DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
2. Claims 7-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 20 February 2026.
Applicant's election with traverse of Group I, claims 1-6, in the reply filed on 20 February 2026 is acknowledged. The traversal is on the ground(s) that:
Using the same criteria as 37 C.F.R. § 1.475, the International Searching Authority, conducting a search on the corresponding set of claims, found unity of invention to be present in the international application. Further, the results from a search for one or more groups will necessarily produce results applicable for examination of the other groups, as each of Groups I, II, and III are directed to a device for obtaining a blood sample comprising a holder for receiving a sample source, the holder having an actuation portion and a port, and a lancet or blood collector attachment removably connected to the holder. Accordingly, results from a search for any group will necessarily produce results applicable for examination of the other groups.
This is not found persuasive because Group I, Group II, and Group III do not share the same or corresponding technical feature. Group I is directed to a device for obtaining a blood sample including a collection container comprising at least one fill line provided on a surface of the collection container, whereas Group II is direct to a device for obtaining a blood sample including a blood collector attachment includes a flash chamber to indicate when the blood sample has been drawn from a patient’s finger held in the holder, and whereas Group III is directed to a device for obtaining a blood sample including a label positioned on the collection container is oriented so as to obstruct a patient’s view of an inner cavity of the collection container.
Furthermore, a search for any of the groups would necessarily produce results that would be different from the other groups. A different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries) would have to be performed for each of the groups. The prior art applicable to one group would not likely be applicable to another group. The groups are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
3. Claim 1 is objected to because of the following informalities:
In line 6, “the container” lacks proper antecedent basis, and should be amended to “the collection container”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
4. 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.
5. 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.
6. Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ivosevic et al., U.S. Patent Application Publication No. 2019/0216380 A1 (“Ivosevic”).
As to Claim 1, Ivosevic teaches the following:
A device (“device”) 10 for obtaining a blood sample (“blood sample”) 18 (see “The present disclosure relates generally to a device for obtaining a biological sample.” in para. [0002]; and see figs. 8, 14, 15, and 23-26), the device 10 comprising:
a holder (“holder”) 12 for receiving a sample source (“sample source, e.g., a finger”) 19 (see “Referring to FIGS. 1-7B, exemplary embodiments of holders 12 of the present disclosure that are able to receive a sample source, e.g., a finger 19, for supplying a biological sample, such as a blood sample 18.” in para. [0060]), the holder 12 having an actuation portion (“actuation portion”) 24 and a port (“port”) 26 (see “A holder 12 of the present disclosure generally includes a finger receiving portion 20 having a first opening 22 (FIG. 5), an actuation portion 24, a port 26 having a second opening 28, …” in para. [0060]);
a blood collector attachment (“lancet housing”) 14 removably connected to the holder 12 (see “Referring to FIGS. 8-10, in one embodiment, with the holder 12 and the lancet housing 14 being separate components, the lancet housing 14 is removably connectable to the port 26 of the holder 12.” in para. [0074]); and
a collection container (“collection container”) 16 removably connectable to the blood collector attachment 14 (see “Referring to FIG. 26, once a desired amount of blood 18 is collected within the container 16, a blood collector portion 74 is detached from the collection device 200 and sealed with cap or septum 76 to send a collected sample 18 to a diagnostic instrument and/or testing device. As discussed above, the collection container 16 may also contain a sample stabilizer, e.g., an anticoagulant, to stabilize blood and fill lines to indicate/meter a collected volume of blood 18.” in para. [0110]),
the [collection] container 16 defining a collection cavity (“collection cavity”) 70 (see “The collection container 16 defines a collection cavity 70 for receiving a blood sample 18, …” in para. [0080]), and
the collection container 16 comprising at least one fill line (“at least one fill line(s)”, not labeled) provided on a surface of the collection container (see “The collection container 16 may also include at least one fill line(s) corresponding to a predetermined volume of sample.” in para. [0092]; and see fig. 8).
As to Claim 2, Ivosevic teaches the following:
wherein the at least one fill line is configured to indicate when a predetermined volume of the blood sample 18 has been filled in the collection container 16 (see “The collection container 16 may also include at least one fill line(s) corresponding to a predetermined volume of sample.” in para. [0092]; and see fig. 8).
As to Claim 3, Ivosevic teaches the following:
wherein the collection container 16 comprises two fill lines provided on the surface of the collection container 16 (see “The collection container 16 may also include at least one fill line(s) corresponding to a predetermined volume of sample.” in para. [0092]; and see fig. 8).
Claim Rejections - 35 USC § 103
7. 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.
8. 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.
9. Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic, as applied to claim 1 above, and further in view of Wilkinson et al., U.S. Patent Application Publication No. 2011/0178424 A1 (“Wilkinson”).
As to Claim 4, Ivosevic teaches the subject matter of claim 1 above. Ivosevic does not teach the following:
wherein the at least one fill line of the collection container is color coded.
