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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/27/2026 has been entered.
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 04/27/2026. Claims 1, 16-17 and 20 are amended. Claim 18 is cancelled. Claim 21 is new. Claims 1-17 and 19-21 are currently pending.
The objection of claim 18 has been withdrawn due to applicant’s amendment.
The rejection of claim 16 under 35 U.S.C. 112(b) has been withdrawn due to applicant’s amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 10/09/2025, with respect to the rejection(s) of claim(s) 1-3, 5-14 and 18 under 35 U.S.C. 103 as being unpatentable over Maguire in view of Silvestro; claim 4 under 35 U.S.C. 103 as being unpatentable over Maguire in view of Silvestro and Chin; claims 15-16 under 35 U.S.C. 103 as being unpatentable over Maguire in view of Silvestro and Kendale; and claim 17 under 35 U.S.C. 103 as being unpatentable over Maguire in view of Silvestro and Scott; claim 19 under 35 U.S.C. 103 as being unpatentable over Maguire in view of Silvestro and Lutz; and claim 20 under 35 U.S.C. 103 as being unpatentable over Maguire in view of Kendale, Silvestro and Lutz, have been fully considered but are not persuasive. The rejection has been modified, necessitated by applicant’s amendments to the claims.
1) Applicant argues the combination does not teach the first and second lumens extending through the end section member of the needle (Remarks, pg. 7).
In response to applicant’s first argument, it is respectfully submitted the arguments are narrower than the claim limitations. The argument appears to be referring to tip 202 of Scott being closed and not having a lumen, however, Scott is not relied on in the combination, therefore applicant’s argument is moot. Further, Maguire discloses cannula 105 being open at the distal end, such that the combination is considered to further teach the claimed flexibility of the distal end of the cannula 105, with first and second lumens extending through the cannula 105 including the distal end as claimed.
2) Applicant further argues one of ordinary skill in the art would not be inspired to modify cannula 105 of Maguire to include the claimed stylet lumen and guidewire lumen in a monolithic body (Remarks, pg. 8).
In response to applicant’s second argument, it is respectfully submitted the arguments are narrower than the claim limitations. Silvestro is relied on to teach distinct lumens for the guidewire and stylet. Silvestro is not relied upon for teaching the monolithic needle shaft. Maguire already teaches a monolithic needle shaft comprising a lumen. Therefore, the combination is considered to further teach the monolithic needle shaft of Maguire comprising two distinct lumens, such that the needle shaft constitutes a single unit with two lumens as claimed.
3) Applicant further argues insert 166 of Kendale cannot be used to stabilize tubes of Silvestro because insert of Kendale is an extrusion (Remarks, pgs. 8-9).
In response to applicant’s third argument, it is respectfully submitted a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements (MPEP 2145(III)). As discussed in the rejection below, the combination of Kendale and Silvestro with Maguire is considered to teach the stylet lumen and guidewire lumen of cannula 105 of Maguire distinct from each other and formed by tubes within an insert. The insert functions to fill space between the tubes and is therefore considered to stabilize the tubes in Maguire (as modified), such that the claimed limitation is considered to be met.
Applicant’s argument with respect to claim 21 has been fully considered, and new claim 21 is rejected as discussed below.
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.
Claim 13 is 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.
Regarding claim 13, the claim recites “wherein the needle has a shaft”. It is unclear whether the phrase is referring to the shaft of the needle previously introduced, or introducing a new, separate shaft. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the shaft of the needle previously introduced.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3 and 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire (US 2016/0361088 A1) (previously of record) in view of Silvestro (US 2015/0032141 A1) (previously of record) and Lampropoulos (US 2014/0171826 A1).
