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 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: “locking mechanism attached to the frame for coupling the pair of reflectors by inserting the edges” in claims 1 and 11.
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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 8 recites the limitation “the frame is made from an ultra-lightweight, flexible, resistant to breakage thermoplastic material configured to adapt any face shape of the patient for maximum comfort” which lack sufficient written description. The limitation and disclosure describe the desired properties of the thermoplastic material of the claimed frame but do not identify the frame material. Thus, the disclosure does not demonstrate the applicant is was in possession of the claimed thermoplastic material at the time of filing.
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 1-9, 11-12 and 20 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.
Regarding claim 1, the metes and bounds of the claim limitations “a pair of reflectors attached to the frame via a locking mechanism” in line 6 and “a locking mechanism attached to the frame for coupling the pair of reflectors” in line 12 cannot be determined by the examiner. It is unclear whether the claim requires two separate locking mechanisms or only a single locking mechanism. The disclosure appears to disclose only one locking mechanism (#122). In an effort to promote compact prosecution, the claim is interpreted to require only one locking mechanism.
Claim 1 recites the limitation "the edges" in line 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the edges" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 12, the metes and bounds of the claim limitations “a storage case” in line 1 cannot be determined by the examiner. It is unclear whether the claim requires a second storage case or if the storage case is the same storage case recited in line 5 of claim 10. The disclosure appears to disclose only one storage case (#102). In an effort to promote compact prosecution, the claim is interpreted to require only one storage case.
Claim 20 recites the limitation "the head strap" in line 3. There is insufficient antecedent basis for this limitation in the claim. A head strap is recited in claim 11; however, claim 20 depends from claim 10.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Tedford et al. (US 2016/0067087) in view of Tapper et al. (US 2016/0051834), Colbaugh et al. (US 2020/0094015), and Masters et al. (US 2020/0159039).
[Claims 1, 4] Tedford discloses a photobiomodulation light therapy device (wearable ophthalmic phototherapy device, #200) comprising:
a frame (#202) extending axially and longitudinally along a bridge (front piece, #204) present in middle of the frame, the frame is configured to be supported on a nose of a patient when worn and positioned in front of a respective eye of the patient [par. 0068];
a pair of reflectors (arrays, #208, which would reflect some amount of light from the areas in between light sources, #210) attached to the frame, one of the pair of reflectors (left array) is adapted to encircle a first eye and other reflector in the pair of reflectors (right array) is adapted to encircle a second eye [par. 0068];
a supporting element associated with the pair of reflectors (see annotated figure);
light modules (light sources, #210a-c) having LED red lights emitting light of specific wavelengths (the light source may be LEDs of 670 nm) [pars. 0069, 0119] with a predefined irradiance level to stimulate cellular function within the eyes placed at a predetermined distance on the pair of reflectors for emitting light penetrating into eyelids of the respective eye of the patient for treating the eyes and the surrounding ocular region including skin of the patient (the selection of the appropriate irradiance of the light beam emitted from the emission surface to achieve a desired irradiance at the level of the target ocular tissue preferably includes, among other factors, the wavelength or wavelengths of light selected, the type of disease (if any), the clinical condition of the subject, and the distance to the target region) [par. 0085] for a pre-set time [par. 0164];
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a button coupled to the frame via an attachment (at least one button incorporated into the frame which implicitly requires attachment), the button is configured to turn ON and OFF the light modules (used to initiate, terminate, or alter operation) [par. 0068]; and
a port connector attached to the frame (port in the frame providing a wired connection), the USB port connector configured to provide power input to the photobiomodulation light therapy device.
Tedford is silent regarding the manner in which the reflectors are attached to the frame and does not disclose a locking mechanism attached to the frame for coupling the pair of reflectors by inserting edges pointing out of the pair of reflectors to the locking mechanism associated with the frame.
Tapper discloses an analogous light therapy device comprising a support frame (Figs. 3-4 #20) that is secured to lenses (Figs. 3-4#24) via snap-out pivot connections (Figs. 3-4 #22) that interface with edges pointing out of the lenses (see annotated figure) [par. 0086].
