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 Invention I in the reply filed on 6/3/2026 is acknowledged.
Claims 8-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/3/2026.
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 6-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements and essential method steps, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships and/or steps are: It is unclear if the treatment applicator and glasses in claims 6 and 7 are structurally related to or part of the step of providing PEMF stimulation to the patient’s eyes as set forth in claim 1.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang ( US 20020035358) hereinafter Wang in view of Varani et al. , Adenosine Receptors as a Biological Pathway for the Anti-Inflammatory and Beneficial Effects of Low Frequency Low Energy Pulsed Electromagnetic Fields, Mediators of Inflammation Volume 2017, Article ID 2740963, 11 pages, Published 1 February 2017. Hereinafter Varani et al.
Wang teaches a method for treating corneal ulcers and other corneal conditions with pulsed electromagnetic fields (PEMFs). Specifically, the present invention includes a two part treatment regimen having particular waveforms, intensities, durations, pulse delays, and stepped frequency modulations which maximize the intrinsic healing capacity of cornea. [0004] In certain preferred embodiments, a PEMF is administered to generate or to enhance a wound healing response of a corneal condition. In certain embodiments, a PEMF is administered to stimulate a release of biological factors from a limbal vasculature including, but not limited to: epidermal growth factor (EGF), the transforming growth factor family of growth factors (TGF, including TGF.alpha. and TGF.beta.), and cytokines. In certain embodiments, a PEMF is administered to increase nerve impulse to the cornea. In certain embodiments, a PEMF is administered to induce and accelerate corneal keratocyte activation. In certain embodiments, a PEMF is administered to induce corneal fibroblast transformation, proliferation, and migration. In certain embodiments, a PEMF is administered to induce and accelerate corneal epithelial cell proliferation or migration, especially in the epithelial layer of the cornea. In certain embodiments, a PEMF is administered to induce corneal endothelial cell proliferation and migration. In certain embodiments, a PEMF is administered to enhance the uptake of fluid from the cornea by the corneal endothelial cell layer. In certain other embodiments, a PEMF is administered to diminish the uptake of fluid from the cornea by the corneal endothelial cell layer. In certain embodiments, a PEMF is administered to treat corneal ulcers. In certain embodiments, a PEMF is administered to stimulate tear production from the lacrimal glands of the eye.
Regarding claim 1, Wang teaches providing PEMF stimulation to a patient's eye cells. In paragraph [0004] Wang teaches a number of effects the PEMF may have on the eyes including an effect on cytokines. [0004] In certain preferred embodiments, a PEMF is administered to generate or to enhance a wound healing response of a corneal condition. In certain embodiments, a PEMF is administered to stimulate a release of biological factors from a limbal vasculature including, but not limited to: epidermal growth factor (EGF), the transforming growth factor family of growth factors (TGF, including TGF.alpha. and TGF.beta.), and cytokines. In certain embodiments, a PEMF is administered to increase nerve impulse to the cornea. In certain embodiments, a PEMF is administered to induce and accelerate corneal keratocyte activation. In certain embodiments, a PEMF is administered to induce corneal fibroblast transformation, proliferation, and migration. In certain embodiments, a PEMF is administered to induce and accelerate corneal epithelial cell proliferation or migration, especially in the epithelial layer of the cornea. In certain embodiments, a PEMF is administered to induce corneal endothelial cell proliferation and migration. In certain embodiments, a PEMF is administered to enhance the uptake of fluid from the cornea by the corneal endothelial cell layer. In certain other embodiments, a PEMF is administered to diminish the uptake of fluid from the cornea by the corneal endothelial cell layer. In certain embodiments, a PEMF is administered to treat corneal ulcers. In certain embodiments, a PEMF is administered to stimulate tear production from the lacrimal glands of the eye. Paragraph [0049] discusses an example where PEMF has an effect on the inflammatory response. [0049] The previous examples are performed wherein on each postoperative day, a randomly chosen rabbit will be sacrificed and globe enucleated for histologic studies. One half of each cornea will be sectioned and H & E stain performed to determine the extent of cellular inflammatory response, and cellular activation and migration. The second half of each cornea will be used for the characterization of the keratocyte apoptosis study using the TUNEL technique (Wang, supra). In previous studies the inventor has demonstrated down-regulation of wound healing responses including inflammation and keratocyte apoptosis using amniotic membrane transplantation (Wang, supra). The inventor has discovered that, in the present invention, PEMF treatment yields the opposite effect, namely, an enhanced wound healing response.
Wang does not specifically teach where the PEMF stimulation causes electrically sensitive adenosine A2aR receptors in the patient's eye cells to translocate to a cellular membrane surface, where the electrically sensitive adenosine A2aR receptors bind with free adenosine or adenosine-like drugs from an intercellular space to activate an adenosine - A2aR anti- inflammatory signaling pathway in the patient's eyes.
