Prosecution Insights
Last updated: July 17, 2026
Application No. 18/729,720

Vial Adaptor Providing Audible Feedback and Connector Assembly for Medical Injection Device Including Vial Adaptor

Non-Final OA §103§112
Filed
Jul 17, 2024
Priority
Jan 18, 2022 — EU 22305047.7 +1 more
Examiner
TRAN, NHU
Art Unit
Tech Center
Assignee
Becton Dickinson Holdings Pte. Ltd.
OA Round
1 (Non-Final)
69%
Grant Probability
Favorable
1-2
OA Rounds
1y 0m
Est. Remaining
96%
With Interview

Examiner Intelligence

Grants 69% — above average
69%
Career Allowance Rate
88 granted / 127 resolved
+9.3% vs TC avg
Strong +27% interview lift
Without
With
+26.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
30 currently pending
Career history
164
Total Applications
across all art units

Statute-Specific Performance

§101
0.5%
-39.5% vs TC avg
§103
91.1%
+51.1% vs TC avg
§102
1.0%
-39.0% vs TC avg
§112
3.5%
-36.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 127 resolved cases

Office Action

§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 . Status of Claims Claims 1-13 are pending in the application. Claims 1-13 are examined on the merits. Priority Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Information Disclosure Statement The information disclosure statement(s) (IDS) submitted on 09/26/2024 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have been considered by the examiner. 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. Claim(s) 1-13 is 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 limitations “a proximal connection portion configured to be removably connectable to a medical injection device; … at least one retention barb extending proximally from the rim and being configured to be engageable with a vial that is to be removably connected to the adaptor” which are indefinite. It is unclear if the claimed “medical injection device” same or different from the “medical injection device” introduced in lines 1-2 of claim 1 and if the claimed “vial” same or different from the “vial” introduced in line 2 of claim 1. The limitation has been examined below as if it read -- a proximal connection portion configured to be removably connectable to [[the medical injection device; … at least one retention barb extending proximally from the rim and being configured to be engageable with [[the vial that is to be removably connected to the adaptor --. Claim(s) 2-4 is/are rejected as being dependent from claim 1 and therefor including all the limitation thereof. Claim 5 recites the limitations “a proximal connection portion configured to be removably connectable to a medical injection device; … at least one retention barb extending proximally from the rim and being configured to be engageable with a vial that is to be removably connected to the adaptor” which are indefinite. It is unclear if the claimed “medical injection device” same or different from the “medical injection device” introduced in line 3 of claim 5 and if the claimed “vial” same or different from the “vial” introduced in line 3 of claim 5. The limitation has been examined below as if it read -- a proximal connection portion configured to be removably connectable to [[the medical injection device; … at least one retention barb extending proximally from the rim and being configured to be engageable with [[the vial that is to be removably connected to the adaptor --. Claim(s) 6-13 is/are rejected as being dependent from claim 5 and therefor including all the limitation thereof. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In this case, claim 2 recites the limitation “the at least one audible barb is configured to extend proximally farther than the at least one retention barb” which does not further limit the subject matter “the at least one audible barb being longer than the at least one retention barb”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. 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. Claim(s) 1-4 is/are rejected under 35 U.S.C 103 as being unpatentable over Mosler (US PGPUB 20210038476) in view of Kriheli (US PGPUB 20150359709). Regarding claim 1, Mosler discloses a vial adaptor (an adapter 300: ¶0078 and Fig. 3) for connecting a medical injection device (syringe 101: ¶0060 and Fig. 3) to a vial (a vial 124: ¶0079 and Fig. 4E), the adaptor (300) comprising: a proximal connection portion (a Luer adapter 109: ¶0079 and Fig. 4B) configured to be removably connectable to the medical injection device (Fig. 4A); a spike (a spike 112: ¶0078 and Figs. 3-4C) extending distally from the proximal connection portion and around a central axis (Figs. 3-4C); a flange (a coupling member 211: ¶0078 and Figs. 3-4C) extending distally from the proximal connection portion and radially outward of the spike around the central axis (Figs. 3-4C); a rim extending around the central axis at a distance distally away from the flange (see annotated Fig. 3 below) and being connected to the flange through a skirt (see annotated Fig. 3 below); and at least one retention barb extending proximally from the rim (see annotated Fig. 3 below) and being configured to be engageable