CTFR 18/455,747 CTFR 97631 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 The amendment filed 04/28/26 has been entered. Claims 1, 9, 14, 17, and 20 have been amended. Claims 2-5 and 12 are in the original/ previously presented form. Claims 6-8, 10 -11, 13, 15-16, and 18-19 are cancelled. Thus, claims 1-5, 9, 12, 14, 17, and 20 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 01/28/26. 07-30-03-h AIA Claim Interpretation 07-30-03 AIA 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. 07-30-05 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 and 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. 07-30-07 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 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 1-2 and 4-5 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) , 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 ” and “ the reinforcement needle comprises a flexible portion that is more flexible than other portions of the reinforcement needle, the flexible portion being located in the first lumen of the catheter at a position proximal of the distal end 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. ” Wisman in view of Muse (FIG. 1) remains silent to “ the reinforcement needle comprises a flexible portion that is more flexible than other portions of the reinforcement needle, the flexible portion being located in the first lumen of the catheter at a position proximal of the distal end of the catheter .” However, in a separate embodiment (see FIG. 21D), Muse teaches a catheter assembly comprising a catheter (802), a reinforcement needle (806), and an inner needle (804), the reinforcement needle (806) comprises a flexible portion (see [0220]: regions with different thicknesses of tubing, aligning with Applicant disclosure of a flexible portion in at least [0028]: flexible portion 30 that has a thin portion formed thinner than other portions of the reinforcement needle 26) that is more flexible than other portions of the reinforcement needle (see [0219-0220]: regions with different thicknesses of tubing to provide desired area moment of inertia/ laterally flexible properties) , the flexible portion (806) being located in a first lumen (see lumen of catheter 802 where 806 is disposed in FIG. 21D) of the catheter (802) at a position proximal of (see [0221], [0224], & [0229]: reinforcement needle 806 shielded within catheter 802 when removed and therefore the flexible portion disposed somewhere along the length of 806 MUST BE proximal of the distal end at least when the reinforcement needle is withdrawn) the distal end (rightward end of 802 in FIG. 21D) of the catheter (802) . 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 Wisman to include a flexible portion (such as by adjusting the wall thickness) being located in the first lumen of the catheter at a position proximal of the distal end of the catheter 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 “ the reinforcement needle comprises a flexible portion that is more flexible than other portions of the reinforcement needle, the flexible portion being located in the first lumen of the catheter at a position proximal of the distal end 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) . 07-22-aia AIA Claim 3 is 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) . 07-22-aia AIA Claim s 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 1 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 1, 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 are formed .” 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 are formed .” 07-22-aia AIA Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Wisman in view of Muse as applied to claim 1 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 1, 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 of the reinforcement needle 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) of the tubular element (3000) 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 of the reinforcement needle 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 .” 07-21-aia AIA 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 (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 (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 ”, “ the reinforcement needle comprises a flexible portion that is more flexible than other portions of the reinforcement needle, the flexible portion being located in the first lumen of the catheter at a position proximal of the distal end 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 (FIG.3) remain silent to “ the reinforcement needle comprises a flexible portion that is more flexible than other portions of the reinforcement needle, the flexible portion being located in the first lumen of the catheter at a position proximal of the distal end 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, in a separate embodiment (see FIG. 21D), Muse teaches a catheter assembly comprising a catheter (802), a reinforcement needle (806), and an inner needle (804), the reinforcement needle (806) comprises a flexible portion (see [0220]: regions with different thicknesses of tubing, aligning with Applicant disclosure of a flexible portion in at least [0028]: flexible portion 30 that has a thin portion formed thinner than other portions of the reinforcement needle 26) that is more flexible than other portions of the reinforcement needle (see [0219-0220]: regions with different thicknesses of tubing to provide desired area moment of inertia/ laterally flexible properties) , the flexible portion (806) being located in a first lumen (see lumen of catheter 802 where 806 is disposed in FIG. 21D) of the catheter (802) at a position proximal of (see [0221], [0224], & [0229]: reinforcement needle 806 shielded within catheter 802 when removed and therefore the flexible portion disposed somewhere along the length of 806 MUST BE proximal of the distal end at least when the reinforcement needle is withdrawn) the distal end (rightward end of 802 in FIG. 21D) of the catheter (802) . 