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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, computing a time interval as a duration between a first intersection point between a first pressure line and a pressure value and a second intersection point between a second pressure line and the pressure value must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Figure 4, which attempts to show the claimed subject matter, does not show P1a as being a time interval between a first intersection point between a first pressure line (415a) and a pressure value (430) and a second intersection point between a second pressure line (415b) and the pressure value (430), nor does it show P2a as being a time interval between a first intersection point between a first pressure line (425a) and a pressure value (430) and a second intersection point between a second pressure line (425b) and the pressure value (430).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1, 4, 15, 16, 18, and 21-24 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 1 and 18, the originally filed specification fails to provide support for computing a time interval during the inflation cycle in which a rate of change of pressure data is less than a threshold. There is no discussion in the specification of comparing a rate of change of pressure data to a threshold level and determining a time interval during which the rate is below the threshold value. Regarding claim 23, the specification fails to provide support for determining a pressure value based on a portion of the pressure data in which a rate of change of the pressure data is less than the threshold value; the specification fails to provide any description of how the pressure value of claim 23 is determined.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4, 15, 16, 18, and 21-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 18 follows.
Regarding claim 18, the claim recites a series of steps or acts, including generating pressure data and detecting an atrophy condition based on the pressure data. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of detecting an atrophy condition in response to a time interval achieving a threshold condition sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 18 recites transmitting a notification about an atrophy condition to a computing device, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The transmitting of the notification does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the transmitted notification, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of activating an inflation cycle of an inflatable medical device, generating pressure data about a pressure within an inflatable member, and computing a time interval during the inflation cycle in which a rate of change of the pressure data is less than a threshold level. The activating, generating, and computing steps are each recited at a high level of generality such that they amount to insignificant presolution activity, e.g., mere data gathering steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes them from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the generating and comparing (the detecting step is a comparison step) steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited pressure sensor is a generic sensor configured to perform pre-solutional data gathering activity, the pump assembly is a generic pump assembly configured to transfer fluid between an inflatable member and a fluid reservoir, and the controller is a computer configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite comparisons of data that can be performed mentally, or computations and observations that can be performed mentally. The elements of the apparatus of claim 1 and the steps recited in claim 18 maintain a high level of generality even when considered in combination with the dependent claims.
Examiner’s Note
The following is a reason for the lack of prior art rejections:
Regarding claim 1, none of the prior art discloses or suggests, either alone or in combination, an inflatable medical device comprising a controller configured to: compute a time interval during an inflation cycle in which a rate of change of pressure data is less than a threshold level, and detect an atrophy condition in response to the time interval achieving a threshold condition, in combination with the other claimed elements.
Regarding claim 18, none of the prior art discloses or suggests, either alone or in combination, a method comprising: computing a time interval during an inflation cycle in which a rate of change of the pressure data is less than a threshold level, and detecting an atrophy condition in response to the time interval achieving a threshold condition, in combination with the other claimed steps.
Response to Arguments
Applicant's arguments filed 19 December 2025 have been fully considered.
Regarding the previous rejections of claims under 35 U.S.C. 112(b), the amendments to the claims have overcome the rejections. However, as noted in paragraph 4 above, the amendments have warranted a new rejection under 35 U.S.C. 112(a). With regard to claims 1 and 18, the Examiner suggests amending the independent claims such that they recite computing a time interval of an initial plateau region of the pressure data in order to overcome the current rejection. The Examiner does not have a suggestion for amendments to claim 23 to overcome the rejection under 35 U.S.C. 112(a).
Regarding the rejection of the claims under 35 U.S.C. 101, Applicant’s arguments are not persuasive. Applicant asserts that the controller of the claimed pump assembly performs specific computational operations and that a human mind cannot mentally calculate the derivative of a fluidic pressure signal from an internal sensor in real-time while tracking temporal intervals. The step of determining a derivate of pressure data is (1) itself drawn to an Abstract Idea (use of a mathematical formula), and (2) not a specific mathematical model. Once the rate of change information of the obtained pressure data is generated, the human mind is capable of, by mental observation and a basic mathematical calculation (subtraction), determining a time interval during which the rate of change is below a threshold level. The human mind is also capable of, by mental evaluation, determining an atrophy condition in response to the time interval achieving a threshold condition. It is further noted that any “sensor data processing” recited in the claims is drawn to pre-solutional data gathering activity and is recited at a very high level of generality.
Regarding Applicant’s argument that the claims provide an improvement to the existing technology, it is noted that Applicant does not provide any evidence of improvements to the current technology. As noted in the previously mailed out Non-Final Office action, prior art exists that teaches an inflatable medical device and a method configured to determine an atrophy condition (in particular with regard to artificial urinary sphincters). Applicant does not provide an explanation as to why the device and method currently being claimed provide an improvement over the existing technology. It is further noted that novelty and non-obviousness (i.e., “non-conventional technological solution”) does not necessarily equal “improvement”.
Regarding the rejections of the claims in view of prior art, the amendments to the claims have overcome the prior art rejections.
The Examiner would also like to note that if the currently rejected claims were amended to overcome the rejections set forth in this Office action, the withdrawn claims would need to be cancelled in order for the claims to proceed to allowance. Issues under 35 U.S.C. 112(a) and 35 U.S.C. 112(b) would be present in the currently withdrawn claims if considered in combination with claims 1 and 18.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791