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 .
Response to Arguments
Applicant’s arguments and amendments, filed 5/15/2026, with respect to the rejection(s) of claim(s) 1, 5, 7, 8 and 14 – 16 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Toomey et al. (US 2005/0010189 A1), 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 Therefore, the rejection has been withdrawn.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 Toomey et al. (US 2005/0010189 A1), Sangha et al. (US 2003/0012701 A1) and Holmes et al. (US 2014/0073990 A1).
Allowable Subject Matter
The indicated allowability of claims 9 – 13 and 17 is withdrawn in view of the reference(s) to Toomey et al. (US 2005/0010189 A1), Sangha et al. (US 2003/0012701 A1) and Holmes et al. (US 2014/0073990 A1). Rejections based on cited reference(s) follow.
Claim Objections
Claim 13 is objected to because of the following informalities: claim 13 is dependent on canceled claim 6. Appropriate correction is required. For claim interpretation and examination purposes, claim 13 is interpreted to be dependent on claim 1.
Note Regarding Prior Art
Examiner cites particular sections, columns, line numbers, paragraphs and figures, in the references as applied to the claims below for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the Applicant fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 5, 7 – 12 and 14 – 16 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Toomey et al. (US 2005/0010189 A1; hereinafter “Toomey”).
Regarding claim 1, Toomey teaches throughout the publication a blood collection assembly (fluid collection apparatus; paragraph 42; figure 10) comprising:
a base (paragraph 72; figure 10);
a stand (96; figure 10) fixedly secured to said base. said stand comprises a pair of support legs (wall extension 92; paragraph 72; figure 10); and
a funnel (housing 12; figures 5 and 10) having a spout, wherein said spout (e.g., the spout (not labeled) at 52 or 48 at the bottom of housing 12 in figure 5) is arranged distally in relation to an opening (e.g., the opening (not labeled) at the top of housing 12 in figure 5) of said funnel, said funnel fixedly secured to said stand (paragraph 73; figure 10);
at least one transverse support member (the apparatus structure connecting 94 to 96 (unlabeled); figure 10) fixedly secured to said pair of support legs (wall extension 92; paragraph 72; figure 10); and
at least one gripping means arranged on said at least one transverse support member, wherein said gripping means is arranged to frictionally secure a blood collection tube therein (an evacuated tube (not shown) is installed in holder 22; paragraph 73; figures 8 and 10).
Regarding claim 5, Toomey teaches the blood collection assembly recited in claim 31, wherein said pair of support legs (e.g., wall extension 92; paragraph 72; figure 10) each comprises a top end and a bottom end, said top end of each of said pair of support legs includes a support fin fixedly secured thereon, said support fin is further arranged to fixedly secure to a sloped outer section of said funnel (housing 12; figure 10).
Regarding claim 7, Toomey teaches the blood collection assembly recited in claim 1 further comprising: a cap (a removable cap can be adapted to removably enclose an opening of the housing such as a spout; paragraphs 19 – 23) having a locking means (e.g., snap arms; paragraph 21) arranged to secure to said spout.
Regarding claim 8, Toomey teaches the blood collection assembly recited in claim 1, wherein said base comprises an aperture, said aperture of said base is further arranged to frictionally secure a blood collection tube therein (an evacuated tube (not shown) is installed in holder 22; paragraph 73; figures 8 and 10).
Regarding claim 9, Toomey teaches the blood collection assembly recited in claim 1, wherein said funnel comprises a support ring (e.g., located at 83 and tope edge 85 in figure 9; figures 9 and 10), said support ring is arranged on an outer surface of said funnel between said sloped section of said funnel and said spout, said support ring is fixedly secured to a top end of each of said pair of support legs (e.g., ribs 88 in figure 9).
Regarding claim 10, Toomey teaches the blood collection assembly recited in claim 7, wherein said spout (a removable cap can be adapted to removably enclose an opening of the housing such as a spout; paragraphs 19 – 23) further includes a groove (e.g., locking surface 48; figures 4 and 5; paragraph 60) circumscribing an outer surface of said spout, said groove is further arranged to mate with said locking means of said cap.
Regarding claim 11, Toomey teaches the blood collection assembly recited in claim 10, wherein said cap comprises a partial through-bore, said partial through-bore is further arranged to accept a distal surface of said spout when engaged thereto (e.g., the removable cap can adapted to removably enclose an opening of the housing and provide a fluid seal with the housing; paragraph 21).
