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 06/17/2025 has been entered.
Claims 2, 10, 19 and 22 have thereby been amended.
Claims 12-30 are being examined in this office action.
Information Disclosure Statement
The information disclosure statement filed 06/17/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. A copy of the foreign patent document CN 308493371 listed in the information disclosure statement filed 06/17/2025, is not attached. It has been placed in the application file, but the information referred to therein has not been considered.
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 2-23, 25, and 27-30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Guala (CA 2581547) in view of Held (EP 1529549) and in further view of Ryan (US 2005/0151105).
Regarding claim 2, Guala discloses a resealable medical connector for use in a medical fluid pathway, the medical connector being configured to transition between a closed position and an open position (page 9, lines 3-4: transitioning between the open/opening condition shown in Fig. 11, and the closed/closing position shown in Fig. 3), the medical connector comprising: a housing (tubular body: 1) comprising: a proximal housing portion (Fig 2: upper housing portion comprising parts 4, 5, and 6) with a first portion (4 and 5) and a second portion (6), an interior surface of the proximal housing portion comprising a first inner diameter (Fig. 3: inner diameter of 4) and a second inner diameter (Fig. 3: inner diameter of 5), the second inner diameter being distal from and larger than the first inner diameter, and an angled shoulder positioned between the first inner diameter and the second inner diameter (Fig. 3: inner diameter at 5 below and larger than the above, smaller diameter at 4, with an internal narrowing sloped wall between them); a distal housing portion (Fig. 2: lower/base housing portion comprising parts 20, 21, and 22) with a first portion (20) and a second portion (22), the first portion of the distal housing portion being attached to the second portion of the proximal housing portion (Fig. 3: 20 attached to 6 at 51); a one-piece seal (page 5, lines 20-21; Figs. 17 and 18) being positioned at least partly within the proximal housing portion (seal 30 within the proximal housing 4, 5, and 6), the seal comprising a proximal end (Fig. 18: 35) and a distal end (Fig. 18: 37), the proximal end of the seal being swabbable (page 5, lines 28-33), the seal being made of an elastomeric material (page 5, lines 20-21), and the seal comprising a collar extending around an outer surface of the seal (Fig. 18: 39), the collar being positioned distal from the proximal end of the seal (39 distal relative to 35), and no guide member being coupled to the seal; and an elongate portion (hollow spike 2) with a proximal tip (Fig. 3: 32), a distal end (Fig. 3: outlet centered in 22), and an internal fluid flow path (a lumen for internal fluid flow is intrinsic to the hollow nature of the tubular spike 2), the elongate portion being within the seal in the closed position (closed position Fig. 3: hollow spike 2 enclosed within the seal 3), and the elongate portion being made of a rigid material (page 4, lines 16-17) and being stationary within the housing as the medical connector transitions between the closed and open positions (hollow spike 2 remains in the same position between Fig. 3 demonstrating the closed position, and Fig. 11 demonstrating the open position); wherein, in the closed position of the medical connector, a portion of the elongate portion is positioned within the collar of the seal (closed position Fig. 3: hollow spike 2 enclosed within the collar just above label 40), a portion of an interior surface of the seal within the collar closely surrounding and conforming with an outer surface of the elongate portion (Fig. 11: the hollow spike 2 in contact with seal 3 all around), and the collar of the seal contacting the shoulder on the interior surface of the proximal housing portion (see annotated Fig. 3 below: collar 39 of seal, between labels 35 and 40, in contact with the inner sloped shoulder); wherein, in the open position of the medical connector, the seal compresses in a distal direction, the collar of the seal separates from the shoulder on the interior surface of the proximal housing portion (open position Fig. 11: portion 39 of the seal is shifted distally and separated from the internal shoulder; see annotated Fig. 11 below); 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 (page 5, lines 16-17; Fig. 16 channels for flow around proximal tip 34), into the internal fluid flow path in a region distal from the proximal tip (Fig. 16: fluid enters hollow spike at 31, in a distal relative location to the hollow spike proximal tip at 33 and 34), and within the elongate portion to a distal end of the distal housing portion (page 7, lines 9-11).
