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 .
Detailed Action
This is in response to the amendment filed 01/13/2026.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 26-46, 49-63 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10-32 of U.S. Patent No. 11,224,449
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 10-32 of the patent generally recite a catheter with an elongate control element, a distal luminal portion, tubular inner liner, reinforcement structure, outerjacket, a coating on the inner liner, the outer jacket formed from a plurality of segments, an outer jacket lawyer tubular segment that creates an outer diameter sized larger than an outer diameter of the distal end region, which are generally recited in claims 26-46, 49-63 of the application.
It is clear that all the elements of claims 26-46, 49-63 of the application are to be found in claims 10-32 of the patent. The difference between claims 26-46, 49-63 of the application and claims 10-32 of the patent lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claims 10-32 of the patent is in effect a “species” of the “generic” invention of claims 26-46, 49-63 of the applciation. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
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) 26-29, 32, 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0081243 (Zhou) in view of U.S. Patent Publication Number 2009/0030400 (Bose)
Regarding claim 26, Zhou discloses a neurovascular catheter as shown in Figure 2D, capable of performing a medical procedure at a treatment site in a cerebral vessel of a patient, the catheter comprising: an elongate control element (shaft 102, see paragraph [0025]) configured to advance the neurovascular catheter comprising a proximal portion and a distal portion (region 108, see paragraph [0025]) comprising a flat ribbon; and a distal luminal portion (sheath 110, see paragraph [0026]) extending along a longitudinal axis having a proximal end region coupled to the control element, wherein the distal luminal portion has a side wall defining a single, inner lumen, the side wall comprising: a tubular inner liner (inner layer 119, see paragraph [0027]); a reinforcement structure (an intermediate reinforcing member 116, see paragraphs [0027], [0028]) wound around (described as coil which would necessarily wind) and bonded to the tubular inner liner; and an outer jacket (outer layer 120, see paragraph [0027]) surrounding the reinforcement structure, wherein a distal end of the elongate control element is coupled to the proximal end region of the distal luminal portion forming a junction sandwiched between layers of the side wall, and wherein the proximal end region of the distal luminal portion includes an outer diameter sized to be capable of forming a seal with a sheath through which the catheter extends (if it is inserted into a sheath with a diameter slightly larger, such as between 1-2 thousandths of an inch, or between 1-4 thousandths of an inch, or between 1-12 thousandths of an inch), wherein a distal end of the flat ribbon has a feature (top external flat surface, shown in Figure 2A) that facilitates a mechanical joint during a weld, the top external flat surface is interpreted as protruding or cut-out feature, because it is made by cutting out a portion of the shaft 102 and it protrudes outwardly.
Zhou fails to disclose the outer jacket surrounding the reinforcement structure is formed of a plurality of tubular segments, an outer jacket layer tubular segment of the plurality of tubular segments over the junction creates an outer diameter sized larger than an outer diameter of the distal end region of the distal luminal portion.
Bose, from the same field of endeavor teaches a similar catheter as shown Fig. 2A, wherein the outer jacket is formed from a plurality of tubular segments, and a distal one of the tubular segments has a durometer of no more than about 35D; see claim 12; proximal one of the tubular segments has a durometer of at least about 60D; see paragraph [0020]; wherein the outer jacket is formed from at least five discrete tubular segments; wherein a difference in durometer between a proximal one of the tubular segments and a distal one of the tubular segments is at least about 20D; wherein the difference is at least about 30D; where the outer jacket is form by at least five discrete segments.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the catheter disclosed by Zhou by substituting the outer jacket disclosed by Zhou for the outer jacket disclosed by Bose, such that the outer jacket surrounding the reinforcement structure is formed of a plurality of tubular segments, an outer jacket layer tubular segment of the plurality of tubular segments over the jacket creates an outer diameter sized larger than an outer diameter of the distal end region of the distal luminal portion, the outer jacket is formed from a plurality of tubular segments positioned coaxially about the helical coil, wherein a proximal one of the plurality of tubular segments has a durometer of at least about 60D and a distal one of the plurality of tubular segments has a durometer of no more than about 35D, wherein the outer jacket is formed from at least five discrete tubular segments, wherein a difference in durometer between a proximal one of the tubular segments and a distal one of the tubular segments is at least about 20D, wherein the difference is at least about 30D, where the outer jacket is form by at least five discrete segments, because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
To be clear, the Office interprets Zhou in view of Bose as teaching an outer jacket layer tubular segment of the plurality of tubular segments over the junction creates an outer diameter sized larger than an outer diameter of the distal end region of the distal luminal portion because Bose teaches the diameter of the tubular segments are tapered toward the distal end of the outer jacket. Since the junction is at the proximal end of the outer jacket, it follows that an outer jacket layer tubular segment of the plurality of tubular segments over the junction creates an outer diameter sized larger than an outer diameter of the distal end region of the distal luminal portion.
