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 1-12 are pending.
Information Disclosure Statement
The Information Disclosure Statement filed on 08/25/2023 has been considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the main clamping arms arranged non-coaxially to the clamping base (Claim 9) and auxiliary clamping arms arranged as separate structures (claim 12) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because it is over the 150 word limit (173). Correction is required. See MPEP § 608.01(b).
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.
Claim 12 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.
Claim 12 is rendered indefinite by the requirement for integrated or separate structures because it is unclear what the intended scope is for the two options. The claims and original disclosure fail to define what the arms are integrated or separate from. Is this referencing them with respect to each other? Is this referencing them with respect to the remainder of the clamping instrument? As explained above only the integrated version is identified with respect to the figures, which shows the two arms connected and then assembled to be integrated within the remainder of the clamping instrument. It is unclear how they would possibly be separate structures because all of the components are linked together making them integrated together.
Claim Rejections - 35 USC § 102
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 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) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ketai et al (Ketai) US 2013/0066341 A1.
1. Ketai discloses 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).
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).
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 6-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ketai in view of Liu CN 106491245 B.
Ketai discloses the invention substantially as claimed being described above. However, Ketai does not disclose the two linking members 68 are elastic.
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.
6. 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).
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 or non-coaxially pivoted to the clamping base (they both pivot about the same axel shown in Figure 18 and [0093] discloses they don’t have to be coaxial).
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 or a separate structure (the arms are connected to the remainder of the instrument so they can be considered an integrated structure, but the instrument can also be disassembled such that the auxiliary arms are removed so they can also be considered separate structures).
Conclusion
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
/Christopher D. Prone/Primary Examiner, Art Unit 3774