DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status: Claims 1, 3, 4, 18, 19, 26, 28-30, 34, 37, 46-48, and 52-54 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 27, 2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 34 have been considered but are moot because the new grounds of rejection have been made necessitated by amendments.
Response to Amendment
With respect to claim objection, Applicant’s amendment has overcome each and every objection.
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.
Claims 1, 3, 4, 18-19, 26, 28-30, 34, 37, 46-48, and 52-54 are rejected under 35 U.S.C. 103 as being unpatentable over Bagnato (BR 102019002501 – Please see the translation copy provided on 6/18/2025) in view of Kim (KR 20120078037 – Please see the translation copy provided on December 17, 2024), Whitehurst (US 6,645,230), and Dougal (US 2011/0178582).
Re Claim 1, Bagnato discloses a method of treating viral lower respiratory illness using a flexible wearable garment (para. [007], Pneumonia is defined as the acute inflammation of the structures of the lung parenchyma that can be caused by different etiological agents (bacteria, viruses, atypical organisms and fungi), Initially, it appears as a colonization of the nasopharyngeal mucosa, later spreading to the lower respiratory tract), comprising:
providing a flexible wearable garment, the flexible wearable garment (para. [0026], a light-emitting device, adjustable to the human chest, to be used in the treatment of microorganisms that cause pulmonary infections; para. [0046], To stabilize the device to the patient's body, two strips (5) parallel to each other are adapted to the blanket (1) that surrounds it. These strips (5) are in the form of a belt, ribbon or other object that performs this function; para. [0022], the use of LEDs or lasers in a flexible mat large enough to completely irradiate the human rib cage. Still in this sense, it should be noted that the flexibility characteristics of the blanket require a complete change in the construction of the device, so that it adapts perfectly to different anatomical profiles.) comprising:
a front piece having a first array of LEDs and wherein the first array comprises two or more sub-arrays of LEDs (fig. 1 and fig. 2, para. [0044], The light emitters (3) are preferably lasers, light emitting diodes (LEDs) – LED arrays; para. [0026], a light-emitting device, adjustable to the human chest, to be used in the treatment of microorganisms that cause pulmonary infections; para. [0046], To stabilize the device to the patient's body, two strips (5) parallel to each other are adapted to the blanket (1) that surrounds it. These strips (5) are in the form of a belt, ribbon or other object that performs this function);
directing photon energy output of the flexible wearable garment primarily to the torso of the human body (para. [0037], The referred equipment presents itself as a versatile device to be used in photodynamic inactivation, presenting such flexibility that it allows anatomical adaptation to the patient's body. Especially for this characteristic, the equipment illuminates the entire chest area of the patient), the photon energy output primarily emitted in a spectral wavelength range of between 600-915 nm (para. [0014], The relationship between wavelength and tissue penetration in biological media is known; and, for treatments that require penetration between the layers of skin, muscles and bones, only those belonging to the range between 600 and 1200nm are able to reach the target, which in this proposal are the lungs; para. [0025], LEDs operate at wavelengths in the infrared range near 600 to 2500nm; para. [0044], The light emitters (3) work in the infrared range, between 600 and 2500nm of the electromagnetic spectrum; para. [0059], green indocyanine (ICV) was used as a photosensitizer and light with a wavelength of 780 nm for photodynamic inactivation (IFD) in vivo).
Bagnato is silent regarding the first array of LEDs comprising lenses protruding from an inner surface of the flexible wearable garment such that the lenses contact an outer layer of skin of the chest region of the human body.
Kim discloses device for curing pain using laser ray (abstract, page 4, laser pain treatment device 50) and teaches the first array of LEDs comprising lenses protruding from an inner surface of the flexible wearable garment such that the lenses contact an outer layer of skin of the chest region of the human body (page 4, at least one laser assembly 20 on the sheet 10. The sheet 10 has a certain length to be worn around a specific part of the wearer’s body. A laser diode 23 inserted into the circuit board. The lens 29 is coupled to the front end of the center portion and is in contact with the wearer’s body skin).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bagnato, by configuring the first array of LEDs to comprise lenses protruding from an inner surface of the flexible wearable garment such that the lenses contact an outer layer of skin of the chest region of the human body, as taught by Kim, for the purpose of amplifying the laser beam emitted from the laser diode, thereby increasing the function of the laser beam (page 5).
Bagnato is silent regarding wherein each sub-array is independently controllable from the other sub-arrays of LEDs.