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It would have been obvious to one having ordinary skill in the art before the effective filing date to configure the device of Tedford to include snap-out pivot connections between the frames and the edges of the reflectors as taught by Tapper in order to securely attach the reflectors to the frame.
Tedford does not disclose the supporting element is a downward V-shaped cushioned element complementary to the shape cut-out formed in the middle of the pair of reflectors.
Tapper discloses a nose bridge (Figs. 3-4 #26) that is a downward V-shaped element complementary to the shape cut-out formed in the middle of the pair of lenses [par. 0086]. The examiner take Official Notice that nose bridges are well-known to be cushioned to provide additional comfort to the wearer.
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the device of Tedford to include a cushioned, V-shaped supporting element as taught by Tapper in order to provide comfort and provide a secure fit of the frames on the wearer.
Tedford discloses a wired port but does not disclose the port is a USB port connector to provide power to the device.
Colbaugh discloses an analogous light therapy device comprising a power module (Fig. 2B #230) in the form of a USB power connection (Fig. 2B #230A) integrated into the frame of glasses [par. 0068].
It would have been obvious to one having ordinary skill in the art before the effective filing date to configure the port of Tedford to be a USB port connector as taught by Colbaugh in order to power the device.
Tedford does not disclose an adjustable head strap inserted into a side cavity present on both ends of the frame.
Masters discloses frames comprising side cavities (receiving portions, Fig. 17 #81) on the ends of the frame configured to receive protruding portions (Figs. 18A-B #82) of an adjustable, detachable head strap (retaining strap, Figs. 18A-B #70) [pars. 0048-0049].
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the device of Tedford to include an detachable, adjustable head strap inserted into a side cavity present on both ends of the frame as taught by Masters in order to hold the frames more securely to a wearer.
[Claim 3] Tedford discloses the specific wavelength emits light in the red spectrum of about 670 nanometers (670 nm ± 10%) [pars. 0041, 0119].
[Claim 5] Tedford discloses the pre-set time is about 3 minutes (treatment period of 1 to 5 minutes) establishing a safe treatment time without the need of external timing devices [par. 0164].
[Claim 6] Tedford discloses the photobiomodulation light therapy deice automatically turns off when the pre-set time reaches 3 minutes (a programmable controller controls a timer that implicitly turns off the device when the pre-set, scheduled time is reached) [par. 0164].
[Claim 7] Tedford discloses the predefined irradiance level is 45 mw/cm2 (irradiance between 10 mW/cm2 to 100 mW/cm2) [par. 0129]. It would have been obvious to one having ordinary skill in the art before the effective filing date to select an irradiance of 45 mw/cm2, because one in the art would have chosen from within the suitable operating irradiance range taught by Tedford for providing treatment to the eyes and skin.
[Claim 9] Tedford implicitly discloses a distance between the light modules and the eye lid but does not disclose an optimized distance between the light modules and the eye lid that is equal to about 3 to 4 millimeters. However, Tedford does disclose the desired irradiance is affected by the distance to the target region [par. 0085]. It would have been obvious to one having ordinary skill in the art before the effective filing date to select a distance of about 3 to 4 millimeters at which to position the light modules and to calculate the irradiance because about 3 to 4 millimeters is in the distance range that frames worn around the head and on the nose are positioned from the eye lids.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Tedford et al. (US 2016/0067087) in view of Tapper et al. (US 2016/0051834), Colbaugh et al. (US 2020/0094015), and Masters et al. (US 2020/0159039) as applied to claim 1 above, and further in view of Dewey et al. (US 2012/0197357).
[Claim 2] Tedford discloses a battery configured to provide power to the photobiomodulation device [par. 0068]. Tedford does not disclose an indicator light present on the button configured to indicate power of the photobiomodulation light therapy device.
Dewey discloses a analogous light therapy device comprising a power button (#38) at least partially backlit with power button LED indicator ring (#38a) [par. 0091].