Varani et al. teaches the anti-inflammatory mechanism of PEMF on a cell is due to its ability to increase the concentration of A2aRs on the cell membrane. PEMF stimulation increases the number of active A2aRs by translocating them from cytoplasm on the cell membrane and making them active and available for binding with adenosine ligand. Generally, the signal to a cell and the biological response of the cell's machinery depends on both the concentration of ligands in the extracellular space and the concentration of receptors on the cell membrane. As a result, the same cellular response can be
achieved by two different ways: by changing concentration of adenosine or adenosine like drugs around the cell or by changing concentration of the receptors on the cell membrane. The essence of discovery of Varani et al. is that the adenosine signaling pathway can be up- regulated without increasing extracellular adenosine concentration. It can be achieved by increasing concentration of A2aRs on the cellular membranes by applying electric field stimulation alone.
Therefore, if it is not at least inherent in Wang that the application of PEMF stimulation causes electrically sensitive adenosine A2aR receptors in the patient's eye cells to translocate to a cellular membrane surface, where the electrically sensitive adenosine A2aR receptors bind with free adenosine or adenosine-like drugs from an intercellular space to activate an adenosine - A2aR anti- inflammatory signaling pathway in the patient's eyes it is obvious in view of Varani et al. that the application of the PEMF in Wang would not only treat Corneal issues but the adenosine A2aR receptors and therefore have a palliative effect for Diabetic Retinopathy.
Claim(s) 2,3, 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang ( US 20020035358) hereinafter Wang in view of Varani et al. , Adenosine Receptors as a Biological Pathway for the Anti-Inflammatory and Beneficial Effects of Low Frequency Low Energy Pulsed Electromagnetic Fields, Mediators of Inflammation Volume 2017, Article ID 2740963, 11 pages, Published 1 February 2017. Hereinafter Varani et al. and further in view of Martinez(CN 104039390) hereinafter Martinez.
Regarding claim 2, Wang in view of Varani et al. set forth the claimed invention as set forth above including applying PEMF to the eyes, but does not specifically teach delivering the PEMF stimulation to the patient's eyes via a first coil disposed in front of a first eye of the patient and a second coil disposed in front of a second eye of the patient.
Martinez teaches in figure 6 and paragraph [0107] Picture 1OA shown having a body 1002 and a single-turn loop antenna 1004 of PEMF device 1000. PEMF device 1000 may be a low thermal PEMF device. single-turn loop antenna 1004 defines an opening 1006 and may have a design forming treating selected areas of human body (e.g., eye, elbow, calf, shoulder, back, etc.). Treating the eyes with a PEMF coil around the eye.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Wang as modified by Verani et al. a PEMF coil disposed in front of the patient’s eye(s) as taught by Martinez and although Wang as modified by Verani et al. in view of Martinez does not teach two coils the addition of a second coil or more coils over or around both eyes would be a mere duplication of parts and applicant’s specification does not set forth any criticality to the number or arrangement of the coils over or around the eyes.
Regarding claim 3, Wang in view of Varani et al. set forth the claimed invention as set forth above including applying PEMF to the eyes, but does not specifically teach delivering the PEMF stimulation to the patient's eyes via a first coil disposed in front of a first eye of the patient and a second coil disposed in front of a second eye of the patient and a third coil and fourth coil adjacent the patient’s eyes.
Martinez teaches in figure 6 and paragraph [0107] Picture 1OA shown having a body 1002 and a single-turn loop antenna 1004 of PEMF device 1000. PEMF device 1000 may be a low thermal PEMF device. single-turn loop antenna 1004 defines an opening 1006 and may have a design forming treating selected areas of human body (e.g., eye, elbow, calf, shoulder, back, etc.). Treating the eyes with a PEMF coil around the eye.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Wang as modified by Verani et al. a PEMF coil disposed in front of the patient’s eye(s) as taught by Martinez and although Wang as modified by Verani et al. in view of Martinez does not teach two coils the addition of a second coil, third coil and fourth or more coils over or around both eyes would be a mere duplication of parts and applicant’s specification does not set forth any criticality to the number or arrangement of the coils over or around the eyes.
Regarding claims 5 and 6, Wang in view of Varani et al. set forth the claimed invention as set forth above including applying PEMF to the eyes, but does not specifically teach delivering the PEMF stimulation to the patient's eyes via a first coil disposed in front of a first eye of the patient and a second coil disposed in front of a second eye of the patient and a third coil and fourth coil adjacent the patient’s eyes.
