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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/27/26 has been entered.
Notice of Amendment
In response to the amendment(s) filed on 3/27/26, amended claim(s) 1, 4, 12, and 15, and new claim(s) 20-21 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-6, 12, and 14-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2021/0228127 to Burkholz et al. (hereinafter “Burkholz”).
For claim 1, Burkholz discloses a flow restriction device (55) (Figs. 6A and 6C) (para [0055]), comprising:
a male luer connector portion (60 including 14 and 50) (as can be seen in Figs. 6A-C) (para [0053] and [0056]) comprising an inner surface (unlabeled, but as can be seen in Figs. 6B-C) defining a first cavity (unlabeled, but as can be seen in Figs. 6A-C) and a first lumen in fluid-flow continuity with the first cavity (unlabeled, but as can be seen in Figs. 6A-C); and
a female luer connector portion (58 including 16 and 18) (as can be seen in Figs. 6A-C) (para [0056] and [0059]) comprising a body (16 and/or 18) (Fig. 6C) (para [0033]), an extension (structure identified by reference numeral “58” in Fig. 6C) (para [0056]) and an inner surface (unlabeled, but as can be seen in Figs. 6B-C), the extension having a proximal end (proximal end of 58), a distal end (distal end of 58), and an outer surface (outer surface of 58), wherein the proximal end of the extension is proximate to the body (Examiner’s Note: proximal and distal directions are not defined in the claims) (see Fig. 6C, 58 being proximal of 16 and/or 18), the inner surface of the female luer connector portion forms (the negative space inside the structure identified by reference numeral “58” in Fig. 6C that connects 62 to the lumen that is adjacent to 63) a second lumen (unlabeled, but the lumen that is adjacent to element 63 Fig. 6C) and a second cavity (cavity defined by 62) (see Fig. 6A), the second lumen extending within the body (as can be seen in Fig. 6C) and through a proximal end of the female luer connector portion (Examiner’s Note: the length and/or dimension of the “proximal end” is not defined) (see Fig. 6C, where the entire female luer connector portion except a most distal tip can be considered the “proximal end portion”), and the second cavity extending within the extension and is in fluid-flow continuity with the second lumen (defined by 62, see in Fig. 6A-C) (para [0056] and [0060]); and
a channel (56) (Figs. 6A and 6C) (para [0056]) defined on the outer surface of the extension (as can be seen in Figs. 6A and 6C) (para [0056]), wherein the channel is helically disposed around the outer surface of the extension between the proximal end of the extension and the distal end of the extension (as can be seen in Figs. 6A and 6C) (para [0056]), wherein the extension is configured to be at least partially disposed within the first cavity (as can be seen in Figs. 6A and 6C), and the channel and an inner surface of the male luer connector portion define a fluid passage in fluid-flow continuity with the first lumen, the second cavity, and the second lumen (as can be seen in Figs. 6A and 6C) (para [0056]).
For claim 3, Burkholz further discloses wherein the channel is in fluid-flow continuity with the second lumen via a port (62) (Fig. 6A) extending through the extension (para [0060]) (see more generally para [0056]-[0060]).
For claim 4, Burkholz further discloses wherein the fluid passage is configured to increase flow resistance through the fluid passage to reduce shear stress experienced by a fluid moving through the fluid passage (as can be seen in Fig. 6A) (para [0034]-[0035]).
For claim 5, Burkholz further discloses wherein the first lumen is configured to be coupled to a catheter hub (“catheter hub,” para [0029]-[0030]).
For claim 6, Burkholz further discloses wherein the second lumen is configured to be coupled to a fluid collection device (34) (Fig. 2) (para [0045]).
