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 .
Election/Restrictions
Applicant's election with traverse of claims 30-44 and 50 in the reply filed on 17 February 2026 is acknowledged. The traversal is on the ground(s) that McNeil does not mention fenestrated distal end feature, hub or fluid drainage features. This is not found persuasive because the lack of special technical feature cited in the lack of unity requirement is tubing and skin anchor which are recited in McNeil. While McNeil does not recite hub or fluid drainage feature, the technical features do not make a contribution of the prior art and therefore there is lack of unity a posteriori.
The requirement is still deemed proper and is therefore made FINAL.
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 30-44 and 50 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12623052. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-25 of the reference patent is more specific than the instant invention, in effect making the invention of patented claims a "species" of the "generic" invention of instant claims 30-44 and 50. It has been held that the generic invention is "anticipated" by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Regarding instant claim 30-44 and 50, claims 1-25 of the reference patent discloses all the limitations of instant claims 30-44 and 50.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the UV light of claim 44 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 30, 32, 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McNeil (US 2008/0312638).
Regarding claim 30, McNeil discloses an indwelling catheter system for draining fluid from a body cavity of a subject ([0001]), comprising:
an indwelling catheter device (device shown in figure 8) comprising a catheter tube (204) with a fenestrated distal end (236, [0049]) configured to reside in the cavity of the subject ([0049]) and a connection hub (hub with 214, 206, 212) disposed on a proximal end (figure 8) of the catheter tube and configured to fluidically couple the catheter tube with a fluid drainage system (234); and
a skin anchoring member (230) to anchor the connection hub to the skin of the subject ([0047], [0049]).
Regarding claim 32, McNeil discloses which the fenestrated distal end of the catheter tube is configured to reside in the pleural cavity or peritoneal cavity of a subject ([0004]).
Regarding claim 50, McNeil discloses wherein the skin anchoring member is separate from and configured for coupling with the connection hub (figure 8).
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 31 is rejected under 35 U.S.C. 103 as being unpatentable over McNeil.
Regarding claim 31, McNeil discloses including an external housing (200) configured for detachable attachment to the connection hub ([0045]) and comprising a connection hub embracing housing with a through lumen (interior cavity of 200) for receipt of the connection hub (inside receives the hub) to expose a proximal end (10A) of the connection hub and a base element (edges of the housing, best labeled as 136, see figures 4 and 8) configured to abut the skin of the subject around the skin anchoring member ([0044]), in which the base element comprises an aperture for pinning/suturing ([0044]) but does not teach an adhesive member for attaching the external housing to the skin of the subject.
However, it would have been obvious to a person of ordinary skill in the art at the effective filling date to substitute McNeil aperture for pinning and suturing with an adhesive since suturing, pinning and using an adhesive are all functionally equivalent ways to attach a device to the body. The structures are functionally equivalent ways and there appears to be no evidence that simple substitution would hinder the functioning of the device.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over McNeil in view of Lokken (US 5758660).
Regarding claim 44, McNeil does not teach the connection hub and/or external housing comprise a UV light configured to direct light on the catheter tube and/or the subject skin at the incision or an antibacterial coating.
Lokken discloses fittings for the body and teaches a external housing (figure 3B) comprise a UV light configured to direct light on the catheter tube and/or the subject skin at the incision or an antibacterial coating (col 1, lines 20-27).
Lokken provides the light to prevent infection (col 1, lines 10-27). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify McNeil with the light of Lokken in order to prevent infection.
Allowable Subject Matter
Claims 33-43 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art fails to teach an actuable closure (25) configured to close the fluid outlet upon actuation, wherein the detachable ambulatory suction module is configured to exert a negative pressure in the catheter tube upon actuation of the closure. McNeil, Tanaka (US 20090209971), Aguirre (US 2011/0288534) and Buckman (US 2005/0234390) while teaching the attachment of the device through an anchor and matching attachment, fail to provide motivation to modify McNeil to arrive at the instant invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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, Rebecca Eisenberg can be reached at (571) 270-5879. 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.
/KAI H WENG/Primary Examiner, Art Unit 3781
Prosecution Insights