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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/9/2026 has been entered.
Response to Amendment
The amendments and remarks, filed on 3/9/2026, has been entered. The claim amendments overcome the previous 112(a) rejection of claims 28 and 29.
The amendments and remarks, filed on 3/9/2026, has been entered. The previous prior art rejection has been modified to address the claim amendments.
Claim Status
Claims 1, 4-9, 20-23, 25-27, and 30-32 are pending and being examined.
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 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.
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.
Claims 1, 4-9, 23, 25-26, and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic et al (US 20170216835 A1; hereinafter “Ivosevic”; already of record on IDS filed 6/27/2023) in view of Burkholz et al (US 20140309551 A1; hereinafter “Burkholz”; already of record on IDS filed 2/16/2022) in view of Crawford et al (US 20080319346 A1; hereinafter “Crawford”).
Regarding claim 1, Ivosevic teaches a biological fluid collection system (Ivosevic; Abstract), comprising:
a collection module adapted to receive a sample (Ivosevic; Fig. 5A, 5B; para [27]; The collection module 10 is adapted to receive a biological fluid sample, such as a blood sample), the collection module comprising:
a housing (Ivosevic; Fig. 1, 2; para [27]; a collection module 10 disposed within an outer housing 34…conventional tube holder 52; examiner interprets the housing to be the structures outside of the collection module, thus comprising both the outer housing 34 and the conventional tube holder 52) having an inlet port and an outlet port, the inlet port and the outlet port in fluid communication (Ivosevic; Fig. 5A; 5B; para [28]; The passageway 28 has a sample introduction opening 30 at the first end 24 of the housing 12 and a sample dispensing opening 32 at the second end 26);
a mixing chamber disposed between the inlet port and the outlet port (Ivosevic; Fig. 5B; para [38]; the blood sample fills the entire passageway 28 by first entering the mixing chamber 16); and
a collection chamber disposed between the mixing chamber and the outlet port (Ivosevic; Fig. 5A; para [38]; holding chamber 18; as seen in Fig. 5A; the holding chamber 18 is between the mixing chamber 16 and the opening 32), the collection chamber including an actuation portion (Ivosevic; para [41]; Fig. 5A; the activation member 22), wherein the actuation portion comprises a first deformable portion located on a first side of the collection chamber (Ivosevic; para [41]; the activation member 22, such as applying an inward pressure in the direction of the arrow on the portion of the elastic sleeve 40 covering the holding chamber 18) transitionable between a first position in which the sample is containable within the collection chamber and a second position in which a portion of the sample is expelled from the collection chamber (Ivosevic; Fig. 5A, 5B; para [41]; The blood sample is then dispensed from the collection module 10 by activation of the activation member 22, such as applying an inward pressure in the direction of the arrow on the portion of the elastic sleeve 40 covering the holding chamber 18 forcing the blood sample out of the holding chamber 18; examiner interprets the first position as position where pressure is not applied to the activation member to dispense the sample and the second position is the position when pressure is applied and the sample is dispensed).
Ivosevic does not teach the actuation portion a second deformable portion located on a second side of the collection chamber opposite the first side, and wherein the first deformable portion and the second deformable portion.
However, Burkholz teaches a biological fluid sampling device (Burkholz; Abstract) comprising a collection chamber (Burkholz; Fig. 2; para [42]; the blood sampling device 110 is configured to eject at least a portion of the collected blood sample) including an actuation portion (Burkholz; Fig. 2; para [42]; a compressible portion 134), wherein the actuation portion comprises a first deformable portion located on a first side of the collection chamber and a second deformable portion located on a second side of the collection chamber opposite the first side (Burkholz; Fig. 2). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the actuation portion comprises a first deformable portion of Ivosevic in the manner of wherein the actuation portion comprises a first deformable portion located on a first side of the collection chamber and a second deformable portion located on a second side as taught by Burkholz as this is a known and suitable substitution for the actuation portion in the art. Further, it is a matter of engineering design to arrange the actuation portion in different ways, where the change in form or shape, without any new or unexpected result, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04). Finally, one would have a reasonable expectation of success by substituting the actuation portion to the claimed limitation as Burkholz teaches comprising two separate deformable portions are a known and suitable arrangement in the art. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Modified Ivosevic does not teach the system comprising a needle and safety shield assembly separate from and selectively engageable with the collection module to provide the sample thereto, the needle and safety shield assembly comprising: a needle structure including a cannula comprising a first cannula end and a second cannula end the second cannula end opposed to the first cannula end and comprising a beveled tip for insertion into a patient to draw the sample; a hub comprising a front hub portion and a separate rear hub portion that may be secured together, wherein the cannula is integral with the front hub portion, and wherein the rear hub portion comprises a threaded connection configured to engage the hub to the housing at the inlet port; and safety shield pivotably engaged with the hub and transitionable from a first shield position in which a portion of the cannula is exposed to a second shield position in which the cannula is shielded by at least a portion of the safety shield; wherein upon engaging of the needle and safety shield assembly with the collection module, via engaging of the threaded connection of the rear hub portion with the housing at the inlet port, the cannula is fluidly connected with the inlet port.
