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 60-74) in the reply filed on 2/27/2026 is acknowledged.
Claim Objections
Claim 66 is objected to because of the following informalities: in claim 66 line 2, “5V to about 40V” is repeated. Appropriate correction is required.
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 63 and 66 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.
Claim 63 depends on claim 60 and recites the limitations "the high frequency” and “the low frequency” in line 1 and 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the claim is considered to depend on claim 62.
Claim 66 depends on claim 60 and recites the limitations "the skin” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 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.
Claims 60, 69-72 and 74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kronberg (U.S. Patent Number: US 5413596 hereinafter “Kronberg”).
Regarding claim 60, Kronberg teaches a method for preventing bone loss (e.g. Abstract), promoting bone growth, or healing a bone in a subject, the method comprising:
directly electrically stimulating bone cells with a low-intensity electrical current (e.g. Abstract: low level alternating current signal, the correct signal is communicated to the underlying bone structures) avoiding muscle contraction;
wherein the low-intensity electrical current is a biphasic current (e.g. abstract: low level alternating current, Fig.1);
administering the electrical stimulation with said low-intensity electrical current in a manner which prevents bone loss and/or heals bones;
wherein said bone cells are selected from a group consisting of arms, legs, pelvis, ribs, trunk, head, spine, wrist (e.g. Col.3 likes 22-26, ankle, and whole body;
administering the electrical stimulation with said low-intensity electrical current in a manner which provides at least one of the following benefits: maintenance of bone quality or bone health; prevention of osteoporosis (e.g. abstract: stimulating bone growth and treating osteoporosis) treatment of osteoporosis; promotion of bone healing; prevention of fractures; treatment of fractures; treatment of spinal fusion; and treatment of spinal-cord injury.
Regarding claim 69, Kronberg teaches administering the electrical stimulation with said low-intensity electrical current in a manner which provides at least one of the following benefits: promotion of bone growth treatment of fractures; promotion of bone mineralization; promotion bone density; increasing bone surface area; stimulation of osteogenesis via proliferation of H-type vessel endothelial cells; modulation and/or interference in signaling pathways that regulate H-type vessels; promoting release of cytokines and growth factors secreted by vascular endothelial cells; or affecting osteocyte interconnections and peri-osteocytic mineralization (e.g. Col. 3 lines 5-26: fractures and osteoporosis).
Regarding claim 70, Kronberg teaches contacting at least one pair of electrodes on a skin surface over said bone; and providing to said at least one pair of electrodes a low-intensity electrical current avoiding muscle contraction; administering said electrical current in a manner which causes stimulation of bone cells (e.g. col. 3 lines 43-46: the present invention in combination with skin contact electrodes, allows site-specific, distortion-free, low level, alternating current, pulse trains to reach an afflicted area, Fig. 5, col. 5 lines 62-66).
Regarding claims 71 and 72, Since Kronberg teaches providing low level alternating current signal using electrodes on a skin surface so that the signal is communicated to the underlying bone structures for bone growth and to treat osteoporosis as discussed above, they teach administering said low-intensity electrical current in a manner which stimulates proliferation of osteoblasts and/or stimulates differentiation of osteoblasts and which inhibits proliferation of osteoclasts, inhibits differentiation of osteoclasts, inhibits bone resorption controlled by osteoclasts and/or cause an increase in osteocalcin as claimed.
Regarding claim 74, Since Kronberg teaches providing low level alternating current signal using electrodes on a skin surface so that the signal is communicated to the underlying bone structures for bone growth and to treat osteoporosis as discussed above, they teach said electrical stimulation is other than electromagnetic stimulation, other than ultrasound, other than electrolysis, other than sacral neuromodulation (SNM), and other than transcutaneous electrical nerve stimulation (TENS) as claimed.
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 61, 64, 65, 66 and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Kronberg (U.S. Patent Number: US 5413596 hereinafter “Kronberg”).
Regarding claims 61, 64, 65, 66 and 68, Kronberg teaches the claimed invention as discussed above and while they teach providing low level alternating biphasic current waveforms with parameters as depicted in Figs. 1, 2 (e.g. Col. 1 lines 49-60), they do not specifically teach the low-intensity electrical current has an intensity of about 6.5 mA to about 10.5 mA and is selected from the currents as listed in claim 64 and has parameters as claimed in claim 65, 66 and 68.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Kronberg with stimulation parameters as claimed in claims 62, 64, 65, 66 and 68, 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] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Claims 62 and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Kronberg (U.S. Patent Number: US 5413596 hereinafter “Kronberg”) in view of Shealy (U.S. Patent Application Publication Number: US 2003/0220669 A1 hereinafter “Shealy”).
Regarding claim 62, Kronberg teaches the claimed invention as discussed above except for the low-intensity electrical current comprising a high frequency (HF) modulated by a low frequency (LF).
In a similar field of endeavor, Shealy teaches improving calcitonin levels to treat osteoporosis (e.g. [0004], [0011]) by providing a low-intensity electrical signal comprising a high frequency (HF) modulated by a low frequency (LF)(e.g. [0023]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the low intensity stimulation current signal in the teachings of Kronberg to comprise a high frequency (HF) modulated by a low frequency (LF) in order to provide the predictable results of providing a more effective therapy.
Regarding claim 63, Kronberg in view of Shealy teaches the claimed invention as discussed above and while they etyach that the stimulation comprises a low intensity electrical current stimulation signal comprising high frequency (HF) modulated by a low frequency (LF) as discussed above, they do not specifically teach that the high frequency is about 800 Hz to about 1000 Hz, and the low frequency is about 1 Hz. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Kronberg with stimulation parameters wherein the modulated low intensity stimulation current signal has high frequency of about 800 Hz to about 1000 Hz, and the low frequency of about 1 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] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Claims 67 and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Kronberg (U.S. Patent Number: US 5413596 hereinafter “Kronberg”) in view of Varner (U.S. Patent Number: US 5792209 hereinafter “Varner”).
Regarding claim 67, Kronberg teaches the claimed invention as discussed above except for applying a current on the hips of about 5 V to about 40 V. In a similar field of endeavor, Varner teaches a method comprising non-invasive stimulation using surface electrodes targeting the hips for the treatment of osteoporosis (e.g. abstract, Fig.1A,2, Col. 4 lines 15-30). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Kronberg to apply stimulation to the hips as taught by Varner in order to provide the predictable results of providing a targeted therapy.
Further while Kronberg in view of Varner teaches general stimulation parameters and Varner also teaches a low intensity (10microV/cm) stimulation, they do not specifically teach that the stimulation is about 5V to 40V. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Kronberg in view of Varner with a stimulation of about 5V to 40V, 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] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Regarding claim 73, Kronberg teaches the claimed invention as discussed above except for said method being used concurrently with at least one of training exercise(s), at least one bisphosphonate drug, and an osteoporosis medication; and wherein said at least one bisphosphonate drug is selected from the group consisting of alendronate, ibandronate, risedronate and zoledronic acid, and wherein the osteoporosis medication is selected from the group consisting romosozumab, romosozumab-aqqg, raloxifene, bazedoxifene, teriparatide, abaloparatide, denosumab, romosozumab, and menopausal hormone therapy (MHT).
In a similar field of endeavor, Varner teaches a method comprising non-invasive stimulation using surface electrodes targeting the hips for the treatment of osteoporosis (e.g. abstract) to be used along with weight bearing exercises (e.g. Col. 3 lines 9-11). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Kronberg to include exercise along with stimulation as taught by Varner in order to provide the predictable results of improving therapy outcomes for the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792