Regarding claims 27-29 Zhou discloses wherein the distal luminal portion has a transition section (generally indicated as A) near where the distal luminal portion couples to the elongate control element, wherein the transition section has an angled cut, wherein the proximal opening is formed within the transition section and the proximal end region of the distal luminal portion is coupled to the distal end region of the control element adjacent the transition section.
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Regarding claim 32, Zhou discloses the flat ribbon has a rectangular cross-sectional dimension that is wider than it is thick. See paragraph [0025] and Figure 2A.
Regrading claim 33, Zho fails to disclose wherein a maximum cross-sectional dimension of the flat ribbon is 0.025″.
It would have been obvious to one of ordinary skill in the art, before effective filing date of the claimed invention to modify the catheter disclosed by Zho such that the flat ribbon has a rectangular cross-sectional dimension that is wider than it is thick or wherein a maximum cross-sectional dimension of the flat ribbon is 0.025" as a matter of engineering design choice.
Applicant has not disclosed that shape of the control device provides an advantage, is used fora particular purpose, or solves a stated problem. See paragraph [0012] of the spec. One of ordinary skill in the art, furthermore, would have expected Zho’s shaft, and applicant's invention, to perform equally well regardless of its size because both shapes would perform the same function of advancing the catheter equally well considering the relative dimensions and materials disclosed.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0081243 (Zhou) in view of U.S. Patent Publication Number 2009/0030400 (Bose) as applied to claim 26 above, and further in view of U.S. Patent Publication Number 2009/0163891 (Ewing)
Regarding claim 30, Zhou fails to disclose a proximal end of the elongate flexible control element is coupled to a tab.
Ewing, from the same field of endeavor teaches a similar catheter as shown in Figure 2, where disclose a proximal end of the elongate flexible control element is coupled to a tab (tab 175, see paragraph [0032]) for the purpose of facilitating manipulation of the elongate flexible control element.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the catheter disclosed by Zhou to include the tab taught by Ewing a proximal end of the elongate flexible control element in order to facilitate manipulation of the elongate flexible control element.
Claim(s) 31, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0081243 (Zhou) in view of U.S. Patent Publication Number 2009/0030400 (Bose) as applied to claim 26 above, and further in view of U.S. Patent Publication Number 2007/0260219 (Root et al.)
Regarding claim 31, Zhou fails to disclose a reversible coupling feature on the control element for organizing the control element of the neurovascular catheter and a component used with the catheter engaged by the reversible coupling feature.
Root et al., from the same field of endeavor teaches a similar catheter as shown in Figure 1, a reversible coupling feature (clip or snap attachment 54, see paragraph [0064) on the control element capable of organizing the control element of the neurovascular catheter and a component (inner catheter 14, see paragraph [0064]) used with the catheter engaged by the reversible coupling feature.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the catheter disclosed by Zhou to include the clip or snap attachment 54 taught by Root et al. on the control element capable of organizing the control element of the neurovascular catheter and a component used with the catheter engaged by the reversible coupling feature, for the purpose of configuring the catheter to reversibly couple to an inner catheter.
