DETAILED ACTION
This is in response to the Patent Application filed 1/2/2024 wherein claims 1-20 are presented for examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 3 and 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/24/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “1000” has been used to designate both a portion of the connector cord and a portion of the control handle in Figure 1.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “B” in Figures 6A and 7A and “S” in Figures 6B and 7B.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 11 is objected to because of the following informalities:
“position he valve” (Claim 11, line 2) is believed to be in error for - - position the valve - -;
“on position., said” (Claim 11, line 4) is believed to be in error for - - on position, said - -;
“component” (Claim 11, line 5) is believed to be in error for - - component. - -
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2 and 4-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the valve well channel" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the valve well" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claims 2 and 4-13 are rejected for the same reasons discussed above based on their dependency to claim 1.
Claim 6 recites the limitation “the valve-well-suction-application port” in lines 7-8. There is insufficient antecedent basis for this limitation in the claim.
Claims 8-11 are rejected for the same reasons above based on their dependency to Claim 6.
Claim 7 recites the limitation "the valve shaft suction channel" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the valve shaft suction application port" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "a valve well" in line 3. It is unclear if the “valve well” recited in line 3 of claim 12 is referring to the same “valve well” recited in line 11 of claim 1 or if it is referring to a different valve well.
Claim 13 is rejected for the same reasons discussed above based on its dependency to claim 12.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scutti et al. (US 2020/0375434).
Regarding Independent Claim 1, Scutti teaches (Figures 1A-5C) a valve shaft (24) configured to shift within the valve well channel (within 12) of a valve assembly (10) of a medical instrument (see abstract) along an actuation axis (a longitudinal axis through 10; see Figures 1A-1B) and between an off position (Figure 1B), in which the valve assembly (10) is in an off configuration (off with respect to the fluid flow through 16 to 18; see Figure 1B), and an on position (Figure 1A), in which the valve assembly (10) is in an on configuration (on with respect to the fluid flow through 16 to 18 and 48; see Figure 1A), said valve shaft (24) comprising:
a valve shaft proximal component (26) having a proximal end (the end near 32) and a distal end (the end near 48) and formed of a first material (Paragraph 0018); and
a valve shaft distal component (28) having a proximal end (the end near 50) and a distal end (the end near 60) and formed of a second material (Paragraphs 0018 and 0025);
wherein:
the first material is more rigid than the second material (see Paragraphs 0018 and 0025);
the second material is configured to seal a port (22) defined in the valve well (within 12; see Figures 1A-1B); and
said valve shaft distal component (28) extends distally beyond (see Figures 1A-1B) said valve shaft proximal component (26).
Claims 1 and 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCabe (US 2021/0378486).
Regarding Independent Claim 1, McCabe teaches (Figures 1-7) a valve shaft (39, 40) configured to shift within the valve well channel (within 46) of a valve assembly (28) of a medical instrument (see title) along an actuation axis (L-L) and between an off position (see Figure 5), in which the valve assembly (28) is in an off configuration (see Figure 5 and Paragraph 0032), and an on position (see Figure 6), in which the valve assembly (28) is in an on configuration (see Figure 6 and Paragraph 0033), said valve shaft (39, 40) comprising:
a valve shaft proximal component (39) having a proximal end (at 72) and a distal end (the end of 39 connected to 40) and formed of a first material (Paragraph 0028); and
a valve shaft distal component (40) having a proximal end (40a) and a distal end (40b) and formed of a second material (Paragraph 0031);
wherein:
the first material is more rigid than the second material (Paragraphs 0028 and 0031);
the second material (the flexible, deformable material; see Paragraph 0031) is configured to seal a port (71) defined in the valve well (within 46); and
said valve shaft distal component (40) extends distally beyond (see Figures 5-6) said valve shaft proximal component (39).
Regarding Claim 5, McCabe teaches the invention as claimed and as discussed above. McCabe further teaches (Figures 1-7) wherein said valve shaft distal component (40) has an outer diameter (at 80) larger than an inner diameter of the valve well channel (within 46) of the valve assembly (28) in which said valve shaft (39, 40) is to be extended (see Figures 5-6).
