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 .
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 7, 2025 has been entered.
Response to Arguments
Applicant's arguments filed December 7, 2025 have been fully considered but they are not persuasive.
Regarding the prior art rejection:
Applicant’s arguments are centered around the design choices in the claimed invention. Applicant believes they are not merely design choices despite the prior art saying the claimed features are. So, it would appear that Applicant is arguing that their claimed invention and choices have provided unexpected results. But Applicant has provided no evidence of this. Applicant’s specification does not discuss this or provide any evidence. In fact, Applicant’s specification appears to provide evidence that each of the elements/limitations are design choices (See at least Paragraphs 030-033, 044, and 048 of Applicant’s specification as filed). It would appear that the prior art is consistent with Applicant’s specification in disclosing the claimed features are things that are design choices, especially ones that could be determined through routine experimentation to yield predictable results. Applicant’s alleged advantages do not even appear to be supported by Applicant’s specification. Applicant states: “Combination of these features provides a device which can accurately be steered while being non-invasive.” This is not supported by the specification, accuracy/accurate isn’t even used as a term at all in the specification. Applicant states: “synergistic benefit” which also isn’t disclosed in their specification. Applicant states: “claim 1 states "thereby preventing axial rotation between the control line and the hollow shaft".” Examiner notes this is functional language and the combined teachings of the prior art must merely provide a structure capable of this. Examiner again notes as Applicant’s specification and the prior art all disclose the claimed features as being design choices one of ordinary skill in the art through routine experimentation can achieve this functionality. As such the mere conclusory statements are not persuasive.
Per MPEP 2145: "A showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997) (conclusory statements regarding unusually low immune response or unexpected biological activity that were unsupported by comparative data held insufficient to overcome prima facie case of obviousness)."
Response to Amendment
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 1-10 and 23-33 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 axial rotation-locked control line" in Lines 8-9. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the other segments" in Lines 17-18. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites ‘the wires’ multiple times in the claim and it is unclear if these wires are part of the ‘a plurality of wound wires’ as claimed in claims 1-3 or not. For the purposes of examination, they will be treated as if they are.
Claim 4 recites the limitation "the transition segment" in Lines 5, 6, and 7. There is insufficient antecedent basis for this limitation in the claim. Examiner notes this should read ‘the at least one transition segment’.
Claim 4 recites ‘a diameter’ multiple times in the claim making it unclear if each recitation refers to the same ‘diameter’ or not.
Claim 4 recites ‘a winding mandrel’ multiple times in the claim making it unclear if each recitation refers to the same ‘winding mandrel’ or not.
Claim 4 recites ‘a winding mandrel in the proximal segment’, ‘a winding mandrel in the transition segment’, and ‘a winding mandrel in the distal segment’ making it unclear if the winding mandrel is part of the overall endovascular device. One of ordinary skill in the art would understand a winding mandrel is used in the method of manufacturing coils, which makes the claim limitations unclear. For examination purposes it will be treated as if the winding mandrel is merely used in the manufacturing/forming of the segment rather than as a structural part of the segment.
Claim 8 recites ‘at least three transition segments’ and is dependent back to claim 1 which recites ‘at least one transition segments’ making it unclear if the recitation in claim 8 is meant to refer to that in claim 1 or not. Further it is unclear exactly how claim 8 is meant to further narrow the scope of claim 1. For examination purposes both limitations will be treated as ‘at least one transition segment’.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 33 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 33 recites ‘wherein the actuation force results in bending of the distal tip with respect to the hollow shaft’ and Claim 33 is dependent back to claim 1 which is an apparatus claim. Claim 33 does not provide any further structure but merely states a result of an action. The action itself is not a required part of a structural apparatus. The result of the action is not a required part of a structural apparatus. Thus, it would appear claim 33 does not further limit claim 1. Examiner suggests amending to recite ‘wherein the distal tip is configured to bend relative to the hollow shaft in response to the actuation force’.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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.
Claim(s) 1-3, 6-8, and 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer et al. (US 2009/0297582) in view of Klint (US 2004/0082879) and Sokel (US 2012/0046652).
