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 § 102
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 10-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barbut et al. (US 6,555,057; hereafter “Barbut 057”).
With respect to Claim 10, Barbut 057 teaches an indwelling catheter system configured to be implantable within a vein of a patient, comprising: a catheter 20 having a lumen (the interior of catheter 20) configured to accommodate passage of fluid therethrough (Figures 2A-3);
an inflow port 24 formed in a wall of the catheter;
a single selectively deployable restrictor 22 for creating a restriction in the vein (Figures 2A-2B and Column 13, Lines 8-22), the single restrictor coupled to the catheter at a location proximal to the inflow port, the restriction being effective to occlude the vein and to at least partially restrict blood flow within the vein so as to create a low-pressure zone downstream of the restriction; and
an activation lumen 23 associated with the catheter and configured to enable selective activation of the single restrictor.
With respect to Claims 11-14, Barbut 057 teaches that the single restrictor comprises a selectively deployable restrictor, specifically a selectively inflatable balloon 22. The balloon 22 is selectively inflatable via an inflation lumen 23 that extends alongside the withdrawal cannula 20. See Figure 3 and Column 13, Line 23 through Column 14, Line 19.
With respect to Claim 15, Barbut 057 teaches that the cannula has a lumen has a diameter of 2 mm to 4 mm, which falls within the claimed range.
With respect to Claim 16, Barbut 057 teaches that the system comprises at least one pressure sensor. See Column 7, Lines 39-56.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
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.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Barbut 057 in view of Barbut et al. (US 6,878,140; hereafter “Barbut 140”).
With respect to Claim 17, Barbut 057 teaches the system substantially as claimed, and further suggests that the balloon of the system may be either fully or partially occluded (Column 13, Line 23 through Column 14, Line 19). Barbut 057, however, does not explicitly teach a mechanism for adjusting a degree of restriction by the balloon based on information acquired by the at least one pressure sensor.
Barbut 140 teaches a catheter system comprising a catheter 1 having a lumen 10 configured to aspirate fluid therethrough, an inflow port 11, and a selectively inflatable balloon 60 coupled to an inflation lumen 61, and a pressure sensor 40 at the distal end of the catheter (Figure 7A). Barbut 140 teaches that the pressure differential (and accordingly, the flow rate) across the balloon may be controlled by controlling the degree of inflation of the balloon (Column 4, Lines 15-36). It would have been obvious to one of ordinary skill in the art at the time of invention to one of ordinary skill at the time of invention to modify Barbut 057’s catheter system to have a distal pressure sensor and means for adjusting the degree of inflation of the balloon, as suggested by Barbut 140, in order to provide a well-known means for optimizing the pressure and flow rate of blood flowing across the balloon
Additionally, with respect to Claim 18, Barbut 057 and Barbut 140 reasonably suggest use of pressure sensors for determining the differential pressure and/or flow rate across the balloon, but do not specifically teach a first pressure sensor located proximal to the restriction and a second pressure sensor located distal to the restriction. However, the examiner takes official notice that it is notoriously well known in the art to place pressure sensors on both ends of a flow system to accurately measure pleasure differential. Once pressure differential has been determined, the flow rate can be calculated. It would have been obvious to one of ordinary skill in the art at the time of invention to provide the system suggested by Barbut 057 and Barbut 140 with proximal and distal pressure sensors, as doing so would provide a well-known means for accurately determining pressure differential and/or flow rate in a vessel.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-9 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-9 of prior U.S. Patent No. 12,115,296. This is a statutory double patenting rejection.
Conclusion
This is a continuation of applicant's earlier Application No. 15/471,842. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Specifically, the instant claims are identical to those filed on 3/28/2017 and rejected in the Non-Final Rejection mailed 10/05/2018.
Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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 Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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