Prosecution Insights
Last updated: July 17, 2026
Application No. 17/890,977

PIVC-INTEGRATED HEMOLYSIS-REDUCTION ACCESSORIES WITH ANTI-SPILLAGE COMPONENT FOR DIRECT BLOOD DRAW

Non-Final OA §102§103§112
Filed
Aug 18, 2022
Priority
Aug 19, 2021 — provisional 63/235,122
Examiner
ALLEN, ROBERT F
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Cardinal Health Inc.
OA Round
3 (Non-Final)
74%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 74% — above average
74%
Career Allowance Rate
118 granted / 160 resolved
+3.8% vs TC avg
Strong +61% interview lift
Without
With
+61.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
47 currently pending
Career history
207
Total Applications
across all art units

Statute-Specific Performance

§101
0.2%
-39.8% vs TC avg
§103
82.3%
+42.3% vs TC avg
§102
3.2%
-36.8% vs TC avg
§112
5.5%
-34.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 160 resolved cases

Office Action

§102 §103 §112
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 27 March 2026 has been entered. Response to Amendment This Office Action is in response to the Applicant’s amendment filed 27 March 2026 wherein Claims 1 – 3 and 16 are amended, no claims are cancelled, no claims are added, and Claims 11 – 15 are previously withdrawn. Therefore Claims 1 – 20 are currently pending wherein Claims 11 – 15 are withdrawn therefrom. Response to Arguments Applicant’s arguments, see pages 7 – 11, filed 27 March 2026, with respect to the rejection(s) of independent claim(s) 1 and 16 and their respective dependent claims under 35 U.S.C. § 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Markham (US 4,549,554 A) and/or modified in view of other secondary references. Claim Objections Claims 1 and 16 are objected to because of the following informalities: Claim 1 recites “and blocks any movement of fluid from the distal housing to proximal housing.” The Examiner suggests amending this to recite “and blocks any movement of fluid from the distal housing to the proximal housing” to provide proper antecedent basis for the proximal housing. Claim 16 recites “and blocks any movement of fluid from the distal housing to proximal housing.” The Examiner suggests amending this to recite “and blocks any movement of fluid from the distal housing to the proximal housing” to provide proper antecedent basis for the proximal housing. Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1 – 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites “the seal is engaged against the internal fluid channels of the proximal and distal housings such that the seal resists the fluid flow from the internal fluid channel of the distal housing into the internal chamber.” It is unclear what “engaged against” means? Is this engagement indirect engagement, direct engagement, or something different? Can the seal be “engaged against” the internal fluid channels of the proximal and distal housings through the internal fluid channel of the intermediate housing? Or, does “engaged against” mean that the seal must abut the internal fluid channel of the proximal and distal housings? The Specification and Drawings only disclose that the seal is directly engaged against the internal fluid channels of the intermediate housing and indirectly engaged against the internal fluid channels of the proximal and distal housings. Claim 1 is rejected as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because the Examiner cannot determine the meaning of “engaged against.” Claims 2 – 10 are rejected under 35 U.S.C. § 112(b) as they are dependent on Claim 1. For the purpose of examination, “engaged against” is interpreted to mean indirect engagement through the internal fluid channels of the intermediate housing. Claim 2 recites the limitation "wherein internal fluid channel of the intermediate housing.” There is insufficient antecedent basis for this limitation in the claim. Claim 4 recites the limitation "the internal fluid channels of the proximal, distal, and intermediate housings.” There is insufficient antecedent basis for the limitation of “the internal fluid channel of the intermediate housing” in the claim. Claim Rejections - 35 USC § 102 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. Claim(s) 1 – 4 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Markham (US 4,549,554 A). With regards to claim 1, Markham discloses (see Fig. 3) a flow restriction device (66) (see Col. 5, lines 36 – 48), comprising: a proximal housing (70) (see Col. 5, lines 36 – 48) configured to couple to a fluid collection device (50) (see Col. 5, lines 13 – 25) and including an internal fluid channel (see Col. 