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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/27/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 32 and 41-42 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 32 recites the limitation "the first and second side sections" in line 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 41 recites the limitation "the first section" in line 4 and “the second section” in line 6. There is insufficient antecedent basis for these limitations in the claim. Dependent claim 42 is rejected for the same reason.
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.
Claim(s) 21-27, 32, 33 and 41-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by USPAP 2003/0229366 (Reggie et al.).
Regarding claim 21, Reggie discloses an implantable medical device (Fig. 1) for preventing backflow a lumen that includes an elongate support member (portion of 14pre overlying stent 12 in Figure 2c) in the form of a tubular membrane that defines a length, a proximal end (16), a distal end (18), and an internal lumen extending between the proximal and distal ends [0013];
A stent (12) on the elongate support member having a first length (see the stent overlaying a portion of the elongate support member (14pre) in Figure 2c [0015-0017]);
and an elongate flexible tubular valve member having a second length (portion of 14 extending past free end FE of the stent frame – see Fig. 2d and [0017]) having a length, an open proximal end having a first diameter (see description of 16), an openable distal end (18) unattached from the elongate support member (portion of 14 overlying stent 12) that defines a uniform second diameter that is less than the first diameter, a tapered portion, and a distal portion having no taper (see marked up drawing below), and a lumen between the open proximal end (16) and the openable distal end (18), the proximal end (16) of the valve member being supported by the support member (12) and configured to be held open thereby in a deployed condition of the device, and the openable distal end (18) of the valve member in the deployed condition being configured to remain closed when fluid flows in a proximal direction (see closed configuration in Figure 3C; [0019]), the valve member (14) being unstented along its length (the portion of 14 extending past free end of the stent FE in Fig. 2D-E is unstented).
As shown in the marked up drawing below, the tapered portion extends along a portion of the second length of the valve member from the proximal end toward the distal portion and the distal portion, and the distal portion extends to the distal end.
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The limitation “for preventing backflow into a false lumen of dissection” is a functional limitation not given full patentable weight. The prior art is not required to disclose the recited function. The device is configured for placement in a body lumen (L) for occlude fluid flow therethrough [0019], and therefore capable of being used into prevent backflow into a false lumen of dissection.
Claims 22 and 23 merely recite functional language and do not recite further structural features. The prior art is not required to disclose the function of the distal end of the valve member receiving instruments through the openable distal end, but merely to have the capability of performing in the recited manner. In this case, Reggie does disclose an instrument (balloon catheter 40) placed through the distal end (18) (see Fig. 3A-B; [0018]). The distal end (18) has a self-sealing opening (21) and returns to a closed state after removal of the balloon catheter due to a compression band (20) (16) (Fig. 3C; [0016]; [0019]).
Regarding claim 24, the openable distal end (21) is biased in a closed condition (see description of compression band 20 at the distal end 21 [0016]; [0019]).
Regarding claim 25: the valve member (14) comprises an unstented graft material tube (ePTFE is disclosed at [0006]).
In regards to claim 26, Reggie discloses a tapered shape of the unstented graft material (see above).
Regarding claim 27, the distal end (18) of the valve member (portion of 14 extending past FE in Fig. 2c) extends distally beyond the distal end of the support
Regarding claims 32 and 33, Reggie discloses the tubular valve (14) member (portion of 14 overlying the stent). comprises a resilient biasing member (compression band 20) that biases the valve into the closed shape of Figure 3C [0016]. Since the band extends the entire circumference, it is on first and second side sections. The band (20) is offset from the distal end of the valve (see esp. Fig. 2E).
In regards to claims 41 and 42, the tapered portion of Reggie can be described as having a first section with a first degree of taper that is greater than a second degree of taper of a second section (see below).
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Regarding claim 43, the distal portion is substantially cylindrical, as realized in the illustrations [0016].
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.
Claim(s) 28-31 and 34-40 are rejected under 35 U.S.C. 103 as being unpatentable over Reggie in view of USPAP 2005/0137681 (Shoemaker et al.).
Regarding claims 28 and 34, Reggie fails to disclose the valve member comprises first and second “lines of attachment” provided along a length of the valve member opposite one another. Shoemaker discloses another implantable prosthesis with a tapered valve member. Shoemaker teaches that to form the tapered portion, a tubular member (504) has portions (569) cut away and edges joined together to form “first and second lines of attachment” opposite one another (see Figures 5A-C; [0051] and marked up figure below). One of ordinary skill in the art would have found it obvious to form the tapered portion of the Reggie valve according to the teachings of Shoemaker to arrive at the valve having first and second lines of attachment, as the modification merely involves a combination of known valves that obtains a predictable result.
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Further regarding claim 34, Reggie discloses the openable distal end can receive an ancillary device (see balloon catheter 40) (see Fig. 3A-B; [0018]). The distal end (18) has a self-sealing opening (21) and returns to a closed state after removal of the balloon catheter due to a compression band (20) (16) (Fig. 3C; [0016]; [0019]).
Regarding claims 29 and 39, Shoemaker discloses first and second lines of attachment are opposite one another relative to an imaginary plane along the longitudinal axis of the device.
Regarding claims 30 and 37, Shoemaker further teaches sutures for attaching components of the prosthesis [0047] and that these fasteners can be used for the lines of attachment [0051]. Therefore, it would have been further obvious to form the lines of attachment of the tapered valve with stitching.
Regarding claims 31, 35 and 38, discloses the graft material comprises circumferential fibers provided on the first and second side sections of the tube (wherein ePTFE comprises a plurality of fibers), wherein the one or more of the fibers are offset from the distal end (18) of the valve member (fibers forming the proximal end would be offset from the distal end).
Regarding claims 36, Reggie discloses the tubular valve (14) comprises a resilient biasing member (see description of compression band 20 at the distal end 21 [0016]; [0019]). Since the band extends the entire circumference, it is on first and second side sections. The band (20) is offset from the distal end of the valve (see esp. Fig. 2E).
Regarding claim 40: the valve member (14) comprises an unstented graft material tube (ePTFE is disclosed at [0006]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-12 of U.S. Patent No. 11,229,438 in view of USPAP 2003/0229366 (Reggie et al.). Although the claims at issue are not identical, they are not patentably distinct from each other because all of the claim limitations of this application are anticipated by the claims of ‘438.
In regards to claim 21: Claim 1 of the ‘438 patent recites an elongate support, a valve member with a closable distal end and a proximal end secured to a support member, and part of the valve being unstented. Claim 8 of ‘438 recites a tapered profile. The ‘438 patent fails to specify the profile of the valve member with different portions having different diameters (although this is understood by the term taper) and a distal portion having no taper.
Reggie teaches a valve having a valve member having an open proximal end with a first diameter, an openable distal end having a smaller second diameter, a tapered portion and a distal portion having no taper (see 102 rejection above), wherein the tapered portion extends from the open proximal end and the distal portion extends to the distal opening. One of ordinary skill in the art would have found it obvious to recite these particular characteristics of the shape of the valve in the claims of the ‘438 patent, since the modification is merely a combination of known valve structures that obtains predictable results of occluding flow.
Further in regards to claim 34, claim 10 of ‘438 recites first and second lines of attachment and defining two side sections. Reggie further renders obvious receiving an ancillary device within the distal opening of the valve, as Reggie teaches the distal end (18) has a self-sealing opening (21) and returns to a closed state after removal of the balloon catheter (40) due to a compression band (20) (16) (Fig. 3C; [0016]; [0019]). It would have been further obvious to recite this feature in the claims of the ‘438 patent, as it was known in the art to include a feature to bias the distal end of the valve to a closed condition after removal of an ancillary/ deployment device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774