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 Objections
Claim is objected to because of the following informalities:
Regarding claim 1, claim recites: “a method …comprising: …the method comprising” which includes unnecessary repetition of the same language and should be removed.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 4-12 and 15 of U.S. Patent No. 12402898 hereinafter “Patent ‘898”. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed towards the same method of applying shock waves to the temple region of a patient to reduce the pressure and inflammation of the tissue behind the eye. Both sets of claims require applying shock wave using a shock wave applicator applying to the temple region of the patient to affect the bulging condition of the eye by affecting the tissue behind the eye. In particular, instant set of claims are anticipated by the claims of patent no. 1240288 as follows:
Claim 1 of instant application is anticipated by claim 15 of patent ‘898.
Claim 2 of instant application is anticipated by claim 2 of patent ‘898.
Claim 3 of instant application is anticipated by claim 4 of patent ‘898.
Claim 4 of instant application is anticipated by claim 5 of patent ‘898.
Claim 5 of instant application is anticipated by claim 6 of patent ‘898.
Claim 6 of instant application is anticipated by claim 7 of patent ‘898.
Claim 7 of instant application is anticipated by claim 8 of patent ‘898.
Claim 8 of instant application is anticipated by claim 9 of patent ‘898.
Claim 9 of instant application is anticipated by claim 10 of patent ‘898.
Claim 10 of instant application is anticipated by claim 11 of patent ‘898.
Claim 11 of instant application is anticipated by claim 9 of patent ‘898.
Claim 12 of instant application is anticipated by claim 15 of patent ‘898.
Claim 13 of instant application is anticipated by claim 4 and 7 of patent ‘898.
Claim 14 of instant application is anticipated by claim 8 of patent ‘898.
Claim 15 of instant application is anticipated by claim 8 of patent ‘898.
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.
Claims 4-6, 10, and 13 are 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.
Regarding claims 4-6, 10, and 13, claims include ranges that are not fully supported by the specification.
In particular, claim 4 requires the amplitude of the positive part of the cycle to be “above 0.1 MPa”. However, this is an open-ended range and could include any amplitude above 0.1MPa while the specification does not provide support for such a range. The specification only has support for the amplitude to be at 0.1MPa and therefore lacks support for the open-ended range that is claimed.
Similarly, claim 5 includes an open rang of nanoseconds and milliseconds which includes any range of time from 1 nanoseconds to 999 milliseconds. However, the specification does not have support for such a large range and therefore, the claim is considered to lack support.
Further claim 6 includes an open range of rise times of the amplitude below 1000ns which would include any rise time between 0 and 1000 nano seconds while the specification does not provide support for the entire range claimed. Therefore, the claimed range is considered to lack support in the specification.
Claim 10 also includes a range of energy densities less than 1.0 mJ/mm2 which includes any energy density between zero and 1.0 mJ/mm2 while the specification does not provide support for the entire claimed range. Therefore, the claimed range is considered to lack support in the specification.
Similarly, claim 13 includes a range of positive amplitudes above 0.1MPa and a time duration not exceeding 1 second which includes an open ended range which is not supported by the specification. Therefore, the claimed ranges are considered to lack support in the specification.
Claims 11, and 14 depend upon unsupported claims 10 and 13 and therefore are considered to lack support in the specification as well due to their dependency.
Allowable Subject Matter
Claims 1-20 are considered to contain allowable subject matter not disclosed in the prior art.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding independent claim 1, Claim is directed towards treating a patient’s bulging eye (proptosis of an eye) by applying a shock producing probe to the temple region of the patient to reduce pressure and inflammation of tissue behind the eye causing the said proptosis to ease using shock waves or pressure pulses. No relevant prior art was found for emitting shock waves to the eye using shock application to the temple of the subject which would ease the proptosis of the eye. The method provides a non-invasive way of treating proptosis which is often originated from Grave’s disease or hyperthyroidism and can treat the condition without the use of pharmaceuticals, thus providing a therapeutic approach to decease pain and inflammation locally and directly to the tissue without the need of a systematic treatment.
Therefore, the prior art fails to anticipate and/or render obvious either solely or in combination: “A method of utilizing an acoustic shock wave system to treat a patient, comprising: engaging an acoustic shock wave applicator of the acoustic shock wave system with an exposed surface of skin at a temple region of the patient adjacent to an eye of the patient, wherein the eye exhibits a bulging condition caused by inflammation within tissue behind the eye, the method comprising; and activating an energy source of the acoustic shock wave system for enabling acoustic shock waves emitted therefrom to impinge upon tissue behind the eye to reduce pressure and inflammation within the tissue.”.
A comparison of the claims to the closest prior art is presented below:
Wang et al. (“Low energy shock wave therapy inhibits inflammatory molecules and suppresses prostatic pain and hypersensitivity in a capsaicin induced prostatitis model in Rats”, Inter. J. of Mol. Sci. 2019) hereinafter “Wang”: Wang is considered to be the closest prior art to the set of claims and discloses the use of low energy shock wave in general to reduce inflammation of tissue by inhibiting specific cytokines and biochemical pathways such as TNF and enhancing the activity of e NOS [see abstract and page 2, second paragraph]. Wang fails to treat the specific action of applying shock waves/pressure pulses directly to the eye and the tissue behind the eye by
Claims 2-20 depend upon allowable base claim 1 and are considered to be allowable at least by virtue of their dependence upon an allowable base claim.
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
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN - SABOKTAKIN whose telephone number is (303)297-4278. The examiner can normally be reached M-F 9 am-5pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARJAN SABOKTAKIN/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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