Regrading claim 35, Zhou fails to disclose a catheter advancement element sized to be positioned within the inner lumen of the catheter, wherein a tapered distal tip of the catheter advancement element extends distal to a distal end of the neurovascular catheter during delivery of the catheter.
Root et al., from the same field of endeavor teaches a similar catheter as shown in Figure 1, which includes a catheter advancement element (inner catheter 14, see paragraphs [0011], [0050]) sized to be positioned within the inner lumen of the catheter, wherein a tapered distal tip of the catheter advancement element extends distal to a distal end of the neurovascular catheter during delivery of the catheter, for the purpose of allowing atraumatic delivery of the catheter.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the catheter disclosed by Zhou to include the inner catheter 14 taught by Root et al. such that the catheter included a catheter advancement element sized to be positioned within the inner lumen of the catheter, wherein a tapered distal tip of the catheter advancement element extends distal to a distal end of the neurovascular catheter during delivery of the catheter in order to allow atraumatic delivery of the catheter.
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0081243 (Zhou) in view of U.S. Patent Publication Number 2009/0030400 (Bose) as applied to claim 26 above, and further in view of U.S. Patent Number 9,241,699 (Kume et al.)
Regarding claim 34, Zhou fails to disclose the neurovascular catheter has a length that when inserted through a sheath positioned at a transfemoral access site so a distal end region of the catheter is located within a middle cerebral artery the proximal end region of the distal luminal portion remains outside the aortic arch.
Kume et al., from the same filed of endeavor teaches a similar catheter as shown in Figure 4, where the neurovascular catheter has a length that when inserted through a sheath positioned at a transfemoral access site so a distal end region of the catheter is located within a middle cerebral artery the proximal end region of the distal luminal portion remains outside the aortic arch, for the purpose of performing a treatment within a middle cerebral artery. See col. 5, lines 23-31, col. 6, lines 13-33 and col. 7, lines 9-31.
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the catheter disclosed by Zhou by substituting the length of the catheter disclosed by Zhou for the length taught by Kume, such that when inserted through a sheath positioned at a transfemoral access site so a distal end region of the catheter is located within a middle cerebral artery the proximal end region of the distal luminal portion remains outside the aortic arch, in order to perform a treatment within a middle cerebral artery or because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0081243 (Zhou) in view of U.S. Patent Publication Number 2009/0030400 (Bose) as applied to claim 26 above, and further in view of U.S. Patent Publication Number 2016/0096002 (Di Caprio et al.)
Regarding claim 36, Zhou fails to disclose a sheath having a central lumen and proximal hemostasis valve configured to couple with a single source of suction, wherein the inner lumen of the neurovascular catheter is sized to insert through the central lumen of the sheath forming a contiguous lumen suitable to remove occlusive material through the contiguous lumen upon application of suction by the single source of suction.
Di Caprio et al., from the same field of endeavor teaches a similar system as shown in Figure 2A, where the system includes a sheath having a central lumen and proximal hemostasis valve configured to couple with a single source of suction, wherein the inner lumen of the neurovascular catheter is sized to insert through the central lumen of the sheath forming a contiguous lumen suitable to remove occlusive material through the contiguous lumen upon application of suction by the single source of suction, for the purpose of removing thrombus, emboli, or debris. See paragraph [0126].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the catheter disclosed by Zhou to include the sheath and hemostasis valve taught by Di Caprio et al. such that the system included a sheath having a central lumen and proximal hemostasis valve configured to couple with a single source of suction, wherein the inner lumen of the neurovascular catheter is sized to insert through the central lumen of the sheath forming a contiguous lumen suitable to remove occlusive material through the contiguous lumen upon application of suction by the single source of suction, in order to configure the system to remove thromboses, emboli, or debris.
