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 .
Response to Amendment
This Office action is in response to the applicant’s communication filed 04/23/2026.
Status of the claims:
Claims 1, 4 – 11 are pending in the application.
Claims 1, 9, and 11 are amended.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “its volume” and “its initial shape” in lines 14 and 18, respectively, although the lines are understood by the Examiner to mean “a volume thereof” / “a volume of each of the plurality of supporting main bodies” and “an initial shape thereof” / “an initial shape of each of the supporting main bodies”, respectively, the Examiner suggests the lines be amended to read “a volume thereof” / “a volume of each of the plurality of supporting main bodies” and “an initial shape thereof” / “an initial shape of each of the supporting main bodies” (or some other equal phrasing) for the purpose of maintaining consistent language throughout the claims;
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.
The rejection of claims 9 and 11 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 01/27/2026 have been withdrawn in light of the Applicant’s arguments filed 04/23/2026. Specifically, the rejection of claims 9 and 11, regarding the phrase "the supporting main body is provided with a hollow cavity, and one end of the supporting main body is provided with a through hole; or, two ends of the supporting main body are provided with through holes”, have been withdrawn as the appropriate corrections have been made.
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.
Claims 1 and 4 – 11 are rejected under 35 U.S.C. 103 as being unpatentable over Okada (US 2002/0038100 A1) (previously cited) in view of Taylor et al (US 5,925,054) (previously cited).
Regarding claim 1 and 4 – 6, Okada discloses a lumen anastomosis supporting dilator (i.e., a dilator capable of supporting an anastomosis device) (shunt tube 10) (abstract, paragraphs [0038 – 0039], Figs. 1 – 5, 7, and claim 4), wherein the lumen anastomosis supporting dilator comprises:
a supporting main body (large diameter sections 14) made of a shape memory material (self-expandable / shape memory resin) and used for at least being partially placed in a lumen to dilate a lumen wall (paragraphs [0043 – 0044] and Fig. 4); and
a single connecting rod (tube 12) connected to the supporting main body (large diameter sections 14) (paragraphs [0036], [0038], [0042], and Figs. 1–5,7);
wherein the supporting main body (large diameter sections 14) comprises a plurality of supporting main bodies (large diameter sections 14 on each end of ube 12) (paragraphs [0036], [0038], [0042], and Figs. 1–5,7), wherein the plurality of supporting main bodies (large diameter sections 14) are [claim 4] rotary bodies and are connected to the single connecting rod (paragraphs [0036], [0038], [0042], and Figs. 1–5,7) (Examiner’s note: the large diameter sections 14 (i.e., the supporting main bodies) are rotatable about an axis, and are thus rotary bodies);
wherein two ends of the single connecting rod (tube 12) are each provided with one of the plurality of supporting main bodies (large diameter sections 14) (paragraphs [0036], [0038], [0042], and Figs. 1–5,7);
wherein each of the plurality of supporting main bodies (large diameter sections 14) is configured to be gripped by an instrument to reduce its volume during insertion into the lumen, and when the each of the plurality of supporting main bodies is released by the instrument they provides sufficient radial supporting force to prop up the lumen wall, and the each of the plurality of supporting main bodies can self-expand to its initial shape even if deformed (Examiner’s note: the large diameter sections 14 are made out of a shape-memory, self-expandable, resin as discussed in paragraphs [0008], [0034], and [0051]; and because the large diameter sections 14 are self-expandable they are also configured to be compressible when gripped with an instrument to reduce their volume during insertion. Additionally, as stated in paragraph [0051] the large diameter sections 14 self-expand to their original shape (i.e., their initial shape), even when deformed. Furthermore, as shown in Figs. 3,4, the large diameter sections 14 prop up the lumen walls, thereby providing sufficient radial force as claimed. Lastly, it should be understood that the preceding limitation is an intended use limitation, which requires only that the structure of the prior art be capable of functioning as claimed; with that said, because the large diameter sections 14 are self-expandable, the large diameter sections are compressible by an instrument and releasable to their initial, unconstrained shape, thus, the large diameter sections 14 are said to be configured to function in the manner claimed);
[claim 5] wherein each of the plurality of supporting main bodies comprises a main body part (proximal portion / proximal end), at least one end of the main body part is provided with a tapered part (distal portion / distal end), and an outer diameter of the tapered part decreases outward from the main body part (Fig. 7), and the maximum outer diameter of the main body part is larger than the maximum outer diameter of the tapered part (Fig. 7) and an included angle between axis lines of the two of the plurality of supporting main bodies (large diameter sections 14) at the ends of the single connecting rod (tube 12) is 0-180 degrees (180 degrees - Fig. 7).
However, Okada is silent regarding (i) [claims 1 and 6] wherein the one of the plurality of supporting main bodies at one end of the single connecting rod is larger than the one of the plurality of supporting main bodies at another end of the singe connecting rod and wherein the maximum outer diameters of the main body parts of each supporting main body are different.
