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 .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 08/25/23 and 10/06/23 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 14-16 and 20 are objected to because of the following informalities:
Claims 14 -16 read “wherein: a material from which the flexible portion is formed is more flexible than a material from which other portions of the reinforcement needle.” but should likely read “wherein: a material from which the flexible portion is formed is more flexible than a material from which other portions of the reinforcement needle are formed.”” for grammatical reasons
In claim 20, it appears that reference character “20” has been included after the catheter hub in the last clause of the claim. It is recommended that the characters be removed in order to ease readability of the claim.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
Claim 1 line 14 and claim 20 line 17: “a first fixing portion configured to fix”. Therefore, claims 1 and 20 are interpreted under 112(f) according to the 3-prong test:
Prong 1: means or generic placeholder is recited— “a first fixing portion” is considered a generic placeholder for “means” because “a first fixing portion” has no specific structural meaning
Prong 2: functional language—configured to fix
Prong 3: not modified by other structural language in the claims—no structure is recited for how the first fixing portion functions in order to achieve the function of being configured to fix the catheter hub and the reinforcement hub. Only the desired outcome of “fix” is recited.
According to Applicant’s disclosure under 112(f), the “first fixing portion configured to fix” is interpreted as a threaded connection or equivalent (see FIG. 3 and [0032]: a screw/thread structure forms the lock portion 40 comprising the first fixing portion). All recitations of the first fixing portion in the depending claims are subsequently interpreted under 112f unless otherwise specified below.
Claim 1 line 18 an claim 20 line 21: “a second fixing portion configured to fix”. Therefore, claims 1 and 20 are interpreted under 112(f) according to the 3-prong test:
Prong 1: means or generic placeholder is recited— “a second fixing portion” is considered a generic placeholder for “means” because “a second fixing portion” has no specific structural meaning
Prong 2: functional language—configured to fix
Prong 3: not modified by other structural language in the claims—no structure is recited for how the second fixing portion functions in order to achieve the function of being configured to fix the reinforcement needle hub and the inner needle hub to each other. Only the desired outcome of “fix” is recited.
According to Applicant’s disclosure under 112(f), the “second fixing portion configured to fix” is interpreted as a friction/ interference fit or equivalent (see FIG. 3 and [0036]). All recitations of the second fixing portion in the depending claims are subsequently interpreted under 112f unless otherwise specified below.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function.
Such claim limitation(s) is/are:
The first fixing portion in claim 3 because further structure is recited such as a first projection that is screwed with a lock portion.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 1-2 and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Wisman (U.S. PGPUB No. 2020/0094025), in view of Muse et al. (U.S. PGPUB No. 2018/0339131), hereinafter Muse.
Regarding claim 1, Wisman discloses a catheter assembly (10, see FIG.6 and see ‘Modified FIG. 2’ and ‘Modified FIG. 3’ below for ease of reference of recited structures)
PNG
media_image1.png
436
735
media_image1.png
Greyscale
PNG
media_image2.png
496
618
media_image2.png
Greyscale
comprising:
a catheter (14) having a first lumen (42, see FIG. 2);
a catheter hub (12) joined to (see [0057]) a proximal end (38) of the catheter (14),
a reinforcement needle (16) inserted through (see [0061] & [0063]) the first lumen (42) of the catheter (14), having a second lumen (48, see [0061]), and including a distal portion (46) that is blunt (see FIG. 2),
a reinforcement needle hub (22, see [0071]) joined to (see [0071]) a proximal end (see [0071]) of the reinforcement needle (16),
an inner needle (18) inserted through the second lumen (see [0065]) of the reinforcement needle (16) and including a sharp needle tip (54) at a distal end (see [0065] and FIG.2) thereof,
an inner needle hub (26) joined to (see [0077]) a proximal end (58, see FIG. 6 and [0077]) of the inner needle (18),
a first fixing portion (structure between 12 and 22, see [0069]: such as threads as interpreted under 112f above) configured to fix the catheter hub (12 comprising proximal end 30) and the reinforcement needle hub (22 comprising distal end 62) so as not to be detachable by an operation of pulling the catheter hub and the reinforcement needle hub in an axial direction (threads require rotation to detach and thus inherently are configured to fix... “so as not to be detachable by an operation of pulling”), and
a second fixing portion (80, see [0080]: 80 of hub 26 friction fit to hub lumen 64 of hub 22, such as interpreted under 112f above) configured to fix the reinforcement needle hub (22) and the inner needle hub (26) to each other (see [0080]), wherein:
the reinforcement needle (16) protrudes from (see FIG. 2) a distal end of the catheter (14), and
the inner needle (18) protrudes from (see FIG. 2) a distal end (46) of the reinforcement needle (16).
Wisman is silent to “a rigidity of the reinforcement needle is higher than a rigidity of the catheter.”
