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 .
Election/Restrictions
The Applicant's election with traverse of species A1 and G2 in the reply filed on 6/10/2025 is acknowledged. The traversal is on the following grounds.
With respect to the election of species A1, the Applicant asserts:
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This argument is not found persuasive. First, just because all the species have some features in common does not negate the fact that there are different structural differences that will need to be searched and examined with respect to the statutory requirements of 35 USC 112, 101, 102, and 103.
Second, the species have physical attributes that are different from each other. The searching for each species will involve different strategies and search terms because different terms are necessarily used to describe different physical attributes. Searching for one set of physical attributes using one set of search terms would not necessarily involve or encompass a different set of physical attributes that is described with different terms.
Furthermore, the examination process is made burdensome by the analysis of multiple structures with respect to the statutory requirements of 35 USC 112, 101, 102, and 103.
With respect to the election of species G2, the Applicant asserts:
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This argument is not found persuasive. First, just because all the species have some features in common does not negate the fact that there are different structural differences that will need to be searched and examined with respect to the statutory requirements of 35 USC 112, 101, 102, and 103.
Second, the species have physical attributes that are different from each other. The searching for each species will involve different strategies and search terms because different terms are necessarily used to describe different physical attributes. Searching for one set of physical attributes using one set of search terms would not necessarily involve or encompass a different set of physical attributes that is described with different terms.
Claim 4 is withdrawn from consideration as being drawn to the non-elected species B2.
Claim 11 is withdrawn from consideration as being drawn to the non-elected species D2.
Claims 14-17 are withdrawn from consideration as being drawn to the non-elected species D2 and F2.
The requirement is still deemed proper and is therefore made FINAL.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-3, 5-10, 12-13, and 18-20 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 1 recites “[a]n extension configured to couple to a catheter assembly” in line 1 and “an instrument” in line 6. However, it is not clear if the catheter assembly is the same as, related to, or different from the instrument. For example, claim 13 recites “wherein the instrument comprises a catheter” in line 1, which suggests that they are the same. In contrast, the language of claim 1 read in isolation connotes the instrument and catheter assembly as being different. This ambiguity renders claim 1 indefinite. The relationship between the two recitations should be made clear.
Claim 1 recites “blood to be collected” in line 15, but it is not clear if this recitation is the same as, related to, or different from “blood can be collected” in line 7. If they are the same, consistent terminology should be used along with the definite article “the” in front of “blood to be collected” in line 15. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claims 2-3, 5-10, and 12-13 are rejected by virtue of their dependence from claim 1.
Claim 18 recites “a catheter assembly” in line 3 and “wherein the instrument comprises a catheter or a probe” in line 6. However, it is not clear if the catheter assembly is the same as, related to, or different from the instrument. For example, the instrument being a catheter suggests that they are the same. In contrast, the language of claim 18 read in isolation connotes the instrument and catheter assembly as being different. This ambiguity renders claim 18 indefinite. The relationship between the two recitations should be made clear.
Claim 18 recites “wherein the instrument is advanced beyond the distal end of the sleeve when the instrument is disposed in the distal position” in lines 7-9, which is an action step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
Claims 19-20 are rejected by virtue of their dependence from claim 18.
Claim 19 recite “the distal end” in line 2, but it is not clear if this recitation is referring to “a distal end” of the sleeve in claim 18, line 2 or “a distal end” of the housing of claim 19, lines 1-2. Clarification is required.
Claim 19 recites “wherein the catheter is advanced to a position beyond the distal end of the housing when the sleeve is compressed in the distal direction” in lines 3-4, which is an action step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
Claim 19 recites “the catheter” in line 3, but it is not clear if this recitation is intended to mean that the recitation “wherein the instrument comprises a catheter or a probe” in claim 18, line 6 must be interpreted to mean “wherein the instrument comprises a catheter” or if some other interpretation is intended. Clarification is required.
