DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 16 objected to because of the following informalities:
Claim 16 recites “wherein the valve stem and the elastomer interface member are monolithic.”
It is unclear from the drawings how the stem and interface member are monolithic to each other. In light of the drawings (FIGs 1a-2b), understood as -- the valve stem and the elastomer interface member are monolithic, respectively—for examination.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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(s) 1-9 and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshimoto et al (US 5257773).
Regarding claim 1, Yoshimoto (FIGs 1-19) discloses “An interface member for a medical device valve, comprising:
a cap (14, 53) adjustable between a first configuration (passive up position like FIGs 2, 18) and a second configuration (pressed down position like FIGs 6, 19), the cap comprising:
a spring portion (bent middle portion in FIG 19) configured to bias the cap to the first configuration (it is elastic);
a first engagement portion (top neck portion and adjacent space that couples to and surrounds 13, 56) configured to engage a valve stem (13, 56); and
a second engagement portion (bottom portion) configured to engage a valve well (8, 9),
wherein the spring portion is configured to adjust radially in response to adjustment of the cap between the first configuration and the second configuration (see FIG 6, 19).”
Regarding claim 2, Yoshimoto (FIGs 1-19) discloses “wherein a proximal end (topmost end) of the cap is configured to adjusted longitudinally when adjusting the cap between the first configuration and the second configuration (top of cap longitudinally displaces during movement).”
Regarding claim 3, Yoshimoto (FIGs 1-19) discloses “wherein the spring portion (bent middle portion) and the first engagement portion (top portion) are configured to adjust longitudinally relative to the second engagement portion when the cap is adjusted between the first configuration and the second configuration (see FIGs 2, 6, 18, 19).”
Regarding claim 4, Yoshimoto (FIGs 1-19) discloses “wherein the spring portion, the first engagement portion, and the second engagement portion are formed from a single component (see FIGs).”
Regarding claim 5, Yoshimoto (FIGs 1-19) discloses “wherein the single component is formed from elastomer (made of rubber).”
Regarding claim 6, Yoshimoto (FIGs 1-11) discloses “wherein the first engagement portion comprises one or more recesses (radially expanded space immediately below the top bottleneck of 14 seen to be a “recess” radially outward relative to the bottleneck) configured to receive the valve stem (radially receives a radially larger portion of 14, to form an axial fixture between 14 and 13 at the top end).”
Regarding claim 7, Yoshimoto (FIGs 1-11) discloses “wherein the first engagement portion (top stem-engaging portion) comprises one or more protrusions (bottleneck that couples to stem read as “protrusion” as it protrudes radially inward relative to body of cap) configured to be received by the valve stem (see FIGs, neck received in a recess of the stem in FIGs).”
Regarding claim 8, Yoshimoto (FIGs 1-11) discloses “wherein the second engagement portion (bottom housing-engaging portion) comprises one or more recesses (variant in FIG 2, lower portion near 9 contains an outer annular recess that contours with 8) configured to receive the valve well.”
Regarding claim 9, Yoshimoto (FIGs 1-19) discloses “wherein a distal end of the cap includes a tapered edge (variant in FIG 11, tapered lower portion of 53 facilitates a contour connection with the upper opening of the well) configured to facilitate a snap connection between the cap and the valve well (understood that a deflecting “snap” would occur when fitting 53 into the well).”
Regarding claim 11, Yoshimoto (FIGs 1-19) discloses “wherein the cap (14) defines an inner space (interior of 14) configured to receive the valve stem (see FIGs), wherein the inner space has an inner diameter that tapers in a proximal direction along a first section (interior of 14 tapers inward in the upward direction from the bending point of 14) of the spring portion and tapers in a distal direction along a second section of the spring portion (interior of 14 tapers radially inwards in the downward direction from the bending point of 14, forming a diamond-like cross-section for the interior of 14).”
Regarding claim 12, Yoshimoto (FIGs 1-19) discloses “wherein the cap has an outer diameter that tapers in the proximal direction along the first section and the second section (14 tapers inward from bottom [at 15] to its topmost end).”
Claim(s) 1-8, 13, and 15-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yabe (US 4562830).
Regarding claim 1, Yabe (FIGs 1-8) discloses “An interface member for a medical device valve, comprising:
a cap (27) adjustable between a first configuration (FIG 2) and a second configuration (FIG 3), the cap comprising:
a spring portion (flexing midsection) configured to bias the cap to the first configuration (due to elastic nature of 27);
a first engagement portion (upper portion including 28) configured to engage a valve stem (23); and
a second engagement portion (lower portion that interacts with 21, 16a) configured to engage a valve well (13, 16),
wherein the spring portion is configured to adjust radially in response to adjustment of the cap between the first configuration and the second configuration (see FIGs 2-3).”
Regarding claim 2, Yabe (FIGs 1-8) discloses “wherein a proximal end (top end) of the cap (27) is configured to adjusted longitudinally when adjusting the cap between the first configuration and the second configuration (see FIGs 2-3).”
Regarding claim 3, Yabe (FIGs 1-8) discloses “wherein the spring portion and the first engagement portion are configured to adjust longitudinally relative to the second engagement portion when the cap is adjusted between the first configuration and the second configuration (see FIGs 2-3).”
Regarding claim 4, Yabe (FIGs 1-8) discloses “wherein the spring portion, the first engagement portion, and the second engagement portion are formed from a single component (see FIGs).”