However, Muse teaches a catheter assembly (see FIG. 1) comprising a catheter (102) with a catheter lumen (172, see ‘Modified FIG. 3’ below), a reinforcement needle (106, see [0107]: stiffener 106, also referred to as “reinforcement”) with a reinforcement needle lumen (178), and inner needle (104) with an inner needle lumen (175),
PNG
media_image3.png
413
693
media_image3.png
Greyscale
Wherein a rigidity of the reinforcement needle (106) is higher than (see [0107]: 106 rigid in axial direction to counteract axial forces applied to catheter 102 and therefore must have a rigidity higher than that of the catheter. See also [0138-0140] & [0100]) a rigidity of the catheter (102).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rigidity of the reinforcement needle disclosed in Wisman to be a higher rigidity than that of the catheter in which the reinforcement needle is disposed as taught by Muse for the purpose of ensuring that the reinforcement needle is substantially stiff in the axial direction to counteract axial forces applied to the system during insertion and advancement of the system into a lumen of a vessel (see [0107]), thus achieving “a rigidity of the reinforcement needle is higher than a rigidity of the catheter.”
Regarding claim 2, the modified system of Wisman teaches the catheter assembly according to claim 1, and Wisman further discloses wherein: the fixation between the catheter hub (12, see FIG. 1) and the reinforcement needle hub (22) implemented by the first fixing portion (structure between 12 and 22, see [0069]: such as thread) is stronger than the fixation between the reinforcement needle hub (22) and the inner needle hub (26) implemented by the second fixing portion (80, see [0080]: 80 of hub 26 friction fit to hub lumen 64 of hub 22, aligning with Applicant disclosure in [0049]: the threaded connection of first fixing portion is “stronger” than the interference fit of the second fixing portion).
Regarding claim 4, the modified system of Wisman teaches the catheter assembly according to claim 1, and Wisman further discloses wherein: the first fixing portion (see [0069]: threaded connection) fixes the catheter hub (12) and the reinforcement needle hub (22) to each other in the axial direction in a rotatable manner (threads inherently fixed in rotatable manner along axial direction).
Regarding claim 5, the modified system of Wisman teaches the catheter assembly according to claim 2, and Wisman further discloses wherein: the first fixing portion (see [0069]: threaded connection) fixes the catheter hub (12) and the reinforcement needle hub (22) to each other in the axial direction in a rotatable manner (threads inherently fixed in rotatable manner along axial direction).
Regarding claim 6, the modified system of Wisman teaches the catheter assembly according to claim 1, and Wisman further discloses the reinforcement needle (16, see FIG.2) comprises a material for providing structural properties to the reinforcement needle (see [0064]).
Wisman in view of Muse (FIG. 4A) is silent to “wherein: the reinforcement needle comprises a flexible portion that enables bending of a distal end of the reinforcement needle.”
However, Muse (FIG. 21D) teaches a catheter assembly comprising a catheter (802), a reinforcement needle (806), and an inner needle (804), wherein: the reinforcement needle (806) comprises a flexible portion (see [0220]: regions with different thicknesses of tubing to provide desired area moment of inertia/ laterally flexible properties) that enables bending of a distal end of the reinforcement needle (806, see [0219-0220]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material for providing structural properties to the reinforcement needle disclosed in Wisman to be flexible (such as by adjusting the wall thickness) to enable bending of the reinforcement needle as taught by Muse for the purpose of permitting the reinforcement needle to permit lateral bending while maintaining a sufficient longitudinal rigidity such that the system can bend at the insertion site to follow the lumen of the vessel (see [0219-0220]), thus achieving “wherein: the reinforcement needle comprises a flexible portion that enables bending of a distal end of the reinforcement needle.”
Regarding claim 7, the modified system of Wisman teaches the catheter assembly according to claim 2, and Wisman further discloses the reinforcement needle (16, see FIG.2) comprises a material for providing structural properties to the reinforcement needle (see [0064]).
Wisman in view of Muse (FIG. 4A) is silent to “wherein: the reinforcement needle comprises a flexible portion that enables bending of a distal end of the reinforcement needle.”
However, Muse (FIG. 21D) teaches a catheter assembly comprising a catheter (802), a reinforcement needle (806), and an inner needle (804), wherein: the reinforcement needle (806) comprises a flexible portion (see [0220]: regions with different thicknesses of tubing to provide desired area moment of inertia/ laterally flexible properties) that enables bending of a distal end of the reinforcement needle (806, see [0219-0220]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material for providing structural properties to the reinforcement needle disclosed in Wisman to be flexible (such as by adjusting the wall thickness) to enable bending of the reinforcement needle as taught by Muse for the purpose of permitting the reinforcement needle to permit lateral bending while maintaining a sufficient longitudinal rigidity such that the system can bend at the insertion site to follow the lumen of the vessel (see [0219-0220]), thus achieving “wherein: the reinforcement needle comprises a flexible portion that enables bending of a distal end of the reinforcement needle.”
Claims 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Wisman in view of Muse as applied to claim 2 above, and further in view of Yamashita et al. (U.S. PGPUB No. 2018/0050177), hereinafter Yamashita.
Regarding claim 3, the modified system of Wisman teaches the catheter assembly according to claim 2, and Wisman further discloses wherein: the first fixing portion (structure between 12 and 22, see [0069]: such as threads) comprises: a first projection that protrudes radially outward (see [0069]: thread at proximal end 30 of hub 12) from a proximal end (30) of the catheter hub (12), and a lock portion that protrudes in a tubular shape (see [0069]: outer surface of 62==tubular shape has complementary thread/ a lock portion) from the reinforcement needle hub (22) in a distal direction (see [0069]: complementary threads of 62 extend to mate with proximal end 30), and comprises a spiral second projection (see [0069]: complementary threads would have a spiral projection), which is screwed with the first projection (see [0069]).