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the button of Tedford to include an LED indicator ring in the button as taught by Dewey in order to indicate the power state of the device.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tedford et al. (US 2016/0067087) in view of Tapper et al. (US 2016/0051834), Colbaugh et al. (US 2020/0094015), and Masters et al. (US 2020/0159039) as applied to claim 1 above, and further in view of Collini et al. (US 2018/0298181).
[Claim 8] Tedford discloses the frame but does not disclose the frame is made from an ultra-lightweight, flexible, resistant to breakage thermoplastic material configured to adapt any face shape of the patient for maximum comfort.
Collini discloses an analogous glass frame made of a lightweight, flexible, impact resistant thermoplastic material that may be heated for adjustment [pars. 0046, 0078].
It would have been obvious to one having ordinary skill in the art before the effective filing date to select a thermoplastic material as taught by Collini from which to construct the frames in order to provide a comfortable and impact resistant frame.
Claims 10, 12-13 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Tedford et al. (US 2016/0067087) in view of Woodman et al. (US 2019/0369402) and Colbaugh et al. (US 2020/0094015).
[Claims 10, 12, 15] Tedford discloses a light therapy system comprising:
a photobiomodulation device (wearable ophthalmic phototherapy device, #200) including:
a frame (#202) extending axially and longitudinally along a bridge (front piece, #204) present in middle of the frame, the frame is configured to be supported on a nose of a patient when worn and positioned in front of a respective eye of the patient [par. 0068];
a pair of reflectors (arrays, #208, which would reflect some amount of light from the areas in between light sources, #210) attached to the frame, one of the pair of reflectors (left array) is adapted to encircle a first eye and other reflector in the pair of reflectors (right array) is adapted to encircle a second eye [par. 0068];
light modules (light sources, #210a-c) having LED red lights emitting light of specific wavelengths (the light source may be LEDs of 670 nm) [pars. 0069, 0119] with a predefined irradiance level to stimulate cellular function within the eyes placed at a predetermined distance on the pair of reflectors for emitting light penetrating into eyelids of the respective eye of the patient for treating the eyes and the surrounding ocular region including skin of the patient (the selection of the appropriate irradiance of the light beam emitted from the emission surface to achieve a desired irradiance at the level of the target ocular tissue preferably includes, among other factors, the wavelength or wavelengths of light selected, the type of disease (if any), the clinical condition of the subject, and the distance to the target region) [par. 0085] for a pre-set time [par. 0164];
a button coupled to the frame via an attachment (at least one button incorporated into the frame which implicitly requires attachment), the button is configured to turn ON and OFF the light modules (used to initiate, terminate, or alter operation) [par. 0068]; and
a port connector attached to the frame (port in the frame providing a wired connection), the USB port connector configured to provide power input to the photobiomodulation light therapy device.
Tedford does not disclose a storage case.
Woodman discloses an analogous wearable device including a storage case (#600) and a charging device/cord (#602). The storage case is waterproof, dust proof, and/or radiation proof protect the wearable device and can serve as an interface for the charging device and wearable device [par. 0061, 0067].
It would have been obvious to one having ordinary skill in the art before the effective filing date to include a storage case as taught by Woodman in order to protect the photobiomodulation device and provide a charging interface.
Tedford discloses a wired port but does not disclose the port is a USB port connector to provide power to the device.
Colbaugh discloses an analogous light therapy device comprising a power module (Fig. 2B #230) in the form of a USB power connection (Fig. 2B #230A) integrated into the frame of glasses [par. 0068].
It would have been obvious to one having ordinary skill in the art before the effective filing date to configure the port of Tedford to be a USB port connector as taught by Colbaugh in order to power the device.
[Claim 13] Tedford discloses a battery configured to provide power to the photobiomodulation device [par. 0068].
[Claim 16] Tedford discloses the specific wavelength emits light in the red spectrum of about 670 nanometers (670 nm ± 10%) [pars. 0041, 0119].
