DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 02/04/2026. As directed by the amendment: claims 1 and 10 have been amended, claim 11 has been cancelled, and no new claims have been added. Thus, claims 1-10 and 12-20 are presently pending in this application, with claims 4-5 and 12-18 being withdrawn from consideration. Applicant’s amendments to the specification and claims have overcome each and every objection set forth in the Non-Final Office Action mailed on 11/04/2025.
Response to Arguments
Applicant's arguments on p.9 of “Remarks” filed 0/04/2026 with respect to the 112(b) rejection of claim 11 have been fully considered but they are not persuasive. In response to applicant’s argument that newly amended claim 1 containing the subject matter of claim 11 has been corrected to address the previous 112(b) rejection of claim 11, the examiner respectfully disagrees. Claim 1 is still indefinite in light of the specification as the proximal and distal directions are not consistent between the inner connector (12) and the outer connector (14). For example, para. 0088 discloses with regards to the inner connector (12), “comprising a first or proximal end 30, a second or distal end 32”. Para. 0093 discloses with regards to the outer connector (14), “a first or proximal end 68, a second or distal end 70.” As seen in Fig. 5A, the proximal and distal directions are not consistent between the two connectors. Examiner suggest applicant amend the specification to consistently reference the proximal and distal directions throughout. The 112(b) rejection has been maintained and updated to reflect the amendment.
Applicant's arguments on p.15-16 of “Remarks” filed 02/04/2026 with respect to the limitations of previous claim 11 have been fully considered but they are not persuasive. Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Applicant argues “Bousquet and Mittleman do not appear to disclose an assembly comprising a flange and locking structure or protrusion as provided by the claimed invention”, the examiner respectfully disagrees. As discussed below with regards to the rejection of claim 1, Bousquet discloses the flange (38) and the locking structure (42, 48a) as provided by the claim. Applicant does not provide any evidence as to why the 103 rejection of record over Bousquet in view of Mittleman fails to disclose the subject of previous claim 11, and therefore, the rejection has been maintained and updated to reflect the amendments.
Examiner notes that p.11 of “Remarks” filed on 02/04/2026 states “applicant submits that independent claim 1 and dependent claims 6-7, and 19-20 are novel…” which incorrectly references claims 19-20 as dependent claims. Examiner notes that claim 19 is an independent claim, and there are no arguments set forth towards claim 19. Thus, the rejections of claims 19-20 are maintained.
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.
Regarding claim 1, the phrase “wherein the outer connector further comprises at least one blocking tab… disposed at a proximal end of the outer connector” in lines 13-15 renders the claim indefinite because it is unclear. It is unclear which direction the first and second ends of the inner and outer connectors are oriented towards. See Fig. 5A, para. 0088, and para. 0093 which define the inner connector 12 comprising “a first or proximal end 30, a second or distal end 32” and the outer connector 14 comprising “a first or proximal end 68, a second or distal end 70”. As illustrated in Fig. 5A, the distal and proximal directions are flipped with regards to the inner connector 12 and the outer connector 14. Examiner is interpreting the directions as illustrated in Fig. 5A and using the definitions provided in para. 0074 with the proximal, first ends being 30 and 70 and the distal, second ends being 68 and 32. Thus, this limitation is being interpreted as the outer connector further comprises at least one locking tab disposed at the distal, second end of the outer connector.
Regarding claims 2-10, these claims are rejected due to their dependency upon claim 1.
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.
Claims 8-10 are 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.
Claim 8 discloses verbatim a limitation that was amended into claim 1, and thus, fails to further limit the subject matter of claim 1.
Claim 9 discloses verbatim a limitation that was amended into claim 1, and thus, fails to further limit the subject matter of claim 1.
Claim 10 is rejected due to its dependency upon claim 9 which fails to further limit the subject matter of claim 1.
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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shaw et al. (U.S Patent Pub. No. 20080132851 A1, “Shaw”).
