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 .
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 1-15, 9 & 17 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 claim 1, the limitation “the inner member and stylette are configured to prevent the distal end of the stylette from passing distally beyond the distal end of the inner member” is vague. Examiner acknowledges that the stylette is configured to passing beyond the distal end of the inner member, However, it does not make sensor that: the inner member is configured to prevent ... from passing distally by its self (from passing distally beyond the distal end of the inner member).
The other claims 2-15 are being rejected due to their dependency.
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 addition, the para [0026] states that: the more proximal section of the inner member 200 may include a perforation, groove, thine section, partial bream, intentional weak spot or other mechanically weakened structure configured to detach the distal section 206. In other words, the “weak portion” is located at the proximal section of the inner member, but not located at the distal section of the inner member, as described in the claims 9 & 17.
Response to the Argument: Applicant states on pg2 of the Remarks 06/2/26 that: the phrase “applied tension” is not a method a step but simply a functional description of the structure feature “the weak portion”.
In response, Examiner disagrees with the statement above. The phrase “under applied tension” does not include any special structure, and therefore, is considered a method of performing in the device claim. As mentioned above, the “weak portion” is located on the proximal section of the inner member (but not at the distal section of the inner member, as required in the claims 9 & 17).
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.
I) Prior art Mickley
Claims 1 & 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mickley (US 6,595,958).
Regarding claim 1, Mickley discloses a catheter system 200, in Fig. 3, comprising:
an outer member 206 that includes a lumen 220 extending therethrough;
an inner member 226 including a distal section (230 area in Fig. 3) and a proximal section (opposite the distal section, near area 222), the inner member 226 being configured to fit inside the lumen of the outer member 206, wherein the inner member 226 is translatable within the outer member to selectively extend beyond a distal end 206 (near 208) of the outer member 206; and
a stylette 236 configured to fit within a lumen 230 of the inner member 226, wherein the stylette 236 has greater bending stiffness and/or columnar stiffness than the inner member, see Fig. 3, wherein the inner member 226 and stylette 236 are configured to prevent the distal end of the stylette from passing distally beyond the distal end of the inner member, see Fig. 3.
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. Mickley discloses that the outer member 106 is formed nitinol and/or a polymer, col. 5, lines 34-46.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Mickley (US 6,595,958) in view of Bowe et al. (US 7,717,899).
Regarding claim 2, Mickley discloses all the claimed subject matter as required. The Fig. 3 shows that the distal section (#226 area) of the inner member 226 is bent. Therefore, it appears to Examiner that the proximal section of the inner member has greater stiffness than the distal section.
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 Mickley 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.
Claims 3-5, 7, 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Mickley (US 6,595,958) in view of Jenson et al. (US 2006/0293612)
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. The Fig. 3 shows that the distal section of the stylette 236 is bent, while the proximal section (near #222) is in straight line. Therefore, the distal section of the stylette microfabricated to have greater flexibility than the proximal section.
In case, Applicant disagrees with Examiner with the statement above. Assuming that Jenson does not disclose the limitation that the distal section of the stylette is having greater flexibility thatn the proximal section. In this case, the inner member can be modified by Jenson as below.
Note: 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 118/186/550 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.
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 stylette member of Mickley with providing the distal section being more flexibility than the proximal section in the stylette , as taught by Jenson, in order to provide a flexibility in the the stylet and able to insert into insert into the curving area into a patient.
Regarding claim 4, Mickley discloses all claimed subject matter except for the limitation that the stylette has a radiopaque marker disposed at or near its distal end.
Jenson discloses that the stylette has a radiopaque marker 659 disposed at or near its distal end, see Fig. 24A.
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 stylette member of Mickley with including a radiopaque marker disposed at or near a distal end of the stylette, as taught by Jenson, in order to allow a physician view the position of the stylet during procedure.
Regarding claims 5 & 7, Mickley discloses all claimed subject matter except for the limitation that the stylette includes a hydrophilic coating; the inner member is configured to avoid bonding to an adhesive assed threre-through.
Jenson discloses that wherein the stylette includes a hydrophilic coating, i.e., lubricious or other coating, paras [0117-0118]. Therefore, 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].
