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 § 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.
Claim 10 is 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 10 recites the limitation "the medical procedure" in line 1. There is insufficient antecedent basis for this limitation in the claim, as claim 2, from which claim 10 is dependent upon, never recites the term “medical procedure”.
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.
Claim(s) 1-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Warlick et al. (US 2019/0209431 A1).
Regarding claim 1, Warlick discloses a treatment method to reduce or eliminate a patient's symptoms caused by a neurological medical condition (treatment method to reduce to eliminate a patient’s symptoms caused by a medical condition or disease; Abstract; treatment method may be used to treat a variety of medical conditions to include neurological conditions such as Parkinson’s disease, Paragraph 0017); the treatment comprises the step of: administering acoustic shock waves or pressure pulses directed to an area near a source of the pain, if any is exhibited, or to a reflexology zone to treat the neurological medical condition (the treatment has the step of administering acoustic shock waves or pressure pulses directed to one or more reflexology zones or to one or more reflexology zones and an area near a source of the medical condition or pain, if any is exhibited, to treat the medical condition, Paragraph 0011, Abstract, and Figure 1).
Regarding claim 2, Warlick further discloses further comprises the steps of: activating acoustic shock waves or pressure pulses of an acoustic shock wave or pressure pulse generator to emit acoustic shock waves or pressure pulses (steps of activating acoustic shock waves or pressure pulses of an acoustic shock wave or pressure pulse generator to emit acoustic shock waves or pressure pulses, Paragraph 0011); subjecting the area at or near the reflexology zone to acoustic shock waves or pressure pulses stimulating the area near the reflexology zone (subjecting the one or more reflexology zones or the one or more reflexology zones and the area near a source of the medical condition or pain to acoustic shock waves or pressure pulses stimulating the one or more reflexology zones or the one or more reflexology zones, Paragraph 0011); and wherein the emitted acoustic shock waves or pressure pulses are focused or unfocused acoustic shock waves or pressure pulses (the emitted acoustic shock waves or pressure pulses can be focused or unfocused acoustic shock waves or pressure pulses, Paragraph 0011).
Regarding claim 3, Warlick further discloses wherein the reflexology zone underlies the patient's skin in a region of a foot or hand or ear (the term target site refers to either a location near the source of the medical condition or pain or to a reflexology location for a specific orthopedic bone structure, nerve, gland and the tissue of the hand or foot at the desired reflexology zone or region being in the path of the shock wave applicator, Paragraph 0064).
Regarding claim 4, Warlick further discloses wherein the shock wave or pressure pulse generator is acoustically coupled to the patient's skin using a coupling gel or liquid (the waves will be transmitted into the patient's body via a coupling media such as, e.g., ultrasound gel or oil, Paragraph 0086).
Regarding claim 5, Warlick further discloses wherein the reflexology zone to treat a neurological medical condition for an orthopedic structure in a region of the foot is located in an outer surface of each foot near or at a toe (the term target site refers to either a location near the source of the medical condition or pain or to a reflexology location for a specific orthopedic bone structure, nerve, gland and the tissue of the hand or foot at the desired reflexology zone or region being in the path of the shock wave applicator, Paragraph 0064; all regions of the hands and/or feet are treated, therefore covering the outer surface of each foot, Paragraph 0018).
Regarding claim 6, Warlick further discloses wherein the reflexology zone to treat a neurological medical condition for an orthopedic structure is a region of the hand at or near fingers and thumb (the term target site refers to either a location near the source of the medical condition or pain or to a reflexology location for a specific orthopedic bone structure, nerve, gland and the tissue of the hand or foot at the desired reflexology zone or region being in the path of the shock wave applicator, Paragraph 0064; all regions of the hands and/or feet are treated, therefore covering the fingers and thumb regions, Paragraph 0018).
Regarding claim 7, Warlick further discloses wherein the stimulating of the area causes a release of nitric oxide (the acoustic shock waves or pressure pulses activate a cellular response within the reflexology treatment site, this response or stimulation causes an increase of nitric oxide Paragraph 0104 and Figure 11), secretion of digestive enzymes, hormones and other fluids (the stimulating of the area causes a secretion of digestive enzymes and hormones and other fluids, Paragraph 0013) reduces inflammation and absorbs plaque (treatment method produces a positive biological response that reduces or eliminates system or local inflammation, Paragraph 0012).
Regarding claim 8, Warlick further discloses wherein the stimulating of the area causes a release of growth factors including, but not limited to VEGF (providing a stimulating cellular release or activation of VEGF and other growth factors, Paragraph 0069).
Regarding claim 9, Warlick further discloses wherein the stimulating of the area causes new blood vessels to be created increasing vascularization (new blood vessel formation, Paragraph 0013).
Regarding claim 10, Warlick further discloses the treatment method is repeated one or more times prior to or during the medical procedure or after the medical procedure (treatments may be repeated, Paragraph 0013; the Examiner also notes the 112b rejection presented above for the claim).
Regarding claim 11, Warlick further discloses wherein the emitted acoustic shock waves or pressure pulses are low energy soft waves (low energy shock waves, Paragraph 0074).
Regarding claim 12, Warlick further discloses wherein the low energy soft waves have an energy density in the range of 0.01 mJ/mm2 to 1.0 mJ/mm2 (the energy density values range as low as 0.000001 mJ/mm.sup.2 and having a high end energy density of below 1.0 mJ/mm.sup.2, preferably 0.40 mJ/mm.sup.2 or less, more preferably 0.20 mJ/mm.sup.2 or less, Paragraph 0074).
