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 .
Priority
This application claims priority from Foreign application FR 1914526, filed 12/16/2019.
Status of Claims
Claims 1-10 are pending.
Information Disclosure Statement
The Information Disclosure Statement filed on 08/15/2022 has been considered by the examiner.
Specification
The abstract of the disclosure is objected to because it includes reference numbers and has not been filed on a separate sheet. Correction is required. See MPEP § 608.01(b).
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, the movable wall of the tank (Claim 6) a single fluid connection between the outlet 12 and the reservoir 13 (claim 8, there is connection between these two components as configured in Figure 3, and no other Figure shows the reservoir) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 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 1-10 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 1 is rendered indefinite by the final step. A person of ordinary skill in the art would not be able to determine the scope of the claimed step for draining the medical device when it is positively requiring filling of the reservoir. The applicant is advised to amend this step to recite draining the reservoir of medical device of air by filling the reservoir with the biocompatible fluid. This way both the filling and discharging is positively claimed in the proper order.
Claim 6 is rendered indefinite because it is unclear how moving a movable wall of the tank will vary the volume of the reservoir. The volume would be the same regardless of the movement of a component of the tank. The applicant is advised to amend claim 6 to say movement of the movable wall of the reservoir, not the tank, performs this action. This will also correct the 112 issue below with regards to claim 7
Claim 7 lacks antecedent basis for the recitation “the moveable wall of the reservoir” in lines 1-2.
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, 2, 6, 8, and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neuenfeldt et al (Neuenfeldt) USPN 5,964,261.
1. Neuenfeldt discloses a method for draining a medical device (1 Figure 1) adapted to be implanted in a human or animal body (3:40-67), the medical device comprising a casing (outer layer of 1 shown in Figure 1) enclosing a fluid reservoir (3) and a fluid outlet (2) forming a fluid connection between the reservoir and a volume external to the casing (the outlet connects to a volume to the right of the implant in Figure 2), comprising:
providing the device in a packaging (over-pouch 4:35-38) comprising a tank (6) (Figure 2), the casing being held in the tank (Figure 2) in a position in which the reservoir is positioned between the bottom of the tank and the fluid outlet (reservoir 3 extends between the bottom of the tank near reference number 6 and the outlet tube 2 extending to the right),
filling the tank (4:51-58) with a biocompatible fluid (4:56), so that a zone of the packaging external to the medical device which is in fluid connection with the fluid outlet of the reservoir is immersed in the fluid (the zone 6 is within the packaging and tank and is in fluid communication with the external surface of the outlet 2 because it contacts and seals around the outlet),
draining the medical device by filling the reservoir (4:56) with the biocompatible fluid ([0015] of the applicant’s disclosure states that the biocompatible fluid may be a liquid, which means the biocompatible fluid need not be a liquid, the biocompatible cells injected into the implant are considered to be a biocompatible fluid 5:65-617) and discharging the air present in the reservoir to the fluid outlet (5:11-13).
2. Neuenfeldt discloses comprising a step of checking horizontality of the bottom of the tank (Neuenfeldt discloses the tank can be rotated 90 degrees to put the inlet 7 upward 5:1-5, prior to this rotation the operator must inherently check that the tank is horizontal otherwise the rotation would not be needed or would be over rotating).
6. Neuenfeldt discloses the step of draining the medical device is performed by moving a movable wall of the tank to vary a volume of the reservoir (5:11-13).
8. Neuenfeldt discloses the casing comprises a single fluid outlet 4 and a single fluid connection between the reservoir and said fluid outlet (since the reservoir fills the entire casing it inherently has a single fluid connection with it).
9. Neuenfeldt discloses the medical device is adapted to control an occlusion of a natural duct of the human or animal body (the device of Neuenfeldt is fully capable of controlling an occlusion by partially filling or fully blocking any appropriately sized occlusion it is placed within).
Allowable Subject Matter
Claims 3-5, 7, and 10 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.
The prior art of record fails to disclose or render obvious the claimed specific horizontality performance steps of claims 3-5 and 7 or the implant is capable of performing the claimed functions of claim 10.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774