DETAILED ACTION
This action is responsive to the claim amendments and Applicant’s Remarks filed 24 June 2026. The Examiner acknowledges the amendments to claims 1, 16, and 20-23, as well as the addition of claim 24. Claims 1-4, 6, 8, 10-16, and 18-24 are pending.
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 .
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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(s) 1-4, 6, 8, 10-16, and 18-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US-20210228127-A1, previously presented) in view of Korogi (US-7559530-B2, previously presented) and Nelson (US-20140276215-A1, previously presented).
Regarding claim 1, Burkholz teaches
A flow restriction device, comprising:
a proximal housing [distal connector 14 (Burkholz Figs. 1A-B), wherein the Examiner notes that “distal” and “proximal” are considered to be relative and non-structurally limiting in the present context] configured to couple to a fluid flow device [a distal connector 14 configured to couple to the catheter assembly (Burkholz ¶0029)];
a distal housing [proximal connector 18 (Burkholz Figs. 1A-B), wherein the Examiner notes that “distal” and “proximal” are considered to be relative and non-structurally limiting in the present context] configured to couple to a fluid flow assembly [a proximal connector 18 configured to couple to a blood collection device (Burkholz ¶0033)];
an intermediate housing interposed between the proximal housing and the distal housing [the adapter 10 may include a middle portion 32 disposed between the distal end 12 and the proximal end 16 (Burkholz ¶0044, Figs. 1A-B)];
an internal fluid channel extending transversely through the proximal, intermediate and distal housings [the adapter 10 may include a fluid pathway 20 disposed between the distal end 12 and the proximal end 16. In some embodiments, fluid within the fluid pathway 20 may flow through the distal end 12 and/or the proximal end 16. In some embodiments, the fluid within the fluid pathway 20 may flow through the proximal end 16 in response to opening of a septum 21 disposed within the proximal end 16 (Burkholz ¶0033, Figs. 1A-B)]; and
a fluid shield device coupled to the distal housing, the fluid shield comprising a flexible material [the septum 21 may include an accordion-like septum 21 that may open when compressed in a distal direction (Burkholz ¶0033, Fig. 1B), wherein the septum 21 being compressible is considered to define a flexible material],
wherein the fluid shield device is configured to cover an end portion of a male center post of the distal housing in an unconnected position [see septum 21 in Burkholz Fig. 1B], and to compress down the male center post into a groove of the distal housing in a connected position [see septum 21 in Burkholz Fig. 1B; the septum 21 may open in response to coupling of the blood collection device to the proximal end 16 of the adapter 10. In some embodiments, the septum 21 may include any suitable septum and may be different from the septum 21 illustrated. In some embodiments, the septum 21 may include an accordion-like septum 21 that may open when compressed in a distal direction (Burkholz ¶0033)].
However, while Burkholz discloses wherein the proximal housing is configured to couple to a catheter assembly [Burkholz ¶0029] and wherein the distal housing is configured to couple to a fluid collection device [Burkholz ¶0033], Burkholz fails to explicitly disclose wherein the proximal housing is specifically configured to couple to a fluid collection device, and wherein the distal housing is configured to couple to a catheter assembly; and wherein the male center post extends outwards past a distal end of the distal housing. Furthermore, while Burkholz describes the fluid shield device as “accordion-like” [Burkholz ¶0033], Burkholz is also silent regarding the fluid shield device being configured to recover the end portion of the male center post to contain fluid within the male center post upon returning to an unconnected position.
Korogi discloses a valved fluid connector, wherein Korogi discloses that the valved fluid connector comprises a proximal housing configured as an outlet and a distal housing configured as an inlet [The simplicity and platform nature of the herein disclosed embodiments allows integration with a multiplicity of devices. Referring to FIGS. 28-30, valved fluid connector 400 is adaptable to standard male connectors with tubing pockets 260 or IV tubing sets (FIG. 28), as well as syringe tips 250 (FIG. 29). In addition, valved fluid connector 500 is adaptable to blood collection tube adapters 270 (FIG. 30), etc as well as female luers as previously disclosed. Each of these aforementioned medical devices often containing fluid potentially harmful to patients and/or clinicians which may be reduced or eliminated using the various embodiments herein disclosed. The embodiments herein are generally adaptable to standard male luer connectors to provide valved male luer functionality (Korogi Col 10:61-11:7, Figs. 28-30)], wherein the valved fluid connector further comprises a fluid shield device coupled to the distal housing and configured to cover an end portion of a male center post extending outwards past a distal end of the distal housing in an unconnected position [Proximal end 137 of tubular member 135 is positioned within and at least partially surrounded by elastic member 121. Proximal end 137 is in sealable relationship with valve member 127 (Korogi Col 9:13-16, Figs. 19-20), wherein the Examiner directs attention to the proximal end 137 extending beyond the housing (housing component 131), and wherein the Examiner notes that “distal” and “proximal” are considered to be relative and non-structurally limiting in the present context, such that proximal end 137 may be considered to be a distal end in the context of an entire fluid flow assembly and is considered to function as an inlet based on the context provided in Korogi Col 10:61-11:7 as cited above], compress down the male center post into a groove of the distal housing in a connected