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 action is entered in response to Applicant's Amendment and Reply of 10/8/25. Claims 1 and 3 have been amended. Claims 1-14 are pending.
Response to Arguments
Applicant’s arguments, filed 10/8/25, with respect to the rejections of claims 1-3, 5-14 under 35 U.S.C. 103 as being unpatentable over Maimon (US2013/0152659) in view of Fox (US2020/0337872) have been considered but they are not persuasive. Applicant argues, the combination of Maimon with Fox does not meet all the limitations of claim 1. In particular claim 1 recites “a displacement actuator to axially displace the displacement shaft” but argues that the catheter stand of Fox does not cause axial displacement. Further stating that the catheter stand of Fox is not capable of displacing the displacement shaft. Examiner disagrees, where the term “actuator” is given its meaning as provided by Collins dictionary as a “a part of a machine which moves or controls another part in response to an input” cited as reference U in the PTO-892. Where the catheter stand of Fox is interpreted as an actuator by guiding/controlling the catheter to be aligned with the crimping device and the operator moves the catheter along the catheter stand providing an input, thereby displacing the catheter. Applicant argues, the interpretation is excessively broad. The Examiner disagrees, the structural limitation is given its plain meaning, in accordance with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time. If Applicant would like a narrower interpretation of the claim language it is suggested the specification be amended with more descriptive structural features.
Applicant further argues, claim 1 recites “a displacement frame engaged to the displacement shaft and displacement actuator” is not taught by the previous rejection. Applicant makes a claim that the structures being “engaged” means the components need to be touching. Examiner disagrees, where the term “engaged” is given its meaning as provided by Infoplease means “built so as to be truly or seemingly attached in part to the structure before which it stands” cited as reference V in the PTO-892. Where the components of the displacement frame (50) being engaged to the displacement shaft (14) and displacement actuator (catheter stand 400 as taught by Fox), are at least indirectly engaged. If Applicant would like a narrower interpretation of the claim language it is suggested the specification be amended with more descriptive structural features.
Applicants amendments to recite “the displacement shaft is configured to attach to the catheter shaft” and “the displacement assembly is configured to movably extend the displacement shaft into the second opening of the housing and out of the first opening of the housing and into the transfer tube” does not overcome the previous rejection as addressed in the rejection below.
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.
Claims 1-14 are 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 1 recites the limitation "the first opening of the brace". There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the catheter". There is insufficient antecedent basis for this limitation in the claim.
Claims 2-14 are rejected under 35 U.S.C. 112(b) by dependency from claim 1.
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 1-3, 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over Maimon (US2013/0152659) in view of Fox (US2020/0337872).
Regarding claim 1, Maimon discloses a catheter loading system, comprising:
a transfer tube (70); and
a crimping assembly, comprising;
a housing (40) with a first opening (opening at side with threads 42, see Fig. 5) and a second opening (opening with flared portion 44, see Fig. 5);
a circumferential compression mechanism (20) located inside the housing and forming a cylindrical cavity aligned with the first and second openings (see Figs. 6, 7);
a brace (80) configured to releasably lock to the housing (40) about the first opening and comprising a transfer opening (opening defined by proximal surface 84, see Fig. 8) configured to receive and to align the transfer tube (70) to the first opening (see Fig. 8), such that an end of the transfer tube (70) extends out of the transfer opening and away from the first opening of the brace (see Fig. 9, where ledge 72 extends out of the opening at proximal surface 84, [0026]); and
a displacement assembly (14/50) comprising a displacement shaft (14) configured with an attachment structure at a first end (where valve is attached to catheter 14) and configured to releasably attach to and to displace the catheter (the valve is crimped to catheter 14 and released, [0020]; where the catheter is not positively recited and the device disclosed is capable of being used with another catheter within catheter 14 in the manner as claimed), and a displacement frame (50) engaged to the displacement shaft (the displacement frame 50 is engaged to the displacement shaft by the structures being coupled together, see Fig. 8), and configured to attach to the housing (40) about the second opening and to align the displacement shaft to the second opening (see Fig. 8, [0032]);
Wherein the displacement assembly is configured to movably extend the displacement shaft into the second opening of the housing (the catheter 14 is moved into the second opening at the flared portion 44 of the housing, see Figs. 8-10, [0021]) and out of the first opening of the housing and into the transfer tube (catheter 14 is moved through both the first opening at the side with threads 42 of the housing and therefore into the transfer tube 70 which is surrounded the first opening, see Figs. 8-10, [0021]).
Maimon teaches axially displacing the displacement shaft ([0007], [0021]). However, Maimon is silent regarding a displacement actuator to axially displace the displacement shaft. Fox teaches a crimping device 100 with a displacement actuator (catheter stand 400) to axially displace the displacement shaft (catheter). The catheter stand 400 acts as an actuator by guiding the catheter to be aligned with the crimping device 100, thereby displacing the catheter ([0019]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to have modified the system of Maimon to include the displacement actuator as taught by Fox in order to properly position and align the catheter body to the aperture of the crimping device ([0019]).
