Prosecution Insights
Last updated: August 30, 2026
Application No. 18/419,909

SAFETY DRIP CHAMBER SPIKE WITH BREAKABLE FEATURE

Non-Final OA §103
Filed
Jan 23, 2024
Priority
Dec 08, 2020 — continuation of 11/911,592
Examiner
CHATRATHI, ARJUNA P
Art Unit
3781
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Cardinal Health Inc.
OA Round
5 (Non-Final)
63%
Grant Probability
Moderate
5-6
OA Rounds
3m
Est. Remaining
84%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allowance Rate
131 granted / 208 resolved
-7.0% vs TC avg
Strong +21% interview lift
Without
With
+21.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
37 currently pending
Career history
262
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
61.9%
+21.9% vs TC avg
§102
14.4%
-25.6% vs TC avg
§112
17.1%
-22.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 208 resolved cases

Office Action

§103
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/26/26 has been entered. Response to Amendment Applicant amended claims 1 and 13. Claims 1-3, 5, 7-16, and 18-20 are currently pending. Response to Arguments Applicant’s arguments, see pages 5-8 of Applicant’s Remarks, filed 02/27/26, with respect to the rejections of claims 1-3, 5, 7-8, 10-11, 13-16, and 18-19 under 35 U.S.C. 103 as being unpatentable over Burke in view of Sadiow and in further view of Guo, of claim 12 in further view of Hirokawa, and of claims 9 and 20 in further view of Nagase, have been fully considered and are not persuasive. Applicant argues that the combination of Burke, Sadiow, and Guo does not disclose or render obvious “the spike cover comprising an elongate body and a base, the base of the spike cover having a protrusion forming a second engagement feature comprising a sharp edge configured to engage against the recess of the first engagement feature when the IV spike is inserted into the elongate body such that twisting the spike cover relative to the IV spike causes the IV spike to break safely within the spike cover” as recited in amended claim 1. However, as discussed below, Guo renders it obvious for an engagement feature on a cap, or cover, comprising an annular protrusion to engage against an engagement feature comprising a recess on the base portion of a sharp needle or IV spike such that turning, bending, or twisting the cap, or cover, relative to the sharp needle or IV spike breaks it off safely within the cap or cover (Guo: Figs. 3-4, feats. 21 and 33; Page 3, line 21 – Page 4, line 20). Guo additionally depicts the second engagement feature, or annular protrusion, (Fig. 3, feat. 33) as having a pointed, and therefore sharp, edge. Therefore, the combination of Burke in view of Sadiow and in further view of Guo discloses or renders obvious all of the limitations of the independent claims. 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 (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. 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. Claims 1-3, 5, 7-8, 10-11, 13-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Burke (US 3,316,908 A) in view of Sadiow (US 2003/0083640 A1) and in further view of Guo (GB 2214082 A). Regarding claim 1, Burke discloses an intravenous (IV) spike assembly for administering a medicinal fluid from a container into a drip chamber while preventing spike injury (Fig. 1; Col. 1, lines 8-12), the IV spike assembly comprising: an IV spike (Figs. 3-4, feat. 20; Col. 5, lines 21-73) comprising a head portion at a proximal end thereof (22), a base portion at a distal end thereof (26), an elongate body portion (24), wherein the elongate body portion extends between the head portion and the base portion (Figs. 3-4: elongate body portion 24 extends between the shoulder 28 of the base portion 26 and the sloping surfaces 38, 42 of the sharp head portion 22) and is configured to be coupled to the container (Col. 5, lines 21-46: 22, 24, and 26 are received within a hole of an intravenous container, while beveled shoulder 28 facilitates insertion as far as possible within the hole); and a spike cover (Figs. 3-4, feat. 60; Col. 6, lines 37-68) comprising an elongate body (62) and a base (64), the base of the spike cover having a protrusion forming a second engagement feature (Figs. 3-4, feat. 70). Burke does not disclose a radial notch extending into an outer surface of the IV spike between a proximal end of the base portion and a distal end of the elongate body portion, that the base portion comprises a recess forming a first engagement feature, or that the second engagement feature in the base of the spike cover is comprises a sharp edge configured to engage against the first engagement feature when the IV spike is inserted into the elongate body such that twisting the spike cover relative to the IV spike causes the IV spike to break safely within the spike cover. Sadiow teaches IV spike assemblies (Figs. 1-7, feat. 30; ¶0032-0034; Figs. 11-14; ¶0037; Figs. 16A-B; ¶0039) comprising a cannula tube with a base portion (Figs. 1-7, feat. 42; Figs. 11-14, feat. 73; Figs. 16A-B, feat. B) and a separable elongate portion with a sharpened head portion (Figs. 1-7, feats. 