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 .
Election/Restrictions
Applicant’s election without traverse of Species H in the reply filed on 12/3/2025 is acknowledged. Accordingly, claims 2-16 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim Objections
Claims 1, 19, 21, 22 and 24 are objected to because of the following informalities:
Each of claims 1, 19 21, 22 and 24 refer to previously recited features and utilize hyphens when hyphens were not utilized when these features were introduced (see “one-or-more extension legs” on lines 6-7 of claim 1 vs “one or more extension legs” on line 6 of claim 1; “needle-hub” on line 13 of claim 1 and line 3 of claim 19 vs “needle hub” on line 12 of claim 1; “needle-shaft” on lines 14 and 17 of claim 1 and line 2 of claim 24 vs “needle shaft” on line 11 of claim 1; “catheter-tube”, “catheter-hub” and “extension-leg” of lines 3-4 of claim 21 vs. “catheter tube” of line 4 of claim 1, “catheter hub” of line 5 of claim 1, and “extension legs” of line 6 of claim 1; “primary-lumen”, “secondary-lumen” and “tertiary-lumen” of lines 2-5 of claim 22 vs “primary lumen”, “secondary lumen” and “tertiary lumen” of lines 2-3 of claim 21). In order to maintain consistency of claim language, all hyphens in these phrases should be removed.
Appropriate correction is required.
Claim 17 is objected to because of the following informalities:
Claim 17 recites “wherein the coupler coupling together the introducer assembly and the access guidewire includes” on lines 1-2. Since claim 1 sets forth that the coupling of the introducer assembly and the access guidewire is just one of three couplings that the coupler can perform, claim 17 should be amended to make it clear that this is the coupling that has been selected. In order to do this, it is suggested to amend lines 1-2 to recite “wherein the coupler couples together the introducer assembly and the access guidewire and includes a rotatable lever”.
Claim 17 recites “the coupler housing” on line 5 but this language is not consistent with the language used when such a housing was introduced on line 3. In order to maintain consistency of claim language, line 5 should be amended to recite “the of the coupler”.
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.
Claims 1 and 17-24 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 “one or more extension legs, each extension leg of the one-or-more extension legs coupled to the catheter hub by a distal portion thereof” on lines 6-7. It is unclear as to which feature – either “each leg of the one or more extension legs” or the “catheter hub” - that the term “thereof” is intended to refer to. For the sake of examination, the term “thereof” is interpreted as referring to each leg of the one or more extension legs. Accordingly, it is suggested to amend lines 6-7 to recite “one or more extension leg, each extension leg of the one or more extension legs coupled to the catheter hub by a distal portion of each extension leg”.
Claims 17-24 are rejected due to their dependence on claim 1.
Claim 21 recites “wherein the RICC includes a set of three lumen including the primary lumen, a secondary lumen, and a tertiary lumen formed of fluidly connected portions of three catheter-tube lumens, three catheter-hub lumens, and three extension-leg lumens” on lines 1-4. This language renders it unclear as to whether the three “catheter-tube lumens” are lumens of the “catheter tube” introduced in claim 1 or are lumens found in other catheter tube(s) (and, if so, if all the lumens are in a single catheter or if each lumen resides in its own catheter), whether the three “catheter-hub lumens” are lumens of the “catheter hub” introduced in claim 1 or are lumens found in other catheter hub(s) (and, if so, if all the lumens are in a single catheter hub or if each lumen resides in its own catheter hub), and whether the three “extension-leg lumens” are lumens of the “one or more extension legs” introduced in claim 1 or are lumens found in other extension leg(s) (and, if so, if all the lumens are in a single extension leg or if each lumen resides in its own extension leg). Based on the disclosure, it is believed that claim is intended to require a first lumen extending through a first extension leg, the catheter hub of claim 1 and the catheter tube of claim 1, a second lumen extending through a second extension leg, the catheter hub of claim 1 and the catheter tube of claim 1, and a third lumen extending through a third extension leg, the catheter hub of claim 1 and the catheter tube of claim 1. Accordingly, it is suggested to amend claim 21 to recite “wherein the one or more extension legs include three extension legs and the RICC includes a set of three lumen including the primary lumen, a secondary lumen, and a tertiary lumen wherein the primary lumen extends through a first of the three extension legs, the catheter hub and the catheter tube, wherein the secondary lumen extends through a second of the three extension legs, the catheter hub and the catheter tube, and wherein the tertiary lumen extends through a third of the three extension legs, the catheter hub and the catheter tube” in order to clarify the scope of the claim.
Claim 22 is rejected due to its dependence on claim 21.
