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 statement (IDS) submitted on 01/19/26 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendment filed 02/23/26 has been entered. Claims 1, 10, 13, 15 have been amended. Claims 2-9, 11-12, and 14 are in the original form. Claims 16-20 remain withdrawn. Thus, claims 1-16 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 01/07/26.
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 2 lines 2-3: “…a securing mechanism engaged with the hub base to secure…”. Therefore, claim 2 is interpreted under 112(f) according to the 3-prong test:
Prong 1: means or generic placeholder is recited— “a securing mechanism” is considered a generic placeholder for “means” because “a securing mechanism” has no specific structural meaning
Prong 2: functional language—to secure
Prong 3: not modified by other structural language in the claims—no structure is recited for how the securing mechanism engaged with the hub base functions in order to “secure” the hub to the sheath. Only the desired outcome of “to secure” is recited.
According to Applicant’s disclosure under 112(f), the a securing mechanism “to secure” is interpreted as a ferrule or equivalent (see Applicant disclosure FIG. 4 [0061]: a ferrule 231 for securing the sheath within the hub).
Claim 12 lines 1-2: “…a securing mechanism for securing…”. Therefore, claim 12 is interpreted under 112(f) according to the 3-prong test:
Prong 1: means or generic placeholder is recited— “a securing mechanism” is considered a generic placeholder for “means” because “a securing mechanism” has no specific structural meaning
Prong 2: functional language—for securing
Prong 3: not modified by other structural language in the claims—no structure is recited for how the securing mechanism functions in order to achieve the function of “securing” the proximal end of the sheath. Only the desired outcome of “for securing” is recited.
According to Applicant’s disclosure under 112(f), the a securing mechanism “for securing” is interpreted as a ferrule or equivalent (see Applicant disclosure FIG. 4 [0061]: a ferrule 231 for securing the sheath within the hub).
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 securing mechanism in claims 3 and 13 because further structure of a ferrule is recited, failing the test at prong C
the securing mechanism in claims 4 and 14 because further structure of a threaded cap is recited, failing the test at prong C
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, 5-8, 10-11, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Patton et al. (U.S. Patent No. 4,886,507), hereinafter Patton in view of Lancette (U.S. PGPUB No. 2016/0114129).
Regarding claim 1, Patton discloses a hemostasis valve hub (20, see FIG. 3) for a sheath (10, see col. 3 lines 39-44 and col. 4 lines 43-50: guide catheter 10), comprising:
a hub base (19) including a first arm (see ‘Modified FIG. 3’ below)
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defining a first lumen (22) and having a distal end (terminating before rotatable coupling 16 of sheath, see ‘Modified FIG. 3’ above) and a proximal end (35, see ‘Modified FIG. 3’ above and col 3 line 64- col. 4 line 6) and a second arm (see ‘Modified FIG. 3’ above) extending from the first arm (see ‘Modified FIG. 3’ above) and defining a second lumen (23) and having a distal end (see ‘Modified FIG. 3’ above) and a proximal end (24, see col. 3 lines 51-53: side arm terminates at 24);
a seal (40, see col. 3 line 64-col. 4 line 6: silicone/ rubber O-ring 40) positioned within (proximal end of lumen 22 extends proximally for passage of 11, see ‘Modified FIG. 2’ below) the first lumen (22)
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and adjacent a lock nut (46/47, see col. 4 lines 7-14: 46 integral with 47), the lock nut (46/47) engaged with the proximal end of the first arm (35, see ‘Modified FIG. 2’ above and col. 3 line 64- col. 4 line 14: 46/47 surround==engaged with socket/proximal end of first arm 35) and positioned at least partially within the first lumen (see col. 4 lines 7-35: 46 inserted into proximal end of branch arm 35 to engage seal 40 and thus is within at least the proximal end of the first lumen as shown in ‘Modified FIG. 2’ above);
a primary seal (55) positioned adjacent (55 near the proximal end of arm 35, see FIG. 2) the proximal end of the first arm (35, see ‘Modified FIG. 2’ above) and a primary cap (57, see col. 4 lines 21-24: cap 57) engaged with the lock nut (46/47);
a secondary seal (28, see FIG. 3 and col. 3 lines 51-63: stopcocks 28. The definition of a stopcock is a valve that is sealed when closed and thus 28 is a secondary seal when closed) positioned adjacent (28 near proximal end of second arm 24, see FIG. 3) the proximal end of the second arm (24);
wherein the first arm (see ‘Modified FIG. 3’ above) is configured for insertion of a first medical device (11) through the seal (40, see col 4 lines 35-40: 11 passes through bore of O-ring 40) and the second arm (see ‘Modified FIG. 3’ above) is configured for insertion of a second medical device (see col. 3 lines 51-63: second arm with lumen 23 has luer lock and thus is “configured for insertion of a second medical device” by way of the luer lock and lumen).
