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
The amendment filed on 4/27/2025 has been entered. Claims 1-9 and 11-20 are pending in the application. Claim 10 is cancelled. The amendments to the claims overcome the 112(d) rejection previously set forth in the Non-Final Office Action mailed on 10/5/2022. The claim objections, 112(b) rejection, and double patenting rejections previously set forth have not been overcome and are included again in this Office Action below.
Claim Objections
Claims 3, 12-14, and 16-17 are objected to because of the following informalities:
-Claim 3, lines 1-2: please correct “that has been sterilized” to “wherein the capping and cleansing device has been sterilized”.
-Claim 12, line 8: please correct “a needlefree” to “the needlefree”
-Claim 13, line 3: please correct "the outer wall" to "an outer wall"
-Claim 13, line 5: please correct "to retained" to "to be retained"
-Claim 13, lines 6-7: please correct "a clockwise direction and a counter-clockwise direction" to "the clockwise direction and the counter-clockwise direction"
-Claim 13, lines 8-9: please correct "a needlefree vascular access connector" to "the needlefree vascular access connector"
-Claim 14, line 2: please correct "the top wall" to "a top wall"
-Claim 14, lines 5-6: please correct "a needlefree vascular access connector" to "the needlefree vascular access connector"
-Claim 16, line 1: please correct "a capping and cleansing device" to "the capping and cleansing device"
-Claim 17, line 2: please correct "a capping and cleansing device" to "the capping and cleansing device"
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.
Claim 6 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.
Regarding claim 6, the limitation “wherein the liquid disinfectant further comprises chlorhexidine, optionally or chlorhexidine gluconate” renders the claim indefinite because the punctuation and use of the term “optionally” makes it unclear which limitations are part of the claimed invention. See MPEP § 2173.05(h). The placement of the comma, the use of optionally, and the use of “optionally or”. It is unclear whether this limitation should be interpreted as reciting an alternative limitation (i.e. “wherein the liquid disinfectant further comprises chlorhexidine or chlorhexidine gluconate”). With the placement of the comma and “or”, it is further unclear whether this limitation should be interpreted as reciting both an alternative limitation and an optional limitation (i.e. “wherein the liquid disinfectant further comprises (a) chlorhexidine, (b) nothing additional, or (c) chlorhexidine gluconate”). For examination purposes, the Examiner interprets claim 6 as “wherein the liquid disinfectant further comprises chlorhexidine or chlorhexidine gluconate”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-5, 9, 16-17, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,065,431. Although the claims at issue are not identical, they are not patentably distinct from each other because they describe each element of the rejected claims.
Claim 1 is rejected over claim 1 of US Patent No. 11,065,431
Claim 2 is rejected over claim 2 of US Patent No. 11,065,431
Claim 4 is rejected over claim 3 of US Patent No. 11,065,431
Claim 5 is rejected over claim 7 of US Patent No. 11,065,431
Claim 9 is rejected over claim 4 of US Patent No. 11,065,431
Claim 16 is rejected over claim 1 of US Patent No. 11,065,431
Claim 17 is rejected over claim 5 of US Patent No. 11,065,431
Claim 19 is rejected over claim 6 of US Patent No. 11,065,431
Allowable Subject Matter
Claims 1-2, 4-5, 9, 16-17, and 19 would be allowable once the Double Patenting rejection is obviated.
Claims 3, 7-8, 11-15, 18, and 20 are objected to as being dependent upon a rejected base claim (since independent claim 1 is rejected for double patenting), but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 6 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 1-9 and 11-20 were indicated as allowable over the prior art in the Office Action mailed on 10/5/2022 and remain allowable over the prior art in view of the references cited in said Office Action. Please see the Office Action mailed on 10/5/2022 for a detailed statement of the reasons for the indication of allowable subject matter.
Response to Arguments
Applicant's arguments filed 4/27/2025 have been fully considered but they are not persuasive.
Applicant states in the Remarks that the claim objections previously set forth in the Non-Final Office Action of 10/5/2022 should be withdrawn because the claim amendments submitted on 4/27/2025 obviate said clam objections. However, the claims which were objected to do not appear to have been amended. Therefore, the claim objections are included again in this Office Action above.
Applicant states in the Remarks that the 112(b) rejection of claim 6 previously set forth in the Non-Final Office Action of 10/5/2022 should be withdrawn because the claim amendments submitted on 4/27/2025 obviate said 112(b) rejection of claim 6. However, the amendments to claim 6 do not appear to clarify the matters of indefiniteness for the reasons described in the 112(b) rejection of claim 6 above. Therefore, the 112(b) rejection of claim 6 is included again in this Office Action above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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