to form the core (140); h) waiting for vulcanization and removing the core (140) from the core mold; i) placing the core into the pad mold; j) pouring the amount of elastomer into the pad mold sufficient to form the applicator module; and k) waiting for vulcanization and removing the applicator module from the pad mold, as taught by Alemany Negrete, because the device would need a process of manufacturing, and because the invention taught by Alemany Negrete provides a manufacturing process which allows for economical and fast production of flexible moulds, and that is it valid for molding any component such as electrical components, which would be in the invention of Jones.
Regarding the limitations,
“d) placing the PCB with the LED light module (110) into the core mold;
e) subsequently placing the heating module (120) into the core mold;
f) then placing the thermal insulation module (130) into the core mold”,
the proposed combination yields wherein the PCB with the Led Light module, the heating module, and the thermal insulation module are placed in the mold, specifically because Jones teaches the PCB of the Led Light module, the heating module, and the thermal insulation module (see in re claim 1 above), therefore, it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the device taught by Jones to incorporate wherein the PCB with the LED light, the heating module, and the thermal insulation module are placed in the mold, because Alemany Negrete teaches that its components are placed and secured inside the mould (see above), and because Alemany Negrete teaches that its manufacturing process allows for fast production of flexible moulds based on the component needed molding.
Additionally, regarding the order of the components getting placed in the mold ( i.e. first the PCB of the LED Light module, then the heating module, then the thermal insulation module) at the time the instant application was filed it would be obvious to try to provide wherein the PCB with the LED Light module is placed in the mold, then the heating module is placed subsequently, and then the thermal insulation module is placed. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified (for instance 6 different outcomes regarding the order they are placed in the mold), predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the order of the PCB of the LED Light module, the heating module, and the thermal insulation module being placed inside the mold is not disclosed as being crucial or unexpected.
Regarding Applicant’s arguments, “Jones discloses only a single LED PCB with surface covers and does not disclose a resistive mesh heating layer at all, much less one positioned above a PCB and below an insulation module”, see above.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In re claim 5, the following limitations lack antecedent basis:
“the mobile application module”
“the wireless communication component”
In re claim 6, the following limitations lack antecedent basis:
“the web application programming interface module
“the database component”
“the user interface component”
“the distributed database”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claims 6 & 14:
“a web application module”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-4 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Jones (US 2014/0288351) in view of Havell et al. (US 2007/0156208).
In re claim 1, Jones discloses a device for transferring heat and infrared energy [0045] with dynamic temperature control [0032, 0093] and homogeneous heat distribution [0195], comprising:
at least one applicator module (fig. 1: soft silicone grid of small windows or wells; [0088]);
a first layer [0101] comprising a PCB [0101] comprising
temperature sensors [0093, 0217],
infrared energy generating system instrumentation [0079], and
a thermoelectric safety component ([0143-0144]: silicon gels is used and is considered a thermoelectric safety component i.e. a component that has poor thermoelectric effect),
each connected via electrical connection tracks [0101-0102] to a multiple connector ([0102]: electrical conductors located on the backside opposite the LEDs),
wherein the infrared energy generating system instrumentation comprises an infrared emitter [0079] comprising LEDs ([0079]: the infrared emitter comprises of LEDs) configured to emit infrared radiation between 800 and 1200 nm ([0079]: LEDs output light in the orange-to-near infrared wavelength range of 595 nm-960 nm, which partially overlaps with the infrared wavelength range of 800 nm to 1200 nm) by converting electrical energy to IR radiation ([0079]: LEDs inherently convert electrical energy to electromagnetic radiation energy i.e. visible light);
a second layer comprising a heating module ([0101-0102]: combination of LED array, heat-conductive material around each LED, and heatsink are interpreted as a second layer comprising a heating module because LED array generates heat [0046] and then the head-conductive material and heatsink transfer heat) comprising a resistance mesh ([0085]: mesh baseplate may be connected to the LEDs as part of the baseplate structure)
embedded in an elastomer ([0089]: vertical silicon polymer is an elastomer that is part of the same molded part as the LED array light source) and
connected via electrical connection tracks to the multiple connector [0101-0102],
wherein
the heating module receives electrical energy to generate heat ([0079]: power supplies provide electrical energy to the LEDs which generate heat that can be controlled by a thermal controller which reduces power if the temperature of the LEDs exceeds a predetermined value; [0045, 0101]),
a third layer ([0089]: LED array) comprising a thermal insulation module ([0089]: LED array acts as an insulator between heat producing LED arrays) formed of a heat-directing material ([0089]: contains silicone and has a heat sink to direct heat; [0084, 0086-0087]);
a core (fig. 2: entire portion of soft silicone lip) that
comprises the elastomer ([0089]: core would include the vertical silicon polymer) and
encapsulates the first layer, the second layer, and the third layer (fig. 2: core would contain the first layer of the PCB, and then the heating module on top, and then the LED array, see above),
the elastomer coupling the PCB, the heating module and the thermal insulation module (see above; fig. 2),
the core being encapsulated within the applicator module (fig. 2: backside silicone grid surrounds top portion of the core); and
a control module ([0079]: thermal controller which controls power supplied; [0091-0093]) including electronics for
power ([0079]: electronics that control power supplied) and
temperature regulation ([0045]: electronics that prevent temperature from exceeding a certain value).