Patton is silent to the second arm is configured for insertion of a second medical device “through the secondary seal, and wherein the secondary seal is configured to seal around the second medical device.”
However, Lancette teaches a hub base (18, see FIG.1) including a first arm (see ‘Modified FIG. 1’ below) and a second arm (see ‘Modified FIG. 1’ below);
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a seal (luer 20/22 has controllable seal and duckbill valves 36/38—see seal in closed position in FIG. 2 and see [0048-0050]) positioned adjacent the first arm (see ‘Modified FIG. 1’ above); a secondary seal (luer 20 has controllable seal and duckbill valves 36/38—see seal in closed position in FIG. 2 and see [0049-0050]) positioned adjacent the proximal end (leftward end of second arm in FIG.1) of the second arm (see ‘Modified FIG. 1’ above); wherein the first arm (see ‘Modified FIG. 1’ above) is configured for insertion of a first medical device (see [0050] and FIG. 4: guide wire/stylet inserted into lumen 31 of valve of luer) and the second arm (see ‘Modified FIG. 1’ above) is configured for insertion of a second medical device through the secondary seal (see [0050] and FIG. 4: guide wire/stylet inserted into lumen 31 through seals 36/38 of luer with controllable seal, such as luer 20), and wherein the secondary seal (controllable seal and duckbill valves 36/38 of luer 20) is configured to seal around the second medical device (see [0050] and FIG.4).
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 substitute the luer lock at the proximal end of the second arm attached to the manifold with secondary seal disclosed in Patton with a luer having a secondary seal configured to seal around a second medical device as taught by Lancette for the purpose of accommodating wire accessories as needed and allowing medical practitioners to easily close and open the seal within the luer (see [0049-0050]), thus achieving the second arm is configured for insertion of a second medical device “through the secondary seal, and wherein the secondary seal is configured to seal around the second medical device.”
Regarding claim 5, the modified device of Patton teaches the hemostasis valve hub of claim 1, and Patton further discloses wherein the lock nut (46/47, see FIG. 2) comprises an inner portion (46) configured to engage (see col. 4 lines 7-35: 46 compresses or relieves pressure on 40 and therefore must be engaged with 40) with the seal (40).
Regarding claim 6, the modified device of Patton teaches the hemostasis valve hub of claim 5, and Patton further discloses wherein the inner portion (46, see FIG. 2) of the lock nut (46/47) is configured to axially compress the seal (40) to decrease the size of a lumen (see col. 3 line -col. 4 line 6: seal 40 in a relaxed condition has lumen/circular opening therethrough of 0.080inch) of the seal (see col. 4 lines 7-35: 46 axially compresses 40 and therefore is “configured to” axially compress the seal to decrease the size of a lumen of the seal).
Regarding claim 7, the modified device of Patton teaches the hemostasis valve hub of claim 1, and Patton further discloses wherein the lock nut (46/47, see FIG. 2) is configured to threadedly engage with (see col. 4 lines 7-14: 47 surrounds and threads onto threads 36 of proximal end of first arm 35) the first arm (proximal end of first arm 35).
Regarding claim 8, the modified system of Patton teaches the hemostasis valve hub of claim 1, and Patton further discloses wherein the primary seal (55) has a diameter (see diameter of 55 shown in FIG. 2), the diameter spanning at least the diameter of a dilation catheter (11, see FIG. 2 and col 4 lines 15-24) .