Guala, however, fails to disclose 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. Guala 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 Guala, to be transparent as taught by Held in order to allow the practitioner to maintain visualization of that fluid flow.
Guala also fails to disclose the open position of the medical connection wherein the proximal tip of the elongate portion extends through and is more proximal than the proximal end of the seal. Guala discloses, as shown in Fig. 11 demonstrating the open position of the connector, the seal 3 being compressed distally while the hollow spike 2 remains stationary. However, the proximal tip of the hollow spike remains covered by the proximal end of the seal, as seen in Figs. 11 and 12. Ryan teaches an analogous needless medical connector in which in the open position the proximal tip of the elongate portion extends through and is more proximal than the proximal end of the seal (Fig. 5: the tip of hollow spike 104 extending above the boot valve 108 when it is compressed distally) in order to facilitate for a more open fluid path (page 3, paragraph [0050]).
Guala, Held, and Ryan are all considered to be analogous to the claimed invention because they are in the same field of needless medical connectors for fluid transfer. Therefore, 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 Guala connector device to incorporate the transparent housing, elongate member and seal in order to make the connector transparent for the purposes of visualizing the internal fluid flow in order to monitor any blockages or bubbles, as well as to incorporate teaching of Ryan that the elongate member extends through the seal in the open position to open a clear path for fluid flow. The modification of these connector components to be transparent as well as the seal member to be pushed distally below the tip of the elongate member would not change the geometries of mechanical properties of the medical connector, making its addition obvious to one of ordinary skill in the art to increase sterilization and visualization abilities.
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Regarding claim 3, as applied to claim 2 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 2, wherein the collar of the seal extends continuously around an outer circumference of the seal (Guala Fig. 17, collar 39 extends continuously and circumferentially).
Regarding claim 4, as applied to claim 2 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 2, wherein the seal comprises a series of circular structures integrally formed together (Guala Fig. 17, circular structures 35-46).
Regarding claim 5, as applied to claim 2 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 2, 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 (see annotated Fig. 3 above).
Regarding claim 6, as applied to claim 2 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 2, wherein an outer surface of the housing is round and comprises a tapered portion (Guala Fig. 1 circumferential roundness; Fig. 2 slightly tapered section 5).
Regarding claim 7, as applied to claim 2 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 2, 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. As described above, modifying the Guala connector in its disclosed geometry, with the teachings of Held such that the housing, elongate member, and surrounding components of the Guala connector are transparent, would create 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. This modification, as described above, would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as it would allow for the flow of fluid within the connector to be visible to monitor the flow and any blockages or bubbles to ensure efficacy (page 2 of translation, sixth paragraph from the bottom).
Regarding claim 8, as applied to claim 2 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 2, wherein the proximal tip of the elongate portion is closed (Guala page 5, lines 13-17).
Regarding claim 9, as applied to claim 2 and 8 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 8, wherein the elongate portion comprises a plurality of openings distal from the proximal tip (Guala Fig. 16, openings 31).