5, lines 36 – 48 and see Examiner annotated Fig. 3 below hereinafter referred to as Fig. A) extending transversely at least partially therethrough (see Fig. 3); a distal housing (72) (see Col. 5, lines 36 – 48) configured to couple to a catheter assembly (the language “a distal housing configured to couple to a catheter assembly” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g). The claim is an apparatus claim, and is limited by structural limitations. MPEP 2114. The Office submits that the device of Markham meets the structural limitations of Claim 1 and is capable of being coupled to a catheter assembly. The flow restriction device of Markham is coupled to a biopsy needle. See Fig. 3 and Col. 5, lines 13 – 25. Therefore the distal housing is capable of being coupled to a catheter assembly comprising a biopsy needle.) and including an internal fluid channel (see Col. 5, lines 36 – 48 and see Fig. A below) extending transversely at least partially therethrough (see Fig. 3); and an intermediate housing (68) (see Col. 5, lines 36 – 48) interposed between the proximal and distal housings (see Fig. 3), the intermediate housing comprising: an internal chamber (74) (see Col. 5, lines 36 – 48); and a slider (76) (see Col. 5, lines 49 – 57) reciprocally disposed in the internal chamber (see Fig. 3 and Col. 5, lines 49 – 57), the slider comprising an internal fluid channel (78) (see Col. 5, lines 49 – 57) extending transversely therethrough and a seal (see Col. 5, line 58 – Col. 6, line 2 “slideable sealing material is received in a peripheral groove 86 formed in the valve stem 76 below the bore 78 at a location which blocks the bores 80 and 82 when the valve stem is in its upper, closed position” wherein the seal is the slideable sealing material disclosed) overlaying an outer surface (86) (see Col. 5, line 58 – Col. 6, line 2) of the slider excluding the internal fluid channel of the slider, wherein the slider is reciprocally movable between (i) a first position (see Col. 5, lines 49 – 57 “When the stem is pushed downwardly, the bore 78 becomes confluent with the bores 80 and 82 and the valve is opened”) where the internal fluid channel of the slider is axially aligned with the internal fluid channels of the proximal and distal housings, and the internal fluid channels of the slider and the proximal and distal housings form an internal flow channel (see Col. 5, lines 49 – 57) through the flow restriction device to allow a flow of fluid from the distal housing to the proximal housing via the intermediate housing (see Col. 6, lines 28 – 55), and (ii) a second position (see Fig. 3 and Col. 5, lines 49 – 57) where the internal fluid channel of the slider is not aligned with the internal fluid channels of the proximal and distal housings and the seal is engaged against the internal fluid channels of the proximal and distal housings such that the seal resists the fluid flow from the internal fluid channel of the distal housing into the internal chamber, and blocks any movement of fluid from the distal housing to proximal housing (see Col. 5, line 49 – Col. 6, line 2 and Col. 6, lines 28 – 55). PNG media_image1.png 443 768 media_image1.png Greyscale With regards to claim 2, Markham discloses the claimed invention of claim 1, and Markham further discloses (see Fig. 3) wherein the internal fluid channel (see Fig. A above) of the intermediate housing (68) (see Col. 5, lines 36 – 48) extends transversely therethrough on opposing sides of the internal chamber (74) (see Col. 5, lines 36 – 48). With regards to claim 3, Markham discloses the claimed invention of claim 1, and Markham further discloses (see Fig. 3) wherein the intermediate housing (68) (see Col. 5, lines 36 – 48) further comprises a resilient member (26) (see Col. 5, lines 26 – 35) mounted in the internal chamber (74) (see Col. 5, lines 36 – 48) and coupled to the slider (76) (see Col. 5, lines 49 – 57), and in a normally closed state, the uncompressed resilient member biases the slider to the second position (see Fig. 3 and Col. 5, lines 26 – 35). With regards to claim 4, Markham discloses the claimed invention of claim 3, and Markham further discloses (see Fig. 3) wherein when subject to an axial force, the resilient member (26) (see Col. 5, lines 26 – 35) compresses to move the slider (76) (see Col. 5, lines 49 – 57) from the normally closed state in the second position (see Fig. 3 and Col. 5, lines 26 – 35) to the first position (see Col. 5, lines 49 – 57 “When the stem is pushed downwardly, the bore 78 becomes confluent with the bores 80 and 82 and the valve is opened”) to allow flow through the