Claim 20 recites “further comprising an adapter coupled with the proximal end of the instrument” in line 2, but it is not clear what further comprises the adapter. Is it the catheter or the instrument or the vascular access device generally? Clarification is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5-9, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-7, and 11-13 of U.S. Patent No. 11,969,247 (the reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of the reference patent has all the features of claim 1 and 13 of the present application.
Claim 2 of the reference patent has all the features of claim 2 of the present application.
Claim 3 of the reference patent has all the features of claim 3 of the present application.
Claim 6 of the reference patent has all the features of claim 5 of the present application.
Claim 7 of the reference patent has all the features of claim 6 of the present application.
Claim 11 of the reference patent has all the features of claim 7 of the present application.
Claim 12 of the reference patent has all the features of claim 8 of the present application.
Claim 13 of the reference patent has all the features of claim 9 of the present application.
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.
Claims 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 3,739,778 (Monestere).
First Interpretation
With respect to claim 18, Monestere teaches a vascular access device, comprising:
a sleeve (the one piece rubber element 11, 12, and 13 of Monestere; col. 2, lines 19-21 of Monestere), comprising a proximal end and a distal end, wherein the distal end is configured to be coupled to a catheter assembly, wherein the sleeve is compressible in a distal direction; and
an instrument (the catheter 31 of Monestere) disposed within the sleeve (FIGS. 1-2 of Monestere),
wherein the instrument comprises a proximal end and a distal tip (the catheter 31 of Monestere has a proximal end and a distal tip),
wherein the instrument comprises a catheter or a probe (the catheter 31 of Monestere),
wherein the instrument is configured to move from a proximal position to a distal position (col. 3, lines 9-20 of Monestere),
wherein the instrument is advanced beyond the distal end of the sleeve when the instrument is disposed in the distal position (col. 3, lines 9-20 of Monestere; FIG. 3 of Monestere).
With respect to claim 19, Monestere teaches a housing (the cylindrical collar 41 of Monestere) comprising a proximal end and a distal end, wherein the distal end is configured to be coupled to the catheter assembly (see FIGS. 1-2 of Monestere), wherein the catheter is advanced to a position beyond the distal end of the housing when the sleeve is compressed in the distal direction (col. 3, lines 9-20 of Monestere; FIG. 3 of Monestere).
Second Interpretation
With respect to claim 18, Monestere teaches a vascular access device, comprising:
a sleeve (the one piece rubber element 11 and 12 of Monestere; col. 2, lines 19-21 of Monestere), comprising a proximal end and a distal end, wherein the distal end is configured to be coupled to a catheter assembly, wherein the sleeve is compressible in a distal direction; and
an instrument (the catheter 31 of Monestere) disposed within the sleeve (FIGS. 1-2 of Monestere),
wherein the instrument comprises a proximal end and a distal tip (the catheter 31 of Monestere has a proximal end and a distal tip),
wherein the instrument comprises a catheter or a probe (the catheter 31 of Monestere),
wherein the instrument is configured to move from a proximal position to a distal position (col. 3, lines 9-20 of Monestere),
wherein the instrument is advanced beyond the distal end of the sleeve when the instrument is disposed in the distal position (col. 3, lines 9-20 of Monestere; FIG. 3 of Monestere).
With respect to claim 19, Monestere teaches a housing (the hub 13 of Monestere) comprising a proximal end and a distal end, wherein the distal end is configured to be coupled to the catheter assembly (see FIGS. 1-3 of Monestere), wherein the catheter is advanced to a position beyond the distal end of the housing when the sleeve is compressed in the distal direction (col. 3, lines 9-20 of Monestere; FIG. 3 of Monestere).
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.
Claims 1-3, 5-10, 13, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 3,739,778 (Monestere), in view of U.S. Patent Application Publication No. 2007/0088279 (Shue).