[Claim 17] Tedford discloses the predefined irradiance level is 45 mw/cm2 (irradiance between 10 mW/cm2 to 100 mW/cm2) [par. 0129]. It would have been obvious to one having ordinary skill in the art before the effective filing date to select an irradiance of 45 mw/cm2, because one in the art would have chosen from within the suitable operating irradiance range taught by Tedford for providing treatment to the eyes and skin.
[Claim 18] Tedford implicitly discloses a distance between the light modules and the eye lid but does not disclose an optimized distance between the light modules and the eye lid that is equal to about 3 to 4 millimeters. However, Tedford does disclose the desired irradiance is affected by the distance to the target region [par. 0085]. It would have been obvious to one having ordinary skill in the art before the effective filing date to select a distance of about 3 to 4 millimeters at which to position the light modules and to calculate the irradiance because about 3 to 4 millimeters is in the distance range that frames worn around the head and on the nose are positioned from the eye lids.
[Claim 19] Tedford discloses the pre-set time is about 3 minutes (treatment period of 1 to 5 minutes) establishing a safe treatment time without the need of external timing devices [par. 0164].
Claims 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Tedford et al. (US 2016/0067087) in view of Woodman et al. (US 2019/0369402) and Colbaugh et al. (US 2020/0094015) as applied to claim 10 above, and further in view of Masters et al. (US 2020/0159039) and Tapper et al. (US 2016/0051834).
[Claims 11, 20] Tedford does not disclose an adjustable head strap inserted into a side cavity present on both ends of the frame.
Masters discloses frames comprising side cavities (receiving portions, Fig. 17 #81) on the ends of the frame configured to receive protruding portions (Figs. 18A-B #82) of an adjustable, detachable head strap (retaining strap, Figs. 18A-B #70) [pars. 0048-0049].
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the device of Tedford to include an detachable, adjustable head strap inserted into a side cavity present on both ends of the frame as taught by Masters in order to hold the frames more securely to a wearer.
Tedford does not disclose a supporting element is a downward V-shaped cushioned element complementary to the shape cut-out formed in the middle of the pair of reflectors.
Tapper discloses a nose bridge (Figs. 3-4 #26) that is a downward V-shaped element complementary to the shape cut-out formed in the middle of the pair of lenses [par. 0086]. The examiner take Official Notice that nose bridges are well-known to be cushioned to provide additional comfort to the wearer.
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the device of Tedford to include a cushioned, V-shaped supporting element as taught by Tapper in order to provide comfort and provide a secure fit of the frames on the wearer.
Tedford is silent regarding the manner in which the reflectors are attached to the frame and does not disclose a locking mechanism attached to the frame for coupling the pair of reflectors by inserting edges pointing out of the pair of reflectors to the locking mechanism associated with the frame.
Tapper discloses an analogous light therapy device comprising a support frame (Figs. 3-4 #20) that is secured to lenses (Figs. 3-4#24) via snap-out pivot connections (Figs. 3-4 #22) that interface with edges pointing out of the lenses (see annotated figure) [par. 0086].
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It would have been obvious to one having ordinary skill in the art before the effective filing date to configure the device of Tedford to include snap-out pivot connections between the frames and the edges of the reflectors as taught by Tapper in order to securely attach the reflectors to the frame.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Tedford et al. (US 2016/0067087) in view of Woodman et al. (US 2019/0369402) and Colbaugh et al. (US 2020/0094015). as applied to claim 10 above, and further in view of Dewey et al. (US 2012/0197357).
[Claim 14] Tedford discloses a button but does not disclose an indicator light present on the button configured to indicate power of the photobiomodulation light therapy device.
Dewey discloses a analogous light therapy device comprising a power button (#38) at least partially backlit with power button LED indicator ring (#38a) [par. 0091].
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the button of Tedford to include an LED indicator ring in the button as taught by Dewey in order to indicate the power state of the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN J JENNESS whose telephone number is (571)270-5055. The examiner can normally be reached M-F 8:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edward Lefkowitz can be reached at 571-272-2180. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN J JENNESS/Supervisory Patent Examiner, Art Unit 3733 08 August 2025