Jones fails to disclose:
wherein… the generated heat is directed toward a contact surface of the applicator module;
Regarding the limitation, “wherein… the generated heat is directed toward a contact surface of the applicator module,” Havell teaches using LEDs to provide light [0011] and heat [0041] therapy [0041], and teaches:
an applicator module (fig. 2: combination of 30 and 24; [0034, 0046]),
a thermal insulation module (26; [0045]),
a heating module (combination of 22, 24, 36, and 34; [0045]: LEDs provide heat; [0034-0035]),
wherein
the thermal insulation module is arranged on the heating module ([0045]; fig. 6),
the heating module receives electrical energy to generate heat [0034], and
the thermal insulation module is made of a material that directs heat generated by the heating module towards a contact surface of the applicator module ([0045]: reflective panel 26 is made out of Mylar and directs any light and heat not oriented toward the skin to go back to the skin; [0037]).
Havell further teaches that the reflective panel maximizes the amount of light and heat that is reflected onto a user’s skin [0045], and to prevent the light from being otherwise absorbed by other components [0045]. Additionally, Havell teaches that this increases efficiency and decreases power needed for treatment [0045].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the device taught by Jones, to provide wherein the generated heat is directed toward a contact surface of the applicator module, as taught by Havell, because doing so will maximize the amount of light and heat that is reflected onto a user’s skin, which will increase efficiency and decrease power needed for treatment.
In re claim 2, the proposed combination yields (all mapping directed to Jones unless otherwise stated) wherein
the heating module is composed of the resistance mesh ([0085]: mesh baseplate may be connected to the LEDs as part of the baseplate structure) woven on a wire mesh ([0178]: thermally conducting and flexible backplane may include),
the resistance mesh bonded with the elastomer that forms the core of the applicator module ([0089]: vertical silicon polymer is an elastomer that is part of the core and is part of the same molded part as the LED array light source)
In re claim 3, the proposed combination yields (all mapping directed to Jones unless otherwise stated) wherein the temperature sensors will allow the control module to know a temperatures in real time ([0045]: thermal controller reduces power when temperature exceeds a predetermined value therefore it’s measure temperatures in real-time) at various points within of the applicator module ([0093]: multiple temperature sensors are at different locations i.e. various points) which will allow the control module to manage the energy supplied to the heating module ([0093]: control module can use the temperature to manage energy supplied by modifying light intensity and/or treatment time).
In re claim 4, the proposed combination yielded in re claim 1 above yields wherein
the thermal insulation module contains holes (Havell: fig. 2: 26),
the elastomer (Havell: [0045]: heating module comprises of flexible circuit substrate 22 i.e. an elastomer) passing through the holes (fig. 2) to ensure a mechanical joint (Havell: fig. 2: combination of 22 and 26), and
the thermal insulation module made of a material that directs heat generated by the heating module towards a contact surface of the applicator module (see in re claim 1 above).
In re claim 12, the proposed combination yields (all mapping directed to Jones unless otherwise stated) teaches wherein the heating module receives electrical energy from the control module ([0079]: thermal controller controls power supplied to the heating element to prevent excessive heat on the skin; [0040]).
In re claim 13, regarding the limitations,
“the second layer is arranged on top of the first layer, and
the third layer is arranged on top of the second layer”,
see in re claim 1 above.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Jones (US 2014/0288351) in view of Havell et al. (US 2007/0156208) in view of Valentine (US 2021/0319872).
