DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The Amendment filed 01/30/2026 has been entered.
Claims 2, 10, 17 and 22 have thereby been amended.
Claims 2-30 are being examined in this office action.
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 10-20 and 25-27 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.
Claims 10 and 17 recite the limitation "the [transparent] valve member". There is insufficient antecedent basis for this limitation in the claim, as “a valve member” is not previously recited and defined. Claims 11-16, 18-20 and 25-27 are included in the rejection because claims that depend on a rejected claim inherit the problems of their parent claims.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2, 5-11, 13-17, 19-22, 29 and 30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hayes-Pankhurst (WO-2009125212) in view of Held (EP 1529549).
Regarding claim 2, Hayes-Pankhurst discloses a resealable medical connector for use in a medical fluid pathway (connector 1), the medical connector being configured to transition between a closed position (Fig. 3; pg. 16, lines 20-22) and an open position (Fig. 4; pg. 17, lines 3-4), the medical connector comprising: a housing (Fig. 3: 5+3) comprising: a proximal housing portion (Fig. 3: 5) with a first portion (see annotated Fig. 3 below) and a second portion (see annotated Fig. 3 below), an interior surface of the proximal housing portion comprising a first inner diameter (see annotated Fig. 3 below) and a second inner diameter (see annotated Fig. 3 below), the second inner diameter being distal from and larger than the first inner diameter (see annotated Fig. 3 below), and an angled shoulder positioned between the first inner diameter and the second inner diameter (see annotated Fig. 3 below); a distal housing portion (Fig. 3: 3) with a first portion (see annotated Fig. 3 below) and a second portion (see annotated Fig. 3 below), the first portion of the distal housing portion being attached to the second portion of the proximal housing portion (see annotated Fig. 3 below); a one-piece seal (Fig. 3: 7) being positioned at least partly within the proximal housing portion (Fig. 3: 7 within housing 5), the seal comprising a proximal end and a distal end (Fig. 3: proximal end of 7 at labels 24/26 and distal end of 7 at housing 3), the proximal end of the seal being swabbable (pg. 13, lines 21-25; pg. 22, lines 20-22), the seal being made of an elastomeric material (pg. 28, lines 11-12), and the seal comprising a collar extending around, and protruding radially outward from, an outer surface of the seal (see annotated Figs. 3 and 4 below), the collar being positioned distal from the proximal end of the seal (see annotated Figs. 3 and 4 below, collar is distal, or below, the proximal top end of 7), and no guide member being coupled to the seal (see annotated Figs. 3 and 4 below); and a elongate portion (Fig. 3: 9) with a proximal tip (Fig. 3: 9b), a distal end (Fig. 3: bottom end of 9 at housing 3), and an internal fluid flow path (Fig. 3: central hollow opening of 9; pg. 19, lines 11-14), the elongate portion being within the seal in the closed position (Fig. 3: 9 fully within 7), and the elongate portion being made of a rigid material (claim 20) and being stationary within the housing as the medical connector transitions between the closed and open positions (Figs. 3 and 4: 9 remains in the same position in both figures); wherein, in the closed position of the medical connector, a portion of the elongate portion is positioned within the collar of the seal (see annotated Fig. 3 below, the collar surrounding a portion of 9), a portion of an interior surface of the seal within the collar closely surrounding and conforming with an outer surface of the elongate portion (see annotated Fig. 3 below, the collar contacting and conforming to a portion of 9), and the collar of the seal contacting the shoulder on the interior surface of the proximal housing portion (see annotated Fig. 3 below, the collar contacting the shoulder); wherein, in the open position of the medical connector, the seal compresses in a distal direction (Fig. 4: 22 compresses 7 downward in the distal direction), the collar of the seal separates from the shoulder on the interior surface of the proximal housing portion (see annotated Fig. 4 below, the collar moves distally away from the shoulder), and the proximal tip of the elongate portion extends through and is more proximal than the proximal end of the seal (Fig. 4: 9b is exposed from and more proximal to the proximal end 7 at 26); wherein the medical connector in the open position is configured to permit medical fluid to be conveyed around the proximal tip of the elongate portion into the internal fluid flow path in a region distal from the proximal tip and within the elongate portion to a distal end of the distal housing portion (pg. 21, lines 2-6). Hayes-Pankhurst does not explicitly disclose the opacity or transparency of any of the parts of the connector that are disclosed.