Regarding claim 19, Shaw discloses (Claim 19) an attachment method for attaching an inner connector (120) to an outer connector (126, see Fig. 11-14), comprising: inserting an inner connector (120) comprising a first end, a second end, a sidewall extending between the first end and the second end (see Fig. 13-14 and annotated Shaw drawing 1 for ends and sidewall), and a flange (130 in Fig. 13) connected to or extending radially outward from the sidewall (see Fig. 13-14 and annotated Shaw drawing 1 above for sidewall), into an outer connector (126) comprising a lock (132, 134) extending radially inwardly from an inner surface of the outer connector (126, see Fig. 13-14 and para. 0052); and moving the inner connector (120) through the outer connector (126), thereby causing the flange (130) of the inner connector (120) to engage the lock (132, 134) of the outer connector (126) to secure the inner connector (120) to the outer connector (126, see Fig. 13-14 and para. 0052 - upon initial insertion, inner connector 120 is moved within outer connector 126 causing flange 130 to engage lock 132, and upon further movement, the flange 130 engages
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lock 134).
Regarding claim 20, Shaw discloses the method of claim 19, as discussed above. Shaw further discloses (Claim 20) the method of claim 19, wherein the inner connector (120) comprises a vascular access device (110) and the outer connector (126) comprises an accessory device configured to engage the vascular access device (110, see Fig. 13-14 and para. 0051).
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.
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 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Bousquet in view of Mittleman (U.S Patent No. 4639019).
Regarding claim 1, Bousquet discloses (Claim 1) a connector assembly (70 in Fig. 1 and 3) comprising:
an inner connector (12) comprising a first end, a second end, a sidewall (sidewall of 22) extending between the first end and the second end (see Fig. 1 and 3, annotated Bousquet drawing 1 below for ends and para. 0035 – inner connector 12 comprises a body 22 having a sidewall extending from second, distal end to its first, proximal end at the flange 38), and a flange (38 in Fig. 1) connected to or extending radially outward from the sidewall (sidewall of 22, see Fig. 1 and 3 and para. 0037); and
an outer connector (connector of 14’ in Fig. 1 and 3) configured to be inserted over the inner connector (12 in Fig. 1 and 3) comprising a first end, a second end, a sidewall (sidewall of 48) extending therebetween (see annotated Bousquet drawing 1 below for ends and sidewall – the outer connector is being interpreted as only the connecting portion of the cap 14’ extending the length of the counter bore 48, the sidewall is being interpreted as the sidewall of the counterbore 48), and a lock (42, 48a in Fig. 2A) extending radially inwardly from an inner surface of the sidewall (sidewall of 48) configured to engage the flange (38) of the inner connector (12) thereby securing the inner connector (12) to the outer connector (connector of 14’, see Fig. 2A-3 and para. 0037-0038 – the sidewall of counterbore 48 comprises threads 42 and a shoulder 48a extending radially inwardly therefrom both configured to engage
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flange 38),
wherein the lock (42, 48a in Fig. 2A) comprises a thread (42) extending radially inwardly from at least a portion of the inner surface of the sidewall (sidewall of 48) of the outer connector (connector of 14’, see annotated Bousquet drawing 1 reproduced below and para. 0037-0038 – outer connector of 14’ comprises a counterbore 48 defining the sidewall which comprises threads 42 and a shoulder 48a extending radially inwardly therefrom both configured to engage flange 38), and
wherein the outer connector (connector of 14’) further comprises at least one blocking tab (48a) separate from the thread (42) extending radially inward from the sidewall (sidewall of 48) of the outer connector (14’) disposed at a distal end of the outer connector (connector 14’) configured to contact the flange (38) to block further advancement of the inner connector (12) into the outer connector (connector of 14’, examiner notes this limitation is being interpreted in light of the 112b rejection above where the at least one blocking tab is being interpreted as being disposed at the distal, second end of the outer connector, see annotated Bousquet drawing 1 above for ends, see Fig. 2A and para. 0038 – shoulder 48a located at the distal, second end of the connector of 14’ extends radially inwardly from the sidewall defined by counter bore 48 of outer connector 14’ and engages with flange 38 to provide a stop).
While Bousquet discloses the flange (38 in Fig. 1) connected to or extending radially outward from the sidewall (sidewall of 22) of the inner connector (12, see Fig. 1 and Fig. 3), Bousquet fails to disclose (Claim 1) wherein the flange of the inner connector comprises a peripheral edge comprising opposing flat portions and opposing curved portions between the flat portions.
Mittleman discloses a luer connection assembly wherein a flange (18) for engaging with threads comprises a peripheral edge comprising opposing flat portions and opposing curved portions between the flat portions (see Fig.1 and annotated Mittleman drawing 1 below).
