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(s) have been considered by the examiner.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-4, and 9-16 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.
Regarding arguments pertaining to claim 17-25
Examiner notes that applicant does argue that the prior art of Thiagarajan “does not disclose a separate antimicrobial component captured in a fluid passageway as recited in the new claim 17”.
However, examiner notes that where a coating is disposed within, or being applied along. a fluid passageway, may be considered captured by that passageway in that the coating is retained within the passageway. Thus, as detailed in examiner's rejection as necessitated by the amendment, the prior art of Thiagarajan may be relied upon for the teachings of an antimicrobial component tubular segment.
Applicant also alleges that the prior art of Schlitt does not disclose this feature nor other limitations of claim 17.
However, examiner details an alternative embodiment of Schlitt not previously relied upon, which does disclose pertinent limitations of claim 17, such that Schlitt’s alternative embodiment in view of Thiagarajan teaches the subject matter of claim 17-25.
Drawings
The drawings are objected to because certain drawing’s numerals which denote the structures described in the written specification do not appear to reflect the structure described in the written specification.
As an example, paragraph 44 recites “Valve stem 16 further comprises a middle portion 42, a frustoconical portion 44 and then a reduced diameter portion 46 preferably extending integrally and circular cylindrically above the base portion 40”, emphasis added. However, applicant’s figure 8 shows the numeral 46 as pointing to an element of the valve cap 14. Further, figure 8 and 10 details a structure with reference numeral 28, but no part of the disclosure describes any structure with that numeral. Further, both figure 8 and 10 use the same reference numeral “58” to designate both an opening in valve cap 14 and an access hole in the valve body 12, respectively. Examiner invites applicant to also thoroughly check their own disclosure for any other possible issues which misconstrue and confuse their disclosure.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Specification
The disclosure is objected to because of the following informalities: In applicant’s paragraph 51, which details the alternative embodiment of fig 11, the disclosure instead mistakenly refers to the initial embodiment as pertaining to only figs 1-9 and the alternative embodiment as being illustrated in fig 10, however applicant had indicated differently in paragraph 27-38.
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1, 3-4, 9-17, 19-25 are rejected under 35 U.S.C. 103 as being unpatentable over EP 1566196 A1, henceforth written as Suzuki, in view of US 20160287758 A1, henceforth written as Thiagarajan.
Regarding Claim 1,
Suzuki discloses:
A needleless connector comprising in combination:
(invention of fig 6-7)
a valve stem operatively secured
(the claimed valve stem comprises together the closing member 34 and the spring seat (not enumerated) which mates with skirt portion 35, see examiner's annotation of Suzuki's fig 6 demonstrating the spring seat)
with a valve body by a valve cap,
(the claimed valve stem is secured between three-way cock 2, therein the claimed valve body, and outer tube 8, therein the claimed valve cap, by the mating of cylindrical outer support 7 with outer tube 8; fig 6-7)
the valve body including a fluid passageway,
(See examiner's annotation of Suzuki's fig 6 noting the fluid passageway of the claimed valve body)
the valve stem including a lumen, such that upon being accessed by an access device, fluid flows through said lumen and said fluid passageway, and
(See examiner's annotation of Suzuki's fig 6 noting the lumen of the claimed valve stem spanning from the inlet of slit 18 to the left most end of the noted spring seat; fig 7 illustrates that accessing of an access device, shown by the luer taper portion 9 at an end of syringe/tube (not enumerated/illustrated), permits fluid to flow through said lumen and fluid passageway)
a tubular segment-- positioned within the fluid flow lumen of the valve stem;
(pipe shaped tube 24; fig 6-7)
wherein the valve stem includes a slit allowing access by the access device:
(slit 18 permits access to portion 9 for dispensing fluid; fig 6-7)
and wherein when an insertion force is applied to the slit by the access device, the slit is caused to sealingly encircle an uppermost edge of the tubular segment.
(fig 6-7 illustrates that upon taper portion 9 having a force applied to it which inserts portion 9 into portion 10 of tube 8, slit 18 sealing encircles the right-most edge of tube 24 at some point in closing member 24's travel)
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Suzuki discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
a tubular segmentcomprising an antimicrobial material
However, Thiagarajan teaches a needleless connector with:
a tubular segment composed of antimicrobial material positioned within the fluid flow.