Claim(s) 37, 40- 41, 43-46, 49-56, 60-62 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0081243 (Zhou) in view of U.S. Patent Publication Number 2010/0057051 (Howat et al.), U.S. Patent Publication Number 2009/0030400 (Bose), U.S. Patent Publication Number 2011/0092910 (Schultz)
Regarding claims 37, 41, 49-56 Zhou discloses a neurovascular catheter system with a neurovascular catheter as shown in Figure 2D, comprising: an elongate control element (shaft 102, see paragraph [0025]) capable of advancing the catheter, the control element comprising a proximal end region, and a distal end region comprising a flat ribbon (region 108, see paragraph [0025]); and a distal luminal portion (sheath 110, see paragraph [0026]) extending along a longitudinal axis having a proximal end region coupled to the distal end region of the control element, wherein the distal luminal portion has a side wall defining a single, inner lumen extending between a proximal opening into the inner lumen at the proximal end region of the distal luminal portion and a distal opening from the central lumen at the distal end region of the distal luminal portion, the side wall comprising: a tubular inner liner (inner layer 119, see paragraph [0027]) having an outer surface; a reinforcement structure that is a coil (an intermediate reinforcing member 116, see paragraphs [0027], [0028]) bonded to the outer surface of the tubular inner liner; and an outer jacket (outer layer 120, see paragraph [0027]) surrounding the helical coil, wherein the distal end region of the elongate control element is coupled to the proximal end region of the distal luminal portion forming a junction sandwiched between layers of the side wall, wherein a distal end of the flat ribbon is skived, ground or cut, wherein the proximal end region of the distal luminal portion includes an outer diameter sized to be capable of forming a seal with a sheath through which the catheter extends (if it is inserted into a sheath with a diameter slightly larger, such as between 1-2 thousandths of an inch, or between 1-4 thousandths of an inch, or between 1-12 thousandths of an inch), wherein a distal end of the flat ribbon has a feature (top external flat surface, shown in Figure 2A) that facilitates a mechanical joint during a weld, the top external flat surface is interpreted as protruding or cut-out feature, because it is made by cutting out a portion of the shaft 102 and it protrudes outwardly.
Zhou fails to disclose the liner has an outer surface coated with a compound suitable for bonding, and the coil is a helical foil, a sheath.
Howat et al., from the same field of endeavor teaches a similar catheter as shown in Figure 2, where the liner has an outer surface coated with a compound suitable for bonding, for the purpose of adding an inner jacket on the liner. See paragraph [0032].
Howat et al. also discloses a similar coil, used for the same purpose of reinforcing the catheter, where the coil is the form of a helical coil. See claim 19
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the catheter disclosed by Zhou to include the coating taught by Howat et al. on the outer surface of the liner, in order to add an inner jacket over the liner.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the catheter disclosed by Zhou by substituting the coil disclosed by Zhou for the helical coil taught by Howat et al. because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Bose, from the same field of endeavor teaches a similar catheter as shown Fig. 2A, wherein the outer jacket is formed from a plurality of tubular segments, and a distal one of the tubular segments has a durometer of no more than about 35D; see claim 12; proximal one of the tubular segments has a durometer of at least about 60D; see paragraph [0020]; wherein the outer jacket is formed from at least five discrete tubular segments; wherein a difference in durometer between a proximal one of the tubular segments and a distal one of the tubular segments is at least about 20D; wherein the difference is at least about 30D; where the outer jacket is form by at least five discrete segments.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the catheter disclosed by Zhou by substituting the outer jacket disclosed by Zhou for the outer jacket disclosed by Bose, such that the outer jacket surrounding the reinforcement structure is formed of a plurality of tubular segments, an outer jacket layer tubular segment of the plurality of tubular segments over the jacket creates an outer diameter sized larger than an outer diameter of the distal end region of the distal luminal portion, the outer jacket is formed from a plurality of tubular segments positioned coaxially about the helical coil, wherein a proximal one of the plurality of tubular segments has a durometer of at least about 60D and a distal one of the plurality of tubular segments has a durometer of no more than about 35D, wherein the outer jacket is formed from at least five discrete tubular segments, wherein a difference in durometer between a proximal one of the tubular segments and a distal one of the tubular segments is at least about 20D, wherein the difference is at least about 30D, where the outer jacket is form by at least five discrete segments, because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
To be clear, the Office interprets Zhou in view of Bose as teaching an outer jacket layer tubular segment of the plurality of tubular segments over the junction creates an outer diameter sized larger than an outer diameter of the distal end region of the distal luminal portion because Bose teaches the diameter of the tubular segments are tapered toward the distal end of the outer jacket. Since the junction is at the proximal end of the outer jacket, it follows that an outer jacket layer tubular segment of the plurality of tubular segments over the junction creates an outer diameter sized larger than an outer diameter of the distal end region of the distal luminal portion.
