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 .
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 limitation “a stopping element” in claim 15; the limitation “additional inner member into the outer member” in claim 19 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.
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 9, 17 & 19-20 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.
In claims 9 & 17, the limitation “the distal section of the inner member includes a week portion that enables selective detachment of the distal section from the proximal section under applied tension” is vague. The original specification has not described clearly that what method or how to apply a tension to detach the weak portion from the proximal section. Therefore, it is unclear to Examiner that what is a method or device of using to apply a tension to break up the weak portion being detached from the proximal section of the inner member.
In claim 19, the limitation “inserting an additional inner member into the outer member …” is vague. In the independent claims 1 & 18 above, the inner member is configured to fit inside the lumen of the outer member, as during use. There is nothing to say that the inner member is being withdrawn from the outer member. Meanwhile, the claim 19 further requires that inserting an additional inner member into the outer member. Therefore, it is unclear to Examiner that only one inner member being inserted once at a time or both of the inner member and the additional inner member being inserted into the outer member in whether same or different lumen at the same time or in different time?
In claim 20, the limitation “detaching the distal section of the inner member” is vague. It is unclear to Examiner that what is a method or how to use to detach the distal section of the inner member (while the device is in the body of a patient).
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.
Claims 1, 3-5, 7, 10-11, 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Jenson (US 2006/0293612).
Regarding claim 1, Jenson discloses a catheter system 10, in Fig. 1 comprising:
an outer member 12 that includes a lumen 20 extending therethrough;
an inner member 22 including a distal section 24 and a proximal section (opposite side of the distal section 24), the inner member 22 being configured to fit inside the lumen of the outer member (e.g., the sheath 22 is at least partially disposed within the lumen 20, see Fig. 1); wherein the inner member 22 is translatable within the outer member to selectively extend beyond a distal end of the outer member, see Fig. 1; and
a stylette 32 configured to fit within a lumen 30 of the inner member 22; wherein the stylet has greater bending stiffness, (Figs. 15-17 & 21 show that the stylet 300 being bent at region 280)
Jenson discloses in different embodiment that a sheath 82 (equivalent to the claimed inner member) formed of polymeric material, or metallic material such as nitinol, stainless steel, and other alloys, paras [0051, 0054, 0064]. Meanwhile, a stylet 94 (or other stylet in different embodiment) formed of metal materials such as stainless steel, nitinol, titanium or other alloys, paras [0052, 0090, 0099].
Therefore, a person skilled in the art would recognize that the stylette has greater bending stiffness (when the stylette formed of stainless steel, nitinol, titanium or other alloys), than the inner member (the sheath formed of polymeric material). Note: the stainless steel, nitinol, titanium or other alloy has flexibility, bending stiffness characteristic.
In addition, assuming that if both of the stylette and the inner member (the sheath) are formed of same material; however, the stylet is in formed of solid rod or no hollow lumen. Meanwhile, the inner member (the sheath) includes a lumen or formed of a hollow member. Therefore, a person skilled in the art would recognize that the stylette (formed in solid rod) has greater bending stiffness than the inner member (formed in hollow tube structure).
Alternatively, the stylet 118 has a columnar 170/230/264, see Figs. 7, 11-12; or the stylet 550 has a columnar (the grooves formed as columnar, in Figs. 23A-B) has greater bending stiffness (solid rod of the stainless steel, nitinol or metallic material) than the inner member (in polymeric or stainless steel, nitinol or metallic material in formed of a hollow tube structure).
Regarding claim 3, it is noted that the product-by-process limitation “microfabricated” has not been given weight in determining the patentability of the device claim. See MEPE §2113. In this case, the applicant states in para [0024] in the original specification that: the gaps and/or cuts in the microfabricated portions. Therefore, for examining purpose, the term “microfabricated” is broadest interpreted as gaps and/or cuts-portion. In this case, Jenson discloses that the stylette includes a distal and proximal section, wherein the distal section 122/156/190/182126/516 of the stylette is microfabricated (e.g., cut, or gap, as shown in Figs. 6, 8-11, 23A) to have greater flexibility than the proximal section.
Regarding claim 4, wherein the stylette has a radiopaque marker 659 disposed at or near its distal end, see Fig. 24A. A person skilled in the art would recognize that the stylette 32 in Fig. 1 can be included a radiopaque marker 659 being provided near the distal end for tracking the stylette inside a patient, also see para [0110].