However, Held teaches a connector device through which fluid flows between medical tubing, and explicitly teaches that the device, including the housing and the hollow spike (drawn to the elongate portion of the instant application), are made of transparent material in order for the flow of fluid within the connector to be visible (page 2 of translation, sixth paragraph from the bottom). Although Held does not explicitly teach a seal component that is also transparent, it would be obvious to one of ordinary skill in the art before the effective date of the claimed invention to have modified the surrounding components of the path of the fluid flow of Hayes-Pankhurst, to be transparent as taught by Held in order to allow the practitioner to maintain visualization of that fluid flow, such that the proximal housing portion as transparent, the one-piece seal as transparent, the elongate portion as transparent, and that at least a portion of the internal fluid flow path is visible through the transparent proximal housing portion, the transparent seal, and the transparent elongate portion.
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Annotated Fig. 3, Hayes-Pankhurst
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Annotated Fig. 3, Hayes-Pankhurst
Regarding claim 5, Hayes-Pankhurst in view of Held teaches the medical connector of claim 2, as described above, wherein the shoulder has a higher degree of taper than in a region on the interior surface of the proximal housing portion that is distal from the shoulder (Hayes-Pankhurst: annotated Fig. 3: the shoulder has a “steeper” taper than the more “shallow” taper in the first portion of the proximal housing, distal to the shoulder).
Regarding claim 6, Hayes-Pankhurst in view of Held teaches the medical connector of claim 2, as described above, wherein an outer surface of the housing is round and comprises a tapered portion (Hayes-Pankhurst: see annotated Fig. 7c below).
Regarding claim 7, Hayes-Pankhurst in view of Held teaches the medical connector of claim 2, as described above, wherein the fluid flow path is visible throughout a region of a single transparent layer of the housing that is proximal from a distal flange at the distal end of the seal and distal from a circular protrusion on the proximal housing portion (Hayes-Pankhurst: Fig. 3: proximal to the flange, there is only a single layer of 5).
Regarding claim 8, Hayes-Pankhurst in view of Held teaches the medical connector of claim 2, as described above, wherein the proximal tip of the elongate portion is closed (Hayes-Pankhurst: Fig. 3: the most proximal end tip of 9/9b is closed, the apertures 11 being more distally located).
Regarding claim 9, Hayes-Pankhurst in view of Held teaches the medical connector of claim 8, as described above, wherein the elongate portion comprises a plurality of openings distal from the proximal tip (Hayes-Pankhurst: Fig. 3: apertures 11 located distal to 9b).
Regarding claim 10, Hayes-Pankhurst discloses a needlefree medical connector for use in a medical fluid pathway (Figs. 3 and 4: connector 1), the medical connector being configured to transition between a closed position (Fig. 3; pg. 16, lines 20-22) and an open position (Fig. 4; pg. 17, lines 3-4), the medical connector comprising: a housing (Fig. 3: 5+3) comprising: a proximal housing portion (Fig. 3: 5) with a first portion (see annotated Fig. 3 above) and a second portion (see annotated Fig. 3 above), the first portion of the proximal housing portion comprising an internal angled shoulder (see annotated Fig. 3 above), external screw threads (Figs. 7a-c: 18), and an external circular protrusion distal from the screw threads that is configured to prevent or inhibit over-insertion of a threaded collar or shroud onto the medical connector (see annotated Fig. 7c below), and comprising an internal shoulder (see annotated Fig. 3 above); a distal housing portion (Fig. 3: 3) with a first portion (see annotated Fig. 3 above) and a second portion (see annotated Fig. 3 above), the first portion of the distal housing portion being attached to the second portion of the proximal housing portion (see annotated Fig. 3 above); a one-piece seal (Fig. 3: 7) being positioned at least partly within the proximal housing portion (Fig. 3: 7 within housing 5), the seal comprising a proximal end (Fig. 3: proximal end of 7 at labels 24/26), a collar (see annotated Fig. 3 above), and a distal end (Fig. 3: distal end of 7 at housing 3), the proximal end of the seal being swabbable (pg. 13, lines 21-25; pg. 