Regarding claim 1, Meyer teaches an endovascular device (Abstract), including:
a hollow shaft (166; 168) having a proximal end and a distal end (Figure 6), the hollow shaft being sized for insertion into a blood vessel (Figure 6);
a control line (172) having a proximal end and a distal end (Figure 6), extending through the hollow shaft (Figure 6);
a distal tip (162) proximate the distal end of the hollow shaft (Figure 6), and configured to receive an actuation force transmitted via the distal end of control line (Paragraph 0335); and
a handle (174; element 174 can be held thus constituting a “handle”) configured to exert the actuation force on the proximal end of the control line, to thereby cause relative movement between the control line and the hollow shaft and to actuate the distal tip (Paragraphs 0335 and 0338), wherein:
the hollow shaft includes a cable formed of a plurality of wound wires (Paragraphs 0031, 0315, 0481-0483);
Meyer is silent on the various segments.
Klint teaches the cable includes a proximal segment, at least one transition segment, and a distal segment; and each of the proximal segment, the at least one transition segment, and the distal segment each include different numbers of wires of the plurality of wound wires from both of the other segments (Paragraphs 0017, 0057, 0079, and 0130; wires must be cut to provide the desired length which creates the various segments having different numbers of wires).
It would have been obvious to one of ordinary skill in the art to have modified Meyer with Klint because Klint teaches this as being a design choice to impart desired flexibility (Paragraph 0017 of Klint).
Sokel teaches that control lines can have varying cross-sectional shapes (Paragraph 0050) thus one could modify Meyer with Sokel to teach a control line having at least a portion including a non-round cross-section, thereby preventing axial rotation between the control line and the hollow shaft. It would have been obvious to one of ordinary skill in the art to have modified Meyer with Sokel because Sokel teaches this feature as being a design choice (Paragraph 0050 of Sokel) and because the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996). Thus in combination Meyer in view of Sokel would teach a distal tip (162 of Meyer) proximate the distal end of the hollow shaft (Figure 6 of Meyer), and configured to receive an actuation force transmitted via the distal end of the axial rotation-locked control line (Paragraph 0335 of Meyer and Paragraph 0050 of Sokel as used above to modify Meyer).
Regarding claim 2, Meyer is silent on the various segments. Klint teaches wherein: the proximal segment includes a first number of wires of the plurality of wound wires; the at least one transition segment includes a second number of wires of the plurality of wound wires, the second number of wires being less than the first number of wires; and the distal segment includes a third number of wires of the plurality of wound wires, the third number of wires being less than the second number of wires (Paragraphs 0017, 0057, 0079, and 0130). It would have been obvious to one of ordinary skill in the art to have modified Meyer with Klint because Klint teaches this as being a design choice to impart desired flexibility (Paragraph 0017 of Klint).
Regarding claim 3, Meyer is silent on the various segments. Klint teaches wherein: the first number of wires are wound at a first pitch angle; the second number of wires are wound at a second pitch angle; and the third number of wires are wound at a third pitch angle (Paragraphs 0017, 0057, 0079, and 0130). It would have been obvious to one of ordinary skill in the art to have modified Meyer with Klint because Klint teaches this as being a design choice to impart desired flexibility (Paragraph 0017 of Klint).
Regarding claim 6, Meyer is silent on the various segments. Klint teaches wherein at least one of the plurality of wound wires extends continuously from the proximal segment to a distal end of the distal segment of the cable (Paragraphs 0017, 0057, 0079, and 0130; wires must be cut to provide the desired length which creates the various segments having different numbers of wires). It would have been obvious to one of ordinary skill in the art to have modified Meyer with Klint because Klint teaches this as being a design choice to impart desired flexibility (Paragraph 0017 of Klint).