In summary, Wisman discloses the catheter hub threads disposed over the reinforcement needle hub threads. Thus, Wisman is silent to the reinforcement needle hub having the lock portion that protrudes in a tubular shape and “surrounds at least a part of an outside of the catheter hub” such that the lock portion has a spiral second projection, which is screwed with the first projection, “on an inner peripheral surface of the lock portion facing the catheter hub”.
However, Yamashita teaches a catheter assembly (see FIG.1 and [0025-0026]) comprising a first hub (81, see ‘Modified FIG. 4A’ below)
PNG
media_image4.png
387
409
media_image4.png
Greyscale
having a lock portion (81a) that protrudes in a tubular shape (see threads along outer surface of hub in tubular shape in ‘Modified FIG. 4A’ above) and surrounds (see FIG. 4B and [0053]) at least a part of an outside of a second hub (52, see mated configuration FIG. 4B with 81a surrounding at least thread 521 and a distal portion of hub 52) such that the lock portion (81a) has a spiral second projection (see [0053]: female screw must have projecting portions), which is screwed with a first projection (521, see [0053]: 521 a male screw portion) of the second hub (52), on an inner peripheral surface (see [0053]: 521 threaded “into” female portion/ into inner peripheral surface) of the lock portion (81a) facing the second hub (52).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have modified the threaded connection between the reinforcement needle hub and the catheter hub disclosed in Wisman such that a female screw portion of the reinforcement needle hub surrounds and receives the male screw portion of the catheter hub as taught in Yamashita, thus achieving the reinforcement needle hub having the lock portion that protrudes in a tubular shape and “surrounds at least a part of an outside of the catheter hub” such that the lock portion has a spiral second projection, which is screwed with the first projection, “on an inner peripheral surface of the lock portion facing the catheter hub”.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple rearrangement of parts to change the locations/positions of hub threads according to another known configuration and such a modification would not modify the device operation (see MPEP § 2144.04.VI.C).
Regarding claim 8, the modified system of Wisman teaches the catheter assembly according to claim 3, and Wisman further discloses the reinforcement needle (16, see FIG.2) comprises a material for providing structural properties to the reinforcement needle (see [0064]).
Wisman is silent to “wherein: the reinforcement needle comprises a flexible portion that enables bending of a distal end of the reinforcement needle.”
However, Muse (FIG. 21D) teaches a catheter assembly comprising a catheter (802), a reinforcement needle (806), and an inner needle (804), wherein: the reinforcement needle (806) comprises a flexible portion (see [0220]: regions with different thicknesses of tubing to provide desired area moment of inertia/ laterally flexible properties) that enables bending of a distal end of the reinforcement needle (806, see [0219-0220]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material for providing structural properties to the reinforcement needle disclosed in Wisman to be flexible (such as by adjusting the wall thickness) to enable bending of the reinforcement needle as taught by Muse for the purpose of permitting the reinforcement needle to permit lateral bending while maintaining a sufficient longitudinal rigidity such that the system can bend at the insertion site to follow the lumen of the vessel (see [0219-0220]), thus achieving “wherein: the reinforcement needle comprises a flexible portion that enables bending of a distal end of the reinforcement needle.”
Claim 9, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Wisman in view of Muse as applied to claim 6 above, and further in view of Intoccia et al. (U.S. PGPUB No. 2008/0300462), hereinafter Intoccia.
Regarding claim 9, the modified system of Wisman teaches the catheter assembly according to claim 6, but Wisman in view of Muse (FIG. 4A) is silent to “wherein: the flexible portion comprises a soft part provided at a position separate from the proximal end by a first distance, and separated from the distal end by a second distance that is less than the first distance.”
However, Muse (FIG. 21D) teaches a catheter assembly comprising a catheter (802), a reinforcement needle (806), and an inner needle (804), wherein: the reinforcement needle (806) comprises a flexible portion (see [0220]: regions with different thicknesses of tubing to provide desired area moment of inertia/ laterally flexible properties) that enables bending of a distal end of the reinforcement needle (806, see [0219-0220]), wherein the flexible portion comprises a soft part (see [0219-0220]: soft part with regions of different wall thicknesses, aligning with Applicant disclosure in [0028]) provided at a position separate from the proximal end by a first distance, and separated from the distal end by a second distance (see [0220]: regions with different thicknesses of tubing to provide desired area moment of inertia/ laterally flexible properties. Thus, the region inherently has a first distance from the proximal end and a second distance from the distal end).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material for providing structural properties to the reinforcement needle disclosed in Wisman to be flexible (such as by adjusting the wall thickness) to enable bending of the reinforcement needle as taught by Muse for the purpose of permitting the reinforcement needle to permit lateral bending while maintaining a sufficient longitudinal rigidity such that the system can bend at the insertion site to follow the lumen of the vessel (see [0219-0220]), thus achieving “wherein: the flexible portion comprises a soft part provided at a position separate from the proximal end by a first distance, and separated from the distal end by a second distance.”
Modified Wisman is silent to wherein: the flexible portion comprises a soft part provided at a position separate from the proximal end by a first distance, and separated from the distal end by a second distance “that is less than the first distance.”