position [When the female connector 79 engages the valved male connector, the forward surface 80 of the female connector engages collar 139 and urges the collar rearwardly. This urges membrane 141 and elastic member 121 into a tensioned or stretched position (as indicated by arrows 147) opening valve member 127 reversibly unsealing the proximal end of the tubular member to allow liquid flow between the two connectors (Korogi Col 9:28-35, Fig. 20)], and to recover the end portion of the male center post to contain fluid within the male center post upon returning to an unconnected position [the return force of the elastic member is substantially generated by the stretching of the elastic member, either from the translating lugs/annular collar and slit, or from the stretching membrane and flange, as shown for example in FIGS. 19-27. Upon removal of a female connector or needle-free valve from the valved male connector, this tension stored in the elastic member provides energy to return the elastic member to the before-tensioned position, thus allowing the slit to re-close and any sliding seals to return to the before-tensioned, sealed closed position (Korogi Col 13:61-14:3, Fig. 19), wherein the Examiner notes that Fig. 19 is considered to depict the fluid shield device in an unconnected position both prior to being in the connection position (Fig. 20) and after being in the connected position].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz to employ the proximal housing to couple to a fluid collection device, employ the distal end to couple to a catheter assembly, and employ wherein the male center post extends outwards past a distal end of the distal housing, as this modification amounts to merely applying a known technique [use of luer or equivalent connectors (Burkholz ¶¶0029, 0033; Korogi Col 10:61-11:7] to a known device ready for improvement to yield predictable results [allow for fluid collection and allow connectivity between different fluid flow devices using standard connections] [MPEP § 2143(I)(D)].
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz to employ the fluid shield device being configured to recover the end portion of the male center post to contain fluid within the male center post upon returning to an unconnected position, so as to allow for the fluid shield device to return to cover the end portion after being in the connected position to maintain sterility [Korogi Col 13:61-14:3, Fig. 19].
However, Burkholz in view of Korogi fails to explicitly disclose wherein the fluid shield device is configured to compress down the male center post beneath a leading edge of a female connector.
Burkholz does disclose that the fluid shield device is defined as “accordion-like” [Burkholz ¶0033, Figs. 1B, 3B, 4B].
Nelson discloses a flow restriction device comprising a fluid shield device coupled to a housing, the fluid shield device comprising a flexible material [FIG. 13 illustrates the medical connector as the medical implement approaches, with the valve member 200 in a closed position, and FIG. 14 illustrates the medical implement once it has been inserted and moved the valve member into an open position. Generally, the tip 310 of the medical implement can be inserted into the upper portion 128 of the body 120 of the medical connector. As the tip enters the upper portion, it will push the valve member 200, compressing it into the body of the medical connector. Various features of the valve member, such as the ribs in the ribbed section 250, can help allow the valve member to compress (Nelson ¶¶0180-181, Figs. 13-14); As the valve member 200 is pushed into the body 120 of the needleless connector, the projection tip 172 can contact the slit 232 in the top 230 of the valve member. As the valve member is compressed further, the tip can pass through the slit, opening it and allowing the valve member to slide down over the projection tip and/or projection body 174 (Nelson ¶0182)]; wherein the fluid shield device is configured to cover an end portion of a male center post of the housing in an unconnected position, to compress down the male center post beneath a leading edge of a female connector and into a groove of the housing in a connected position, and to recover the end portion of the male center post to prevent fluid flow through the male center post upon returning to an unconnected position [Nelson ¶¶0180-0182, Figs. 13-14; after a valve member has been compressed by a medical implement, the medical implement is removed or being removed, and the valve member begins to return to the illustrated closed position. As the valve member moves upward, the top 230 of the valve member will pass the uppermost point of the projection tip 172, allowing the slit 232 to close and seal (Nelson ¶0199)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz in view of Korogi to employ wherein the fluid shield device is configured to compress down the male center post beneath a leading edge of a female connector, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [allow for resilient movement of the fluid shield device between an uncompressed position to a compressed position and vice versa] [MPEP § 2143(I)(D)].
Regarding claim 2, Burkholz in view of Korogi and Nelson teaches
The flow restriction device of Claim 1.
However, Burkholz in view of Korogi and Nelson as presently modified fails to explicitly disclose wherein the flexible material of the fluid shield device comprises a shape memory material.
Korogi defines the flexible material of the fluid shield device as a shape memory material [Korogi Col 9:28-35, 13:61-14:3, Figs. 19-20; The elastic member may be comprised of a silicone or polyurethane material, for example, or any material that possesses inherent resiliency, good sealing properties, radiotransparency, ability to slit, and low compression set properties. Examples of such materials include, but are not limited to, natural rubbers and latex, or synthetic materials such as synthetic polyisoprene, thermoplastic elastomer, thermoset rubber, latex-free rubber, etc (Korogi Col 13:7-14)].