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 the method of Wisman to include a flexible portion (such as by adjusting the wall thickness) being located in the first lumen of the catheter at a position proximal of the distal end of the catheter as taught by Muse (FIG.3) 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 “ the reinforcement needle comprises a flexible portion that is more flexible than other portions of the reinforcement needle, the flexible portion being located in the first lumen of the catheter at a position proximal of the distal end of the catheter ”. Wisman in view of Muse (FIG.3 & FIG. 21D) 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 ” . Response to Arguments 07-37 AIA Applicant's arguments filed 0 4/28/26 h ave been fully considered but they are not persuasive. On page 8, Applicant argues that the flexible portion taught in Muse MUST be a thickness formed on the entire length of the reinforcement needle and therefore Muse cannot teach the amended limitation of the reinforcement needle having a flexible portion “that is more flexible than other portions of the reinforcement needle.” The examiner disagrees and has maintained the rejection under Wisman in view of Muse. Muse teaches in [0220]: “In some instances, the flexibility is substantially the same in all lateral directions, or stated otherwise, the stiffener 806 is substantially symmetrically flexible in all dimensions transverse to the longitudinal axis thereof”. Thus, [0220] similarly teaches that in some instances, the flexibility is non-symmetrically flexible along the longitudinal axis, which would be from differing thicknesses along the length of the catheter (see MPEP § 2123.I: “ A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art…”. ” A person of ordinary skill in the art would have found Muse to suggest a non-symmetrical flexibility achieved by differing thicknesses along the length, especially because modifying shaft wall thicknesses is well known in the art to achieve desired flexibility characteristics ) . Therefore, the examiner was not persuaded by this argument and has maintained the 35 U.S.C. § 103 claim rejections under Wisman in view of Muse. However, should Applicant disagree with the examiner’s view, the examiner also asserts that a rejection similar to claim 12 could be applied to claim 1 in view of Intoccia (Wisman in view of Muse and Intoccia teach the concave portions/ different thicknesses that would also teach the newly amended limitation of the flexible portion as argued). Therefore, Applicant is encouraged to further amend the claims in view of all of the prior art of record. On pages 8-9, Applicant submits that the flexible portion is not located proximal of the distal end of the catheter. The examiner disagrees (see rejection of claim 1 above—the flexible portion is located proximal of the distal end of the catheter AT LEAST in a retracted state) in view of Muse FIG. 21D. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the flexible portion of the reinforcement needle being proximal to the distal end of the catheter at a certain point in time during use of the device) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns , 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, the examiner has maintained the rejection of claim 1 under Wisman in view of Muse. On page 10, Applicant submits that the rejection of claim 20 should be withdrawn for similar reasons as presented for claim 1. However, the examiner was not persuaded by these arguments and therefore maintains the 35 U.S.C. § 103 claim rejection of claim 20 as well. Because no further arguments were presented, the depending claim rejections were subsequently maintained by the examiner. Conclusion 07-40 AIA 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 KATHLEEN PAIGE VOKES 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 VOKES/Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783 Application/Control Number: 18/455,747 Page 2 Art Unit: 3783 Application/Control Number: 18/455,747 Page 3 Art Unit: 3783 Application/Control Number: 18/455,747 Page 4 Art Unit: 3783 Application/Control Number: 18/455,747 Page 5 Art Unit: 3783 Application/Control Number: 18/455,747 Page 6 Art Unit: 3783 Application/Control Number: 18/455,747 Page 7 Art Unit: 3783 Application/Control Number: 18/455,747 Page 8 Art Unit: 3783 Application/Control Number: 18/455,747 Page 9 Art Unit: 3783 Application/Control Number: 18/455,747 Page 10 Art Unit: 3783 Application/Control Number: 18/455,747 Page 11 Art Unit: 3783 Application/Control Number: 18/455,747 Page 12 Art Unit: 3783 Application/Control Number: 18/455,747 Page 13 Art Unit: 3783 Application/Control Number: 18/455,747 Page 14 Art Unit: 3783 Application/Control Number: 18/455,747 Page 15 Art Unit: 3783 Application/Control Number: 18/455,747 Page 16 Art Unit: 3783 Application/Control Number: 18/455,747 Page 18 Art Unit: 3783 Application/Control Number: 18/455,747 Page 19 Art Unit: 3783 Application/Control Number: 18/455,747 Page 20 Art Unit: 3783 Application/Control Number: 18/455,747 Page 21 Art Unit: 3783 Application/Control Number: 18/455,747 Page 22 Art Unit: 3783 Application/Control Number: 18/455,747 Page 23 Art Unit: 3783 Application/Control Number: 18/455,747 Page 24 Art Unit: 3783 Application/Control Number: 18/455,747 Page 25 Art Unit: 3783 Application/Control Number: 18/455,747 Page 26 Art Unit: 3783 Application/Control Number: 18/455,747 Page 27 Art Unit: 3783 Application/Control Number: 18/455,747 Page 28 Art Unit: 3783 Application/Control Number: 18/455,747 Page 29 Art Unit: 3783 Application/Control Number: 18/455,747 Page 30 Art Unit: 3783 Application/Control Number: 18/455,747 Page 31 Art Unit: 3783
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