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Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the peripheral edge of the flange of the inner connector taught by Bousquet to have the opposing flat portions in between the opposing curved portions as taught by Mittleman by known methods, and that in combination the flanges would each perform the same function of engaging with an inwardly protruding threads as they do separately. One of ordinary skill in the art would have recognized that changing the shape of the flange would be predictable. In combination, the annular, outwardly extending flange (38) of Bousquet would be modified to have opposing flat portions that are in between opposing curved portions such that the modified flange would still abut with the lock (42, 48a) of the outer connector (14’) of Bousquet.
In combination, Bousquet in view of Mittleman would disclose the limitation of (Claim 1) the outer connector comprises at least one blocking tab configured to contact the opposing curved portions of the flange. Examiner notes the blocking tab (48a in Fig. 2A) would be capable of being configured to contact the opposing curved portions taught by Mittleman of the modified flange (38) of Bosquet as the modified opposing curved portions of the flange (38) would be threaded within the threads (42) and then abut the blocking tab (48a).
Regarding claim 6, modified Bousquet discloses the connector assembly of claim 1, as discussed above. In modified Bousquet, Bousquet discloses (Claim 6) wherein the inner connector (12 in Fig. 1) comprises a vascular access device (“C”) and the outer connector (connector of 14’ in Fig. 3) comprises an accessory device (14’) configured to engage the vascular access device (“C”, see Fig. 1, Fig. 3, and para. 0033 for catheter “C”, and para. 0046-0047 - connector of 14’ is formed on sterilization cap 14’ storing a sterilization agent).
Regarding claim 7, modified Bousquet discloses the connector assembly of claim 6, as discussed above. In modified Bousquet, Bousquet discloses (Claim 7) wherein the vascular access device (“C” in Fig. 1) a catheter (see para. 0033), and wherein the accessory device (14’) comprises a disinfecting cap (see Fig. 3 and para. 0046-0047).
Regarding claim 8, modified Bousquet discloses the connector assembly of claim 1, as discussed above. In modified Bousquet, Bousquet discloses (Claim 8) the flange (38 in Fig. 1) connected to or extending radially outward from the sidewall (sidewall of 22) of the inner connector (12, see Fig. 1 and 3 and para. 0037).
In modified Bousquet, Mittleman discloses (Claim 8) wherein the flange (18) for engaging with threads comprises a peripheral edge comprising opposing flat portions and opposing curved portions between the flat portions (see Fig.1 and annotated Mittleman drawing 1 below).
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Regarding claim 9, modified Bousquet discloses the connector assembly of claim 1, as discussed above. In modified Bousquet, Bousquet discloses (Claim 9) wherein the lock (42, 48a in Fig. 2A) comprises a thread (42) extending radially inwardly from at least a portion of the inner surface of the sidewall (sidewall of 48) of the outer connector (connector of 14’, see annotated Bousquet drawing 1 reproduced below for sidewall, see Fig. 2A, Fig. 3, and para 0037).
Claim(s) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Bousquet in view of Mittleman as applied to claim 1 above, and further in view of Schultz (U.S Patent Pub. No. 20140276651 A1).
Regarding claim 2, modified Bousquet discloses the connector assembly of claim 1, as discussed above. While Bousquet discloses that the inner connector (12 in Fig. 2A-2B) “may be a more or less standard connector of the type used to terminate catheters in the medical industry, e.g. a screw-type connector as shown or a luer connector. The illustrated connector 12 attached to each catheter C happens to be a male screw-type connector” (see para. 0040), modified Bousquet fails to disclose (Claim 2) wherein the inner connector comprises a male luer connector comprising: a stem comprising a proximal end connected to the sidewall, a distal end protruding distally beyond the second end of the sidewall, and a body extending between the proximal end and the distal end through a space defined by the sidewall of the inner connector; and at least one thread on an inner surface of the sidewall configured to engage corresponding threads of a female luer connector.
