DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 12/28/2023. Claims 1-20 are pending and examined below.
Election/Restrictions
Applicant's election with traverse of Invention I in the reply filed on 02/02/2026 is acknowledged. The traversal is on the ground(s) that no serious search burden exists on the Examiner to search and examiner Groups II and II together.
This is not found persuasive because the inventions would require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries); the prior art applicable to one invention would not likely be applicable to another invention; the inventions are likely to raise different non-prior art issues under 35 USC 101 and/or 35 USC 112, first and second paragraphs
The requirement is still deemed proper and is therefore made FINAL.
Claim 19 (Invention II) is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/02/2026.
Claims 1-18 and 20 are pending and examined below.
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) 1-8, 10-12, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190216380 A1 (hereinafter referred to as “Ivosevic”), in view of US 20030056384 A1 (hereinafter referred to as “Brown”) and “Guidelines for Using Anthropometric Data in Product Design” (hereinafter referred to as “HFES”).
Regarding claim 1, Ivosevic teaches a kit of parts for obtaining a capillary blood samples (abstract) comprising:
parts for obtaining a capillary blood sample, including a holder, lancet, and collection container that may be provided as discrete components (“capillary blood collection device”; paragraphs [0053]–[0056] and [0059]; Figures 1–10), wherein the holder is selected based on the size of the particular patient’s finger (“holder 12 having an appropriate size for the desired finger 19”; paragraph [0085]; Figure 27), and wherein the blood collection device comprises a finger holder having a finger-receiving portion configured to receive the patient’s finger (paragraphs [0060]–[0061]; Figures 1–7B).
Ivosevic does not explicitly teach a plurality of capillary blood collection devices of different sizes provided together as a kit, a sizing tool for identifying which of the differently sized devices should be used, a unique ideal finger size and unique size range assigned to each device, or selecting the size ranges so that a majority of fingers in a patient population are accommodated.
Brown teaches a system having a plurality of finger-receiving products made in multiple standard sizes (“plurality of gloves made in a multiple of standard glove sizes”; paragraph [0116]; Figure 6), a sizing tool used to determine which standard size corresponds to a particular user’s measured finger and hand dimensions (“hand-sizing tool 20”; paragraphs [0089]–[0094]; Figure 3), respective best-fit areas defining the dimensional ranges intended to be accommodated by each product size (paragraphs [0101]–[0103] and [0110]–[0113]; Figure 5), and arranging the best-fit areas so that the available product sizes fit a majority of the intended population (“majority of the male and female population”; paragraphs [0104] and [0112]; Figure 5). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Ivosevic to provide a plurality of Ivosevic’s blood collection devices having differently sized finger holders and to provide Brown’s sizing tool for selecting the appropriately sized holder because Ivosevic expressly requires selecting a holder appropriate for the desired finger, while Brown provides a known method and tool for reliably selecting among differently sized finger-receiving products.
Further, HFES teaches determining multiple product sizes using anthropometric data for a target population, locating a representative design case within each size category, and using the representative case dimensions to manufacture the corresponding product size (sections 7.2.4–7.2.5; pages 55–56; Figures 16–17). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Ivosevic to determine the holder sizes and associated size ranges according to the anthropometric design methodology of HFES because doing so would predictably accommodate a selected majority of the patient population, improve fit and comfort, and provide consistent application of pressure during blood collection.
Regarding claim 2, Ivosevic, in view of Brown and HFES, teaches wherein the ideal finger sizes comprise an ideal finger width, ideal finger height, and/or ideal finger length, and wherein the unique size ranges comprise a range of finger widths, a range of finger heights, and/or a range of finger lengths (paragraphs [0097]–[0099] and [0101]–[0106]; Figures 4–5; as taught by Brown; sections 7.2.3–7.2.5; pages 54–56; Figures 15–17; as taught by HFES).
Regarding claim 3, Ivosevic, in view of Brown and HFES, teaches wherein the finger holders of the blood collection devices further comprise an actuation portion and a port (paragraphs [0060]–[0062]; Figures 1–10; as taught by Ivosevic).
Regarding claim 4, Ivosevic, in view of Brown and HFES, teaches wherein the blood collection devices each further comprise:
a container engagement portion connected to the holder (port 26 and locking portion 32 of holder 12, which receive and lock a collection container to the holder; paragraphs [0062], [0073], and [0087]; Figures 8–10 and 29); and
a collection container removably connectable to the container engagement portion, the container defining a collection cavity (paragraphs [0070]–[0073]; Figures 8–10),
wherein the actuation portion comprises at least two wings configured to create pressure for the patient's finger positioned within the finger receiving portion (“pair of opposed tabs or wings 38”; paragraphs [0065]–[0067] and [0088]; Figures 2–3 and 29–30).
