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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-13) and sub-species 1A (Fig. 4B) in the reply filed on 08/10/2026 is acknowledged.
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-13 are hereby considered pending and under examination.
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 1-13 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 1, the limitation, “the group consisting of…” lacks antecedent basis.
In re claim 4, the limitation, “the group consisting of…” lacks antecedent basis.
In re claim 10, the limitation, “the pulse frequency of the SPDT relay” lacks antecedent basis.
In re claim 13, the limitation, “the group consisting of…” lacks antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-6, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oron (US 6,537,304).
In re claim 1, Oron discloses a device (fig. 3: 40) for treating neonatal (Col. 4, lines 47-60: treating newborns) intraventricular hemorrhage or brain injury (Col. 3, lines 40-43: treatment of an ischemic region of brain cells in a cranium; Col. 2, lines 42-51: apparatus results in a regenerative process in injured brain cells in an ischemic zone), the device comprising:
at least one laser (fig. 3: laser source 12; Col. 3, lines 52-65: multiple laser sources 12 may be used such as in apparatus 10; Col. 6, lines 40-47: invention may include combinations of features) configured to emit laser energy directed to a fontanelle or unfused suture of a neonatal cranium (Col. 4, lines 47-60: laser energy may be delivered to fontanels of newborns); and
a control unit (fig. 1: combination of 15 and 1; Col. 3, lines 52-65) electronically coupled to the at least one laser (fig. 1: 15 is controlled to lasers 12; Col. 3, lines 52-65),
the control unit configured to determine at least one laser parameter (Col. 3, lines 52-65: servo system 18 includes actuators 20 which can move laser sources further or closer to a cranium);
wherein the at least one laser parameter is selected from the group consisting of
a wavelength,
an irradiance intensity,
a voltage intensity,
a power output (Col. 4, lines 54-56: different energy delivery coefficients may be calculated and would affect power output),
a focus angle,
a focus distance (Col. 3, lines 52-65: moving the laser sources would control a focus distance),
a duration of emission (Col. 5, lines 39-43: duration of laser emission is 2 minutes),
a mode of emission, and
a pulse frequency.
In re claim 2, Oron discloses further comprising a platform (skull covering 14; Col. 3, lines 52-58) configured to hold (fig. 1) and position (fig. 1) a neonate during treatment (Col. 4, lines 50-54: skull coverings of different sizes may be used for a newborn, which would hold and position their skull during treatment; fig. 1).
Additionally, the limitation, “a platform configured to hold and position a neonate during treatment” is a recitation of functional language of the claimed invention.
The recitation of functional language must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim.
In this case, the platform has all the necessary structures to result in the platform being configured to hold and position a neonate during treatment; see MPEP § 2114 (I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432).
In re claim 3, Oron discloses wherein the platform comprises a cranial holder (Col. 3, lines 14-18: apparatus is a skull covering to focus a plurality of laser beams into a cranium; fig. 1) configured to expose and secure the neonatal cranium (Col. 4, lines 47-60: laser beam paths are positioned into the cranium of a newborn and would require securing and exposing the neonatal cranium, such as with skull covering 14; fig. 1) to allow laser energy to reach
the fontanelle (Col. 4, lines 47-60) or
unfused suture (optional).
Additionally, the limitation, “wherein the platform comprises a cranial holder configured to expose and secure the neonatal cranium to allow laser energy to reach the fontanelle or unfused suture” is a recitation of functional language of the claimed invention.
The recitation of functional language must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim.
In this case, the platform and cranial holder have all the necessary structures to result in the cranial holder being configured to expose and secure the neonatal cranium to allow laser energy to reach the fontanelle or unfused suture; see MPEP § 2114 (I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432).
In re claim 5, Oron discloses wherein the laser energy is directed through a neonate's Anterior Fontanelle, Posterior Fontanelle, or Sagittal Suture (see in re claim 1 above, where laser energy may be delivered to fontanels of newborns).