Regarding claim 10, Guala discloses a needlefree medical connector for use in a medical fluid pathway, the medical connector being configured to transition between a closed position and an open position (page 9, lines 3-4: transitioning between the open/opening condition shown in Fig. 11, and the closed/closing position shown in Fig. 3), the medical connector comprising: a housing (tubular body: 1) comprising: a proximal housing portion (Fig 2: upper housing portion comprising parts 4, 5, and 6) with a first portion (4 and 5) and a second portion (6), the first portion of the proximal housing portion comprising an internal angled shoulder (Fig. 3: slope between labels 7 and 40), external screw threads (Fig. 2: screw threads on section 4), 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. 2 below), the proximal housing portion comprising an internal shoulder (Fig. 3: slope between labels 7 and 40); a distal housing portion (Fig. 2: lower/base housing portion comprising parts 20, 21, and 22) with a first portion (20) and a second portion (22), the first portion of the distal housing portion being attached to the second portion of the proximal housing portion (Fig. 3: 20 attached to 6 at 51); a one-piece seal (page 5, lines 20-21; Figs. 17 and 18) being positioned at least partly within the proximal housing portion (seal 30 within the proximal housing 4, 5, and 6), the seal comprising a proximal end (Fig. 18: 35), a collar (Fig. 17: 39), and a distal end (Fig. 18: 37), the proximal end of the seal being swabbable (page 5, lines 28-33), the seal being made of an elastomeric material (page 5, lines 20-21), the seal comprising a transverse flange of the seal with a diameter that is wider than the rest of the seal (Fig. 18: flange 46), the transverse flange being distal from the collar (Fig. 18: flange 46 distal from collar 39), the collar of the seal contacting the shoulder of the proximal housing portion in the closed position (closed position Fig. 3: sloped collar portion of seal 3 abutted against internal shoulder located at the sloped portion between labels 7 and 40), and no guide member coupled to the seal; and an elongate portion (hollow spike 2) with a proximal end (Fig. 3: 32), a distal end (Fig. 3: outlet centered in 22), and an internal fluid flow path (a lumen for internal fluid flow is intrinsic to the hollow nature of the tubular spike 2), the elongate portion being positioned at least partly within the seal (Fig. 3: hollow spike 2 enclosed within the seal 3) and being stationary within the housing as the medical connector transitions between the closed and open positions (hollow spike 2 remains in the same position between Fig. 3 demonstrating the closed position, and Fig. 11 demonstrating the open position), the elongate portion being made of a rigid material (page 4, lines 16-17), and in the closed position a portion of the elongate portion being positioned within the collar of the seal (closed position Fig. 3: hollow spike 2 enclosed within the collar just above label 40), an interior surface of the seal within the collar contacting an outer surface of the elongate portion, (Fig. 11: the hollow spike 2 in contact with seal 3 all around) and; wherein, in the open position of the medical connector, the seal compresses in a distal direction, the collar separates from the shoulder (open position Fig. 11: portion 39 of the seal is shifted distally and separated from the internal shoulder; see annotated Fig. 11 above); 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 (page 8, lines 9-12); and wherein there is no overlap between the proximal housing portion and the distal housing portion proximal from the transverse flange of the seal (Fig. 3: proximal housing 6 overlaps with distal housing 20 only distally relative to seal flange 46).
Guala, however, fails to disclose that the proximal housing portion as transparent, the one-piece seal as transparent, the elongate portion as transparent, and the connector such that in the closed position the fluid flow path is visible throughout a region of a single transparent layer of the housing that is proximal from the transverse flange of the seal and distal from the protrusion on the proximal housing portion, and through the transparent valve member and the transparent elongate portion. Guala 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 Guala, to be transparent as taught by Held in order to allow the practitioner to maintain visualization of that fluid flow.
Guala also fails to disclose the open position of the medical connection wherein the proximal end of the elongate portion extends through and is more proximal than the proximal end of the seal. Guala discloses, as shown in Fig. 11 demonstrating the open position of the connector, the seal 3 being compressed distally while the hollow spike 2 remains stationary. However, the proximal tip of the hollow spike remains covered by the proximal end of the seal, as seen in Figs. 11 and 12. Ryan teaches an analogous needless medical connector in which in the open position the seal compresses in the distal direction and the proximal end of the elongate portion extends through and is more proximal than the proximal end of the seal (Fig. 5: the tip of hollow spike 104 extending above the boot valve 108 when it is compressed distally) in order to facilitate for a more open fluid path (page 3, paragraph [0050]).
Guala, Held, and Ryan are all considered to be analogous to the claimed invention because they are in the same field of needless medical connectors for fluid transfer. Therefore, 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 Guala connector device to incorporate the transparent housing, elongate member and seal in order to make the connector transparent for the purposes of visualizing the internal fluid flow in order to monitor any blockages or bubbles, as well as to incorporate teaching of Ryan that the elongate member extends through the seal in the open position to open a clear path for fluid flow. The modification of these connector components to be transparent as well as the seal member to be pushed distally below the tip of the elongate member would not change the geometries of mechanical properties of the medical connector, making its addition obvious to one of ordinary skill in the art to increase sterilization and visualization abilities.
