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 .
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 1-4, 7, 8, 10-14, 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, 11-14, 16-19, 23 of copending Application No. 18/709,614 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because all of the elements of the claims listed above can be found in the corresponding application claims.
Application
18/709614
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claim(s) 1, 5-9, 11-13, 15-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Norman et al (US 2020/0086028).
Regarding claim 1, Norman discloses a peritoneal dialysis ("PD") system comprising: a PD machine (page 6, para. 0079); a patient line 50 extending from the PD machine (fig. 1; page 7, para. 008); and a filter set 100 in fluid communication with the patient line 50 (fig. 1; page 8, para. 0095), the filter set 100 including a filter membrane (page 8, para. 0097) positioned and arranged such that fresh PD fluid flows through the filter membrane into a filtered fluid compartment 120 (fig. 3; page 8, para. 0097), wherein the filtered fluid compartment includes an outlet 150a to a port 108 (fig. 3), and wherein the port is in fluid communication with a used PD fluid tube 118 positioned and arranged to carry used PD fluid past the filter membrane without contacting the filter membrane (fig. 3; page 8, para. 0099).
Regarding claim 5, Norman discloses that the port 108 extends to used PD fluid tube 118 (fig. 3).
Regarding claim 6, Norman discloses that the outlet 150a is releasably covered by at least one hinged closure flap (fig. 3; page 8, para. 0098: duckbill valves are formed from flaps on a living hinge).
Regarding claim 7, Norman discloses at least one rib 136 located within the filtered fluid compartment for supporting the filter membrane (fig. 6; page 9, para. 0108).
Regarding claim 8, Norman discloses that the filter membrane 140, 142 is a flat sheet filter membrane (fig. 5), and wherein the filter set 100 includes an outer compartment located on an opposing side of the flat sheet filter membrane from the filtered fluid compartment (figs. 4, 5).
Regarding claim 9, Norman discloses that the filter set 100 includes a fresh PD fluid port 116 positioned and arranged to introduce fresh PD fluid to the outer compartment (figs. 3, 4).
Regarding claim 11, Norman discloses that the filter set 100 includes a cap 112 cooperating with the filter membrane 140 to form the outer compartment (fig. 4).
Regarding claim 12, Norman discloses that the cap includes at least one vent opening 152 and at least one hydrophobic membrane sealingly covering the at least one vent opening (fig. 4; page 9, para. 0105).
Regarding claim 13, Norman discloses that the filter set 100 includes a flexible tube configured to connect to the patient's transfer set (fig. 2).
Regarding claim 15, Norman discloses that the PD machine is configured to close a used PD fluid valve 150b during a patient fill, urging the filtered fresh PD fluid to flow to the port instead of along the used PD fluid tube (fig. 3; page 8, para. 0099, 0100).
Regarding claim 16, Norman discloses that the PD machine is configured to close a fresh PD fluid valve 150a during a patient drain, urging used PD fluid to flow along the used PD fluid tube instead of into the filtered fluid compartment (page 8, para. 0099, 0100).
Regarding claim 17, Norman discloses that the filter membrane is a sterilizing grade filter membrane (page 8, para. 0092).
Regarding claim 18, Norman discloses a filter set 100 comprising: a port 108; a filtered fluid compartment 110 including an outlet 150a to the port 108; a filter membrane 140 positioned and arranged such that fresh PD fluid flows through the filter membrane into the filtered fluid compartment (page 8, para. 0097); and a used PD fluid tube 118 in fluid communication with the port (fig. 3), the used PD fluid tube positioned and arranged to carry used PD fluid past the filter membrane without contacting the filter membrane (page 8, para. 0100).
Claim Rejections - 35 USC § 103
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) 2-4, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Norman in view of Navis (US 6,659,134).
Claim 2 differs from Norman in calling for the patient line to be a dual lumen patient line including a fresh PD fluid lumen and a used PD fluid lumen, the used PD fluid lumen placed in fluid communication with the used PD fluid tube. Navis teaches a patient line for use in peritoneal dialysis wherein the patient line includes a fresh PD fluid lumen 12 (inflow conduit) and a used PD fluid lumen 14 (outflow conduit) which provides improved peritoneal dialysis that is suitable for continuous use, allowing simultaneous inflow and outflow (col. 1, lines 58-60; col. 2, lines 64-65; figs. 1, 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patient line of Norman to be a dual lumen patient line including a fresh PD fluid lumen and a used PD fluid lumen as taught by Navis to provide improved peritoneal dialysis by allowing continuous inflow and outflow. The resulting structure of this modification is the used PD fluid lumen in fluid communication with the used PD fluid tube.
Regarding claim 3, Norman discloses that the filter set 100 includes a fresh PD fluid port 116 for fluid communication with the fresh PD fluid lumen and a used PD fluid port 150b for fluid communication with the used PD fluid lumen (fig. 3).
Regarding claim 4, Norman discloses that the used PD fluid tube 118 is in fluid communication with the used PD fluid port 150b (fig. 3).
Regarding claim 19, Norman discloses a method for priming a filter set 100 connected to patient line 50 (fig. 2), wherein during treatment a tube is located between the filter set 100 and a patient's transfer set (fig. 2), the method comprising: delivering fresh peritoneal dialysis ("PD") fluid through a fresh PD fluid lumen 50 of the patient line to the filter set 100 (page 7, para. 0085); forcing the fresh PD fluid through a filter membrane 140 of the filter set, so that the fresh PD fluid displaces air towards a used PD fluid lumen of the patient line (page 8, para. 0095, 0096) and pulling used PD fluid from the patient, through the patient's transfer set, through the tube, through a used PD fluid portion of the filter set, and into the used PD fluid lumen of the patient line ((page 8, para. 0100).
Claim 19 differs from Norman in calling for the patient line to be a dual lumen patient line including a fresh PD fluid lumen and a used PD fluid lumen. Navis teaches a patient line for use in peritoneal dialysis wherein the patient line includes a fresh PD fluid lumen 12 (inflow conduit) and a used PD fluid lumen 14 (outflow conduit) which provides improved peritoneal dialysis that is suitable for continuous use, allowing simultaneous inflow and outflow (col. 1, lines 58-60; col. 2, lines 64-65; figs. 1, 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patient line of Norman to be a dual lumen patient line including a fresh PD fluid lumen and a used PD fluid lumen as taught by Navis to provide improved peritoneal dialysis by allowing continuous inflow and outflow. The resulting structure of this modification is the used PD fluid lumen in fluid communication with the used PD fluid tube.
Allowable Subject Matter
Claims 10, 14 are 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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