Schultz, from the same the same field of endeavor teaches a similar system as shown in Figure 1, where the system includes a sheath (sheath 12, see paragraph [0021]) and a catheter where the outer diameter of the catheter is sized to form a seal with the sheath through which the catheter extends.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Zhou to include the sheath taught by Schultz in order to guide the catheter to its intended to location within the body.
So modified, the Office interprets Zhou in view of Howat and Schultz as disclosing a system with a sheath and a neurvascular catheter with an outer diameter sized to form a seal with the sheath through which the catheter extends for aspiration thrombectomy.
Regarding claim 40, Zhou discloses wherein the distal luminal portion and the flat ribbon are joined by a weld bond, a mechanical bond, or an adhesive bond. See paragraph [0027].
Regarding claims 43-47 Zhou discloses wherein the distal luminal portion has a transition section (generally indicated as A) near where the distal luminal portion couples to the elongate control element, wherein the transition section has an angled cut, wherein the proximal opening is formed within the transition section and the proximal end region of the distal luminal portion is coupled to the distal end region of the control element adjacent the transition section, wherein a proximal end of the distal luminal portion is angled in an oblique manner relative to a longitudinal axis of the catheter, wherein the proximal end and the proximal opening into the lumen are at an angle other than 90 degrees to the longitudinal axis of the catheter.
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Regarding claim 50, Zhou discloses wherein the tubular liner comprises polytetrafluoroethylene. See paragraphs [0029], [0039].
Regarding claims 51, 52, Zhou discloses wherein the helical coil comprises a shape memory material, wherein the helical coil comprises Nitinol. See paragraphs [0029], [0039].
Regarding claim 60, Zhou fails to disclose wherein a distal end of the tubular segment is angled in an oblique manner relative to the longitudinal axis.
It would have been obvious to one of ordinary skill in the art, before effective filing date of the claimed invention to modify the catheter disclosed by Zho such a distal end of the tubular segment is angled in an oblique manner relative to the longitudinal axis as a matter of engineering design choice.
Applicant has not disclosed the angle the distal end is relative to the longitudinal axis provides an advantage, is used fora particular purpose, or solves a stated problem. See paragraph [00270] of the spec. One of ordinary skill in the art, furthermore, would have expected Zho’s distal luminal portion, and applicant's invention, to perform equally well regardless of its size because both shapes would perform the same function of providing a lumen within the body equally well considering the relative dimensions and materials disclosed.
Regarding claim 61, Zhou discloses the flat ribbon has a rectangular cross-sectional dimension that is wider than it is thick. See paragraph [0025] and Figure 2A.
Regrading claim 62, Zho fails to disclose wherein a maximum cross-sectional dimension of the flat ribbon is 0.025″.
It would have been obvious to one of ordinary skill in the art, before effective filing date of the claimed invention to modify the catheter disclosed by Zho such that the flat ribbon has a rectangular cross-sectional dimension that is wider than it is thick or wherein a maximum cross-sectional dimension of the flat ribbon is 0.025" as a matter of engineering design choice.
Applicant has not disclosed that shape of the control device provides an advantage, is used fora particular purpose, or solves a stated problem. See paragraph [0012] of the spec. One of ordinary skill in the art, furthermore, would have expected Zho’s shaft, and applicant's invention, to perform equally well regardless of its size because both shapes would perform the same function of advancing the catheter equally well considering the relative dimensions and materials disclosed.