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 stylette member of Mickley with providing a hydrophilic coating on/at the stylette member, and/or the inner member being made by thermoplastic polymer, i.e. polyurethane, as taught by Jenson, in order to prevent an adhesive in between the stylette and the inner member during insertion.
Regarding claim 13, Mickley discloses all claimed subject matter except for the limitation as required in 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 inner member 226 in Mickley is as an intravascular catheter and can be formed from a plurality of polymers, as described in the catheter 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 Mickley with providing plurality of polymer layers, as taught by Jenson, in order to provide different flexibility in different region in the catheter.
Regarding claim 14, Mickley in view of Jenson discloses all claimed subject matter as required. Jenson further discloses that 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].
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mickley (US 6,595,958) in view of Manzo (US 4,763,667).
Mickley discloses all claimed subject matter as required. The hub 234 includes threads 234. It appears to Examiner that the hub 234 is a Luer connection.
In case Applicant disagrees with the Examiner, assuming that Jenson does not disclose the hub provides as a Luer connector (e.g. a proximal end of the inner member includes a Luer connection). In this case, the inner member can be modified by Manzo as below.
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 Mickley with including a Luer connection being located at a proximal end of the inner member, as taught by Manzo, in order to improve of engagement in to different connector/adapter/hub of catheter/syringe...
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Mickley (US 6,595,958) in view of Sutherland et al. (US 9,468,739).
Mickley discloses all claimed subject matter as required except for the limitation that the distal section of the inner member is selective 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 form the proximal section under applied tension.
Sutherland discloses a tubular member 16 comprising: a distal section 26 & 30 is selectively detachable from a proximal section 16 of the tubular member 16; wherein the distal section 26 & 30 includes a weak portion 26 that enables selective detachment of the distal section from the proximal section under applied tension, see Fig. 2B.
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 Mickley with including a weak portion at a distal section of the tubular/inner member, as taught by Sutherland, in order to delivery embolic agent in solid form.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Mickley (US 6,595,958) in view of Groshong et al. (US 4,431,426).
Mickley discloses all claimed subject matter as required except for the limitation that the distal section of the inner member is selective 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 form the proximal section under applied tension.
Groshong discloses a catheter system comprising: an outer member 35; an inner member 10; where’re a distal section 38 of the inner member 10 is selective detachable from the proximal section of the inner member; wherein the distal section 38 of the inner member includes a weak portion (inner thread portion) that enables selective detachment of the distal section form the proximal section under applied tension.
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 Mickley with a weak portion that being detached the distal section from the proximal section, as taught by Groshong, in order to perform short term or long-term intravenous therapy or hyperalimentation.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Mickley (US 6,595,958)in view of Griffin et al. (US 2004/0193140).
Regarding claim 12, Mickley discloses all the claimed subject matter as required. Mickley discloses that the outer member comprises a polymer, col. 5, lines 43-46, but does not disclose that a distal section of the outer member is microfabricated to include circumferentially extending rings and axially extending beams; wherein a polymer disposed within spaces defined by the rings and beams.
Griffin discloses a medical device 10 comprising: a catheter 12 is microfabricated (grooves, cuts, slits, slots or the like by micromachine, laser cutting..., para [0040]) to include circumferentially extending rings and axially extending beam, see Figs. 1-3; wherein the apertures 44 (are formed extending rings and axially extending beam) formed in a portion of, or along the entire length of the tubular. Therefore, the distal section also includes the circumferentially extending rings and axially extending beams. 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 Mickley with providing a reinforcing member (defined as circumferentially extending rings and axially extending beams) and providing a polymer being disposed within spaces defined by the rings and the beams, as taught by Griffin, in order to enhance the flexibility and to aid in insertion and steerability.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mickley (US 6,595,958) in view of deCiutiis (US 5,092,848).
Mickley discloses all the claimed subject matter as required except for the limitation that the inner member includes a stopping element configured to prevent the distal end of the stylette from passing distally beyond the stopping element.
deCiutiis discloses an intravenous catheter, in Figs. 1 & 5-6 comprising: a tubular member 12; a stylette 60 configured to fit within a lumen 26/66 of the tubular member 12; wherein the tubular member includes a stopping element 62/64 configured to prevent the distal end 70 of the stylette 60 from passing distally beyond the stopping element 62/64.