Regarding claim 5, Jenson discloses that wherein the stylette includes a hydrophilic coating, i.e., lubricious or other coating, paras [0117-0118].
Regarding claim 7, Jenson discloses that wherein the inner member is configured to avoid bonding to an adhesive passed therethrough. It is noted that the original specification states that the use of a thermoplastic polyurethane as a material that avoids bonding to an adhesive. In this case, Jenson also discloses that the user of polymer material that is a thermoplastic polymer includes polyurethane, para [0046].
Regarding claim 10, wherein the outer member is formed of nitinol and/or a polymer (e.g., the elongated shaft 405 comprises any suitable material which includes polymers, metals and alloys, stainless steel, nickel-titanium, see Fig. 22, para [0084]. Note: the elongate shaft 450 is a part of guidewire assembly 400, para [0083]; however, the elongate shaft 450 has a similar structure as a catheter shaft, i.e., elongate shaft includes a hollow lumen. Therefore, the elongate shaft 450 is fair enough to consider as a catheter member or an outer member of the catheter system.
Regarding claim 11, it is noted that the product-by-process limitation “microfabricated” has not been given weight in determining the patentability of the device claim. See MEPE §2113. Therefore, the limitation “microfabricated” is interpreted as small cut, slit, groove… In this case, Jenson discloses that the elongate shaft 405 (equivalent to the claimed outer member) having a tubular wall 418 including a plurality of apertures 420, such as grooves, cuts, slits, slots, or the like, processed therein…, see paras [0085-0086]. Jenson further states in para [0087] that: [0087] Some additional examples of shaft constructions and/or arrangements of cuts or slots formed in a tubular member are disclosed in U.S. Pat. Nos. 6,428,489 and 6,579,246, which are each incorporated herein by reference. Additionally, U.S. Publication No. 2004/0193140, which is incorporated herein by reference, illustrates additional arrangements of apertures providing a degree of lateral flexibility formed in a medical device. Therefore, Jenson discloses at least distal section of the outer member is microfabricated to include circumferentially extending rings and axially extending beams.
Evidence: Now turn into US’140 (Griffin et al. US 2004/0193140) shows in Fig. 1 that a catheter is microfabricated to include circumferentially extending rings and axially extending beam, see Figs. 1-3 in Griffin.
Regarding claim 13, Jenson discloses an intravascular catheter 42 in Fig. 2 is formed from a plurality of polymers 60, 62 & 66, see Fig. 3. A person skilled in the art would recognize that the outer member (outer catheter 14) is as an intravascular catheter and can be formed from a plurality of polymers, as described in the catheter 42.
Regarding claim 14, wherein the plurality of polymers have varying stiffness and are arranged to provide a gradient stiffness that decreases toward a distal end of the inner member, para [0042].
Regarding claim 15, wherein the inner member includes a stopping element 130 (in Fig. 6) configured to prevent the stylette from passing distally in certain length. Although the stopping element 130 is not preventing the distal end of the stylette from passing distally beyond the stopping element; however, this is a limitation and only requires performing a function. In this case, a person skilled in the art would recognize that stopping element 130 can be positioned in different location, i.e., a little bit further in proximal direction, as considered as rearrangement parts, for preventing the distal of the styllette from passing distally beyond the stopping element if one wish does not want the distal end of the styllete extending beyond the distal end of the inner member.
Note: the inner member (as modified in Fig. 6) that includes the stopping element 130.
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Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Jenson (US 2006/0293612) in view of Bowe et al. (US 7,717,899).
Jenson discloses all the claimed subject matter as required. Jenson discloses a catheter 42 is an intravascular catheter. In other words, the catheter 42 can be used as an inner catheter; wherein the catheter 42 (or the inner catheter 42 has a proximal section of the inner member has greater stiffness than a distal section of the inner member, para [0042]).
In case, Applicant disagrees with Examiner with the statement above. Assuming that Jenson does not disclose the limitation that the proximal section of the inner member has greater stiffness than the distal section of the inner member. In this case, the inner member can be modified by Bowe as below.
Bowe discloses a catheter system comprising: an outer member 4; an inner member 7; wherein a proximal section of the inner member 7 has greater stiffness than a distal section of the inner member (e.g., the inner member has variable bending stiffness along its length. The distal end of the inner catheter is more flexible than the proximal end, col. 6, lines 39-42).