Regarding claim 1, Maguire discloses (see abstract; paras. [0049]-[0155]; figs. 1-19) an access kit (para. [0050]) for creating a transjugular intrahepatic portosystemic shunt (“TIPS”) shunt (accesses a body lumen and therefore considered to be configured for use such as creating a TIPS shunt, further note this limitation recites intended use and does not result in a structural difference between Maguire and the claimed invention, para. [0005]), comprising:
a needle (105, para. [0049]) having sufficient flexibility for advancing the needle through a patient's vasculature and sufficient rigidity for puncturing stiff, diseased liver tissue (cannula 105 considered to be sufficiently flexible and rigid as claimed, since cannula 105 may be dimensioned to advance through a working channel of an endoscope and has a level of flexibility via apertures 190, and is configured to access a body lumen by piercing a luminal wall, paras. [0052]-[0057]), the needle comprising:
an end section member (sharpened distal end of cannula 105, para. [0055]) arranged at a distalmost end of the needle (fig. 2a);
a first lumen (110, para. [0052]) extending longitudinally through the needle (fig. 1); and
a first longitudinal end including a needle tip (distal end of 105, which may be sharpened for piercing tissue, para. [0055]) for puncturing the stiff, diseased liver tissue (configured to pierce tissue such as the wall of a body lumen, therefore considered to be capable of puncturing tissue such as a diseased liver, para. [0055]) and a second longitudinal end (proximal end) arranged for manipulation by a user (para. [0061]); and
one or more stylets (135, para. [0049]) suitable for being advanced through the first lumen (para. [0050]),
wherein the needle and the one or more stylets are arranged so that, as one of the one or more stylets is advanced through the first lumen, the curvature of the needle changes (para. [0056]; figs. 2a-c).
However, Maguire fails to disclose the end section member made of a lower flexibility material than a shaft of the needle proximal to the end section member; the needle comprising a second lumen extending longitudinally through the needle, the first lumen and the second lumen extending longitudinally through the end section member at the distalmost end of the needle.
Lampropoulos teaches (paras. [0113]-[0114]; figs. 24-25), in the analogous art of the claimed invention, a needle (170) comprising an end section member (172, para. [0108]) made of a lower flexibility material than a shaft of the needle proximal to the end section member (distal tip is distal of flexible segment, considered to have a lower flexibility than flexible segment in shaft of 170, further note para. [0113] describes the flexible segment being more flexible than a portion of the instrument disposed distally of the flexible segment), for the purpose of providing distinct sections for traversing a curved bend or path that do not interfere with operative segments configured to isolate, sever, or contain tissue samples (para. [0111]).
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 sharpened portion of the cannula of Maguire to have lower flexibility than the portion of the cannula including apertures 190, in order to provide distinct sections for traversing a curved bend or path that do not interfere with operative segments configured to sever or pierce tissue, based on the teachings of Lampropoulos (para. [0111]).
Maguire (as modified) still fails to teach the needle comprising a second lumen extending longitudinally through the needle, the first lumen and the second lumen extending longitudinally through the end section member at the distalmost end of the needle.
Silvestro teaches (para. [0054]; fig. 5), in the analogous art of the claimed invention, an occlusion apparatus which enters a vessel in tissue (abstract) comprising an apparatus (500) comprising a first lumen (through lumen) and a second lumen (separate guidewire lumen) extending longitudinally through the apparatus (considered to extend longitudinally), in place of the through lumen accommodating the guidewire in a single lumen (para. [0054]).
The substitution of one known element (a distinct separate lumen for the guidewire) for another (a single lumen for introduction of both the stylet and the guidewire, para. [0054] of Silvestro, para. [0050] of Maguire) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the separate guidewire lumen as taught by Silvestro, would have yielded predictable results, specifically, introduction of the guidewire through a separate lumen, which would not require removal of the stylet in order to introduce the guidewire.
Maguire (as modified) further teaches the first lumen and the second lumen extending longitudinally through the end section member at the distalmost end of the needle (combination considered to further teach first and second lumens of cannula 105 of Maguire extending through sharpened distal end of Maguire, similarly to the lumen disclosed in Maguire, fig. 2a of Maguire).
Regarding claim 2, Maguire (as modified) teaches the access kit according to claim 1. Maguire further discloses wherein the needle is bent in an unconstrained state (fig. 2b), and wherein the curvature of the needle reduces as one of the one or more stylets is advanced through the first lumen (depicted in fig. 2a, cannula 105 straightens such that curvature is reduced).
Regarding claim 3, Maguire (as modified) teaches the access kit according to claim 2. Maguire further discloses wherein the needle has an angle of deflection in the range of from 20° to 50° in the unconstrained state (angle may be 45 degrees, para. [0071]).
