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 Amendment
The Amendment filed July 07, 2026 has been entered. Claims 1-19 remain pending in the application.
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 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.
Claims 1-4, 6 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Massaro (US 2014/0000391 A1) (“Massaro”).
Regarding claim 1, Massaro discloses A device for obtaining a blood sample, the device comprising (Abstract and entire document):
a collection container defining a cavity to receive the blood sample (FIG. 1 and [0037], vessels 10 which hold sample 11); and
an adaptor defining a cavity to receive the collection container, wherein the adaptor comprises retention features to automatically orient the collection container into a desired position when inserted into the adaptor (FIG. 1 and [0037], holder 20 defining cavities 25 to receive the vessels 10; see further [0037] – 0038], the holder 20 includes orientation features 23 which interacts with positioning features 15 on the vessels 10 to orient the vessels 10 in a suitable alignment relative to holder 20. See further [0036] – [0038], “In some cases described in more detail below, interaction between a positioning feature 15 and an orientation feature 23 may allow for the vessel 10 to be automatically placed in an appropriate alignment orientation, e.g., the positioning and orientation features may interact to cause movement of the vessel 10 to the alignment orientation.” and FIG. 12-15 and [0049] discussing the automatic orientation into a desired position, reciting, “However, because of the arrangement of the positioning feature 15 and the orientation feature 23, the vessel 10 may tend to rotate (e.g., under the pull of gravity or other force) so that the positioning feature 15 is located at a low side of the slanted portion 32 (which in this case includes a slot-like groove 33). FIG. 14 shows the vessel 10 in the process of rotating (in a counterclockwise direction looking down on the vessel 10) so that the positioning feature 15 moves toward the slot 33. This rotation may be caused by gravity pulling down on the vessel 10”. Thus gravity and the orientation and positioning features work to automatically orient the collection container into a desired position into the adaptor.).
Regarding claim 2, Massaro discloses The device of claim 1, wherein the adaptor includes at least one protrusion extending from an end of the adaptor (FIG. 1, orientation features 23 at the top end of holder 20; see [0044], the orientation feature includes a tab which engages with a slot of positioning feature 15 in vessel 10,”).
Regarding claim 3, Massaro discloses The device of claim 2, wherein the collection container defines at least one groove configured to receive the at least one protrusion of the adaptor (FIG. 1, orientation features 23 at the top end of holder 20; see [0044], the orientation feature includes a tab which engages with a slot of positioning feature 15 in vessel 10,”).
Regarding claim 4, Massaro discloses The device of claim 1, wherein the adaptor is made of a transparent material such that a barcode positioned on the collection container is viewed through the adaptor (FIG. 1 and [0042] holder may be transparent, see id feature 12 on vessels 10, see also [0037], identification feature 12 such as a bar code; the holder 20 may be transparent to electromagnetic radiation used by a reader 30 to read the identification regions 12).
Regarding claim 6, Massaro discloses The device of claim 1, wherein the adaptor includes a height adjusting member in a bottom of the adaptor to raise a height of the collection container in the adaptor (FIG. 22 orientation feature 23 at bottom of holder 20; 23 of the holder and 15 of the vessel 10 cooperate to vertically position the level of 10 within holder 20, see [0052]; engagements of the positioning features of the vessel and orientation features of the holder so that the identification of feature 12 of vessel 10 is located at a desired depth, see [0043]).
Regarding claim 8, Massaro discloses The device of claim 1, wherein the adaptor comprises axial retention features and rotational retention features ([0043], engagement of the positioning features of the vessels and orientation features of the holder fixes the position of the vessel in both linear and rotational directions”).
Regarding claim 9, Massaro discloses The device of claim 1, wherein the adaptor comprises rotational retention features ([0043], engagement of the positioning features of the vessels and orientation features of the holder fixes the position of the vessel in both linear and rotational directions”).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Massaro in view of Pinto et al. (US 2022/0062103 A1) (“Pinto”).
Regarding claim 5, Massaro discloses The device of claim 4, Massaro fails to disclose wherein the adaptor is made of Methylmethacrylate Acrylonitrile Butadiene Styrene.
However, in the same field of endeavor, Pinto teaches wherein the adaptor is made of Methylmethacrylate Acrylonitrile Butadiene Styrene ([0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Massaro to include wherein the adaptor is made of Methylmethacrylate Acrylonitrile Butadiene Styrene as taught by Pinto to use an injection grade polymer ([0058]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Massaro in view of Taylor et al. (US 2017/0238857 A1) (“Taylor”).