However, Crawford teaches an analogous art of a needle and safety shield assembly (Crawford; para [298]; needle assembly 30c2 and safety shield 64c2) separate from and selectively engageable with the collection module to provide the sample thereto (Crawford; para [296]; the needle holder 42c2 is engaged with a portion of the rear hub portion 5012), the needle and safety shield assembly comprising: a needle structure including a cannula comprising a first cannula end and a second cannula end the second cannula end opposed to the first cannula end and comprising a beveled tip for insertion into a patient to draw the sample (Crawford; Fig. 111; para [291]; Distal needle portion 5002 represents a patient end of the needle structure 32c2, and may be beveled to define a puncture tip for puncturing the skin of a patient and accessing the vasculature of the patient; the examiner interprets the first end as the end with the puncture tip and the second end as the end within the front hub portion 5010 as seen in Fig. 111); a hub comprising a front hub portion and a separate rear hub portion that may be secured together (Crawford; para [292]; The hub 58c2 may include a front hub portion 5010 and a rear hub portion 5012), wherein the cannula is integral with the front hub portion (Crawford; para [292]; the distal needle portion 5002 may be integral with the front hub portion 5010), and wherein the rear hub portion comprises a threaded connection configured to engage the hub to the housing at the inlet port (Crawford; para [173]; the distal end 82 of the specimen collection container holder 78 may include an engagement portion 92 having a mating structure, such as a threaded engagement, adapted to receive the rear hub portion 68 of the hub 64; the examiner notes that the hubs comprise the threads as seen Figures 111-115); and safety shield pivotably engaged with the hub and transitionable from a first shield position in which a portion of the cannula is exposed to a second shield position in which the cannula is shielded by at least a portion of the safety shield1 (Crawford; para [298]; the safety shield 64c2 may include a thumb press-region 64c2 a for enabling a medical practitioner to pivot the safety shield 64c2 to engage a portion of the proximal IV shield 5038 prior to puncturing the skin of a patient); wherein upon engaging of the needle and safety shield assembly with the collection module, via engaging of the threaded connection of the rear hub portion with the housing at the inlet port, the cannula is fluidly connected with the inlet port (Crawford; para [173, 298]; the distal end 82 of the specimen collection container holder 78 may include an engagement portion 92 having a mating structure, such as a threaded engagement, adapted to receive the rear hub portion 68 of the hub 64…the safety shield 64c2 may include a thumb press-region 64c2 a for enabling a medical practitioner to pivot the safety shield 64c2 to engage a portion of the proximal IV shield 5038 prior to puncturing the skin of a patient). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the conventional tube holder of modified Ivosevic to comprise the needle and safety shield assembly as taught by Crawford, because Crawford teaches the needle assembly is often used with a specimen collection tube for drawing a sample of blood or other bodily fluid from a patient (Crawford; para [7]).
1 The limitation “transitionable from a first shield position in which a portion of the cannula is exposed to a second shield position in which the cannula is shielded by at least a portion of the safety shield” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation 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. See MPEP § 2114. As such, it is deemed that the claimed safety shield is not differentiated from the safety shield of modified Ivosevic and thus is configured for and capable of performing the intended use and/or function language of transitioning from a first shield position in which a portion of the cannula is exposed to a second shield position in which the cannula is shielded by at least a portion of the safety shield.