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the inner member of Jenson with providing a variable stiffness such as a proximal section of the inner member being greater stiffness than a distal section of the inner member, as taught by Bowe, in order to improve guiding catheter system for adjusting a distal shape for venous access and cannulation.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Jenson (US 2006/0293612) in view of Manzo (US 4,763,667).
Jenson discloses all the claimed subject matter as required in the claimed invention. It appears in the Figs. 2 & 14, the catheter includes a Luer connection 52/290 at a proximal end of the catheter. Alternatively, Manzo discloses a catheter system comprising: an outer catheter 16; an inner catheter 20; wherein a proximal end of the inner member 30 includes a Luer connection 32, col. 2, lines 51-56.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the inner member device of Jenson with including a Luer connection being located at a proximal end of the inner member, as taught by Manzo, in order to improve a securing in between the outer and inner catheters.
Claims 8-9 & 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jenson (US 2006/0293612) in view of Rosenbluth et al. (US 6,015,424).
Regarding claims 8-9, Jenson discloses all the claimed subject matter as required except for the limitation that: the distal section of the inner member is selectively detachable from the proximal section of the inner member; wherein the distal section of the inner member includes a weak portion that enables selective detachment of the distal section from the proximal section under applied tension
Rosenbluth discloses a catheter system comprising: an outer member 14; an inner member 34 includes a distal section 12 and a proximal section (opposite the distal section 12); wherein the distal section 12 is selectively detachable from a proximal section of the inner member 34, col. 4, lines 34-35; wherein the distal section of the inner member includes a weak portion (an outer surface is located at proximal portion of the embolic device 12) that enables selective detachment of the distal section from the proximal section under applied tension (via pressure of the fluid that pushes the embolic device 12 out of the holding element 24, col. 4, lines 32-34).
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the catheter device of Jenson (i.e., modify the inner member of Jenson) with providing a distal section being configured to detach from a proximal section of the inner member, as taught by Rosenbluth, in order to deploy an embolic device to a treatment site.
Regarding claims 16-17, these claims 16-17 contains all claimed subject matter as required in claims 1 & 8-9. Therefore, the claims 16-17 are being rejected same analysis as noted in the combination of claims 1 & 8-9 above.
Regarding claim 18, Jenson discloses a method for embolizing targeted anatomy, comprising:
providing the catheter system of claim 1, see the rejection in claim 1 above;
guiding the outer member towards the targeted anatomy (e.g., the elongated shaft is advanced through a patient’s vasculature, see Fig. 1, para [0035];
guiding the inner member to the targeted anatomy by translating the inner member within the outer member (the elongate shaft 12 has reached an appropriate position, the sheath 22 is advanced distally through the shaft lumen 20. In other embodiments, the elongate shaft 12 is advanced through the patient’s vasculature with the sheath 22 already positioned within the shaft lumen 20, Fig. 1 and para [0035]), wherein the distal end of the inner member is extended past the distal end of the outer member (the sheath 22 is advanced distally so that the distal end 26 extends distally beyond the distal end 16 of the elongate shaft 12, para [0036].
Jenson does not disclose the steps of injecting an embolic agent toward the targeted anatomy; and withdrawing the inner member from the outer member.
Rosenbluth discloses a method for embolizing targeted anatomy 36 comprising:
guiding the outer member 12 towards the targeted anatomy 36, see Fig. 3
guiding an inner member 16 to the targeted anatomy 40 by translating the inner member 16 (or within the outer member 12, see Fig. 3;
injecting an embolic agent, i.e., saline solution toward the targeted anatomy, col. 4, line 31-32 & Fig. 4; and
withdrawing the inner member 16 from the outer member (e.g., the deployment tube 16 is withdrawn from the microcatheter, col 4, lines 34-35).
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the method of embolizing targeted anatomy of Jenson with including the steps of injecting an embolic agent toward the targeted anatomy and withdrawing the inner member 16 from the outer member, as taught by Rosenbluth, in order to treat an occlusion of blood vessel such as to control vascular bleeding, to occlude the blood supply to tumors, and to occlude vascular aneurysms.