Additionally, the limitation, “wherein the laser energy is directed through a neonate's Anterior Fontanelle, Posterior Fontanelle, or Sagittal Suture” is a recitation of functional language of the claimed invention.
The recitation of functional language must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim.
In this case, the device has all the necessary structures to result in the laser energy being directed through a neonate's Anterior Fontanelle, Posterior Fontanelle, or Sagittal Suture; see MPEP § 2114 (I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432).
In re claim 6, Oron discloses wherein the control unit is configured to store the at least one laser parameter (see in re claim 1 above, where it’s inherent that parameters such as a duration of emission, energy delivery coefficients, and a distance that the laser should be positioned would be stored by the control unit).
In re claim 8, Oron discloses comprising twelve lasers arranged in a circle or an arc (fig. 1: at least 12 laser sources are arranged in an arc; Col. 6, lines 40-47: invention may include combinations of features).
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 4, 7, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Oron (US 6,537,304) in view of Coleman (US 2021/0112647).
In re claim 4, Oron fails to disclose wherein the at least one laser comprises a laser selected from the group consisting of:
Light-Emitting Diodes (LEDs),
Vertical-Cavity Surface-Emitting Lasers (VCSELs),
Quantum Cascade Lasers (QCLs),
Semiconductor Lasers,
Solid-State Lasers,
Fiber Lasers,
Diode-Pumped Solid-State Lasers (DPSSLs),
Optical Amplifiers, and
Organic Light- Emitting Diodes (OLEDs).
Coleman teaches a system comprising an Angularly Varying Light Emitting Device (AVLED) [0003] for photomodulation [0231] to benefit traumatic brain injury [0231] using a spatial array light source [0231], and teaches
wherein the spatial array light source may be selected from a group consisting of:
Light-Emitting Diodes (LEDs) [0077] and
Organic Light- Emitting Diodes (OLEDs) [0077]; and
wherein a wavelength of a laser energy is about 650 nm to about 660 nm ([0038]: AVLED light source may within a wavelength range of 400 nanometers to 700 nanometers).
Coleman further teaches that the spatial array light source may be selected from a variety of light sources [0077, 0079], depending on which dimensions and features are preferred [0077].
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 Oron, to provide wherein the at least one laser comprises a laser selected from the group consisting of Light-Emitting Diodes (LEDs) and Organic Light- Emitting Diodes (OLEDs),and wherein a wavelength of a laser energy is about 650 nm to about 660 nm, as taught by Coleman, because the laser may be selected from a variety of light sources, depending on which dimensions and features are preferred.
In re claim 7, Oron fails to disclose wherein the control unit includes a display and user interface for monitoring and adjusting the at least one laser parameter.
Coleman teaches wherein a control unit ([0033]: portion of AVLED which electrically controls light output based on user input or sensor input; [0162]: user input may adjust illumination and/or irradiation)
includes a display [0162] and user interface [0162] for monitoring ([0162]: monitors spatial zones where illumination and/or irradiation may be controlled or changes) and adjusting at least one laser parameter ([0162]: user may select spatial zones where illumination and/or irradiation is controlled or changes, including adjusting specific illumination and/or irradiation properties, as well as change wavelengths and colors of light sources, which would affect power output).
Coleman further teaches that the user interface may be used to adjust various laser parameters [0162] and also allows a user to select which spatial zones should receive illumination and/or irradiation [0162].
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 Oron, to provide wherein the control unit includes a display and user interface for monitoring and adjusting the at least one laser parameter, as taught by Coleman, because the user interface may be used to adjust various laser parameters and also allows a user to select which spatial zones should receive illumination and/or irradiation.
In re claim 11, regarding the limitation, “wherein the wavelength of the laser energy is about 650 nm to about 660 nm”, see in re claim 4 above.
At the time the instant application was filed it would be obvious to try to provide wherein the wavelength of the laser energy is about 650 nm to about 660 nm. 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 wavelength of the laser energy is not disclosed as being crucial or unexpected.