22, lines 20-22), the seal being made of an elastomeric material (pg. 28, lines 11-12), the seal comprising a transverse flange of the seal (see annotated Fig. 3 above) with a diameter that is wider than the rest of the seal (see annotated Fig. 3 above), the transverse flange being distal from the collar (see annotated Fig. 3: flange distal to collar), the collar of the seal protruding radially outward from and contacting the shoulder of the proximal housing portion in the closed position (see annotated Fig. 3 above, collar contacts internal shoulder), and no guide member coupled to the seal (see annotated Figs. 3 and 4 above); and a elongate portion (Fig. 3: 9) with a proximal end (Fig. 3: 9b), a distal end (Fig. 3: bottom end of 9 at housing 3), and an internal fluid flow path (Fig. 3: central hollow opening of 9; pg. 19, lines 11-14), the elongate portion being positioned at least partly within the seal (Figs. 3 and 4: 9 within/mostly within 7) and being stationary within the housing as the medical connector transitions between the closed and open positions (Figs. 3 and 4: 9 remains in the same position in both figures), the elongate portion being made of a rigid material (claim 20), and in the closed position a portion of the elongate portion being positioned within the collar of the seal (see annotated Fig. 3 below, the collar surrounding a portion of 9), an interior surface of the seal within the collar contacting an outer surface of the elongate portion (see annotated Fig. 3 above, the collar contacting and conforming to an outer portion of 9), and; wherein, in the open position of the medical connector, the seal compresses in a distal direction (Fig. 4: 22 compresses 7 downward in the distal direction), the collar separates from the shoulder (see annotated Fig. 4 below, the collar moves distally away from the shoulder), and the proximal end of the elongate portion extends through and is more proximal than the proximal end of the seal (Fig. 4: 9b is exposed from and more proximal to the proximal end 7 at 26); wherein the medical connector in the open position is configured to permit medical fluid to be conveyed through the elongate portion to a distal end of the distal housing portion (pg. 21, lines 2-6); and wherein there is no overlap between the proximal housing portion and the distal housing portion proximal from the transverse flange of the seal (see annotated Fig. 3 above: proximal to the flange, 3 and 5 do not overlap one another), such that in the closed position the fluid flow path is throughout a region of a single layer of the housing that is proximal from the transverse flange of the seal and distal from the protrusion on the proximal housing portion (Fig. 3: proximal to the flange, there is only a single layer of 5) and a valve member (Fig. 7b: valve formed by small hole in the top surface of seal 7c). Hayes-Pankhurst does not explicitly disclose the opacity or transparency of any of the parts of the connector that are disclosed.
However, Held teaches a connector device through which fluid flows between medical tubing, and explicitly teaches that the device, including the housing and the hollow spike (drawn to the elongate portion of the instant application), are made of transparent material in order for the flow of fluid within the connector to be visible (page 2 of translation, sixth paragraph from the bottom). Although Held does not explicitly teach a seal component that is also transparent, it would be obvious to one of ordinary skill in the art before the effective date of the claimed invention to have modified the surrounding components of the path of the fluid flow of Hayes-Pankhurst, to be transparent as taught by Held in order to allow the practitioner to maintain visualization of that fluid flow, such that the proximal housing portion as transparent, the one-piece seal as transparent, the elongate portion as transparent, and that at least a portion of the internal fluid flow path is visible through the transparent proximal housing portion, the transparent seal, and the transparent elongate portion.
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Annotated Fig. 7c, Hayes-Pankhurst
Regarding claim 11, Hayes-Pankhurst in view of Held teaches the needlefree medical connector of claim 10, as described above, wherein a diameter of the distal flange of the seal is smaller than a maximum inner diameter of the proximal housing portion (Hayes-Pankhurst: see annotated Fig. 3 above, flange is narrower than second inner diameter of the proximal housing 5).