44 and 46; Figs. 11-14, feat. 72; Figs. 16A-B, feat. S). The base and separable elongate portion are divided by line of weakness or fracture joint (Figs. 1-7, feat. 48; Figs. 11-14, feat. 75; Figs. 16A-B, feat. 48) so that separable elongate portion may be separated from the base while the cannula is within a container, thereby allowing the separated elongate portion to float to the upper surface of the fluid in the container and indicate the liquid level (¶0005, 0033-0035, and 0037). The line of weakness or fracture joint (Fig. 3A, feat. 48; Fig. 12, feat. 75) may have a smaller diameter than at least a portion of the separable elongate portion (Fig. 3A, feat. 44; Fig. 12, feat. 72), and is therefore a radial notch extending into the outer surface of the cannula tube. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the spike assembly disclosed by Burke so that it includes a radial notch extending into an outer surface of the IV spike between a proximal end of the base portion and a distal end of the elongate body portion in order to allow the elongate body portion to be separated from the base portion while the IV spike is within a container, thereby allowing the separated elongate body portion to float to the upper surface of the fluid in the container and indicate the liquid level as taught by Sadiow. Burke in view of Sadiow does not suggest that the base portion comprises a recess forming a first engagement feature or that the second engagement feature in the base of the spike cover is comprises a sharp edge configured to engage against the first engagement feature when the IV spike is inserted into the elongate body such that twisting the spike cover relative to the IV spike causes the IV spike to break safely within the spike cover. Guo teaches a syringe (Fig. 1, feat. 1; Page 3, lines 12-20) comprising a needle head (Figs. 1 and 3, feat. 2) comprising a base portion (23 and 24) and an elongate body portion ending in a sharpened head portion (22). The base portion comprises an annular groove or recess (21), corresponding to the claimed first engagement feature, which engages with an annular protrusion (33), corresponding to the second engagement feature disclosed by Burke and claimed, on the inner surface of a cover (3) such that when the cover is attached to the base and is bent or turned, the base breaks at the annular groove or recess (Page 3, line 21 – Page 4, line 20). The annular protrusion has a pointed, or sharp, edge (Fig. 3, feat. 33) which engages with the annular groove or recess (Fig. 3, feat. 21). Guo teaches that this advantageously allows the sharp needle to be permanently enclosed within the cap and prevents it from contacting anyone (Page 1, line 4 – Page 2, line 21). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the assembly suggested by Burke in view of Sadiow so that the base portion comprises a recess forming a first engagement feature and so that the second engagement feature in the base of the spike cover is comprises a sharp edge configured to engage against the first engagement feature when the IV spike is inserted into the elongate body such that twisting the spike cover relative to the IV spike causes the IV spike to break safely within the spike cover. in order to permanently enclose the head and elongate body portion of the IV spike and prevent them from contacting and harming any one as taught by Guo. Regarding claim 2, Burke in view of Sadiow and in further view of Guo suggests the assembly of claim 1, and Burke further discloses that the base portion (Figs. 3-4, feat. 26; Col. 5, lines 47-51) comprises an outer diameter that is greater than an outer diameter of the elongate body portion (Figs. 3-4, feats. 