internal fluid channels of the proximal, distal, and intermediate housings (see Fig. A above). With regards to claim 8, Markham discloses the claimed invention of claim 2, and Markham further discloses (see Fig. 3) wherein the internal fluid channels of the proximal, intermediate, and distal housings (see Fig. A above) and the slider (72) (see Col. 5, lines 36 – 48) through which the fluid flows from the distal housing (72) (see Col. 5, lines 36 – 48) to the proximal housing (70) (see Col. 5, lines 36 – 48) and into the fluid collection device (50) (see Col. 5, lines 13 – 25) comprise linear fluid channels defining a linear internal flow channel though the flow restriction device in the first position (see Col. 5, lines 49 – 57 “When the stem is pushed downwardly, the bore 78 becomes confluent with the bores 80 and 82 and the valve is opened” and see Fig. 3). 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 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) 5 – 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markham and Miethke (US 2018/0214678 A1). Miethke is cited within the Notice of References Cited form dated 14 August 2025. With regards to claim 5, Markham discloses the claimed invention of claim 3, however, Markham is silent with regards to wherein the intermediate housing further comprises a mount disposed in the internal chamber and having an outer surface and an inner surface defining a lumen extending at least partially therethrough, at least a portion of the slider is reciprocally disposed in the lumen, and the resilient member is disposed around and coupled to the outer surface of the mount. Nonetheless Miethke, which is within the analogous art of adjustable valves (see abstract), teaches (Figs. 1 – 2) the intermediate housing (15) (see [0139]) further comprises a mount (16) (see [0139]) disposed in the internal chamber (see at 1 in Fig. 1) and having an outer surface (see the outer surface of the guide 16 in Fig. 1 which the spiral spring 1 couples against)) and an inner surface (see the inner surface of the guide 16 in Fig. 1 which the axle 9 couples against) defining a lumen (see the lumen of the guide 16 which the axle rests within) extending at least partially therethrough (see Fig. 1), at least a portion of the slider (9) (see [0139]) is reciprocally disposed in the lumen (see [0139] “The axile 9 is axially slidable”), and the resilient member (1) (see [0139]) is disposed around and coupled to the outer surface of the mount (see Fig. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the intermediate housing of the flow restriction device of Markham in view of a teaching of Miethke such that the intermediate housing further comprises a mount disposed in the internal chamber and having an outer surface and an inner surface defining a lumen extending at least partially therethrough, at least a portion of the slider is reciprocally disposed in the lumen, and the resilient member is disposed around and coupled to the outer surface of the mount. One of ordinary skill in the art would have been motivated to make this modification because Miethke teaches that this structure secures the slider and resilient member within the intermediate housing while still allowing for sliding motion (see [0139] and [0140] of Miethke). The flow restriction device of Markham modified in view of a teaching of Miethke will hereinafter be referred to as the flow restriction device of Markham and Miethke. With regards to claim 6, the flow restriction device of Markham and Miethke teaches the claimed invention of claim 5, and Markham further teaches (see Fig. 3) wherein the internal chamber (74) (see Col. 5, lines 36 – 48) extends through an outer surface of the intermediate housing (68) (see Col. 5, lines 36 – 48) to an exterior thereof (see Fig. 3), and the slider (76) (see Col. 5, lines 49 – 57) comprises a head (see Examiner annotated Fig. 3 below hereinafter referred to as “Fig. B”), a body (see Fig. B below), and a stem (see Fig. B below). PNG media_image2.png 228 881 media_image2.png Greyscale With regards to claim 7, the flow restriction device of Markham and Miethke teaches the claimed invention of claim 6, and Markham further teaches wherein in the second position (see Fig. 3 and Col. 5, lines 26 – 35) at least a portion of the head (see Fig. B above) extends to the exterior of the intermediate housing (68) (see Col. 5, lines 36 – 48). Claim(s) 9 and 16 – 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markham and Bullington et al. (US 2020/0289039 A1) (hereinafter referred to as “Bullington”). Bullington is cited within the Notice of