Regarding claim 13, Hayes-Pankhurst in view of Held teaches the needlefree connector of claim 10, as described above, wherein the seal comprises a tapered portion (Hayes-Pankhurst: see annotated Fig. 3 above, seal 7 tapers within the first portion of the proximal housing).
Regarding claim 14, Hayes-Pankhurst in view of Held teaches the needlefree connector of claim 10, as described above, wherein an outer surface of the housing comprises a tapered portion (Hayes-Pankhurst: see annotated Fig. 7c above).
Regarding claim 15, Hayes-Pankhurst in view of Held teaches the needlefree connector of claim 10, as described above, wherein the proximal tip of the elongate portion is closed (Hayes-Pankhurst: Fig. 3: the most proximal end tip of 9/9b is closed, the apertures 11 being more distally located).
Regarding claim 16, Hayes-Pankhurst in view of Held teaches the needlefree medical connector of claim 10, as described above, wherein the elongate portion comprises a plurality of radial openings distal from the proximal tip (Hayes-Pankhurst: Fig. 3: apertures 11 located distal to 9b).
Regarding claim 17, Hayes-Pankhurst discloses a resealable medical connector for use in a medical fluid pathway (Figs. 3 and 4: connector 1), the medical connector being configured to transition between a closed position (Fig. 3; pg. 16, lines 20-22) and an open position (Fig. 4; pg. 17, lines 3-4), the medical connector comprising: a housing (Fig. 3: 5+3) comprising: a proximal housing portion (Fig. 3: 5) with a first region (see annotated Fig. 3 above, labeled “first portion”) and a second region (see annotated Fig. 3 above, labeled “second portion”), the first region of the proximal housing portion comprising screw threads (see annotated Fig. 7c above) and a protrusion distal from the screw threads that is configured to prevent or inhibit over-insertion of a threaded collar or shroud onto the medical connector (see annotated Fig. 7c above), an interior surface of the proximal housing portion comprising a tapering shoulder (see annotated Fig. 3 above); a distal housing portion (Fig. 3: 3) with a first region (see annotated Fig. 3 above, labeled “first portion”) and a second region (see annotated Fig. 3 above, labeled “second portion”), the first region of the distal housing portion being attached to the second region of the proximal housing portion (see annotated Fig. 3 above); a one-piece seal (Fig. 3: 7) being positioned at least partly within the proximal housing portion (Fig. 3: 7 within housing 5), the seal comprising a proximal end and a distal end (Fig. 3: proximal end of 7 at labels 24/26 and distal end of 7 at housing 3), the proximal end of the seal being swabbable (pg. 13, lines 21-25; pg. 22, lines 20-22), the seal being made of an elastomeric material (pg. 28, lines 11-12), and the seal comprising a collar extending around, and protruding radially outward from, an outer surface of the seal (see annotated Figs. 3 and 4 above), the collar being positioned distal from the proximal end of the seal (see annotated Figs. 3 and 4 above, collar is distal, or below, the proximal top end of 7), the seal comprising a flange distal from the collar with a diameter that is wider than the rest of the seal (see annotated Fig. 3 above: flange), and no guide member being coupled to the seal (see annotated Figs. 3 and 4 above); and a elongate portion (Fig. 3: 9) with a proximal end (Fig. 3: 9b), a distal end (Fig. 3: bottom end of 9 at housing 3), and an internal fluid flow path (Fig. 3: central hollow opening of 9; pg. 19, lines 11-14), the elongate portion being within the seal (Fig. 3: 9 within 7) and being stationary within the housing as the medical connector transitions between the closed and open positions (Figs. 3 and 4: 9 remains in the same position in both figures), the elongate portion being made of a rigid material (claim 20), and in the closed position a portion of the elongate portion being positioned within the collar