However, Intoccia teaches a catheter assembly (see FIG. 1) comprising a tubular element (50 with distal portion 60 as shown in FIG. 5, see [0048] and ‘Modified FIG. 1’ and ‘Modified FIG. 5’ below for reference) with a flexible portion (82),
PNG
media_image5.png
706
445
media_image5.png
Greyscale
PNG
media_image6.png
494
641
media_image6.png
Greyscale
wherein: the flexible portion (82) comprises a soft part (see [0056-0057]: slots remove material and thus vary thickness of the tube) provided at a position separate from the proximal end by a first distance (see ‘Modified FIG. 1’ and ‘Modified FIG. 5’ above), and separated from the distal end (62) by a second distance that is less than the first distance (see ‘Modified FIG. 1’ and ‘Modified FIG. 5’ above).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the location of the flexible portion taught by Modified Wisman to be located farther from the proximal end than the distal end such that the second distance is less than the first distance as taught by Intoccia for the purpose of providing the bending flexibility to a distal end portion of the device (see [0056-0057]), thus achieving wherein: the flexible portion comprises a soft part provided at a position separate from the proximal end by a first distance, and separated from the distal end by a second distance “that is less than the first distance.”
Regarding claim 12, the modified system of Wisman teaches the catheter assembly according to claim 9, but Modified Wisman is silent to “wherein: the flexible portion has a concave-convex structure comprising a plurality of concave portions formed by thinning an outer periphery of the reinforcement needle, and a plurality of convex portions provided adjacent to the concave portions.”
However, Intoccia teaches a catheter assembly (see FIG. 1) comprising a tubular element (50 with distal portion 60 as shown in FIG. 5, see [0048] and ‘Modified FIG. 1’ and ‘Modified FIG. 5’ below for reference) with a flexible portion (82), wherein: the flexible portion (82) has a concave-convex structure (see [0057]: slots may have curved geometry which would create a concave-convex structure) comprising a plurality of concave portions (thinner edge formed by curved slot, see ‘Modified FIG. 5i’ below) formed by thinning an outer periphery of the tubular element (see ‘Modified FIG. 5i’ below and [0056-0057]),
PNG
media_image7.png
387
510
media_image7.png
Greyscale
and a plurality of convex portions (see ‘Modified FIG. 5i’ above) provided adjacent to the concave portions (see [0057]: slots may have curved geometry which would create a concave-convex structure).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flexible portion formed of thinner/thicker wall portions taught by Modified Wisman to comprise a concave-convex structure as taught by Intoccia for the purpose of modifying the wall geometry of the flexible portion to achieve a desire torqueability and bending characteristic of the distal end (see [0057]), thus achieving “wherein: the flexible portion has a concave-convex structure comprising a plurality of concave portions formed by thinning an outer periphery of the reinforcement needle, and a plurality of convex portions provided adjacent to the concave portions.”
Regarding claim 14, the modified system of Wisman teaches the catheter assembly according to claim 9, and Wisman further discloses the reinforcement needle (16, see FIG.2) comprises a material for providing structural properties to the reinforcement needle (see [0064]).
Modified Wisman is silent to “wherein: a material from which the flexible portion is formed is more flexible than a material from which other portions of the reinforcement needle.”
However, Intoccia teaches a catheter assembly (see FIG. 1) comprising a tubular element (50 with distal portion 60 as shown in FIG. 5, see [0048] and ‘Modified FIG. 1’ and ‘Modified FIG. 5’ above for reference) with a flexible portion (82), wherein: a material from which the flexible portion (82) is formed is more flexible than a material from which other portions of the tubular element are formed (see [0053]: tubular element 50 can comprise different material segments with varying degrees of flexibility based on material selection and [0057]: 80 with flexible region 82 should bend==more flexible than rest of shaft).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the material of the flexible portion taught by Modified Wisman to be more flexible than the rest of the shaft as taught by Intoccia for the purpose of forming the distal end segment with the flexible portion to have a desired bendability based on material selection (see [0053] and [0057]), thus achieving “wherein: a material from which the flexible portion is formed is more flexible than a material from which other portions of the reinforcement needle.”
Claims 10, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wisman in view of Muse as applied to claim 7 above, and further in view of Intoccia (U.S. PGPUB No. 2008/0300462).
Regarding claim 10, the modified system of Wisman teaches the catheter assembly according to claim 7, but Wisman in view of Muse (FIG. 4A) is silent to “wherein: the flexible portion comprises a soft part provided at a position separate from the proximal end by a first distance, and separated from the distal end by a second distance that is less than the first distance.”
However, Muse (FIG. 21D) teaches a catheter assembly comprising a catheter (802), a reinforcement needle (806), and an inner needle (804), wherein: the reinforcement needle (806) comprises a flexible portion (see [0220]: regions with different thicknesses of tubing to provide desired area moment of inertia/ laterally flexible properties) that enables bending of a distal end of the reinforcement needle (806, see [0219-0220]), wherein the flexible portion comprises a soft part (see [0219-0220]: soft part with regions of different wall thicknesses, aligning with Applicant disclosure in [0028]) provided at a position separate from the proximal end by a first distance, and separated from the distal end by a second distance (see [0220]: regions with different thicknesses of tubing to provide desired area moment of inertia/ laterally flexible properties. Thus, the region inherently has a first distance from the proximal end and a second distance from the distal end).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material for providing structural properties to the reinforcement needle disclosed in Wisman to be flexible (such as by adjusting the wall thickness) to enable bending of the reinforcement needle as taught by Muse for the purpose of permitting the reinforcement needle to permit lateral bending while maintaining a sufficient longitudinal rigidity such that the system can bend at the insertion site to follow the lumen of the vessel (see [0219-0220]), thus achieving “wherein: the flexible portion comprises a soft part provided at a position separate from the proximal end by a first distance, and separated from the distal end by a second distance.”