Note: Although the Fig. 3 shows that the stylett 220 is not extended beyond the inner member; however, if the stylette has a longer length that will be extending beyond the distal end of the inner member.
Giving such a teaching by deCiutiis, a person having ordinary skill in the art would have easily recognized that modifying the inner member of Mickley with providing a stopping element at a distal portion of the tubular member, as taught by deCiutiis, would provide the benefit of preventing the stylette (in different size of length) further extending beyond the stopping element (or beyond the tubular member).
II) Prior art Lorenzo
Claims 1, 7-10 & 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lorenzo et al. (US 7,344,558).
Regarding claim 1, Lorenzo discloses a catheter system 10, comprising:
an outer member 12 that includes a lumen extending therethrough;
an inner member 16 including a distal section and a proximal section, the inner member 16 being configured to fit inside the lumen of the outer member, wherein the inner member is translatable within the outer member to selectively extend beyond a distal end of the outer member, see Figs. 2-2A;
Note: as seen in Fig. 1, a space/passage is formed in between the inner and outer member without any an obstruction. Therefore, a person skilled in the art would recognize that the inner member is able to extend beyond the distal end of the outer member. Alternatively, the tubular members 34 & 38 are being attached to a distal portion 18 of the inner member 16, see col. 5, lines 24-49 & col. 6, lines 19-31. Therefore, with broadest interpretation, the elements #40 & #26 are considered as a part of the inner member 16. Therefore, the inner member is translatable within the outer member to selectively extend beyond a distal end of the outer member;
a stylette 36 configured to fit within a lumen 20 of the inner member 16, wherein the stylette 36 has greater bending stiffness (can be inserted into tortuous path within the patient, col. 6, lines 50-54) and/or columnar 39/41 stiffness than the inner member, wherein the inner member 16 and stylette 36 are configured to prevent the distal end of the stylette from passing distally beyond the distal end 18 of the inner member 16, see Figs. 1-3.
Note: the inner member 16 is comprised flexible coil or flexible polymer sheath, the stylette 26 is comprised of metallic or polymeric material, col. 6, lines 40-55; however, the columnar 39 is formed of solid structure and having larger thickness than the wall of the inner member 16. Therefore, the columnar 39/41 is stiffer than the inner member. In addition, with broadest interpretation, Examiner interprets that the inner member 16 formed of polymer material, meanwhile, the stylette 36 formed of metallic material. Therefore, the stylette has greater bending stiffness and/or columnar stiffness than the inner member.
Regarding claim 7, The Fig. 1 show that a space/passage is formed in between the inner member and outer member. Therefore, the inner member is configured to avoid bonding to an adhesive passed therethrough.
Regarding claims 8-9, wherein the distal section 40/44 of the inner member 16 is selectively detachable from the proximal section of the inner member 16, see Fig. 3; wherein the distal section of the inner member includes a weak portion 35 that enables selective detachment of the distal section from the proximal section under applied tension.
Regarding claim 10, Lorenzo discloses the claimed invention except for the limitation that the outer member formed of a nitinol and/or polymer . It would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain nitinol and/or polymer material in the outer member, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claims 13-14, the inner member 16 is formed from plurality of polymers (e.g., the #34, 26, 38 & 16 are formed in different polymers (see the cross-in section in Figs. 2A-3 in those elements 24, 26, 38 & 16) ; wherein the plurality of polymers have varying stiffness (in coil 32 and other tubular elements 34, 38) and are arranged to provide a gradient stiffness than decreases toward a distal end of the inner member 16.
Regarding claim 15, the inner member includes a stopping element 38 is configured to prevent the distal end of the stylette 36 from passing distally beyond the stopping element 38.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lorenzo et al. (US 7,344,558) in view of Bowe et al. (US 7,717,899).
Regarding claim 2, Lorenzo discloses all the claimed subject matter as required. Lorenzo discloses that the inner member 16 has flexibility to be guided through tortuous pathways within the vasculature of a patient, col. 6, lines 40-46 but does not disclose that the proximal section of the inner member has greater stiffness than the distal section of the inner member.
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 Lorenzo 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.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Lorenzo et al. (US 7,344,558) in view of Griffin et al. (US 2004/0193140).