Regarding claim 13, Warlick further discloses wherein the low energy soft waves have an energy density in the range of 0.04 mJ/mm2 to 0.3 mJ/mm2. (the energy density values range as low as 0.000001 mJ/mm.sup.2 and having a high end energy density of below 1.0 mJ/mm.sup.2, preferably 0.40 mJ/mm.sup.2 or less, more preferably 0.20 mJ/mm.sup.2 or less, Paragraph 0074).
Regarding claim 14, Warlick further discloses wherein each subjected reflexology zone receives between 100 and 2000 acoustic shock waves or pressure pulses per therapy session (treating the feet and hands with 1000 shocks per treatment, therefore falling within the claimed range, Paragraph 0116).
Regarding claim 15, Warlick further discloses wherein the emitted acoustic shock waves or pressure pulses are spherical, radial, convergent, divergent, planar, near planar, focused or unfocused from a source with or without a lens that is one of electrohydraulic, electromagnetic, piezoelectric, ballistic or water jets configured to produce an acoustic shock wave and wherein the acoustic shock waves or pressure pulses are administered invasively or noninvasively (the emitted acoustic shock waves or pressure pulses are spherical, radial, convergent, divergent, planar, near planar, focused or unfocused from a source with or without a lens that is one of electrohydraulic, electromagnetic, piezoelectric, ballistic or water jets configured to produce an acoustic shock wave and wherein the acoustic shock waves or pressure pulses are administered invasively or noninvasively, Paragraph 0013).
Regarding claim 16, Warlick further discloses wherein the number of repeated treatments occur on a schedule over a period of three or more weeks, and treatments can be repeated over time as a pain prevention protocol over longer durations of time between repeated treatments (number of repeated treatments occur on a schedule over a period of three or more weeks, and treatments can be repeated over time as a treatment protocol over longer durations of time between repeated treatments, Paragraph 0013).
Regarding claim 17, Warlick further discloses wherein the neurological medical condition is one of Alzheimer's Disease, Amyotrophic Lateral Sclerosis (ALS), Ataxia, Epilepsy and Seizures, headache, Hydrocephalus, Meningitis, Parkinson's Disease, Stroke, Cluster Headaches, Tension Headaches, Migraine Headaches, Encephalitis (treatment method treating various medical conditions such as Parkinson’s disease, Paragraph 0017).
Regarding claim 18, Warlick further discloses wherein the emitted acoustic shock waves or pressure pulses have an energy density in the range of 0.01 mJ/mm2 to 50 mJ/mm2. (The emitted acoustic shock waves or pressure pulses can be low energy soft waves wherein the low energy soft waves have an energy density in the range of 0.01 mJ/mm.sup.2 to 1.0 mJ/mm.sup.2, preferably in the range of 0.04 mJ/mm.sup.2 to 0.3 mJ/mm.sup.2. Alternatively, the emitted acoustic shock waves or pressure pulses can be higher energy waves in the range of 1.0 mJ/mm.sup.2 up to and including 50 mJ/mm.sup.2, therefore falling within the claimed range, Paragraph 0013).
Regarding claim 19, Warlick discloses a treatment method to reduce or eliminate a patient's symptoms caused by a neurological medical condition (treatment method to reduce to eliminate a patient’s symptoms caused by a medical condition or disease; Abstract; treatment method may be used to treat a variety of medical conditions to include neurological conditions such as Parkinson’s disease, Paragraph 0017); the treatment comprises the step of: administering acoustic shock waves or pressure pulses directed to an area near a source of the neurological medical condition, and to a reflexology zone to treat the neurological medical condition (the treatment has the step of administering acoustic shock waves or pressure pulses directed to one or more reflexology zones or to one or more reflexology zones and an area near a source of the medical condition or pain, if any is exhibited, to treat the medical condition, Paragraph 0011, Abstract, and Figure 1).
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.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Warlick et al. (US 2019/0209431 A1) in view of Lue et al. (US 2017/0258676 A1).
Regarding claim 20, Warlick discloses the treatment method of claim 19, with Warlick further teaching the treatment reducing neurological inflammation and plaque (treatment method produces a positive biological response that reduces or eliminates system or local inflammation, plaque formation is a result from inflammation, Paragraph 0012), with Warlick further teaching the treatment being used to treat neurological conditions such as Parkinson’s disease (treatment method may be used to treat a variety of medical conditions to include neurological conditions such as Parkinson’s disease, Paragraph 0017), however Warlick does not explicitly state wherein the neurological medical condition is Alzheimer's disease.
However, Lue teaches a treatment method utilizing low energy acoustic shockwaves to treat various tissues and organs (Abstract) wherein the method is used to treat neurological conditions such as Alzheimer’s disease (treat or prevent disease conditions such as cerebral vascular accident, amyotrophic lateral sclerosis (ALS), ischemic damage, Alzheimer's, Parkinson's disease, brain trauma, dementia, and other neurological or brain-related conditions or diseases, Paragraph 0066).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Warlick’s treatment method to include utilizing the treatment method for treating Alzheimer’s disease, as taught by Lue, as safe and effective dosages of low energy shock waves may be used to treat and/or prevent neurological conditions such as Alzheimer’s disease, therefore providing Warlick’s treatment method with a wider variety of neurological conditions to be capable of treating.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Cioanta et al. (US 2018/0221688 A1), Slayton et al. (US 9,713,731 B2), and Crum et al. (US 9,198,635 B2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached on (571)-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH B LEDERER/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785