DETAILED ACTION
Claims 1-21 are pending and hereby under examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 6 and 15 are objected to because of the following informalities:
Regarding claims 6 and 15, the word “between” should be removed from line 2 for consistent language used in specification paragraph 0068.
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“advancement member” first recited in claim 1; and
“collection device” first recited in claim 1;
The identified structure for the corresponding claim limitations are as follows:
“advancement member” is identified as “The advancement member 68 of blood draw device 60 includes a first portion 86 and a second portion 88. The first portion 86 is movably disposed along an upper surface 90 of the housing 62 and the second portion 88 is movably disposed within the inner volume 76 of the housing 62 … As the first and second portions 86, 88 are joined together, movement of the first portion 86 along the upper surface 90 of the housing 62 results in a corresponding movement of the second portion 88 within the inner volume 76. As shown in FIGS. 2-5, the first portion 86 of the advancement member 68 may be configured as a tab or tab having a contact surface 94a engageable by a user and an underside 94b that is in contact with the outer surface 90 of the housing 62 … As shown in FIGS. 2-5, the second portion 88 includes an opening 98 extending therethrough that is configured to grip or retain a portion of the catheter tube 66” (Paragraphs 0052-0054).
“collection device” is identified as “Any suitable vacuum or non-vacuum assisted blood sample collection device such as a sampling syringe, vacutainer, LLAD, POC sampling device, integrated POC cartridge, blood culture collection system, or the like” (Paragraph 0057).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 14-15 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harding (US 20210290264 – cited by Applicant).
Regarding claim 14, Harding teaches a method of manufacturing an arterial blood draw device operable to collect an arterial blood sample, the method comprising:
providing a catheter tube (Fig. 1, instrument 102);
housing the catheter tube within an inner volume of a housing having a proximal end portion and a distal end portion, the catheter tube movable within the housing (Fig. 1, housing 104 with instrument 102 within);
coupling an advancement member to the catheter tube and to housing (Fig. 1, advancement tab coupled to housing 104 and to translate instrument 2), with the advancement member movable relative to the housing, so as to cause a corresponding movement of the catheter tube between a first position, in which the catheter tube is disposed within the housing, and a second position, in which a distal end of the catheter tube is disposed beyond the distal end portion of the housing (Figs. 2A-B, wherein instrument 102 is disposed beyond distal end 108 of housing 104);
connecting a secondary catheter to the advancement member, the secondary catheter extending proximally from the advancement member and out through the proximal end portion of the housing, the secondary catheter in fluid communication with the catheter tube (Figs. 7, extension tube 126 extending from proximal end of housing 104; Paragraph 0067, ”the fluid pathway of the vascular access system, which may include one or more of the blood collection device, the extension tube 126, the adapter 124, and the catheter assembly, may include an entirety of a blood collection pathway”);
connecting a collection device at a proximal end of the secondary catheter, the collection device comprising one of a vacuum-assisted collection device and a non-vacuum- assisted collection device (Paragraph 0058, “and the extension tube 126 may be used for blood collection and/or fluid infusion”; Paragraph 0062, vacutainer; Paragraph 0095, syringe); and
configuring the catheter tube and the secondary catheter to collectively provide a fluid path having a geometric factor, Gf, defined as a ratio of a length of the fluid path, L, to an inner diameter of the fluid path, D, with the geometric factor, Gf, having a first value or value range when the collection device is a vacuum-assisted collection device and having a second value or value range when the collection device is a non-vacuum-assisted collection device (Equation 3; Paragraph 0066, choosing a geometric factor to be the same or less than the max shear stress for use with a vacutainer; Paragraph 0095, wherein using a syringe is also disclosed; Paragraphs 0066, wherein Harding discloses that other values may be used with the instrument; thus, a geometric factor would inherently be chosen for a different collection device such as the disclosed syringe).
Regarding claim 15 and 17-19, Harding further teaches wherein the geometric factor, Gf, is equal to or greater than 35 (1/Dmin3) for a non-vacuum-assisted collection device and equal to or greater than 220 (1/Dmin3) for a vacuum-assisted collection device (Paragraphs 0066-0067, wherein the geometric factor may be more than 7.34*106 (1/in3), defined by Equations 3-5).