(paragraph 31-32; fluid pathways 40 have a non-eluting copper coating 42; fig 2)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Thiagarajan’s teachings of coating a fluid passageway with antimicrobial copper to the tubular segment disclosed by Suzuki in order to advantageously arrive at an invention which provides antimicrobial effect to inhibit the establishment/survival of microbes which reduces the likelihood of the establishment/proliferation of microbes on the treated surface, see paragraph 31+38 of Thiagarajan, and consequently reduces the likelihood that a fluid dispensed to a patient carries a life threatening infectious microbe population.
Regarding claim 3, Suzuki in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 1, further including a mounting flange for mounting said tubular segment within said lumen of said valve stem.
Suzuki: (tubular body 24 is mounted in tubular body support 4, the claimed mounting flange; fig 6-7)
Regarding claim 4, Suzuki in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 3, wherein an annular space is defined between an outer diameter of said tubular segment and an inner diameter of said lumen of said valve stem.
(See examiner's annotation of Suzuki's fig 6 noting the annular space bound by the outer diameter of tube 24 and the inner diameter of the skirt portion 25 of the claimed valve stem)
Regarding claim 9, Suzuki in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 1, wherein said valve stem comprises an elastomeric valve stem.
Suzuki: (paragraph 40; skirt portion 35 is formed from an elastic material, and fig 7 demonstrates that closing member 34 is composed of the same material as skirt portion 35, such that the claimed valve stem can be considered elastomeric)
Regarding Claim 10,
Suzuki in view of Thiagarajan discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The needleless connector as set forth in Claim 1, wherein said valve stem comprises a [geometry] that seals within a corresponding [geometry] of said valve cap.
Suzuki: (closing member 26 is shaped with a collar portion 27 and reduced diameter end portion, noted in examiner’s annotation above, to mate with, and thus sealing with, regulating portion 15 of connector 10; fig 4+6-7)
However, Suzuki in view of Thiagarajan is silent regarding:
a frustoconical configuration that seals within a corresponding frustoconical configuration
However, Suzuki teaches in an alternative embodiment that such a closing member 11 may have a frustoconical shape, see fig 1-2, for likewise mating with a corresponding shape of connector 10.
Examiner also notes that MPEP 2144.04(IV)(B) provides that modifications to an invention only involving a change of shape is a matter of obvious design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed invention was significant.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement the frustoconical mating shapes taught by Suzuki’s alternative embodiment to the shape of the valve stem and valve cap of the presently modified invention of Suzuki in view of Thiagarajan, as such a modification would only involve a change of shape of the invention and thus a matter of obvious design choice, which was already envisioned by the prior art of record as equivalent means for mating a valve stem and valve cap, within the routine skill of a person of ordinary skill in the art, see fig 1-2 of Suzuki and MPEP 2144.04(IV)(B).
Regarding claim 11, Suzuki in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 1, wherein said slit is exposed from said valve cap so as to be capable of being swabbed prior to use.
Suzuki: (fig 6 best illustrates the slit 18 in a configuration where it is exposed from connecting portion 10 and therein exposes a right-most surface outside of portion 10 and thus is capable of being swabbed prior to use)
Regarding claim 12, Suzuki in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 1, wherein the valve stem includes a reduced diameter end portion extending through a central aperture in the valve cap, wherein the slit is disposed in the reduced diameter end portion.
(See examiner's annotation of Suzuki's fig 6 noting the reduced diameter end portion as reduced diameter portion of cock portion 36, and demonstrating its extension through the central aperture of the valve cap, defined by the annular opening in the annular convex portion 21 of connector 10)
Regarding claim 13, Suzuki in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 3, wherein the mounting flange is a circular cylindrical upstanding mounting flange, and
Suzuki: (fig 6-7 demonstrate the circular cylindrical shape of cylindrical tubular body support 4)
wherein the tubular segment is press-fit into circular cylindrical upstanding mounting flange.
Examiner notes that claim language of "the tubular segment is press-fit into circular cylindrical upstanding mounting flange" constitutes a product-by-process claim, and thus the patentability of such a claim is determined by the product itself and not necessarily the method of production, see MPEP 2113.
Suzuki: (fig 6-7 demonstrates that tubular body support 4 has an inner diameter of a size that is compatible with receiving the outer diameter of tube 24 and consequently retaining tube 24, and consequently arrives at the resulting structure of a tubular segment press fit into a circular cylindrical upstanding mounting flange)
Regarding claim 14, Suzuki in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 1, wherein the valve cap is secured to an outer circular cylindrical boss of the valve body,
Suzuki: (paragraph 22; fig 6-7 demonstrate the circular cylindrical shape of cylindrical outer tube support 7, as well as the manner that outer tube 8 secures with support 7)
wherein a base portion of the valve stem is sealingly retained in the outer circular cylindrical boss.