As to the above, Taylor teaches, in the same field of endeavor, a lumen anastomosis supporting dilator (shunt of Fig. 17) (abstract, col. 19 lines 10 – 20, col. 19 line 46 – 61, and col. 19 line 62 – col. 20 line 5) comprising two supporting main bodies (bulbous structures on tapered ends 294,296) wherein one of the supporting main bodies is larger / has a maximum outer diameter, at the main body part, being larger than that of the other of the supporting main body for the purpose of matching the changing shape of the blood vessel (abstract, col. 19 lines 20 – 30, and Fig. 17).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify one of the supporting main bodies of Okada to be larger / have a maximum outer diameter, at the main body part, be larger than the other of the supporting main bodies, based on the teachings of Taylor, for the purpose of being able to accommodate a change in the vessel diameter that occurs along the length of the vessel (col. 19 lines 20 – 30 – Taylor).
Regarding claim 7, as discussed above, the combination of Okada and Taylor make obvious the device of claim 1. Additionally, Okada discloses wherein the lumen anastomosis supporting dilator (shunt tube 10) further comprises an operating rod (string 16) and an end of the operating rod is connected to the middle of the single connecting rod (tube 12) (paragraph [0036] and Fig. 1).
Regarding claim 8, as discussed above, the combination of Okada and Taylor make obvious the device of claim 1. Additionally, Okada discloses wherein the single connecting rod (tube 12) can be bent so that the relative positions between the two of the plurality of the supporting main bodies can be adjusted (Examiner’s note: as stated in paragraph [0036] and shown in Fig. 4, the tube 12 (i.e., the singular connecting rod) is flexible and bendable).
Regarding claim 9, as discussed above, the combination of Okada and Taylor make obvious the device of claim 1. Additionally, Okada discloses wherein the supporting main bodies (large diameter sections 14) is provided with a hollow cavity (channel running through the large diameter sections 14) (Fig. 7), and two ends of the supporting main body (large diameter sections 14 on each end of ube 12) are respectively provided with through holes (openings on the proximal and distal end of the larger diameter sections) communicating with the hollow cavity (Fig. 7).
Regarding claim 10, as discussed above, the combination of Okada and Taylor make obvious the device of claim 1. Additionally, Okada discloses wherein the single connecting rod (tube 12) is provided with a fluid channel (lumen 26) (paragraph [0038] and Figs. 1 – 7), and the fluid channel is communicated with the hollow cavity of the supporting main body (Fig. 7).
Regarding claim 11, as discussed above, the combination of Okada and Taylor make obvious the device of claim 1. Additionally, Okada discloses wherein the supporting main bodies (large diameter sections 14) includes a thin wall defining an open hollow cavity (channel running through the large diameter sections 14) (Fig. 7) (Examiner’s note: the term thin is a relative term, and the wall of the large diameter sections is/are considered to be thin since they are sized to fit within the body).
Response to Arguments
Applicant's arguments filed 04/23/2026 have been fully considered but they are not persuasive. More specially:
With respect to Applicant’s argument that “Okada does not disclose to a lumen anastomosis supporting dilator” and “Taylor et al. also does not disclose to a lumen anastomosis supporting dilator”, it should be understood that when reading the preamble in the context of the entire claim, the recitation “a lumen anastomosis supporting dilator” is not limiting because the body of the claim describes a complete invention (i.e., a dilator) and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention's limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02. Furthermore, the phrase “a lumen anastomosis supporting dilator” only requires dilator capable of supporting a lumen anastomosis. With that said, as shown in of Okada Figs. 3,4 the device dilates the vessel, and as discussed in paragraph [0038] the device is used in an anastomosis procedure, therefore the device of Okada is a dilator supporting / capable of supporting an anastomosis lumen; and as discussed in the abstract, col. 19 lines 10 – 20, col. 19 line 46 – 61, col. 19 line 62 – col. 20 line 5, col. 24 lines 1 – 4, and shown in Fig. 10B of Taylor the device is a dilator used to support an anastomosis lumen, therefore the device of Okada is a dilator supporting / capable of supporting an anastomosis lumen.
With respect to Applicant’s argument that “there is no connecting rod in Taylor et al.'s perfusion device; the tapered ends 294 and 296 are connected by a central member 292 to form an integral support for a short segment of blood vessel, and the central member 292 cannot be changed into a thinner rod structure which cannot provide the integral support”, it should be understood that the modification above does not rely on any structure of the device of Taylor, and only relies on the reason for having different sized “supporting main bodies”; therefore, any arguments directed at the structure of Taylor are not relevant to the rejection above and are thus not persuasive.
With respect to Applicant’s arguments directed to the newly added claim limitations not being taught by Okada, the Examiner has responded with a more in depth explanation as to how Okada reads on the limitations as claimed.
With respect to Applicant’s arguments directed to the newly added claim limitations not being taught by Taylor, it should be understood that the modification above does not rely on any structure of the device of Taylor, and only relies on the reason for having different sized “supporting main bodies”; therefore, any arguments directed at the structure of Taylor are not relevant to the rejection above and are thus not persuasive.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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