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz in view of Korogi and Nelson to employ wherein the flexible material of the fluid shield device comprises a shape memory material, so as to allow for the fluid shield device to return to cover the end portion after being in the connected position to maintain sterility [Korogi Col 13:61-14:3, Fig. 19].
Regarding claim 3, Burkholz in view of Korogi and Nelson teaches
The flow restriction device of Claim 2, wherein the shape memory material comprises one of elastic rubber, elastomeric silicone and latex [Korogi Col 13:7-14].
Regarding claim 4, Burkholz in view of Korogi and Nelson teaches
The flow restriction device of Claim 1.
However, Burkholz in view of Korogi and Nelson as presently modified fails to explicitly disclose wherein a portion of the flexible material is affixed to the groove by one of an adhesive and a solvent.
Korogi discloses wherein a portion of the flexible material is affixed to the groove by one of an adhesive and a solvent [Alternatively, elastic member 5 may be directly attached to the tubular member flange without a housing member. Attachment may be, for example, by adhesive, welding, solvent bonding or snap-fit, for example (Korogi Col 6:47-50, Figs. 1-3)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz in view of Korogi and Nelson to employ wherein a portion of the flexible material is affixed to the groove by one of an adhesive and a solvent, so as to secure the flexible material within the device.
Regarding claim 6, Burkholz in view of Korogi and Nelson teaches
The flow restriction device of Claim 1.
However, Burkholz in view of Korogi and Nelson fails to explicitly disclose wherein a portion of the flexible material is welded to the distal housing.
Korogi discloses wherein a portion of the flexible material is welded to the male center post [Korogi Col 6:47-50, Figs. 1-3], which is understood to comprise the distal housing.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz in view of Korogi and Nelson to employ wherein a portion of the flexible material is welded to the distal housing, so as to secure the flexible material within the device.
Regarding claim 8, Burkholz in view of Korogi and Nelson teaches
The flow restriction device of Claim 1, wherein a portion of the flexible material is molded to the distal housing [wherein the septum 21 (see Burkholz Figs. 1-2) being formed to fit in the distal housing is considered to read on being “molded to the distal housing”, based on the broadest reasonable interpretation of “molded” being defined as “to fit the contours of” (https://www.merriam-webster.com/dictionary/mold)].
Regarding claim 10, Burkholz in view of Korogi and Nelson teaches
The flow restriction device of Claim 1.
However, Burkholz in view of Korogi fails to explicitly disclose wherein the fluid shield device is coupled to the male center post by a friction fit.
Nelson discloses that the fluid shield device is coupled to the male center post by a friction fit [the upper section of the compressible seal can have an interference fit with the internal projection member (Nelson ¶0030), wherein an interference fit is considered to be equivalent to a friction fit].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flow restriction device of Burkholz in view of Korogi and Nelson to employ a friction fit to couple the fluid shield device to the male center post, so as to secure the fluid shield device to the distal housing.
Regarding claim 11, Burkholz in view of Korogi and Nelson teaches
The flow restriction device of Claim 1, wherein a portion of the fluid shield device is configured to slide down into the groove along an outer surface of the male center post under a compressive force [Burkholz ¶0033, Figs. 1B, 2B].
Regarding claim 12, Burkholz in view of Korogi and Nelson teaches
The flow restriction device of Claim 11, wherein the portion of the fluid shield device is configured to slide up along the outer surface of the male center post upon removal of the compressive force [Korogi Col 13:61-14:3].
Regarding claim 13, Burkholz in view of Korogi and Nelson teaches
The flow restriction device of Claim 1, wherein the flow restriction device is configured to flow blood from the proximal housing to the distal housing and into the fluid collection device [wherein in light of the § 103 modification of claim 1 above, the flow restriction device of Burkholz in view of Korogi is considered to allow fluid flow in the claimed direction], and the fluid collection device comprises a blood collection device [see § 103 modification above; Burkholz ¶¶0029, 0033].
Regarding claim 14, Burkholz in view of Korogi and Nelson teaches
The flow restriction device of Claim 1, wherein the proximal housing, the intermediate housing and the distal housing comprise an integral connector assembly [wherein the adapter 10 being defined by distal/proximal ends on either side of an intermediate portion is considered to define a integral assembly (see Burkholz ¶¶0029, 0033, 0044] having a female connector at the proximal housing [Burkholz ¶0029] and a male connector at the distal housing [Burkholz ¶0033].
Regarding claim 15, Burkholz in view of Korogi and Nelson teaches
The flow restriction device of Claim 1, wherein the intermediate housing comprises an intravenous tube [tube 28 (Burkholz Figs. 1-2); the catheter may include a peripheral intravenous catheter (PIVC) (Burkholz ¶0030)] connecting a female connector at the proximal housing and a male connector comprising the male center post at the distal housing, the internal fluid channel extending through the female connector, the intravenous tube and the male connector [Burkholz ¶¶0029, 0033].