24). Regarding claim 3, Burke in view of Sadiow and in further view of Guo suggests the assembly of claim 1. Guo further teaches that the recess forming the first engagement feature (Figs. 1 and 3, feat. 21) is along the circumference of the outer surface of the base (23 and 24). Therefore, Burke in view of Sadiow and in further view of Guo further suggests that the first engagement feature is at least partially along a circumference of the outer surface of the IV spike. Regarding claim 5, Burke in view of Sadiow and in further view of Guo suggests the assembly of claim 1, and Burke further discloses that the base portion (Figs. 3-4, feat. 26) comprises a cross-sectional area that decreases toward the elongate body portion (Figs. 3-4: Base portion 26 is tapered towards the elongate body portion 24). Regarding claim 7, Burke in view of Sadiow and in further view of Guo suggests the assembly of claim 1. As discussed above, Sadiow teaches that the line of weakness or fracture joint (Fig. 3A, feat. 48; Fig. 12, feat. 75) may have a smaller diameter than at least a portion of the separable elongate portion (Fig. 3A, feat. 44; Fig. 12, feat. 72). Therefore, Burke in view of Sadiow and in further view of Guo further suggests that a diameter of the radial notch is less than an outer diameter of the elongate body portion. Regarding claim 8, Burke in view of Sadiow and in further view of Guo suggests the assembly of claim 1. Sadiow further teaches that the line of weakness or fracture joint (Fig. 3A, feat. 48; Fig. 12, feat. 75) may extend along the circumference of the outer surface of the cannula tube (Figs. 1-2; ¶0034; Figs. 11-12; ¶0037). Therefore, Burke in view of Sadiow and in further view of Guo further suggests that the radial notch extends along an entire circumference of the outer surface of the IV spike. Regarding claim 10, Burke in view of Sadiow and in further view of Guo suggests the assembly of claim 1, and Burke further discloses that the head portion comprises a spike head disposed at the proximal end (Fig. 4, feat. 22; Col. 5, lines 21-36), the spike head having a puncture tip (40’; Col. 5, lines 68-73) and a puncture base (38; Col. 5, lines 47-67) having a fluid inlet at an upper end thereof (36’’), wherein a fluid channel extends from the fluid inlet, through the elongate body portion, and into a drip chamber (36; Col. 5, lines 47-67). Regarding claim 11, Burke in view of Sadiow and in further view of Guo suggests the assembly of claim 1, and Burke further discloses that the IV spike comprises a thermoplastic polymer material (Col. 5, lines 21-36). Regarding claim 13, Burke discloses a method of providing an IV spike assembly for administering a medicinal fluid from a container into a drip chamber while preventing spike injury (Col. 1, lines 8-12; Col. 1, lines 54-58), the method comprising: providing (Col. 1, lines 54-58) an IV spike (Figs. 3-4, feat. 20; Col. 5, lines 21-36) comprising a head portion at a proximal end thereof (22), a base portion at a distal end thereof (26), an elongate body portion (24), wherein the elongate body portion extends between the head portion and the base portion (Figs. 3-4: elongate body portion 24 extends between the shoulder 28 of the base portion 26 and the sloping surfaces 38, 42 of the sharp head portion 22); and providing (Col. 1, lines 54-58) a spike cover (Figs. 3-4, feat. 60; Col. 6, lines 37-68) comprising an elongate body (62) and a base (64), the base of the spike cover having a protrusion forming a second engagement feature (Figs. 3-4, feat. 70) Burke does not disclose a radial notch extending into an outer surface of the IV spike between a proximal end of the base portion and a distal end of the elongate body portion, that the base portion comprises a recess forming a first engagement feature, or that the second engagement feature in the base of the spike cover comprises a sharp edge, such that the second engagement feature engages against the recess of the first engagement feature when the IV spike is inserted into the elongate body and twisting the spike cover relative to the IV spike causes the IV spike to break safely within the spike cover. Sadiow teaches IV spike assemblies (Figs. 1-7, feat. 30; ¶0032-0034; Figs. 11-14; ¶0037; Figs. 16A-B; ¶0039) comprising a cannula tube with a base portion (Figs. 1-7, feat. 42; Figs. 11-14, feat. 73; Figs. 16A-B, feat. B) and a separable elongate portion with a sharpened head portion (Figs. 1-7, feats. 44 and 46; Figs. 11-14, feat. 72; Figs. 16A-B, feat. S). The base and separable elongate portion are divided by line of weakness or fracture joint (Figs. 1-7, feat. 48; Figs. 11-14, feat. 75; Figs. 16A-B, feat. 48) so that separable elongate portion may be separated from the base while the cannula is within a container, thereby allowing the separated elongate portion to float to the upper surface of the fluid in the container and indicate the liquid level (¶0005, 0033-0035, and 0037). The line of weakness or fracture joint (Fig. 3A, feat. 48; Fig. 12, feat. 75) may have a smaller diameter than at least a portion of the separable elongate portion (Fig. 3A, feat. 44; Fig. 12, feat. 72), and is therefore a radial notch extending into the outer surface of the cannula tube. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the spike assembly provided by the method disclosed by Burke so that it includes a radial notch extending into an outer surface of the IV spike between a proximal end of the base portion and a distal end of the elongate body portion in order to allow the elongate body portion to be separated from the base portion while the IV spike is within a container, thereby allowing the separated elongate body portion to float to the upper surface of the fluid in the container and indicate the liquid level as taught by Sadiow. Burke in view of Sadiow does not suggest that the base portion comprises a recess forming a first engagement feature or that the second engagement feature in the base of the spike cover comprises a sharp edge, such that the second engagement feature engages against the recess of the first engagement feature when the IV spike is inserted into the elongate body and twisting the spike cover relative to the IV spike causes the IV spike to break safely within the spike cover. Guo teaches a syringe (Fig. 1, feat. 1; Page 3, lines 12-20) comprising a needle head (Figs. 1 and 3, feat. 2) comprising a base portion (23 and 24) and an elongate body portion ending in a sharpened head portion (22). The base portion comprises an annular groove or recess (21), corresponding to the claimed first engagement feature, which engages with an annular protrusion (33), corresponding to the second engagement feature disclosed by Burke and claimed, on the inner surface of a cover (3) such that when the cover is attached to the base and is bent or turned, the base breaks at the annular groove or recess (Page 3, line 21 – Page 4, line 20). The annular protrusion has a pointed, or sharp, edge (Fig. 3, feat. 33) which engages with the annular groove or recess (Fig. 3, feat. 21). Guo teaches that this advantageously allows the sharp needle to be permanently enclosed within the cap and prevents it from contacting anyone (Page 1, line 4 – Page 2, line 21). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the assembly provided by the method disclosed by Burke in view of Sadiow so that the base portion comprises a recess forming a first engagement feature and so that the second engagement feature in the base of the spike cover comprises a sharp edge, such that the second engagement feature engages against the recess of the first engagement feature when the IV spike is inserted into the elongate body and twisting the spike cover relative to the IV spike causes the IV spike to break safely within the spike cover in order to permanently enclose the head and elongate body portion of the IV spike and prevent them from contacting and harming any one as taught by Guo. Regarding claim 14, Burke in view of Sadiow and in further view of Guo suggests the method of providing the assembly of claim 13. As discussed above, Sadiow teaches that the line of weakness or fracture joint (Sadiow: Figs. 1-7, feat. 48; Figs. 11-14, feat. 75; Figs. 16A-B, feat. 48), and therefore the claimed radial notch, allows the elongate body portion to be separated from the base when force is exerted on the cannula tube (Sadiow: ¶0034 and 0037). Guo further teaches that when the cap (Guo: Figs. 3-4, feat. 3) is attached to the base (Guo: 23 and 24) via the first (Guo: 21) and second (Guo: 33) engagement features, it may be turned to break the base (Page 4, lines 6-20). Therefore, Guo teaches that when the cover is attached to the assembly, applying a bending force to the cover transmits sufficient force to the assembly to break a line of weakness, fracture joint, or radial notch. Therefore, Burke in view of Sadiow and in further view of Guo further suggests that the IV spike is configured to break along the radial notch, such that the base portion separates from the elongate body portion, when any of a twisting and/or bending force is exerted on the spike cover. Regarding claim 15, Burke in view of Sadiow and in further view of Guo suggests the method of claim 14. As discussed above, Guo teaches that the cap permanently encloses the detached needle, which is corresponds to the claimed IV spike (Page 1, line 4 – Page 2, line 21). Therefore, Burke in view of Sadiow and in further view of Guo further suggests that when the base portion separates from the elongate body portion, the IV spike remains within the spike cover. Regarding claim 16, Burke in view of Sadiow and in further view of Guo suggests the method of claim 13. Guo further teaches that the recess forming the first engagement feature (Figs. 1 and 3, feat. 21) is along the circumference of the outer surface of the base (23 and 24). Therefore, Burke in view of Sadiow and in further view of Guo further suggests that the first engagement feature is at least partially along a circumference of the outer surface of the IV spike. Regarding claim 18, Burke in view of Sadiow and in further view of Guo suggests the method of claim 13. As discussed above, Sadiow teaches IV spike assemblies (Figs. 1-7, feat. 30; ¶0032-0034; Figs. 11-14; ¶0037; Figs. 16A-B; ¶0039) comprising a cannula tube with a base portion (Figs. 1-7, feat. 42; Figs. 11-14, feat. 73; Figs. 16A-B, feat. B) and a separable elongate portion with a sharpened head portion (Figs. 1-7, feats. 