of the seal (see annotated Fig. 3 below, the collar surrounding a portion of 9), and a portion around a circumference of an interior surface of the seal within the collar matching a shape of an outer surface of the elongate portion (see annotated Fig. 3 below, the collar contacting and conforming to an outer portion of 9), and; wherein, in the closed position of the medical connector, the collar of the seal contacts the shoulder on the interior surface of the proximal housing portion (see annotated Fig. 3 above, collar contacts internal shoulder within 5); wherein, in the open position of the medical connector, the seal compresses in a distal direction (Fig. 4: 22 compresses 7 downward in the distal direction), the collar of the seal separates from the shoulder on the interior surface of the proximal housing portion (see annotated Fig. 4 below, the collar moves distally away from the shoulder), and the proximal end of the elongate portion extends through and is more proximal than the proximal end of the seal (Fig. 4: 9b is exposed from and more proximal to the proximal end 7 at 26); wherein the medical connector in the open position is configured to permit medical fluid to be conveyed through the elongate portion to the second end of the distal housing portion (pg. 21, lines 2-6); and wherein there is no overlap between the proximal housing portion and the distal housing portion in a proximal direction from the flange of the seal (see annotated Fig. 3 above: proximal to the flange, 3 and 5 do not overlap one another), such that in the closed position the fluid flow path is throughout a region of a single layer of the housing that is proximal from the flange of the seal and distal from the protrusion on the proximal housing portion (Fig. 3: proximal to the flange, there is only a single layer of 5), and a valve member (Fig. 7b: valve formed by small hole in the top surface of seal 7c). Hayes-Pankhurst does not explicitly disclose the opacity or transparency of any of the parts of the connector that are disclosed.
However, Held teaches a connector device through which fluid flows between medical tubing, and explicitly teaches that the device, including the housing and the hollow spike (drawn to the elongate portion of the instant application), are made of transparent material in order for the flow of fluid within the connector to be visible (page 2 of translation, sixth paragraph from the bottom). Although Held does not explicitly teach a seal component that is also transparent, it would be obvious to one of ordinary skill in the art before the effective date of the claimed invention to have modified the surrounding components of the path of the fluid flow of Hayes-Pankhurst, to be transparent as taught by Held in order to allow the practitioner to maintain visualization of that fluid flow, such that the proximal housing portion as transparent, the one-piece seal as transparent, the elongate portion as transparent, and that at least a portion of the internal fluid flow path is visible through the transparent proximal housing portion, the transparent seal, and the transparent elongate portion.
Regarding claim 19, Hayes-Pankhurst in view of Held teaches the medical connector of claim 17, as described above, wherein the seal is not fixed to the housing (Hayes-Pankhurst: Figs. 3 and 4: 7 not fixed 5).
Regarding claim 20, Hayes-Pankhurst in view of Held teaches the medical connector of claim 17, as described above, wherein the proximal end of the elongate portion is closed (Hayes-Pankhurst: Fig. 3: the most proximal end tip of 9/9b is closed, the apertures 11 being more distally located).
Regarding claim 21, Hayes-Pankhurst in view of Held teaches the medical connector of claim 2, as described above, wherein the interior surface of the seal within the collar contacts the elongate portion (Hayes-Pankhurst: annotated Figs. 3 and 4: the interior surface of the collar of 7 contacts the outer surface of 9).
