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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 5, 6, 8, 14, and 19 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 5 recites the limitation "a temperature change" in line 3. It is not clear if this is intended to refer to the previously recited temperature change or a separate temperature change. If the former is intended, the limitation should read --the temperature change--.
Claim 6 is rejected by virtue of its dependence upon claim 5.
Claim 8 recites the limitation “wherein the actuator comprises: a threaded shaft coupling the device base to the device housing” in lines 1-2. However, claim 1 already recites a threaded shaft coupling the device base to the device housing. It is not clear if claim 8 is intended to recite a separate threaded shaft, or to clarify that the threaded shaft recited in claim 1 is part of the actuator (and not just the compression device), or something else.
Claim 14 recites the limitation “substantially planar” in lines 1-2. This term is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification notes that terms of degree such as “substantially” mean a reasonable amount of deviation, for example, a deviation of up to ±0.1%, ±1%, ±5%, or ±10%. There is no guidance as to which of these limits is meant in this case, or whether these limits are even applicable (as they are only recited as examples). Thus, there are no readily determinable metes and bounds on how planar the contact surface must be to meet the claim language.
Claim 19 recites the limitation "a subject" in line 3. It is not clear if this is intended to refer to the previously recited subject or a separate subject. If the former is intended, the limitation should read --the subject--.
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 1, 8, 10, 14, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Benet Pozo et al. (U.S. Pub. No. 2018/0193220 A1; hereinafter known as “Benet Pozo”).
Regarding claim 1, Benet Pozo discloses an apparatus capable of being used for bladder control (Abstract; Figs. 1, 12, 13), comprising: a garment or accessory 78 configured to be worn at least partially around a lower truncal region of a subject ([0049]); and a compression device coupled to the garment or accessory and configured to pressurize an abdominal wall of the subject when the garment or accessory is worn by the subject, the compression device comprising: a device housing 56 comprising a contact surface, a device base 30/70, a threaded shaft 80 coupling the device base to the device housing, an actuator 51 configured to translate the device housing in relation to the device base in a medial or lateral direction relative to the subject such that the contact surface of the device housing applies compressive forces to the abdominal wall of the subject when translated ([0061]-[0063]), and a portable power supply configured to power the actuator ([0052]).
Regarding claim 8, Benet Pozo discloses that the actuator comprises a threaded shaft 80 coupling the device base to the device housing; and a rotary gear 52 configured to rotate the threaded shaft to translate the device housing in relation to the device base ([0061]).
Regarding claim 10, Benet Pozo discloses that the compression device is configured to be in wireless communication with a remote device, and wherein the compression device is configured to apply compressive forces to the abdominal wall of the subject automatically in response to a user input applied to the remote device ([0020]; [0075]).
Regarding claim 14, Benet Pozo discloses that the contact surface is substantially planar (Fig. 5).
Regarding claim 19, Benet Pozo discloses a method capable of controlling a bladder of a subject (Abstract; Figs. 1, 12, 13), the method comprising: securing a compression device to the subject with a garment or accessory 78 configured to be worn at least partially around a lower truncal region of a subject ([0049]), the compression device coupled to the garment or accessory and configured to pressurize an abdominal wall of the subject when the garment or accessory is worn by the subject, the compression device comprising a device housing 56 comprising a contact surface, a device base 30/70, a threaded shaft 80 coupling the device base to the device housing, an actuator 51 configured to translate the device housing in relation to the device base in a medial or lateral direction relative to the subject such that the contact surface of the device housing applies compressive forces to the abdominal wall of the subject when translated, and a portable power supply configured to power the actuator ([0052]); and translating the device housing in relation to the device base such that the contact surface of the device housing applies compressive forces to the abdominal wall of the subject when translated ([0061]-[0063]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Benet Pozo as applied to claim 1 above, and further in view of Hathorn (U.S. Pub. No. 2016/0120732 A1). Benet Pozo discloses the invention as claimed, see rejection supra, but fails to disclose a heating element configured to apply heat to the abdominal wall of the subject. Hathorn discloses a similar apparatus (Abstract) comprising a heating element configured to apply heat to the abdominal wall of a subject in order to further treat IBS ([0060]; [0071]; claim 10). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Benet Pozo with a heating element, as taught by Hathorn, in order to further treat IBS.
Allowable Subject Matter
Claims 2-4, 7, 11-13, and 15-18 are 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.
Claims 5 and 6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 20 is allowed.
The following is an examiner’s statement of reasons for allowance and the indication of allowable subject matter: regarding claims 2-7, none of the prior art of record teaches or reasonably suggests a shape memory actuator configured to translate the device housing in relation to the device base in response to a temperature change, in combination with the other recited components. Regarding claim 11, none of the prior art of record teaches or reasonably suggests applying compressive forces to the abdominal wall automatically in response to a user input that is a manipulation of a sensation meter graphic shown on a display of the remote device, in combination with the other recited components. Regarding claims 12 and 13, none of the prior art of record teaches or reasonably suggests an ultrasound unit comprising an ultrasound probe that detects a volume within the subject’s bladder, in combination with the other recited components. Regarding claims 15-18, none of the prior art of record teaches or reasonably suggests a fluid-filled covering that covers part of the device housing and is configured to conform to an anatomy of the subject, in combination with the other recited components. Regarding claim 20, none of the prior art of record teaches or reasonably suggests a remote device in wireless communication with the compression device that provides feedback to the compression device in response to characteristics of the subject’s bladder, in combination with the other recited components.
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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M. Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791