Monestere teaches a catheter assembly comprising a catheter adapter (the hub 11, the rubber tube 12, and the hub 13 of Monestere) having a distal end from which a catheter (the catheter 10 of Monestere) extends, a first port (the perforation made by the needle 22 of Monestere) formed at a proximal end by which an introducer needle (the needle 22 of Monestere) having a sharp distal tip for puncturing and configured to introduce the catheter into vasculature is selectively coupled to the catheter adapter, and a side port (the hub 13 of Monestere). Monestere teaches another catheter 31 (FIG. 3 of Monestere).
Monestere teaches that, to place the catheter 31 in the vein, it is grasped lightly through the sleeve 39 a short distance from the collar 41 and pushed forward step by step into and through the catheter 10 to a desired distance where it is held by finger pressure (col. 3, lines 9-20 of Monestere). Monestere also teaches that the catheter 31 may be used for fluid removal (abstract and col. 3, lines 55-66 of Monestere). In the same field of medical retracting devices, Shue teaches an intravenous catheter with an outlet needle 30 protruding into a receiving chamber 51, the catheter being used for blood collection using the chamber 61, 61’ in which the catheter is moved forward along a barrel 7 via a guideway 73 (FIGS. 30-35 of Shue; paragraphs 0097-0102 of Shue). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to attach the barrel 7 with the guideway 73 to the hub 13 of Monestere (rather than the collar 41 and the sleeve 39 of Monestere) and slide the proximal end of the catheter along the guideway since it is a simple substitution of one known element for another to obtain predictable results. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the proximal end of the catheter 31 of Monestere with an outlet needle 30 protruding into a receiving chamber 51 for the receipt of the blood collecting chambers 61, 61’ since it permits blood collection.
With respect to claim 1, the combination teaches or suggests an extension configured to couple to a catheter assembly, the extension comprising:
a housing (the barrel 7 of Shue) having a proximal end, a distal end, and a slot (the guideway 73 of Shue), wherein the slot comprises a proximal end and a distal end, wherein the proximal end of the slot is distal to the proximal end of the housing; and
an instrument (the catheter 31 of Monestere with an outlet needle 30 protruding into a receiving chamber 51 of Shue) disposed within the housing,
wherein the instrument comprises a proximal end and a distal portion forming a distal tip (the blunt distal tip of the catheter 31 of Monestere) through which blood can be collected,
wherein the proximal end of the instrument extends out through the slot to form a blood collection adapter (the receiving chamber 51 of Shue), the proximal end of the instrument, including the blood collection adapter, being configured to move along the slot from a proximal position distal to the proximal end of the slot to a distal position (FIGS. 30-35 of Shue; paragraphs 0097-0102 of Shue),
wherein the extension is configured such that, when the proximal end of the instrument is in the proximal position distal to the proximal end of the slot, the distal tip of the instrument is disposed within the housing (FIGS. 30-35 of Shue; paragraphs 0097-0102 of Shue),
wherein in response to movement of the proximal end of the instrument from the proximal position to the distal position, the distal tip of the instrument is configured to advance distal to the housing to thereby enable blood to be collected directly from a patient’s vasculature via the blood collection adapter (FIG. 2 of Monestere; FIGS. 30-35 of Shue; paragraphs 0097-0102 of Shue).
With respect to claim 2, the combination teaches or suggests that the blood collection adapter comprises a cavity (the receiving chamber 51 of Shue) configured to receive a syringe or a blood collection tube, wherein the blood collection adapter further comprises a cannula (the outlet needle 30 of Shue) disposed within the cavity and configured to puncture a septum of the syringe or the blood collection tube in response to the syringe or the blood collection tube being advanced into the cavity of the blood collection adapter (FIGS. 30-35 of Shue; paragraphs 0097-0102 of Shue).
With respect to claim 3, the combination teaches or suggests that the blood collection adapter is angled with respect to the housing (the cavity 51 of Shue is angled with respect to the barrel 7 of Shue).
With respect to claim 5, the combination teaches or suggests an advancement tab coupled with the instrument (the bumps on the shifter 87 of Shue).