Regarding claim 11-12, Lorenzo discloses all the claimed subject matter as required but does not disclose the limitations as required in the claims 11-12.
Griffin discloses a medical device 10 comprising: a catheter 12 is microfabricated (grooves, cuts, slits, slots or the like by micromachine, laser cutting..., para [0040]) to include circumferentially extending rings and axially extending beam, see Figs. 1-3; wherein the apertures 44 (are formed extending rings and axially extending beam) formed in a portion of, or along the entire length of the tubular. Therefore, the distal section also includes the circumferentially extending rings and axially extending beams. 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 Lorenzo with providing a reinforcing member (defined as circumferentially extending rings and axially extending beams) and providing a polymer being disposed within spaces defined by the rings and the beams, as taught by Griffin, in order to enhance the flexibility and to aid in insertion and steerability.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lorenzo et al. (US 7,344,558) in view of Rosenbluth et al. (US 6,015,424).
Regarding claim 18, Lorenzo discloses a method for embolizing targeted anatomy, comprising:
providing the catheter system of claim 1, see the rejection claim 1 in the prior art Lorenzo.
guiding the outer member 12 towards the targeted anatomy, col. 4, lines 45-52;
guiding the inner member to the targeted anatomy by translating the inner member 14/16 within the outer member, wherein the distal end of the inner member is extended pass the distal end of the outer member.
Note: as seen in Fig. 1, a space/passage is formed in between the inner and outer member without any an obstruction. Therefore, a person skilled in the art would recognize that the inner member is able to extend beyond the distal end of the outer member.
Lorenzo does not disclose the limitation that: 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, comprising: injecting an embolic agent (saline solution) toward the targeted anatomy (fluid, i.e., saline solution is injected through the axial lumen 15 (see arrow 38 in Fig. 2), col. 4, lines 31-32; and withdrawing an inner member 16/34 from the outer member 14 (e.g. the deployment tube 16/34 is then withdrawn from the microcatheter 14, col. 4, lines 34-35; col. 6,lines 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 method of Lorenzo with including a method of injecting an embolic agent toward to the targeted anatomy, and withdrawing the inner member from the outer member, as taught by Rosenbluth, in order to treat an occluding a blood vessel by embolizing a targeted anatomy.
Regarding claim 19, Lorenzo in view of Rosenbluth discloses all claimed subject matter as required. Rosenbluth further discloses that after withdrawing the inner member from the outer member, inserting an additional inner member into the outer member; and injecting embolic agent through the additional inner member (e.g., if the size of the aneurysm 36 requires more than one embolic device 12 to fill it completely, the deployment tube 16 (inner member) is withdrawn through the microcatheter 14 (outer member) and reloaded with another embolic device 12, and the above-described deployment process is repeated as often as is needled to fill the aneurysm 36 completely (Fig. 4), col. 6, lines 61-66.
Note: having said in the Rosenbluth above, in order to reloaded with another embolic device 12, it has to require inserting an inner member (in this case, a person skilled in the art would recognize that the inner member for inserting in second time must be used a new or additional inner member 16/34) into the outer member 14 to keep in sterile condition during procedure.
Regarding claim 20, Lorenzo in view of Rosenbluth discloses all claimed subject matter as required. Lorenzo discloses that detaching the distal section 40/42 of the inner member following injection of the embolic agent.
III) Prior art Jenson
Claims 16-17 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 16-17, Jenson discloses a catheter system 10, in Figs. 1 & 15-17 & 21 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 does not disclose 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 for aneurysm in a soft, complaint state, thereby minimizing the risk of aneurysm rupture or vascular damage.
Response to Arguments
Applicant's arguments filed 06/22/26 have been fully considered but they are not persuasive.
Independent claim 16
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, the devices in both of Jenson and Rosenbluth are used to treat in occluded vasculature. Since Jenson and Rosenbluth are both from the same field of endeavor, the purpose disclosed by Rosenbluth would have been recognized in the pertinent art of Jenson.
Therefore, a person skilled in the art would recognize that modifying the catheter device system in 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 for aneurysm or occluded vasculature thereby minimizing the risk of aneurysm rupture or vascular damage.
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
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 QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached M-F 7:30 am-4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUYNH-NHU H. VU/ Primary Examiner, Art Unit 3783
Prosecution Insights