Regarding claim 4, modified Ivosevic teaches the biological fluid collection system of claim 1, wherein the mixing chamber further comprises a sample stabilizer disposed therein (Ivosevic; Fig. 5A; para [29, 30]; the mixing chamber 16 may, for example, include an open cell foam…The open cell foam may be treated with an anticoagulant to form a dry anticoagulant powder).
Regarding claim 5, modified Ivosevic teaches the biological fluid collection system of claim 4, wherein the mixing chamber further comprises an open cell foam having pores and the sample stabilizer is disposed within the pores of the open cell foam (Ivosevic; Fig. 5A; para [29, 30]; the mixing chamber 16 may, for example, include an open cell foam…The open cell foam may be treated with an anticoagulant to form a dry anticoagulant powder).
Regarding claim 6, modified Ivosevic teaches the biological fluid collection system of claim 5, wherein the open cell foam is a melamine foam (Ivosevic; para [31]; the open cell foam may be a soft deformable open cell foam that is inert to blood, for example, a melamine foam).
Regarding claim 7, modified Ivosevic teaches the biological fluid collection system of claim 1, wherein sample is drawn from a patient through the cannula and into the mixing chamber (Ivosevic; para [37]; In use, a needle cannula 50 (FIGS. 5A and 5C) is inserted into the passageway 28 of the housing 12 through the sample introduction opening 30), wherein the sample is passively mixed with a sample stabilizer prior to entering the collection chamber (Ivosevic; para [30]; As the blood sample enters the mixing chamber 16, the blood sample passes through the open cell foam and is exposed to the anticoagulant powder available throughout the internal pore structure of the open cell foam).
Regarding claim 8, modified Ivosevic teaches the biological fluid collection system of claim 7, wherein the mixing chamber includes an open cell melamine foam and the sample stabilizer is disposed within pores of the open cell melamine foam (Ivosevic; Fig. 5A; para [29, 30, 31]; the mixing chamber 16 may, for example, include an open cell foam…The open cell foam may be treated with an anticoagulant to form a dry anticoagulant powder… the open cell foam may be a soft deformable open cell foam that is inert to blood, for example, a melamine foam), and the sample passively mixed with the sample stabilizer as it passes through the open cell melamine foam (Ivosevic; para [30]; As the blood sample enters the mixing chamber 16, the blood sample passes through the open cell foam and is exposed to the anticoagulant powder available throughout the internal pore structure of the open cell foam).
Regarding claim 9, modified Ivosevic teaches the biological fluid collection system of claim 1 (the biological fluid collection system of modified Ivosevic is modified to comprise the needle and safety shield assembly as taught by Crawford as discussed above in claim 1), wherein the actuation portion is deflectable between the first position and the second position (Ivosevic; Fig. 5A, 5B; para [41]; The blood sample is then dispensed from the collection module 10 by activation of the activation member 22, such as applying an inward pressure in the direction of the arrow on the portion of the elastic sleeve 40 covering the holding chamber 18 forcing the blood sample out of the holding chamber 18) after the safety shield has been transitioned from the first position to the second position (Crawford; para [298]; the safety shield 64c2 may include a thumb press-region 64c2 a for enabling a medical practitioner to pivot the safety shield 64c2 to engage a portion of the proximal IV shield 5038 prior to puncturing the skin of a patient).
Regarding claim 23, modified Ivosevic teaches the biological fluid collection system of claim 1, wherein the cannula is secured to the housing at the inlet port (Ivosevic; para [37]; needle cannula 50 (FIGS. 5A and 5C) is inserted into the passageway 28 of the housing 12 through the sample introduction opening 30).
Regarding claim 25, modified Ivosevic teaches the biological fluid collection system of claim 1 (the biological fluid collection system of modified Ivosevic is modified to comprise the needle and safety shield assembly as taught by Crawford as discussed above in claim 1), wherein the first end of the cannula terminates in the front hub (Crawford; para [292]; the distal needle portion 5002 may be integral with the front hub portion 5010).