(See examiner's annotation of Suzuki's fig 6 noting the base portion of the valve stem as the leftward extending leg of the noted spring seat, and therein demonstrating its sealing mating with the support 7)
Regarding claim 15, Suzuki in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 1, wherein the outer circular cylindrical boss of the valve body extends approximately 90 degrees from the fluid passageway.
(See examiner's annotation of Suzuki's fig 6 noting the direction of extension of support 7, the claimed boss, extending 90 degrees away from the claimed fluid passageway)
Regarding claim 16, Suzuki in view of Thiagarajan teaches:
The needleless connector as set forth in Claim 1, wherein the antimicrobial material comprises copper.
Thiagarajan: (paragraph 31-32; fluid pathways 40 have a non-eluting copper coating 42; fig 2)
Regarding Claim 17,
Suzuki discloses:
A needleless connector comprising in combination:
(invention of fig 6-7)
a valve stem operatively secured
(the claimed valve stem comprises together the closing member 34 and the spring seat (not enumerated) which mates with skirt portion 35, see examiner's annotation of Suzuki's fig 6 demonstrating the spring seat)
with a valve body by a valve cap,
(the claimed valve stem is secured between three-way cock 2, therein the claimed valve body, and outer tube 8, therein the claimed valve cap, by the mating of cylindrical outer support 7 with outer tube 8; fig 6-7)
the valve body including a fluid passageway,
(See examiner's annotation of Suzuki's fig 6 noting the fluid passageway of the claimed valve body)
a tubular segment -- received in the fluid passageway;
(pipe shaped tube 24; fig 6-7)
wherein an outer diameter of a proximal end of the tubular segment is greater than a diameter of the lumen of the valve stem, such that the tubular segment is captured within the fluid passageway.
(fig 6 and examiner's annotation of Suzuki's fig 6 illustrate that the outer diameter of a right most end, the claimed proximal end, of tube 24 is larger the lumen of slit 18, a lumen portion of the claimed lumen of the claimed valve stem; examiner's annotation of Suzuki's fig 6 demonstrates the manner that tube 24 is disposed, therein captured, within the claimed fluid passageway)
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Suzuki discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
a tubular segmentcomprising an antimicrobial material
However, Thiagarajan teaches a needleless connector with:
a tubular segment composed of antimicrobial material positioned within the fluid flow.
(paragraph 31-32; fluid pathways 40 have a non-eluting copper coating 42; fig 2)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Thiagarajan’s teachings of coating a fluid passageway with antimicrobial copper to the tubular segment disclosed by Suzuki in order to advantageously arrive at an invention which provides antimicrobial effect to inhibit the establishment/survival of microbes which reduces the likelihood of the establishment/proliferation of microbes on the treated surface, see paragraph 31+38 of Thiagarajan, and consequently reduces the likelihood that a fluid dispensed to a patient carries a life threatening infectious microbe population.
Regarding claim 19, Suzuki in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 17, wherein said valve stem comprises an elastomeric valve stem.
Suzuki: (paragraph 40; skirt portion 35 is formed from an elastic material, and fig 7 demonstrates that closing member 34 is composed of the same material as skirt portion 35, such that the claimed valve stem can be considered elastomeric)
Regarding Claim 20,
Suzuki in view of Thiagarajan discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The needleless connector as set forth in Claim 1, wherein said valve stem comprises a [geometry] that seals within a corresponding [geometry] of said valve cap.
Suzuki: (closing member 26 is shaped with a collar portion 27 and reduced diameter end portion, noted in examiner’s annotation above, to mate with, and thus sealing with, regulating portion 15 of connector 10; fig 4+6-7)
However, Suzuki in view of Thiagarajan is silent regarding:
a frustoconical configuration that seals within a corresponding frustoconical configuration
However, Suzuki teaches in an alternative embodiment that such a closing member 11 may have a frustoconical shape, see fig 1-2, for likewise mating with a corresponding shape of connector 10.
