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 abstract of the disclosure is objected to because in line 6, “calibration module calibration module” is duplicated. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: in paragraph [0005], “calibration module calibration module” is duplicated.
Appropriate correction is required.
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.
Claim 1-20 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. The specification is filled with the phrase “In some embodiments” rendering the structure required by any one embodiment to be unclear. The specification sets forth a “calibration module” without setting forth the specific structure required to perform the functions set forth with respect to the “calibration module” in the claims. These functions include “determine if the inflatable member is applying pressure to a body portion” paragraph [0028]; “determine when the inflatable member” is not applying pressure the body portion, paragraph [0040]; “determine atmospheric pressure” paragraph [0029]; determine when the inflatable is applying pressure and when it is not, paragraph [0040], determine when atmospheric pressure is a greater or less than normal, ie. is changing, paragraph [0041] and controlling pumps [0042].
Paragraphs [0048] through [0061], sets forth every possible structure to perform the functions set forth in the specification but only in high level of generality, ie a processor with program or custom circuitry without one specific structure set forth. The office is not capable of determining what would be considered an equivalent of the “calibration module” when only generically recited structure is set forth.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “calibration module” in claims 1-20 and evaluation module claim 11. It is unclear from the specification the specific structure of the calibration module and in view of paragraphs [0048]-[0061], any structure or structure plus software will be considered equivalents.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1-18 are objected to because of the following informalities: in claim 1 line 8 and line 13 of claim 16, "calibration module calibration module." is repeated. Appropriate correction is required.
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) 1-6, 8, 10, 11, 13-15 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hohlrieder et al(2019/0133737, hereinafter Hohl).
Claim 1 – Hohl teaches an apparatus, including: a bodily implant, band -1-, hose -9- and pump -10- configured to be implanted into a body of a patient, the implant including an inflatable member, see hollow chamber -3- inside elements -1- and -1a-, a sensor -22-, and a calibration module -17- and -20-, the inflatable member -1- being configured to be disposed proximate a portion of the body of the patient, urethra see paragraph [0028], the sensor -22- is operatively coupled to the inflatable member and is configured to detect a fluidic pressure within the inflatable member, and the calibration module calibration module is configured to receive pressure data from the sensor and determine when the inflatable member is placing a pressure on the portion of the body of the patient, see paragraph [0055].
Claim 2 – Hohl teaches the inflatable member is configured to be disposed in an inflated configuration, figure 6 and a deflated configuration, figure 5.
Claims 3 and 4 – Hohl teaches, wherein the inflatable member is configured to be disposed in an inflated configuration, figure 6 and a deflated configuration, figure 5, the inflatable member being configured to place a first pressure on the portion of the body of the patient when the inflatable member is in its inflated configuration, to close urethra and a second pressure on the portion of the body of the patient when the inflatable member is in its deflated configuration, to allow for urination, the first pressure being greater than the second pressure.
Claim 5 – Hohl teaches the bodily implant includes a pump -11-, the pump being operatively coupled to the inflatable member -1a- and configured to pump a fluid out of the inflatable member, figure 5.
Claim 6 – Hohl teaches a pump -11-, the pump being operatively coupled to the inflatable member -1a- and configured to pump a fluid into the inflatable member, figure 6.
Claim 8 – Hohl teaches the bodily implant includes an electric pump, element -15- electric drive.
Claim 10 – Hohl teaches the bodily implant includes a reservoir configured to hold fluid, inside pump part -11-.
Claim 11 – Hohl teaches the calibration module -17- and -20- includes an evaluation module, the evaluation module being configured to evaluate pressure data, see paragraph [0055]-[0060].
Claim 13 – Hohl teaches the inflatable member is configured to be disposed proximate a urethra of a patient, see paragraphs [0053] and [0054].
Claim 14 – Hohl teaches the inflatable member -1- is configured to be disposed in a circular configuration as shown in figure 4.
Claim 15 – Hohl teaches the inflatable member -1- is configured to be disposed in a circular configuration and is configured to surround a urethra of a patient, see paragraphs [0053] and [0054].
Claim 19 – Hohl teaches deflating an inflatable member -1- and -1a- that is disposed within a body of a patient, paragraphs [0058] through [0061]; sensing the pressure applied by the inflatable member to a portion of the body of the patient with sensor -22-; and determining when the inflatable member is no longer applying a pressure to the portion of the body of the patient, at the commencement of urination.