Regarding claim 26, modified Ivosevic teaches the biological fluid collection system of claim 1 (the biological fluid collection system of modified Ivosevic is modified to comprise the needle and safety shield assembly as taught by Crawford as discussed above in claim 1), wherein the hub defines a flashback indicator therein (Crawford; para [292]; the hub 58c2 defines a flashback indicator 60c2).
Regarding claim 27, modified Ivosevic teaches the biological fluid collection system of claim 1, wherein the front hub portion includes a protrusion for engaging a corresponding recess integral to the rear hub portion (Crawford; para [292]; The front hub portion 5010 may include a protrusion 5014, such as a raised annular ring, for engaging a corresponding recess 5016 integral to the rear hub portion 5012).
Regarding claim 30, modified Ivosevic teaches the biological fluid collection system of claim 1 (the biological fluid collection system of modified Ivosevic is modified to comprise the needle and safety shield assembly as taught by Crawford as discussed above in claim 1), wherein the needle structure further comprises a rear needle portion separate from the cannula (Crawford; para [291]; The proximal needle portion 5004 represents a non-patient end of the needle structure 32bc2, which is provided for puncturing of an evacuated blood collection tube), the rear needle portion having a first needle end and a second needle end, with the second needle end extending outward from the rear hub portion and into an internal cavity or channel of the front hub portion (Crawford; Fig. 111; the examiner interprets the second needle end to be the side covered by the multiple sample 5008 and the first needle end to be the side near the distal needle portion 5002), so as to be aligned with and adjacent to the first end of the cannula, and so as to fluidly connect the rear needle portion with the cannula (Crawford; para [291]; Distal needle portion 5002 and proximal needle portion 5004 may be separate needles, both of which represent needle cannula defining central lumen 5006 extending therethrough).
Regarding claim 31, modified Ivosevic teaches the biological fluid collection system of claim 30, wherein the first end of the rear needle portion terminates in the threaded connection of the rear hub portion (Crawford; Fig. 111; the first needle end is interpreted to be the side near the distal needle portion 5002). Thus, the first needle end does not extend past the threaded connection as seen in Fig. 111.
Regarding claim 32, modified Ivosevic teaches the biological fluid collection system of claim 1, wherein the hub comprises a collar for surrounding an attachment bearing of the safety shield, to pivotably connect the safety shield to the hub (Crawford; para [293]; The hub 58c2 may further include a collar 5018 for surrounding at least a portion of the safety shield 64c2, such as a pivot 5020 of the safety shield 64c2), the collar comprising includes a first collar portion formed on the front hub portion (Crawford; para [293]; the front hub portion 5010 includes a first collar portion 5022) and a second collar portion formed on the rear hub portion (Crawford; para [293]; the rear hub portion 5012 includes a second collar portion 5024), with the first collar portion comprising a generally c-shaped region for accommodating the attachment bearing (Crawford; para [293]; The first collar portion 5022 may include a generally c-shaped region 5028 for accommodating an attachment bearing 5026 of the safety shield 64c2) and the second collar portion comprising a cap region having an interior surface substantially corresponding to the attachment bearing (Crawford; para [293]; The second collar portion 5024 may include a cap region 5030 having an interior surface 5032 substantially corresponding to the attachment bearing 5026 of the safety shield 64c2).
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic in view of Burkholz in view of Crawford, and in further view of Wacks (EP 0616541 B1; hereinafter “Wacks”; English translation attached; already of record).
Regarding claim 20, modified Ivosevic teaches the biological fluid collection system of claim 1, further comprising:
a tip cap disposed over at least a portion of the outlet port (Ivosevic; para [34]; A cap 20 disposed at the second end 26 of the housing 12 covers the sample dispensing opening 32), the tip cap including a venting plug (Ivosevic; para [34]; The cap 20 includes a vented plug, such as a porous plug 44) therein that allows air to pass therethrough and prevents the sample from passing therethrough (Ivosevic; para [34]; the vented plug 44 allows air to pass through the cap 20 while preventing the blood sample from passing through the cap 20); and
a power source, the power source configured to create a vacuum that draws the sample into the collection chamber (Ivosevic; para [44]; syringe or other power source may be used to draw the sample into the collection module 10).