Regarding claim 22, Hayes-Pankhurst discloses a resealable medical connector for use in a medical fluid pathway (Figs. 3 and 4: connector 1), the medical connector being configured to transition between a closed position (Fig. 3; pg. 16, lines 20-22) and an open position (Fig. 4; pg. 17, lines 3-4), the medical connector comprising: a housing (Fig. 3: 5+3) comprising: a proximal housing portion (Fig. 3: 5) with a first portion (see annotated Fig. 3 above) and a second portion (see annotated Fig. 3 above), an interior surface of the proximal housing portion comprising a first inner diameter (see annotated Fig. 3 above) and a second inner diameter (see annotated Fig. 3 above), the second inner diameter being distal from and larger than the first inner diameter (see annotated Fig. 3 above), and an angled shoulder positioned between the first inner diameter and the second inner diameter (see annotated Fig. 3 above); a distal housing portion (Fig. 3: 3) with a first portion (see annotated Fig. 3 above) and a second portion (see annotated Fig. 3 above), the first portion of the distal housing portion being attached to the second portion of the proximal housing portion (see annotated Fig. 3 above); a one-piece seal (Fig. 3: 7) being positioned at least partly within the proximal housing portion (Fig. 3: 7 within housing 5), the seal comprising a proximal end and a distal end (Fig. 3: proximal end of 7 at labels 24/26 and distal end of 7 at housing 3), the proximal end of the seal being swabbable (pg. 13, lines 21-25; pg. 22, lines 20-22), the seal being made of an elastomeric material (pg. 28, lines 11-12), and the seal comprising a collar extending around, and protruding radially outward from, an outer surface of the seal (see annotated Fig. 3 above), the collar being positioned distal from the proximal end of the seal (see annotated Fig. 3 above), and no guide member being coupled to the seal (see annotated Figs. 3 and 4 above); and a elongate portion (Fig. 3: 9) with a proximal tip (Fig. 3: 9b), a distal end (Fig. 3: bottom end of 9 at housing 3), and an internal fluid flow path (Fig. 3: central hollow opening of 9; pg. 19, lines 11-14), the elongate portion being within the seal in the closed position (Fig. 3: 9 within 7), and the elongate portion being made of a rigid material (claim 20) and being stationary within the housing as the medical connector transitions between the closed and open positions (Figs. 3 and 4: 9 remains in the same position in both figures); wherein, in the closed position of the medical connector, a portion of the elongate portion contacts an interior surface of the seal within the collar (see annotated Fig. 3 above, the collar surrounding a portion of 9), and an exterior surface of the collar of the seal contacts the shoulder on the interior surface of the proximal housing portion (see annotated Fig. 3 above); wherein, in the open position of the medical connector, the seal compresses in a distal direction (Fig. 4: 22 compresses 7 downward in the distal direction), the collar of the seal separates from the shoulder on the interior surface of the proximal housing portion (see annotated Fig. 4 below, the collar moves distally away from the interior shoulder surface), and the proximal tip of the elongate portion extends through and is more proximal than the proximal end of the seal (Fig. 4: 9b is exposed from and more proximal to the proximal end 7 at 26); wherein the medical connector in the open position is configured to permit medical fluid to be conveyed around the proximal tip of the elongate portion into the internal fluid flow path in a region distal from the proximal tip and within the elongate portion to a distal end of the distal housing portion (pg. 21, lines 2-6). Fig. 3: proximal to the flange, there is only a single layer of 5). Hayes-Pankhurst does not explicitly disclose the opacity or transparency of any of the parts of the connector that are disclosed.
However, Held teaches a connector device through which fluid flows between medical tubing, and explicitly teaches that the device, including the housing and the hollow spike (drawn to the elongate portion of the instant application), are made of transparent material in order for the flow of fluid within the connector to be visible (page 2 of translation, sixth paragraph from the bottom). Although Held does not explicitly teach a seal component that is also transparent, it would be obvious to one of ordinary skill in the art before the effective date of the claimed invention to have modified the surrounding components of the path of the fluid flow of Hayes-Pankhurst, to be transparent as taught by Held in order to allow the practitioner to maintain visualization of that fluid flow, such that the proximal housing portion as transparent, the one-piece seal as transparent, the elongate portion as transparent, and that at least a portion of the internal fluid flow path is visible through the transparent proximal housing portion, the transparent seal, and the transparent elongate portion.
Regarding claim 29, Hayes-Pankhurst in view of Held teaches the medical connector of claim 22, as described above, wherein the proximal tip of the elongate portion is more proximal than the shoulder (Hayes-Pankhurst: see annotated Fig. 3 above: 9b is more proximal than the shoulder).
Regarding claim 30, Hayes-Pankhurst in view of Held teaches the medical connector of claim 22, as described above, wherein the proximal end of the seal comprises a lip that contacts an inner surface of the proximal housing portion in the closed position (Hayes-Pankhurst: Fig. 3: lip 26 of 7).
Claims 3, 4, 12 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over the second embodiment of Hayes-Pankhurst (WO-2009125212) in view of Held (EP 1529549).