References Cited form dated 14 August 2025. With regards to claim 9, Markham discloses the claimed invention of Claim 1, however, Markham is silent with regards to wherein the fluid flowing from the proximal housing to the distal housing and into the fluid collection device comprises blood, and the fluid collection device comprises a blood collection device. Nonetheless Bullington, which is within the analogous art of fluid control devices and methods of using the same (see abstract and title)¸ teaches the fluid flowing from the proximal housing (214) (see [0076]) to the distal housing (213) (see [0076]) and into the fluid collection device (see [0076] “The outlet 214 is configured to be fluidically coupled to a fluid collection device”) comprises blood (see [0033], [0038], and [0109]), and the fluid collection device comprises a blood collection device (see [0074] “the fluid collection device can be a sample reservoir, a syringe, an intermediary bodily transfer device, adapter, or vessel”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the flow restriction device of Markham in view of a teaching of Bullington such that the fluid flowing from the proximal housing to the distal housing and into the fluid collection device comprises blood, and the fluid collection device comprises a blood collection device. One of ordinary skill in the art would have been motivated to make this modification because Markham discloses the fluid collection device discharges and draws liquid (see Claim 2). Therefore, one of ordinary skill in the art would have been motivated to modify the liquid that is drawn into the syringe because Bullington teaches the fluid collection device could be used for a variety of functionalities such as sample reservoirs, intermediary bodily transfer devices, and more (see [0074] of Bullington). Here, modifying the fluid collection device such that the fluid flowing from the proximal housing to the distal housing and into the fluid collection device comprises blood, and the fluid collection device comprises a blood collection device is beneficial because a PHOSITA could use the fluid collection device to collect a sample of blood and serve as an intermediary bodily transfer device. The fluid restriction device of Markham modified in view of a teaching of Bullington will hereinafter be referred to as the fluid restriction device of Markham and Bullington. With regards to claim 16, Markham discloses (see Fig. 3) a blood collection system (see Fig. 3), comprising: a blood collection device (50) (see Col. 5, lines 13 – 25); a flow restriction device (66) (see Col. 5, lines 36 – 48) fluidly coupled to the blood collection device (see Fig. 3), the flow restriction device comprising: an intermediate housing (68) (see Col. 5, lines 36 – 48) comprising: an internal chamber (74) (see Col. 5, lines 36 – 48) and an internal fluid channel extending therethrough on opposing sides of the internal chamber (see Fig. A reiterated below); and a slider (76) (see Col. 5, lines 49 – 57) reciprocally mounted in the internal chamber (see Fig. 3 and Col. 5, lines 49 – 57), the slider comprising an internal fluid channel (78) (see Col. 5, lines 49 – 57) extending transversely therethrough and a seal (see Col. 5, line 58 – Col. 6, line 2 “slideable sealing material is received in a peripheral groove 86 formed in the valve stem 76 below the bore 78 at a location which blocks the bores 80 and 82 when the valve stem is in its upper, closed position” wherein the seal is the slideable sealing material disclosed)overlaying an outer surface (86) (see Col. 5, line 58 – Col. 6, line 2) of the slider excluding the internal fluid channel of the slider; a distal housing (72) (see Col. 5, lines 36 – 48) including an internal fluid channel (see Fig. A reiterated below and Col. 5, lines 36 – 48) extending at least partially therethrough; and a proximal housing (70) (see Col. 5, lines 36 – 48) coupled to the blood collection device (see Fig. 3) and including an internal fluid channel (see Fig. A reiterated below and Col. 5, lines 36 – 48) extending at least partially therethrough, wherein, in a non-actuated state of the slider (see Fig. 3 and Col. 5, lines 49 – 57), the internal fluid channel of the slider is not aligned with the internal fluid channels of the proximal, distal, and intermediate housings and the seal is engaged against the internal fluid channels of the intermediate housing such that the seal resists a fluid flow from the internal fluid channel of the intermediate housing and the internal fluid channel of the distal housing into the internal chamber and blocks any