Regarding claim 7, Meyer is silent on the various segments. Klint teaches wherein the distal segment has a flexibility greater than a flexibility of the proximal segment (Paragraphs 0017, 0057, 0079, and 0130; wires must be cut to provide the desired length which creates the various segments having different numbers of wires; less wires would increase flexibility). It would have been obvious to one of ordinary skill in the art to have modified Meyer with Klint because Klint teaches this as being a design choice to impart desired flexibility (Paragraph 0017 of Klint).
Regarding claim 8, Meyer is silent on the various segments. Klint teaches including at least three transition segments (Paragraphs 0017, 0057, 0079, and 0130; wires must be cut to provide the desired length which creates the various segments having different numbers of wires). It would have been obvious to one of ordinary skill in the art to have modified Meyer with Klint because Klint teaches this as being a design choice to impart desired flexibility (Paragraph 0017 of Klint).
Regarding claim 28, Meyer is silent on the wires in each segment. Klint teaches wherein each wire of the third number of wires of the distal segment extends continuously from the proximal segment, through the at least one transition segment to the distal segment, without any connection points between wires along the cable (Paragraph 0057). It would have been obvious to one of ordinary skill in the art to have modified Meyer with Klint because Klint teaches this as being a design choice to impart desired flexibility (Paragraph 0017 of Klint).
Regarding claim 29, Meyer is silent on the wires in each segment. Klint teaches wherein each wire of the second number of wires of the at least one transition segment extends continuously from the proximal segment to the at least one transition segment (Paragraph 0057). It would have been obvious to one of ordinary skill in the art to have modified Meyer with Klint because Klint teaches this as being a design choice to impart desired flexibility (Paragraph 0017 of Klint).
Regarding claim 30, Meyer is silent on wherein at least a portion of the control line, other than the at least a portion of the control line including a non-round cross section, has a circular cross section. Sokel teaches that control lines can have varying cross-sectional shapes (Paragraph 0050) thus one could modify Meyer with Sokel to teach wherein at least a portion of the control line has a circular cross section. It would have been obvious to one of ordinary skill in the art to have modified Meyer with Sokel because Sokel teaches this feature as being a design choice (Paragraph 0050 of Sokel) and because the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer et al. (US 2009/0297582) in view of Klint (US 2004/0082879) and Sokel (US 2012/0046652) as applied to claim 3 above in further view of Jensen (US Patent No. 6566994).
Regarding claim 4, Meyer is silent on
wherein the first pitch angle is determined for the proximal segment based on at least one of a diameter of the wires in the proximal segment, the first number of wires and a diameter of a winding mandrel in the proximal segment,
wherein the second pitch angle is determined for the transition segment based on at least one of a diameter of the wires in the transition segment, the second number of wires and a diameter of a winding mandrel in the transition segment, and
wherein the third pitch angle is determined for the distal segment, based on at least one of a diameter of the wires in the distal segment, the third number of wires, and a diameter of a winding mandrel in the distal segment.
Jensen teaches that a relationship exists between the various factors such as diameter of the winding mandrel (diameter and circumference which includes diameter), the pitch of the wires, the wire diameter (i.e. the wire gauge), and the number of wires (number of layers, more layers means more “wires”) (Column 3, Lines 3-15).
It would have been obvious to one of ordinary skill in the art to have modified Meyer with Jensen to have wherein the first pitch angle is determined for the proximal segment based on at least one of a diameter of the wires in the proximal segment, the first number of wires and a diameter of a winding mandrel in the proximal segment, wherein the second pitch angle is determined for the transition segment based on at least one of a diameter of the wires in the transition segment, the second number of wires and a diameter of a winding mandrel in the transition segment, and wherein the third pitch angle is determined for the distal segment, based on at least one of a diameter of the wires in the distal segment, the third number of wires, and a diameter of a winding mandrel in the distal segment because Meyer teaches the changing of a mandrel size for desired characteristics as being known in the art (Paragraph 0354 of Meyer) and Jensen teaches these factors are all interrelated and thus a coil of any desired dimensions can be readily determined by using the proper factors (Column 3, Lines 3-32 of Jensen).
Regarding claim 5, Meyer is silent on the various segments and the pitch angles of the wires in each segment.