With respect to claim 6, the combination teaches or suggests that the advancement tab is offset from the slot (the bumps on the shifter 87 are offset from the guideway 73 of Shue).
With respect to claim 7, the combination teaches or suggests that he distal portion of the instrument has a smaller outer diameter than a proximal portion of the instrument (the catheter 31 of Monestere has a smaller outer diameter than the receiving chamber 51 of Shue).
With respect to claim 8, the combination teaches or suggests that a stiffness of the instrument varies along a length of the instrument (the stiffnesses are different for the receiving chamber 51 of Shue and the catheter 31 of Monestere).
With respect to claim 9, the combination teaches or suggests that the distal portion of the instrument is less rigid than a proximal portion of the instrument (the narrower the catheter 31 of Monestere is less rigid than the receiving chamber 51 of Shue).
With respect to claim 10, the combination teaches or suggests that the instrument comprises a probe (the catheter 31 of Monestere with an outlet needle 30 protruding into a receiving chamber 51 of Shue is considered to be a sampling probe).
With respect to claim 13, the combination teaches or suggests that the instrument comprises a catheter (the catheter 31 of Monestere with an outlet needle 30 protruding into a receiving chamber 51 of Shue).
With respect to claim 20, the combination teaches or suggests the instrument comprises the catheter (the catheter 31 of Monestere with an outlet needle 30 protruding into a receiving chamber 51 of Shue), further comprising an adapter coupled with the proximal end of the instrument, wherein the adapter comprises a cavity (the receiving chamber 51 of Shue) configured to receive a syringe or blood collection tube, wherein the adapter further comprises a cannula (the outlet needle 30 of Shue) disposed within the cavity and configured to puncture a septum of the syringe or the blood collection tube in response to the syringe or the blood collection tube being advanced into the cavity of the adapter (FIGS. 30-35 of Shue; paragraphs 0097-0102 of Shue).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 3,739,778 (Monestere), in view of U.S. Patent Application Publication No. 2007/0088279 (Shue), and further in view of U.S. Patent No. 6,719,722 (Trask).
Trask teaches that a luer lock connection is a known form of connection between a fitting and housing (col. 4, lines 50-60 of Trask). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the luer lock connection of Trask as the connection between the barrel 7 of Shue and the hub 13 of Monestere since it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 12, the combination teaches or suggests that the distal end of the housing includes a luer coupling mechanism (the luer fitting suggested by Trask for the barrel 7 of Shue).
Claims 1-3, 5-10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2013/0237925 (Trainer), in view of Shue, and further in view of Monestere.
Trainer teaches a catheter assembly comprising a catheter adapter (the catheter adapter 14 of Trainer) having a distal end from which a catheter (the catheter 12 of Trainer) extends, a first port (the port near the septum 22 of Trainer) formed at a proximal end by which an introducer needle (the introducer needle 20 of Trainer) having a sharp distal tip (FIG. 7 of Trainer) for puncturing and configured to introduce the catheter into vasculature is selectively coupled to the catheter adapter, and a side port (the port 30 of Trainer). Trainer further teaches that a separate access device can be coupled to the catheter adapter 14 through the port 30 to establish fluid communication therethrough (paragraph 0033 of Trainer).
In the same field of medical retracting devices, Shue teaches an intravenous catheter with an outlet needle 30 protruding into a receiving chamber 51, the catheter being used for blood collection using the chamber 61, 61’ in which the catheter is moved forward along a barrel 7 via a guideway 73 (FIGS. 30-35 of Shue; paragraphs 0097-0102 of Shue). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the catheter of Shue by attaching the barrel 7 with the guideway 73 via the luer connection at port 30 of Trainer and slide the proximal end of the catheter along the guideway since (1) it is a simple substitution of one known element for another to obtain predictable results, (2) Trainer teaches a separate access device may be coupled and Shue teaches one such device, and/or (3) it permits blood collection.