Claim Rejections - 35 USC § 103
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 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) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hohlrieder et al(2019/0133737, hereinafter Hohl) as applied to claim 1 above and further in view of Smith et al(2020/0222188, hereinafter Smith).
Claim 7 – Hohl teaches an implant as claimed but uses an internal reservoir and a single pump to deliver fluid to and remove fluid from the inflatable member not a two pump system.
Smith teaches an inflatable implant -204- a reservoir -202- a first pump -208- to pump fluid from the reservoir to the inflatable member and a second pump -210- to pump fluid from the inflatable implant back to the reservoir.
It would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to use the reservoir and two pump system as taught by Smith in place of the reservoir and single pump system of Hohl as an ordinary substitution of functionally equivalent systems to provide fluid from a reservoir to the inflatable device and to return fluid from the inflatable member to the reservoir.
Claim 9 – the pumps -208 and -210- taught by Smith are electric pumps.
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hohlrieder et al(2019/0133737, hereinafter Hohl) in view of Smith et al(2020/0222188, hereinafter Smith).
Claim 16 – Hohl teaches an apparatus, including: a bodily implant, -1-, -9- and -10- configured to be implanted into a body of a patient, the implant including an inflatable member -1-, -1a-, a reservoir, within -11-, pump -11-, a sensor -22-, and a calibration module -17- and -20-, the inflatable member -1a- being configured to be disposed proximate a portion of the body of the patient, the sensor -22- is operatively coupled to the inflatable member and is configured to detect a fluidic pressure within the inflatable member, and the calibration module calibration module is configured to receive pressure data from the sensor and determine when the inflatable member is placing a pressure on the portion of the body of the patient, see paragraphs [0054]-[0061]. Hohl does not teach a two pump system as claimed.
Smith teaches an inflatable implant -204- a reservoir -202- a first electrical pump -208- to pump fluid from the reservoir to the inflatable member and a second electrical pump -210- to pump fluid from the inflatable implant back to the reservoir.
It would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to use the reservoir and two pump system as taught by Smith in place of the reservoir and single pump system of Hohl as an ordinary substitution of functionally equivalent systems to provide fluid from a reservoir to the inflatable device and to return fluid from the inflatable member to the reservoir.
Claim 17 - the inflatable member -1- is configured to be disposed proximate a urethra of a patient, see paragraphs [0053] and [0054].
Claim 18 - the inflatable member -1- is configured to be disposed in a circular configuration and is configured to surround a urethra of a patient, see figure 1 and paragraphs [0053] and [0054].
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hohlrieder et al(2019/0133737, hereinafter Hohl) as applied to claim 1 above, and further in view of Bratteli(6,733,461, hereinafter Brat) .
Claim 12 – Hohl teaches an apparatus as claimed but does not teach a smoothing module configured to smooth the pressure data.
Brat teaches an apparatus for improving pressure calibration including a smoothing module for smoothing the pressure data to enable consistent determining and marking changes in the pressure, column 9 lines 53.
It would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed include a smoothing module(filter) configured to smooth the pressure data measured by the sensor -22- to more effectively determine the changes in the pressure as suggested by Brat. Such smoothing is accomplished by using appropriate filtering which produces smoothed pressure data as taught by Brat.
Such a modification to the apparatus of Hohl would produce an apparatus including the appropriate filters configured to smooth the pressure data as suggested by Brat.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hohlrieder et al(2019/0133737, hereinafter Hohl) as applied to claim 19 above, and further in view of Bratteli(6,733,461, hereinafter Brat) .
Claim 20 – Hohl teaches a method as claimed but does not teach smoothing the pressure data.
Brat teaches a method of improving pressure calibration including smoothing the pressure data to enable consistent determining and marking changes in the pressure, column 9 lines 53.
It would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to smooth the pressure data measured by the sensor -22- to more effectively determine the changes in the pressure as suggested by Brat. Such smoothing is accomplished by using appropriate filtering which produces smoothed pressure data as taught by Brat.
Such a modification to the method of Hohl would produce a method including smoothing the pressure data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL G GILBERT whose telephone number is (571)272-4725. The examiner can normally be reached MaxiFlex; M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at 571-272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL G GILBERT/Primary Examiner, Art Unit 3791
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