Patton is silent to “and the secondary seal has a diameter, the diameter of the primary seal being greater than the diameter of the secondary seal.”
However, Lancette teaches a hub base (18, see FIG.1) including a first arm (see ‘Modified FIG. 1’ below) and a second arm (see ‘Modified FIG. 1’ below); a secondary seal (luer 20 has controllable seal and duckbill seals—see seal in closed position in FIG. 2 and see [0049-0050]) positioned adjacent the proximal end (leftward end of second arm in FIG.1) of the second arm (see ‘Modified FIG. 1’ above); and the secondary seal (controllable seal and duckbill seals of luer 20) has a diameter (such as the diameter of duckbill seal 36 spanning lumen 31, see FIG. 4 and [0050]), the diameter of the secondary seal spanning at least the diameter of a guidewire (see [0050]).
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 substitute the luer lock at the proximal end of the second arm attached to the manifold with secondary seal disclosed in Patton with a luer having a secondary seal configured to seal around a second medical device and secondary seal diameter as taught by Lancette for the purpose of accommodating wire accessories as needed and allowing medical practitioners to easily close and open the seal within the luer (see [0049-0050]), thus achieving “and the secondary seal has a diameter and the secondary seal has a diameter, the diameter of the primary seal being greater than the diameter of the secondary seal.”
Regarding claim 10, Patton discloses a delivery system for a plurality of medical devices into a blood vessel (see col. 3 lines 39-44: delivering guide catheter 10, dilation catheter 11, and balloon 12 into heart via coronary artery), comprising:
a sheath (10, see FIG. 3) for insertion into the blood vessel (see col. 3 lines 39-44 and col. 4 lines 43-50: guide catheter 10), the sheath (10) having a proximal end (see col. 4 lines 43-50: guide catheter proximal portion connected to Y connector) and a distal end (see col. 4 lines 43-50: guide catheter distal portion first inserted through patient arm/leg); and
a hemostasis valve hub (20, see col. 3 line 47) for attachment to the proximal end (see col. 4 lines 43-50: guide catheter proximal portion connected to Y connector, and see col. 3 lines 45-50: proximal portion connected to y-connector at the rotator 16) of the sheath (10), the hemostasis valve hub (20) including:
a hub base (19) including a first arm (see ‘Modified FIG. 3’ below)
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defining a first lumen (22) and having a distal end (terminating before rotatable coupling 16 of sheath, see ‘Modified FIG. 3’ above) and a proximal end (35, see ‘Modified FIG. 3’ above and col 3 line 64- col. 4 line 6) and a second arm (see ‘Modified FIG. 3’ above) extending from the first arm (see ‘Modified FIG. 3’ above) and defining a second lumen (23) and having a distal end (see ‘Modified FIG. 3’ above) and a proximal end (24, see col. 3 lines 51-53: side arm terminates at 24);
a seal (40, see col. 3 line 64-col. 4 line 6: silicone/ rubber O-ring 40) positioned within (proximal end of lumen 22 extends proximally for passage of 11, see ‘Modified FIG. 2’ below) the first lumen (22)
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and adjacent a lock nut (46/47, see col. 4 lines 7-14: 46 integral with 47), the lock nut (46/47) engaged with the proximal end of the first arm (35, see ‘Modified FIG. 2’ above and col. 3 line 64- col. 4 line 14: 46/47 surround==engaged with socket/proximal end of first arm 35) and positioned at least partially within the first lumen (see col. 4 lines 7-35: 46 inserted into proximal end of branch arm 35 to engage seal 40 and thus is within at least the proximal end of the first lumen as shown in ‘Modified FIG. 2’ above);
a primary seal (55) positioned adjacent (55 near the proximal end of arm 35, see FIG. 2) the proximal end of the first arm (35, see ‘Modified FIG. 2’ above) and a primary cap (57, see col. 4 lines 21-24: cap 57) engaged with the lock nut (46/47); and
a secondary seal (28, see FIG. 3 and col. 3 lines 51-63: stopcocks 28. The definition of a stopcock is a valve that is sealed when closed and thus 28 is a secondary seal when closed) positioned adjacent (28 near proximal end of second arm 24, see FIG. 3) the proximal end of the second arm (24);
wherein the first arm (see ‘Modified FIG. 3’ above) is configured for insertion of a first medical device (11) through the primary seal (55, see col 4 lines 17-21: 55 grips and seals catheter 11) into the sheath (10, see FIG. 1 with 11 extending through sheath 10 and col 3 lines 39-44) and the second arm (see ‘Modified FIG. 3’ above) is configured for insertion of a second medical device (see col. 3 lines 51-63: second arm with lumen 23 has luer lock and thus is “configured for insertion of a second medical device” by way of the luer lock and lumen) into the sheath (10, see FIG. 1: sheath 10 at distal end of hub and therefore second medical device is configured for insertion into the sheath).