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Regarding claim 11, as applied to claim 10 above, Guala in view of Held and in further view of Ryan teaches the needlefree medical connector of Claim 10, wherein a diameter of the distal flange of the seal is smaller than a maximum inner diameter of the proximal housing portion (Guala Fig. 3: seal flange 46 diameter is less than inner diameter of proximal housing 6 which it is in contact with, because flange 46 fits within housing 6).
Regarding claim 12, as applied to claim 10 above, Guala in view of Held and in further view of Ryan teaches the needlefree medical connector of Claim 10, wherein the seal comprises a series of circular structures integrally formed together (Guala Fig. 17, circular structures 35-46).
Regarding claim 13, as applied to claim 10 above, Guala in view of Held and in further view of Ryan teaches the needlefree connector of Claim 10, wherein the seal comprises a tapered portion (Guala Fig. 18: seal sections 45 and 39 are tapered).
Regarding claim 14, as applied to claim 10 above, Guala in view of Held and in further view of Ryan teaches the needlefree connector of Claim 10, wherein an outer surface of the housing comprises a tapered portion (Guala Fig. 2 slightly tapered section 5).
Regarding claim 15, as applied to claim 10 above, Guala in view of Held and in further view of Ryan teaches the needlefree connector of Claim 10, wherein the proximal tip of the elongate portion is closed (Guala page 5, lines 13-17).
Regarding claim 16, as applied to claim 10 above, Guala in view of Held and in further view of Ryan teaches the needlefree medical connector of Claim 10, wherein the elongate portion comprises a plurality of radial openings distal from the proximal tip (Guala Fig. 16, openings 31).
Regarding claim 17, Guala discloses a resealable medical connector for use in a medical fluid pathway, the medical connector being configured to transition between a closed position and an open position (page 9, lines 3-4: transitioning between the open/opening condition shown in Fig. 11, and the closed/closing position shown in Fig. 3), the medical connector comprising: a housing comprising (tubular body: 1): a proximal housing portion with a first region and a second region (Fig 2: upper housing portion comprising parts 4 and 5 as first region, and 6 as second region), the first region of the proximal housing portion comprising screw threads (Fig. 2: screw threads on section 4) 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. 2 above), an interior surface of the proximal housing portion comprising a tapering shoulder (Fig. 3: slope between labels 7 and 40); a distal housing portion (Fig. 2: lower/base housing portion comprising parts 20, 21, and 22) with a first region (20) and a second region (22), the first region of the distal housing portion being attached to the second region of the proximal housing portion (Fig. 3: 20 attached to 6 at 51); a one-piece seal (page 5, lines 20-21; Figs. 17 and 18) being positioned at least partly within the proximal housing portion (seal 30 within the proximal housing 4, 5, and 6), the seal comprising a proximal end (Fig. 18: 35) and a distal end (Fig. 18: 37), the proximal end of the seal being swabbable (page 5, lines 28-33), the seal being made of an elastomeric material (page 5, lines 20-21), and the seal comprising a collar extending around an outer surface of the seal (Fig. 18: 39), the collar being positioned distal from the proximal end of the seal (39 distal relative to 35), the seal comprising a flange distal from the collar with a diameter that is wider than the rest of the seal (Fig. 18: flange 46), and no guide member being coupled to the seal; and an elongate portion (hollow spike 2) with a proximal end (Fig. 3: 32), a distal end (Fig. 3: outlet centered in 22), and an internal fluid flow path (page 8, lines 9-12), the elongate portion being within the seal (Fig. 3: hollow spike 2 within the seal 3) and being stationary within the housing as the medical connector transitions between the closed and open positions (hollow spike 2 remains in the same position between Fig. 3 demonstrating the closed position, and Fig. 11 demonstrating the open position), the elongate portion being made of a rigid material (page 4, lines 16-17), and in the closed position a portion of the elongate portion being positioned within the collar of the seal (closed position Fig. 3: hollow spike 2 enclosed within the collar just above label 40), 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 (Fig. 11: the hollow spike 2 in contact with seal 3 all around), 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 (Fig. 3: sloped collar section 39 of seal 3 in contact with sloped shoulder between labels 7 and 40); wherein, in the open position of the medical connector, the seal compresses in a distal direction, the collar of the seal separates from the shoulder on the interior surface of the proximal housing portion (open position Fig. 11: portion 39 of the seal is shifted distally and separated from the internal shoulder; see annotated Fig. 11 above); 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 (page 8, lines 9-12); 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 (Fig. 3: proximal housing 6 overlaps with distal housing 20 only distally relative to seal flange 46).