Claim 23 recites “a needle tip of the needle” on line 3. However, the phrase “the needle” lacks proper antecedent basis since claim 1 only introduces “an introducer needle” and “a needle shaft”. It is unclear as to which of these two features that the phrase “the needle” is intended to refer to. For the sake of examination, “the needle” of line 3 is interpreted as referring to “the needle shaft”. Accordingly, it is suggested to amend the claim in this manner in order to clarify the scope of the claim.
Claim 24 is rejected due to its dependence on claim 23.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 19 and 23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Murphy (PG PUB 2022/0203075)1.
Re claim 1, Murphy discloses a rapidly insertable central catheter ("RICC") insertion assembly 110 (Fig 5; it is noted that all reference characters cited below refer to Fig 5 unless otherwise noted), comprising: a RICC 100 (best seen in Fig 6J) including: a catheter tube (labeled in Fig A below); a catheter hub (labeled in Fig A below) coupled to a proximal portion (directed to the right in Fig 6J) of the catheter tube (as seen in Fig 6J and Fig A below); and one or more extension legs (labeled in Fig A below), each extension leg of the one-or-more extension legs coupled to the catheter hub by a distal portion (directed to the left in Fig 6J) thereof (as seen in Fig 6J and Fig A below); an introducer assembly (all components seen in Fig 6E except for housing 12, catheter 100, dilator 102 and guidewire 24) including: a syringe 14+20 (Fig 63); and an introducer needle (comprising the needle shaft 132, the needle mount 150, and the housing portion of sealing mechanism 164 that is labeled in Fig B below) coupled to the syringe ((as seen in Fig 6E; Para 46), the introducer needle including: a needle shaft 132; and a needle hub (150 + the housing portion of sealing mechanism 164 that is labeled in Fig B below) over a proximal portion of the needle shaft (as seen in Fig 6F), the needle hub including a needle-hub through hole (152 + the passageway extending through sealing mechanism 164) passing through a side of the needle hub (as seen in Fig 6F, the through hole passes through the proximal side of the needle hub) and connecting to a needle-shaft lumen 133 (Fig 6F) (as seen in Fig 6F); an access guidewire 24 including: a proximal portion (to the right in Fig 5) disposed in a primary lumen of the RICC (Para 69); and a distal portion (to the left in Fig 5) disposed in the needle-shaft lumen by way of the needle-hub through hole (as seen in Fig 6F); and a coupler 112 coupling together the RICC and the introducer assembly, the RICC and the access guidewire, or the introducer assembly and the access guidewire (as seen in Fig 5, the coupler 112 directly couples together the RICC and the introducer assembly via mount sections 180 (Para 72) and indirectly couples the introducer assembly and the access guidewire since the access guidewire is within the RICC).
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Re claim 19, Murphy discloses that the needle-hub through hole includes a gasket (seen in Fig 6F but not labeled; labeled in Fig B above) disposed therein (as seen in Fig 6F and Fig B above) configured to seal around the access guidewire and allow a vacuum to be drawn with the syringe without leaking through the needle- hub through hole (Para 75).
Re claim 23, Murphy discloses that the RICC insertion assembly is in a ready-to-deploy state thereof with a guidewire tip (the distal-most end of wire 26) of the access guidewire disposed just proximal of a needle tip (the distal-most end of needle 132) of the needle (Para 57, “the proximal end of the wire may be right at the tip 33 or rearwardly of the tip as it is passed into the tissue 82).
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.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Murphy (PG PUB 2022/0203075) in view of Samson (US Pat 4,582,181)
Re claim 20, Murphy discloses all the claimed features except that the gasket includes one or more O-rings. Samson, however, teaches using an O-ring as a gasket (Col 3, Lines 54-57) for the purpose of ensuring that a fluid-tight seal is formed with the guidewire while permitting rotation of the guide wire about its axis (Col 3, Lines 54-57). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy to include the gasket so that it includes one or more O-rings, as taught by Samson, for the purpose of ensuring that a fluid-tight seal is formed with the guidewire while permitting rotation of the guide wire about its axis (Col 3, Lines 54-57).
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy (PG PUB 2022/0203075) in view of Martin et al. (US Pat 5,195,962).