Patton is silent to the second arm is configured for insertion of a second medical device “through the secondary seal”, and “wherein the secondary seal is configured to seal around the second medical device.”
However, Lancette teaches a hub base (18, see FIG.1) including a first arm (see ‘Modified FIG. 1’ below) and a second arm (see ‘Modified FIG. 1’ below);
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a seal (luer 20/22 has controllable seal and duckbill valves 36/38—see seal in closed position in FIG. 2 and see [0048-0050]) positioned adjacent the first arm (see ‘Modified FIG. 1’ above); a secondary seal (luer 20 has controllable seal and duckbill valves 36/38—see seal in closed position in FIG. 2 and see [0049-0050]) positioned adjacent the proximal end (leftward end of second arm in FIG.1) of the second arm (see ‘Modified FIG. 1’ above); wherein the first arm (see ‘Modified FIG. 1’ above) is configured for insertion of a first medical device (see [0050] and FIG. 4: guide wire/stylet inserted into lumen 31 of valve of luer) and the second arm (see ‘Modified FIG. 1’ above) is configured for insertion of a second medical device through the secondary seal (see [0050] and FIG. 4: guide wire/stylet inserted into lumen 31 through seals 36/38 of luer with controllable seal, such as luer 20), and wherein the secondary seal (controllable seal and duckbill valves 36/38 of luer 20) is configured to seal around the second medical device (see [0050] and FIG.4).
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 substitute the luer lock at the proximal end of the second arm attached to the manifold with secondary seal disclosed in Patton with a luer having a secondary seal configured to seal around a second medical device as taught by Lancette for the purpose of accommodating wire accessories as needed and allowing medical practitioners to easily close and open the seal within the luer (see [0049-0050]), thus achieving the second arm is configured for insertion of a second medical device “through the secondary seal”, and “wherein the secondary seal is configured to seal around the second medical device.”
Regarding claim 11, the modified system of Patton teaches the delivery system of claim 10, and Patton further discloses wherein the primary seal (55) has a first diameter (see diameter of 55 shown in FIG. 2), the first diameter spanning at least the diameter of a dilation catheter (11, see FIG. 2 and col 4 lines 15-24) .
Patton is silent to “and the secondary seal has a second diameter, the first diameter is greater than the second diameter.”
However, Lancette teaches a hub base (18, see FIG.1) including a first arm (see ‘Modified FIG. 1’ below) and a second arm (see ‘Modified FIG. 1’ below); a secondary seal (luer 20 has controllable seal and duckbill seals—see seal in closed position in FIG. 2 and see [0049-0050]) positioned adjacent the proximal end (leftward end of second arm in FIG.1) of the second arm (see ‘Modified FIG. 1’ above); and the secondary seal (controllable seal and duckbill seals of luer 20) has a diameter (such as the diameter of duckbill seal 36 spanning lumen 31, see FIG. 4 and [0050]), the diameter of the secondary seal spanning at least the diameter of a guidewire (see [0050]).