Whitehurst discloses a therapeutic light source (abstract) and each sub-array is independently controllable from the other sub-arrays of LEDs (col. 7, lines 46-49, fig. 16a, 16b, Each of the arrays is independently switchable so that selected sections of the patient can be treated.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bagnato as modified by Kim, configuring each sub-array to be independently controllable from the other sub-arrays of LEDs, as taught by Whitehurst, for the purpose of treatment of selected sections of the patient (col. 7, lines 46-49).
Bagnato is silent regarding at least one wing portion that extends laterally relative to a width of the flexible wearable garment, wherein a portion of the first array of LEDs extends onto the at least one wing portion, and wrapping the flexible wearable garment about a circumference of a torso of a human body having the viral respiratory illness such that the wing portion extends above a chest line of the human body.
However, Dougal discloses an apparatus for treatment of respiratory disease (abstract) comprising: a flexible wearable garment (para. [0013], the “C” shaped device is made of a relatively flexible material so that it may be partially expanded so that it can be fitted about the individual; para. [0074], Panels are hinged at upper and lower edges with an adjacent panel so that the panels are flexible and can be wrapped around a body or body part.) comprising: a front piece having a first array of LEDs and wherein the first array comprises two or more sub-arrays of LEDs (para. [0071], the apparatus is configured so as to encase the thoracic or chest region of an individual; para. [0032], a plurality of LEDs arranged on a surface of the apparatus which is to be in contact with or in close proximity to the site being treated of the human or animal body; para. [0080], a plurality of LEDs arranged to emit uniform distribution of light from light emitting surface; para. [0069], a series of hinged panels each having a plurality of light emitting devices on the surface which is in contact with or in close proximity to a part of the human or animal body to be treated – one of the panels reads on “the first array of LEDs”) and teaches at least one wing portion that extends laterally relative to a width of the flexible wearable garment, wherein a portion of the first array of LEDs extends onto the at least one wing portion, and wrapping the flexible wearable garment about a circumference of a torso of a human body having the viral respiratory illness such that the wing portion extends above a chest line of the human body (annotated fig. 4C, para. [0076], The main function of this light applicator is to facilitate the simultaneous treatment of all the aspects of the chest from all directions. In the event the light is pulsed, the “ON” pulses all coincide, hence achieving a greater penetration of the target tissue – This disclosure teaches the first array of LEDs extending onto the at least one wing portion).
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Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bagnato as modified by Kim and Whitehurst, by adding at least one wing portion that extends laterally relative to a width of the flexible wearable garment, wherein a portion of the first array of LEDs extends onto the at least one wing portion, and wrapping the flexible wearable garment about a circumference of a torso of a human body having the viral respiratory illness such that the wing portion extends above a chest line of the human body, as taught by Dougal, for the purpose of facilitating the simultaneous treatment of all the aspects of the chest from all directions (para. [0076]).
Re Claim 34, Bagnato discloses an apparatus for treatment of COVID-19 respiratory virus, comprising:
a flexible wearable garment configured to at least partially cover a chest region of a human body (para. [0026], a light-emitting device, adjustable to the human chest, to be used in the treatment of microorganisms that cause pulmonary infections; para. [0046], To stabilize the device to the patient's body, two strips (5) parallel to each other are adapted to the blanket (1) that surrounds it. These strips (5) are in the form of a belt, ribbon or other object that performs this function; para. [0022], the use of LEDs or lasers in a flexible mat large enough to completely irradiate the human rib cage. Still in this sense, it should be noted that the flexibility characteristics of the blanket require a complete change in the construction of the device, so that it adapts perfectly to different anatomical profiles.), the flexible wearable garment including:
a front piece having a first array of LEDs, wherein the first array of LEDs are configured to direct a photon energy output primarily in a spectral wavelength range between 600-915 nm at the chest region when the flexible wearable garment is being worn and wherein the first array comprises two or more sub-arrays of LEDs (fig. 1 and fig. 2, para. [0044], The light emitters (3) are preferably lasers, light emitting diodes (LEDs) – LED arrays; para. [0026], a light-emitting device, adjustable to the human chest, to be used in the treatment of microorganisms that cause pulmonary infections; para. [0046], To stabilize the device to the patient's body, two strips (5) parallel to each other are adapted to the blanket (1) that surrounds it. These strips (5) are in the form of a belt, ribbon or other object that performs this function; para. [0014], The relationship between wavelength and tissue penetration in biological media is known; and, for treatments that require penetration between the layers of skin, muscles and bones, only those belonging to the range between 600 and 1200nm are able to reach the target, which in this proposal are the lungs; para. [0025], LEDs operate at wavelengths in the infrared range near 600 to 2500nm; para. [0044], The light emitters (3) work in the infrared range, between 600 and 2500nm of the electromagnetic spectrum; para. [0059], green indocyanine (ICV) was used as a photosensitizer and light with a wavelength of 780 nm for photodynamic inactivation (IFD) in vivo).