Regarding claim 12, Toomey teaches the blood collection assembly recited in claim 1, wherein said spout is further arranged to have a sloped outer surface (e.g., a vertical slope surface on the outside surface at connector 30 or needle hub 54; figures 5 – 7; paragraphs 58 and 60), said sloped outer surface is further arranged to fixedly secure to an inside surface of an opening of a blood collection tube (evacuated tube 28) frictionally securing said blood collection tube to said spout (figures 5 – 7).
Regarding claim 14, Toomey teaches the blood collection assembly recited in claim 1, wherein said funnel is removable from said stand (e.g., it is implicit that the component parts, such as the funnel 18 or 20 (or housing 12 in figure 5), can be removable; paragraph 47; figures 1 – 5).
Regarding claim 15, Toomey teaches the blood collection assembly recited in claim 1, wherein said stand further comprises a pair of transverse support members fixedly secured to said pair of support legs (the apparatus structure connecting 94 to 96 (unlabeled) fixedly secured to each of said pair of support legs (wall extension 92; paragraph 72; figure 10).
Regarding claim 16, Toomey teaches the blood collection assembly recited in claim 15, wherein said pair of transverse support members each include a gripping means (an evacuated tube (not shown) is installed in holder 22; paragraph 73; figures 8 and 10).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toomey et al. (US 2005/0010189 A1; hereinafter “Toomey”).
Regarding claim 13, Toomey does not specifically teach wherein the opening of said funnel is an elliptical shape. However, the change in form or shape, without any new or unexpected results, is an obvious engineering design (see MPEP § 2144.04). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the opening of said funnel is an elliptical shape.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toomey et al. (US 2005/0010189 A1; hereinafter “Toomey”) in view of Sangha et al. (US 2003/0012701 A1; hereinafter “Sangha”) in view of Holmes et al. (US 2014/0073990 A1; hereinafter “Holmes”).
Toomey teaches that the disclosed body fluid collection apparatus can be used for collecting blood samples (e.g., paragraph 42).
Toomey does teach the step of inserting an opening of a blood collection tube (evacuated tube 28) onto a distal end of said spout (e.g., the rubber stopper 58 of evacuated tube 28 is connected to needle cannula 56 of the spout; paragraph 57 as shown in figure 5; paragraph 57) (figures 5 – 7) for enabling the collection of a blood sample in the blood collection tube.
Regarding claim 17, Toomey does not specifically teach a method for using the blood collection assembly recited in claim 1, comprising the steps of:
removing a warm-up pad and said blood collection assembly from a sealed container; heating said warm-up;
placing a finger into said warm-up pad for a period of time and applying pressure to said warm-up pad during said period of time;
removing said finger from said warm-up pad and sterilizing said finger;
lancing said finger to draw blood; and
aiming said finger over said funnel to drop blood into said funnel of said blood collection assembly to collect blood in said blood collection tube.
However, Holmes teaches the use of warming pads or heat patches for use on a finger to increase blood flow in the finger for blood extraction (paragraph 283).
Sangha additionally teaches a method and specimen kit for obtaining a blood sample for subsequent analysis. Sangha teaches all of the kit components are provide in a sealed container or package to a user (paragraph 9). Sangha teaches the use of an alcohol pad 34 for sterilizing the finger before the blood sample is taken (paragraph 36). Sangha teaches the use of a lance 36 for lancing the finger to draw blood (paragraph 36). Sangha further teaches allowing blood from the lanced finger to drip through funnel 33 into specimen vial 31 as shown in figure 3 (paragraph 36).
It would have been obvious to a person of ordinary skill in the art to also provide the heat patches in a sealed container in addition to the other kit components as taught by Sangha. Consequently, Toomey, Holmes and Sangha teach all of the recited apparatus of the claimed methodology and their respective functions. It would have been considered suitable and predictable to a person of ordinary skill in the art to combine the recited kit components to enable the collection of a blood sample using the blood collection assembly as taught by Toomey. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, the Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) has affirmed that the threshold requirement for a prima facie case of obviousness is “demonstrating that each element was, independently, known in the prior art.” Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide a method for using the blood collection assembly recited in claim 1, comprising the steps of:
removing a warm-up pad and said blood collection assembly from a sealed container; heating said warm-up;
inserting an opening of a blood collection tube onto a distal end of said spout;
placing a finger into said warm-up pad for a period of time and applying pressure to said warm-up pad during said period of time;
removing said finger from said warm-up pad and sterilizing said finger;
lancing said finger to draw blood; and
aiming said finger over said funnel to drop blood into said funnel of said blood collection assembly to collect blood in said blood collection tube.
Examiner submits that these arguments are in line with the Supreme Court unanimous opinion, KSR International v. Teleflex, Inc., 127 S. Ct. 1727, 1741 (2007), in which the Court stated that “[a] court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id. at 1731.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
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