Modified Wisman is silent to wherein: the flexible portion comprises a soft part provided at a position separate from the proximal end by a first distance, and separated from the distal end by a second distance “that is less than the first distance.”
However, Intoccia teaches a catheter assembly (see FIG. 1) comprising a tubular element (50 with distal portion 60 as shown in FIG. 5, see [0048] and ‘Modified FIG. 1’ and ‘Modified FIG. 5’ below for reference) with a flexible portion (82),
PNG
media_image5.png
706
445
media_image5.png
Greyscale
PNG
media_image6.png
494
641
media_image6.png
Greyscale
wherein: the flexible portion (82) comprises a soft part (see [0056-0057]: slots remove material and thus vary thickness of the tube) provided at a position separate from the proximal end by a first distance (see ‘Modified FIG. 1’ and ‘Modified FIG. 5’ above), and separated from the distal end (62) by a second distance that is less than the first distance (see ‘Modified FIG. 1’ and ‘Modified FIG. 5’ above).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the location of the flexible portion taught by Modified Wisman to be located farther from the proximal end than the distal end such that the second distance is less than the first distance as taught by Intoccia for the purpose of providing the bending flexibility to a distal end portion of the device (see [0056-0057]), thus achieving wherein: the flexible portion comprises a soft part provided at a position separate from the proximal end by a first distance, and separated from the distal end by a second distance “that is less than the first distance.”
Regarding claim 13, the modified system of Wisman teaches the catheter assembly according to claim 10, but Modified Wisman is silent to “wherein: the flexible portion has a concave-convex structure comprising a plurality of concave portions formed by thinning an outer periphery of the reinforcement needle, and a plurality of convex portions provided adjacent to the concave portions.”
However, Intoccia teaches a catheter assembly (see FIG. 1) comprising a tubular element (50 with distal portion 60 as shown in FIG. 5, see [0048] and ‘Modified FIG. 1’ and ‘Modified FIG. 5’ below for reference) with a flexible portion (82), wherein: the flexible portion (82) has a concave-convex structure (see [0057]: slots may have curved geometry which would create a concave-convex structure) comprising a plurality of concave portions (thinner edge formed by curved slot, see ‘Modified FIG. 5i’ below) formed by thinning an outer periphery of the tubular element (see ‘Modified FIG. 5i’ below and [0056-0057]),
PNG
media_image7.png
387
510
media_image7.png
Greyscale
and a plurality of convex portions (see ‘Modified FIG. 5i’ above) provided adjacent to the concave portions (see [0057]: slots may have curved geometry which would create a concave-convex structure).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flexible portion formed of thinner/thicker wall portions taught by Modified Wisman to comprise a concave-convex structure as taught by Intoccia for the purpose of modifying the wall geometry of the flexible portion to achieve a desire torqueability and bending characteristic of the distal end (see [0057]), thus achieving “wherein: the flexible portion has a concave-convex structure comprising a plurality of concave portions formed by thinning an outer periphery of the reinforcement needle, and a plurality of convex portions provided adjacent to the concave portions.”
Regarding claim 15, the modified system of Wisman teaches the catheter assembly according to claim 10, and Wisman further discloses the reinforcement needle (16, see FIG.2) comprises a material for providing structural properties to the reinforcement needle (see [0064]).
Modified Wisman is silent to “wherein: a material from which the flexible portion is formed is more flexible than a material from which other portions of the reinforcement needle.”
However, Intoccia teaches a catheter assembly (see FIG. 1) comprising a tubular element (50 with distal portion 60 as shown in FIG. 5, see [0048] and ‘Modified FIG. 1’ and ‘Modified FIG. 5’ above for reference) with a flexible portion (82), wherein: a material from which the flexible portion (82) is formed is more flexible than a material from which other portions of the tubular element are formed (see [0053]: tubular element 50 can comprise different material segments with varying degrees of flexibility based on material selection and [0057]: 80 with flexible region 82 should bend==more flexible than rest of shaft).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the material of the flexible portion taught by Modified Wisman to be more flexible than the rest of the shaft as taught by Intoccia for the purpose of forming the distal end segment with the flexible portion to have a desired bendability based on material selection (see [0053] and [0057]), thus achieving “wherein: a material from which the flexible portion is formed is more flexible than a material from which other portions of the reinforcement needle.”
Claims 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wisman in view of Muse and Yamashita as applied to claim 8 above, and further in view of Intoccia (U.S. PGPUB No. 2008/0300462).
Regarding claim 11, the modified system of Wisman teaches the catheter assembly according to claim 8, but Wisman in view of Muse (FIG. 4A) is silent to “wherein: the flexible portion comprises a soft part provided at a position separate from the proximal end by a first distance, and separated from the distal end by a second distance that is less than the first distance.”