Regarding claim 5, Maguire (as modified) teaches the access kit according to claim 1. Maguire further discloses wherein the needle changes its angle of deflection by at least 2° as at least one of the one or more stylets is advanced through the first lumen (assumes linear configuration which is 0 degrees, therefore changing the angle by at least 2 degrees, para. [0071]; figs. 2a-b).
Regarding claim 6, Maguire (as modified) teaches the access kit according to claim 1. Maguire further discloses wherein, as one of the one or more stylets is advanced through the first lumen, the curvature of the needle changes in a region adjacent to the first longitudinal end (changes at the distal end as depicted in figs. 2a-c), and wherein the region adjacent to the first longitudinal end is defined to be within 20% of the length of the needle from the first longitudinal end (length of distal section 130 ranges from approximately 0.20-1 inches, which falls within the claimed range since cannula 105 is disclosed to have a length of approximately 70 inches, paras. [0053] and [0088]).
Regarding claim 7, Maguire (as modified) teaches the access kit according to claim 1. Maguire further discloses wherein the first lumen ends at the first longitudinal end of the needle (120, para. [0052]).
Regarding claim 8, Maguire (as modified) teaches the access kit according to claim 1. Maguire further discloses wherein the first lumen ends at the second longitudinal end of the needle (115, para. [0052]).
Regarding claim 9, Maguire (as modified) teaches the access kit according to claim 1. Maguire further discloses further comprising a handle (170, para. [0050]; fig. 1) arranged at the second longitudinal end of the needle (figs. 1 and 13), wherein the handle is arranged for allowing the introduction of one of the one or more stylets into the first lumen (para. [0050]).
Regarding claim 10, Maguire (as modified) teaches the access kit according to claim 1. Maguire (as modified) further teaches further comprising a guidewire (155, para. [0050]) that can be advanced through the second lumen (combination considered to further teach the guidewire 155 advanced through the separate guidewire lumen, para. [0054] of Silvestro).
Regarding claim 11, Maguire (as modified) teaches the access kit according to claim 10. Maguire further discloses further comprising a handle (170, para. [0050]; fig. 1) arranged at the second longitudinal end of the needle (figs. 1 and 13), wherein the handle is arranged for allowing the introduction of one of the one or more stylets into the first lumen (para. [0050]), and wherein the handle is arranged for allowing the introduction of the guidewire into the second lumen (combination considered to further teach handle 170 arranged appropriately for introduction of guidewire 155 into separate guidewire lumen, para. [0054] of Silvestro).
Regarding claim 12, Maguire (as modified) teaches the access kit according to claim 1. Maguire further discloses further comprising an introducer sheath (180, para. [0050]) arranged so as to surround the needle (cannula 105 extends through sheath 180, figs. 1 and 13).
Regarding claim 13, Maguire (as modified) teaches the access kit according to claim 1. Maguire further discloses wherein the needle has a shaft (shaft of 105) arranged for puncturing diseased liver tissue (para. [0052]), and wherein the shaft is made of nitinol (para. [0054]).
Regarding claim 14, Maguire (as modified) teaches the access kit according to claim 1. Maguire further discloses wherein one or more of the one or more stylets has a length that is at least 90% of the length of the needle (depicted in fig. 1 as extending along the full length of 105, therefore encompassing the claimed range, further note 135 is extended distally past 105, para. [0062]; fig. 3).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire in view of Silvestro and Lampropoulos as applied to claim 1 above, and further in view of Chin (US 2004/0111101 A1) (previously of record).
Regarding claim 4, Maguire (as modified) teaches the access kit according to claim 1.
However, Maguire (as modified) fails to teach wherein the needle is straight in an unconstrained state, and wherein the curvature of the needle increases as one of the one or more stylets is advanced through the first lumen.
Chin teaches (para. [0041]), in the analogous art of the claimed invention, an access device (abstract) comprising a probe straight in an unconstrained state (considered to be straight prior to receiving bent stylet), and wherein the curvature of the probe increases as one or more stylets is advanced through a lumen of the probe (accepts bent stylet to impart bend in probe), in place of the probe formed with a predetermined bend and forced into a straightened-out configuration (para. [0041]).
The substitution of one known element (bent stylet) for another (straight stylet) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the bent stylet as taught by Chin, would have yielded predictable results, specifically, providing a bend to the needle when desired as opposed to a predetermined bend formed within the needle, which would take up more physical space within an access kit, and provide less flexibility with imparting specific bends to the access device dependent on the curvature of the introduced stylet.
