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 .
Response to Amendment
2. According to the Amendment, filed 16 June 2026, the status of the claims is as follows:
Claim 1 is currently amended;
Claims 2-6 are as originally filed; and
Claims 7-15 are withdrawn.
3. The objection to claim 1 for minor informalities is withdrawn in view of the Amendment, filed 16 June 2026.
Response to Arguments
4. Applicant’s arguments, see Remarks, pp. 5-6, filed 16 June 2026, with respect to the rejection of claims 1-3 under 35 U.S.C. 102(a)(1) as being anticipated by Ivosevic et al., U.S. Patent Application Publication No. 2019/0216380 A1, and the rejection of claims 4-6 under 35 U.S.C. 103 as being unpatentable over Ivosevic, as applied to claim 1, and further in view of Wilkinson et al., U.S. Patent Application Publication No. 2011/0178424 A1, have been fully considered, and are persuasive in view of the Amendment, filed 16 June 2026. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection, which was necessitated by amendment, is discussed below.
Claim Rejections - 35 USC § 103
5. 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.
6. 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.
7. 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.
8. Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic et al., U.S. Patent Application Publication No. 2019/0216380 A1 (“Ivosevic”), in view of Crawford et al., U.S. Patent Application Publication No. 2010/0279397 A1 (“Crawford”).
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) (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) and a label provided on a surface of the collection container 16 (see “The devices for obtaining a blood sample of the present disclosure may be associated with a self-standing unit that provides automated pumping, controlled finger squeezing, and automated sample labeling and processing.” in para. [01117]), …
Ivosevic does not teach the following:
wherein the label positioned on the collection container is oriented so as to obstruct a patient’s view of the collection cavity of the collection container while also permitting a user of the device a clear line of sight of the collection cavity of the collection container.
However, Crawford teaches the following:
a label (“label”) 22 positioned on a collection container (“tube”) 20 (see figs. 3A and 3B) is oriented so as to obstruct a patient’s view of a collection cavity (“collection tube”) 60b of the collection container 20 while also permitting a user of the device (“biological sample collection container”) 10 a clear line of sight of the collection cavity 60b of the collection container 20 (see “In accordance with another embodiment of the invention, label 22 comprises on a backside 22a information pertaining to at least one of a manufacture catalog number, identifiable bar code, shelf life, lot identification number, or container specific identifier of tube 20, wherein the backside is adhered to the sidewall of tube 20. In accordance with another embodiment of the invention, the label 22 further comprises on its other side (opposite of 22a) information specific to a sample intended to be placed or already placed into the container of which the label 22 is adhered to and/or information specific to a patient in a hospital.” in para. [0032]).
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 device to have Crawford’s label (“label 22”) be positioned on a collection container (“tube”) 20 (see figs. 3A and 3B) so that it is capable of obstructing a patient’s view of the collection cavity of the collection container while also permitting a user of the device a clear line of sight of the collection cavity of the collection container, as taught by Crawford, in order to provide “… information specific to a sample intended to be placed or already placed into the container of which the label 22 is adhered to and/or information specific to a patient in a hospital” (see Crawford, para. [0032]).
The limitation “the label … is oriented so as to obstruct a patient’s view of the collection cavity of the collection container while also permitting a user of the device a clear line of sight of the collection cavity of the collection container” is a matter of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, Crawford’s “label 20” is capable of being positioned on the “tube 20” to permit a user of the “container 10” a clear line of sight of the inside of the “tube 20” (see fig. 3B perspective), while the front side of “label 22” block’s the patient’s view of the inside of the “tube 20” (see fig. 3A perspective).
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).
9. Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic in view of Crawford, 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 in view of Crawford teaches the subject matter of claim 1 above. Ivosevic in view of Crawford 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 in view of Crawford teaches the subject matter of claim 1 above. Ivosevic in view of Crawford 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. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
11. 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.
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, Jason M Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 08/31/2026
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