In re claim 5, Jones fails to disclose wherein the mobile application module communicates using the wireless communication component with the wireless communication component that is in the control module
in order to exchange information and
with the possibility of controlling the applicator module from the mobile application module.
Valentine teaches a drug dispensing device [0043], which is analogous in being able to provide treatment to a patient [0430] and teaches
a mobile application module ([0054: smartphone) comprising
a user interface ([0054]: smartphone is a user interface device with input screens),
a control logic (inherent feature of a computer and mobile app; [0053-0054]: control logic is needed to read and input data),
a wireless communication [0054], and
a database ([0071-0072]: Drug Specific and Patient Tailored App creates a patient specific database; [0054];
a web application programming interface module ([0127]: API; [0027]: drug specific app 12 may be configured using an API; [0053-0054]) comprising
a communication logic ([0127]: inherent to comprise a communication logic),
a data management [0222, 0254], and
an administrative interface [0254;
wherein said mobile application module communicates using the wireless communication component with the wireless communication component that is in a control module [0054]
in order to exchange information [0224] and
with the possibility of controlling an applicator module (fig. 1: drug dispenser 16) from the mobile application module ([0224]: drug dispenser 16 is controlled using components including Bluetooth).
Valentine further teaches that the Drug Specific App uses the interface and Bluetooth communication to control the drug dispenser as well as send screen messages, alerts, alarms, emails, and make calls [0224]. This allows the drug dispenser to be controlled for each patient [0025] and controls treatment [0230].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the device yielded by the proposed combination, to provide a mobile application module comprising a user interface, a control logic, a wireless communication, and a database; a web application programming interface module comprising a communication logic, a data management, and an administrative interface, and wherein the mobile application module communicates using the wireless communication component with the wireless communication component that is in the control module in order to exchange information and
with the possibility of controlling the applicator module from the mobile application module, as taught by Valentine, because doing so allows the Drug Specific App to use the interface and Bluetooth communication to control treatment for each patient as well as send screen messages, alerts, alarms, emails, and make calls.
In re claim 6, Jones fails to yield
wherein the web application programming interface module will obtain information shared by connected users through their respective mobile application module, and will
save,
update, or
delete
the information in the database component according to what is indicated by an administrator,
using the user interface component, and wherein the information that users share is stored in the distributed database with which a global analysis of all information within said distributed database can be carried out.
Valentine teaches
wherein a web application programming interface module [0127] will obtain information shared by connected users through their respective mobile application modules [0254-0255; 0053], and will
save,
update ([0254]: API communicate with one another and enable the drug specific app to aggregate i.e. update prescribed information regarding the patient; [0222]: API can update patient database), or
delete
the information in a database component according to what is indicated by an administrator ([0222]: data servers must be authorized (i.e. by an administrator) to access patient electronic medical record before an API can be utilized and used to update a patient’s database),
using a user interface component ([0254]: API utilizes interface), and
wherein the information that users share is stored in a distributed database ([0222]: data servers contain database for each of the patients [0076, 0520]) with which a global analysis of information within said distributed database can be carried out (the limitation “with which a global analysis of all information within said database can be carried out” is functional and the device discloses all of the necessary structure that would allow the device to be capable of performing the recited limitation, see MPEP 2114).
Valentine further teaches that using a distributed database allows an API to trace treatment and accountability information based on the patient following through with treatment [0222], and that using a user interface and API provide Wi-Fi communications, which allows different devices to be connected together and used to make treatment decisions [0254]. Valentine additionally teaches that authorization (i.e. from an administrator) is needed to access patient records and is required in accordance with HIPPA and governmental guidelines [0222].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the device taught by Jones, to incorporate wherein the web application programming interface module will obtain information shared by connected users through their respective mobile application module, and will save, update, or delete the information in the database component according to what is indicated by an administrator, using the user interface component, and wherein the information that users share is stored in the distributed database with which a global analysis of all information within said distributed database can be carried out, as taught by Valentine, because doing using a distributed database allows an API to trace treatment and accountability information based on the patient following through with treatment, and that a user interface and API provide Wi-Fi communications, which connects various devices together so treatment can be made based on various information, and also because authorization i.e. an indication from the administrator is needed to access and update patient records in accordance with HIPPA and governmental guidelines.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Jones (US 2014/0288351) in view of Havell et al. (US 2007/0156208) in view of Kothare et al. (US 2019/0000529).