For claim 12, Burkholz discloses a peripheral intravenous catheter assembly (“peripheral intravenous catheter,” para [0029]-[0030]) configured to limit hemolysis during drawing of blood from a patient (Abstract) (para [0034]-[0035]), comprising:
a catheter hub having a proximal end and a distal end (“catheter hub,” para [0029]-[0030]);
a fluid collection device (34) (Fig. 2) (para [0045]); and
a flow restriction device (55) (Figs. 6A and 6C) (para [0055]), comprising:
a male luer connector portion (60 including 14 and 50) (as can be seen in Figs. 6A-C) (para [0053] and [0056]) comprising an inner surface (unlabeled, but as can be seen in Figs. 6B-C) defining a first cavity (unlabeled, but as can be seen in Figs. 6A-C) and a first lumen in fluid-flow continuity with the first cavity and the catheter hub (unlabeled, but as can be seen in Figs. 6A-C); and
a female luer connector portion (58 including 16 and 18) (as can be seen in Figs. 6A-C) (para [0056] and [0059]) comprising a body (16 and/or 18) (Fig. 6C) (para [0033]), an extension (structure identified by reference numeral “58” in Fig. 6C) (para [0056]) and an inner surface (unlabeled, but as can be seen in Figs. 6B-C), the extension having a proximal end (proximal end of 58), a distal end (distal end of 58), and an outer surface (outer surface of 58), wherein the proximal end of the extension is proximate to the body (Examiner’s Note: proximal and distal directions are not defined in the claims) (see Fig. 6C, 58 being proximal of 16 and/or 18), the inner surface of the female luer connector portion forms (the negative space inside the structure identified by reference numeral “58” in Fig. 6C that connects 62 to the lumen that is adjacent to 63) a second lumen (unlabeled, but the lumen that is adjacent to element 63 Fig. 6C) and a second cavity (cavity defined by 62) (see Fig. 6A), the second lumen extending within the body (as can be seen in Fig. 6C) and through a proximal end of the female luer connector portion (Examiner’s Note: the length and/or dimension of the “proximal end” is not defined) (see Fig. 6C, where the entire female luer connector portion except a most distal tip can be considered the “proximal end portion”), and the second cavity extending within the extension and is in fluid-flow continuity through the second lumen (defined by 62, see in Fig. 6A-C) (para [0056] and [0060]); and
a channel (56) (Figs. 6A and 6C) (para [0056]) defined on the outer surface of the extension (as can be seen in Figs. 6A and 6C) (para [0056]), wherein the channel is helically disposed around the outer surface of the extension between the proximal end of the extension and the distal end of the extension (as can be seen in Figs. 6A and 6C) (para [0056]), wherein the extension is configured to be at least partially disposed within the first cavity (as can be seen in Figs. 6A and 6C), and the channel and an inner surface of the male luer connector portion define a fluid passage in fluid-flow continuity with the first lumen, the second cavity, and the second lumen (as can be seen in Figs. 6A and 6C) (para [0056]).
For claim 14, Burkholz further discloses wherein the channel is in fluid-flow continuity with the second lumen via a port (62) (Fig. 6A) extending through the extension (para [0060]) (see more generally para [0056]-[0060]).
For claim 15, Burkholz further discloses wherein the fluid passage is configured to increase flow resistance through the fluid passage to reduce shear stress experienced by the fluid (as can be seen in Fig. 6A) (para [0034]-[0035]).
For claim 16, Burkholz further discloses wherein the first lumen is configured to be coupled to the catheter hub (“catheter hub,” para [0029]-[0030]).
For claim 17, Burkholz further discloses wherein the second lumen is configured to be coupled to the fluid collection device (34) (Fig. 2) (para [0045]).
For claim 18, Burkholz further discloses wherein the extension comprises a port (62) (Fig. 6A) forming a fluid path between the channel and the second cavity (para [0056] and [0060])).
For claim 19, Burkholz further discloses wherein the extension comprises a port (62) (Fig. 6A) forming a fluid path between the channel and the second cavity (para [0056] and [0060])).
For claim 20, Burkholz further discloses wherein the port is positioned between the proximal end of the extension and the distal end of the extension (see Fig. 6A).
For claim 21, Burkholz further discloses wherein the port is positioned between the proximal end of the extension and the distal end of the extension (see Fig. 6A).
Response to Arguments
Applicant’s arguments filed 3/27/26 have been fully considered.
With respect to the 112(b) rejections, Applicant’s amendments and arguments are persuasive and thus the rejections are withdrawn.
With respect to the 102 rejections, Applicant’s arguments have been fully considered. However, it appears that Applicant’s arguments may not be commensurate in scope with the claim language. Specifically, the “proximal end of the female luer connector portion” appears to be broader, under the broadest, reasonable interpretation, than Applicant may be arguing. Since the claims don’t specify the length or give a cutoff for what may be considered the “proximal end,” anything that is not a “distal end” of the female luer connector portion may be considered the “proximal end.” As an illustrative example, if the distal end only cover 5 – 10% of the female luer connector portion, then it would one could deduce that the proximal end would cover the remaining 90 – 95% of the female luer connector. Such a wide range allows Burkholz to still read on the claim language. Hopefully, this information can give Applicant an idea on how to clarify the claim language to overcome the Burkholz reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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