Regarding claim 16, Burkholz teaches
A blood collection system, comprising:
a blood collection device [the proximal end 16 may be coupled to the blood collection device 34… As another example, the proximal end 16 may include the female luer connector, which may be coupled with a male luer connector of the blood collection device 34 (Burkholz ¶0045, Figs. 2A-D); As illustrated in FIG. 2A, in some embodiments, the blood collection device 34 may include a needle assembly 36, which may include a needle 38 configured to receive a blood collection container. In these and other embodiments, the blood collection container may include an evacuated blood collection tube (Burkholz ¶0046, Fig. 2A)];
a catheter assembly [the vascular access device may include a catheter assembly. In some embodiments, the adapter 10 may include a distal end 12, which may include a distal connector 14 configured to couple to the catheter assembly (Burkholz ¶0029)]; and
a flow restriction device fluidly coupled to the blood collection device [adapter 10 (Burkholz ¶0029, Figs, 2A-C)], the flow restriction device comprising:
a proximal housing [distal connector 14 (Burkholz Figs. 1A-B), wherein the Examiner notes that “distal” and “proximal” are considered to be relative and non-structurally limiting in the present context] configured to couple to a fluid flow device [a distal connector 14 configured to couple to the catheter assembly (Burkholz ¶0029)];
a distal housing [proximal connector 18 (Burkholz Figs. 1A-B), wherein the Examiner notes that “distal” and “proximal” are considered to be relative and non-structurally limiting in the present context] comprising a male luer connector [the proximal connector 18 may include a female luer connector or another suitable connector (Burkholz ¶0033), wherein the Examiner notes that the fluid pathway 20 is considered to structurally define a “male” pathway (proximal end 26) as depicted in Figs. 1B and 2B];
an intermediate housing interposed between the proximal housing and the distal housing [the adapter 10 may include a middle portion 32 disposed between the distal end 12 and the proximal end 16 (Burkholz ¶0044, Figs. 1A-B)];
an internal fluid channel extending transversely through the proximal, intermediate and distal housings [the adapter 10 may include a fluid pathway 20 disposed between the distal end 12 and the proximal end 16. In some embodiments, fluid within the fluid pathway 20 may flow through the distal end 12 and/or the proximal end 16. In some embodiments, the fluid within the fluid pathway 20 may flow through the proximal end 16 in response to opening of a septum 21 disposed within the proximal end 16 (Burkholz ¶0033, Figs. 1A-B)]; and
a fluid shield device coupled to the distal housing and disposed within a groove concentrically adjacent to a male center post, the fluid shield device comprising a flexible material [the septum 21 may include an accordion-like septum 21 that may open when compressed in a distal direction (Burkholz ¶0033, Fig. 1B), wherein the septum 21 being compressible is considered to define a flexible material],
wherein the fluid shield device is configured to cover an end portion of the male center post of the male luer connector in an uncompressed position [see septum 21 in Burkholz Fig. 1B], to slide down the male center post into the groove of the distal housing in a compressed position [see septum 21 in Burkholz Fig. 1B; the septum 21 may open in response to coupling of the blood collection device to the proximal end 16 of the adapter 10. In some embodiments, the septum 21 may include any suitable septum and may be different from the septum 21 illustrated. In some embodiments, the septum 21 may include an accordion-like septum 21 that may open when compressed in a distal direction (Burkholz ¶0033)].
However, while Burkholz discloses wherein the proximal housing is configured to couple to a catheter assembly [Burkholz ¶0029] and wherein the distal housing is configured to couple to a fluid collection device [Burkholz ¶0033], Burkholz fails to explicitly disclose wherein the proximal housing is coupled to a male connector of the blood collection device, wherein the distal housing is configured to couple to a female connector of the catheter assembly; and wherein the male center post extends outwards past a distal end of the distal housing. Furthermore, while Burkholz describes the fluid shield device as “accordion-like” [Burkholz ¶0033], Burkholz is also silent regarding the fluid shield device comprising a flexible shape memory material and being configured to recover the end portion of the male center post to contain fluid within the male center post upon returning to an unconnected position.