Jensen teaches that a relationship exists between the various factors such as diameter of the winding mandrel (diameter and circumference which includes diameter) used and the pitch of the wires (Column 3, Lines 3-15). It would have been obvious to one of ordinary skill in the art to have modified Meyer with Jensen to have the first pitch angle less than the second pitch angle and the second pitch angle being less than the third pitch angle because Meyer teaches the changing of a mandrel size for desired characteristics as being known in the art (Paragraph 0354 of Meyer) and Jensen teaches these factors are all interrelated and thus a coil of any desired dimensions can be readily determined by using the proper factors (Column 3, Lines 3-32 of Jensen).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer et al. (US 2009/0297582) in view of Klint (US 2004/0082879) and Sokel (US 2012/0046652) as applied to claim 1 above in further view of Marchand et al. (US 2008/0065011).
Regarding claim 9, Meyer is silent on the 1:1 rotational force. Marchand teaches wherein a rotational force exerted on the proximal end of the hollow shaft causes a rotational force to be applied to the distal tip, a ratio of the rotational force exerted on the proximal end of the hollow shaft to the rotational force applied to the distal tip being approximately 1:1 (Paragraphs 0005 and 0105). It would have been obvious to one of ordinary skill in the art to have modified Meyer with Marchand in order to facilitate steering (Paragraph 0005 of Marchand).
Claim(s) 10 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer et al. (US 2009/0297582) in view of Klint (US 2004/0082879) and Sokel (US 2012/0046652) as applied to claim 1 above in further view of Conlon et al. (US 2011/0276057).
Regarding claim 10, Meyer is silent on the transferring of the rotational torque upon the shaft being rotated. Conlon teaches wherein the cable is configured to transfer the rotational torque to the distal end of the distal tip when the proximal end of the hollow shaft is rotated (Paragraph 0065). It would have been obvious to one of ordinary skill in the art to have modified Meyer with Conlon because it allows for better articulation of the working element (Paragraphs 0065-0067 of Conlon).
Myere is silent on wherein the at least a portion of the control line having non-circular cross section resists rotation during rotation of the cable.
Sokel teaches that control lines can have varying cross-sectional shapes (Paragraph 0050) thus one could modify Meyer with Sokel to teach wherein the at least a portion of the control line having non-circular cross section. It would have been obvious to one of ordinary skill in the art to have modified Meyer with Sokel because Sokel teaches this feature as being a design choice (Paragraph 0050 of Sokel) and because the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996). Examiner notes that with this modification this would also teach resists rotation during rotation of the cable since that is a functionality of it and the structure must merely be capable of performing this structure which it would given the shape change as desired.
Regarding claim 31, Meyer is silent on wherein the non-circular cross section of the at least a portion of the control line prevents axial rotation of the control line during axial rotation of the cable without preventing axial movement of the control line. Sokel teaches that control lines can have varying cross-sectional shapes (Paragraph 0050) thus one could modify Meyer with Sokel to teach wherein the non-circular cross section of the at least a portion of the control line. It would have been obvious to one of ordinary skill in the art to have modified Meyer with Sokel because Sokel teaches this feature as being a design choice (Paragraph 0050 of Sokel) and because the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996). Examiner notes that with this modification this would also teach prevents axial rotation of the control line during axial rotation of the cable without preventing axial movement of the control line since that is a functionality of it and the structure must merely be capable of performing this structure which it would given the shape change as desired.
Claim(s) 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer et al. (US 2009/0297582) in view of Klint (US 2004/0082879) and Sokel (US 2012/0046652) as applied to claim 1 above in further view of Septka (US Patent No. 4955862).
Regarding claim 23, Meyer is silent on wherein at least a portion of an inner cross section of the hollow shaft is non-circular. Septka teaches wherein at least a portion of an inner cross section of the hollow shaft is non-circular (Column 4, Lines 13-29). It would have been obvious to one of ordinary skill in the art to have modified Meyer with Septka because Septka teaches this feature as being a design choice (Column 4, Lines 13-29 of Septka) and because the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996).