Where the modified invention would have the displacement frame (50) engaged to the displacement shaft and displacement actuator (the displacement frame 50 is engaged to the displacement shaft and displacement actuator as taught by Fox, by the structures being coupled together are at least indirectly engaged, see Fig. 8, where the displacement actuator would hold the catheter 14).
Regarding claim 2, Maimon/Fox makes obvious the system of claim 1, Maimon further discloses wherein the transfer tube (70) comprises a flanged end (annular ledge 72, see Fig. 5).
Regarding claim 3, Maimon/Fox makes obvious the system of claim 1, Maimon further discloses wherein the circumferential compression mechanism (20) comprises an annular arrangement of a plurality of crimping elements (elongated members 28, see Fig. 7) forming the cylindrical cavity.
Regarding claim 5, Maimon/Fox makes obvious the system of claim 2, Maimon further discloses wherein the brace (80) further comprises a flange receiving cavity (opening with threads 82, see Fig. 2) concentrically aligned with transfer opening (opening defined by ledge 48, see Fig. 5).
Regarding claim 6, Maimon/Fox makes obvious the system of claim 5, Maimon further discloses further comprising a flange collar (threads 42 of housing, [0029]) comprising a flange opening (opening at distal end of 40) complementary to an outer surface of the flanged end (44) of the transfer tube (complementary structures by being concentric and aligned, see Figs. 8-10), and wherein the flange collar is sized to be received in the flange receiving cavity of the brace (see Figs. 8-10, [0029]).
Regarding claim 7, Maimon/Fox makes obvious the system of claim 1, Maimon further discloses further comprising a loading container (90/100) with a loading cavity (cavity of 90, see Fig. 11) and an upper cavity opening (opening of cavity of 90, see Fig. 11), wherein the loading cavity is configured to contain the crimping assembly such that the first and second openings of the crimping assembly are below the upper cavity opening (the first and second openings of 40 are below the upper cavity opening of 90 looking down the longitudinal axis, see Fig. 11; and the diameter of the part 90 is larger than 40 and is therefore capable of containing part 40).
Regarding claim 8, Maimon/Fox makes obvious the system of claim 7, Maimon further discloses wherein the loading container (90) comprises a sloped base surface (bottom surface defined by lower jaw 100, see Fig. 8) configured to position the crimping assembly at a non-horizontal angle (capable of positioning the assembly at a non-horizontal angle).
Regarding claim 9, Maimon/Fox makes obvious the system of claim 8, Maimon further discloses wherein the sloped base surface is provided on a distal angled support (hinge 102 interpreted as an angled support by allowing the jaw 100 to move at an angle, [0031]) configured to reside in the loading container to attach to an edge of the upper cavity opening (attached to edge of upper cavity opening of 90 by a screw, [0030], see Fig. 8).
Regarding claim 10, Maimon/Fox makes obvious the system of claim 9, Maimon further discloses wherein the distal angled support comprises a sloped upper surface (upper surface defined by upper jaw 100, see Fig. 8) that is higher than sloped based surface configured to support a catheter shaft (see Fig. 8) and comprising a slope angle (angle along the outside of the jaw, see Fig. 8) that the same as the sloped base surface (the two separate jaws are the same in structure, see Fig. 8).
Regarding claim 11, Maimon/Fox makes obvious the system of claim 10, Maimon further discloses further comprising a catheter stand (stop 60, [0025]) configured to support a catheter at the same slope angle as the sloped upper surface of the distal angled support (stop 60 supports the catheter by engagement with the jaws, [0032]; stop 60 is capable of supporting the catheter at this slope angle of the upper surface of the jaw 100, see Fig. 8), but at a higher position than the sloped upper surface.
Regarding claim 12, Maimon/Fox makes obvious system of claim 1, Maimon further discloses wherein the displacement shaft (14) comprises a first non-removable stop structure (outer surface of catheter 14 that engages jaws 100) and a second removable stop structure (one of the jaws 100 that clamp delivery catheter 14, [0031]; the jaws are interpretated as removable by being disengaged from the catheter 14, [0031]), wherein each stop structure is configured to limit further displacement of the displacement shaft relative to the crimping assembly ([0031]).
Regarding claim 13, Maimon/Fox makes obvious the system of claim 12, Maimon further discloses wherein the displacement shaft further comprises a third removable stop structure (one of the other jaws 100 that clamp delivery catheter 14, [0031]).
Regarding claim 14, Maimon/Fox makes obvious the system of claim 1, Maimon further discloses wherein the circumferential compression mechanism (20) comprises recesses or grooves (spaces between the elongate members 22, see Fig. 6) to engage an implant (spaces are closed to engage the implant, [0022]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Maimon in view of Fox as applied to claim 1, and further in view of Mellor (WO200006337).
Regarding claim 4, Maimon/Fox makes obvious the system of claim 1; yet, is silent regarding wherein the circumferential compression mechanism comprises an annular inflatable member forming the cylindrical cavity. Mellor teaches a bladder 64 that deforms a hollow pipe through it (Page 8, lines 4-6, see Fig. 6). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have modified the invention of Maimon to include an annular inflatable member within the cylindrical cavity in order to finely adjust the level of pressure applied to the tubular component being deformed/crimped (Page 9, lines 13-15).
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 MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached on (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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/M.A.M/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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