with the vial that is to be removably connected to the adaptor (Figs. 4E-5C). Mosler does not disclose the adaptor further comprises at least one audible barb extending proximally from the rim and being configured to be snap-fitted onto the vial, the at least one audible barb being thinner and longer than the retention barb. In the same field of endeavor, vial adaptors, Kriheli discloses a vial adaptor 200 (¶0157 and Figs. 23A-B) comprising an upward projecting structure 120 and a spike 118 extending distally from the upward projecting structure 120 (¶0156 and Fig. 22). Kriheli further discloses at least one audible barb (snaps 112 with an audible sound: ¶0157, 0162; Figs. 23A-B and 26) extending from a rim (Figs. 23A-B and 26) for the benefit of confirming to a user that an attachment between a vial and the vial adaptor has been completed (¶0162). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the vial adaptor of Mosler in view of Kriheli by incorporating at least one audible barb extending proximally from the rim, in order to confirm to a user that an attachment between a vial and the vial adaptor has been completed, as suggested in ¶0162 of Kriheli. Mosler/Kriheli does not disclose the at least one audible barb being thinner and longer than the at least one retention barb. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the vial adaptor of Mosler in view of Kriheli by having the at least one audible barb thinner and longer than the retention barb, motivated by the desires to provide another manufacturing choice for the design of the at least one audible barb. In the instant case, the at least one audible barb of Mosler in view of Kriheli would not perform differently with the claimed barb. Furthermore, a person of ordinary skill would try to make the at least one audible barb being thinner and longer than the at least one retention barb because of aesthetic or convenient purpose. “A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). In addition, there was no evidence of the criticality of having the at least one audible barb being thinner and longer than the at least one retention barb within Applicant’s published application. PNG media_image1.png 770 666 media_image1.png Greyscale Regarding claim 2, Mosler/Kriheli discloses the at least one audible barb is configured to extend proximally farther than the at least one retention barb (see rejection of claim 1 above). Regarding claim 3, Mosler/Kriheli further discloses the at least one retention barb comprises two retention barbs and the at least one audible barb comprises two audible barbs (see rejection of claim 1 above). Regarding claim 4, Mosler/Kriheli discloses the claimed invention except for the arrangement of the two retention barbs and the two audible barbs in such a way that each of the two audible barbs is disposed between the two retention barbs. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the vial adaptor of Mosler in view of Kriheli by arranging the two retention barbs and the two audible barbs in such a way that each of the two audible barbs is disposed between the two retention barbs, motivated by the desires to provide another manufacturing choice for the design of the two retention barbs and the two audible barbs. Furthermore, a person of ordinary skill would try to arrange the two retention barbs and the two audible barbs in such a way that each of the two audible barbs is disposed between the two retention barbs because of aesthetic or convenient purpose. “A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). In addition, there was no evidence of the criticality of having the two retention barbs and the two audible barbs in such a way that each of the two audible barbs is disposed between the two retention barbs within Applicant’s published application. Claim(s) 5 is/are rejected under 35 U.S.C 103 as being unpatentable over Mosler (US PGPUB 20210038476) in view of Kriheli (US PGPUB 20150359709) and Fangrow (US PGPUB 20220112966). Regarding claim 5, Mosler discloses a connector assembly (an adapter assembly: Fig. 3) comprising: a vial adaptor (an adapter 300: ¶0078 and Fig. 3) for connecting a medical injection device (syringe 101: ¶0060 and Fig. 3) to a vial (a vial 124: ¶0079 and Fig. 4E), the adaptor (300) comprising: a proximal connection portion (a Luer adapter 109: ¶0079 and Fig. 4B) configured to be removably connectable to the medical injection device (Fig. 4A); a spike (a spike 112: ¶0078 and Figs. 3-4C) extending distally from the proximal connection portion and around a central axis (Figs. 3-4C); a flange (a coupling member 211: ¶0078 and Figs. 3-4C) extending distally from the proximal connection portion and radially outward of the spike around the central axis (Figs. 3-4C); a rim extending around the central axis at a distance distally away from the flange (see annotated Fig. 3 above) and being connected to the flange through a skirt (see annotated Fig. 3 above); and at least one retention barb extending proximally from the rim (see annotated Fig. 3 below) and being configured to be engageable with the vial that is to be removably