44 and 46; Figs. 11-14, feat. 72; Figs. 16A-B, feat. S). The base and separable elongate portion are divided by line of weakness or fracture joint (Figs. 1-7, feat. 48; Figs. 11-14, feat. 75; Figs. 16A-B, feat. 48), which corresponds to the claimed radial notch. Because the radial notch separates the base and elongate portions of the spike, it is on the opposite side of the elongate portion from the sharpened head portion, and is therefore closer to the base than to the head portion. Therefore, Burke in view of Sadiow and in further view of Guo further suggests positioning the radial notch on the elongate body at a position closer to the base than to the head portion. Regarding claim 19, Burke in view of Sadiow and in further view of Guo suggests method of claim 13. Sadiow further teaches that the line of weakness or fracture joint (Fig. 3A, feat. 48; Fig. 12, feat. 75) may extend along the circumference of the outer surface of the cannula tube (Figs. 1-2; ¶0034; Figs. 11-12; ¶0037). Therefore, Burke in view of Sadiow and in further view of Guo further suggests that the radial notch extends along an entire circumference of the outer surface of the IV spike. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Burke in view of Sadiow, in further view of Guo, and in further view of Hirokawa et al. (EP 0174011 B1). Regarding claim 12, Burke in view of Sadiow and in further view of Guo suggests the assembly of claim 1. As discussed above, Sadiow teaches an IV spike assembly in which the elongate body portion may be broken within a container at a line of weakness or fracture joint (Sadiow: ¶0005, 0033-0035, and 0037). Therefore, Burke in view of Sadiow and in further view of Guo further suggests breakage of the elongate body portion in the container at the radial notch. Burke in view of Sadiow and in further view of Guo does not disclose that the IV spike comprises a glass fiber reinforcement material such that a stress concentration point is formed at the radial notch when a force is exerted on the IV spike in order to facilitate breakage of the elongate body portion in the container. Hirokawa teaches a medical puncture needle formed from a thermoplastic resin and a fibrous material dispersed in that resin (Page 2, lines 30-49). Hirokawa further teaches that the thermoplastic resin may be acrylonitrile butadiene styrene (ABS), similarly to Burke (Col. 5, lines 21-36), and that the fibrous material may be fiber glass (Page 3, lines 15-53). Hirokawa teaches that a mixture of these materials produces a hard and strong needle that won’t break while piercing a rubber stopper while still being injection moldable (Page 2, lines 10-27; Page 3, lines 54-59). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the IV spike assembly suggested by Burke in view of Sadiow and in further view of Guo so that the IV spike comprises a glass fiber reinforcement material such that a stress concentration point is formed at the radial notch when a force is exerted on the IV spike in order to facilitate breakage of the elongate body portion in the container so that the spike is hard and strong enough not to break while piercing the stopper of a container while still being injection moldable as taught by Hirokawa. Claims 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Burke in view of Sadiow, in further view of Guo, and in further view of Nagase et al. (US 2011/0301547 A1). Regarding claim 9, Burke in view of Sadiow and in further view of Guo suggests the assembly of claim 1, but does not disclose that each of the first engagement feature and the second engagement feature comprise complementary threads. As discussed above, Burke in view of Sadiow in further view of Guo discloses a spike assembly with a in which the spike cover (Guo: Fig. 3, feat. 3) comprises a radially inwardly directed rib (Guo: 33), which corresponds to the second engagement means of claim 1, engages against recess in the base (Guo: 21), which corresponds to the first engagement means of claim 1. Because attaching the cover via the protrusion and recess of Burke in view of Sadiow and in further view of Guo, permanently encloses the spike, as taught