Re claims 21 and 22, Murphy discloses that the RICC includes three extension legs (as seen in Fig 6J and Fig A above), each with a lumen therein (wherein the middle lumen receives dilator 102, Para 60, and the two outer lumen include ports that feed into the catheter, Para 69), wherein the middle lumen is the primary lumen and has a primary-lumen aperture in a distal end of the catheter tube (as seen in Fig 6A; Para 60) and the two outer lumen form secondary and tertiary lumen. Murphy is silent as to these three lumen extending through the catheter hub and through the catheter tube (as required by claim 21), wherein the secondary lumen has a secondary-lumen aperture in a side of the distal portion of catheter tube, and the tertiary lumen has a tertiary-lumen aperture in the side of the distal portion of the catheter tube proximal of the secondary-lumen aperture (as required by claim 22). Martin, however, teaches a RICC 20 (Fig 2) comprising three extension legs 32,34,35 (Fig 2), a catheter hub 30 (Fig 2) and a catheter tube 26 (Fig 2), wherein a primary lumen 54 (Fig 3-5) extends within a central leg 35 of the extension legs, the catheter hub and the catheter tube to a primary-lumen aperture 64 (Fig 3) in a distal end 28 (Fig 2,3) of the catheter tube (Col, 6, Lines 2-9 and 41-42), a secondary lumen 52 (Fig 3) extends within an outer leg 34 of the extension legs, the catheter hub and the catheter tube to a secondary-lumen aperture 45 (Fig 3) in a side of the distal portion of the catheter tube (as seen in Fig 3; Col 5, Lines 53-57), and a tertiary lumen 50 extends within the other outer leg 32 of the extension legs, the catheter hub and the catheter tube to a tertiary-lumen aperture 44 (Fig 3) in a side of the distal portion of the catheter tube proximal of the secondary-lumen aperture (as seen in Fig 3; Col 6, Lines 13-18) for the purpose of allowing the RICC to be used in procedures that require the removal and delivery of fluids without risk of cross flow (Col 5, Lines 57-52 and Col 6, Lines 28-31). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy to include each of the lumen within the extensions legs such that they extend through the catheter hub and the catheter tube so that the primary lumen extends to an aperture in the distal end of the catheter tube, the secondary lumen extends to an aperture in a side of the distal portion of the catheter tube, and the tertiary lumen extends to an aperture in a side of the distal portion of the catheter tube that is proximal to the aperture of the secondary lumen, as taught by Martin, for the purpose of allowing the RICC to be used in procedures that require the removal and delivery of fluids without risk of cross flow (Col 5, Lines 57-52 and Col 6, Lines 28-31).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Murphy (PG PUB 2022/0203075) in view of Franklin et al. (PG PUB 2020/0197682).
Re claim 24, Murphy discloses that the guidewire tip is straight in the needle-shaft lumen in the ready-to-deploy state of the RICC insertion assembly (as seen in Fig 2A, for example), but is silent as to it adopting a 'J' shape when advanced beyond the needle tip in a deployed state of the RICC insertion assembly. Franklin, however, teaches providing a guidewire tip that is straight within a lumen of a needle prior to deployment from the needle, but adopts a J shape when advanced beyond a tip of the needle in a deployed state of the needle (Para 10, “the tip may have a J-shape or curved shape that uncoils upon exiting from the tip of the needle within the vessel”) for the purpose of limiting trauma to the vessel upon insertion of the guidewire in the vessel (Para 10). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy to include the guidewire such that its tip adopts a J shape when advanced beyond the needle tip in the deployed state of the RICC insertion assembly, as taught by Franklin, for the purpose of limiting trauma to the vessel upon insertion of the guidewire in the vessel (Para 10).
Allowable Subject Matter
Claims 17 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if (1) rewritten in independent form including all of the limitations of the base claim and any intervening claims, (2) amended to overcome the objections to claim 17 set forth above, and (3) claim 1 were amended to overcome the 112(b) rejection set forth above.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of dependent claim 17 (upon which claim 18 depends) could not be found nor was suggested in the prior art of record in combination with the subject matter of independent claim 1. Claim 17 requires the coupler of claim 1 to (a) couple together the introducer assembly and the access guidewire and (b) comprise a housing with a distal housing piece and a lock that includes a rotatable lever, wherein the lock has a locked state for locking the needle hub with the distal housing piece and an unlocked state for unlocking the needle hub from the distal housing piece.
The coupler 112 of Murphy indirectly couples together the introducer assembly and the access guidewire – since (1) the guidewire is within the RICC and (2) the RICC is directly coupled to the introducer assembly via mount sections 180 of the coupler – and comprises a housing (the entirety of body 112) with a distal housing piece 16, but does not include a housing lock that comprises a rotatable lever and that locks and unlocks the needle hub from the distal housing piece of the coupler. Couplers having locks that comprise rotatable levers can be found in the art – see locking lever 761 in Fig 7A in PG PUB 2017/0368255 to Provost et al., for example – and it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy to include such a lever on mount section 180 (for the purpose of attaching an elongate member to another element during use, Para 60). However, this modification would not result in the lever being located such that it locks and unlocks the needle hub from the distal housing piece of the coupler. Additionally, a coupler having the structure and function recited in claim 17 could not be found nor was suggested elsewhere in the prior art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 Effective filing date of 12/15/2020.