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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/04/2025 has been entered.
Response to Amendment
The amendments filed on 06/04/2025 has been entered. Claims 1 and 7 have been amended. Accordingly, claims 1-12 are pending and under consideration.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-12 have been considered but are moot because the new ground of rejection does not rely on the same claim rejection mappings applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In light of further search and consideration, claims 1 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Braun et al. US 2012/0022572 A1, as cited in the IDS.
Claim Interpretation
Regarding claim 1 and claim 7, the limitation of “ a lumen through which blood may flow” is currently interpreted that blood may or may not flow through the lumen. Therefore, for examining purposes, any lumen through which blood may or may not will read on the limitation.
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 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the catheter" in line 10. There is insufficient antecedent basis for this limitation in the claim. For examining purposes, Examiner currently interprets that “the catheter” as “the catheter tube” as previously recited in the preceding paragraphs.
Accordingly, claims 2-6 are rejected as being dependent upon claim 1.
Claim 7 recites the limitation "the catheter" in line 11. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether Applicant refers to the “catheter system” or “catheter tube”. For examining purposes, Examiner currently interprets that “the catheter” as “the catheter tube” as previously recited in the preceding paragraphs.
Accordingly, claims 8-12 are rejected as being dependent upon claim 7.
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.
Claims 1, 2, 3, 6, 7, 8, 9, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Braun et al. US 2012/0022572 A1 (newly cited), as cited in the IDS.
Regarding claim 1, Braun discloses a stylet 1600 (Fig. 17 – pusher 1600) configured to be slidably inserted into an elastically-deformable catheter tube 1706 (Fig. 17 – catheter shaft 1706, Par. 147 – “the outer pusher tube 1606 slides axially within the catheter hub 1702”, and Par. 148 – “The catheter 1700 comprises the proximal expandable mesh 1820,… a distal expandable mesh 1822”) to expand an axial length of the catheter tube 1706 while decreasing an outer diameter of the catheter tube 1706 (Fig. 18A, and Par. 149 – “This distal force on the plug 1812 can cause the proximal length change region 1836 to become longer forcing the proximal expandable mesh 1820 to collapse diametrically, radially, or in cross-sectional area”),
wherein the catheter tube 1706 (Fig. 17) has an expandable expansion portion 1822 (Fig. 18A – distal expandable mesh 1822), a shaft portion 1814 (Fig. 18A – tapered region 1814) provided at a proximal end of the expansion portion 1822 (Fig. 18A – tapered region 1814 is proximal to the distal expandable mesh 1822), a distal tip 1832 (Fig. 19A – distal tip 1832), and a lumen 1816 (Fig. 18A – central plug lumen 1816) through which blood may flow, the stylet 1600 (Fig. 17) comprising:
an outer peripheral member 1606 (Fig. 16 – outer pusher tube 1606) extending in an axial direction (Fig. 16 – outer pusher tube 1606 has a length) having an outer periphery (Fig. 18A – pusher tube 1606 has an exterior surface) conformable to an inner periphery of the shaft portion 1814 (Fig. 18A – the exterior surface of outer pusher tube 1606 fits to the inner lumen of tapered region 1814), and having an inner passage 1624 (Fig. 16 – hollow central lumen 1624, and Par. 143 – “The outer pusher tube 1606 comprises a hollow central lumen 1624”) defined by an inner periphery of the outer peripheral member 1606 (Fig. 16 – the interior surface of outer pusher tube 1606 forms the lumen 1624), wherein the outer peripheral member 1606 (Fig. 18A) has an outer diameter the same as an inner diameter of the shaft portion 1814 (Fig. 18A) of the catheter 1606 (Fig. 18A);