With respect to the intravenous catheter of Shue, Monestere teaches that such movable cannulas within catheter adapters can be a flexible conduit with a blunt distal tip at the distal end thereof when introducer needles are used (FIG. 3 of Monestere; col. 3, lines 9-20 of Monestere). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a flexible catheter with a blunt distal tip at the distal end of the catheter of Shue since it provides more versatile motion within the catheter adapter and prevents unnecessary sharp points.
With respect to claim 1, the combination teaches or suggests an extension configured to couple to a catheter assembly, the extension comprising:
a housing (the barrel 7 of Shue) having a proximal end, a distal end, and a slot (the guideway 73 of Shue), wherein the slot comprises a proximal end and a distal end, wherein the proximal end of the slot is distal to the proximal end of the housing; and
an instrument (the flexible cannula replacing the cannula 21 of Shue) disposed within the housing,
wherein the instrument comprises a proximal end and a distal portion forming a distal tip (the blunt tip end of the flexible cannula replacing the cannula 21 of Shue) through which blood can be collected,
wherein the proximal end of the instrument extends out through the slot to form a blood collection adapter (the cavity 51 of Shue), the proximal end of the instrument, including the blood collection adapter, being configured to move along the slot from a proximal position distal to the proximal end of the slot to a distal position (FIGS. 30-35 of Shue; paragraphs 0097-0102 of Shue),
wherein the extension is configured such that, when the proximal end of the instrument is in the proximal position distal to the proximal end of the slot, the distal tip of the instrument is disposed within the housing (FIGS. 30-35 of Shue; paragraphs 0097-0102 of Shue),
wherein in response to movement of the proximal end of the instrument from the proximal position to the distal position, the distal tip of the instrument is configured to advance distal to the housing to thereby enable blood to be collected directly from a patient’s vasculature via the blood collection adapter (FIGS. 30-35 of Shue; paragraphs 0097-0102 of Shue).
With respect to claim 2, the combination teaches or suggests that the blood collection adapter comprises a cavity (the cavity 51 of Shue) configured to receive a syringe or a blood collection tube, wherein the blood collection adapter further comprises a cannula disposed within the cavity and configured to puncture a septum of the syringe or the blood collection tube in response to the syringe or the blood collection tube being advanced into the cavity of the blood collection adapter (FIGS. 30-35 of Shue; paragraphs 0097-0102 of Shue).
With respect to claim 3, the combination teaches or suggests that the blood collection adapter is angled with respect to the housing (the cavity 51 of Shue is angled with respect to the barrel 7 of Shue).
With respect to claim 5, the combination teaches or suggests an advancement tab coupled with the instrument (the bumps on the shifter 87 of Shue).
With respect to claim 6, the combination teaches or suggests that the advancement tab is offset from the slot (the bumps on the shifter 87 are offset from the guideway 73 of Shue).
With respect to claim 7, the combination teaches or suggests that the distal portion of the instrument has a smaller outer diameter than a proximal portion of the instrument (the flexible cannula replacing the cannula 21 of Shue has a smaller outer diameter than the cavity 51 of Shue).
With respect to claim 8, the combination teaches or suggests that a stiffness of the instrument varies along a length of the instrument (the stiffnesses are different for the cavity 51 of Shue and the flexible cannula replacing the cannula 21 of Shue).
With respect to claim 9, the combination teaches or suggests that the distal portion of the instrument is less rigid than a proximal portion of the instrument (the flexible cannula replacing the cannula 21 of Shue is less rigid than the cavity 51 of Shue).
With respect to claim 10, the combination teaches or suggests that the instrument comprises a probe (the flexible cannula replacing the cannula 21 of Shue is considered to be a fluid collecting probe).
With respect to claim 12, the combination teaches or suggests that the distal end of the housing includes a luer coupling mechanism (the luer connection of Trainer; paragraph 0033 of Trainer).
With respect to claim 13, the combination teaches or suggests that the instrument comprises a catheter (the flexible cannula replacing the cannula 21 of Shue is considered to be a catheter).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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