Bagnato is silent regarding wherein the first array of LEDs comprises lenses configured to protrude from an inner surface of the flexible wearable garment such that the lenses are configured to contact an outer layer of skin of the chest region of the human body.
Kim discloses device for curing pain using laser ray (abstract, page 4, laser pain treatment device 50) and teaches the first array of LEDs comprises lenses configured to protrude from an inner surface of the flexible wearable garment such that the lenses are configured to contact an outer layer of skin of the chest region of the human body (page 4, at least one laser assembly 20 on the sheet 10. The sheet 10 has a certain length to be worn around a specific part of the wearer’s body. A laser diode 23 inserted into the circuit board. The lens 29 is coupled to the front end of the center portion and is in contact with the wearer’s body skin).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bagnato, by configuring the first array of LEDs to comprise lenses configured to protrude from an inner surface of the flexible wearable garment such that the lenses are configured to contact an outer layer of skin of the chest region of the human body, as taught by Kim, for the purpose of amplifying the laser beam emitted from the laser diode, thereby increasing the function of the laser beam (page 5).
Bagnato is silent regarding wherein each sub-array is independently controllable from the other sub-arrays of LEDs.
Whitehurst discloses a therapeutic light source (abstract) and each sub-array is independently controllable from the other sub-arrays of LEDs (col. 7, lines 46-49, fig. 16a, 16b, Each of the arrays is independently switchable so that selected sections of the patient can be treated.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bagnato as modified by Kim, configuring each sub-array to be independently controllable from the other sub-arrays of LEDs, as taught by Whitehurst, for the purpose of treatment of selected sections of the patient (col. 7, lines 46-49).
Bagnato is silent regarding the flexible wearable garment configured to wrap about a circumference of the torso of the human body and at least one wing portion that extend laterally relative to a width of the flexible wearable garment, the wing portion configured to extend above a chest line when in use, wherein a portion of the first array of LEDs extends onto the at least one wing portion.
However, Dougal discloses an apparatus for treatment of respiratory disease (abstract) comprising: a flexible wearable garment (para. [0013], the “C” shaped device is made of a relatively flexible material so that it may be partially expanded so that it can be fitted about the individual; para. [0074], Panels are hinged at upper and lower edges with an adjacent panel so that the panels are flexible and can be wrapped around a body or body part.) comprising: a front piece having a first array of LEDs and wherein the first array comprises two or more sub-arrays of LEDs (para. [0071], the apparatus is configured so as to encase the thoracic or chest region of an individual; para. [0032], a plurality of LEDs arranged on a surface of the apparatus which is to be in contact with or in close proximity to the site being treated of the human or animal body; para. [0080], a plurality of LEDs arranged to emit uniform distribution of light from light emitting surface; para. [0069], a series of hinged panels each having a plurality of light emitting devices on the surface which is in contact with or in close proximity to a part of the human or animal body to be treated – one of the panels reads on “the first array of LEDs”) and teaches the flexible wearable garment configured to wrap about a circumference of the torso of the human body and at least one wing portion that extend laterally relative to a width of the flexible wearable garment, the wing portion configured to extend above a chest line when in use, wherein a portion of the first array of LEDs extends onto the at least one wing portion (annotated fig. 4C, para. [0076], The main function of this light applicator is to facilitate the simultaneous treatment of all the aspects of the chest from all directions. In the event the light is pulsed, the “ON” pulses all coincide, hence achieving a greater penetration of the target tissue – This disclosure teaches the first array of LEDs extending onto the at least one wing portion).
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Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bagnato as modified by Kim and Whitehurst, by configuring the flexible wearable garment to wrap about a circumference of the torso of the human body and adding at least one wing portion that extend laterally relative to a width of the flexible wearable garment, the wing portion configured to extend above a chest line when in use, wherein a portion of the first array of LEDs extends onto the at least one wing portion, as taught by Dougal, for the purpose of facilitating the simultaneous treatment of all the aspects of the chest from all directions (para. [0076]).
