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 .
Priority
This application claims priority from foreign application CN202110512243.3, filed 05/11/2021.
Status of Claims
Claims 1-5 and 7-12 are pending.
Information Disclosure Statement
The Information Disclosure Statement filed on 04/15/2026 has been considered by the examiner.
Drawings
The objections to the drawings have been withdrawn in view of the applicant’s amendments.
Specification
The objection to the abstract has been withdrawn in view of the applicant’s amendments.
Claim Rejections - 35 USC § 112
The 112 rejection has been withdrawn in view of the applicant’s amendments.
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.
Claims 1-5 and 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ketai et al (Ketai) US 2013/0066341 A1 in view of Liu CN 106491245 B.
1. Ketai discloses the invention substantially as claimed being a clamping instrument (14 Figure 18-21), comprising: a locking structure 106 being capable of performing switching action between a locking state and a non-locking state [0111]; and a plurality of clamping structures16/18, each of the clamping structures being respectively connected to the locking structure and capable of being linked with the switching action of the locking structure (Figures 18-21), so as to adjust each of clamping angles formed by each of the clamping structures; wherein each of the clamping angles formed by each of the clamping structures is adjusted to allow each of the clamping structures to clamp or release each of target tissues (Figures 3A-C [0017]); and wherein when the locking structure is in the locking state (Figure 20), the locking structure will apply a continuous pushing force to each of the clamping structures (the locking mechanism stabilizes the bases 69/19 of the instrument and maintains the force applied by the linking arms 68 to each of the clamping structures), such that each of the clamping angles formed by each of the clamping structures is maintained to be minimum, thereby clamping each of the target tissues (compressing the clamping arms together causing the maximum amount of pinching tissue which inherently reduces the angle to a minimum).
However, Ketai does not disclose the two linking members 68 are elastic arms.
Liu teaches the use of a valve clamping device where the main clamp arms 31 are driven by elastic spring arms 41 (Figures 3, 4, and 10-11) in the same field of endeavor for the purpose of providing an elastic means to ensure the main clamp arms are driven and maintained in the closed position.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to replace the linking members 68 of Ketai with the elastic arms 41 of Liu in order to provide an elastic means that ensures the main clamp arms are driven and maintained in the closed position after insertion.
Ketai as modified discloses each of the clamping structures respectively comprises a main clamping arm 18, an auxiliary clamping arm 16, and an elastic arm (see modification in view of Liu); the main clamping arm and the auxiliary clamping arm are pivotally connected to the clamping base respectively (Figure 18), and two opposite ends of the elastic arm are pivotally connected to the adjusting base and the main clamping arm respectively (when replacing the locking member 68 of Ketai with the elastic arm of Liu the connection points are maintained, the lower loop will still connect to the adjusting base 69 with the same pivot axel rod and the opposing ends will still connect to each clamping arm with the existing pivot axel rod); wherein when the locking structure performs the switching action between the locking state and the non-locking state, the spacing distance between the clamping base and the adjusting base will be increased or decreased (Best shown in Figures 12A-13B), so as to drive each of the main clamping arms to pivot relative to the clamping base via the elastic arm (Best shown in Figures 12A-13B); and when the locking structure is maintained to be in the locking state, a continuous elastic pushing force will be applied to each of the main clamping arms via each of the elastic arms to urge each of the main clamping arms to pivot towards a direction close to the auxiliary clamping arm relative to the clamping base, such that a clamping angle formed between the main clamping arm and the auxiliary clamping arm is maintained to be minimum (the movement of the elastic arms is best shown in Figures 14-17 of Liu).
2. Ketai discloses the target tissues comprise cardiac valves [0017].
3. Ketai discloses comprising a mandrel 74, wherein the locking structure comprises a clamping base 106 and an adjusting base 69 which are coaxially disposed on the mandrel (Figures 18-21), and each of the clamping structures is respectively connected to the clamping base and the adjusting base (Figure 18); and wherein when the locking structure is gradually switched from the non-locking state to the locking state, a spacing distance between the clamping base and the adjusting base is gradually decreased (Best shown in Figures 12A-13B), and a pivoting angle between each of the clamping structures and the mandrel is gradually decreased (Best shown in Figures 12A-13B).