Regarding claim 7, Massaro discloses The device of claim 1, Massaro fails to disclose wherein an upper edge of a height adjusting member includes a sinusoidal cam surface to self-orient the collection container when inserted into the adaptor.
However, in the same field of endeavor, Taylor teaches wherein an upper edge of a height adjusting member includes a sinusoidal cam surface to self-orient the collection container when inserted into the adaptor ([0139] discussing the connection/orientation surfaces as sinusoidal or similar, etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Massaro to include wherein an upper edge of a height adjusting member includes a sinusoidal cam surface to self-orient the collection container when inserted into the adaptor as taught by Taylor as a simple substitution of one known connection mechanism for another ([0139]).
Claims 10-13, 15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Massaro in view of Ivosevic et al. (US 2019/0216380 A1) (“Ivosevic”) .
Regarding claim 10, Massaro discloses A device for obtaining a blood sample, the device comprising (Abstract and entire document):
a collection container defining a cavity to receive the blood sample (FIG. 1 and [0037], vessels 10 which hold sample 11); and
an adaptor defining a cavity to receive the collection container, wherein the adaptor comprises retention features to automatically orient the collection container into a desired position when inserted into the adaptor (FIG. 1 and [0037], holder 20 defining cavities 25 to receive the vessels 10; see further [0037] – 0038], the holder 20 includes orientation features 23 which interacts with positioning features 15 on the vessels 10 to orient the vessels 10 in a suitable alignment relative to holder 20. See further [0036] – [0038], “In some cases described in more detail below, interaction between a positioning feature 15 and an orientation feature 23 may allow for the vessel 10 to be automatically placed in an appropriate alignment orientation, e.g., the positioning and orientation features may interact to cause movement of the vessel 10 to the alignment orientation.” and FIG. 12-15 and [0049] discussing the automatic orientation into a desired position, reciting, “However, because of the arrangement of the positioning feature 15 and the orientation feature 23, the vessel 10 may tend to rotate (e.g., under the pull of gravity or other force) so that the positioning feature 15 is located at a low side of the slanted portion 32 (which in this case includes a slot-like groove 33). FIG. 14 shows the vessel 10 in the process of rotating (in a counterclockwise direction looking down on the vessel 10) so that the positioning feature 15 moves toward the slot 33. This rotation may be caused by gravity pulling down on the vessel 10”. Thus gravity and the orientation and positioning features work to automatically orient the collection container into a desired position into the adaptor.).
Massaro fails to disclose a holder for receiving a sample source, the holder having an actuation portion and a port;
However, in the same field of endeavor, Ivosevic teaches a holder for receiving a sample source, the holder having an actuation portion and a port (FIG. 8, device 10 for collecting blood sample see [0008]; see also holder 12, see [0060], the holder receives a sample source such as a finger for supplying the blood sample; actuation portion 24 to apply pressure to the sample source to better extract blood, para [0065]-[0066]; see port 26, Fig 8, port 26 configured for receiving a lancet housing 14 and collection container 16, para [0062]);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Massaro to include a holder for receiving a sample source, the holder having an actuation portion and a port as taught by Ivosevic to provide a single device which can be used for both obtaining and collecting a blood sample to streamline the collection process, wherein the detachable collection container is then inserted in the adaptor in order to better identify the blood sample for further processing (device that simplifies and streamlines the capillary blood collection, para [0008]).
Regarding claim 11, Massaro discloses The device of claim 10, Massaro as modified further discloses wherein the adaptor includes at least one protrusion extending from an end of the adaptor (Massaro FIG. 1, orientation features 23 at the top end of holder 20; see [0044], the orientation feature includes a tab which engages with a slot of positioning feature 15 in vessel 10,”).
Regarding claim 12, Massaro discloses The device of claim 11, Massaro as modified further discloses wherein the collection container defines at least one groove configured to receive the at least one protrusion of the adaptor (Massaro FIG. 1, orientation features 23 at the top end of holder 20; see [0044], the orientation feature includes a tab which engages with a slot of positioning feature 15 in vessel 10,”).
Regarding claim 13, Massaro discloses The device of claim 10, Massaro as modified further discloses wherein the adaptor is made of a transparent material such that a barcode positioned on the collection container is viewed through the adaptor (Massaro FIG. 1 and [0042] holder may be transparent, see id feature 12 on vessels 10, see also [0037], identification feature 12 such as a bar code; the holder 20 may be transparent to electromagnetic radiation used by a reader 30 to read the identification regions 12).