an inner peripheral member 1608 (Fig. 16 – inner pusher tube 1608) received in the inner passage 1624 (Fig. 16) and provided with an exposed portion (see annotated Fig. 16 below) extending from a distal end of the outer peripheral member 1606 (see annotated Fig. 16 below – the annotated exposed portion of inner pusher tube 1608 extends from the distal end of the outer pusher tube 1606), wherein the inner peripheral member 1608 (Fig. 16) is slidable with respect to the outer peripheral member 1606 (Fig. 16, and Par. 143 – “The outer pusher tube 1606 comprises a hollow central lumen 1624 through which the inner pusher tube 1608 slidably moves”), wherein the inner peripheral member 1608 (Fig. 16) has an end surface (see annotated Fig. 18B below) adapted to press the distal tip 1832 (see annotated Fig. 18B below, and Par. 150 – “a distal tip 1832 further comprising a distal coil 1842, and a distal plug 1830”, wherein said annotated end surface is pressing against the plug 1830 and coil 1842 of distal tip 1832) of the catheter 1706 (Fig. 18B) to extend the expansion portion 1822 (Fig. 18B, and Par. 151 – “…the distal expandable mesh 1822 is affixed to the exterior of the distal tip 1832. The distal plug 1830 is affixed to the interior of the distal tip 1832. Thus, when the inner pusher tube 1608 is advanced distally thereagainst, the plug 1830 can be forcibly advanced distally by the inner pusher tube 1608. This forceable advancement of the distal end of the distal bond 1826 lengthens the length changeable region 1834 causing the distal expandable region 1822 to collapse radially or diametrically”), and wherein the inner peripheral member 1608 (Fig. 18B) has a lumen 1622 (Fig. 16 – hollow central lumen 1622) adapted to receive a guidewire 1610 (Fig. 16 – guidewire 1610, and Par. 151 – “The inner lumen of the inner pusher tube 1608 comprises the guidewire 1610 slidably disposed therein”);
a fitting member 1602 (Fig. 16 – first hub 1602) joined to an outer periphery of the outer peripheral member 1606 (Fig. 16) at a proximal end of the outer peripheral member 1606 (Fig. 16 – hub 1602 is joined on the exterior surface of the outer pusher tube 1606 and at the proximal end of outer pusher tube 1606); and
a fitting stopper 1614 (Fig. 16 – hub 1614) which is grippable (Examiner notes that the hub 1614 can be held/gripped by an operator) and fixed at a proximal end of the inner peripheral member 1608 (Fig. 16 – hub 1614 is joined at the proximal end of inner pusher tube 1608) and defining an inner region (see annotated Fig. 16 below) between a fitted portion 1616 (Fig. 16 – hub locking adapter 1616) and a hub 1616 (Fig. 16), in which the outer peripheral member 1606 (Fig. 16) and the fitting member 1602 (Fig. 16) are movable over a length in the axial direction corresponding to an extension length of the expansion portion 1822 (Par. 144 – “The outer pusher tube 1606 can be bonded, welded, insert molded, pinned, or otherwise affixed to the first hub 1602 such that axial movement of the first second hub 1614 relative to the first hub 1602 results in the inner pusher 1608 to move axially relative to the outer pusher tube 1606”, and Par. 149 – “The inner pusher tube 1608 can slide freely within the outer pusher tube 1606 thus allowing independent control of the expansion of… the distal expandable mesh 1822”),
wherein the fitting member 1602 (Fig. 16) moves between positions which abut the fitted portion 1616 and the hub 1614 (Fig. 16, and Par. 144 – “The first hub locking adapter 1604 is integral, or affixed, to the first hub 1602”);
wherein the outer periphery of the outer peripheral member 1606 (Fig. 18A) is adapted to prevent inward contraction of the shaft portion 1814 (Fig. 18a) of the catheter 1706 (Fig. 17 and Fig. 18A – the exterior surface of outer pusher tube 1606 fits to the inner lumen of tapered region 1814, thus preventing inward contraction) when the inner peripheral member 1608 (Fig. 18B) presses the distal tip 1832 (see annotated Fig. 18B below) of the catheter 1706 (Fig. 17 and Fig. 18B) to extend the expansion portion 1822 (Fig. 18B).
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Annotated Fig. 6 of Braun
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Annotated Fig. 18B of Braun
Regarding claim 7, Braun discloses a catheter system 1700 (Fig. 17 – catheter 1700) configured to be inserted into a living body to convey blood (Par. 10), comprising:
an elastically-deformable catheter tube 1706 (Fig. 17 – catheter shaft 1706, and Par. 148 – “The catheter 1700 comprises the proximal expandable mesh 1820,… a distal expandable mesh 1822”) having an expandable expansion portion 1822 (Fig. 18A – distal expandable mesh 1822), a shaft portion 1814 (Fig. 18A – tapered region 1814) provided at a proximal end of the expansion portion 1822 (Fig. 18A – tapered region 1814 is proximal to the distal expandable mesh 1822), a distal tip 1832 (Fig. 19A – distal tip 1832), and a lumen 1816 (Fig. 18A – central plug lumen 1816) through which the blood may flow; and
a stylet 1600 (Fig. 17 – pusher 1600) slidably inserted into the catheter tube 1706 (Fig. 17 – catheter shaft 1706, Par. 147 – “the outer pusher tube 1606 slides axially within the catheter hub 1702”, and Par. 148 – “The catheter 1700 comprises the proximal expandable mesh 1820,… a distal expandable mesh 1822”), wherein the stylet 1600 (Fig. 17) comprises:
