DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 25 February 2026 has been entered.
The Examiner acknowledges the amendments to claims 1, 15-16, and 19-20, the previous cancelation of claims 5, 7, 9, and 17, and the addition of new claims 21-23. Claims 1-4, 6, 8, 10-16, and 18-23 are pending.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 21 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation “a portion of the flexible shape memory material” [lines 1-2], wherein the Examiner notes that “the flexible shape memory material” lacks antecedent basis, as claim 1 only provided antecedent basis for a “flexible material” [line 8 in claim 1]; and wherein the recited limitation is further considered indefinite, as it is not clear whether claim 21 is meant to be dependent from claim 2 instead, as claim 2 discloses “wherein the flexible material of the fluid shield device comprises a shape memory material”, which would provide antecedent basis to claim 21, or whether claim 21 is meant to define the flexible material as comprising a shape memory material similar to claim 2. For examination purposes, the Examiner has interpreted claim 21 to define the flexible material as comprising a shape memory material.
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, 11-16, and 18-23 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).
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].
Regarding claim 2, Burkholz in view of Korogi teaches
The flow restriction device of Claim 1.
However, Burkholz in view of Korogi 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 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 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 teaches
The flow restriction device of Claim 1.
However, Burkholz in view of Korogi 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 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 teaches
The flow restriction device of Claim 1.
However, Burkholz in view of Korogi 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 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 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 11, Burkholz in view of Korogi 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 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 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 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 an 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 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, 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 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 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].
Regarding claim 18, Burkholz in view of Korogi 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 an 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 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 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)].
Regarding claim 21, Burkholz in view of Korogi teaches
The flow restriction device of Claim 1.
However, Burkholz in view of Korogi as presently modified fails to explicitly disclose wherein a portion of the flexible shape memory 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 shape memory 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 device of Burkholz in view of Korogi to employ wherein a portion of the flexible shape memory 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 teaches
The flow restriction device of Claim 16.
However, Burkholz in view of Korogi as presently modified fails to explicitly disclose wherein a portion of the flexible shape memory 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 shape memory material 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 system of Burkholz in view of Korogi to employ wherein a portion of the flexible shape memory 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 secure the flexible material within the device.
Regarding claim 23, Burkholz in view of Korogi teaches
The flow restriction device of Claim 20.
However, Burkholz in view of Korogi as presently modified fails to explicitly disclose wherein a portion of the flexible shape memory 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 shape memory material 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 device of Burkholz in view of Korogi to employ wherein a portion of the flexible shape memory 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 secure the flexible material within the device.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Korogi, as applied to claim 1 above, in further view of Nelson (US-20140276215-A1, previously presented).
Regarding claim 10, Burkholz in view of Korogi 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 a flow restriction device, wherein the flow restriction device comprises a fluid shield device positioned about a male center post, and wherein the fluid shield device is configured to compress around a male center post upon application of a compressing force [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 ¶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, Figs. 13-14)], wherein Nelson further 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 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.
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 7, filed 25 February 2026, with respect to the previously applied rejection(s) under § 112(b) have been fully considered and are persuasive. The rejections of claims 15 and 19 under § 112(b) have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 7-10, with respect to the rejection(s) of claim(s) 1, 16, and 20 under § 103 as being obvious over Burkholz in view of Paradis and Elias 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) with respect to claims 1, 16, and 20.
The Applicant asserts that the amendment to claim 1 [and similar amendments to claims 16 and 20] “wherein the fluid shield device is 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, to compress down the male center post into a groove of the distal housing in a connected position, 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” fails to be disclosed, taught, or suggested by the previously cited references of Burkholz [Applicant directs attention to elastomeric sheath 26, which the Applicant notes fails to extend out past the end surface/septum 21 of the housing (Burkholz Fig. 1B)], Paradis [Applicant directs attention to internal cannula 52 and plug 60, which the Applicant notes each fails to extend out past the end surface of the inlet housing 51 (Paradis Fig. 6C)], and Elias [Applicant directs attention to cannula 18 and valve member 16, wherein the Applicant notes that cannula 18 fails to extend past the second end surface 24 of housing 14 (Elias Fig. 1)]. However, 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. Korogi is considered to teach a fluid shield device configured to cover an end portion of a male center post extending outwards past a distal end of a distal housing of a flow restriction device [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; 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)], such that Burkholz in view of Korogi is considered to teach the amended limitation.
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791