Modified Ivosevic does not disclose the power source removably connectable with the tip cap, at the outlet port of the collection module.
However, Wacks teaches an analogous art of an automatic injector/aspirator (Wacks; Abstract) comprising a power source (Wacks; Fig. 1; pp 10, para [2]; pp 11, para [2]; The injection/aspiration device; examiner notes that the device comprises d.c. motor, power source and electronic components as seen in Fig. 1) removably connectable with the tip cap, at the outlet port of the collection module (Wacks; col 8, line 1; plunger shaft 215 which is reversibly attached to cartridge vial shaft end 216). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the power source of modified Ivosevic to be connected to the tip cap as taught by Wacks, because Wacks teaches that the power source controls the rate of injection or withdrawal of the sample (Wacks; pp 10, para [2]).
Regarding claim 21, modified Ivosevic teaches the biological fluid collection system of claim 20, with the power source.
Modified Ivosevic does not disclose wherein the power source includes: a barrel attached to the tip cap; a piston movable within the barrel; a spring configured to move the piston within the barrel; a lock transitionable between a locked position, in which the lock locks the piston in a first piston position and maintains the spring in a compressed position, and an unlocked position, in which the piston is unlocked and the spring is permitted to drive the piston to a second piston position; and an activation button configured to transition the lock between the locked position and the unlocked position; wherein movement of the piston from the first position to the second position creates a vacuum that draws the sample within the collection chamber, with the venting plug preventing the sample from exiting the tip cap.
However, Wacks teaches an analogous art of an automatic injector/aspirator (Wacks; Abstract) comprising a power source (Wacks; Fig. 1; pp 10, para [2]; pp 11, para [2]; The injection/aspiration device; examiner notes that the device comprises d.c. motor, power source and electronic components as seen in Fig. 1), wherein the power source includes: a barrel attached to the tip cap (Wacks; Fig. 1; pp 9-pp 10, para [1]; a chamber 219 for reversibly receiving a cartridge vial); a piston movable within the barrel (Wacks; Fig. 1; pp 7, para [7]; a cartridge vial piston operating plunger slidably disposed within the housing…plunger shaft 215); a spring configured to move the piston within the barrel (Wacks; pp 15, para [5]; Piston driver 2007 is also provided with piston driver spring 2013); a lock transitionable between a locked position, in which the lock locks the piston in a first piston position and maintains the spring in a compressed position, and an unlocked position, in which the piston is unlocked and the spring is permitted to drive the piston to a second piston position (Wacks; pp 15, para [5]; Piston driver 2007 is also provided with piston driver spring 2013 which is coiled around piston driver release arms 2015 in a compressed condition and abutting on piston driver spring shoulder 2009 and housing spring shelf 2016 thus biasing piston driver 2007 toward cartridge vial receiving chamber 2005; and an activation button configured to transition the lock between the locked position and the unlocked position (Wacks; pp 10, para [2]; All of the components of the device are energized by d.c. power source 225 through the operation of switch 227); wherein movement of the piston from the first position to the second position creates a vacuum that draws the sample within the collection chamber, with the venting plug preventing the sample from exiting the tip cap (Wacks; pp 13, para [5]; The direction of force on plunger shaft head 49 may then be reversed causing a slight withdrawal of piston 45 away from end cap 3). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the power source of modified Ivosevic to comprise the barrel, the piston, the spring, the lock, and the activation button as taught by Wacks, because Wacks teaches that the device drives the plunger to expel or aspirate fluid (Wacks; pp 8, para [1]).
Regarding claim 22, modified Ivosevic teaches the biological fluid collection system of claim 20, wherein with the cannula engaged with a patient (Tan; para [126]; at least one cannula 732 having a patient puncture tip 738), the power source is configured to create a vacuum that draws the sample into the collection chamber (Ivosevic; para [44]; syringe or other power source may be used to draw the sample into the collection module 10).
Response to Arguments
Applicant’s arguments filed, 3/9/2026, have been considered and the some of the arguments are found to be persuasive. However, those arguments are directed towards the claim amendments. The examiner notes that the previous prior art rejection is withdrawn and a new prior art rejection is applied to address the claim amendments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/A.Q.L./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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