Guala, however, fails to disclose that the proximal housing portion as transparent, the one-piece seal as transparent, the elongate portion as transparent, and the connector such that in the closed position the fluid flow path is visible throughout a region of a single transparent layer of the housing that is proximal from the flange of the seal and distal from the protrusion on the proximal housing portion, and through the transparent valve member and the transparent elongate portion. Guala 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 Guala, to be transparent as taught by Held in order to allow the practitioner to maintain visualization of that fluid flow.
Guala also fails to disclose the open position of the medical connection wherein the proximal end of the elongate portion extends through and is more proximal than the proximal end of the seal. Guala discloses, as shown in Fig. 11 demonstrating the open position of the connector, the seal 3 being compressed distally while the hollow spike 2 remains stationary. However, the proximal tip of the hollow spike remains covered by the proximal end of the seal, as seen in Figs. 11 and 12. Ryan teaches an analogous needless medical connector in which in the open position the seal compresses in the distal direction and the proximal end of the elongate portion extends through and is more proximal than the proximal end of the seal (Fig. 5: the tip of hollow spike 104 extending above the boot valve 108 when it is compressed distally) in order to facilitate for a more open fluid path (page 3, paragraph [0050]).
Guala, Held, and Ryan are all considered to be analogous to the claimed invention because they are in the same field of needless medical connectors for fluid transfer. Therefore, 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 Guala connector device to incorporate the transparent housing, elongate member and seal in order to make the connector transparent for the purposes of visualizing the internal fluid flow in order to monitor any blockages or bubbles, as well as to incorporate teaching of Ryan that the elongate member extends through the seal in the open position to open a clear path for fluid flow. The modification of these connector components to be transparent as well as the seal member to be pushed distally below the tip of the elongate member would not change the geometries of mechanical properties of the medical connector, making its addition obvious to one of ordinary skill in the art to increase sterilization and visualization abilities.
Regarding claim 18, as applied to claim 17 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 17, wherein the collar of the seal extends continuously around an outer circumference of the seal (Guala Fig. 17, collar 39 extends continuously and circumferentially).
Regarding claim 19, as applied to claim 17 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 17, wherein the seal is not fixed to the housing (see annotated Fig. 11 above).
Regarding claim 20, as applied to claim 17 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 17, wherein the proximal end of the elongate portion is closed (Guala page 5, lines 13-17).
Regarding claim 21, as applied to claim 2 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 2, wherein the interior surface of the seal within the collar contacts the elongate portion ( Guala Fig. 11: the hollow spike 2 in contact with seal 3 all around and at sloped collar 39).
Regarding claim 22, Guala discloses a resealable medical connector for use in a medical fluid pathway, the medical connector being configured to transition between a closed position and an open position (page 9, lines 3-4: transitioning between the open/opening condition shown in Fig. 11, and the closed/closing position shown in Fig. 3), the medical connector comprising: a housing (tubular body: 1) comprising: a proximal housing portion with a first portion and a second portion, an interior surface of the proximal housing portion (Fig 2: upper housing portion comprising parts 4, 5, and 6) comprising a first inner diameter (Fig. 3: inner diameter of 4) and a second inner diameter (Fig. 3: inner diameter of 5), the second inner diameter being distal from and larger than the first inner diameter, and an angled shoulder positioned between the first inner diameter and the second inner diameter (Fig. 3: inner diameter at 5 below and larger than the above, smaller diameter at 4, with an internal narrowing sloped wall between them); a distal housing portion with a first portion and a second portion (Fig. 2: lower/base housing portion comprising parts 20, 21, and 22), the first portion of the distal housing portion being attached to the second portion of the proximal housing portion (Fig. 3: 20 attached to 6 at 51); a one-piece seal (page 5, lines 20-21; Figs. 17 and 18) being positioned at least partly within the proximal housing portion (seal 30 within the proximal housing 4, 5, and 6), the seal comprising a proximal end (Fig. 18: 35) and a distal end (Fig. 18: 37), the proximal end of the seal being swabbable (page 5, lines 28-33), the seal being made of an elastomeric material (page 5, lines 20-21), and the