Claim(s) 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire in view of Silvestro and Lampropoulos as applied to claim 1 above, and further in view of Kendale (US 2007/0129719 A1) (previously of record).
Regarding claim 15, Maguire (as modified) teaches the access kit according to claim 1.
Maguire further discloses the needle comprising an outer tube (105 depicted as tubular, figs. 1-4b).
However, Maguire (as modified) fails to teach the needle further comprising two inner tubes arranged inside the outer tube, wherein the two inner tubes respectively define the first and the second lumen.
Kendale teaches (paras. [0322]-[0327]; figs. 6a-e), in the analogous art of the claimed invention, a device for accessing a surgical space (abstract) comprising an instrument (10) comprising an outer tube (17, para. [0322]), the instrument further comprising two inner tubes (162 formed as independent tubes, para. [0324]) arranged inside the outer tube (para. [0324]; figs. 6a-e), wherein the two inner tubes respectively define the first and the second lumen (para. [0324]), for the purpose of forming multiple lumens with the main tube 17, allowing multiple, interchangeable inserts to change the lumen configuration when desired (paras. [0322]-[0323]).
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 arrangement of lumens in Maguire (as modified) to be formed by tubes within an insert as claimed, in order to have multiple, interchangeable inserts to change the lumen configuration when desired, based on the suggestions and teachings of Kendale (paras. [0322]-[0323]).
Regarding claim 16, Maguire (as modified) teaches the access kit according to claim 15. Maguire (as modified) further teaches wherein interstices between the outer tube and one or both inner tubes of the two inner tubes are filled with a filling material (material of insert 166, which is formed of plastic, paras. [0322]-[0324] of Kendale).
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire in view of Silvestro and Lampropoulos as applied to claim 1 above, and further in view of Scott (US 2021/0128873 A1) (previously of record).
Regarding claim 17, Maguire (as modified) teaches the access kit according to claim 1.
However, Maguire (as modified) fails to teach wherein the lower flexibility material of the end section member including the needle tip is a harder material than the shaft of the needle for puncturing the stiff, diseased liver tissue.
Scott teaches (para. [0034]; figs. 1-3), in the same field of endeavor, an access device comprising an end section member including a tip (202) made of a harder material than a shaft (para. [0034]), for the purpose of withstanding compressive forces during tip entry into tissue (para. [0034]).
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 needle tip of Maguire (as modified) to be made of a harder material than the shaft of the needle, in order to withstand compressive forces during tip entry into tissue, such as stiff, diseased liver tissue, based on the suggestions and teachings of Scott (para. [0034]).
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire in view of Silvestro and Lutz (US 2022/0105316 A1) (previously of record).
Regarding claim 19, Maguire discloses (see abstract; paras. [0049]-[0155]; figs. 1-19) an access kit (para. [0050]) for creating a transjugular intrahepatic portosystemic shunt (accesses a body lumen and therefore considered to be configured for use such as creating a TIPS shunt, further note this limitation recites intended use and does not result in a structural difference between Maguire and the claimed invention, para. [0005]), comprising:
an introducer sheath (180, para. [0050]);
a needle (105, para. [0049]) configured for insertion into the introducer sheath (cannula 105 extends through sheath 180, figs. 1 and 13), the needle including:
a monolithic needle shaft (shaft of 105, considered to constitute a single unit, para. [0054]) having sufficient flexibility for advancing the needle through a patient's vasculature and sufficient rigidity for puncturing stiff, diseased liver tissue (cannula 105 considered to be sufficiently flexible and rigid as claimed, since cannula 105 may be dimensioned to advance through a working channel of an endoscope and has a level of flexibility via apertures 190, and is configured to access a body lumen by piercing a luminal wall, paras. [0052]-[0057]);
a stylet lumen (110, para. [0052]) longitudinally extending through the needle (fig. 1); and
a needle tip (distal end of 105, which may be sharpened for piercing tissue, para. [0055]) for puncturing the stiff, diseased liver tissue (configured to pierce tissue such as the wall of a body lumen, therefore considered to be capable of puncturing tissue such as a diseased liver, para. [0055]); and
a guidewire (155, para. [0050]) configured to advance through the guidewire lumen of the needle.
