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 .
This action is in response to the amendment filed on 12/04/2025. Claims 1-6, 8-14, 16-18, and 32-35 are pending. Claims 5, 6, 10, 13, 14, and 16-18 are withdrawn. Claims 7, 15, and 19-31 are canceled.
Claim Objections
Claim 32 is objected to because of the following informalities:
Claim 32, line 2, “oval-shaped” should be amended to --is oval-shaped--.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently, none of the claim limitations are interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 103
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 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 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.
Claim(s) 1-4, 32, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Layton et al. (US Pub. No.: 2011/0264117) in view of Nicolo (US Pub. No.: 2003/0144675).
Regarding claims 1-4, 32, and 33, Layton discloses [claim 1] a fistula formation device (10 which includes 14 and 18, Fig. 1 and Para. [0051]-[0054]), comprising: a first engagement member (18, Fig. 1) configured to be positioned within a first vessel, the first engagement member comprising a plate (member 18 defines a plate, Fig. 1) defining a first opening (central opening in 18 for 14 to pass through, Fig. 1) therethrough; and a second engagement member (12, Fig. 1) configured to be positioned within a second vessel (Fig. 1), the second engagement member comprising: a base plate (26, Fig. 1) comprising a second opening (38, Fig. 1 and Para. [0051]) extending therethrough; and one or more retention members (30 with laterally extending threads 42, Fig. 53 and Para. [0053]) extending from the base plate around the second opening, wherein the one or more retention members are configured to extend through the plate of the first engagement member to secure the first engagement member to the second engagement member and form an open conduit through the first engagement member and the second engagement member between the first vessel and the second vessel (Paras. [0051]-[0054], the one or more retention members are configured to extend through the plate of the first engagement member to secure the first engagement member to the second engagement member and form an open conduit through the first engagement member and the second engagement member between the first vessel and the second vessel similar to what is shown in Fig. 2); [claim 2] wherein: the plate of the first engagement member comprises a first surface fully capable to engage a wall of the first vessel and a second surface opposite the first surface (Fig. 1, the plate of the first engagement member comprises a first surface fully capable to engage a wall of the first vessel and a second surface opposite the first surface similar to what is shown in Fig. 1 or 2); and the one or more retention members are configured to be inserted through the first opening of the first engagement member and comprise one or more retention tabs that engage the second surface of the plate (Para. [0053]-[0054], also see Fig. 2 for example); [claim 3] wherein the one or more retention members comprise a single retention member (30, Fig. 1) which circumscribes the second opening; [claim 4] wherein the first engagement member and the second engagement member are bioabsorbable (Paras. [0050] and [0052]). However, Layton does not specifically disclose that the first opening being elongated in a direction transverse to a flow path through the fistula formation device.
Nicolo teaches, in the same field of endeavor (fistula/anastomotic formation device), [claim 1] a first engagement member (60, Figs. 5 and 6) having a plate (oval ring plate of 60, Fig. 5); a second engagement member (62, Figs. 5 and 6) having a base plate (oval ring plate of 62, Figs. 6 and 5); a first opening (central oval-shaped opening of 60, Fig. 5 and Para. [0037])) of the first engagement member is elongated in a direction transverse to a flow path through the fistula formation device (Fig. 5); [claim 32] wherein the plate of the first engagement member is oval-shaped (Fig. 5 and Para. [0037]); [claim 33] wherein the base plate of the second engagement member is oval-shaped (Fig. 5 and Para. [0037]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill to modify the device of Layton to include that the first opening being elongated in a direction transverse to a flow path through the fistula formation device; wherein the plate of the first engagement member is oval-shaped; and wherein the base plate of the second engagement member is oval-shaped as taught by Nicolo in order to obtain the advantage of better approximating the lumen shape than does the prior art circle (Nicolo, Paras. [0037] and [0031]).
Claim(s) 8, 9, 11, 12, and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Layton et al. (US Pub. No.: 2011/0264117) in view of McKenna et al. (US Pub. No.: 2008/0082114) and Nicolo (US Pub. No.: 2003/0144675).
Regarding claims 8, 9, 11, and 12, Layton discloses [claim 8] a fistula formation device (10 which includes 14 and 18, Fig. 1 and Para. [0051]-[0054]) configured to be delivered to a first vessel and a second vessel, the fistula formation device, comprising: a first engagement member (18, Fig. 1) configured to be positioned within a first vessel, the first engagement member comprising a plate (member 18 defines a plate, Fig. 1) defining a first opening (central opening in 18 for 14 to pass through, Fig. 1) therethrough; and a second engagement member (12, Fig. 1) configured to be positioned within a second vessel (Fig. 1), the second engagement member comprising: a base plate (26, Fig. 1) defining a second opening (38, Fig. 1 and Para. [0051]); and one or more retention members (30 with laterally extending threads 42, Fig. 53 and Para. [0053]) extending from the base plate around the second opening, wherein the one or more retention members are configured to extend through the plate of the first engagement member to secure the first engagement member to the second engagement member and form an open conduit through the first engagement member and the second engagement member between the first vessel and the second vessel (Paras. [0051]-[0054], the one or more retention members are configured to extend through the plate of the first engagement member to secure the first engagement member to the second engagement member and form an open conduit through the first engagement member and the second engagement member between the first vessel and the second vessel similar to what is shown in Fig. 2); [claim 11] wherein: the plate of the first engagement member comprises a first surface fully capable to engage a wall of the first vessel and a second surface opposite the first surface (Fig. 1, the plate of the first engagement member comprises a first surface fully capable to engage a wall of the first vessel and a second surface opposite the first surface similar to what is shown in Fig. 1 or 2); and the one or more retention members are configured to be inserted through the first opening of the first engagement member and comprise one or more retention tabs that engage the second surface of the plate (Para. [0053]-[0054], also see Fig. 2 for example); [claim 12] wherein the one or more retention members comprise a single retention member (30, Fig. 1) which circumscribes the second opening. However, Layton does not disclose [claim 8] one or more sheaths configured to be advanced through at least one of a first vessel and a second vessel for delivering the fistula formation device through the first vessel and second vessel; and the first opening being elongated in a direction transverse to a flow path through the fistula formation device; [claim 9] wherein: the one or more sheaths comprise a first sheath configured to be advanced through the first vessel and a second sheath configured to be advanced through the second vessel; the first sheath is configured to deliver the first engagement member to the first vessel; and the second sheath is configured to deliver the second engagement member to the second vessel.