seal comprising a collar extending around an outer surface of the seal (Fig. 18: 39), the collar being positioned distal from the proximal end of the seal (39 distal relative to 35), and no guide member being coupled to the seal; and an elongate portion (hollow spike 2) with a proximal tip (Fig. 3: 32), a distal end (Fig. 3: outlet centered in 22), and an internal fluid flow path (a lumen for internal fluid flow is intrinsic to the hollow nature of the tubular spike 2), the elongate portion being within the seal in the closed position (closed position Fig. 3: hollow spike 2 enclosed within the seal 3), and the elongate portion being made of a rigid material (page 4, lines 16-17) and being stationary within the housing as the medical connector transitions between the closed and open positions (hollow spike 2 remains in the same position between Fig. 3 demonstrating the closed position, and Fig. 11 demonstrating the open position); 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 (Fig. 11: the hollow spike 2 in contact with seal 3 all around and at sloped collar 39), 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: collar 39 of seal, between labels 35 and 40, in contact with the inner sloped shoulder); wherein, in the open position of the medical connector, the seal compresses in a distal direction, the collar of the seal separates from the shoulder on the interior surface of the proximal housing portion (open position Fig. 11: portion 39 of the seal is shifted distally and separated from the internal shoulder; see annotated Fig. 11 above); 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 (page 5, lines 16-17; Fig. 16 channels for flow around proximal tip 34), and within the elongate portion to a distal end of the distal housing portion (Fig. 16: fluid enters hollow spike at 31, in a distal relative location to the hollow spike proximal tip at 33 and 34).
Guala, however, fails to disclose that the proximal housing portion as transparent, the one-piece seal as transparent, the elongate portion as transparent, and the connector wherein 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. Guala 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 Guala, to be transparent as taught by Held in order to allow the practitioner to maintain visualization of that fluid flow.
Guala also fails to disclose the open position of the medical connection wherein the proximal tip of the elongate portion extends through and is more proximal than the proximal end of the seal. Guala discloses, as shown in Fig. 11 demonstrating the open position of the connector, the seal 3 being compressed distally while the hollow spike 2 remains stationary. However, the proximal tip of the hollow spike remains covered by the proximal end of the seal, as seen in Figs. 11 and 12. Ryan teaches an analogous needless medical connector in which in the open position the seal compresses in the distal direction and the proximal tip of the elongate portion extends through and is more proximal than the proximal end of the seal (Fig. 5: the tip of hollow spike 104 extending above the boot valve 108 when it is compressed distally) in order to facilitate for a more open fluid path (page 3, paragraph [0050]).
Guala, Held, and Ryan are all considered to be analogous to the claimed invention because they are in the same field of needless medical connectors for fluid transfer. Therefore, 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 Guala connector device to incorporate the transparent housing, elongate member and seal in order to make the connector transparent for the purposes of visualizing the internal fluid flow in order to monitor any blockages or bubbles, as well as to incorporate teaching of Ryan that the elongate member extends through the seal in the open position to open a clear path for fluid flow. The modification of these connector components to be transparent as well as the seal member to be pushed distally below the tip of the elongate member would not change the geometries of mechanical properties of the medical connector, making its addition obvious to one of ordinary skill in the art to increase sterilization and visualization abilities.
Regarding claim 23, as applied to claim 2 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 2, wherein the connector is configured to establish neutral displacement during use (Ryan page 1 paragraph [0012], and page 5 paragraph [0065]). Although Guala does not disclose the establishment of neutral displacement of the fluids during use of the connector, 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 Guala 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 pate 1 paragraph [0012]).
Regarding claim 25, as applied to claim 10 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 10, wherein the connector is configured to establish neutral displacement during use (Ryan page 1 paragraph [0012], and page 5 paragraph [0065]). Although Guala does not disclose the establishment of neutral displacement of the fluids during use of the connector, 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 Guala 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 pate 1 paragraph [0012]).