Regarding claim 3, Hayes-Pankhurst in view of Held teaches the medical connector of claim 2, as described above. Although Hayes-Pankhurst does not show an outside view of the seal of Figs. 3 and 4 that explicitly shows the collar extending fully around the circumference, Hayes-Pankhurst does show this for the nearly identical seal and collar of the embodiments in Figs. 3a-b, 4a, 5 and 5a, wherein the collar of the seal extends continuously around an outer circumference of the seal (Hayes-Pankhurst: Figs. 6 and 6a: the collar portion seen in Figs. 3a-b, 4a, 5 and 5a extends around the circumference). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated this explicit teaching of the collar extending fully around the circumference of the seal in this Hayes-Pankhurst embodiment, into the embodiment of Figs. 3 and 4 of Hayes-Pankhurst used in the combination above, in order to create sealing between the collar and the shoulder without any gaps.
Regarding claim 4, Hayes-Pankhurst in view of Held teaches the medical connector of claim 2, as described above. Although Hayes-Pankhurst does not show an outside view of the seal of Figs. 3 and 4 that explicitly shows the collar made of a series of circular structures, Hayes-Pankhurst does show this for the nearly identical seal and collar of the embodiments in Figs. 3a-b, 4a, 5 and 5a, wherein the seal comprises a series of circular structures integrally formed together (Hayes-Pankhurst: Figs. 6 and 6a: the concentric circular structures of 7 forming the bellowed shape seen in the cross sections). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated this explicit teaching of the collar being made of a series of circular structures in this Hayes-Pankhurst embodiment, into the embodiment of Figs. 3 and 4 of Hayes-Pankhurst used in the combination above, since both embodiments exhibit the same bellowed structures of the seal in the cross sections, in order to allow the seal to be easily compressed for opening of the connector.
Regarding claim 12, Hayes-Pankhurst in view of Held teaches the needlefree medical connector of claim 10, as described above. Although Hayes-Pankhurst does not show an outside view of the seal of Figs. 3 and 4 that explicitly shows the collar made of a series of circular structures, Hayes-Pankhurst does show this for the nearly identical seal and collar of the embodiments in Figs. 3a-b, 4a, 5 and 5a, wherein the seal comprises a series of circular structures integrally formed together (Hayes-Pankhurst: Figs. 6 and 6a: the concentric circular structures of 7 forming the bellowed shape seen in the cross sections). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated this explicit teaching of the collar being made of a series of circular structures in this Hayes-Pankhurst embodiment, into the embodiment of Figs. 3 and 4 of Hayes-Pankhurst used in the combination above, since both embodiments exhibit the same bellowed structures of the seal in the cross sections, in order to allow the seal to be easily compressed for opening of the connector.
Regarding claim 18, Hayes-Pankhurst in view of Held teaches the medical connector of claim 17, as described above. Although Hayes-Pankhurst does not show an outside view of the seal of Figs. 3 and 4 that explicitly shows the collar extending fully around the circumference, Hayes-Pankhurst does show this for the nearly identical seal and collar of the embodiments in Figs. 3a-b, 4a, 5 and 5a, wherein the collar of the seal extends continuously around an outer circumference of the seal (Hayes-Pankhurst: Figs. 6 and 6a: the collar portion seen in Figs. 3a-b, 4a, 5 and 5a extends around the circumference). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated this explicit teaching of the collar extending fully around the circumference of the seal in this Hayes-Pankhurst embodiment, into the embodiment of Figs. 3 and 4 of Hayes-Pankhurst used in the combination above, in order to create sealing between the collar and the shoulder without any gaps.
Claims 23, 25, 27 and 28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hayes-Pankhurst (WO-2009125212) in view of Held (EP 1529549) in further view of Ryan (US 20050151105).
Regarding claim 23, Hayes-Pankhurst in view of Held teaches the medical connector of claim 2, as described above, but fails to explicitly teach the establishment of neutral displacement.
Ryan teaches an analogous an analogous needless medical connector wherein the connector is configured to establish neutral displacement during use (para. [0012], and para. [0065]). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Hayes-Pankhurst in view of Held device to incorporate the neutral fluid displacement of Ryan in order to minimize the undesired backflow of fluids in the connector during use, especially due to the intended medical use of the connector to minimize contamination (Ryan: para. [0012]).