Re Claim 3, Bagnato as modified by Kim, Whitehurst, and Dougal discloses the claimed invention substantially as set forth in claim 1.
Bagnato further discloses directing, during a first session, the photon energy output of the flexible wearable garment primarily to the torso of the human body (para. [0037], the equipment illuminates the entire chest area of the patient; para. [0045], it must be understood that the blanket (1), the sinks (2) and the light emitters (3) form the flexible part of the device, which comes into contact and fits on the patient's back, from where the light must be radiated for the photodynamic inactivation of bacteria that cause pulmonary infections).
Bagnato discloses that the LEDs of the flexible wearable garment are configured to deliver 4-20 J/cm2 (para. [0044], lighting doses varying between 4 and 150 J/cm2).
Bagnato disclose providing claimed wavelengths (para. [0025], LEDs operate at wavelengths in the infrared range near 600 to 2500nm) with a total light dosage of from 4-20 J/cm2 (para. [0044], lighting doses varying between 4 and 150 J/cm2) and operating time (para. [0051], The parameterization buttons (9) are intended to provide the selection by the operator of the light emitters (3) that will work, the irradiation power and the operating time. With this, it is possible to adjust the light irradiation according to the needs of each patient, in an individual, specific and simplified way) for the purpose of treating viral respiratory illness (para. [007], Pneumonia is defined as the acute inflammation of the structures of the lung parenchyma that can be caused by different etiological agents (bacteria, viruses, atypical organisms and fungi), Initially, it appears as a colonization of the nasopharyngeal mucosa, later spreading to the lower respiratory tract).
Bagnato is silent regarding directing the photon energy output for a treatment period of 20-60 minutes.
Bagnato discloses that there is a treatment time (para. [0051], operating time) based on the needs of each patient (para. [0051]) while light wavelengths are between 600 and 2500nm of the electromagnetic spectrum with lighting intensity between 10 and 1200 mW/cm2 and lighting doses varying between 4 and 150 J/cm2 (para. [0044]).
Treatment time is a result-effective variable together with light intensity to determine light doses.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bagnato as modified by Kim, Whitehurst, and Dougal, by configuring the treatment period to be 20-60 minutes, 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. MPEP 2144.05.
Bagnato is silent regarding repeating the step of directing for at least two additional sessions.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bagnato as modified by Kim, Whitehurst, and Dougal, by adding a step of repeating the step of directing for at least two additional sessions. As an initial matter, merely replicating the treatment step one or more additional times would have been obvious to one of ordinary skill in the art, at least until the desired outcome was achieved. For example, in Perfect Web Tech., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328-29, 92 USPQ2d 1849, 1854 (Fed. Cir. 2009), the Federal Circuit held that mere repetition of a known procedure until success is achieved was merely the logical result of common sense application of the maxim "try, try again." (see MPEP 2143). Regarding the specifics of the instant claim(s), one of ordinary skill in the art before the effective filing date of the invention would have found it obvious to engage in routine experimentation to discover the optimal parameters of the instant claim(s). See MPEP 2144.05(II)(A)("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation")(citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCCPA 1955)).
Re Claim 4, Bagnato discloses that the photon energy output is emitted primarily in a spectral wavelength of 830 nm or 904 nm (para. [0044], The light emitters (3) work in the infrared range, between 600 and 2500nm of the electromagnetic spectrum; para. [0014], The relationship between wavelength and tissue penetration in biological media is known; and, for treatments that require penetration between the layers of skin, muscles and bones, only those belonging to the range between 600 and 1200nm are able to reach the target, which in this proposal are the lungs; para. [0025], LEDs operate at wavelengths in the infrared range near 600 to 2500nm).
Re Claim 19, Bagnato discloses that the photon energy output emitted sweeps over a range of spectral wavelengths (para. [0025], lasers or light emitting diodes (LEDs), which operate at wavelengths in the infrared range near 600 to 2500nm).
Re Claim 26, Bagnato discloses that the pulmonary inflammation is caused by a viral infection (para. [007], Pneumonia is defined as the acute inflammation of the structures of the lung parenchyma that can be caused by different etiological agents (bacteria, viruses, atypical organisms and fungi)).
Re Claim 28, Bagnato discloses directing the photon energy output of the flexible wearable garment primarily to a chest region, a back region opposite a chest region, or both a chest region and a back region opposite a chest region of the human body (para. [0037], the equipment illuminates the entire chest area of the patient; para. [0045], it must be understood that the blanket (1), the sinks (2) and the light emitters (3) form the flexible part of the device, which comes into contact and fits on the patient's back, from where the light must be radiated for the photodynamic inactivation of bacteria that cause pulmonary infections.).
