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 Objections
Claim 1 is objected to because of the following informalities: the claim recites “said inflatable element” at line 16 but appears clear that it intends to refer back to the “at least one inflatable element” of claim 1 at line 13, therefore, the recitation should be reflected to read as “said at least one inflatable element” to be in better form. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: the claim recites “at least one inflatable element” at lines 27-28 but appears clear that it intends to refer back to the “at least one inflatable element” of claim 1 at line 13, therefore, the recitation should be reflected to read as “the at least one inflatable element” to be in better form. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: the claim recites “at least one inflatable element” at lines 29-30 but appears clear that it intends to refer back to the “at least one inflatable element” of claim 1 at line 13, therefore, the recitation should be reflected to read as “the at least one inflatable element” to be in better form. Appropriate correction is required.
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, 4, 8-9, 11, and 15 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 recites the limitation “the distal end of said intracorporeal segment” in line 14. There is insufficient antecedent basis for this limitation in the claim. Rather, claim 1 previously establishes a “distal segment” of the intracorporeal segment, but it is unclear whether “distal segment” and “distal end” comprise the same scope or different scopes.
Claim 11 recites “a second inflatable element”. Claim 1, from which claim 11 depends, recites “at least one inflatable element”. Note also that Applicant has left in the reference numerals in the claims, and that these inflatable elements are referred to by different reference numerals. It is unclear whether the second inflatable element of claim 11 is an additional one of the “at least one inflatable element” in claim 1 or whether it refers to a different and separate inflatable element, therefore rendering the claim indefinite. Further, the claim recites “the first inflatable element”, which lacks antecedent basis. For examination purposes, it will presume to refer to a different inflatable element.
Claim 15 recites the limitation "the conduit-to-conduit connector" in line 52. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the bypass conduit" in line 53. There is insufficient antecedent basis for this limitation in the claim.
Claims 4, 8-9, 11, and 15 are indefinite by virtue of their dependency on indefinite base claim 1.
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, 4, 8-9, 11, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2002/0091398 A1 to Galdonik et al. (hereinafter “Galdonik”).
Regarding claim 1, Galdonik discloses (see abstract; Figs. 1-56; and [0081]-[0183]) an anastomosis device (as shown in the Figures) configured to suturelessly anastomose a conduit to a blood vessel (see [0081]/[0183]), said device comprising: an intracorporeal conduit (10 housing balloon catheter 300) configured to provide a fluid path to and from a blood vessel or graft (20) (see [0081]-[0083]), wherein said intracorporeal conduit comprises a distal segment (distal portion of tube 306 within balloon 302 in Fig. 8), a proximal segment (proximal portion of tube 306, Fig. 8), and at least one inflation/deflation lumen (316) (see Figs. 1/8 and [0101]), said distal segment being fixedly attached to and within at least one inflatable element surrounding said intracorporeal conduit (see Figs. 8/24); and at least one inflatable element (balloon 302 + connector 200) configured to be inflated inside a blood vessel or graft (see Figs. 23-24 and [0151]), suturelessly (see [0183]) anastomose the distal end of said intracorporeal conduit to said blood vessel or graft (see Figs. 23-25 and [0151]), and seal the anastomosis site (see [0151]), characterized in that the profile and shape of said inflatable element, when inflated, are customized by localized reinforcements (struts of connector 200, see [0179] & [0105]-[0108] & [0116]-[0118]) made of supraelastic shape-memory material (see [0085]/[0181]) pre-shaped through a process of shape setting (see [0085]-[0089], [0105] & [0179]).
Galdonik further discloses (claim 4) characterized in that the material reinforcements are configured such that said inflatable elements, when inflated, are at an angle (255) of 15 to 45 degrees with respect to the longitudinal axis of the blood vessel (see Figs. 23-24, elements 206/218 are shown deflecting at an angle that falls within the claimed range as compared to the long. axis of vessel 20); (claim 8) characterized in that at least one inflatable element is configured as fingers (222) around a central ring (body of 200, see Figs. 2-7); (claim 9) characterized in that at least one inflatable element is configured as a basket (see Figs. 2-7); (claim 11) further comprising another inflatable element (400), characterized in that one inflatable element inflated (400) inside the blood vessel (Fig. 22) is smaller and thinner than the other inflatable element (balloon 302 + connector 20)) inflated outside the blood vessel in order for the first inflatable element to minimize impact on blood flow (Figs. 22-23), and for the second inflatable element to ensure increased sealing and reliable fixation at the anastomosis site (Figs. 23-24).
Regarding claim 15, Galdonik discloses (see abstract; Figs. 1-56; and [0081]-[0183]) a percutaneous bypass method (see Figs. 44-56 and [0158]-[0165]), the method characterized in that it uses two anastomosis devices according to claim 1 (see [0158] and Fig. 44): gaining percutaneous access to a first blood vessel at a first bypass target location (see Fig. 45 and [0158]); percutaneously deploying a first anastomosis device according to claim 1 to the first target location (see Figs. 45-49 and [0158]); gaining percutaneous access to a second blood vessel at a second bypass target location (see Figs. 49-50 and [0159]); percutaneously deploying a second anastomosis device according to claim 1 to the second target location (see Figs. 44 and 52-53); tunneling the intracorporeal conduit of first anastomosis device according to claim 1 and the intracorporeal conduit of second anastomosis device according to claim 1 towards an accessible connection location (see Figs. 45-48);connecting the intracorporeal conduit of said first anastomosis device to the intracorporeal conduit of said second anastomosis device using the conduit-to-conduit connector (10) (see Figs. 45-49), thus establishing the bypass conduit between the first and the second blood vessels (see Fig. 44).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See the PTO-892 Notice of References cited for additional prior art disclosing anastomosis devices having balloons and shape memory structures.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771