However, Muse (FIG. 21D) teaches a catheter assembly comprising a catheter (802), a reinforcement needle (806), and an inner needle (804), wherein: the reinforcement needle (806) comprises a flexible portion (see [0220]: regions with different thicknesses of tubing to provide desired area moment of inertia/ laterally flexible properties) that enables bending of a distal end of the reinforcement needle (806, see [0219-0220]), wherein the flexible portion comprises a soft part (see [0219-0220]: soft part with regions of different wall thicknesses, aligning with Applicant disclosure in [0028]) provided at a position separate from the proximal end by a first distance, and separated from the distal end by a second distance (see [0220]: regions with different thicknesses of tubing to provide desired area moment of inertia/ laterally flexible properties. Thus, the region inherently has a first distance from the proximal end and a second distance from the distal end).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material for providing structural properties to the reinforcement needle disclosed in Wisman to be flexible (such as by adjusting the wall thickness) to enable bending of the reinforcement needle as taught by Muse for the purpose of permitting the reinforcement needle to permit lateral bending while maintaining a sufficient longitudinal rigidity such that the system can bend at the insertion site to follow the lumen of the vessel (see [0219-0220]), thus achieving “wherein: the flexible portion comprises a soft part provided at a position separate from the proximal end by a first distance, and separated from the distal end by a second distance.”
Modified Wisman is silent to wherein: the flexible portion comprises a soft part provided at a position separate from the proximal end by a first distance, and separated from the distal end by a second distance “that is less than the first distance.”
However, Intoccia teaches a catheter assembly (see FIG. 1) comprising a tubular element (50 with distal portion 60 as shown in FIG. 5, see [0048] and ‘Modified FIG. 1’ and ‘Modified FIG. 5’ below for reference) with a flexible portion (82),
PNG
media_image5.png
706
445
media_image5.png
Greyscale
PNG
media_image6.png
494
641
media_image6.png
Greyscale
wherein: the flexible portion (82) comprises a soft part (see [0056-0057]: slots remove material and thus vary thickness of the tube) provided at a position separate from the proximal end by a first distance (see ‘Modified FIG. 1’ and ‘Modified FIG. 5’ above), and separated from the distal end (62) by a second distance that is less than the first distance (see ‘Modified FIG. 1’ and ‘Modified FIG. 5’ above).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the location of the flexible portion taught by Modified Wisman to be located farther from the proximal end than the distal end such that the second distance is less than the first distance as taught by Intoccia for the purpose of providing the bending flexibility to a distal end portion of the device (see [0056-0057]), thus achieving wherein: the flexible portion comprises a soft part provided at a position separate from the proximal end by a first distance, and separated from the distal end by a second distance “that is less than the first distance.”
Regarding claim 16, the modified system of Wisman teaches the catheter assembly according to claim 11, and Wisman further discloses the reinforcement needle (16, see FIG.2) comprises a material for providing structural properties to the reinforcement needle (see [0064]).
Modified Wisman is silent to “wherein: a material from which the flexible portion is formed is more flexible than a material from which other portions of the reinforcement needle.”
However, Intoccia teaches a catheter assembly (see FIG. 1) comprising a tubular element (50 with distal portion 60 as shown in FIG. 5, see [0048] and ‘Modified FIG. 1’ and ‘Modified FIG. 5’ above for reference) with a flexible portion (82), wherein: a material from which the flexible portion (82) is formed is more flexible than a material from which other portions of the tubular element are formed (see [0053]: tubular element 50 can comprise different material segments with varying degrees of flexibility based on material selection and [0057]: 80 with flexible region 82 should bend==more flexible than rest of shaft).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the material of the flexible portion taught by Modified Wisman to be more flexible than the rest of the shaft as taught by Intoccia for the purpose of forming the distal end segment with the flexible portion to have a desired bendability based on material selection (see [0053] and [0057]), thus achieving “wherein: a material from which the flexible portion is formed is more flexible than a material from which other portions of the reinforcement needle.”
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Wisman in view of Muse as applied to claim 6 above, and further in view of Yang et al. (U.S. PGPUB No. 2017/0239447), hereinafter Yang.
Regarding claim 17, the modified system of Wisman teaches the catheter assembly according to claim 6, but Modified Wisman is silent to “wherein: the reinforcement needle comprises a rigid member that is wound along an outer peripheral portion from the proximal end to the distal end to impart rigidity to the reinforcement needle, and the flexible portion is formed by a portion of the rigid member being wound at a lower density than a remained of the rigid member.”
However, Yang teaches a catheter assembly comprising a tubular element (3000, see FIG. 30) wherein: the tubular element (3000) comprises a rigid member (3024, see [0181]: a coil wire, aligning with Applicant disclosure in [0058]) that is wound (see [0181]) along an outer peripheral portion (3020, see [0183]: 3020 is outer jacket and thus is outer periphery) from a proximal end (3022) to a distal end (3038) to impart rigidity to the tubular element (see [0181] and [0185]: coil design varies rigidity according to Shore hardness test), and a flexible portion (3036) is formed by a portion of the rigid member being wound at a lower density (see increased spacing from 3022 to 3034 as shown in FIG.30 and described in [0181]) than a remained of the rigid member (see [0185]: closer wound wire such as in 3022 has increased flexibility compared to zones 3034 with less dense coils).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reinforcement needle disclosed in Modified Wisman to include a rigid member wound around the outer periphery in the manner taught by Yang for the purpose of combining materials and structural elements such as coiled wires to achieve a catheter assembly with a high degree of flexibility with sufficient pushability to traverse treacherous vessels (see [0179-0185]), thus achieving “wherein: the reinforcement needle comprises a rigid member that is wound along an outer peripheral portion from the proximal end to the distal end to impart rigidity to the reinforcement needle, and the flexible portion is formed by a portion of the rigid member being wound at a lower density than a remained of the rigid member.”