by Guo (Page 1, line 4 – Page 2, line 21), the protrusion and recess form a snap fit. Therefore, the assembly of Burke in view of Sadiow and in further view of Guo differs from the assembly of claim 9 by the substitution of the claimed complementary threads for the prior art snap fit. Nagase teaches a syringe system (Figs. 1-3, feat. 100; ¶0023-0029) comprising a cannula (110; ¶0024) or IV spike (114) with respective hubs (102 and 108) which removably receive a protective cover (112; ¶0025 and 0028-0029). Nagase teaches that the protective cover may be attached to the hub via a snap fit, or may be screwed onto the hub (¶0025), which would take place using complementary threads. Therefore, Nagase teaches that attaching a protective cover to a cannula via engagement features comprising complementary threads was known in the art, and further teaches that substituting a snap fit protective cover with a screw on protective cover would predictably result in the cover continuing to protect users from the needle or cannula, and vice versa, due to the protective function being related to the length of the cover and not the attachment mechanism (¶0025). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the spike assembly suggested by Burke in view of Sadiow and in further view of Guo so that each of the first engagement feature and the second engagement feature comprise complementary threads. Please see MPEP §2143(I)(B). Regarding claim 20, Burke in view of Sadiow and in further view of Guo suggests the method providing the assembly of claim 13, but does not disclose that each of the first engagement feature and the second engagement feature comprise complementary threads. As discussed above, Burke in view of Sadiow in further view of Guo suggests a spike assembly with a in which the spike cover (Guo: Fig. 3, feat. 3) comprises a radially inwardly directed rib (Guo: 33), which corresponds to the second engagement means of claim 1, engages against recess in the base (Guo: 21), which corresponds to the first engagement means of claim 1. Because attaching the cover via the protrusion and recess of Burke in view of Sadiow and in further view of Guo, permanently encloses the spike, as taught by Guo (Page 1, line 4 – Page 2, line 21), the protrusion and recess form a snap fit. Therefore, the assembly provided by the method of Burke in view of Sadiow and in further view of Guo differs from that of claim 20 by the substitution of the claimed complementary threads for the prior art snap fit. Nagase teaches a syringe system (Figs. 1-3, feat. 100; ¶0023-0029) comprising a cannula (110; ¶0024) or IV spike (114) with respective hubs (102 and 108) which removably receive a protective cover (112; ¶0025 and 0028-0029). Nagase teaches that the protective cover may be attached to the hub via a snap fit, or may be screwed onto the hub (¶0025), which would take place using complementary threads. Therefore, Nagase teaches that attaching a protective cover to a cannula via engagement features comprising complementary threads was known in the art, and further teaches that substituting a snap fit protective cover with a screw on protective cover would predictably result in the cover continuing to protect users from the needle or cannula, and vice versa, due to the protective function being related to the length of the cover and not the attachment mechanism (¶0025). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify method of providing the spike assembly suggested by Burke in view of Sadiow and in further view of Guo so that each of the first engagement feature and the second engagement feature comprise complementary threads. Please see MPEP §2143(I)(B). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00. 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, Sarah Al-Hashimi can be reached at 5712727159. 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. /ARJUNA P CHATRATHI/Examiner, Art Unit 3781 /JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781
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Prosecution Timeline

Show 6 earlier events
May 16, 2025
Response after Non-Final Action
Jul 02, 2025
Non-Final Rejection mailed — §103
Sep 29, 2025
Response Filed
Jan 27, 2026
Final Rejection mailed — §103
Feb 27, 2026
Response after Non-Final Action
Mar 26, 2026
Request for Continued Examination
Apr 17, 2026
Response after Non-Final Action
Jul 14, 2026
Non-Final Rejection mailed — §103 (current)

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Prosecution Projections

5-6
Expected OA Rounds
63%
Grant Probability
84%
With Interview (+21.2%)
2y 10m (~3m remaining)
Median Time to Grant
High
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