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0081243 (Zhou) in view of U.S. Patent Publication Number 2010/0057051 (Howat et al.), U.S. Patent Publication Number 2009/0030400 (Bose), U.S. Patent Publication Number 2011/0092910 (Schultz) as applied to claim 37 above, and further in view of U.S. Patent Number 5,682,894 (Orr et al.)
Regarding claim 42, Zhou fails to disclose wherein a region of overlap between a distal end of the ribbon and the proximal end region of the distal luminal portion is at least about 1 cm.
Orr et al., from a related field of endeavor teaches a similar overlap region which is attached in the same manner as described in Zhou (welding), where the region of overlap is at least about 1 cm for the purpose of for forming a proper weld. See col. 3, lines 29-60
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the region of overlap between a distal end of the ribbon and the proximal end region of the distal luminal portion disclosed by Zhou by substituting the length of the region of overlap between a distal end of the ribbon and the proximal end region of the distal luminal portion disclosed by Zhou for the length of the overlap region taught by Orr et al. in order to ensure enough space for a proper weld or because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0081243 (Zhou) in view of U.S. Patent Publication Number 2010/0057051 (Howat et al.), U.S. Patent Publication Number 2009/0030400 (Bose), U.S. Patent Publication Number 2011/0092910 (Schultz) as applied to claim 37 above, and further in view of U.S. Patent Publication Number 2009/0124956 (Swetlin et al.)
Regarding claim 57, Zhou fails to disclose wherein the distal luminal portion is non-expandable.
Swetlin, from the same filed of endeavor teaches a similar system as shown in Figure 12, which includes a tubular segment (segment of 58) which is non-expandable. See paragraph [0160]
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Zhou by substituting the material of the outer jacket disclosed by Zhou for the non-expandable material disclosed by Swetlin because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over U U.S. Patent Publication Number 2014/0081243 (Zhou) in view of U.S. Patent Publication Number 2010/0057051 (Howat et al.), U.S. Patent Publication Number 2009/0030400 (Bose), U.S. Patent Publication Number 2011/0092910 (Schultz) as applied to claim 37 above, and further in view of U.S. Patent Publication Number 2009/0163891 (Ewing)
Regarding claim 58, Zhou fails to disclose a proximal end of the elongate flexible control element is coupled to a tab.
Ewing, from the same field of endeavor teaches a similar catheter as shown in Figure 2, where disclose a proximal end of the elongate flexible control element is coupled to a tab (tab 175, see paragraph [0032]) for the purpose of facilitating manipulation of the elongate flexible control element.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the catheter disclosed by Zhou to include the tab taught by Ewing a proximal end of the elongate flexible control element in order to facilitate manipulation of the elongate flexible control element.
Claim(s) 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0081243 (Zhou) in view of U.S. Patent Publication Number 2010/0057051 (Howat et al.), U.S. Patent Publication Number 2009/0030400 (Bose), U.S. Patent Publication Number 2011/0092910 (Schultz) as applied to claim 37 above, and further in view of U.S. Patent Publication Number 2007/0260219 (Root et al.)
Regarding claim 59, Zhou fails to disclose a reversible coupling feature on the control element for organizing the control element of the neurovascular catheter and a component used with the catheter engaged by the reversible coupling feature.
Root et al., from the same field of endeavor teaches a similar catheter as shown in Figure 1, a reversible coupling feature (clip or snap attachment 54, see paragraph [0064) on the control element capable of organizing the control element of the neurovascular catheter and a component (inner catheter 14, see paragraph [0064]) used with the catheter engaged by the reversible coupling feature.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the catheter disclosed by Zhou to include the clip or snap attachment 54 taught by Root et al. on the control element capable of organizing the control element of the neurovascular catheter and a component used with the catheter engaged by the reversible coupling feature, for the purpose of configuring the catheter to reversibly couple to an inner catheter.