Examiner also notes that MPEP 2144.04(IV)(B) provides that modifications to an invention only involving a change of shape is a matter of obvious design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed invention was significant.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement the frustoconical mating shapes taught by Suzuki’s alternative embodiment to the shape of the valve stem and valve cap of the presently modified invention of Suzuki in view of Thiagarajan, as such a modification would only involve a change of shape of the invention and thus a matter of obvious design choice, which was already envisioned by the prior art of record as equivalent means for mating a valve stem and valve cap, within the routine skill of a person of ordinary skill in the art, see fig 1-2 of Suzuki and MPEP 2144.04(IV)(B).
Regarding claim 21, Suzuki in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 17, wherein the valve stem includes a slit allowing access by the access device.
Suzuki: (slit 18 permits access to portion 9 for dispensing fluid; fig 6-7)
Regarding claim 22, Suzuki in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 21, wherein said slit is exposed from said valve cap so as to be capable of being swabbed prior to use.
Suzuki: (fig 6 best illustrates the slit 18 in a configuration where it is exposed from connecting portion 10 and therein exposes a right-most surface outside of portion 10 and thus is capable of being swabbed prior to use)
Regarding claim 23, Suzuki in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 21, wherein the valve stem includes a reduced diameter end portion extending through a central aperture in the valve cap, wherein the slit is disposed in the reduced diameter end portion.
(See examiner's annotation of Suzuki's fig 6 noting the reduced diameter end portion as reduced diameter portion of cock portion 36, and demonstrating its extension through the central aperture of the valve cap, defined by the annular opening in the annular convex portion 21 of connector 10)
Regarding claim 24, Suzuki in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 17, wherein the valve cap is secured to an outer circular cylindrical boss of the valve body,
Suzuki: (paragraph 22; fig 6-7 demonstrate the circular cylindrical shape of cylindrical outer tube support 7, as well as the manner that outer tube 8 secures with support 7)
wherein a base portion of the valve stem is sealingly retained in the outer circular cylindrical boss.
(See examiner's annotation of Suzuki's fig 6 noting the base portion of the valve stem as the leftward extending leg of the noted spring seat, and therein demonstrating its sealing mating with the support 7)
Regarding claim 25, Suzuki in view of Thiagarajan teaches:
The needleless connector as set forth in Claim 17, wherein the antimicrobial material comprises copper.
Thiagarajan: (paragraph 31-32; fluid pathways 40 have a non-eluting copper coating 42; fig 2)
Claim 17-25 are rejected under 35 U.S.C. 103 as being unpatentable over US 20170252551 A1, henceforth written as Schlitt, in view of US 20160287758 A1, henceforth written as Thiagarajan.
Regarding Claim 17,
Schlitt discloses:
A needleless connector comprising in combination:
(invention of fig 1-9)
a valve stem operatively secured with
(valve body 11; fig 7-9)
a valve body by
(connection piece 3; fig 1-2)
a valve cap,
(cover 8; fig 1-9)
the valve body including a fluid passageway,
(the claimed fluid passageway spans from the inlet of slit 14 to the outlet of base portion 7, shown respectively at the top and bottom of fig 7; see examiner’s annotation of Schlitt’s fig 2)
the valve stem including a lumen, such that
(internal contour 17 defines the lumen of body 11; fig 4)
upon being accessed by an access device, fluid flows through said lumen and said fluid passageway, and --
(functional part F constitutes the claimed access device which upon accessing the invention, permits fluid to flow through the lumen and fluid passageway; fig 7-9)
a tubular segment comprising -- received in the fluid passageway;
(the tapered inner surface of base portion 7, which spans from the top opening of contour 19 to the bottom of portion 7 as illustrated in fig 7, is considered the claimed tubular segment, and fig 2+7-9 best illustrates its arrangement, therein reception, of this tapered inner surface of base portion 7 in the noted fluid passageway, which spans from the inlet of slit 14 to the bottom of base portion 7; see examiner’s annotation of Schlitt’s fig 2)
wherein an outer diameter of a proximal end of the tubular segment is greater than a diameter of the lumen of the valve stem, such that the tubular segment is captured within the fluid passageway.
(fig 4+7 demonstrates that the opening of contour 19 has a greater outer diameter than the diameter of slit 14, a diameter of the lumen of the valve stem; accordingly the tubular segment is disposed within, and thus is captured within, the fluid passageway; see examiner’s annotation of Schlitt’s fig 2)
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Schlitt discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
a tubular segment comprising an antimicrobial material
However, Thiagarajan teaches a needleless connector with:
a tubular segment composed of antimicrobial material
(paragraph 31-32; fluid pathways 40 have a non-eluting copper coating 42; fig 2)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Thiagarajan’s teachings of coating a fluid passageway with antimicrobial copper to the tubular segment disclosed by Schlitt in order to advantageously arrive at an invention which provides antimicrobial effect to inhibit the establishment/survival of microbes which reduces the likelihood of the establishment/proliferation of microbes on the treated surface, see paragraph 31+38 of Thiagarajan, and consequently reduces the likelihood that a fluid dispensed to a patient carries a life threatening infectious microbe population.