Regarding Claim 6, McCabe teaches the invention as claimed and as discussed above. McCabe further teaches (Figures 1-7) wherein: said valve shaft distal component (40) defines a valve shaft suction channel (the channel formed between 40b and 46 in the position shown in Figure 6) therethrough extending along the actuation axis (L-L) and in fluid communication (see Figure 6) with a valve-well-suction-source port (73) at a distal end (see Figures 5-6) of the valve well channel (within 46); and said valve shaft (39, 40) further defines a valve-shaft-suction-application port (71) extending transverse to the actuation axis (L-L) and in fluid communication with (see the flow arrows in Figure 6) the valve shaft suction channel (the channel formed between 40b and 46 in the position shown in Figure 6); when said valve shaft (39, 40) is in the off position (see Figure 5 and Paragraph 0032), said valve shaft distal component (40) seals the valve-well-suction-application port (71) from fluid communication with (see Figure 5) the valve-well-suction-source port (73); and when said valve shaft (39, 40) is in the on position (see Figure 6), the valve-shaft-suction-application port (71) is in fluid communication with (see Figure 6) the valve-well-suction-application port (73) to put the valve-well-suction-application port (73) in fluid communication with the valve-well-suction-source port (71) via the valve shaft suction channel (the channel formed between 40b and 46 in the position shown in Figure 6).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over McCabe (US 2021/0378486) in view of Neelamegam et al. (US 2020/0138277).
Regarding Claim 2, McCabe teaches the invention as claimed and as discussed above. McCabe further teaches (Figures 1-7) said valve shaft proximal component (39) has a distal extension (annotated below) configured to extend into the proximal end (annotated below) of said valve shaft distal component (40). McCabe teaches that the sealing member is formed of a flexible, deformable material such as silicon or silicone rubber, TPE (thermoplastic elastomer), TPR (thermoplastic rubber), or PVC (see Paragraph 0031). McCabe does not teach, however, that the valve shaft distal component is formed of foam.
Neelamegam teaches (Figures 1-29) a seal member (100, 200, 300) that may comprise of a material such as plastic, foam, silicone, rubber, or elastomer that may be suitable for sealing about a medical device (Paragraph 0109).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify McCabe to have the valve shaft distal component be formed of foam, as taught by Neelamegam, since it has been held to be within the general skill of a worker in the art to select a known material (or material compound) on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
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Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over McCabe (US 2021/0378486) in view of Scutti et al. (US 2020/0375434).
Regarding Claim 4, McCabe teaches the invention as claimed and as discussed above. McCabe does not teach, as discussed so far, wherein said valve shaft proximal component and said valve shaft distal component are secured together by being at least one of insert molded, overmolded, snap-fitted, interference fitted, welded, bonded, or adhered together.
Scutti teaches (Figures 1A-5C) a valve shaft proximal component (102) and a valve shaft distal component (160) that are secured together by bonding or adhesive (Paragraph 0045).
It would have been obvious to one having ordinary skill in the art before the effective filing date fo the claimed invention to have said valve shaft proximal component and said valve shaft distal component are secured together by being at least one of insert molded, overmolded, snap-fitted, interference fitted, welded, bonded, or adhered together, as taught by Scutti, so that the seal and valve stem may be formed of different materials (Paragraph 0045 of Scutti).
In accordance to MPEP 2113, the method of forming the device is not germane to the issue of patentability of the device itself. Therefore, this limitation has been given very little patentable weight. Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product (in this case the valve shaft proximal component and valve shaft distal component) , does not depend on its method of production (i.e. insert molded, overmolded, snap-fitted, interference fitted, welded, bonded, or adhered together), In re Thorpe, 227 USPQ 964, 966 (Federal Circuit 1985). Further, where a product by process claim is rejected over a prior art product that appears to be identical, although produced by a different process, the burden is upon the applicants to come forward with evidence establishing an unobvious difference between the two. See In re Marosi, 218 USPQ 289 (Fed. Cir. 1983).
Additionally, it has been held in re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). “[I]t is the patentability of the product claimed (in this case the valve shaft proximal component and valve shaft distal component) and not of the recited process steps (in this case the insert molded, overmolded, snap-fitted, interference fitted, welded, bonded, or adhered process) which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” (see MPEP 2113).
Claims 1 and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Keiji (JP 2004/4166944 – see IDS filed 4/11/2024) in view of McCabe (US 2021/0378486).
Regarding Independent Claim 1, Keiji teaches (Figures 1-19) a valve shaft (59) configured to shift within the valve well channel (within 27) of a valve assembly (the assembly shown in Figures 6-10) of a medical instrument (see abstract) along an actuation axis (a central longitudinal axis through piston body 59) and between an off position (see Figure 6), in which the valve assembly (the assembly shown in Figures 6-10) is in an off configuration (see Figure 6), and an on position (see Figure 10), in which the valve assembly (the assembly shown in Figures 6-10) is in an on configuration (see Figure 10), said valve shaft (59) comprising:
a valve shaft proximal component (annotated below) having a proximal end (annotated below) and a distal end (annotated below) and formed of a first material (see Figures 6-10); and
a valve shaft distal component (annotated below) having a proximal end (annotated below) and a distal end (annotated below) and formed of a second material (see Figures 6-10);
wherein:
the second material (the material of the valve shaft distal component; see annotation below) is configured to seal a port (43) defined in the valve well (within 27); and
said valve shaft distal component (annotated below) extends distally beyond (see Figures 6-10) said valve shaft proximal component (annotated below).