In re claim 9, the proposed combination fails to yield further comprising
one or more additional applicator modules identical or equivalent to the first applicator module,
wherein each applicator module is
operatively connected to the control module and
configured to operate simultaneously with the others.
Kothare teaches an analogous treatment system(fig. 6: 600) that comprises
a first applicator module (208a)
one or more additional applicator modules (208f) identical or equivalent to the first applicator module (fig. 6; [0036]: each applicator may be a square are apply energy to a patient’s skin and therefore the applicators are considered equivalent to one another; [0051]),
wherein each applicator module is
operatively connected to a control module ([0034]: each applicator is connected to a control algorithm which maintains a temperature) and
configured to operate simultaneously with the others [0051].
Kothare further teaches that having multiple applicators allows for multiple different areas [0005] to be treated simultaneously [0051] from a single device [0051].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the device yielded by the proposed combination, to provide one or more additional applicator modules identical or equivalent to the first applicator module, wherein each applicator module is operatively connected to the control module and configured to operate simultaneously with the others, as taught by Kothare, because having multiple applicators allows for multiple different areas to be treated simultaneously from a single device.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Jones (US 2014/0288351) in view of Havell et al. (US 2007/0156208) in view of Li et al. (US 2005/0288748).
In re claim 10, the proposed combination fails to yield wherein upon heating, the resistance mesh maintains a uniform and constant temperature across its surface.
Li teaches a heating apparatus [0020] that treats skin itching [0020], and teaches
wherein upon heating [0061-0062], a body heater [0061] maintains
a uniform [0062] and
constant [0062]
temperature across its surface [0062], and
wherein the uniform and constant temperature is between 44 °C and 64 °C ([0021]: range of about 46 °C to 62 °C, however, based on specific treatments, heating may be within a tolerance (either more or less) than about 2 °C).
Li further teaches that continually monitoring the temperature of the skin area and automatically controlling the supply of heating power to the skin area eliminated edema and rebound itch [0062]. Li further teaches that different treatments for different patients will require substantially unique temperatures [0021].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the resistance mesh of the device yielded by the proposed combination, to maintains a uniform and constant temperature across its surface upon heating and wherein the uniform and constant temperature is between 44 C and 66 C, as taught by Li, because doing so will prevent edema and rebound itch during skin treatment and allows for the temperature to be controlled for different treatments and patients.
In re claim 11, regarding the limitation, “wherein the uniform and constant temperature is between 40 C and 45 C,” see in re claim 10 above.
Additionally, at the time the instant application was filed it would be obvious to try to provide wherein the uniform and constant temperature is between 40 C and 45 C. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed temperature is not disclosed as being crucial or unexpected. Further, a person of ordinary skill in the art would consider a temperature that was high enough for the patient to receive therapeutic outcomes, but not too high to potentially harm the patient.
Even if the proposed combination fails to yield “wherein the uniform and constant temperature is between 40 C and 45 C”, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the uniform and constant temperature is between 40 C and 45 C, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Jones (US 2014/0288351) in view of Havell et al. (US 2007/0156208) in view of Valentine (US 2021/0319872) in view of Francois (US 2017/0262604).
In re claim 14, regarding the limitations, “further comprising:
a mobile application module comprising
a user interface,
a control logic,
a wireless communication, and
a database;
a web application programming interface module comprising
a communication logic,
a data management, and
an administrative interface”,
see the proposed combination yielded in re claim 5 above.
The proposed combination fails to yield a web application module configured to visualize synchronized therapy data.
Francois teaches an analogous patient monitoring system [0006], and teaches a web application module [0117] configured to visualize synchronized therapy data ([0117]: data collected by device is synchronized to website; [0264]: data displayed on physical or patient dashboard; [0343]: web browser may be used to view therapy data such as health data acquired according to a T-plan; [0006, 0014, 0255]).
Francois further teaches that web browsers can run on mobile devices and personal computers [0455] and allows patient data to be viewed [0006, 0343-0344] without requiring downloading or installing a product software on a user device [0455].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the device yielded by the proposed combination, to provide a web application module configured to visualize synchronized therapy data, as taught by Francois, because web browsers can run on mobile devices and personal computers and allows patient data to be viewed without requiring downloading or installing a product software on a user device.