Regarding claim 24, Meyer is silent on wherein for the at least a portion of the control line which has a non-circular cross section, the non-circular cross section has a rectangular or flattened cross sectional shape. Sokel teaches that control lines can have varying cross-sectional shapes (Paragraph 0050) thus one could modify Meyer with Sokel to teach wherein for the at least a portion of the control line which has a non-circular cross section, the non-circular cross section has a rectangular or flattened cross sectional shape. It would have been obvious to one of ordinary skill in the art to have modified Meyer with Sokel because Sokel teaches this feature as being a design choice (Paragraph 0050 of Sokel) and because the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996).
Regarding claim 25, Meyer is silent on wherein the at least a portion of the control line having a non-circular cross section has an axial overlap with the at least a portion of the inner cross section of the hollow shaft which is non-circular.
Sokel teaches that control lines can have varying cross-sectional shapes (Paragraph 0050) thus one could modify Meyer with Sokel to teach wherein the at least a portion of the control line having a non-circular cross section. It would have been obvious to one of ordinary skill in the art to have modified Meyer with Sokel because Sokel teaches this feature as being a design choice (Paragraph 0050 of Sokel) and because the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996).
Septka teaches wherein the at least a portion of the inner cross section of the hollow shaft which is non-circular (Column 4, Lines 13-29). It would have been obvious to one of ordinary skill in the art to have modified Meyer with Septka because Septka teaches this feature as being a design choice (Column 4, Lines 13-29 of Septka) and because the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996).
Sokel and Septka teach being able to alter the geometries in locations as desired thus one of ordinary skill in the art could modify Meyer with Sokel and Septka to teach wherein the at least a portion of the control line having a non-circular cross section has an axial overlap with the at least a portion of the inner cross section of the hollow shaft which is non-circular since it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C).
Regarding claim 26, Meyer is silent on wherein the relative movement between the control line and the hollow shaft has a smaller extent than an axial extent of the overlap, the portions overlapping ever during the relative movement between the control line and the hollow shaft.
Sokel teaches that control lines can have varying cross-sectional shapes (Paragraph 0050) thus one could modify Meyer with Sokel to teach wherein the at least a portion of the control line having a non-circular cross section. It would have been obvious to one of ordinary skill in the art to have modified Meyer with Sokel because Sokel teaches this feature as being a design choice (Paragraph 0050 of Sokel) and because the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996).
Septka teaches wherein the at least a portion of the inner cross section of the hollow shaft which is non-circular (Column 4, Lines 13-29). It would have been obvious to one of ordinary skill in the art to have modified Meyer with Septka because Septka teaches this feature as being a design choice (Column 4, Lines 13-29 of Septka) and because the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996).
Sokel and Septka teach being able to alter the geometries in locations as desired thus one of ordinary skill in the art could modify Meyer with Sokel and Septka to teach wherein the relative movement between the control line and the hollow shaft has a smaller extent than an axial extent of the overlap, a portion of the control line having non-circular cross section overlapping with a portion of the hollow shaft having non-circular cross section even during the relative movement between the control line and the hollow shaft since it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C). This modification would only involve the design choice taught Sokel and Septka to have different shaped cross sections of the control line and hollow shaft as desired in the locations as desired. Placing the different shaped cross sections in the appropriate place would allow for the claimed functionality.
Regarding claim 27, Meyer is silent on the element attached to an inner wall of the cable. Klint teaches wherein the cable has a circular cross section (Paragraph 0070); wherein the endovascular device comprises an element attached to an inner wall of the cable to provide the non-circular inner cross section of the at least a portion of the hollow shaft (Paragraph 0057; can include a weld which would be an element that can provide a non-circular inner cross section). It would have been obvious to one of ordinary skill in the art to have modified Meyer with Klint because it allows for securing of the wires (Paragraph 0057 of Klint).
Claim(s) 1 and 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer et al. (US 2009/0297582) in view of Klint (US 2004/0082879) and Sokel (US 2012/0046652) and Patel et al. (US 2010/0274270).