connected to the adaptor (Figs. 4E-5C); a cap (a cap 120: ¶0078 and Fig. 3) comprising a cap body defining an inner cavity extending around the central axis (Fig. 4C), the inner cavity being open at a proximal end of the cap body (Fig. 3) and is closed at a distal end of the cap body (Fig. 3); wherein the connector assembly is configured such that the cap is removably connected to the adaptor in such a way that the spike is accommodated within the inner cavity (¶0066, 0077-0078, and Figs. 3-4C). Mosler does not disclose the adaptor further comprises at least one audible barb extending proximally from the rim and being configured to be snap-fitted onto the vial, the at least one audible barb being thinner and longer than the retention barb. In the same field of endeavor, vial adaptors, Kriheli discloses a vial adaptor 200 (¶0157 and Figs. 23A-B) comprising an upward projecting structure 120 and a spike 118 extending distally from the upward projecting structure 120 (¶0156 and Fig. 22). Kriheli further discloses at least one audible barb (snaps 112 with an audible sound: ¶0157, 0162; Figs. 23A-B and 26) extending from a rim (Figs. 23A-B and 26) for the benefit of confirming to a user that an attachment between a vial and the vial adaptor has been completed (¶0162). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the vial adaptor of Mosler in view of Kriheli by incorporating at least one audible barb extending proximally from the rim, in order to confirm to a user that an attachment between a vial and the vial adaptor has been completed, as suggested in ¶0162 of Kriheli. Mosler/Kriheli does not disclose the at least one audible barb being thinner and longer than the at least one retention barb. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the vial adaptor of Mosler in view of Kriheli by having the at least one audible barb thinner and longer than the retention barb, motivated by the desires to provide another manufacturing choice for the design of the at least one audible barb. In the instant case, the at least one audible barb of Mosler in view of Kriheli would not perform differently with the claimed barb. Furthermore, a person of ordinary skill would try to make the at least one audible barb being thinner and longer than the at least one retention barb because of aesthetic or convenient purpose. “A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). In addition, there was no evidence of the criticality of having the at least one audible barb being thinner and longer than the at least one retention barb within Applicant’s published application. Mosler/Kriheli does not disclose the cap is removably connected to the adaptor by press-fit between the spike and the inner cavity. In the same field of endeavor, adaptors, Fangrow discloses a connector assembly 100 comprising an adapter 110 and a spike 150 (¶0077 and Figs. 2B-C). Fangrow further discloses a cap 175 is connected to the spike 150 in a press-fit arrangement (¶0078) for the benefit of securing the cap around the spike (¶0078). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the assembly of Mosler in view of Fangrow by using press-fitting between the spike and the inner cavity, in order to securing the cap around the spike, as suggested in ¶0078 of Fangrow and as it has been held that the use of known technique to yield predictable result is prima facie obvious. See MPEP § 2143 (I) (C & G). Furthermore, one would have been motivated to connect the cap and the spike in a press-fit arrangement to provide a tight seal for the connector assembly before used. Claim(s) 6 and 8 is/are rejected under 35 U.S.C 103 as being unpatentable over Mosler (US PGPUB 20210038476) in view of Kriheli (US PGPUB 20150359709) and Fangrow (US PGPUB 20220112966), as applied to claim 5 above, and further in view of Kitani (US PGPUB 20080004600). Regarding claim 6, Mosler/Kriheli/Fangrow does not disclose the cap comprises threads on an outer circumference of the cap body and the flange comprises on its inner surface at least one engaging protrusion configured to be engageable with the threads. In an analogous art for being directed to solve the same problem, providing luer-locking fitting connection mechanism, Kitanis discloses an infusion line set 10 provided with a luer-locking fitting connection mechanism 20 (¶0021 and Fig. 1). Kitanis further discloses the luer-locking fitting connection mechanism 20 comprising a connection between female connector 21 and a male connector 22 (¶0022 and Fig. 1). Kitanis also discloses the female connector 21 comprising male threads 25 on an outer circumference of the female connector 21 (¶0023 and Fig. 2) and the male connector 22 comprising on its inner surface engaging protrusion configured to be engageable with the male threads 25 (female threads 34: ¶0029 and Fig. 4) for the benefit(s) of preventing loosening of the screwed together state of the male threads and female threads and strongly tightening together the male threads and female threads to eliminate problems such as formation of cracks and leakage of medicinal solution if a gap is formed (¶0033 and 0035). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the connector assembly of Mosler in view of Kitani by incorporating threads on an outer circumference of the cap body and at least one engaging protrusion configured to be engageable with the threads on inner surface of the flange, in order to prevent loosening of the screwed together state of the male threads and female threads and strongly tighten together the male threads and female threads to eliminate problems such as formation of cracks and leakage of medicinal solution if a gap is formed, as suggested in ¶0033 and 0035 of Kitani. Regarding claim 8, Mosler/Kriheli/Fangrow does not disclose the cap comprises at least one tooth on an outer circumference of the cap body and the flange comprises on its inner surface at least one engaging rib configured to be engageable with the at least one tooth. Kitanis also discloses the female connector 21 comprising at least one tooth (male threads 25) on an outer circumference of the female connector 21 (¶0023 and Fig. 2) and the male connector 22 comprising on its inner surface at least one engaging rib (female threads 34) configured to be engageable with the at least one tooth 25 (¶0029 and Fig. 4) for the benefit(s) of preventing loosening of the screwed together state of the male threads and female threads and strongly tightening together the male threads and female threads to eliminate problems such as formation of cracks and leakage of medicinal solution if a gap is formed (¶0033 and 0035). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the connector assembly of Mosler in view of Kitani by incorporating at least one tooth on an outer circumference of the cap body and at least one engaging rib configured to be engageable with the at least one tooth on inner surface of the flange, in order to prevent loosening of the screwed together state of the male threads and female threads and strongly tighten together the male threads and female threads to eliminate problems such as formation of cracks and leakage of medicinal solution if a gap is formed, as suggested in ¶0033 and 0035 of Kitani. Claim(s) 7 is/are rejected under 35 U.S.C 103 as being unpatentable over Mosler (US PGPUB 20210038476) in view of Kriheli (US PGPUB 20150359709), Fangrow (US PGPUB 20220112966), and Kitani (US PGPUB 20080004600), as applied to claim 6 above, and further in view of Cooke (US PAT 3952899). Regarding claim 7, Mosler/Kriheli/Fangrow/Kitani does not disclose the cap further comprises a stopper disposed in a helical groove delimited by the threads and the engaging protrusion is formed with a locking groove configured to receive the stopper when the cap is connected to the adaptor. In an analogous art for being directed to solve the same problem, providing connection between two elements, Cooke discloses a cap 11 adapted to be threadedly engaged with a neck portion 12 of a container 13 (Col. 3, lines 32-41; and Fig. 1). Cooke further discloses the cap 11 comprising a stopper (a shoulder 18: Col. 3, lines 32-41; and Fig. 1) disposed in a helical groove delimited by threads (a helical groove formed by thread 16: Col. 3, lines 32-41; and Fig. 1) and an engaging protrusion (thread 21: Col. 3, lines 32-48; and Fig. 1) is formed with a locking groove configured to receive the stopper when the cap is connected to the container 13 (a cooperating shoulder 19: Col. 3, lines 32-48; and Fig. 1) for the benefit of sealing the cap with the container while requiring a special manipulative procedure to remove the cap (Col. 1, lines 11-16). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the connector assembly of Mosler in view of Cooke by incorporating a stopper disposed in a helical groove delimited by the threads of the cap and an engaging protrusion formed with a locking groove configured to receive the stopper when the cap is connected to the adaptor, in order to seal the cap with the adaptor while requiring a special manipulative procedure to remove the cap, as suggested in Col. 1, lines 11-16 of Cooke. Claim(s) 9-11 and 13 is/are rejected under 35 U.S.C 103 as being unpatentable over Mosler (US PGPUB 20210038476) in view of Kriheli (US PGPUB 20150359709) and Fangrow (US PGPUB 20220112966), as applied to claim 5 above, and further in view of Yan (US PGPUB 20210186814). Regarding claims 9-10, Mosler/Kriheli/Fangrow does not disclose the cap further comprising a collar extending distally from the cap body and radially outward of the cap body around the central axis, the collar being configured to rest on the rim when the cap is assembled with the adaptor; and the collar has a ring shape. In the same field of endeavor, a connector for connecting a medical injection device, Yan discloses a connector 2 comprising a sealing cap 50 mounted on a hollow spike 30 (¶0136, 0170, and Fig. 15) and a skirt 22 comprising a rim 25 extending around a central axis (¶0150 and Figs. 13-15). Yan further discloses the cap 50 comprising a collar extending distally from a cap body and radially outward of the cap body (a ring 58: ¶0169 and Figs. 13-15) and the collar configured to rest on the rim 25 (¶0169 and Fig. 15) for the benefit of preventing the cap from being pulled off during sterilization, handling, and/or transportation of the connector (¶0169). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the connector assembly of Mosler in view of Yan by incorporating a collar extending distally from the cap body and radially outward of the cap body around the central axis and resting on the rim when the cap is assembled with the adaptor, in order to prevent the cap from being pulled off during sterilization, handling, and/or transportation of the connector, as suggested in ¶0169 of Yan. Regarding claim 11, Mosler/Kriheli/Fangrow does not disclose the cap further comprising at least one locking claw configured to be engageable with the at least one retention barb. Yan further discloses the cap 50 comprising at least one locking claw (a ring 58: ¶0169 and Figs. 13-15) configured to be engageable with at least one retention barb (a rim 25 of the skirt 22: ¶0169 and Fig. 15) for the benefit of preventing the cap from being pulled off during sterilization, handling, and/or transportation of the connector (¶0169). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the connector assembly of Mosler in view of Yan by incorporating at least one locking claw configured to be engageable with the at least one retention barb, in order to prevent the cap from being pulled off during sterilization, handling, and/or transportation of the connector, as suggested in ¶0169 of Yan. Regarding claim 13, Mosler/Kriheli/Fangrow does not disclose the flange of the adaptor comprises on its inner surface at least one support rib protruding radially inwardly. Yan further discloses a flange 21 comprising on its inner surface at least one support rib protruding radially inwardly (a rim 15: ¶0165 and Fig. 15) for the benefit(s) of maintaining a sealing between the cap and the spike as well as ensuring an optimal sealing of the spike (¶0165). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the connector assembly of Mosler in view of Yan by incorporating on the inner surface of the flange at least one support rib protruding radially inwardly, in order to maintain a sealing between the cap and the spike as well as ensure an optimal sealing of the spike, as suggested in ¶0165 of Yan. Claim(s) 12 is/are rejected under 35 U.S.C 103 as being unpatentable over Mosler (US PGPUB 20210038476) in view of Kriheli (US PGPUB 20150359709), Fangrow (US PGPUB 20220112966), and Yan (US PGPUB 20210186814), as applied to claim 11 above, and further in view of McLoughlin (US PGPUB 20140358083). Regarding claim 12, Mosler/Kriheli/Fangrow/Yan does not disclose the at least one locking claw has a forked tip. In an analogous art for being directed to solve the same problem, providing caps for protecting fluid transfer spikes/needles, McLoughlin discloses a cassette unit 1 comprising a housing 20 and a cap 50 configured to cover a medical spike/needle 15 (¶0275-0276 and Figs. 2B-3). McLoughlin further discloses the cap further comprising a locking claw 52 having a forked tip (Fig. 3) for the benefit(s) of connecting the cap and the housing and preventing ingress of contaminants into the needle receiving part of the housing (¶0068 and 0275). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the connector assembly of Mosler in view of McLoughlin by substituting the at least one locking claw with a locking claw having a forked tip, in order to assist in connecting the cap and the adaptor and prevent ingress of contaminants into the spike, as suggested in ¶0068 and 0275 of McLoughlin and as it has been held that the substitution of a known element for another exchangeable element supports a prima facie obviousness determination (See MPEP § 2143 (I) (B)). Conclusion A relevant application 18/729372 which also discloses a connector assembly comprising an adaptor and a cap; wherein the adaptor comprising a proximal connection portion configured to be removably connectable to the medical injection device and a spike extending distally from the proximal connection portion and around a central axis; wherein the cap comprising a cap body defining an inner cavity extending around the central axis, the inner cavity being open at a proximal end of the cap body and is closed at a distal end of the cap body; and wherein the connector assembly is configured such that the cap is removably connected to the adaptor in such a way that the spike is accommodated within the inner cavity (see Claims 1-6, 8, and 11-12 of application 18/729372). Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST). 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 (571) 272-7159. 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. /NHU Q. TRAN/Examiner, Art Unit 3781 /ANDREW J MENSH/Primary Examiner, Art Unit 3781
Read full office action

Prosecution Timeline

Jul 17, 2024
Application Filed
Jun 16, 2026
Non-Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
69%
Grant Probability
96%
With Interview (+26.6%)
3y 0m (~1y 0m remaining)
Median Time to Grant
Low
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