Claims 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jones (US 2014/0288351) in view of Havell et al. (US 2007/0156208) in view of Alemany Negrete et al. (US 2019/0047198).
In re claim 15, regarding the limitations, “a device to transfer heat and infrared energy with dynamic temperature control and homogeneous heat distribution, comprising the following stages:
a) manufacturing components to be encapsulated to form a core,
the core configured to be further encapsulated within an applicator module,
the components comprising:
a first layer comprising a PCB with an LED light module;
a second layer comprising a heating module comprising a resistance mesh configured to receive electrical energy to generate heat; and
a third layer comprising a thermal insulation module (130),
the thermal insulation module formed of a heat-directing material;
b) a core mold for forming the core of the applicator module”,
see in re claim 1 above, where it’s inherent that components part of the core would be manufactured.
Jones fails to disclose “a manufacturing process of a device to transfer heat and infrared energy with dynamic temperature control and homogeneous heat distribution
b) preparing a core mold configured to receive the components for forming the core of the applicator module;
c) preparing a pad mold;
d) placing the PCB with the LED light module (110) into the core mold;
e) subsequently placing the heating module (120) into the core mold;
f) then placing the thermal insulation module (130) into the core mold;
g) pouring an amount of elastomer into the core mold sufficient to encapsulate the components to form the core (140);
h) waiting for vulcanization and removing the core (140) from the core mold;
i) placing the core into the pad mold;
j) pouring the amount of elastomer into the pad mold sufficient to form the applicator module; and
k) waiting for vulcanization and removing the applicator module from the pad mold.”
Alemany Negrete teaches a manufacturing process [0008, 0021], comprising the following stages
b) preparing a core mold [0008-0009] configured to receive components ([0046]: inner portions of the mold) for a core of an applicator module ([0009]: upper mould is the applicator module), which contains structural elements to secure each component in place ([0009]: fasteners secure mould parts together which would secure the components (i.e. inner portions of the mold [0046]) in the mould),
wherein the mold contains a series of fastening elements (which can be magnets or presses) [0009] strategically placed to secure and compact the components in the vulcanization process ([0009-0010]: vulcanized silicone mould includes fasteners to secure the two mould parts together and would also be secured during the vulcanization process),
said structural elements separable from the core once an elastomer is vulcanized ([0009]: vulcanized silicon mould is separated into two parts);
c) preparing a pad mold [0012], which will receive the core ([0014]: distribution chamber i.e. core is part of the upper mould [0044]);
d) opening the core mold to place the components ([0044]: melted material inlet receives injected material);
h) secure and compact all components ([0046]: fasteners used to secure the inner components of the mold; fig. 6: 2);
i) preparing the elastomer and submitting it to a vacuum chamber for air removal ([0025-0027]: air is removed while elastomer (inner part of mould) is being prepared);
j) pouring an exact amount of elastomer necessary to form a core ([0020]: elastomer can be used as the injected material; inherent that the exact amount of elastomer would be used);
k) waiting for vulcanization and disassembling the core ([0048]: vulcanized silicone mould is used and then the injection is inserted afterwards, and then the mould is separated after being filled and cooled so there core would be disassembled after vulcanization)
l) assembling the core in the pad mold ([0020-0021]: pouring the injected material into the mould is considered as assembling the core in the pad mold);
m) preparing the elastomer and submitting it to the vacuum chamber for air removal [0026];
n) pour the exact amount of elastomer needed to form the pad ([0048]: pad is considered to be one of the items generated in the cavities which would inherently require the exact amount of elastomer to be formed);
o) waiting for vulcanization and removing the pad ([0048]: pad i.e. part of the items generated in the cavities occurs after the silicone mould is vulcanized).
Alemany Negrete further teaches that the disclosed manufacturing process allows for economical and fast production of flexible moulds [0006], and that is it valid for moulding any component such as electrical components [0006].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the device taught by Jones, to provide wherein a manufacturing process of a device to transfer heat and infrared energy with dynamic temperature control and homogeneous heat distribution b) preparing a core mold configured to receive the components for forming the core of the applicator module; c) preparing a pad mold; d) placing the PCB with the LED light module (110) into the core mold; e) subsequently placing the heating module (120) into the core mold; f) then placing the thermal insulation module (130) into the core mold; g) pouring an amount of elastomer into the core mold sufficient to encapsulate the components to form the core (140); h) waiting for vulcanization and removing the core (140) from the core mold; i) placing the core into the pad mold; j) pouring the amount of elastomer into the pad mold sufficient to form the applicator module; and k) waiting for vulcanization and removing the applicator module from the pad mold, as taught by Alemany Negrete, because the device would need a process of manufacturing, and because the invention taught by Alemany Negrete provides a manufacturing process which allows for economical and fast production of flexible moulds, and that is it valid for molding any component such as electrical components, which would be in the invention of Jones.