Regarding claim 1, Meyer teaches an endovascular device (Abstract), including:
a hollow shaft (166; 168) having a proximal end and a distal end (Figure 6), the hollow shaft being sized for insertion into a blood vessel (Figure 6);
a control line (172) having a proximal end and a distal end (Figure 6), extending through the hollow shaft (Figure 6);
a distal tip (162) proximate the distal end of the hollow shaft (Figure 6), and configured to receive an actuation force transmitted via the distal end of control line (Paragraph 0335); and
a handle (174; element 174 can be held thus constituting a “handle”) configured to exert the actuation force on the proximal end of the control line, to thereby cause relative movement between the control line and the hollow shaft and to actuate the distal tip (Paragraphs 0335 and 0338), wherein:
the hollow shaft includes a cable formed of a plurality of wound wires (Paragraphs 0031, 0315, 0481-0483);
Meyer is silent on the various segments.
Klint teaches the cable includes a proximal segment, at least one transition segment, and a distal segment; and each of the proximal segment, the at least one transition segment, and the distal segment each include different numbers of wires of the plurality of wound wires from both of the other segments (Paragraphs 0017, 0057, 0079, and 0130; wires must be cut to provide the desired length which creates the various segments having different numbers of wires).
It would have been obvious to one of ordinary skill in the art to have modified Meyer with Klint because Klint teaches this as being a design choice to impart desired flexibility (Paragraph 0017 of Klint).
Sokel teaches that control lines can have varying cross-sectional shapes (Paragraph 0050) thus one could modify Meyer with Sokel to teach a control line having at least a portion including a non-round cross-section, thereby preventing axial rotation between the control line and the hollow shaft. It would have been obvious to one of ordinary skill in the art to have modified Meyer with Sokel because Sokel teaches this feature as being a design choice (Paragraph 0050 of Sokel) and because the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996). Thus in combination Meyer in view of Sokel would teach a distal tip (162 of Meyer) proximate the distal end of the hollow shaft (Figure 6 of Meyer), and configured to receive an actuation force transmitted via the distal end of the axial rotation-locked control line (Paragraph 0335 of Meyer and Paragraph 0050 of Sokel as used above to modify Meyer).
In the interest of compact prosecution: Meyer is silent on the handle in that it is the element being held by a person during use.
Patel teaches a handle configured to exert the actuation force on the proximal end of the control line, to thereby cause relative movement between the control line and the hollow shaft and to actuate the distal tip (Paragraphs 0047 and 0096; Figure 1).
It would have been obvious to one of ordinary skill in the art to have modified Meyer with Patel because Patel teaches the use of a proximal handle to control a distal end of a guidewire/catheter as being conventional in the art (Paragraph 0013 of Patel) and thus implementing one with Meyer would only involve routine experimentation yielding predictable results of allowing steering and control of the device (Paragraph 0025 of Patel).
Regarding claim 32, Patel teaches wherein the handle is attached to the proximal end of the hollow shaft; wherein the handle comprises a slider which is attached to a proximal end of the control line (Paragraph 0096; Figure 1). It would have been obvious to one of ordinary skill in the art to have modified Meyer with Patel because Patel teaches the use of a proximal handle to control a distal end of a guidewire/catheter as being conventional in the art (Paragraphs 0013 and 0025-0026 of Patel) and thus implementing one with Meyer would only involve routine experimentation yielding predictable results of allowing steering and control of the device (Paragraph 0025-0026 of Patel).
Regarding claim 33, Patel teaches wherein the actuation force results in bending of the distal tip with respect to the hollow shaft (Paragraphs 0047 and 0096; Figure 1).
It would have been obvious to one of ordinary skill in the art to have modified Meyer with Patel because Patel teaches the use of a proximal handle to control a distal end of a guidewire/catheter as being conventional in the art (Paragraph 0013 of Patel) and thus implementing one with Meyer would only involve routine experimentation yielding predictable results of allowing steering and control of the device (Paragraph 0025 of Patel).
Conclusion
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791