Re Claim 29, Bagnato discloses that the flexible wearable garment is placed in contact with skin of the human body (para. [0037], the equipment illuminates the entire chest area of the patient; para. [0045], it must be understood that the blanket (1), the sinks (2) and the light emitters (3) form the flexible part of the device, which comes into contact and fits on the patient's back, from where the light must be radiated for the photodynamic inactivation of bacteria that cause pulmonary infections.).
Re Claim 30, Bagnato as modified by Kim, Whitehurst, and Dougal discloses the claimed invention substantially as set forth in claim 1.
Bagnato is silent regarding that the photon energy output is directed to at least 20% of a circumference around the torso.
Dougal discloses teaches the flexible wearable garment configured to wrap about a circumference of the torso of the human body (annotated fig. 4C, para. [0076], The main function of this light applicator is to facilitate the simultaneous treatment of all the aspects of the chest from all directions. In the event the light is pulsed, the “ON” pulses all coincide, hence achieving a greater penetration of the target tissue – This disclosure teaches the first array of LEDs extending onto the at least one wing portion), which reads on “the photon energy output is directed to at least 20% of a circumference around the torso”.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bagnato as modified by Kim and Whitehurst, by configuring the photon energy output to be directed to at least 20% of a circumference around the torso, as taught by Dougal, for the purpose of facilitating the simultaneous treatment of all the aspects of the chest from all directions (para. [0076]).
Re Claim 37, Bagnato discloses that the photon energy output is emitted primarily in a spectral wavelength range between 630 to 830 nm (para. [0044], The light emitters (3) work in the infrared range, between 600 and 2500nm of the electromagnetic spectrum; para. [0059], green indocyanine (ICV) was used as a photosensitizer and light with a wavelength of 780 nm for photodynamic inactivation (IFD) in vivo).
Re Claim 46, Bagnato discloses that the flexible wearable garment further comprises:
an adjustable strap; a mechanical fastener to couple the front piece with the chest region of the human body (para. [0047], The two fixing pieces (4) are responsible for establishing the appropriate adjustment of the strips (5) to the patient's body. For this reason, these are arranged one on each strip (5). The fixing parts (4) are in the form of a loop, buckle, velcro or other device that performs this function.); and
a second array of LEDs configured to primarily direct the photon energy output in a torso region of the human body (annotated fig. 4 shows second array of LEDs; para. [0037], the equipment illuminates the entire chest area of the patient).
Re Claim 47, Bagnato as modified by Kim, Whitehurst, and Dougal discloses the claimed invention substantially as set forth in claims 34 and 46.
Bagnato is silent regarding the second array of LEDs is positioned on the adjustable strap.
However, Dougal discloses an apparatus for treatment of COVID-19 respiratory virus, comprising:
a wearable garment configured to at least partially cover a chest region of a human body (fig. 1 and 2, fig. 4A-4E, para. [0071], the apparatus is configured so as to encase the thoracic or chest region of an individual; para. [0087], In COPD there has been destruction of normal lung tissue which has been replaced with scar tissue. Normal lung tissue has a high degree of elasticity which allows the lungs to contract to a small fraction of their volume if it were not for the vacuum between the chest wall and the lungs in the pleural cavity. Loss of this elasticity results in reduced lung compliance and poorer lung function in addition to the destruction of the alveolar lung tissue itself.),
the wearable garment including: a front piece having a first array of LEDs, wherein the first array of LEDs are configured to direct a photon energy output at the chest region when the wearable garment is being worn (para. [0071], the apparatus is configured so as to encase the thoracic or chest region of an individual; para. [0032], a plurality of LEDs arranged on a surface of the apparatus which is to be in contact with or in close proximity to the site being treated of the human or animal body; para. [0069], a series of hinged panels each having a plurality of light emitting devices on the surface which is in contact with or in close proximity to a part of the human or animal body to be treated – one of the panels reads on “the first array of LEDs”).