However, Maguire fails to disclose a guidewire lumen longitudinally extending through the needle; a plurality of stylets differing in stiffness, each stylet configured to advance through the stylet lumen of the needle and differentially adjust a curvature of a distal end portion of the needle; the guidewire configured to advance through the guidewire lumen of the needle.
Silvestro teaches (para. [0054]; fig. 5), in the analogous art of the claimed invention, an occlusion apparatus which enters a vessel in tissue (abstract) comprising an apparatus (500) comprising a first lumen (through lumen) and a second lumen (separate guidewire lumen) extending longitudinally through the apparatus (considered to extend longitudinally), in place of the through lumen accommodating the guidewire in a single lumen (para. [0054]).
The substitution of one known element (a distinct separate lumen for the guidewire) for another (a single lumen for introduction of both the stylet and the guidewire, para. [0054] of Silvestro, para. [0050] of Maguire) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the separate guidewire lumen as taught by Silvestro, would have yielded predictable results, specifically, introduction of the guidewire through a separate lumen, which would not require removal of the stylet in order to introduce the guidewire.
Maguire (as modified) further teaches a guidewire lumen longitudinally extending through the needle; the guidewire configured to advance through the guidewire lumen of the needle (combination considered to further teach guidewire 155 advanced through the separate guidewire lumen of 105, para. [0054] of Silvestro).
Maguire (as modified) still fails to teach a plurality of stylets differing in stiffness, each stylet configured to advance through the stylet lumen of the needle and differentially adjust a curvature of a distal end portion of the needle.
Lutz teaches (para. [0096]), in the same field of endeavor, an access kit (para. [0096]) comprising a plurality of stylets differing in stiffness (vary in rigidity), each stylet configured to advance through a lumen of a cannula and differentially adjust a curvature of a distal end portion of the cannula (para. [0096]), for the purpose of customizing the curve or stiffness of the cannula based on the particular needs of the individual patient (para. [0096]).
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 kit of Maguire (as modified) to further include a plurality of stylets, in order to customize the curve or stiffness of the needle based on the particular needs of the individual patient, based on the teachings of Lutz (para. [0096]).
Claim(s) 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire in view of Kendale, Silvestro and Lutz.
Regarding claim 20, Maguire discloses (see abstract; paras. [0049]-[0155]; figs. 1-19) an access kit (para. [0050]) for creating a transjugular intrahepatic portosystemic shunt (accesses a body lumen and therefore considered to be configured for use such as creating a TIPS shunt, further note this limitation recites intended use and does not result in a structural difference between Maguire and the claimed invention, para. [0005]), comprising:
an introducer sheath (180, para. [0050]);
a needle (105, para. [0049]) configured for insertion into the introducer sheath (cannula 105 extends through sheath 180, figs. 1 and 13), the needle including:
a needle shaft (shaft of 105, para. [0054]) having sufficient flexibility for advancing the needle through a patient's vasculature and sufficient rigidity for puncturing stiff, diseased liver tissue (cannula 105 considered to be sufficiently flexible and rigid as claimed, since cannula 105 may be dimensioned to advance through a working channel of an endoscope and has a level of flexibility via apertures 190, and is configured to access a body lumen by piercing a luminal wall, paras. [0052]-[0057]), the needle shaft including:
an outer tube (outer tube of 105);
a stylet lumen (110, para. [0052]) longitudinally extending through the needle (fig. 1); and
a needle tip (distal end of 105, which may be sharpened for piercing tissue, para. [0055]) for puncturing the stiff, diseased liver tissue (configured to pierce tissue such as the wall of a body lumen, therefore considered to be capable of puncturing tissue such as a diseased liver, para. [0055]); and
a guidewire (155, para. [0050]).
However, Maguire fails to disclose the needle shaft including an outer tube, a pair of inner tubes adjacent to each other, and a filling material between the outer tube and the pair of inner tubes, thereby stabilizing the pair of inner tubes in the outer tube; the stylet lumen defined by a first inner tube of the pair of inner tubes; a guidewire lumen longitudinally extending through the needle, the guidewire lumen defined by a second inner tube of the pair of inner tubes; a plurality of stylets differing in stiffness, each stylet configured to advance through the stylet lumen of the needle and differentially adjust a curvature of a distal end portion of the needle; the guidewire configured to advance through the guidewire lumen of the needle.