Martinez teaches in figure 6 and paragraph [0107] Picture 1OA shown having a body 1002 and a single-turn loop antenna 1004 of PEMF device 1000. PEMF device 1000 may be a low thermal PEMF device. single-turn loop antenna 1004 defines an opening 1006 and may have a design forming treating selected areas of human body (e.g., eye, elbow, calf, shoulder, back, etc.). Treating the eyes with a PEMF coil around the eye.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Wang as modified by Verani et al. a PEMF coil disposed in front of the patient’s eye(s) as taught by Martinez and although Wang as modified by Verani et al. in view of Martinez does not teach two coils the addition of a second coil, third coil and fourth or more coils over or around both eyes would be a mere duplication of parts and applicant’s specification does not set forth any criticality to the number or arrangement of the coils over or around the eyes.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang ( US 20020035358) hereinafter Wang in view of Varani et al. , Adenosine Receptors as a Biological Pathway for the Anti-Inflammatory and Beneficial Effects of Low Frequency Low Energy Pulsed Electromagnetic Fields, Mediators of Inflammation Volume 2017, Article ID 2740963, 11 pages, Published 1 February 2017. Hereinafter Varani et al. and further in view of Martinez(CN 104039390) hereinafter Martinez and further in view of Farahmand(US 6406419) hereinafter Farahmand.
Regarding claim 7, Wang in view of Varani et al. and Martinez set forth applying PEMF energy to a patient’s eyes via a coil around the eyes but does not specifically teach wherein the treatment applicator is an eyeglass frame.
Farahmand teaches incorporating magnetics into a eye glasses to treat the eyes.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Wang as modified by Varani et al. and Martinez incorporating the PEMF coils into the frames of eye glasses as taught by Farahmand to ensure the coils are mounted immediately in front of the eyes for an optimum effect.
Allowable Subject Matter
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: The prior art of record to Wang ( US 20020035358) teaches applying PEMF stimulation to the eyes and in Verani et al. that the anti-inflammatory mechanism of PEMF on a cell is due to its ability to increase the concentration of A2aRs on the cell membrane. PEMF stimulation increases the number of active A2aRs by translocating them from cytoplasm on the cell membrane and making them active and available for binding with adenosine ligand. Generally, the signal to a cell and the biological response of the cell's machinery depends on both the concentration of ligands in the extracellular space and the concentration of receptors on the cell membrane. As a result, the same cellular response can be achieved by two different ways: by changing concentration of adenosine or adenosine like drugs around the cell or by changing concentration of the receptors on the cell membrane. The essence of discovery of Varani et al. is that the adenosine signaling pathway can be up- regulated without increasing extracellular adenosine concentration. It can be achieved by increasing concentration of A2aRs on the cellular membranes by applying electric field stimulation alone. Martinez(CN 104039390) teaches applying PEMF stimulation to the eyes and Farahmand(US 6406419) teaches incorporating magnetic therapy into the frames of eyeglasses.
The closest prior art of record does not reasonably teach alone or in combination the subject matter of the independent claim and intervening claims along with the subject matter of claim 4 including applying PEMF to stimulate the patient’s eyes with first, second, third and fourth coils with two coils in front of the patient’s eyes and a third and fourth coils to the side of the patient’s eyes where the stimulation includes alternating pulses between the first and third coils and alternating pulses between the second and fourth coils.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Alvarado( US 20070073096) teaches apparatus for magnetic therapy of eye conditions such as cataracts, eye floaters, chronic glaucoma, age-related maculopathy, diabetic retinopathy, dry eyes, watery eyes and myopia is disclosed. The apparatus comprises a combination of two bi-polar magnets enclosed in a supportive cover that saddles the upper rim of regular eyeglasses. The magnets are placed in a proper position in front of the affected eye and their polarity can be changed at any time without any difficulty.
Pilla et al.( 20120116149) teaches treating neurological injury and conditions, in particular, traumatic brain injury and physiological responses arising from injury or conditions. These treatment methods can include the steps of generating a pulsed electromagnetic field from a pulsed electromagnetic field source and applying the pulsed electromagnetic field 1 in proximity to a target region affected by the neurological injury or condition to reduce a physiological response to the neurological injury or condition.
Chornenky et al.( US 9884199) teaches treatment of chronic kidney disease (CKD), particular diabetic nephropathy, are disclosed. The method comprises activation of adenosine A2a receptors in parenchymal and immune cells infiltrated into kidneys. The activation is performed by PEMF (pulsed electromagnetic field) stimulation applied locally to kidneys. Adenosine A2a signaling pathway is a potent anti-inflammatory and immuno-suppressive regulator that has been proven to attenuate inflammation and injury in diabetic nephropathy. Efficient activation of A2a receptors is achieved by applying electromagnetic field stimulation consecutively in 3 spatial dimensions. This allows attaining a significant increase in activation of A2a receptors in comparison with one-dimensional stimulation. Assistant thermal stimulation may be applied to increase expression of heat shock proteins (HSPs) in parenchymal cells. HSPs improve protein functions, protect cells from apoptosis and necrosis, increase metabolism, and symbiotically enhance effects of electric stimulation on CKD.
Goldberg et al.( US 20150238357) teaches magnetic eye shields that comprise a magnet. When worn by a patient, the magnetic eye shields are configured to generate an intraocular magnetic field of sufficient magnitude and direction to move a magnetic therapeutic and/or diagnostic agent positioned inside the eye to target tissue within the eye.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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/BRIAN L CASLER/ Primary Examiner, Art Unit 3791
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