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 .
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 10/09/2025. Claims 1-9, 11, 13 and 15-17 are amended. Claims 18-20 are new. Claims 1-20 are currently pending.
The objection to the drawings has been withdrawn, due to applicant’s submission of replacement drawings.
The objection of claims 1, 7-8, 11 and 15 has been withdrawn due to applicant’s amendment.
The rejection of claims 3, 5-6 and 17 under 35 U.S.C. 112(b) has been withdrawn due to applicant’s amendment.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 and 4 under 35 U.S.C. 103 as being unpatentable over Morris in view of Maguire, have been fully considered and are persuasive, in combination with the amendments to the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Maguire in view of Silvestro and Chin as discussed below.
Applicant argues Morris does not teach the claimed first and second lumens of the needle, however, Morris is no longer relied upon to teach the claimed limitations. Therefore, applicant’s arguments are moot.
Applicant’s arguments with respect to the rejection of claims 1-3, 5-10, 12-14 and 17 under 35 U.S.C. 103 as being unpatentable over Maguire in view of Silvestro; and claims 15-16 under 35 U.S.C. 103 as being unpatentable over Maguire in view of Silvestro and Kendale, have been fully considered but are not persuasive. The rejection has been modified, necessitated by applicant’s amendments to the claims.
Applicant argues the simple substitution rationale is improper, because there is no second lumen in Maguire’s cannula such that the lumen is unknown and it is improper to substitute one known element for another known element (Remarks, pgs. 10-11).
In response to applicant’s argument, it is respectfully submitted the simple substitution rationale relies on substitution of some components (double lumen device as taught by Silvestro) with other components (single lumen device, as disclosed in Maguire). The singular lumen of Maguire and double lumen of Silvestro are both known components. Further, Silvestro specifies the device comprising a through lumen accommodating a guidewire, and the device further containing a separate guidewire lumen, signifying substitution of a known component (through lumen for accommodating a guidewire) with another known component (a separate guidewire lumen). Accordingly, Maguire and Silvestro each disclose known components such that the rationale is met.
Applicant’s argument with respect to claims 18-20 have been fully considered, and new claims 18-20 are rejected as discussed below.
Claim Objections
Claim 18 is objected to because of the following informalities: In claim 18, line 2, the phrase “has monolithic” should read “has a monolithic”. Appropriate correction is required.
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 16 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 16, the claim recites “the one or two inner tubes” in line 2. There is insufficient antecedent basis for this limitation in the claim, since one of the one or two inner tubes has not specifically been previously introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the two inner tubes 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, 5-14 and 18 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).
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:
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 needle comprising a second lumen extending longitudinally through 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.
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).
Regarding claim 18, 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 the stiff, diseased liver tissue (para. [0052]), and wherein the shaft has monolithic body (shaft of 105 considered to constitute a single unit, para. [0054]).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire in view of Silvestro as applied to claim 1 above, and further in view of Chin (US 2004/0111101 A1).
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 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 one or two inner tubes and the outer tube 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 as applied to claim 1 above, and further in view of Scott (US 2021/0128873 A1).
Regarding claim 17, Maguire (as modified) teaches the access kit according to claim 1.
Maguire further discloses the needle further comprising an end section member (130) arranged at a distalmost end of the needle (figs. 1-3),
However, Maguire (as modified) fails to teach wherein the end section member including the needle tip is made of a harder material than a 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).
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 is 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; 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. P0322]-[0324]) between the outer tube and the pair of inner tubes (figs. 6a-e), 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]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2010/0106093 A1 to McGuckin, Jr., disclosing a medical needle.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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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.
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/BRIGID K BYRD/Examiner, Art Unit 3771