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Wisman in view of Muse as applied to claim 7 above, and further in view of Yang (U.S. PGPUB No. 2017/0239447).
Regarding claim 18, the modified system of Wisman teaches the catheter assembly according to claim 7, but Modified Wisman is silent to “wherein: the reinforcement needle comprises a rigid member that is wound along an outer peripheral portion from the proximal end to the distal end to impart rigidity to the reinforcement needle, and the flexible portion is formed by a portion of the rigid member being wound at a lower density than a remained of the rigid member.”
However, Yang teaches a catheter assembly comprising a tubular element (3000, see FIG. 30) wherein: the tubular element (3000) comprises a rigid member (3024, see [0181]: a coil wire, aligning with Applicant disclosure in [0058]) that is wound (see [0181]) along an outer peripheral portion (3020, see [0183]: 3020 is outer jacket and thus is outer periphery) from a proximal end (3022) to a distal end (3038) to impart rigidity to the tubular element (see [0181] and [0185]: coil design varies rigidity according to Shore hardness test), and a flexible portion (3036) is formed by a portion of the rigid member being wound at a lower density (see increased spacing from 3022 to 3034 as shown in FIG.30 and described in [0181]) than a remained of the rigid member (see [0185]: closer wound wire such as in 3022 has increased flexibility compared to zones 3034 with less dense coils).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reinforcement needle disclosed in Modified Wisman to include a rigid member wound around the outer periphery in the manner taught by Yang for the purpose of combining materials and structural elements such as coiled wires to achieve a catheter assembly with a high degree of flexibility with sufficient pushability to traverse treacherous vessels (see [0179-0185]), thus achieving “wherein: the reinforcement needle comprises a rigid member that is wound along an outer peripheral portion from the proximal end to the distal end to impart rigidity to the reinforcement needle, and the flexible portion is formed by a portion of the rigid member being wound at a lower density than a remained of the rigid member.”
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Wisman in view of Muse and Yamashita as applied to claim 8 above, and further in view of Yang (U.S. PGPUB No. 20170239447).
Regarding claim 19, the modified system of Wisman teaches the catheter assembly according to claim 8, but Modified Wisman is silent to “wherein: the reinforcement needle comprises a rigid member that is wound along an outer peripheral portion from the proximal end to the distal end to impart rigidity to the reinforcement needle, and the flexible portion is formed by a portion of the rigid member being wound at a lower density than a remained of the rigid member.”
However, Yang teaches a catheter assembly comprising a tubular element (3000, see FIG. 30) wherein: the tubular element (3000) comprises a rigid member (3024, see [0181]: a coil wire, aligning with Applicant disclosure in [0058]) that is wound (see [0181]) along an outer peripheral portion (3020, see [0183]: 3020 is outer jacket and thus is outer periphery) from a proximal end (3022) to a distal end (3038) to impart rigidity to the tubular element (see [0181] and [0185]: coil design varies rigidity according to Shore hardness test), and a flexible portion (3036) is formed by a portion of the rigid member being wound at a lower density (see increased spacing from 3022 to 3034 as shown in FIG.30 and described in [0181]) than a remained of the rigid member (see [0185]: closer wound wire such as in 3022 has increased flexibility compared to zones 3034 with less dense coils).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reinforcement needle disclosed in Modified Wisman to include a rigid member wound around the outer periphery in the manner taught by Yang for the purpose of combining materials and structural elements such as coiled wires to achieve a catheter assembly with a high degree of flexibility with sufficient pushability to traverse treacherous vessels (see [0179-0185]), thus achieving “wherein: the reinforcement needle comprises a rigid member that is wound along an outer peripheral portion from the proximal end to the distal end to impart rigidity to the reinforcement needle, and the flexible portion is formed by a portion of the rigid member being wound at a lower density than a remained of the rigid member.”
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wisman (U.S. PGPUB No. 2020/0094025) in view of Muse (U.S. PGPUB No. 2018/0339131) and Isaacson et al. (U.S. PGPUB No. 2019/0038877), hereinafter Isaacson.