Keiji does not teach that the first material is more rigid than the second material.
McCabe teaches (Figures 1-7) a valve shaft (39, 40) comprising: a valve shaft proximal component (39) having a proximal end (at 72) and a distal end (the end of 39 connected to 40) and formed of a first material (Paragraph 0028); and a valve shaft distal component (40) having a proximal end (40a) and a distal end (40b) and formed of a second material (Paragraph 0031); wherein: the first material is more rigid than the second material (Paragraphs 0028 and 0031); the second material (the flexible, deformable material; see Paragraph 0031) is configured to seal a port (71) defined in the valve well (within 46); and said valve shaft distal component (40) extends distally beyond (see Figures 5-6) said valve shaft proximal component (39).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Keiji to have the first material be more rigid than the second material, as taught by McCabe, in order for the stem to be formed of a rigid material and extend upwardly from the valve body interior and for the sealing member to be formed of a flexible, deformable material (Paragraphs 0028 and 0031 of McCabe). In addition, it has been held to be within the general skill of a worker in the art to select a known material (or material compound) on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
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Regarding Claim 5, Keiji in view of McCabe teaches the invention as claimed and as discussed above. Keiji further teaches (Figures 1-19) wherein said valve shaft distal component (annotated above) has an outer diameter (at S1 and S2) that is larger than an inner diameter of the valve well channel (within 27) of the valve assembly (see Figures 6-10) in which said valve shaft (59) is to be extended (see Figures 6-10).
It is noted that McCabe also teaches (Figures 1-7) wherein said valve shaft distal component (40) has an outer diameter (at 80) larger than an inner diameter of the valve well channel (within 46) of the valve assembly (28) in which said valve shaft (39, 40) is to be extended (see Figures 5-6).
Regarding Claim 6, Keiji in view of McCabe teaches the invention as claimed and as discussed above. Keiji further teaches (Figures 1-19) wherein: said valve shaft distal component (annotated above) defines a valve shaft suction channel (82) therethrough extending along the actuation axis (see Figures 6-10) and in fluid communication (see Figure 10) with a valve-well-suction-source port (41) at a distal end (see Figures 6-10) of the valve well channel (within 27); and said valve shaft (59) further defines a valve-shaft-suction-application port (83) extending transverse to the actuation axis (see Figures 6-10) and in fluid communication with (see Figure 6-10) the valve shaft suction channel (82); when said valve shaft (59) is in the off position (see Figure 6), said valve shaft distal component (annotated above) seals the valve-well-suction-application port (43) from fluid communication with (see Figure 6) the valve-well-suction-source port (41); and when said valve shaft (59) is in the on position (see Figure 10), the valve-shaft-suction-application port (83) is in fluid communication with (see Figure 10) the valve-well-suction-application port (43) to put the valve-well-suction-application port (43) in fluid communication with the valve-well-suction-source port (41) via the valve shaft suction channel (82).
Regarding Claim 7, Keiji in view of McCabe teaches the invention as claimed and as discussed above. Keiji further teaches (Figures 1-19) wherein the valve shaft suction channel (82) and the valve shaft suction application port (83) are defined in said valve shaft distal component (annotated above) distal to the distal end (annotated above) of said valve shaft proximal component (annotated above).
Regarding Claim 8, Keiji in view of McCabe teaches the invention as claimed and as discussed above. Keiji further teaches (Figures 1-19) wherein said valve shaft distal component (annotated above) includes one or more circumferential seal elements (S1, S2) extending circumferentially around and radially outwardly therefrom (see Figures 6-10) to seal with respect to the valve well channel (within 27).
Regarding Claim 9, Keiji in view of McCabe teaches the invention as claimed and as discussed above. Keiji further teaches (Figures 1-19) wherein said one or more circumferential seal elements (S1, S2) are axially spaced apart from one another along the actuation axis (see Figures 6-10).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Keiji (JP 2004/4166944 – see IDS filed 4/11/2024) in view of McCabe (US 2021/0378486) as applied to claims 8 and 9 above, and further in view of Busch et al. (US 2023/0404377).
Regarding Claim 10, Keiji in view of McCabe teaches the invention as claimed and as discussed above. Keiji further teaches (Figures 1-19) when said valve shaft (59) is in the on position (see Figure 10), said valve shaft (59) is sealed from fluid communication with the valve shaft suction channel (82) and the valve-well-suction-source port (41) by at least one of said circumferential seal elements (S1, S2). Keiji in view of McCabe does not teach, as discussed so far, wherein when said valve shaft is in the off position the valve shaft suction channel is in the fluid communication with bleed passages in the valve assembly and with the valve-well-suction-source port,
Busch teaches (Figures 1-10) wherein when said valve shaft (13) is in the off position (see Figure 7) the valve shaft suction channel (at 18) is in the fluid communication with bleed passages (the flow through 31, 28; see Figure 7) in the valve assembly (see Figure 5) and with the valve-well-suction-source port (at 12).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Keiji in view of McCabe to have the valve shaft suction channel is in the fluid communication with bleed passages in the valve assembly and with the valve-well-suction-source port when said valve shaft is in the off position, as taught by Busch, in order to allow air from the surroundings to be sucked into the suction valve in the valve closed state to avoid a built-up of a vacuum in the valve closed state which would result in an undesirable rapid increase in suction flow when the valve is transferred from the valve closed state to the valve open state (Paragraph 0107 of Busch).