Regarding claim 15, Massaro discloses The device of claim 10, Massaro as modified further discloses wherein the adaptor includes a height adjusting member in a bottom of the adaptor to raise a height of the collection container in the adaptor (Massaro FIG. 22 orientation feature 23 at bottom of holder 20; 23 of the holder and 15 of the vessel 10 cooperate to vertically position the level of 10 within holder 20, see [0052]; engagements of the positioning features of the vessel and orientation features of the holder so that the identification of feature 12 of vessel 10 is located at a desired depth, see [0043]).
Regarding claim 17, Massaro discloses The device of claim 10, Massaro as modified further discloses wherein the adaptor comprises axial retention features and rotational retention features (Massaro [0043], engagement of the positioning features of the vessels and orientation features of the holder fixes the position of the vessel in both linear and rotational directions”).
Regarding claim 18, Massaro discloses The device of claim 10, Massaro as modified further discloses wherein the adaptor comprises rotational retention features (Massaro [0043], engagement of the positioning features of the vessels and orientation features of the holder fixes the position of the vessel in both linear and rotational directions”).
Regarding claim 19, Massaro discloses The device of claim 10, Massaro as modified further discloses further comprising a lancet removably connected to the port of the holder to lance the sample source (Ivosevic FIG. 8, lancet 14 is also removably connected to port 26; port 26 is configure for receiving lancet housing 14, para [0062]; lancet 14 is activated to lance the sample source, para [0074]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Massaro in view of Ivosevic in further view of Pinto.
Regarding claim 14, Massaro discloses The device of claim 13, Massaro as modified fails to disclose wherein the adaptor is made of Methylmethacrylate Acrylonitrile Butadiene Styrene.
However, in the same field of endeavor, Pinto teaches wherein the adaptor is made of Methylmethacrylate Acrylonitrile Butadiene Styrene ([0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Massaro as modified to include wherein the adaptor is made of Methylmethacrylate Acrylonitrile Butadiene Styrene as taught by Pinto to use an injection grade polymer ([0058]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Massaro in view of Ivosevic in further view of Taylor.
Regarding claim 16, Massaro discloses The device of claim 10, Massaro as modified fails to disclose wherein an upper edge of a height adjusting member includes a sinusoidal cam surface to self-orient the collection container when inserted into the adaptor.
However, in the same field of endeavor, Taylor teaches wherein an upper edge of a height adjusting member includes a sinusoidal cam surface to self-orient the collection container when inserted into the adaptor ([0139] discussing the connection/orientation surfaces as sinusoidal or similar, etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Massaro as modified to include wherein an upper edge of a height adjusting member includes a sinusoidal cam surface to self-orient the collection container when inserted into the adaptor as taught by Taylor as a simple substitution of one known connection mechanism for another ([0139]).
Response to Arguments
Applicant's arguments filed July 07, 2026 have been fully considered but they are not persuasive. With respect to the arguments regarding the 102 and 103 rejections, the arguments are not persuasive. Applicant has amended the claims and argues Massaro fails to disclose the amended limitations, “an adaptor defining a cavity to receive the collection container, wherein the adaptor includes retention features to automatically orient the collection container into a desired position when inserted into the adaptor”, the arguments are not persuasive. Massaro, see [0038], “In some cases described in more detail below, interaction between a positioning feature 15 and an orientation feature 23 may allow for the vessel 10 to be automatically placed in an appropriate alignment orientation, e.g., the positioning and orientation features may interact to cause movement of the vessel 10 to the alignment orientation.” See further FIG. 12-15 and [0049], “However, because of the arrangement of the positioning feature 15 and the orientation feature 23, the vessel 10 may tend to rotate (e.g., under the pull of gravity or other force) so that the positioning feature 15 is located at a low side of the slanted portion 32 (which in this case includes a slot-like groove 33). FIG. 14 shows the vessel 10 in the process of rotating (in a counterclockwise direction looking down on the vessel 10) so that the positioning feature 15 moves toward the slot 33. This rotation may be caused by gravity pulling down on the vessel 10”. Thus gravity and the orientation and positioning features work to automatically orient the collection container into a desired position into the adaptor. The arguments are not persuasive. The arguments regarding Ivosevic, Pinto, Taylor and any dependent claims are moot as there do not appear to be any further arguments.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH A TOMBERS/Examiner, Art Unit 3791
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