Examiner notes for the sake of clarity that in the above modified invention of Schlitt in view of Thiagarajan, that the tubular segment is physically defined by the thickness of the uniform copper coating 42 which follows the shape of the tubular segment of Schlitt, spanning from the opening of contour 19 to the bottom of tapered portion of base portion 7.
Regarding Claim 18, Schlitt in view of Thiagarajan discloses:
The needleless connector as set forth in claim 17, wherein a circular cylindrical portion of the tubular segment extends into the fluid passageway and the proximal end of the tubular segment is funnel-shaped and received in a chamfered end of the fluid passageway.
(See examiner’s annotation of Schlitt’s fig 2, delineating what may be considered the respective circular cylindrical portion and funnel-shaped proximal end of the tubular segment; examiner notes that a cylindrical shape may be used to describe a number of specific geometries such as an elliptic cylinder, hollow cylinder, tapered or conic cylinder, right cylinder, and oblique cylinder and further the circular shape of such a cylinder describes the base planar shape of such a cylinder, accordingly the conic/tapered cylindrical shape within base portion 7 may be considered to have a circular cylindrical portion; Examiner notes that broadest reasonable interpretation of the claim term " funnel " to a person of ordinary skill in the art, not inconsistent with the disclosure, may be best provided by Oxford's English dictionary: "a cone shaped vessel ". )
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Examiner notes that in light of the above combination of Schlitt in view of Thiagarajan, the tapered shape of base portion 7 defines a chamfered end of the fluid passageway as the external radius of the fluid passageway is bound by the radially inner surfaces of the inlet of slit 14 to the radially inner opening surface at the bottom of portion 7. Further each portion of the claimed tubular segment can be considered to extend into the fluid passageway in that it 1) is disposed within the fluid passageway and 2) has a dimension parallel with central axis L, and thus extends into and within the fluid passageway.
Regarding claim 19, Schlitt in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 17, wherein said valve stem comprises an elastomeric valve stem.
Schlitt: (paragraph 36; valve body 11 is formed from an elastomer)
Regarding claim 20, Schlitt in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 17, wherein said valve stem comprises a frustoconical configuration that seals within a corresponding frustoconical configuration of said valve cap.
Schlitt: (fig 7-9 demonstrate the mating frustoconical shapes of valve body 11 and cover 8)
Regarding claim 21, Schlitt in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 17, wherein the valve stem includes a slit allowing access by the access device.
Schlitt: (slit 14; fig 1-9)
Regarding claim 22, Schlitt in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 21, wherein said slit is exposed from said valve cap so as to be capable of being swabbed prior to use.
Schlitt: (fig 2-3+6-7 demonstrate that slit 14 is exposed from cover 8 such that it is functionally capable of being swabbed prior to use)
Regarding claim 23, Schlitt in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 21, wherein the valve stem includes a reduced diameter end portion extending through a central aperture in the valve cap, wherein the slit is disposed in the reduced diameter end portion.
Schlitt: (slit 14 is disposed in top region 12, the claimed reduced diameter end portion, and fig 7 demonstrates region 12's extension through passage 10 of cover 8)
Regarding claim 24, Schlitt in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 17, wherein the valve cap is secured to an outer circular cylindrical boss of the valve body,
Schlitt: (fig 1-2 best illustrate the circular cylindrical shape of base portion 7, the claimed boss of the valve body)
wherein a base portion of the valve stem is sealingly retained in the outer circular cylindrical boss.
Schlitt: (fig 7-9 best illustrate base ring 16, the base portion of the valve stem, being sealingly retained between the portion 7 and cover 8, therein within the radial bounds of portion 7)
Regarding claim 25, Schlitt in view of Thiagarajan discloses:
The needleless connector as set forth in Claim 17, wherein the antimicrobial material comprises copper.
Thiagarajan: (paragraph 31-32; fluid pathways 40 have a non-eluting copper coating 42; fig 2)
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 FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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 on (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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/FORREST B DIPERT/Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783