Regarding Claim 11, Keiji in view of McCabe teaches the invention as claimed and as discussed above. Keiji further teaches (Figures 1-19) when said valve shaft (59) is in the on position (see Figure 10), said valve shaft (59) is sealed from fluid communication with the valve shaft suction channel (82) and the valve-well-suction-source port (41) by said valve shaft distal component (annotated above). Keiji in view of McCabe does not teach, as discussed so far, wherein when said valve shaft is in the off position the valve shaft suction channel is in the fluid communication with bleed passages in the valve assembly and with the valve-well-suction-source port,
Busch teaches (Figures 1-10) wherein when said valve shaft (13) is in the off position (see Figure 7) the valve shaft suction channel (at 18) is in the fluid communication with bleed passages (the flow through 31, 28; see Figure 7) in the valve assembly (see Figure 5) and with the valve-well-suction-source port (at 12).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Keiji in view of McCabe to have the valve shaft suction channel is in the fluid communication with bleed passages in the valve assembly and with the valve-well-suction-source port when said valve shaft is in the off position, as taught by Busch, in order to allow air from the surroundings to be sucked into the suction valve in the valve closed state to avoid a built-up of a vacuum in the valve closed state which would result in an undesirable rapid increase in suction flow when the valve is transferred from the valve closed state to the valve open state (Paragraph 0107 of Busch).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Keiji (JP 2004/4166944 – see IDS filed 4/11/2024) in view of McCabe (US 2021/0378486) as applied to claim 1 above, and further in view of Fukushima et al. (US 2015/0148608).
Regarding Claim 12, Keiji in view of McCabe teaches the invention as claimed and as discussed above. Keiji in view of McCabe does not teach, as discussed so far, wherein: said valve shaft is axially shiftable between the off position and on position with respect to a valve cap configured to be coupled to a valve well of the valve assembly; and said valve shaft proximal component comprises one or more hard stop features engaging the valve cap to limit axial and/or rotational movement of said valve shaft with respect to the valve cap.
Fukushima teaches (Figures 1-11) a valve shaft (51) that is axially shiftable between an off position and on position (see Figures 9-11) with respect to a valve cap (47, 52) configured to be coupled to a valve well (50) of the valve assembly (29); and said valve shaft proximal component (65, 52) comprises one or more hard stop features (76b, 90a, 90b) engaging the valve cap (47, 52) to limit axial and/or rotational movement of (see Figures 9-11 and Paragraphs 0057 and 0087) said valve shaft (51) with respect to the valve cap (47, 52).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Keiji in view of McCabe to have said valve shaft be axially shiftable between the off position and on position with respect to a valve cap configured to be coupled to a valve well of the valve assembly; and said valve shaft proximal component comprises one or more hard stop features engaging the valve cap to limit axial and/or rotational movement of said valve shaft with respect to the valve cap, as taught by Fukushima, in order to couple the valve cylinder with the cap device firmly without rotation (Paragraph 0057 of Fukushima).
Regarding Claim 13, Keiji in view of McCabe and Fukushima teaches the invention as claimed and as discussed above. Keiji in view of McCabe and Fukushima does not teach, as discussed so far, wherein the valve cap is configured to be rotationally fixed with respect to the valve well; and said valve shaft is rotationally fixed with respect to the valve cap and axially shiftable with respect thereto.
Fukushima teaches (Figures 1-11) wherein the valve cap (47, 52) is configured to be rotationally fixed with (see Paragraphs 0057 and 0087) respect to the valve well (50); and said valve shaft (51) is rotationally fixed with respect to the valve cap (47, 52) and axially shiftable with respect thereto (see Figures 9-11, Paragraph 0057, and Paragraph 0087).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Keiji in view of McCabe and Fukushima to have the valve cap be configured to be rotationally fixed with respect to the valve well; and said valve shaft is rotationally fixed with respect to the valve cap and axially shiftable with respect thereto, as taught by Fukushima, for the same reasons discussed above in claim 12.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS P BURKE whose telephone number is (571)270-5407. The examiner can normally be reached M-F 8:30-5:00 PM.
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/THOMAS P BURKE/Primary Examiner, Art Unit 3741
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