Regarding claim 5, Yabe (FIGs 1-8) discloses “wherein the single component is formed from elastomer (27 is made of rubber).”
Regarding claim 6, Yabe (FIGs 1-8) discloses “wherein the first engagement portion comprises one or more recesses (radially expanded space immediately below the top bottleneck 28 seen to be a “recess” radially outward relative to the bottleneck)configured to receive the valve stem.”
Regarding claim 7, Yabe (FIGs 1-8) discloses “wherein the first engagement portion comprises one or more protrusions (28 read as “protrusion” as it protrudes radially inward relative to body of cap) configured to be received by the valve stem (see FIGs).”
Regarding claim 8, Yabe (FIGs 1-8) discloses “wherein the second engagement portion comprises one or more recesses configured to receive the valve well (recesses that receive 21, 16a).”
Regarding claim 13, Yabe (FIGs 1-8) discloses “A valve for a medical device, comprising:
a valve stem (23) including a proximal end (top end), a distal end (bottom end), one or more orifices (25), and a lumen (interior) in fluid communication with at least one orifice in the one or more orifices (see FIGs); and
an elastomer interface member (27) coupled with the valve stem and configured to adjust between a first configuration (FIG 2) and a second configuration (FIG 3), the elastomer interface member comprising:
a spring portion (flexing midsection) configured to bias the elastomer interface member to the first configuration;
a first engagement portion (upper portion including 28) configured to engage the valve stem (23); and
a second engagement portion (lower portion that interacts with 21, 16a) configured to engage a valve well (13, 16).”
Regarding claim 15, Yabe (FIGs 1-8) discloses “wherein in response to adjustment of the elastomer interface member between the first configuration and the second configuration, the spring portion is configured to adjust radially and the valve stem is configured to adjust longitudinally (see FIGs 2-3).”
Regarding claim 16 as best understood, Yabe (FIGs 1-8) discloses “wherein the valve stem and the elastomer interface member are monolithic (each component is respectively monolithic like the applicant’s drawings).”
While not currently presented as a formal rejection, the idea of a monolithic combined cap and stem is nevertheless shown in Yoshimoto (US 5299561), hereinafter Yoshimoto2.
Regarding claim 17, Yabe (FIGs 1-8) discloses “wherein the spring portion and the second engagement portion are distal of the first engagement portion (both are axially spaced from 28).”
Regarding claim 18, Yabe (FIGs 1-8) discloses “wherein the first engagement portion comprises one or more protrusions (28 seen as a radially inward protrusion) configured to be received by the valve stem.”
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshimoto.
Regarding claim 19, Yoshimoto (FIGs 1-19) discloses An interface member for a cleaning valve, comprising:
a cap (14, 53) configured to engage a proximal end (top) of a valve stem (13, 56) of the cleaning valve and extend along a portion of a length of the valve stem (axially overlaps stem along most of stem’s length), the cap having an outer surface (exterior), an inner surface (inner wall), and a longitudinal axis (axis coincident with stem),
wherein the cap comprises a spring portion (bent middle portion in FIG 6, 19) having a first section along which the inner surface of the cap tapers in a proximal direction at an angle (interior of 14 tapers inward in the upward direction from the bending point of 14) … relative to the longitudinal axis and a second section along which the inner surface of the cap tapers in a distal direction (interior of 14 tapers radially inwards in the downward direction from the bending point of 14, forming a diamond-like cross-section for the interior of 14) … relative to the longitudinal axis.”
Yoshimoto is silent regarding “the inner surface of the cap tapers in a proximal direction at an angle in a range of 14 degrees to 36 degrees … the inner surface of the cap tapers in a distal direction at an angle in a range of 5 degrees to 21 degrees…”.
It would have been obvious, before the effective filing date, to modify the taper angle of Yoshimoto such that “the inner surface of the cap tapers in a proximal direction at an angle in a range of 14 degrees to 36 degrees … the inner surface of the cap tapers in a distal direction at an angle in a range of 5 degrees to 21 degrees…”, as Yoshimoto already discloses an angle taper, and choosing a desired angle for that taper to achieve the same expected result (diamond shape interior to have a natural spring shape) would be within routine skill in the art.
Regarding claim 20, Yoshimoto (FIGs 1-19) discloses “wherein the outer surface tapers in the proximal direction along the spring portion (14 tapers inward from bottom [at 15] to its topmost end).”
Allowable Subject Matter
Claims 10 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 10, closest art Yoshimoto and Yabe are respectively silent regarding “wherein the cap further comprises a plug configured to be inserted into an axial opening in the valve stem.” In the context of the claim.
It would not be obvious to modify Yoshimoto or Yabe to teach this limitation without undue hindsight reasoning.
Regarding claim 14, closest art Yoshimoto and Yabe are respectively silent regarding “wherein the elastomer interface member is configured to seal an orifice of the at least one orifice when the elastomer interface member is coupled with the valve stem” in the context of the claim.
It would not be obvious to modify Yoshimoto or Yabe to teach this limitation without undue hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. A devices similar to the application are shown in Burchett (US 2657563) and Chikashige (US 4412531).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK C WILLIAMS whose telephone number is (571)431-0767. The examiner can normally be reached M-F 9:00-5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kenneth Rinehart can be reached at 571-272-4881. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK C WILLIAMS/Primary Examiner, Art Unit 3753
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