Kendale teaches (paras. [0322]-[0327]; figs. 6a-e), in the analogous art of the claimed invention, a device for accessing a surgical space (abstract) comprising an instrument (10) comprising an outer tube (17, para. [0322]), a pair of inner tubes adjacent to each other (162 formed as independent tubes, para. [0324]) arranged inside the outer tube (para. [0324]; figs. 6a-e), and a filling material (material of insert 166, paras. [0322]-[0324]) between the outer tube and the pair of inner tubes (figs. 6a-e), thereby stabilizing the pair of inner tubes in the outer tube (material of insert 166 is considered to stabilize the pair of inner tubes due to the nature of placement of insert 166, e.g., forming a friction fit with main tube 17), for the purpose of forming multiple lumens with the main tube 17, allowing multiple, interchangeable inserts to change the lumen configuration when desired (paras. [0322]-[0323]).
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 arrangement of lumens in Maguire to be formed by tubes within an insert as claimed, in order to have multiple, interchangeable inserts to change the lumen configuration when desired, based on the suggestions and teachings of Kendale (paras. [0322]-[0323]).
Maguire (as modified) further teaches the stylet lumen defined by a first inner tube of the pair of inner tubes (combination considered to further teach a first inner tube of the pair of inner tubes defining the stylet lumen).
Maguire (as modified) still fails to teach a guidewire lumen longitudinally extending through the needle, the guidewire lumen defined by a second inner tube of the pair of inner tubes; a plurality of stylets differing in stiffness, each stylet configured to advance through the stylet lumen of the needle and differentially adjust a curvature of a distal end portion of the needle; the guidewire configured to advance through the guidewire lumen of the needle.
Silvestro teaches (para. [0054]; fig. 5), in the analogous art of the claimed invention, an occlusion apparatus which enters a vessel in tissue (abstract) comprising an apparatus (500) comprising a first lumen (through lumen) and a second lumen (separate guidewire lumen) extending longitudinally through the apparatus (considered to extend longitudinally), in place of the through lumen accommodating the guidewire in a single lumen (para. [0054]).
The substitution of one known element (a distinct separate lumen for the guidewire) for another (a single lumen for introduction of both the stylet and the guidewire, para. [0054] of Silvestro, para. [0050] of Maguire) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the separate guidewire lumen as taught by Silvestro, would have yielded predictable results, specifically, introduction of the guidewire through a separate lumen, which would not require removal of the stylet in order to introduce the guidewire.
Maguire (as modified) further teaches the guidewire lumen defined by a second inner tube of the pair of inner tubes (combination considered to further teach the second inner tube of the pair of inner tubes defining the guidewire lumen), the guidewire configured to advance through the guidewire lumen of the needle (combination considered to further teach guidewire 155 advanced through the separate guidewire lumen of 105, para. [0054] of Silvestro).
Maguire (as modified) still fails to teach a plurality of stylets differing in stiffness, each stylet configured to advance through the stylet lumen of the needle and differentially adjust a curvature of a distal end portion of the needle.
Lutz teaches (para. [0096]), in the same field of endeavor, an access kit (para. [0096]) comprising a plurality of stylets differing in stiffness (vary in rigidity), each stylet configured to advance through a lumen of a cannula and differentially adjust a curvature of a distal end portion of the cannula (para. [0096]), for the purpose of customizing the curve or stiffness of the cannula based on the particular needs of the individual patient (para. [0096]).
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 kit of Maguire (as modified) to further include a plurality of stylets, in order to customize the curve or stiffness of the needle based on the particular needs of the individual patient, based on the teachings of Lutz (para. [0096]).
Regarding claim 21, Maguire (as modified) teaches the access kit according to claim 20. Maguire (as modified) further teaches wherein the outer tube and the pair of inner tubes are made of stainless steel (paras. [0320] and [0324] of Kendale) and the filling material between the outer tube and the pair of inner tubes is a plastic material (para. [0324] of Kendale).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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, Darwin Erezo can be reached at (571)-272-4695. 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.
/BRIGID K BYRD/Examiner, Art Unit 3771
Prosecution Insights