Regarding claim 27, as applied to claim 17 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 17, wherein the connector is configured to establish neutral displacement during use (Ryan page 1 paragraph [0012], and page 5 paragraph [0065]). Although Guala does not disclose the establishment of neutral displacement of the fluids during use of the connector, 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 Guala 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 pate 1 paragraph [0012]).
Regarding claim 28, as applied to claim 22 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 22, wherein the connector is configured to establish neutral displacement during use (Ryan page 1 paragraph [0012], and page 5 paragraph [0065]). Although Guala does not disclose the establishment of neutral displacement of the fluids during use of the connector, 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 Guala 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 pate 1 paragraph [0012]).
Regarding claim 29, as applied to claim 22 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 22, wherein the proximal tip of the elongate portion is more proximal than the shoulder (Ryan Fig. 8: proximal tip of hollow spike 304a is more distal than the H-guide shoulder protrusion 110). Although Guala does not disclose the proximal tip of the elongate portion being more proximal than the sloped shoulder, 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 Guala device to incorporate the geometry of the connector of Ryan, which possesses the same components of the hollow elongate member, seal with collar, and internal shoulder of the housing abutted to the seal collar, in order to make the shoulder slightly more distal than the tip of the elongate member. Since such a modification as shifting the shoulder distally is a simple rearrangement of parts that would not have altered the functions of the components or of the overall connector in its use, it would be considered obvious within a level of ordinary skill in the art (see MPEP 2144.04 IV A).
Regarding claim 30, as applied to claim 22 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 22, wherein the proximal end of the seal comprises a lip that contacts an inner surface of the proximal housing portion in the closed position (Guala Fig. 18: lip 36 of seal 3; closed position Fig. 3: 36 in contact with proximal housing 5).
Claims 24 and 26 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Guala (CA 2581547) in view of Held (EP 1529549) and in further view of Ryan (US 2005/0151105) as applied to claims 2, 10, 23 and 25 above, and further in view of Stroup (WO 2009/111596).
Regarding claim 24, as applied to claims 2 and 23 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 23, but does not teach the connector further comprising a regulator. Guala 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 Guala 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, as applied to claims 10 above, Guala in view of Held and in further view of Ryan teaches the medical connector of Claim 25, but does not teach the connector further comprising a regulator with a valve. Guala 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 Guala 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 06/17/2025 regarding the 112(a) rejection of claim 19 has been fully considered and is persuasive. The 112(a) rejection of claim 19 has hereby been withdrawn.
Applicant's arguments filed 06/17/2025 regarding the prior art rejections of claims 2-30 have been fully considered but they are not persuasive:
Regarding claims 2, 10 and 17, Applicant argues that Guala fails to disclose that “a portion of the elongate portion is positioned within the collar of the seal, a portion of an interior surface of the seal within the collar closely surrounding and conforming with an outer surface of the elongate portion” when the connector is in the closed position. The phrases “closely surrounding” and “conforming with” are broad limitations that do not alone necessitate contact, fixture, or describe an exact relative positioning of the collar to the elongate portion. Under the broadest reasonable interpretation of these limitations, Examiner maintains that Guala does disclose “a portion of the elongate portion is positioned within the collar of the seal, a portion of an interior surface of the seal within the collar closely surrounding and conforming with an outer surface of the elongate portion” when the connector is in the closed position, as can be seen in Fig. 11, in which the collar surrounds a portion of the elongate portion, and conforms with the outer surface of it in that the general contour of the elongate portion is reproduced by the shape of the collar, and seal in general. Although Fig. 3, referenced by the previous office action in regards to this limitation, shows the open position of the connector, these positional relationships of the collar and elongate portion are disclosed in both the open and closed positions.
Regarding claims 2, 10, 17 and 22, Examiner also maintains the contact of the seal to the interior housing shoulder, as described in the citations above. Contact of at least a portion of the should to at least a portion of the seal can be seen in the annotated figures included in the rejection above.
Therefore, all dependent claims also stand rejected by Guala in view of Held and in further view of Ryan and Stroup. The rejections recited above are maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/K.A.W./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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