Claim(s) 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0081243 (Zhou) in view of U.S. Patent Publication Number 2010/0057051 (Howat et al.), U.S. Patent Publication Number 2009/0030400 (Bose), U.S. Patent Publication Number 2011/0092910 (Schultz) as applied to claim 37 above, and further in view of U.S. Patent Number 9,241,699 (Kume et al.)
Regarding claim 67, Zhou fails to disclose the neurovascular catheter has a length that when inserted through a sheath positioned at a transfemoral access site so a distal end region of the catheter is located within a middle cerebral artery the proximal end region of the distal luminal portion remains outside the aortic arch.
Kume et al., from the same filed of endeavor teaches a similar catheter as shown in Figure 4, where the neurovascular catheter has a length that when inserted through a sheath positioned at a transfemoral access site so a distal end region of the catheter is located within a middle cerebral artery the proximal end region of the distal luminal portion remains outside the aortic arch, for the purpose of performing a treatment within a middle cerebral artery. See col. 5, lines 23-31, col. 6, lines 13-33 and col. 7, lines 9-31.
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the catheter disclosed by Zhou by substituting the length of the catheter disclosed by Zhou for the length taught by Kume, such that when inserted through a sheath positioned at a transfemoral access site so a distal end region of the catheter is located within a middle cerebral artery the proximal end region of the distal luminal portion remains outside the aortic arch, in order to perform a treatment within a middle cerebral artery or because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Response to Arguments
Applicant’s arguments, see pages 9-15 filed 01/13/2026, with respect to the rejection of the claims Zhou in view of Bose have been considered, but are no persuasive.
Applicant argues Zhou fails to disclose an elongate control element that has a distal portion in the form of a flat ribbon with an external feature to facilitate a junction. In response, the Office respectfully disagrees. Zhou discloses region 108 as a flattened form, but in other embodiments this area may take any desired cross-sectional shape, such as cylindrical, circular, rhombic, rectangular, oval, semicircular, which one of ordinary skill in the art would recognize as a flat ribbon. See paragraph [0025]. Further, the top external flat surface meets the literal definition of one or more features capable of facilitating a junction as recited in claims.
The applicant argues region 108 cannot be the flat ribbon and the claimed feature, but this ignores that rejection specified the feature was a particular surface of the flat ribbon and the claim recites the feature is a part of the distal portion.
The applicant further argues Bose teaches away from modeling the design of neurovascular guide catheters after cardiovascular guide catheters in paragraphs [0004]-[0005]. In response, the Office respectfully disagrees. Paragraph [0004] specifically discloses neurovascular guide catheters are modeled after cardiovascular guide catheters. It is unclear to the Office how acknowledging the similarity between neurovascular guide catheters and cardiovascular guide catheters constitutes a teaching away from one to the other.
The Federal Circuit's discussion in ICON also makes clear that if the reference does not teach that a combination is undesirable, then it cannot be said to teach away. See In re ICON Health & Fitness, Inc., 496 F.3d 1374,1382 (Fed. Cir. 2007).
The applicant argues that substituting the outer jacket disclosed by Zhou for the one disclosed by Bose would not produce predictable results because Bose uses differences in outer jacket segment wall thicknesses to provide a flexibility gradient and Zhou uses welded points in the reinforcement layer of the extension catheter.
In response, the Office respectfully disagrees differences in outer jacket segment wall thicknesses would not prevent the use of welded points in the reinforcement layer taught by Zhou. Zhou describes its out jacket 120 as made of a suitable biocompatible material in paragraph [0029]. It in no way excludes the outer jacket taught by Bose. In fact, Zhou excludes a limiting interpretation of the disclosure in paragraph [0040], [0041] of its specification.
The applicant further argues the Office has failed to provide a teaching or suggestion of desirability for an outer jacket as taught by Bose to have a larger proximal outer diameter. In response, the office will note, this is not the standard the Office used for obviousness. The position of the Office was that it was obvious to make the modification because it was the substitution of one known alternative configuration for another to produce nothing but predictable results.