Regarding claim 20, Wisman discloses a method for inserting a catheter into a blood vessel of a patient (see [0081]), the method comprising:
providing a catheter assembly (10, see FIG.6 and see ‘Modified FIG. 2’ and ‘Modified FIG. 3’ below for ease of reference of recited structures)
PNG
media_image1.png
436
735
media_image1.png
Greyscale
PNG
media_image2.png
496
618
media_image2.png
Greyscale
comprising:
the catheter (14), which has a first lumen (42, see FIG. 2),
a catheter hub (12) joined to (see [0057]) a proximal end (38) of the catheter (14),
a reinforcement needle (16) inserted through (see [0061] & [0063]) the first lumen (42) of the catheter (14), having a second lumen (48, see [0061]), and including a distal portion (46) that is blunt (see FIG. 2),
a reinforcement needle hub (22, see [0071]) joined to (see [0071]) a proximal end (see [0071]) of the reinforcement needle (16),
an inner needle (18) inserted through the second lumen (see [0065]) of the reinforcement needle (16) and including a sharp needle tip (54) at a distal end (see [0065] and FIG.2) thereof,
an inner needle hub (26) joined to (see [0077]) a proximal end (58, see FIG. 6 and [0077]) of the inner needle (18),
a first fixing portion (structure between 12 and 22, see [0069]: such as threads as interpreted under 112f above) configured to fix the catheter hub (12 comprising proximal end 30) and the reinforcement needle hub (22 comprising distal end 62) so as not to be detachable by an operation of pulling the catheter hub and the reinforcement needle hub in an axial direction (threads require rotation to detach and thus inherently are configured to fix.. “so as not to be detachable by an operation of pulling”), and
a second fixing portion (80, see [0080]: 80 of hub 26 friction fit to hub lumen 64 of hub 22, such as interpreted under 112f above) configured to fix the reinforcement needle hub (22) and the inner needle hub (26) to each other (see [0080]), wherein:
the reinforcement needle (16) protrudes from (see FIG. 2) a distal end of the catheter (14), and
the inner needle (18) protrudes from (see FIG. 2) a distal end (46) of the reinforcement needle (16);
holding the catheter hub 20 (12) and the reinforcement needle hub (22) of the catheter assembly (see [0082]);
puncturing the blood vessel of the patient with the needle tip of the inner needle (see [0082]) such that blood inside the blood vessel flows back through the inner needle (see [0082]);
gripping the inner needle hub (26) and pulling the inner needle hub (26) toward a direction of a proximal end of the catheter assembly (shown best in FIG.6 and see [0084]), while the reinforcement needle and the reinforcement needle hub are not pulled out from the catheter assembly (see [0084-0085]);
after the inner needle (18) and the inner needle hub (26) are completely removed from the catheter assembly (see [0084] and [0093]), pushing forward the catheter (14) into the blood vessel in a state of being reinforced by the reinforcement needle (16, see [0085-0086]); and
after the distal end of the catheter (14) is inserted into the blood vessel by a desired length (see [0085-0086]), releasing a locked state between the catheter hub (12) and the reinforcement needle hub (22, disengaging structures/ releasing a locked state, see [0086]), pulling out the reinforcement needle hub (22) from the catheter hub 20 (12) so as to completely remove the reinforcement needle (16) and the reinforcement needle hub (22) from the catheter (14) and the catheter hub (12, see FIG. 7 and [0086]).
Wisman is silent to “a rigidity of the reinforcement needle is higher than a rigidity of the catheter”, and puncturing the blood vessel of the patient with the needle tip of the inner needle such that blood inside the blood vessel flows back through the inner needle and “flows into the inner needle hub”.
However, Muse teaches a method for inserting a catheter into a blood vessel of a patient (see FIG. 4A and [0143]), the method comprising providing a catheter assembly (100, see FIG. 4A and ‘Modified FIG. 3’ below for visual of interdisposed tubular structures) comprising a catheter (102) with a catheter lumen (172), a reinforcement needle (106, see [0107]: stiffener 106, also referred to as “reinforcement”) with a reinforcement needle lumen (178), and inner needle (104) with an inner needle lumen (175),
PNG
media_image3.png
413
693
media_image3.png
Greyscale
Wherein a rigidity of the reinforcement needle (106) is higher than (see [0107]: 106 rigid in axial direction to counteract axial forces applied to catheter 102 and therefore must have a rigidity higher than that of the catheter. See also [0138-0140] & [0100]) a rigidity of the catheter (102).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rigidity of the reinforcement needle disclosed in Wisman to be a higher rigidity than that of the catheter in which the reinforcement needle is disposed as taught by Muse for the purpose of ensuring that the reinforcement needle is substantially stiff in the axial direction to counteract axial forces applied to the system during insertion and advancement of the system into a lumen of a vessel (see [0107]), thus achieving “a rigidity of the reinforcement needle is higher than a rigidity of the catheter”
Wisman in view of Muse remain silent to puncturing the blood vessel of the patient with the needle tip of the inner needle such that blood inside the blood vessel flows back through the inner needle and “flows into the inner needle hub”.
However, Isaacson teaches a method for inserting a catheter into a blood vessel of a patient (see [0037]) comprising providing a catheter assembly (112, see ‘Modified FIG. 13’ below)
PNG
media_image8.png
538
721
media_image8.png
Greyscale
comprising an inner needle (10, see FIG. 9 for numeral 10) with a needle tip (22, see FIG. 9 and [0038]), the inner needle(10) fixed to an inner needle hub (134), and the method comprising puncturing the blood vessel of the patient with the needle tip (22, see [0039]) of the inner needle (10) such that blood inside the blood vessel flows back through the inner needle (10, see [0045]) and flows into the inner needle hub (see [0045]: blood flashback into flashback chamber of needle hub 134).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner needle hub affixed to the inner needle that permits proximal blood flow during the puncturing method step disclosed in Wisman to include a flashback chamber of the inner needle hub that to allow blood to collect within the inner needle hub as taught by Isaacson for the purpose of providing the system with a secondary flashback mechanism to further ensure that the system has been properly introduced into a blood vessel (see [0045]), thus achieving puncturing the blood vessel of the patient with the needle tip of the inner needle such that blood inside the blood vessel flows back through the inner needle and “flows into the inner needle hub”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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, Michael Tsai can be reached at (571) 270-5246. 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.
/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783