However, Wilkinson teaches the following:
wherein the at least one fill line (“transitional fill-volume indicator”) 30 of the collection container (“specimen collection container”) 10 is color coded (“first colored portion 38” and “second colored portion 40”) (see “The transitional fill-volume indicator 30 may also include a first colored portion 38 and at least a portion of the sidewall 16 of the specimen collection container 10 includes a second colored portion 40, with the second colored portion 40 being different than the first colored portion 38. For example, the transitional fill-volume indicator 30 may be a colored band circumferentially extending about the sidewall 16. The sidewall 16 may be a clear or other colored appearance or portion adjacent the transitional fill-volume indicator 30. In another embodiment, the specimen collection container 10 may include a color contrast or visual effects contrast between at least a portion of the transitional fill-volume indicator 30 and at least a portion of the sidewall 16 of the specimen collection container 10. Examples of color contrasts may include contrasting color portions or variations in hue and/or intensity of the same color. Examples of visual effects contrasts may include the presence of a color modifier, such as pearlesence, sheen, metallicizers, and the like. In a further embodiment, the transitional fill-volume indicator 30 can be formed by spraying, stenciling, or otherwise applying the appropriate markings directly to a surface of the sidewall 16 of the specimen collection container 10, such as the outer surface 36 of the sidewall 16. The transitional fill-volume indicator 30 can also be formed by roughening or otherwise modifying a portion of the sidewall 16 of the specimen collection container 10 to impart a distinct visual appearance and/or texture as compared with an adjacent portion of the sidewall 16. For example, the transitional fill-volume indicator 30 may be formed by electrical discharge machining, etching, or other similar process to impart a textured appearance.” in para. [0083]).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Ivosevic’s at least one fill line (“at least one fill line(s)”, not labeled) to be Wilkinson’s at least one fill line (“transitional fill-volume indicator 30”) that is color coded (“first colored portion 38” and “second colored portion 40”) because it is a simple substitution of one known feature, i.e. “at least one fill line(s)”, for another, i.e. “transitional fill-volume indicator 30” that includes “first colored portion 38” and “second colored portion 40”, to yield similar predictable results, i.e. to communicate the different fill-volumes required for manual and automatic sample extraction (see Wilkinson, para. [0007]).
As to Claims 5 and 6, Ivosevic teaches the subject matter of claim 1 above. Ivosevic does not teach the following:
wherein the at least one fill line of the collection container has a lighter shade of color; and
wherein the at least one fill line of the collection container has a darker shade of color.
However, Wilkinson teaches the following:
at least one fill line (“transitional fill-volume indicator”) 30 of the collection container (“specimen collection container”) 10 has a lighter shade of color or a darker shade of color (“color contrasts may include contrasting color portions or variations in hue and/or intensity of the same color”, not labeled) (see “The transitional fill-volume indicator 30 may also include a first colored portion 38 and at least a portion of the sidewall 16 of the specimen collection container 10 includes a second colored portion 40, with the second colored portion 40 being different than the first colored portion 38. For example, the transitional fill-volume indicator 30 may be a colored band circumferentially extending about the sidewall 16. The sidewall 16 may be a clear or other colored appearance or portion adjacent the transitional fill-volume indicator 30. In another embodiment, the specimen collection container 10 may include a color contrast or visual effects contrast between at least a portion of the transitional fill-volume indicator 30 and at least a portion of the sidewall 16 of the specimen collection container 10. Examples of color contrasts may include contrasting color portions or variations in hue and/or intensity of the same color. Examples of visual effects contrasts may include the presence of a color modifier, such as pearlesence, sheen, metallicizers, and the like. In a further embodiment, the transitional fill-volume indicator 30 can be formed by spraying, stenciling, or otherwise applying the appropriate markings directly to a surface of the sidewall 16 of the specimen collection container 10, such as the outer surface 36 of the sidewall 16. The transitional fill-volume indicator 30 can also be formed by roughening or otherwise modifying a portion of the sidewall 16 of the specimen collection container 10 to impart a distinct visual appearance and/or texture as compared with an adjacent portion of the sidewall 16. For example, the transitional fill-volume indicator 30 may be formed by electrical discharge machining, etching, or other similar process to impart a textured appearance.” in para. [0083]).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Ivosevic’s at least one fill line (“at least one fill line(s)”, not labeled) to be Wilkinson’s at least one fill line (“transitional fill-volume indicator 30”) that is a lighter shade of color or a darker shade of color (“color contrasts may include contrasting color portions or variations in hue and/or intensity of the same color”) because it is a simple substitution of one known feature, i.e. “at least one fill line(s)”, for another, i.e. “transitional fill-volume indicator 30” that includes “color contrasts may include contrasting color portions or variations in hue and/or intensity of the same color”, to yield similar predictable results, i.e. to communicate the different fill-volumes required for manual and automatic sample extraction (see Wilkinson, para. [0007]).
Conclusion
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 03/24/2026