Regarding the limitations,
“d) placing the PCB with the LED light module (110) into the core mold;
e) subsequently placing the heating module (120) into the core mold;
f) then placing the thermal insulation module (130) into the core mold”,
the proposed combination yields wherein the PCB with the Led Light module, the heating module, and the thermal insulation module are placed in the mold, specifically because Jones teaches the PCB of the Led Light module, the heating module, and the thermal insulation module (see in re claim 1 above), therefore, it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the device taught by Jones to incorporate wherein the PCB with the LED light, the heating module, and the thermal insulation module are placed in the mold, because Alemany Negrete teaches that its components are placed and secured inside the mould (see above), and because Alemany Negrete teaches that its manufacturing process allows for fast production of flexible moulds based on the component needed molding.
Additionally, regarding the order of the components getting placed in the mold ( i.e. first the PCB of the LED Light module, then the heating module, then the thermal insulation module) at the time the instant application was filed it would be obvious to try to provide wherein the PCB with the LED Light module is placed in the mold, then the heating module is placed subsequently, and then the thermal insulation module is placed. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified (for instance 6 different outcomes regarding the order they are placed in the mold), predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the order of the PCB of the LED Light module, the heating module, and the thermal insulation module being placed inside the mold is not disclosed as being crucial or unexpected.
In re claim 16, regarding the limitations,
“wherein the thermal insulation module comprises holes, and
wherein pouring an amount of the elastomer into the core mold further comprises
allowing the elastomer to pass through the holes and
mechanically bond with the resistance mesh of the heating module”, see in re claim 4 above.
In re claim 17, the proposed combination yields wherein the first layer comprising the PCB is placed into the core mold before the second layer comprising the heating module, and the second layer is placed before the third layer comprising the thermal insulation module (see in re claim 1 above, where the PCB is the bottom layer, and then the heating module is the second layer, and then the insulation module is the top layer, which means they must be placed in that order to form the core mold).
Additionally, at the time the instant application was filed it would be obvious to try to provide wherein the first layer comprising the PCB is placed into the core mold before the second layer comprising the heating module, and the second layer is placed before the third layer comprising the thermal insulation module. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed order of the layers is not disclosed as being crucial or unexpected, and also because there are a finite number of ways to assemble the order of the layers.
In re claim 18, the proposed combination fails to yield further comprising submitting the elastomer to a vacuum chamber for air removal prior to pouring the elastomer into the core mold and prior to pouring the elastomer into the pad mold.
Alemany Negrete teaches further comprising submitting the elastomer to a vacuum chamber for air removal (see in re claim 15 above)
prior to pouring the elastomer into the core mold ([0026-0028]: vacuum chamber occurs before mould is filled) and
prior to pouring the elastomer into the pad mold [0026-0028].
Alemany Negrete further teaches that removing air should be done while the mould is still being filled [0026].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the device yielded by the proposed combination, to provide further comprising submitting the elastomer to a vacuum chamber for air removal prior to pouring the elastomer into the core mold and prior to pouring the elastomer into the pad mold, as taught by Alemany Negrete, because air should be removed before the mould is fully filled.
In re claim 19, the proposed combination yields further comprising securing the PCB ,the heating module, and the thermal insulation module in position within the core mold before pouring the elastomer (see in re claim 15, wherein the core mold that comprises the PCB, heating module, and thermal insulation module would require proper position before pouring the elastomer).
In re claim 20, the proposed combination yielded in re claim 15 above yields wherein preparing the core mold includes providing at least one fastening element configured to hold the PCB, the heating module, and the thermal insulation module in position during formation of the core (Alemany Negrete: [0009-0010]: vulcanized silicone mould includes fasteners to secure and compact the components in the vulcanization process; proposed combination would yield wherein the PCG, the heating module, and the thermal insulation modules are held in position while the core is formed).
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.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796