The applicant argues modifying Zhou in view of Bose is non-obvious because Zhou solves the problem of flexibility gradient by welding points of the braid, so using the different diameters of Bose is unnecessary. In response, the Office respectfully disagrees. The Office’s combination does not eliminate the use of the braid. The Office’s proposed combination is a substitution of the physical material of the outer jacket taught by Zhou for the physical material of the outer jacket taught by Bose, and then welding the braid as normal. Thus, applicant’s suggestion that the Office’s position eliminates a function is incorrect. If anything, the Office’s proposed combination augments the function of flexibility gradient already recognized as beneficial.
"Although statements limiting the function or capability of a prior art device require fair consideration, simplicity of the prior art is rarely a characteristic that weighs against obviousness of a more complicated device with added function." In re Dance, 160 F.3d 1339, 1344, 48 USPQ2d 1635, 1638 (Fed. Cir. 1998).
In this case having an outer jacket with a flexibility gradient provided by the thickness of the material and welding points of braid is clearly an added function.
The applicant notes the claimed function of the outer jacket (forming a seal) is different from the reference’s reason for the structure (creating stiffness).
Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. See In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979).
In this case, forming a seal as the applicant describes is clearly a latent property of outer jackets already recognized in their field of art for providing flexibility gradients.
The applicant then argues it is not obvious to use the outer jacket of Bose which is intended to provide a flexibility gradient for the outer jacket of Zhou which achieve the flexibility gradient in a different manner. In response, the Office respectfully disagrees. The Office’s position does not eliminate the braid from Zhou. Second, the Office’s position is that substituting the outer jackets would be obvious because it would require the substitution of one known alternative configuration for another to produce nothing but predictable results. It is the position of the Office that functions of the outer jackets are to cover the inner lines of surgical catheters within the lumens of the body. Both Zhou and Bose disclose this. Substituting one for the other would produce nothing but the predictable result of covering the inner liner of catheter. Nothing in the applicant’s remarks disputes this. Accordingly, the applicant’s remarks cannot be considered persuasive for this reason alone.
Third, Zhou disclose the use of the braid to provide a flexibility gradient of the braid, not the catheter itself. See paragraph [0030]. Thus, using the outer jacket to provide a flexibility gradient for the material of the outer jacket itself is not duplicative of the function of welds disclosed by Zhou. Fourth, Zhou disclose the use of the braid to provide a flexibility as optional and nonexclusive. See paragraph [0030]. Using both the welds of the braid and the material of the outer jacket to provide overall flexibility to the catheter would be an added functional complementary.
"Although statements limiting the function or capability of a prior art device require fair consideration, simplicity of the prior art is rarely a characteristic that weighs against obviousness of a more complicated device with added function." In re Dance, 160 F.3d 1339, 1344, 48 USPQ2d 1635, 1638 (Fed. Cir. 1998).
The applicant further argues the office is using hindsight to reject the claims. In response, the Office respectfully disagrees. Applicants may argue that the examiner’s conclusion of obviousness is based on improper hindsight reasoning. However, "[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper." see In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). "
Nowhere in the rejection does the Office rely on rationale gleaned from the applicant’s specification.
The applicant then argues the Office’s combination is not obvious because it would require a substantial reconstruction and redesign of the elements shown.
In response, the Office respectfully disagrees. The applicant does not identify what elements beyond substituting a single element for another single element would be required. It is the position of the Office that is not a substantial reconstruction and redesign. As explained above, Zho describe outer jacket as made of biocompatible material and has excluded a limiting interpretation of the embodiment. There is nothing in Zhou to suggest substituting the outer jacket disclosed by Zhou for the one disclosed by Bose would produce anything but the predictable result of covering the inner liner of the catheter.
Applicant’s request to hold the double patenting rejections in abeyance is acknowledged, but rejected. Only matters of form are allowed to be held in abeyance. See 37 C.F.R. 1.111. Issues of double patenting are not matters of form and cannot be held in abeyance.
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 extension fee 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 date of this final action.
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/RICHARD G LOUIS/ Primary Examiner, Art Unit 3771
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