4. Ketai discloses the clamping base is movably disposed on the mandrel and capable of reciprocating in an axial direction of the mandrel (Best shown in Figures 12A-13B); and the adjusting base is fixedly disposed on the mandrel (Figures 18-19).
5. Ketai discloses the locking structure further comprises a first fastener 82 and a second fastener 110 which are respectively disposed on the clamping base and the adjusting base [0114]; wherein the first fastener and the second fastener are configured to be buckled with each other to maintain the locking structure to be in the locking state (the barbells buckle into the grooves to establish the locking state [0114]); and wherein after the first fastener and the second fastener are buckled with each other, at least a portion of the mandrel will be retained in the clamping instrument (Figure 21), or the mandrel will be completely withdrawn from the clamping instrument (the instrument could be disassembled or full expanded to completely withdraw the mandrel).
7. Ketai as modified discloses the locking structure is in the locking state, the main clamping arm will apply an opposite acting force to the elastic arm according to a thickness of the target tissue, so as to elastically deform the elastic arm to different degrees until an elastic pushing force of the elastic arm is balanced with the opposite acting force of the main clamping arm (the combination of Ketai and Liu have the same type of main clamping arms, pivot points, and elastic arms applying the same directional forces so the prior art combination inherently applies the same opposing and balancing forces).
8. Ketai as modified discloses the elastic arm comprises an arcuate bent part (See Figure 11 of Liu)
9. Ketai as modified discloses each of the main clamping arms is enable to be coaxially pivoted to the clamping base (they both pivot about the same axel shown in Figure 18).
10. Ketai as modified discloses the auxiliary clamping arm is configured to be elastically deformed with a stress being applied (Liu discloses the arm is a spring arm with coils which inherently allow it to be deformed with stress applied), so as to pivot towards a direction away from the main clamping arm relative to the clamping base, such that the clamping angle formed between the auxiliary clamping arm and the main clamping arm is increased (Liu Figure 14); and the auxiliary clamping arm is configured to be elastically recovered without a stress being applied, so as to pivot towards a direction close to the main clamping arm relative to the clamping base, such that the clamping angle formed between the auxiliary clamping arm and the main clamping arm is decreased (Liu Figures 16-17).
11. Ketai as modified discloses the auxiliary clamping arm comprises a clamping part (near 411 Figure 11 of Liu) and a pivoting part (near 412 Figure 11 of Liu), and the clamping part is pivoted to the clamping base via the pivoting part (See application of arm to Ketai explained within claim 6 above); and the pivoting part is configured to be elastically deformed with a stress being applied and elastically recovered without a stress being applied (Figures 14 and 16-17 of Liu), so as to allow the clamping part to pivot relative to the clamping base (Figures 14 and 16-17 of Liu).
12. Ketai as modified discloses each of the auxiliary clamping arms is of an integrated structure (the arms are connected to the remainder of the instrument so they are considered an integrated structure).
Response to Arguments
Applicant's arguments filed 04/15/2026 have been fully considered but they are not persuasive.
With respect to the prior art rejection, the applicant argues that the elements of claim 6 are not disclosed by the prior art combination. This is not persuasive because all elements of claim 6 were clearly identified within the Liu reference. The applicant builds their argument with a plurality of benefits about how their elastic arms perform such as elastic arms compressing and how they generate forces. However, none of these limitations are currently present within the claims. The applicant then goes on to point towards possible issues within in the inventions of the prior art, but they fail to disqualify the references as teachings away or facts that support the combination no longer being functional. The applicant is advised to put all of the bolded limitations from page three of their arguments within the independent claim.
Finally the applicant argues that Liu wouldn’t teach a PHOSITA to combine Ketai and Liu. This argument was not supported with any facts or reasoning. As explained above modifying the arms to be elastic would provide a biasing force to encourage the arms to stay in the desired positions.
Conclusion
THIS ACTION IS MADE FINAL. 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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christopher D. Prone/Primary Examiner, Art Unit 3774
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