Schultz discloses improved medical-connector contamination prevention systems, where a medical syringe (103) comprises a standard male luer-lock-type connector (106, see Fig. 1A and 3 and para. 0073). Schultz teaches (Claim 2) wherein the inner connector (106 in Fig. 1A and 3) comprises a male luer connector (see para. 0073) comprising: a stem (125 in Fig. 1A) comprising a proximal end connected to the sidewall (116 in Fig. 1A, see annotated Schultz drawing 1 below for proximal end and para. 0073), a distal end (104 in Fig. 1A) protruding distally beyond the second end of the sidewall (116, see annotated Schultz drawing 1 below for distal end 104 and para. 0073), and a body (body of 125) extending between the proximal end and the distal end (104) through a space defined by the sidewall (116) of the inner connector (102, see annotated Schultz drawing 1 below for proximal end); and at least one thread (“internal threads” in para. 0073 and Fig. 1A) on an inner surface (inner surface of 119) of the sidewall (116) configured to engage corresponding threads of a female luer connector (see para. 0073).
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Since Bousquet discloses a male inner connector (12) that may be any standard connector such as a luer connector (see para. 0040) which incorporates an additional outer flange (38, see para. 0042), and Schultz discloses a standard male luer-lock-type connector (106) having a male 6% stem (125) and a luer locking cylindrical skirt (116) with internal threads (119) for connection to compatible female connector (see Fig. 1A, see para. 0006), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the male connector taught by modified Bousquet to be a standard male luer connector as taught by Schultz by known methods, and that in combination, each element of the separate male connectors would perform the same functions as they do separately. One of ordinary skill in the art would have recognized that modifying a male connector to be a standardized luer connector would be predictable. Further, Schultz teaches that standard luer connectors are well known in the art (i.e. ubiquitous throughout the healthcare industry and frequency used to provide connections to intravascular access, see para. 0008). Thus, in combination, the inner connector (12) of modified Bousquet would be modified to be a standard male luer connector as taught by Schultz such that it incorporates a stem and sidewall wherein the flange (38) would extend radially outwardly from the sidewall.
Regarding claim 3, modified Bousquet discloses the connector assembly of claim 2, as discussed above. In modified Bousquet, Schultz discloses (Claim 3) wherein
the inner connector (106 in Fig. 1A) comprises the stem (125) and at least one thread ((“internal threads” in para. 0073 and Fig. 1A).
Thus, in combination, the inner connector (12) of modified Bousquet incorporates the stem and sidewall of Schultz to thus be a male luer connector, wherein the flange (38) would extend radially outwardly from the sidewall and engages the outer connector (connector of 14’ in Fig. 3, see para. 0042 – the flange 38 engages the connector of cap 14’ which is interpreted as the connector structures including threads 42 and shoulder 48a). Therefore, the outer connector (connector of 14’) would engage the inner connector (12) without contacting the modified stem and at least on thread on the inner surface of the sidewall.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bousquet in view of Mittleman as applied to claim 9 above, and further in view of Dombrowski et al. (U.S Patent Pub. No. 20180361003 A1, “Dombrowski”).
Regarding claim 10, modified Bousquet discloses the connector assembly of claim 9, as discussed above.
While Bousquet discloses the threads (42) of the outer connector (connector of 14’, see Fig. 2B and 3), Bousquet fails to disclose (Claim 10) wherein the thread extends about the inner surface of the sidewall of the outer connector by less than a full rotation.
Dombrowski discloses an outer connector (10 in Fig. 1) in the form of a connector cap, wherein the outer connector (10) comprises threads (30, see Fig. 1 and para. 0025). Dombrowski teaches (Claim 10) wherein the thread (30) extends about the inner surface (24) of the sidewall (14) of the outer connector (10) by less than a full rotation (see para. 0026 – threads 30 may be discontinuous threads).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the threads of the outer connector taught by Bousquet to be discontinuous threads as taught by Dombrowski. Dombrowski recognizes that there is a problem with threaded, luer-compatible caps wherein the thread tolerances can prevent the caps from securing properly to the connector (see para. 0016), and Dombrowski further provides that there are a finite number of identified, predictable potential solutions thereto such as a cap (10) having threads (30) that may comprise continuous threads, discontinuous threads, or combinations thereof (see para. 0026). Thus, it would have been obvious for one of ordinary skill in the art to have pursued the known potential solutions with a reasonable expectation of success such the outer connector comprises threads that are discontinuous to resist premature disengagement of the cap to its connector (see para 0026 and 0028).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 PM EST.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783