Regarding claim 5, Ivosevic does not explicitly teach wherein at least 95% of the patient fingers for the population of patients are within one of the unique size ranges.
HFES teaches targeting the central 90%–95% of an intended design population (“central 90%-95% of the intended design population”; section 3.4; pages 15–16), expressly provides 95% accommodation as an exemplary design requirement, and reports that the five-size glove system accommodated hand lengths and circumferences covering more than 95% of users (section 7.2.6; page 58; Figure 17). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Ivosevic to select 95% as the target accommodation rate, as taught by HFES, because HFES expressly identifies 95% as a conventional target for anthropometric product design, and selection of 95% would predictably maximize population accommodation while avoiding the disproportionate cost associated with accommodating the extreme ends of the distribution.
Regarding claim 6, Ivosevic, in view of Brown and HFES, teaches wherein the population of patients comprises a population of all adult patients living within a selected geographic region, and wherein the finger sizes for the population of patients substantially matches a normal distribution (HFES teaches defining the target population according to where the product will be sold or used, including a regional market such as North America, and using nationality, age, gender, and other demographic characteristics that affect anthropometric distributions (sections 3.1–3.2; pages 14–15); HFES further teaches that a normal distribution is a bell-shaped distribution that closely approximates many human body-measurement distributions (“normal distribution”; Appendix A; page 69), and illustrates hand-length and hand-circumference distributions for a selected population (section 7.2.4; page 55; Figure 16).
Regarding claim 7, Ivosevic, in view of Brown and HFES, teaches wherein a difference between a maximum value and a minimum value for each of the unique size ranges are equal to each other (HFES teaches distributing representative glove lengths at equal 14-mm intervals along the Hand Length axis and locating a representative case within each corresponding category; section 7.2.4; page 56; Figure 17).
Regarding claim 8, Ivosevic, in view of Brown and HFES, teaches wherein the unique ideal finger sizes for the plurality of blood collection devices are equally between the minimum value and the maximum value for each of the unique size ranges (HFES teaches locating the representative ideal case centrally within each size category; “locates a case centrally within each length category”; section 7.2.4; page 56; Figure 17).
Regarding claim 10, Ivosevic, in view of Brown and HFES, teaches wherein the unique ideal finger sizes for the plurality of blood collection devices are a minimum value of the unique size range for each of the plurality of blood collection devices (HFES teaches representative design cases located at the minimum and maximum boundaries of an anthropometric distribution (“minimum, the maximum”; section 5.3; pages 33–36; Figure 9), and Brown teaches intentionally selecting a shorter or tighter size where a user dimension falls between available size designations (paragraphs [0093]–[0094]; Figure 3)).
Regarding claim 11, Ivosevic, in view of Brown and HFES, teaches wherein the unique ideal finger sizes for the plurality of blood collection devices is a maximum value of the unique size range for each of the plurality of blood collection devices (HFES teaches maximum and upper-boundary cases as known representative design cases (section 5.3; pages 33–36; Figure 9), and Brown teaches selecting the next larger size when a looser fit or easier donning is desired (paragraph [0094]; Figure 3).).
Regarding claim 12, Ivosevic, in view of Brown and HFES, teaches wherein the unique ideal finger sizes for the plurality of blood collection devices is greater than a middle value of the unique size range for each of the plurality of blood collection devices (HFES teaches selecting central, boundary, and distributed cases throughout a desired accommodation region and selecting case locations according to fit requirements and relevant design constraints (sections 5.2–5.4; pages 31–40; Figures 8–11) and Brown teaches intentionally selecting a tighter or looser fit based on the desired product performance and the importance of donning, tactility, and fit tolerance (paragraphs [0093]–[0094] and [0110]; Figures 3 and 5)).
Regarding claim 17, Ivosevic, in view of Brown and HFES, teaches wherein the sizing tool comprises at least one measuring tool, such as a ruler or calipers, configured to directly measure at least one of a width, height, and/or length of the patient's finger (wherein Brown further teaches that the sizing tool may comprise a ruler or calipers configured to directly measure the length of the index finger and the width of the hand (“ruler, scale or calipers”; paragraphs [0096]–[0099]; Figure 4)).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic, in view of Brown and HFES, as applied to claim 1 above, and further in view of US 20190029542 A1 (hereinafter referred to as “Gaus”).
Regarding claim 14, Ivosevic, in view of Brown and HFES, does not explicitly teach wherein the kit comprises at least four blood collection devices of different sizes.