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 substitute the luer lock at the proximal end of the second arm attached to the manifold with secondary seal disclosed in Patton with a luer having a secondary seal configured to seal around a second medical device and secondary seal diameter as taught by Lancette for the purpose of accommodating wire accessories as needed and allowing medical practitioners to easily close and open the seal within the luer (see [0049-0050]), thus achieving “and the secondary seal has a second diameter, the first diameter is greater than the second diameter.”
Regarding claim 15, the modified system of Patton teaches the delivery system of claim 10, and Patton further discloses wherein an engagement (see col. 4 lines 7-35: 46 compresses or relieves pressure on 40 and therefore must be engaged with 40) of the lock nut (46/47, see ) and the seal (40) causes a lumen of the seal to decrease in size (see col. 3 line 64-col. 4 line 6: seal 40 in a relaxed condition has lumen/circular opening therethrough of 0.080 inch and see col. 5 lines 4-27: fully compressed valve will completely block flow through lumen 22, including lumen through seal, decreasing the size of the lumen to as closely match the catheter ~ 0.04 to 0.035”, which is less than 0.08 inches).
Claims 2-3 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Patton in view of Lancette as applied to claims 1 and 10, respectively, above, and further in view of Carlyon et al. (U.S. PGPUB No. 2008/0082082), hereinafter Carlyon.
Regarding claim 2, the modified system of Patton teaches the hemostasis valve hub of claim 1, and Patton further discloses wherein the hemostasis valve hub (20, see FIG. 3) further comprises a securing mechanism (21) engaged with (21 formed on 19 and is therefore “engaged with”) the hub base (19) to secure (see col. 3 lines 45-50: luer slip 21 of hub base 19 connects to rotatable coupling 16 of sheath 10) the hemostasis valve hub (20) to the sheath (10).
Modified Patton is silent to the securing mechanism being specifically a ferrule as interpreted under 112f above.
However, Carlyon teaches a hemostasis valve hub (see FIG. 1 and [0046]) for a sheath (108), the hemostasis valve hub having a hub base (106), wherein the hub base (106) comprises a securing mechanism (107, see [0045]: ferrule 107 secured to hub 106) engaged with (see [0045]: ferrule 107 secured within hub 106 and is therefore “engaged with”) the hub base (106) to secure (see [0045]: ferrule 107 secured to 108) the hemostasis valve hub (hub comprises hub base 106) to the sheath (108).
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 securing mechanism disclosed in Patton to include a ferrule as taught by Carlyon for the purpose of forming the mechanical coupling of the securing mechanism by preferred conventional means (see [0045]), thus achieving the securing mechanism being specifically a ferrule as interpreted under 112f.
Regarding claim 3, the modified system of Patton teaches the hemostasis valve hub of claim 2, but Modified Patton is silent to “wherein the securing mechanism is a ferrule positioned within the hub base.”
However, Carlyon teaches a hemostasis valve hub (see FIG. 1 and [0046]) for a sheath (108), the hemostasis hub valve having a hub base (106) comprising a securing mechanism (107, see [0045]: ferrule 107 secured to hub 106), wherein the securing mechanism (107) is a ferrule (see [0045]) positioned within (see [0045]: ferrule 107 secured within hub 106) the hub base (106).
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 securing mechanism of the hemostasis valve hub base disclosed in Patton to include a ferrule positioned within the hub base as taught by Carlyon for the purpose of forming the mechanical coupling of the securing mechanism by preferred conventional means (see [0045]), thus achieving “wherein the securing mechanism is a ferrule positioned within the hub base.”
Regarding claim 12, the modified system of Patton teaches the delivery system of claim 10, and Patton further discloses wherein the hub base (19, see FIG. 3) comprises a securing mechanism (21) for securing to the proximal end (see col. 3 lines 45-50: luer slip 21 of hub base 19 connects to rotatable coupling 16 of sheath 10) of the sheath (10).
Modified Patton is silent to the securing mechanism being specifically a ferrule as interpreted under 112f above.