an outer peripheral member 1606 (Fig. 16 – outer pusher tube 1606) extending in an axial direction (Fig. 16 – outer pusher tube 1606 has a length) having an outer periphery (Fig. 18A – pusher tube 1606 has an exterior surface) conformable to an inner periphery of the shaft portion 1814 (Fig. 18A – the exterior surface of outer pusher tube 1606 fits to the inner lumen of tapered region 1814) and having an inner passage 1624 (Fig. 16 – hollow central lumen 1624, and Par. 143 – “The outer pusher tube 1606 comprises a hollow central lumen 1624”) defined by an inner periphery of the outer peripheral member 1606 (Fig. 16 – the interior surface of outer pusher tube 1606 forms the lumen 1624), wherein the outer peripheral member 1606 (Fig. 18A) has an outer diameter the same as an inner diameter of the shaft portion 1814 (Fig. 18A) of the catheter 1606 (Fig. 18A - the exterior surface of outer pusher tube 1606 fits to the inner lumen of tapered region 1814);
an inner peripheral member 1608 (Fig. 16 – inner pusher tube 1608) received in the inner passage 1624 (Fig. 16) and provided with an exposed portion (see annotated Fig. 16 above) extending from a distal end of the outer peripheral member 1606 (see annotated Fig. 16 above – the annotated exposed portion of inner pusher tube 1608 extends from the distal end of the outer pusher tube 1606), wherein the inner peripheral member 1608 (Fig. 16) is slidable with respect to the outer peripheral member 1606 (Fig. 16, and Par. 143 – “The outer pusher tube 1606 comprises a hollow central lumen 1624 through which the inner pusher tube 1608 slidably moves”), wherein the inner peripheral member 1608 (Fig. 16) has an end surface (see annotated Fig. 18B above) adapted to press the distal tip 1832 (see annotated Fig. 18B above, and Par. 150 – “a distal tip 1832 further comprising a distal coil 1842, and a distal plug 1830”, wherein said annotated end surface is pressing against the plug 1830 and coil 1842 of distal tip 1832) of the catheter 1706 (Fig. 18B) to extend the expansion portion 1822 (Fig. 18B, and Par. 151 – “…the distal expandable mesh 1822 is affixed to the exterior of the distal tip 1832. The distal plug 1830 is affixed to the interior of the distal tip 1832. Thus, when the inner pusher tube 1608 is advanced distally thereagainst, the plug 1830 can be forcibly advanced distally by the inner pusher tube 1608. This forceable advancement of the distal end of the distal bond 1826 lengthens the length changeable region 1834 causing the distal expandable region 1822 to collapse radially or diametrically”);
a fitting member 1602 (Fig. 16 – first hub 1602) joined to an outer periphery of the outer peripheral member 1606 (Fig. 16) at a proximal end of the outer peripheral member 1606 (Fig. 16 – hub 1602 is joined on the exterior surface of the outer pusher tube 1606 and at the proximal end of outer pusher tube 1606); and
a fitting stopper 1614 (Fig. 16 – hub 1614) which is grippable (Examiner notes that the hub 1614 can be held/gripped by an operator) and fixed at a proximal end of the inner peripheral member 1608 (Fig. 16 – hub 1614 is joined at the proximal end of inner pusher tube 1608) and defining an inner region (see annotated Fig. 16 above) between a fitted portion 1616 (Fig. 16 – hub locking adapter 1616) and a hub 1616 (Fig. 16) in which the outer peripheral member 1606 (Fig. 16) and the fitting member 1602 (Fig. 16) are movable over a length in the axial direction corresponding to an extension length of the expansion portion 1822 (Par. 144 – “The outer pusher tube 1606 can be bonded, welded, insert molded, pinned, or otherwise affixed to the first hub 1602 such that axial movement of the first second hub 1614 relative to the first hub 1602 results in the inner pusher 1608 to move axially relative to the outer pusher tube 1606”, and Par. 149 – “The inner pusher tube 1608 can slide freely within the outer pusher tube 1606 thus allowing independent control of the expansion of… the distal expandable mesh 1822”), wherein the fitting member 1602 (Fig. 16) moves between positions which abut the fitted portion 1616 and the hub 1614 (Fig. 16, and Par. 144 – “The first hub locking adapter 1604 is integral, or affixed, to the first hub 1602”);
wherein the outer periphery of the outer peripheral member 1606 (Fig. 18A) is adapted to prevent inward contraction of the shaft portion 1814 (Fig. 18a) of the catheter 1706 (Fig. 17 and Fig. 18A – the exterior surface of outer pusher tube 1606 fits to the inner lumen of tapered region 1814, thus preventing inward contraction) when the inner peripheral member 1608 (Fig. 18B) presses the distal tip 1832 (see annotated Fig. 18B above) of the catheter 1706 (Fig. 17 and Fig. 18B) to extend the expansion portion 1822 (Fig. 18B).