However, Gaus teaches medical devices fitted around a patient’s finger in at least five different sizes, namely XS, S, M, L, and XL (“XS indicating extra small or XL indicating extra-large”; paragraph [0031]; Figures 5A–5B; claims 9 and 27). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Ivosevic, in view of Brown and HFES, to have at least 4 sizes, as taught by Gaus, because doing so ensures different sizes for a wide range of people.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic, in view of Brown and HFES, as applied to claim 1 above, and further in view of US 3,548,506 (hereinafter referred to as “Somers”).
Regarding claim 15, Ivosevic, in view of Brown and HFES, does not explicitly teach wherein the sizing tool comprises a sizing card for a size exclusion determination, the sizing card comprising a plurality of elliptical openings, wherein each of the plurality of elliptical openings is sized to correspond to a maximum value of the unique size range for one of the plurality of blood collection devices.
However, Somers teaches wherein the sizing tool comprises a sizing card for a size exclusion determination, the sizing card comprising a plurality of elliptical openings, wherein each of the plurality of elliptical openings is sized to correspond to a maximum value of the unique size range for one of the plurality of blood collection devices (Somers teaches a planar card carrying a plurality of calibrated finger-sizing gauges (“stiff planar card-form carrying members”; column 3, lines 6–24; Figures 1 and 3), wherein the gauges provide graduated openings through which a user inserts a finger to determine the corresponding finger-product size (“graduated size-openings”; column 4, lines 50–62), and wherein the gauges may be oval rather than circular (“oval rather than round gauge rings”; column 4, lines 10–34; Figure 5)). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Ivosevic, in view of Brown and HFES, to having a sizing card, as taught by Somers, because doing so ensures the proper size is found for the user.
Regarding claim 16, Ivosevic, in view of Brown, HFES, and Somers, teaches wherein the plurality of elliptical openings each comprise a major diameter corresponding to a maximum finger width and a minor diameter corresponding to a maximum finger height for the unique size range for the one of the plurality of blood collection devices (column 4, lines 10–34; Figure 5; as taught by Somers).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic, in view of Brown and HFES, as applied to claim 1 above, and further in view of US 20130179288 A1 (hereinafter referred to as “Bartov”).
Regarding claim 18, Ivosevic, in view of Brown and HFES, teaches a computer processor that receives an image of a patient’s finger, processes the image to determine a finger dimension, and causes an output device to display the blood collection device size corresponding to that dimension.
However, Bartov teaches wherein the sizing tool comprises a computer processor configured to:
receive at least one image of the patient's finger (paragraphs [0085], [0098]–[0099], [0225]-[0229] and [0279]; Figures 1 and 4);
process the received at least one image to determine at least one of a finger width, height, and/or length of the patient's finger (paragraphs [0085], [0098]–[0099], [0225]-[0229] and [0279]; Figures 1 and 4); and
cause an output device to display an indication of which of the plurality of blood collection devices to use for the patient's finger determined based, at least in part, on the finger width, height, and/or length of the patient's finger determined by the processing of the at least one image and the unique size ranges for the plurality of blood collection devices (paragraphs [0085], [0098]–[0099], [0225]-[0229] and [0279]; Figures 1 and 4). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Ivosevic, in view of Brown and HFES, to apply Bartov’s image-based sizing process to the finger-size ranges, because it automates the measurement, comparison, and display process.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bartov in view of Ivosevic.
Regarding claim 20, Bartov teaches A computer-implemented method for determining a correct device size for a patient's finger (paragraphs [0085], [0098]–[0099], [0225]-[0229] and [0279]; Figures 1 and 4), the method comprising:
receiving, with at least one computer processor, at least one image of the patient's finger (paragraphs [0085], [0098]–[0099], [0225]-[0229] and [0279]; Figures 1 and 4);
processing, with the at least one computer processor, the received at least one image to determine at least one dimension of the patient's finger (paragraphs [0085], [0098]–[0099], [0225]-[0229] and [0279]; Figures 1 and 4); and
causing, with the at least one computer processor, an output device to provide a visual indication of which device of a plurality of devices having unique finger size ranges to use for the patient's finger determined based, at least in part, on the determined at least one dimension of the patient's finger and the unique size ranges for the devices (paragraphs [0085], [0098]–[0099], [0225]-[0229] and [0279]; Figures 1 and 4); but does not explicitly teach the device being a blood collection device.
However, Ivosevic teaches the device being a blood collection holder. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bartov, to the device being a blood collection device, as taught by Ivosevic, because doing so provides a device that is dependent on a patient’s finger size.
Conclusion
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/ABID A MUSTANSIR/ Examiner, Art Unit 3791
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