an adjustable strap (para. [0069], a series of hinged panels each having a plurality of light emitting devices on the surface which is in contact with or in close proximity to a part of the human or animal body to be treated; para. [0074], a series of hinged panels (FIGS. 1 and 2) each panel comprising a light emitting surface and a non-emitting surface. The LEDs may be embedded in the panel or fixedly attached thereto. Panels are hinged at upper and lower edges with an adjacent panel so that the panels are flexible and can be wrapped around a body or body part. The hinges may be releasable detachable so that the series can be two or more panels depending on users requirements – The series of hinged panels, the number of which can be adjusted based on user’s needs reads on “an adjustable strap”);
a mechanical fastener to couple the front piece with the chest region of the human body (para. [0074], Panels are hinged at upper and lower edges with an adjacent panel so that the panels are flexible and can be wrapped around a body or body part. The hinges may be releasable detachable so that the series can be two or more panels depending on users requirements; para. [0015], [0023], the front and back panels of the whole body apparatus are fastened together about the individual by any suitable means such as a snap fit mechanism or clip, the securing means are arranged at the periphery of each panel so that the whole body of the individual may be securely encased in the apparatus.); and
a second array of LEDs configured to primarily direct the photon energy output in a torso region of the human body, wherein the second array of LEDs is positioned on the adjustable strap (para. [0060], exposing at least the thoracic/chest region of an individual suffering from the disease to divergent electromagnetic radiation; para. [0016], the inner surface of the front panel comprises a plurality of means for emitting electromagnetic radiation; para. [0032], a plurality of LEDs arranged on a surface of the apparatus which is to be in contact with or in close proximity to the site being treated of the human or animal body; para. [0069], a series of hinged panels each having a plurality of light emitting devices on the surface which is in contact with or in close proximity to a part of the human or animal body to be treated – one of the hinged panels reads on “the first array of LEDs”, another hinged panel reads on “the second array of LEDs”).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bagnato as modified by Kim, Whitehurst, and Dougal, by adding an adjustable strap and a mechanical fastener to couple the front piece with the chest region of the human body, wherein the second array of LEDs is positioned on the adjustable strap, as taught by Dougal, for the purpose of enabling treatment of large areas of the human body and providing light sources around a body part (para. [0074]).
Re Claim 48, Bagnato as modified by Kim, Whitehurst, and Dougal discloses the claimed invention substantially as set forth in claims 34 and 46.
Bagnato discloses that the apparatus can be used for patient’s back (para. [0045], it must be understood that the blanket (1), the sinks (2) and the light emitters (3) form the flexible part of the device, which comes into contact and fits on the patient's back, from where the light must be radiated for the photodynamic inactivation of bacteria that cause pulmonary infections.).
Bagnato is silent regarding the adjustable strap includes a widened portion forming a back piece, the back piece including the second array of LEDs
However, Dougal discloses an apparatus for treatment of COVID-19 respiratory virus, comprising:
a wearable garment configured to at least partially cover a chest region of a human body (fig. 1 and 2, fig. 4A-4E, para. [0071], the apparatus is configured so as to encase the thoracic or chest region of an individual; para. [0087], In COPD there has been destruction of normal lung tissue which has been replaced with scar tissue. Normal lung tissue has a high degree of elasticity which allows the lungs to contract to a small fraction of their volume if it were not for the vacuum between the chest wall and the lungs in the pleural cavity. Loss of this elasticity results in reduced lung compliance and poorer lung function in addition to the destruction of the alveolar lung tissue itself.),
the wearable garment including: a front piece having a first array of LEDs, wherein the first array of LEDs are configured to direct a photon energy output at the chest region when the wearable garment is being worn (para. [0071], the apparatus is configured so as to encase the thoracic or chest region of an individual; para. [0032], a plurality of LEDs arranged on a surface of the apparatus which is to be in contact with or in close proximity to the site being treated of the human or animal body; para. [0069], a series of hinged panels each having a plurality of light emitting devices on the surface which is in contact with or in close proximity to a part of the human or animal body to be treated – one of the panels reads on “the first array of LEDs”).