Regarding claim 2 and claim 8, Braun discloses the invention of claim 1 and claim 7, respectively. Braun further discloses wherein a length of the exposed portion (see annotated Fig. 6 above) in the axial direction corresponds to a length of the expansion portion 1822 (Fig. 18A and Fig. 19A) before being extended (Par. 149 – “The inner pusher tube 1608…, as illustrated in FIG. 16 is centered by the outer pusher tube 1606 and can slidably extend through the central lumen 1816 of the proximal plug 1812 and on into the more distal regions of the catheter. The inner pusher tube 1608 can slide freely within the outer pusher tube 1606 thus allowing independent control of the expansion of… the distal expandable mesh 1822”, which indicates a corresponding relationship between the length of the exposed portion of the inner pusher tube 1608 and the length of mesh 1822).
Regarding claim 3 and claim 9, Braun discloses the invention of claim 1 and claim 7. Braun further discloses wherein a length in the axial direction of the region (see annotated Fig. 6 above – inner region) of the fitting stopper 1614 (Fig. 16) corresponds to a length by which the expansion portion 1822 (Fig. 18A and Fig. 19A) extends in the axial direction (Fig. 18A and Fig. 19A – inner pusher tube 1608 is advanced a distance corresponding to the expanded length of the mesh 1822) when the shaft portion 1814 (Fig. 18A) starts contracting (Given Fig. 19A of Braun and the establishment in claim 1 and claim 7 that the exterior surface of outer pusher tube 1606 fits to the shaft portion 1814, there inherently exists a contracting force by the shaft portion 1814 onto the exterior surface of the outer pusher tube 1606, while there is a corresponding pushing force by the exterior surface of the outer pusher tube 1606 onto the shaft portion 1814. Thus, the limitation is met).
Regarding claim 6 and claim 12, Braun discloses the invention of claim 1 and claim 7, respectively. Braun further discloses further comprising: a regulation member 1620 (Fig. 16 – second hub hemostasis valve 1620) joined to the outer periphery of the outer peripheral member 1606 (Fig. 16-17) and configured to be fittable into a lock connector 1704 (Fig. 17 – catheter hemostasis valve 1704, and Par. 147 – “The hemostasis valve 1704 is similar in construction to the catheter hemostasis valve 1620 of FIG. 16, but comprises a somewhat larger diameter sealing capability to accommodate the outside diameter of the outer pusher tube 1606” and “the catheter hemostasis valve 1704 can comprise a Tuohy-Borst type tightening or constricting valve that can be used to selectively lock the outer pusher tube 1606 in place, using friction, interference, or part engagement…”) of the catheter tube 1706 (Fig. 17).
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.
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.
Claims 5, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Braun.
Regarding claim 5 and claim 11, Braun discloses the invention of claim 1 and claim 7, respectively. However, Braun does not currently disclose wherein the inner peripheral member is formed of a material softer than a material of the outer peripheral member.
Braun, in another embodiment, teaches wherein the inner peripheral member is formed of a material softer (Par. 44 – “the inner member, the innermost catheter tube… can be fabricated… from polyurethane, silicone,…”) than a material of the outer peripheral member (Par. 49 – “the outer member can be constructed of composite materials having reinforced intermediate structures such as, but not limited to, perforated metal tubes, coils, braided metals or polymers, or the like”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of Braun’s inner peripheral member to be softer than that of the outer peripheral member, also as taught by Braun, since Braun teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Claims 4 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Braun in view of Edwards et al. US 2022/0184292 A1 (newly cited, hereinafter Edwards).
Regarding claim 4 and claim 10, Braun discloses the invention of claim 1 and claim 7, respectively. However, Braun does not disclose wherein a distal end part of the outer peripheral member is tapered toward the exposed portion of the inner peripheral member.
Edwards, in the same field of endeavor of dual lumen assembly in extracorporeal treatment (Par. 8), teaches wherein a distal end part 50 (Fig. 6 – tapering section 50) of the outer peripheral member 14 (Fig. 2 and Fig. 6 – second drainage tube 14) is tapered (Fig. 6) toward the exposed portion of the inner peripheral member 12 (Fig. 2 – the portion extending out of the tapering end of tube 14).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer peripheral member of Braun to be tapered toward the exposed portion of the inner peripheral member as taught by Edwards, in order to define a smooth transition with the walls of the inner peripheral member (Par. 49 of Edwards). One of ordinary skill in the art would have had the technological capability to recognize that components inserted into any bodily cavity should have minimized sharp edges, thus a smoothing effect at the joint between components can reduce tissue damage when inside a patient’s body.
Conclusion
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/QUYNH DAO LE/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781