Regarding claim 19, Jenson in view of Rosenbluth discloses all the claimed subject matter as required. Rosenbluth further discloses a step of inserting an additional inner member 30/32 (or 26) into the outer member and injecting embolic agent through the additional inner member 30/32 (or 26).
Regarding claim 20, Jenson in view of Rosenbluth discloses all the claimed subject matter as required. Rosenbluth further discloses a step of detaching the distal section12 (embolic device 12) of the inner member 16 following injection of the embolic agent (e.g., a saline solution is injected through the axial lumen 20 and into the holding element 24 of the deployment tube 16. The pressure of the fluid pushes the embolic device 13 out of the holding element, thereby detaching the embolic device 12 from the deployment tube, col. 4, lines 30-35).
Claims 8-9 & 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Jenson (US 2006/0293612) in view of Chebator (US 2014/0018737)
Regarding claims 8-9 & 16-17, Jenson discloses all the claimed subject matter as required except for the limitation that: the distal section of the inner member is selectively detachable from the proximal section of the inner member; wherein the distal section of the inner member includes a weak portion that enables selective detachment of the distal section from the proximal section under applied tension
Chebator discloses a catheter member 120 comprising: a distal section 142 and a proximal section 122; wherein the distal section is selectively detachable from a proximal section 122 of the catheter member; wherein the distal section of the inner member includes a weak portion (thread portions) that enables selective detachment of the distal section from the proximal section under applied tension via manually by user’s hand.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the catheter device of Jenson (i.e., modify the inner member of Jenson) with providing a distal section 142 being configured to detach from a proximal section of the inner member, as taught by Chebato, in order to facilitate passage through subcutaneous tissue or to allow the distal segment for creating tunnel.
Regarding claims 16-17, these claims 16-17 contains all claimed subject matter as required in claims 1 & 8-9. Therefore, the claims 16-17 are being rejected same analysis as noted in the combination of claims 1 & 8-9 above.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Jenson (US 2006/0293612) in view of Griffin et al. (US 2004/0193140).
Regarding claim 12, Jenson discloses all the claimed subject matter as required.
As mentioned in claim 11 above, Jenson further states in para [0087] that: Some additional examples of shaft constructions and/or arrangements of cuts or slots formed in a tubular member are disclosed in U.S. Pat. Nos. 6,428,489 and 6,579,246, which are each incorporated herein by reference. Additionally, U.S. Publication No. 2004/0193140, which is incorporated herein by reference, illustrates additional arrangements of apertures providing a degree of lateral flexibility formed in a medical device.
In other words, the distal section of the outer member is microfabricated to include circumferentially extending rings and axially extending beams.
Jenson does not disclose that a polymer disposed within spaces defined by the rings and beams.
Griffin discloses a medical device 10 comprising: a catheter 12 is microfabricated to include circumferentially extending rings and axially extending beam, see Figs. 1-3. Griffin further discloses that a lubricious polymer, a hydrophilic polymer is applied over portions or all of the shaft 12, para [0064]. In other words, the lubricious polymer or hydrophilic polymer is disposed within spaces defined by the rings and the beams.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the outer member device of Jenson with providing polymer being disposed within spaces defined by the rings and the beams, as taught by Griffin, in order to improve catheter handling, device exchanges and to aid in insertion and steerability.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Jenson (US 2006/0293612) in view of deCiutiis (US 5,092,848).
Jenson discloses all the claimed subject matter as required in the claimed invention. Jenson discloses that wherein the inner member includes a stopping element 130 (in Fig. 6) configured to prevent the stylette from passing distally in certain length. Although the stopping element 130 is not preventing the distal end of the stylette from passing distally beyond the stopping element; however, this is a limitation and only requires performing a function. Therefore, the catheter system in Jenson can be modified by deCiutiis as below.
deCiutiis discloses that a catheter member 12 (can be equivalent the claimed inner member) comprising: a cutting tip located at distal end; a stylette 60; wherein the catheter member 12 (inner member) includes a stopping element 62/64 configured to prevent a distal end 70 of the stylette 60 from passing distally beyond the stopping element 62/64.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the catheter device of Jenson with providing a cutting tip at distal end of the inner member and providing a stopping element that being configured to prevent a distal end 70 of the stylette 60 from passing distally beyond the stopping element, as taught by deCiutiis, for the benefits of using the inner member for cutting tissue and the stylette for supporting the catheter/inner member without passing the catheter/inner member during use.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783