an adjustable strap (para. [0069], a series of hinged panels each having a plurality of light emitting devices on the surface which is in contact with or in close proximity to a part of the human or animal body to be treated; para. [0074], a series of hinged panels (FIGS. 1 and 2) each panel comprising a light emitting surface and a non-emitting surface. The LEDs may be embedded in the panel or fixedly attached thereto. Panels are hinged at upper and lower edges with an adjacent panel so that the panels are flexible and can be wrapped around a body or body part. The hinges may be releasable detachable so that the series can be two or more panels depending on users requirements – The series of hinged panels, the number of which can be adjusted based on user’s needs reads on “an adjustable strap”);
a mechanical fastener to couple the front piece with the chest region of the human body (para. [0074], Panels are hinged at upper and lower edges with an adjacent panel so that the panels are flexible and can be wrapped around a body or body part. The hinges may be releasable detachable so that the series can be two or more panels depending on users requirements; para. [0015], [0023], the front and back panels of the whole body apparatus are fastened together about the individual by any suitable means such as a snap fit mechanism or clip, the securing means are arranged at the periphery of each panel so that the whole body of the individual may be securely encased in the apparatus.); and
a second array of LEDs configured to primarily direct the photon energy output in a torso region of the human body, wherein the adjustable strap includes a portion forming a back piece, the back piece including the second array of LEDs (para. [0060], exposing at least the thoracic/chest region of an individual suffering from the disease to divergent electromagnetic radiation; para. [0016], the inner surface of the front panel comprises a plurality of means for emitting electromagnetic radiation; para. [0032], a plurality of LEDs arranged on a surface of the apparatus which is to be in contact with or in close proximity to the site being treated of the human or animal body; para. [0014], the apparatus comprising a front and back panel the front and/or back panels being contoured or profiled to fit about the chest or torso of an individual; para. [0069], a series of hinged panels each having a plurality of light emitting devices on the surface which is in contact with or in close proximity to a part of the human or animal body to be treated – one of the hinged panels reads on “the first array of LEDs”, another hinged panel for patient’s back reads on “the back piece including the second array of LEDs”).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bagnato as modified by Kim, Whitehurst, and Dougal, by adding an adjustable strap and a mechanical fastener to couple the front piece with the chest region of the human body, wherein the adjustable strap includes a portion forming a back piece, the back piece including the second array of LEDs, as taught by Dougal, for the purpose of enabling treatment of large areas of the human body and providing light sources to the patient’s back (para. [0074], [0014]).
Dougal is silent regarding “a widened portion” forming a back piece.
Dougal discloses that the apparatus comprising a front and back panel the front and/or back panels being contoured or profiled to fit about the chest or torso of an individual (para. [0014]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bagnato as modified by Kim, Whitehurst, and Dougal, by configuring the portion forming a back piece to be a widened portion, for the purpose of contouring and profiling the back piece to fit about the patient’s back (Dougal, para. [0014], the apparatus comprising a front and back panel the front and/or back panels being contoured or profiled to fit about the chest or torso of an individual) and since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. MPEP 2144.04 IV.
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Re Claim 52, Bagnato as modified by Kim, Whitehurst, and Dougal discloses the claimed invention substantially as set forth in claim 34.
Bagnato discloses that the LEDs of the flexible wearable garment are configured to deliver 4-20 J/cm2 (para. [0044], lighting doses varying between 4 and 150 J/cm2).
Bagnato is silent regarding a treatment period of 20 to 60 minutes.
Bagnato disclose providing claimed wavelengths (para. [0025], LEDs operate at wavelengths in the infrared range near 600 to 2500nm) with claimed lighting dose of 4-20 J/cm2 (para. [0044], lighting doses varying between 4 and 150 J/cm2) and operating time (para. [0051], The parameterization buttons (9) are intended to provide the selection by the operator of the light emitters (3) that will work, the irradiation power and the operating time. With this, it is possible to adjust the light irradiation according to the needs of each patient, in an individual, specific and simplified way) for the purpose of treating viral respiratory illness (para. [007], Pneumonia is defined as the acute inflammation of the structures of the lung parenchyma that can be caused by different etiological agents (bacteria, viruses, atypical organisms and fungi), Initially, it appears as a colonization of the nasopharyngeal mucosa, later spreading to the lower respiratory tract).
Bagnato discloses that there is a treatment time (para. [0051], operating time) based on the needs of each patient (para. [0051]) while light wavelengths are between 600 and 2500nm of the electromagnetic spectrum with lighting intensity between 10 and 1200 mW/cm2 and lighting doses varying between 4 and 150 J/cm2 (para. [0044]).
Treatment time is a result-effective variable together with light intensity to determine light doses.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bagnato, by configuring the treatment period to be 20 to 60 minutes, 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. MPEP 2144.05.
Re Claim 53, Bagnato discloses that the directing the photon energy output of the flexible wearable garment comprises delivering a dose of 4-20 J/cm2 of light to the torso of the human body (para. [0044], lighting doses varying between 4 and 150 J/cm2).
Re Claim 54, Bagnato as modified by Kim, Whitehurst, and Dougal discloses the claimed invention substantially as set forth in claims 1 and 53.