However, Carlyon teaches a delivery system for a plurality of medical devices (108 & 156, see FIG. 1) into a blood vessel (see [0046]) comprising a sheath (108) and a hub base (106), wherein the hub base (106) comprises a securing mechanism (107, see [0045]: ferrule 107 secured to hub 106) for securing the proximal end (see [0045]: ferrule 107 secured to 108 and securement at proximal end as seen in FIG.1) of the sheath (108).
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 securing mechanism disclosed in Patton to include a ferrule as taught by Carlyon for the purpose of forming the mechanical coupling of the securing mechanism by preferred conventional means (see [0045]), thus achieving the securing mechanism being specifically a ferrule as interpreted under 112f.
Regarding claim 13, the modified system of Patton teaches the delivery system of claim 12, but Modified Patton is silent to “wherein the securing mechanism is a ferrule positioned within the hub base of the hemostasis valve hub.”
However, Carlyon teaches a delivery system for a plurality of medical devices (108 & 156, see FIG. 1) into a blood vessel (see [0046]) comprising a sheath (108) and a hub base (106), wherein the hub base (106) comprises a securing mechanism (107, see [0045]: ferrule 107 secured to hub 106) and wherein the securing mechanism (107) is a ferrule (see [0045]) positioned within (see [0045]: ferrule 107 secured within hub) the hub base (106).
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 securing mechanism of the hemostasis valve hub base disclosed in Patton to include a ferrule positioned within the hub base as taught by Carlyon for the purpose of forming the mechanical coupling of the securing mechanism by preferred conventional means (see [0045]), thus achieving “wherein the securing mechanism is a ferrule positioned within the hub base of the hemostasis valve hub.”
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Patton in view of Lancette and Carlyon as applied to claims 2 and 12, respectively, above, and further in view of Haslam et al. (U.S. PGPUB No. 2022/0184367), hereinafter Haslam.
Regarding claim 4, the modified system of Patton teaches the hemostasis valve hub of claim 2, but Modified Patton is silent to “wherein the hub base comprises a narrowed portion and the securing mechanism includes a threaded cap engaged with the narrowed portion and the sheath.”
However, Haslam teaches a hemostasis valve hub (see FIG. 2A) with a hub base (110) and a securing mechanism (170) engaged with (see [0045]: 170 coupled to distal end of base 110) the hub base (110) to secure the hemostasis valve hub to a sheath (see [0045]: a catheter, such as catheter 102, see [0049]), wherein the hub base (110) comprises a narrowed portion (111, seen best in ‘Modified FIG. 9A’ below)
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and the securing mechanism (170) includes a threaded cap (174, see [0045]: rotator body 174 includes a threaded nut 178) engaged with (see FIG. 2A) the narrowed portion (111) and the sheath (catheter, see [0045]: 174 includes 178 for coupling to female luer of medical device and thus is engaged with the sheath via female luer).
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 securing mechanism taught by Modified Patton to be a swivel fitting including a threaded cap engaged with a narrowed portion of the hub base and the sheath as taught by Haslam for the purpose of facilitating manipulation of the catheter by allowing the hemostasis valve device to be placed on a flat surface without rotating the catheter (see [0045]), thus achieving “wherein the hub base comprises a narrowed portion and the securing mechanism includes a threaded cap engaged with the narrowed portion and the sheath”.
Regarding claim 14, the modified system of Patton teaches the delivery system of claim 12, but Modified Patton is silent to “wherein the securing mechanism is composed of a narrowed portion of the hub base having a threaded portion and a threaded cap configured for attachment to the threaded portion.”
However, Haslam teaches a delivery system for a plurality of medical devices into a blood vessel (see [0029]), comprising: a sheath (102, see [0049]: a catheter 102) and a hub base (110) comprising a securing mechanism (170, see FIG. 2A and [0045]: fluid fitting 170 includes swivel fitting 171 formed of hub 172, collar 173, body 174, and O-ring 176) for securing to the proximal end (see ‘Modified FIG. 9Ai’ below) of the sheath (102),
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wherein the securing mechanism (170) is composed of a narrowed portion (111, see ‘Modified FIG. 9A above) of the hub base (110, see FIG. 2A) having a threaded portion (172, see [0045]: 172 is fixedly coupled to distal end of body 110, which is the narrowed portion such as seen clearly in FIG. 3A) and a threaded cap (178) configured for attachment to the threaded portion (see [0045]: 178 provided on 174 which forms 171 of 170 together with threaded portion 172 and 173/176. Therefore 178 is “configured for attachment” to threaded portion 172 by way of 174).