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.
Claims 1-4, 6-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Harding (US 20210290264 – cited by Applicant) and Devgon (US 20170216564).
Regarding claim 1, Harding discloses a blood draw device useable with an indwelling arterial catheter for performing arterial blood collection, the blood draw device comprising:
a catheter tube (Fig. 1, instrument 102);
a housing having a proximal end portion and a distal end portion and defining an inner volume configured to movably receive the catheter tube (Fig. 1, housing 104 with instrument 102 within);
an advancement member movably coupled to the housing (Fig. 1, advancement tab coupled to housing 104) and configured to move relative to the housing to move the catheter tube between a first position, in which the catheter tube is disposed within the housing, and a second position, in which a distal end of the catheter tube is disposed beyond the distal end portion of the housing (Figs. 2A-B, wherein instrument 102 is disposed beyond distal end 108 of housing 104) and past a distal tip of the indwelling arterial catheter (Paragraph 0007, wherein the vascular access device may deliver the instrument through an existing intervascular catheter and push past occlusions at the catheter tip).
a secondary catheter extending out proximally therefrom and out through the proximal end portion of the housing, the secondary catheter in fluid communication with the catheter tube (Figs. 7, extension tube 126 extending from proximal end of housing 104; Paragraph 0067, ”the fluid pathway of the vascular access system, which may include one or more of the blood collection device, the extension tube 126, the adapter 124, and the catheter assembly, may include an entirety of a blood collection pathway”); and
a collection device coupled to the proximal end of the secondary catheter, so as to be in fluid communication with the secondary catheter and the catheter tube (Paragraph 0058, “and the extension tube 126 may be used for blood collection and/or fluid infusion”; Paragraph 0062);
wherein a fluid path comprising the catheter tube and the secondary catheter has a controlled geometric factor, Gf, defined as a ratio of a length of the fluid path, L, to an inner diameter of the fluid path, D (Paragraph 0065, “the extension tube 126 may have multiple sections with lengths (L1, L2, L3) and inner diameters of (D1, D2, D3), the geometric factor”; Equations 3-6; Paragraph 0067, “The system geometric factor Gfs for the fluid pathway of the vascular access system can be determined in similar fashion as the Gf value of the extension tube 126 described earlier”).
While Harding discloses that the extension tube is coupled and extends from the proximal end of the housing, Harding fails to explicitly disclose wherein the extension tube is coupled to the advancement tab.
However, Devgon teaches a transfer device (Fig. 2, transfer device 200) to be attached to a catheter to extract blood volume wherein a secondary catheter 265 is coupled to the second portion 275 of the actuator 270 (Fig. 16 and Paragraph 0085), a configuration useful to reduce and/or prevent leaks with fluid flowing between the catheter and secondary catheter. Therefore, 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 advancement tab and extension tube of Harding to couple as taught by the actuator 270 and secondary catheter 265 in Devgon to reduce and/or prevent fluid leaking.
Regarding claim 2, Harding as modified further discloses wherein the blood draw device comprises a coupler connected to a proximal end of the secondary catheter, and wherein the collection device is connected to the coupler (Fig. 7, extension tube 126 with connector 300 (not labeled); Paragraph 0062, wherein connector 300 is coupled to a blood collection device).
Regarding claim 3, Harding as modified further discloses wherein the collection device comprises a vacuum-assisted collection device (Paragraph 0062, vacutainer)
Regarding claim 4, Harding as modified further discloses wherein the collection device comprises a non-vacuum-assisted collection device (Paragraph 0095, syringe).
Regarding claims 6-9, Harding as modified further discloses wherein the geometric factor is equal to or greater than 35 (1/Dmin3) for a non-vacuum-assisted collection device and equal to or greater than 220 (1/Dmin3) (Paragraph 0067, wherein the geometric factor may be more than 7.34*106 (1/in3), defined by Equations 3-5).
Regarding claims 10 and 11, Harding as modified discloses the distal end of the catheter tube extending out past the distal tip as described above, but fails to explicitly disclose a distance of the catheter extending out 10 mm or less.