Bagnato discloses directing the photon energy output of the flexible wearable garment comprises delivering light to the torso of the human body (para. [0037], the equipment illuminates the entire chest area of the patient; para. [0045], it must be understood that the blanket (1), the sinks (2) and the light emitters (3) form the flexible part of the device, which comes into contact and fits on the patient's back, from where the light must be radiated for the photodynamic inactivation of bacteria that cause pulmonary infections).
Bagnato is silent regarding directing the photon energy output for a treatment period of 20 to 60 minutes.
Bagnato disclose providing claimed wavelengths (para. [0025], LEDs operate at wavelengths in the infrared range near 600 to 2500nm) with claimed lighting dose of 4-20 J/cm2 (para. [0044], lighting doses varying between 4 and 150 J/cm2) and operating time (para. [0051], The parameterization buttons (9) are intended to provide the selection by the operator of the light emitters (3) that will work, the irradiation power and the operating time. With this, it is possible to adjust the light irradiation according to the needs of each patient, in an individual, specific and simplified way) for the purpose of treating viral respiratory illness (para. [007], Pneumonia is defined as the acute inflammation of the structures of the lung parenchyma that can be caused by different etiological agents (bacteria, viruses, atypical organisms and fungi), Initially, it appears as a colonization of the nasopharyngeal mucosa, later spreading to the lower respiratory tract).
Bagnato discloses that there is a treatment time (para. [0051], operating time) based on the needs of each patient (para. [0051]) while light wavelengths are between 600 and 2500nm of the electromagnetic spectrum with lighting intensity between 10 and 1200 mW/cm2 and lighting doses varying between 4 and 150 J/cm2 (para. [0044]).
Treatment time is a result-effective variable together with light intensity to determine light doses.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bagnato as modified by Kim, Whitehurst, and Dougal, by configuring the treatment period to be 20 to 60 minutes, 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. MPEP 2144.05.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Bagnato (BR 102019002501 – Please see the translation copy provided on 6/18/2025) as modified by Kim (KR 20120078037 – Please see the translation copy provided on December 17, 2024), Whitehurst (US 6,645,230), and Dougal (US 2011/0178582), and further in view of Harris et al. (US 2010/0234925).
Re Claim 18, Bagnato as modified by Kim, Whitehurst, and Dougal discloses the claimed invention substantially as set forth in claim 1.
Bagnato discloses that the photon energy output is emitted in a pulsating pattern (para. [0019], the use of low-intensity infrared laser and that is pulsed).
Bagnato is silent regarding the pulsating pattern being a 50% duty cycle at a rate of 2.5 Hz or a 50% duty cycle at 10 Hz.
However, Harris discloses a light therapy for various pneumonias (e.g., bacterial, viral, and fungal) (para. [0142]) and teaches a wavelength range of 550 nm and 1800 nm (para. [0021]) and 50% duty cycle at 20 Hz (para. [0103], For example, as shown in FIG. 4A, a burst 22 may last for 1/2 second and have 10 pulses (i.e., pulses repeated at 20 Hz), with the duty cycle being one half on, and one half off for the bursts).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bagnato as modified by Kim, Whitehurst, and Dougal, by configuring the pulsating pattern to be a 50% duty cycle at a rate of 20 Hz, as taught by Harris, for the purpose of treatment of viral lower respiratory illness (para. [0142]).
Harris is silent regarding pulsating pattern at 2.5 Hz or 10 Hz.
The pulse repetition rate is a result-effective variable to determine light dosage (para. [0104], Increasing the number of pulses may also result in damage or harm to the host by excess heating. Cycling of the laser energy (i.e., the duty cycle) on and off between bursts can help to limit the thermal accumulation in the host, yet still provides thermal accumulation in the target; para. [0105], para. [0108], By increasing the number of pulses, the amount of energy for each pulse at a given depth within the host may be decreased. However, the use of multiple pulses may result in thermal heating of the host, which may cause pain or damage to the host. Thus, an evaluation can be made whether the increased number of pulses is damaging to the host; para. [0109]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bagnato as modified by Kim, Whitehurst, Dougal, and Harris, by configuring the pulsating pattern to be a 50% duty cycle at a rate of 2.5 Hz or a 50% duty cycle at 10 Hz, 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. MPEP 2144.05
Conclusion
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/JONATHAN T KUO/ Primary Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, September 30, 2025Examiner, Art Unit 3792