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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/10/2025 has been entered.
Response to Amendment
This Office action is in response to the applicant’s communication filed 11/10/2025.
Status of the claims:
Claims 1, 4 – 11 are pending in the application.
Claims 1, 5, 7, 8, and 10 are amended.
Claim 11 is new.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The rejection of claims 5 and 6 under U.S.C 35 112(a) for failing to comply with the written description requirement, recited in the previous action dated 08/12/2025 have been withdrawn in light of the Applicant’s amendments filed 11/10/2025. Specifically, the rejection of claim 5, regarding the phrase “one end of the tapered part connected to the main body part towards the other end of the tapered part which is not connected to the main body part”, has been withdrawn as the claim no longer requires the main body part to not be connected to the tapered part and the rejection of claim 6 has been withdrawn as claim 6 is no longer dependent on a claim rejected under 112(a).
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 5, 6, and 8 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 08/12/2025 have been withdrawn in light of the Applicant’s arguments filed 11/10/2025. Specifically, the rejection of claims 5 and 8, regarding the phrase "two of the plurality of supporting main bodies”, have been withdrawn as the appropriate corrections have been made, the rejection of claim 5 regarding being dependent on a cancelled claim (i.e., claim 2), has been withdrawn as claim 5 is now dependent on claim 1, and the rejection of claim 6 for being dependent on an indefinite claim has been withdrawn as the claim has been cancelled. However, new rejections have been set forth below in light of Applicant’s amendments.
Claims 9 and 11 are is 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.
Regarding claims 9 and 11, the phrases "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" and “wherein the supporting main body includes a thin wall”, respectively, renders the claim indefinite because it is unclear if Applicant is intending for the “supporting main body” to be one of the plurality of the supporting main bodies or if Applicant is intending for the “supporting main body” to be the “supporting main body” which comprises “the plurality of main bodies” such that all of the plurality of main bodies comprise the structural limitations of claims 9 and 11. For the purpose of examination, the Examiner will read the claims to mean the latter, such that the claims require the plurality of supporting main bodies to comprise the structure and/or function recited in the claims.
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) in view of Taylor et al (US 5,925,054).
Regarding claim 1 and 4 – 6, Okada discloses a lumen anastomosis supporting dilator (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 (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 the supporting main bodies (large diameter sections 14) can self-expand to their initial shape (paragraphs [0043 – 0044] and Fig. 4);
[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) 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 body (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 body (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: 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 11/10/2025, with respect to the rejection of claims 1, 4 – 11 under Kim and, separately, under Snow have been considered but are moot as the arguments are directed to Applicant’s amendments, and the previous rejection of the claims has been withdrawn in light of said amendments. Specifically, the rejections were withdrawn because neither Kim or Snow teach wherein the supporting main bodies can self-expand. It is noted that a new rejection has been made under Okada and Taylor. Wherein the teachings of Okada are relied upon for teaching the newly added limitations as discussed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lepley, Jr. et al (US 4,168,708), Jessen (US 5,192,289), and Rosengart (US 5,868,764) teach lumen anastomosis supporting dilators with a plurality of supporting main bodies attached to a single control rod.
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