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 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.
Claim(s) 1-7, 11-17, 20-21, and 26-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Warlick (US 2019/0350803).
Warlick shows a method of treating a patient to activate cellular function ([0005]), the method comprises the steps of: activating an acoustic shock wave generator to emit acoustic shock waves ([0004], [0059]), wherein the acoustic shock waves provide pressure pulses each comprising a plurality of cycles of a positive pressure part and a negative pressure part ([0027]) and wherein the shock waves comprise an energy density of less than 0.5 mJ/mm2 ([0005], [0069], [0111], [0114]) and subjecting target tissue of the patient to a plurality of treatments of exposure to the acoustic shock waves for causing stimulation of cells of the target tissue to initiate genetic expression of cells of the target tissue, wherein said stimulation of cells of the target tissue to initiate genetic expression causes at least one of release of exosomes, activation of at least one cellular receptor, and shedding of micro-vesicles from said cells ([0005]).
Warlick also shows said stimulation of cells causes activation of at least one cellular receptor ([0005]); and said at least one cellular receptor is operable to cause transition of said cells from at least one of a pathologic state, an ischemic state, and an inflammatory state to a target physiological state ([0005]); wherein said stimulation of cells causes all of: the release of exosomes; the shedding of microvesicles; and the activation of at least one cellular receptor (while not explicitly stated, operating the shockwave device at the desired parameters such as the desired low energy density and number of pressure pulses to stimulate the cells of a human patient will necessarily produce all of the therapeutic effects on the patient’s cellular anatomy including release of exosomes, shedding of microvesicles, and activating a cellular receptor; [0005]); wherein said stimulation of cells further causes the release of at least one of a protein, cytokines, and MRNA into the extracellular matrix of the target tissue ([0005]); wherein said stimulation of cells causes activation of at least one cellular receptor ([0005]); wherein said at least one cellular receptor includes at least one of a Toll Like receptor and Biglycan ([0005]); wherein said subjecting target tissue of the patient to the acoustic shock waves for causing stimulation of cells to activate the genetic expression includes: providing between about 25 pressure pulses per treatment and about 6000 pressure pulses per treatment ([0005], [0063]); and maintaining the energy density between about 0.01 mj/mm2 and about 0.5 mj/ mm2; for each of said treatments ([0005]); wherein the acoustic shock waves providing pressure pulses each comprising a plurality of cycles of a positive pressure part and a negative pressure includes the positive pressure part and the negative part of each pressure pulse being jointly configured to cause pressure within the cells to enable a cellular membrane including exosome channels of a respective one of the cells to sufficiently expand for providing the release of exosome from within the cells ([0005], [0027]); wherein said subjecting target tissue of the patient to the acoustic shock waves for causing stimulation of cells to activate the genetic expression includes: providing between about 25 pressure pulses per treatment and about 6000 pressure pulses per treatment; and maintaining the energy density between about 0.01 mj/mm2 and about 0.5 mj/ mm2; for each of said treatments ([0005], [0069], [0111], [0114]).
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.
Claim(s) 8-10, 18-19, and 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Warlick (US 2019/0350803).
Warlick shows the invention substantially as described in the 102 rejection above.
Warlick fails to explicitly state wherein said subjecting target tissue of the patient to the acoustic shock waves for causing stimulation of cells to activate the genetic expression includes providing at least 20 treatments within not more than a twelve week period.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have selected a desired treatment protocol for the patient, such as providing at least 20 treatments within not more than a twelve week period, to achieve the desired treatment effect, where the treatment protocol may be selected depending on a patient’s specific anatomy, the location of the anatomy to be treated, the severity of the disease, health conditions of the patient, physician’s preferences, etc.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN CWERN/Primary Examiner, Art Unit 3797
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