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 securing mechanism taught by Modified Patton to be a swivel fitting including a threaded cap engaged with a threaded narrowed portion of the hub base as taught by Haslam for the purpose of facilitating manipulation of the catheter by allowing the hemostasis valve device to be placed on a flat surface without rotating the catheter (see [0045]), thus achieving “wherein the securing mechanism is composed of a narrowed portion of the hub base having a threaded portion and a threaded cap configured for attachment to the threaded portion.”
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Patton in view of Lancette as applied to claim 1 above, and further in view of Fantuzzi et al. (U.S. PGPUB No. 2021/0085923), hereinafter Fantuzzi.
Regarding claim 9, Patton discloses wherein the primary seal (55) has a thickness (see ‘Modified FIG. 3ii’ below).
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Patton is silent to “and the secondary seal has a thickness, the thickness of the primary seal being greater than the thickness of the secondary seal.”
However, Lancette teaches a hub base (18, see FIG.1) including a first arm (see ‘Modified FIG. 1’ below) and a second arm (see ‘Modified FIG. 1’ below); a secondary seal (luer 20 has controllable seal and duckbill seals—see seal in closed position in FIG. 2 and see [0049-0050]) positioned adjacent the proximal end (leftward end of second arm in FIG.1) of the second arm (see ‘Modified FIG. 1’ above); and the secondary seal (controllable seal and duckbill seals of luer 20) has a thickness (such as the thickness of duckbill valve 36, see ‘Modified FIG. 4’ below).
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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 substitute the luer lock at the proximal end of the second arm attached to the manifold with secondary seal disclosed in Patton with a luer having a secondary seal configured to seal around a second medical device and secondary seal thickness as taught by Lancette for the purpose of accommodating wire accessories as needed and allowing medical practitioners to easily close and open the seal within the luer (see [0049-0050]), thus achieving “and the secondary seal has a thickness.”
Patton in view of Lancette remain silent to “the thickness of the primary seal being greater than the thickness of the secondary seal.”
However, Fantuzzi teaches a hemostasis valve hub for a sheath comprising a hub base including a first arm (230, see [0032]) having a primary seal (238, see [0032]: first arm 230 forming lumen 235 sealed by valve 238) positioned adjacent (as seen in FIG. 2) a proximal end (232) of the first arm (230) and a second arm (250) having a secondary seal (258, see [0032]: 258 seals lumen 255 of second arm 250) positioned adjacent (as seen in FIG. 2) a proximal end (252) of the second arm (250). Fantuzzi further teaches wherein the primary seal (238) has a thickness (see [0032]: 238 has opening for medical device passage. Thus, the thickness if from the opening to the edge of the valve as seen in ‘Modified FIG. 2’ below)
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and the secondary seal (258) has a thickness (see [0032]: 258 has opening for medical device passage. Thus, the thickness if from the opening to the edge of the valve as seen in ‘Modified FIG. 2’ above), the thickness of the primary seal (238) being greater than (as seen in ‘Modified FIG. 2’ above and [0032]) the thickness of the secondary seal (258).
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 primary seal thickness relative to the secondary seal thickness taught by Modified Patton to be larger than the secondary seal thickness as taught by Fantuzzi for the purpose of allowing a smaller sized medical device therethrough (See [0032]. A smaller internal opening through the primary seal would fit a smaller device and increase the thickness of the valve, which is the distance from the opening to the valve edge as shown in ‘Modified FIG. 2’ above), thus achieving “the thickness of the primary seal being greater than the thickness of the secondary seal”.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
A new rejection under Patton in view of Lancette has been used to address the newly amended claim limitations, rendering the arguments against Patton moot.
Conclusion
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 FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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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.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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