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.
Notice of Amendment
In response to the amendment(s) filed on 1/9/26, amended claim(s) 1, 4, 12, and 16-17, canceled claim(s) 2 and 13, and new claim(s) 18-19 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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) 12 and 14-18 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.
For claim 12, the claim terms “an extension” (line 8) and “an extension” (line 9) are ambiguous. It is unclear whether the same extensions are being referred to or whether these are supposed to be different extensions. The claim is examined under the former interpretation.
Dependent claim(s) 14-18 fail to cure the ambiguity of independent claim 12, thus claim(s) 12 and 14-18 is/are rejected under 35 U.S.C. 112(b).
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 14-19 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 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) defining a second cavity along the extension (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) and a second lumen (unlabeled, but the lumen that is adjacent to element 63 Fig. 6C) in fluid-flow continuity with the second cavity (unlabeled, but as can be seen in Figs. 6A-C) (para [0056] and [0060]), the extension comprising:
a first end (unlabeled, but as can be seen in Figs. 6A-C);
a second end (unlabeled, but as can be seen in Figs. 6A-C);
an outer surface (unlabeled, but as can be seen in Figs. 6A-C); 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 and extends between the first and second ends (as can be seen in Figs. 6A and 6C) (para [0056]), 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 the fluid (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 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) defining a second cavity along the extension (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) and a second lumen (unlabeled, but the lumen that is adjacent to element 63 Fig. 6C) in fluid-flow continuity with the fluid collection device (as can be seen in Figs. 6A-C) and an extension in fluid-flow continuity wit the second cavity (unlabeled, but as can be seen in Figs. 6A-C) (para [0056] and [0060]), the extension comprising:
a first end (unlabeled, but as can be seen in Figs. 6A-C);
a second end (unlabeled, but as can be seen in Figs. 6A-C);
an outer surface (unlabeled, but as can be seen in Figs. 6A-C); 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 and extends between the first and second ends (as can be seen in Figs. 6A and 6C) (para [0056]), 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])).
Response to Arguments
Applicant’s arguments filed 1/9/26 have been fully considered.
With respect to the claim objection, Applicant’s amendments and arguments are persuasive and thus claim objection is withdrawn.
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 considered but are moot because the arguments do not address the new grounds of rejection necessitated by Applicant’s amendments presented in the response filed 1/9/26.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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