However, Devgon teaches wherein the catheter 260 can extend distal to the catheter inserted into the patient by between 0 and 100 mm (Paragraph 0103, explicitly stating multiple ranges between 0-100 mm), but states the length can be any predetermined and/or desired distance from the distal surface (Paragraph 0103). As applicant appears to have placed no criticality on the claimed range and since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Therefore, 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 catheter of Harding to incorporate the teaching of moving the catheter past the distal tip the catheter inserted into the patient of Devgon to obtain a desired distance from the distal surface.
Regarding claim 13, Harding as modified further discloses a spacer positioned within the inner volume of the housing and proximally from the advancement member, the space limiting movement of the advancement member along the housing (Fig. 17, stop feature 1300; Paragraphs 0082-0085, wherein the stop feature may correspond to the proximal end of the housing which may include detents to maintain the advancement tab as any such position).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Harding and Devgon as applied to claim 4 above, and further in view of Burkholz (US 20200046948 – cited by Applicant).
Regarding claim 5, Harding as modified discloses the device as described above but fails to disclose a venting feature.
However, Burkholz teaches a catheter system with a vent cap (Figs. 1B-C, vent cap 44) to relieve residual pressure and/or allow blood flow to fill the catheter system (Paragraphs 0047-0048). Therefore, 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 Harding and Devgon to incorporate the vent cap of Burkholz to relieve pressure in the system and/or allow blood to fill the vascular access device.
Claim 12 are rejected under 35 U.S.C. 103 as being unpatentable over Harding and Devgon as applied to claim 1, and further in view of Yeo (US 20220265250).
Regarding claim 12, Harding as modified discloses the housing as described above but fails to explicitly disclose the housing having a length of 103 – 110 mm or 122 – 129 mm.
However, Yeo teaches a collection device wherein the housing has a length of about 15 cm (Paragraph 0037). While not within the claimed range, the courts have held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Therefore, 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 housing of Harding as modified by Devgon to incorporate the teaching of the housing length of Yeo.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Harding as applied to claim 14 above, and further in view of Devgon (US 20170216564).
Regarding claim 16, Harding discloses the distal end of the catheter tube extending out past the distal tip (Paragraph 0007, wherein the vascular access device may deliver the instrument through an existing intervascular catheter and push past occlusions at the catheter tip), but fails to explicitly disclose a distance of the catheter extending out 10 mm or less.
However, Devgon teaches wherein the catheter 260 can extend distal to the catheter inserted into the patient by between 0 and 100 mm (Paragraph 0103, explicitly stating multiple ranges between 0-100 mm), but states the length can be any predetermined and/or desired distance from the distal surface (Paragraph 0103). As applicant appears to have placed no criticality on the claimed range and since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Therefore, 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 catheter of Harding to incorporate the teaching of moving the catheter past the distal tip the catheter inserted into the patient of Devgon to obtain a desired distance from the distal surface.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Harding as applied to claim 14, and further in view of Yeo (US 20220265250).
Regarding claim 20, Harding discloses the housing as described above but fails to explicitly disclose the housing having a length of 103 – 110 mm or 122 – 129 mm.
However, Yeo teaches a collection device wherein the housing has a length of about 15 cm (Paragraph 0037). While not within the claimed range, the courts have held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Therefore, 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 housing of Harding to incorporate the teaching of the housing length of Yeo.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Harding as modified by Yeo as applied to claim 20, and further in view of Devgon (US 20170216564).
Regarding claim 21, Harding as modified discloses the advancement tab coupled to the housing (Fig. 1, advancement tab 112 coupled to housing 104), wherein the distal end of the catheter tube extends out past the distal tip (Paragraph 0007, wherein the vascular access device may deliver the instrument through an existing intervascular catheter and push past occlusions at the catheter tip), but fails to explicitly disclose a distance of the catheter extending out 10 mm or less.
However, Devgon teaches wherein the catheter 260 can extend distal to the catheter inserted into the patient by between 0 and 100 mm (explicitly stating multiple ranges between 0-100 mm), but states the length can be any predetermined and/or desired distance from the distal surface (Paragraph 0103). Therefore, 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 catheter of Harding to incorporate the teaching of moving the catheter past the distal tip the catheter inserted into the patient of Devgon to get to a desired distance from the distal surface.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791 /JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791