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(a)
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, 3-27 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling. The disclosure does not enable one of ordinary skill in the art to practice the invention without a rigid casing, which is critical or essential to the practice of the invention but not included in the claim(s). See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976).
In the disclosure, the invention is described as utilizing the “water column” effect to carry out the detection of orientation or change in orientation based on a measurement of pressure. In order to utilize the water column effect, there is a requirement for a deformable element and rigid casing.
“The medical device 1 generally comprises a rigid casing 2 and a deformable element 3” (page 6, Detailed Description, second paragraph).
“Due to the "water column" phenomenon, the pressure measured by the sensor 11 is different in the two positions.
In the upright position, and as the casing 2 is rigid and is hermetically linked to the end of the tubular connection connected to the reservoir, there is no direct transmission of the pressure due to the "water column" phenomenon, the pressure in the occlusive sleeve 3 is therefore substantially equal to the pressure measured by the sensor 11 in the reservoir 6 plus the pressure corresponding to the water column H above the sleeve 3 and which therefore applies a corresponding pressure“ (page 9, seventh and eighth paragraphs).
However, claim 1 is directed towards a device that implicitly utilizes the water column effect but does not require that the casing be “rigid”. Rather, this limitation is introduced in claim 2. As such, claim 1 is missing the critical feature of the rigid casing.
Similarly, claim 10 is directed towards a method of using a device that implicitly utilizes the water column effect but does not require that the casing be “rigid”. As such, claim 10 is missing the critical feature of the rigid casing.
Similarly, claim 25 is directed towards a device that implicitly utilizes the water column effect but does not require that the casing be “rigid”. As such, claim 10 is missing the critical feature of the rigid casing.
Claim Rejections - 35 USC § 112(b)
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 10, 12 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.
Regarding Claim 10, it is not understood if the claim limitation “position sensor” is the same as the one from the parent claim (“sensor”), since they are both claimed as performing the same functions (i.e. measurements of orientation based on pressure). Should the claim read as detecting the orientation or the change in orientation from the position sensor, e.g. accelerometer? If so, how is claim 10 any different than claim 11?
Claim 12 is rejected based on its dependency from claim 10.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 21, 22 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The steps of Claim 21 (i.e. “measuring or calculating…” and “detecting an orientation or a change in orientation…”) are already included as part of parent claim 18. Further, Claim 21 makes the steps optional (“at least one of…”), thereby not including both of the steps required by the parent claim.
Claim 22 is rejected based on its dependency from claim 21.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
The claimed invention is not being rejected under 35 USC 101. Although the claims include the natural phenomenon of detecting pressure and the mathematical relationship of converting it to orientation or change in orientation with respect to the direction of gravity of at least one part of said body, the claims also include a particular device that relies upon the water column effect, of which is not routine, well-known, or conventional in the context of medical implants.
Allowable Subject Matter
Claim 2 is 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 1, 3-27 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112 set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not teach or suggest a medical implant utilizing the water column effect to detect pressure and convert it into orientation or change in orientation of the body part. Lamraoui (US 20150374288) teaches similar hardware as the claimed invention and the pressure sensor would inherently detect pressures that fluctuate with a change in orientation or orientation of the body. However, Lamraoui does not utilize any software for converting the measured pressure into an orientation or change in orientation, as required by the claimed invention. It would not be obvious to utilize the recorded pressures of Lamraoui in this manner since Lamraoui includes other means for detecting orientation or change in orientation (e.g. accelerometer), and pressure measurements are not typically associated with orientation or change in orientation of a body part.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799
Prosecution Insights