Regarding claim 25, Hayes-Pankhurst in view of Held teaches the medical connector of claim 10, as described above, but fails to explicitly teach the establishment of neutral displacement.
Ryan teaches an analogous an analogous needless medical connector wherein the connector is configured to establish neutral displacement during use (para. [0012], and para. [0065]). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Hayes-Pankhurst in view of Held device to incorporate the neutral fluid displacement of Ryan in order to minimize the undesired backflow of fluids in the connector during use, especially due to the intended medical use of the connector to minimize contamination (Ryan: para. [0012]).
Regarding claim 27, Hayes-Pankhurst in view of Held teaches the medical connector of claim 17, as described above, but fails to explicitly teach the establishment of neutral displacement.
Ryan teaches an analogous an analogous needless medical connector wherein the connector is configured to establish neutral displacement during use (para. [0012], and para. [0065]). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Hayes-Pankhurst in view of Held device to incorporate the neutral fluid displacement of Ryan in order to minimize the undesired backflow of fluids in the connector during use, especially due to the intended medical use of the connector to minimize contamination (Ryan: para. [0012]).
Regarding claim 28, Hayes-Pankhurst in view of Held teaches the medical connector of claim 22, as described above, but fails to explicitly teach the establishment of neutral displacement.
Ryan teaches an analogous an analogous needless medical connector wherein the connector is configured to establish neutral displacement during use (para. [0012], and para. [0065]). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Hayes-Pankhurst in view of Held device to incorporate the neutral fluid displacement of Ryan in order to minimize the undesired backflow of fluids in the connector during use, especially due to the intended medical use of the connector to minimize contamination (Ryan: para. [0012]).
Claims 24 and 26 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hayes-Pankhurst (WO-2009125212) in view of Held (EP 1529549) in further view of Ryan (US 20050151105) in further view of Stroup (WO 2009111596).
Regarding claim 24, Hayes-Pankhurst in view of Held in further view of Ryan teaches the medical connector of claim 23, as described above, but fails to explicitly teach a regulator.
Hayes-Pankhurst and Ryan both teach a single valve integrated in their respective seal members for the regulation of fluid flow. However, Stroup teaches a needless connector with a dual valve system in which a second, distal valve acts as a regulator for the fluid flow, such that the opening of the fluid path can be more controlled by the user, as the valves can be opened or actuated independently of one another (Figs. 43 A-C: first valve 1500A, second valve 1500B; page 59 lines 18-20 and 26-33). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connector of Hayes-Pankhurst with the second regulator valve and dual valve system of Stroup in order to obtain a more controlled opening of the fluid path through the connector or achieve the desired pressure within the connector, such as for ejecting fluid or preventing backflow in the connector to maintain sterility (page 60, lines 1-17).
Regarding claim 26, Hayes-Pankhurst in view of Held in further view of Ryan teaches the medical connector of claim 25, as described above, but fails to explicitly teach a regulator with a valve.
Hayes-Pankhurst and Ryan both teach a single valve integrated in their respective seal members for the regulation of fluid flow. However, Stroup teaches a needless connector with a dual valve system in which a second, distal valve acts as a regulator for the fluid flow, such that the opening of the fluid path can be more controlled by the user, as the valves can be opened or actuated independently of one another (Figs. 43 A-C: first valve 1500A, second valve 1500B; page 59 lines 18-20 and 26-33). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connector of Hayes-Pankhurst with the second regulator valve and dual valve system of Stroup in order to obtain a more controlled opening of the fluid path through the connector or achieve the desired pressure within the connector, such as for ejecting fluid or preventing backflow in the connector to maintain sterility (page 60, lines 1-17).
Response to Arguments
Applicant's arguments filed 01/30/2026 have been fully considered but are moot, as the independent claims 2, 10, 17 and 22, as well as any of their depending claims, no longer rely on Guala alone or in combination to teach any of the limitations. The claims now rely on Hayes-Pankhurst in combination with Held, Ryan and Stroup to teach all limitations of the claimed invention.
Conclusion
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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