Korogi discloses a valved fluid connector, wherein Korogi discloses that the valved fluid connector comprises a proximal housing configured as an outlet and a distal housing configured as an inlet [The simplicity and platform nature of the herein disclosed embodiments allows integration with a multiplicity of devices. Referring to FIGS. 28-30, valved fluid connector 400 is adaptable to standard male connectors with tubing pockets 260 or IV tubing sets (FIG. 28), as well as syringe tips 250 (FIG. 29). In addition, valved fluid connector 500 is adaptable to blood collection tube adapters 270 (FIG. 30), etc as well as female luers as previously disclosed. Each of these aforementioned medical devices often containing fluid potentially harmful to patients and/or clinicians which may be reduced or eliminated using the various embodiments herein disclosed. The embodiments herein are generally adaptable to standard male luer connectors to provide valved male luer functionality (Korogi Col 10:61-11:7, Figs. 28-30)], wherein the valved fluid connector further comprises a fluid shield device coupled to the distal housing and configured to cover an end portion of a male center post extending outwards past a distal end of the distal housing in an unconnected position [Proximal end 137 of tubular member 135 is positioned within and at least partially surrounded by elastic member 121. Proximal end 137 is in sealable relationship with valve member 127 (Korogi Col 9:13-16, Figs. 19-20), wherein the Examiner directs attention to the proximal end 137 extending beyond the housing (housing component 131), and wherein the Examiner notes that “distal” and “proximal” are considered to be relative and non-structurally limiting in the present context, such that proximal end 137 may be considered to be a distal end in the context of an entire fluid flow assembly and is considered to function as an inlet based on the context provided in Korogi Col 10:61-11:7 as cited above], compress down the male center post into a groove of the distal housing in a connected position [When the female connector 79 engages the valved male connector, the forward surface 80 of the female connector engages collar 139 and urges the collar rearwardly. This urges membrane 141 and elastic member 121 into a tensioned or stretched position (as indicated by arrows 147) opening valve member 127 reversibly unsealing the proximal end of the tubular member to allow liquid flow between the two connectors (Korogi Col 9:28-35, Fig. 20)], and to recover the end portion of the male center post to contain fluid within the male center post upon returning to an unconnected position [the return force of the elastic member is substantially generated by the stretching of the elastic member, either from the translating lugs/annular collar and slit, or from the stretching membrane and flange, as shown for example in FIGS. 19-27. Upon removal of a female connector or needle-free valve from the valved male connector, this tension stored in the elastic member provides energy to return the elastic member to the before-tensioned position, thus allowing the slit to re-close and any sliding seals to return to the before-tensioned, sealed closed position (Korogi Col 13:61-14:3, Fig. 19), wherein the Examiner notes that Fig. 19 is considered to depict the fluid shield device in an unconnected position both prior to being in the connection position (Fig. 20) and after being in the connected position]. Korogi further defines the flexible material of the fluid shield device as a shape memory material [Korogi Col 9:28-35, 13:61-14:3, Figs. 19-20; The elastic member may be comprised of a silicone or polyurethane material, for example, or any material that possesses inherent resiliency, good sealing properties, radiotransparency, ability to slit, and low compression set properties. Examples of such materials include, but are not limited to, natural rubbers and latex, or synthetic materials such as synthetic polyisoprene, thermoplastic elastomer, thermoset rubber, latex-free rubber, etc (Korogi Col 13:7-14)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Burkholz to employ the proximal housing to couple to a male connector of the blood collection device, employ the distal housing to couple to a female connector of the catheter assembly, and employ wherein the male center post extends outwards past a distal end of the distal housing, as this modification amounts to merely applying a known technique [use of luer or equivalent connectors (Burkholz ¶¶0029, 0033; Korogi Col 10:61-11:7] to a known device ready for improvement to yield predictable results [allow for fluid collection and allow connectivity between different fluid flow devices using standard connections] [MPEP § 2143(I)(D)].
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Burkholz to employ the fluid shield device to comprise a flexible shape memory material to be configured to recover the end portion of the male center post to contain fluid within the male center post upon returning to an unconnected position, so as to allow for the fluid shield device to return to cover the end portion after being in the connected position to maintain sterility [Korogi Col 13:61-14:3, Fig. 19].
However, Burkholz in view of Korogi fails to explicitly disclose wherein the fluid shield device is configured to slide down the male center post beneath a leading edge of the female connector of the catheter assembly.
Burkholz does disclose that the fluid shield device is defined as “accordion-like” [Burkholz ¶0033, Figs. 1B, 3B, 4B].
Nelson discloses a flow restriction device comprising a fluid shield device coupled to a housing, the fluid shield device comprising a flexible material [FIG. 13 illustrates the medical connector as the medical implement approaches, with the valve member 200 in a closed position, and FIG. 14 illustrates the medical implement once it has been inserted and moved the valve member into an open position. Generally, the tip 310 of the medical implement can be inserted into the upper portion 128 of the body 120 of the medical connector. As the tip enters the upper portion, it will push the valve member 200, compressing it into the body of the medical connector. Various features of the valve member, such as the ribs in the ribbed section 250, can help allow the valve member to compress (Nelson ¶¶0180-181, Figs. 13-14); As the valve member 200 is pushed into the body 120 of the needleless connector, the projection tip 172 can contact the slit 232 in the top 230 of the valve member. As the valve member is compressed further, the tip can pass through the slit, opening it and allowing the valve member to slide down over the projection tip and/or projection body 174 (Nelson ¶0182)]; wherein the fluid shield device is configured to cover an end portion of a male center post of the housing in an unconnected position, to slide down the male center post beneath a leading edge of a female connector and into a groove of the housing in a connected position, and to recover the end portion of the male center post to prevent fluid flow through the male center post upon returning to an unconnected position [Nelson ¶¶0180-0182, Figs. 13-14; after a valve member has been compressed by a medical implement, the medical implement is removed or being removed, and the valve member begins to return to the illustrated closed position. As the valve member moves upward, the top 230 of the valve member will pass the uppermost point of the projection tip 172, allowing the slit 232 to close and seal (Nelson ¶0199)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz in view of Korogi to employ wherein the fluid shield device is configured to slide down the male center post beneath a leading edge of the female connector of the catheter assembly, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [allow for resilient movement of the fluid shield device between an uncompressed position to a compressed position and vice versa] [MPEP § 2143(I)(D)].