Even if the proposed combination fails to yield “wherein the wavelength of the laser energy is about 650 nm to about 660 nm”, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the wavelength of the laser energy is about 650 nm to about 660 nm, 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.
In re claim 12, Oron discloses wherein the control unit is electronically coupled to at least one physiological monitoring device (heartbeat sensor probe 42) configured to monitor a physiological parameter (Col. 4, lines 26-31: heartbeat sensor probe would provide monitoring of a physiological parameter).
Oron fails to disclose wherein the control unit is configured to adjust the at least one laser parameter in response to the physiological parameter.
Coleman teaches wherein the control unit is configured to adjust at least one laser parameter in response to a physiological parameter ([0033]: controller such as a program on an input device may respond automatically to sensor input to change angular output and light flux output, which would affect power outage; [0098]: sensor may be a heart rate or heartbeat monitor).
Coleman further teaches that the physiological parameter may be used to automatically change the at least one laser parameter [0033].
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 Oron, to provide wherein the control unit is configured to adjust the at least one laser parameter in response to the physiological parameter, as taught by Coleman, because the physiological parameter may be used to automatically change the at least one laser parameter.
In re claim 13, the proposed combination yields wherein the physiological parameter comprises a parameter selected from the group consisting of:
cerebral oxygenation,
blood pressure,
heart rate (see Oron: Col. 4, lines 26-31; see also Coleman: [0098]),
temperature,
electrocardiogram (ECG),
respiratory rate (RR),
oxygen saturation (SpO2),
end- tidal C02 (ETCO2),
cardiac output (CO),
central venous pressure (CVP),
intracranial pressure (ICP),
arterial blood gas (ABG),
non-invasive cardiac monitoring (NICOM),
pulse pressure, and
mean arterial pressure (MAP).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Oron (US 6,537,304) in view of Meloul et al. (US 6,013,020).
In re claim 9, Orna discloses comprising
a first set of lasers (fig. 1: first set of lasers may be interpreted as first 6 lasers going from left to right of lasers 12) and
a second set of lasers (fig. 1: second set of lasers may be interpreted as last 7 lasers going from right to left of lasers 12).
Orna fails to disclose wherein the control unit is configured to operate the first and second sets of lasers in a Single Pole Double Throw (SPDT) relay.
Meloul teaches an intraluminal radiation system (Col. 1, lines 9-15) for delivery of treatment elements in a patient (Col. 1, lines 9-15), and teaches wherein
a control unit (Col. 32, lines 43-51: sleep circuit comprising of on-switch 666) is configured to operate lasers (Col. 32, lines 43-67: on-switch and sleep circuit are used to control LEDs 508a and 508b) in a Single Pole Double Throw (SPDT) relay (Col. 32, lines 43-67) and
wherein the pulse frequency of the SPDT relay is 3.4 Hz (Col. 32, lines 43-67).
Meloul further teaches that the SPDT relay may be used to control power supply (Col. 32, lines 43-67).
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 Oron, to provide wherein the control unit is configured to operate the first and second sets of lasers in a Single Pole Double Throw (SPDT) relay and wherein the pulse frequency of the SPDT relay is 10 Hz, as taught by Meloul, because the SPDT relay may be used to control power supply.
In re claim 10, regarding the limitation, “wherein the pulse frequency of the SPDT relay is 10 Hz”, see in re claim 9 above.
At the time the instant application was filed it would be obvious to try to provide wherein the pulse frequency of the SPDT relay is 10 Hz. 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 pulse frequency of the SPDT relay is not disclosed as being crucial or unexpected.
Even if the proposed combination fails to yield “wherein the pulse frequency of the SPDT relay is 10 Hz”, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the pulse frequency of the SPDT relay is 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. In re Aller, 105 USPQ 233.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Cassano et al. (US 2022/0323784) discloses a photobiomodulation therapy garment (abstract) that comprises of one or more near-infrared light sources (abstract) that applied light to a brain [0003].
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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