McKenna teaches, in the same field of endeavor (system for forming a fistula), one or more sheaths (81 and 25, Figs. 5-8) fully capable to be advanced through at least one of a first vessel and a second vessel for delivering a fistula formation device through the first vessel and second vessel (Figs. 5-8); wherein: the one or more sheaths comprise a first sheath (81, Figs. 5-8) configured to be advanced through the first vessel and a second sheath (25, Figs. 5-8) configured to be advanced through the second vessel; the first sheath is configured to deliver a first engagement member (70, Figs. 5-8) to the first vessel; and the second sheath is configured to deliver a second engagement member (65, Figs. 5-8) to the second vessel.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the system of Layton to include one or more sheaths configured to be advanced through at least one of a first vessel and a second vessel for delivering the fistula formation device through the first vessel and second vessel; wherein: the one or more sheaths comprise a first sheath configured to be advanced through the first vessel and a second sheath configured to be advanced through the second vessel; the first sheath is configured to deliver the first engagement member to the first vessel; and the second sheath is configured to deliver the second engagement member to the second vessel as taught by McKenna in order to facilitate the delivery of each of the first and second engagement members.
Nicolo teaches, in the same field of endeavor (fistula/anastomotic formation device), [claim 8] a first engagement member (60, Figs. 5 and 6) having a plate (oval ring plate of 60, Fig. 5); a second engagement member (62, Figs. 5 and 6) having a base plate (oval ring plate of 62, Figs. 6 and 5); a first opening (central oval-shaped opening of 60, Fig. 5 and Para. [0037])) of the first engagement member is elongated in a direction transverse to a flow path through the fistula formation device (Fig. 5).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill to modify the device of Layton to include that the first opening being elongated in a direction transverse to a flow path through the fistula formation device as taught by Nicolo in order to obtain the advantage of better approximating the lumen shape than does the prior art circle (Nicolo, Paras. [0037] and [0031]).
Regarding claim 34, McKenna discloses a first pusher (combination of 80 and 40, Fig. 6) and coupled to the first engagement member and slidably positioned within the first sheath (Figs. 5-9 and Paras. [0031]-[0036]); and a second pusher (combination of 35 and rod connecting to 35 for moving 35, Figs. 7 and 8 and Paras. [0031]-[0036]) coupled to the second engagement member and slidably positioned within the second sheath; wherein the first pusher and the second pusher are configured to snap off of the first engagement member and the second engagement member, respectively (Para. [0026]), when the first engagement member is coupled to the second engagement member (Figs. 8-9 and Para. [0026]). Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill to modify the device of Layton to include a first pusher coupled to the first engagement member and slidably positioned within the first sheath; and a second pusher coupled to the second engagement member and slidably positioned within the second sheath; wherein the first pusher and the second pusher are configured to snap off of the first engagement member and the second engagement member, respectively, when the first engagement member is coupled to the second engagement member, and the corresponding detachable attachment structures on the engagement members as taught by McKenna in order to facilitate the delivery and adjustment of the engagement members.
Allowable Subject Matter
Claim 35 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 8, 9, 11, 12, and 32-34 have been considered but are moot in view of new grounds of rejection.
In response to the argument(s) on pages 7-11 of the remarks, the newly applied prior art, Nicolo (US Pub. No.: 2003/0144675), teaches, in the same field of endeavor (fistula/anastomotic formation device), a first engagement member (60, Figs. 5 and 6) having a plate (oval ring plate of 60, Fig. 5); a second engagement member (62, Figs. 5 and 6) having a base plate (oval ring plate of 62, Figs. 6 and 5); a first opening (central oval-shaped opening of 60, Fig. 5 and Para. [0037])) of the first engagement member is elongated in a direction transverse to a flow path through the fistula formation device (Fig. 5); wherein the plate of the first engagement member is oval-shaped (Fig. 5 and Para. [0037]); wherein the base plate of the second engagement member is oval-shaped (Fig. 5 and Para. [0037]). Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill to modify the device of Layton to include that the first opening being elongated in a direction transverse to a flow path through the fistula formation device; wherein the plate of the first engagement member is oval-shaped; and wherein the base plate of the second engagement member is oval-shaped as taught by Nicolo in order to obtain the advantage of better approximating the lumen shape than does the prior art circle (Nicolo, Paras. [0037] and [0031]).
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 JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JING RUI OU/Primary Examiner, Art Unit 3771
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