Regarding claim 18, Burkholz in view of Korogi and Nelson teaches
The blood collection system of Claim 16, wherein the proximal housing, the intermediate housing and the distal housing comprise an integral connector assembly [wherein the adapter 10 being defined by distal/proximal ends on either side of an intermediate portion is considered to define a integral assembly (see Burkholz ¶¶0029, 0033, 0044] having a female connector at the proximal housing [Burkholz ¶0029] and the male luer at the distal housing [Burkholz ¶0033].
Regarding claim 19, Burkholz in view of Korogi and Nelson teaches
The flow restriction device of Claim 16, wherein the intermediate housing comprises an intravenous tube [tube 28 (Burkholz Figs. 1-2); the catheter may include a peripheral intravenous catheter (PIVC) (Burkholz ¶0030)] connecting a female connector at the proximal housing and the male luer connector comprising the male center post at the distal housing, the internal fluid channel extending through the female connector, the intravenous tube and the male luer connector [Burkholz ¶¶0029, 0033].
Regarding claim 20, Burkholz teaches
A fluid shield device for a male luer connector [the septum 21 may include an accordion-like septum 21 that may open when compressed in a distal direction (Burkholz ¶0033, Fig. 1B)], comprising:
a flexible material [Burkholz ¶0033, wherein the septum 21 being compressible is considered to define a flexible material],
wherein the fluid shield device is configured to cover an end portion of a male center post of the male luer connector in an uncompressed position [see septum 21 in Burkholz Fig. 1B], to slide down the male center post into a bottom end of a groove concentrically disposed around the male center post in a compressed position [see septum 21 in Burkholz Fig. 1B; the septum 21 may open in response to coupling of the blood collection device to the proximal end 16 of the adapter 10. In some embodiments, the septum 21 may include any suitable septum and may be different from the septum 21 illustrated. In some embodiments, the septum 21 may include an accordion-like septum 21 that may open when compressed in a distal direction (Burkholz ¶0033)].
However, Burkholz fails to explicitly disclose wherein the flexible material is a flexible shape memory material, wherein the fluid shield device is configured to cover an end portion of a male center post extending outwards past an outer end of the male luer connector in an uncompressed position, and wherein the fluid shield device is configured to slide up the male center post and over the end portion of the male center post to contain fluid within the male center post upon returning to an uncompressed position.
Korogi discloses a fluid shield device comprising a flexible shape memory material [Korogi Col 9:28-35, 13:61-14:3, Figs. 19-20; The elastic member may be comprised of a silicone or polyurethane material, for example, or any material that possesses inherent resiliency, good sealing properties, radiotransparency, ability to slit, and low compression set properties. Examples of such materials include, but are not limited to, natural rubbers and latex, or synthetic materials such as synthetic polyisoprene, thermoplastic elastomer, thermoset rubber, latex-free rubber, etc (Korogi Col 13:7-14)] and configured to cover an end portion of a male center post extending outwards past an outer end of a male luer connector in an uncompressed position [Proximal end 137 of tubular member 135 is positioned within and at least partially surrounded by elastic member 121. Proximal end 137 is in sealable relationship with valve member 127 (Korogi Col 9:13-16, Figs. 19-20), wherein the Examiner directs attention to the proximal end 137 extending beyond the housing (housing component 131), and wherein the Examiner notes that “distal” and “proximal” are considered to be relative and non-structurally limiting in the present context, such that proximal end 137 may be considered to be a distal end in the context of an entire fluid flow assembly and is considered to function as an inlet based on the context provided in Korogi Col 10:61-11:7 as cited above], compress down the male center post into a groove of the distal housing in a connected position [When the female connector 79 engages the valved male connector, the forward surface 80 of the female connector engages collar 139 and urges the collar rearwardly. This urges membrane 141 and elastic member 121 into a tensioned or stretched position (as indicated by arrows 147) opening valve member 127 reversibly unsealing the proximal end of the tubular member to allow liquid flow between the two connectors (Korogi Col 9:28-35, Fig. 20)], and wherein the fluid shield device is configured to slide up the male center post and over the end portion of the male center post to contain fluid within the male center post upon returning to an uncompressed position [the return force of the elastic member is substantially generated by the stretching of the elastic member, either from the translating lugs/annular collar and slit, or from the stretching membrane and flange, as shown for example in FIGS. 19-27. Upon removal of a female connector or needle-free valve from the valved male connector, this tension stored in the elastic member provides energy to return the elastic member to the before-tensioned position, thus allowing the slit to re-close and any sliding seals to return to the before-tensioned, sealed closed position (Korogi Col 13:61-14:3, Fig. 19), wherein the Examiner notes that Fig. 19 is considered to depict the fluid shield device in an unconnected position both prior to being in the connection position (Fig. 20) and after being in the connected position].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid shield device of Burkholz to employ wherein the flexible material is a flexible shape memory material and wherein the fluid shield device is configured to slide up the male center post and over the end portion of the male center post to contain fluid within the male center post upon returning to an uncompressed position, so as to allow for the fluid shield device to return to cover the end portion after being in the connected position to maintain sterility [Korogi Col 13:61-14:3, Fig. 19].