movement of fluid from the distal housing to proximal housing (see Col. 5, line 49 – Col. 6, line 2 and Col. 6, lines 28 – 55). PNG media_image1.png 443 768 media_image1.png Greyscale However, Markham is silent with regards to the blood collection set comprising: a catheter assembly; and the distal housing being coupled to the catheter assembly. Nonetheless Bullington, which is within the analogous art of fluid control devices and methods of using the same (see abstract and title), teaches a catheter assembly (IV catheter) (see [0076]); and the distal housing (213) (see [0076]) being coupled to the catheter assembly (see [0076]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the blood collection system of Markham in view of a teaching of Bullington such that the blood collection system comprises a catheter assembly; and the distal housing being coupled to the catheter assembly. Here the needle 36 of Markham would be replaced with the catheter assembly of Bullington and the collection system of Markham would be used to collect a sample of blood. One of ordinary skill in the art would have been motivated to make this modification because Bullington teaches that it is common to attach an IV catheter to a flow restriction device (see [0066] of Bullington). Furthermore, using an IV catheter is preferred over a needle because it provides greater stability, longer access, and reduced risk of complications. These characteristics are beneficial when using the blood collection set to collect a blood sample. The blood collection set of Markham modified in view of a teaching of Bullington will hereinafter be referred to as the blood collection set of Markham and Bullington. With regards to claim 17, the blood collection set of Markham and Bullington teaches the claimed invention of claim 16, and the blood collection set of Markham and Bullington further teaches (see Fig. 3 of Markham) wherein in an actuated state (see Col. 5, lines 49 – 57 of Markham “When the stem is pushed downwardly, the bore 78 becomes confluent with the bores 80 and 82 and the valve is opened”) of the slider (76), the internal fluid channel (78) (see Col. 5, lines 49 – 57 of Markham) of the slider is axially aligned with the internal fluid channels of the proximal, distal, and intermediate housings (see Fig. A reiterated above) to allow blood (see the rejection of Claim 16 above where Bullington teaches using the flow restriction device to take a blood sample) to flow from the distal housing to the proximal housing via the internal fluid channels of the proximal, distal, and intermediate housings and the internal fluid channel of the slider (see Col. 5, lines 49 – 57 and Col. 6, lines 28 – 55 of Markham). With regards to claim 18, the blood collection set of Markham and Bullington teaches the claimed invention of claim 17, and Markham further teaches (see Fig. 3) wherein the internal chamber (74) (see Col. 5, lines 36 – 48) extends through an outer surface of the intermediate housing (68) (see Col. 5, lines 36 – 48) to an exterior thereof (see Fig. 3), and the intermediate housing further comprises a resilient member (26) (see Col. 5, lines 26 – 35) mounted in the internal chamber and coupled to the slider (76) (see Col. 5, lines 49 – 57), wherein in the non-actuated state, the uncompressed resilient member biases the slider to at least partially extend to the exterior of the intermediate housing (see Fig. 3 and Col. 5, lines 26 – 35). With regards to claim 19, the blood collection set of Markham and Bullington teaches the claimed invention of claim 18, and Markham further teaches (see Fig. 3) wherein when subject to an axial force (see Col. 5, lines 49 – 57 “When the stem is pushed downwardly, the bore 78 becomes confluent with the bores 80 and 82 and the valve is opened”), the resilient member (26) (see Col. 5, lines 26 – 35) compresses to move the slider (76) (see Col. 5, lines 49 – 57) from the non-actuated state (see Fig. 3) to the actuated state (see Col. 5, lines 49 – 57 where the actuated state is when the stem is pushed downardly) to allow the blood (see the rejection of Claim 16 above where Bullington teaches using the flow restriction device to take a blood sample) to flow through the internal flow channels of the proximal, distal, and intermediate housings (see Fig. A reiterated above). Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markham and Bullington as applied to Claim 9 above, and in further view of Bullington et al. (US 2018/0140240) (hereinafter referred to as “Bullington ’240”). With regards to claim 10, the fluid restriction device of Markham and Bullington teaches the claimed invention of claim 9, however, Markham is silent with regards to wherein the blood collection device comprises a luer lock access device. Nonetheless Bullington ‘240, which is within the analogous art of systems and methods for sample collection with reduced hemolysis (see abstract and title), teaches (Fig. 51) wherein the blood collection device (2460) (see [0186]) comprises a luer lock access device (see [0186] “The fluid reservoir 2460 has a proximal end portion 2461 and a distal end portion 2462…the distal end portion 2462 can include a locking mechanism (e.g., a Luer Lok® or the like) configured to be physically and fluidically coupled to an adapter such as, for example, the adapter 2430”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the blood collection device of the flow restriction device of Markham and Bullington in view of a teaching of Bullington ‘240 such that the blood collection device comprises a luer lock access device. One of ordinary skill in the art would have been motivated to make this modification because Bullington ‘240 teaches a luer lock access device as a structure that physically and fluidly couples the proximal housing and blood collection device together (see [0186] of Bullington ‘240). This structure prevents inadvertent disconnection and fluid leakage. Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markham and Bullington as applied to Claim 18 in further view of Miethke. With regards to claim 20, the blood collection set of Markham and Bullington teaches the claimed invention of claim 18, however Markham is silent with regards to wherein the intermediate housing further comprises a mount disposed in the internal chamber and having an outer surface and an inner surface defining a lumen extending at least partially therethrough, at least a portion of the slider is reciprocally disposed in the lumen, and the resilient member is disposed around and coupled to the outer surface of the mount. Nonetheless Miethke, which is within the analogous art of adjustable valves (see abstract), teaches (Figs. 1 – 2) the intermediate housing (15) (see [0139]) further comprises a mount (16) (see [0139]) disposed in the internal chamber (see at 1 in Fig. 1) and having an outer surface (see the outer surface of the guide 16 in Fig. 1 which the spiral spring 1 couples against) and an inner surface (see the inner surface of the guide 16 in Fig. 1 which the axle 9 couples against) defining a lumen (see the lumen of the guide 16 which the axle rests within) extending at least partially therethrough (see Fig. 1), at least a portion of the slider (9) (see [0139]) is reciprocally disposed in the lumen (see [0139] “The axile 9 is axially slidable”), and the resilient member (1) (see [0139]) is disposed around and coupled to the outer surface of the mount (see Fig. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the intermediate housing of the flow restriction device of the blood collection set of Markham and Bullington in view of a teaching of Miethke such that the intermediate housing further comprises a mount disposed in the internal chamber and having an outer surface and an inner surface defining a lumen extending at least partially therethrough, at least a portion of the slider is reciprocally disposed in the lumen, and the resilient member is disposed around and coupled to the outer surface of the mount. One of ordinary skill in the art would have been motivated to make this modification because Miethke teaches that this structure secures the slider and resilient member within the intermediate housing while still allowing for sliding motion (see [0139] and [0140] of Miethke). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET. 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, Chelsea Stinson can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ROBERT F ALLEN/Examiner, Art Unit 3783 /WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 05/28/2026
Read full office action

Prosecution Timeline

Aug 18, 2022
Application Filed
Aug 14, 2025
Non-Final Rejection mailed — §102, §103, §112
Oct 30, 2025
Response Filed
Jan 30, 2026
Final Rejection mailed — §102, §103, §112
Mar 27, 2026
Response after Non-Final Action
Apr 23, 2026
Request for Continued Examination
Apr 29, 2026
Response after Non-Final Action
Jun 02, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
74%
Grant Probability
99%
With Interview (+61.0%)
3y 2m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 160 resolved cases by this examiner. Grant probability derived from career allowance rate.

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