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid shield device of Burkholz to employ wherein the fluid shield device is configured to cover an end portion of a male center post extending outwards past an outer end of the male luer connector in an uncompressed position, as this modification amounts to merely applying a known technique [use of luer or equivalent connectors (Burkholz ¶¶0029, 0033; Korogi Col 10:61-11:7] to a known device ready for improvement to yield predictable results [allow for fluid collection and allow connectivity between different fluid flow devices using standard connections] [MPEP § 2143(I)(D)].
However, Burkholz in view of Korogi fails to explicitly disclose wherein the fluid shield device is configured to slide down the male center post beneath a leading edge of a female connector.
Burkholz does disclose that the fluid shield device is defined as “accordion-like” [Burkholz ¶0033, Figs. 1B, 3B, 4B].
Nelson discloses a flow restriction device comprising a fluid shield device coupled to a housing, the fluid shield device comprising a flexible material [FIG. 13 illustrates the medical connector as the medical implement approaches, with the valve member 200 in a closed position, and FIG. 14 illustrates the medical implement once it has been inserted and moved the valve member into an open position. Generally, the tip 310 of the medical implement can be inserted into the upper portion 128 of the body 120 of the medical connector. As the tip enters the upper portion, it will push the valve member 200, compressing it into the body of the medical connector. Various features of the valve member, such as the ribs in the ribbed section 250, can help allow the valve member to compress (Nelson ¶¶0180-0181, Figs. 13-14); As the valve member 200 is pushed into the body 120 of the needleless connector, the projection tip 172 can contact the slit 232 in the top 230 of the valve member. As the valve member is compressed further, the tip can pass through the slit, opening it and allowing the valve member to slide down over the projection tip and/or projection body 174 (Nelson ¶0182)]; wherein the fluid shield device is configured to cover an end portion of a male center post of the housing in an unconnected position, to slide down the male center post beneath a leading edge of a female connector and into a groove of the housing in a connected position, and to recover the end portion of the male center post to prevent fluid flow through the male center post upon returning to an unconnected position [Nelson ¶¶0180-0182, Figs. 13-14; after a valve member has been compressed by a medical implement, the medical implement is removed or being removed, and the valve member begins to return to the illustrated closed position. As the valve member moves upward, the top 230 of the valve member will pass the uppermost point of the projection tip 172, allowing the slit 232 to close and seal (Nelson ¶0199)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz in view of Korogi to employ wherein the fluid shield device is configured to slide down the male center post beneath a leading edge of a female connector, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [allow for resilient movement of the fluid shield device between an uncompressed position to a compressed position and vice versa] [MPEP § 2143(I)(D)].
Regarding claim 21, Burkholz in view of Korogi and Nelson teaches
The flow restriction device of Claim 1.
However, Burkholz in view of Korogi and Nelson as presently modified fails to explicitly disclose wherein a portion of the flexible material is configured to be one of: affixed to the male center post by one of an adhesive and a solvent; welded to the male center post; and integrally molded to the male center post.
Korogi discloses wherein a portion of the flexible material [Korogi Col 9:28-35, 13:7-14, 61-14:3, Figs. 19-20] is configured to be one of: affixed to the male center post by one of an adhesive and a solvent [Korogi Col 6:47-50, Figs. 1-3]; welded to the male center post [Korogi Col 6:47-50, Figs. 1-3]; and integrally molded to the male center post.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flow restriction device of Burkholz in view of Korogi and Nelson to employ wherein a portion of the flexible material is configured to be one of: affixed to the male center post by one of an adhesive and a solvent; welded to the male center post; and integrally molded to the male center post, so as to allow for the fluid shield device to return to cover the end portion after being in the connected position to maintain sterility [Korogi Col 13:61-14:3, Fig. 19] and so as to secure the flexible material within the device.
Regarding claim 22, Burkholz in view of Korogi and Nelson teaches
The blood collection system of Claim 16.
However, Burkholz in view of Korogi and Nelson as presently modified fails to explicitly disclose wherein a portion of the flexible material is configured to be one of: affixed to the male center post by one of an adhesive and a solvent; welded to the male center post; and integrally molded to the male center post.
Korogi discloses wherein a portion of the flexible material [Korogi Col 9:28-35, 13:7-14, 61-14:3, Figs. 19-20] is configured to be one of: affixed to the male center post by one of an adhesive and a solvent [Korogi Col 6:47-50, Figs. 1-3]; welded to the male center post [Korogi Col 6:47-50, Figs. 1-3]; and integrally molded to the male center post.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the blood collection system of Burkholz in view of Korogi and Nelson to employ wherein a portion of the flexible material is configured to be one of: affixed to the male center post by one of an adhesive and a solvent; welded to the male center post; and integrally molded to the male center post, so as to allow for the fluid shield device to return to cover the end portion after being in the connected position to maintain sterility [Korogi Col 13:61-14:3, Fig. 19] and so as to secure the flexible material within the device.
Regarding claim 23, Burkholz in view of Korogi and Nelson teaches
The fluid shield device of claim 20.
However, Burkholz in view of Korogi and Nelson as presently modified fails to explicitly disclose wherein a portion of the flexible material is configured to be one of: affixed to the male center post by one of an adhesive and a solvent; welded to the male center post; and integrally molded to the male center post.
Korogi discloses wherein a portion of the flexible material [Korogi Col 9:28-35, 13:7-14, 61-14:3, Figs. 19-20] is configured to be one of: affixed to the male center post by one of an adhesive and a solvent [Korogi Col 6:47-50, Figs. 1-3]; welded to the male center post [Korogi Col 6:47-50, Figs. 1-3]; and integrally molded to the male center post.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid shield device of Burkholz in view of Korogi and Nelson to employ wherein a portion of the flexible material is configured to be one of: affixed to the male center post by one of an adhesive and a solvent; welded to the male center post; and integrally molded to the male center post, so as to allow for the fluid shield device to return to cover the end portion after being in the connected position to maintain sterility [Korogi Col 13:61-14:3, Fig. 19] and so as to secure the flexible material within the device.
Regarding claim 24, Burkholz in view of Korogi and Nelson teaches
The flow restriction device of Claim 1, wherein a first end of the fluid shield device is in contact with a bottom end of the groove, the groove disposed concentrically adjacent to the male center post [See septum 21 in Burkholz Fig. 1B].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 7, filed 24 June 2026, with respect to the previously applied rejection of claim 21 under § 112(b) have been fully considered and are persuasive. The rejection of claim 21 under § 112(b) has been withdrawn.
The Examiner notes that claims 22-23 were amended for “proper antecedent basis” as listed in the Applicant’s Remarks regarding the previously applied § 112(b) rejection of claim 21 and as reflected in the amendments to claims 22-23. However, the Examiner notes that while the present amendments to claims 22-23 are not considered to raise any issues regarding antecedent basis, claims 16 and 20 already provided antecedent basis for “flexible shape memory material” as recited in claims 22 and 23, respectively.
Applicant’s arguments, see Applicant’s Remarks p. 7-10, with respect to the rejection(s) of claim(s) 1, 16, 20, and those dependent therefrom under § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Burkholz (US-20210228127-A1, previously presented) in view of Korogi (US-7559530-B2, previously presented) and Nelson (US-20140276215-A1, previously presented).
Regarding claims 1, 16, and 20 [wherein the Examiner notes that the arguments against the previously applied § 103 rejections of claims 16 and 20 are asserted in light of the reasons applied in the remarks for claim 1], the Applicant asserts that Fig. 20 of Korogi depicts the bottom edge of female connector 80 pushing down collar 139 of the valved male connector so that the bottom of the collar 139 pushes down on the bottom end of the elastic member 121 to pull the top end of the elastic member 121 slightly down along the tubular membrane 135 [Korogi Col 9:28-35], which the Applicant asserts is different from the amended subject matter of claim 1, which discloses that the leading edge of the female connector 315 directly pushes the fluid shield device 120 down into the groove 117 such that the leading edge of the female connector 315 is completely above the top portion of the fluid shield device 120 in the compressed position [see Applicant’s Fig. 7]. The Examiner notes that Applicant’s arguments with respect to claim(s) 1, 16, and 20 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. Burkholz (US-20210228127-A1, previously presented) in view of Korogi (US-7559530-B2, previously presented) and Nelson (US-20140276215-A1, previously presented) is presently applied to teach claims 1, 16, and 20, wherein the Examiner notes that Nelson discloses a flow restriction device comprising a fluid shield device coupled to a housing, the fluid shield device comprising a flexible material [Nelson Col ¶¶0180-0182, Figs. 13-14]; wherein the fluid shield device is configured to cover an end portion of a male center post of the housing in an unconnected position, to compress/slide down the male center post beneath a leading edge of a female connector and into a groove of the housing in a connected position, and to recover the end portion of the male center post to prevent fluid flow through the male center post upon returning to an unconnected position [Nelson ¶¶0180-0182, 0199, Figs. 13-14].
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.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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