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 Arguments
Applicant's arguments filed 9/10/2026 have been fully considered.
With regard to the double patenting rejection, Applicant has requested that the rejection be held in abeyance until allowable subject matter has been identified. The examiner notes that this is not a complete response. Per MPEP 804,
A complete response to nonstatutory double patenting (NSDP) is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 C.F.R 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional.
As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Replies with an omission should be treated as provided in MPEP § 714.03. [Amendments Not Fully Responsive].
In accordance with compact prosecution, this response will be treated as a bona fide response, however Applicant is required to provide a complete response in the future.
Regarding the rejection under 102 over Norman, Applicant’s response has been considered and is not persuasive. Applicant argues that Norman teaches an open area 110 that is shared by fresh dialysis fluid pathway 120 and used fluid dialysis fluid pathway 118 via respective ports, and Norman does not disclose the claimed outlet to a used PD fluid tube. This argument is not convincing. The open area 110 forms a filtered fluid compartment because the filtered fluid at least temporarily resides in that compartment after it passes out of valve 150a. The opening of the used PD fluid pathway 118 forms the claimed filtered fluid compartment outlet to a used PD fluid tube as marked in annotated fig. 3 below as fluid exits the compartment at that location and enters the used PD fluid tube 118.
PNG
media_image1.png
875
912
media_image1.png
Greyscale
Applicant’s arguments regarding Navis have been considered and are not convincing as they rely on the arguments against Norman discussed above. Applicant states Norman and Navis fail to teach a filtered fluid compartment having an outlet to a used PD fluid tube such that fresh PD fluid exiting the filtered fluid compartment at least partially shares a path with the used PD fluid pathway via the outlet. The examiner notes that this argument does not appear to be commensurate in scope with the claimed invention which does not discuss the filtered fluid compartment at least partially sharing a path with the used PD fluid pathway via the outlet. However, is it noted that Norman discloses that both filtered PD fluid and used PD fluid pass through the compartment 110.
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
1
1
2
2
3
3
4
4
7
7
8
11
10
12
11
13
12
14
13
16
14
17
17
18
18
19
19
23
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 3 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 3 calls for “a used PD fluid port”. Claim 1, from which claim 3 depends, recites “the used PD fluid tube is in fluid communication with a port”. It is not clear if these claims refer to the same port or two different ports.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 5, 7-9, 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 110 (fig. 3; page 8, para. 0097), wherein the filtered fluid compartment includes an outlet to a used PD fluid tube (fig. 3 annotated below), wherein the used PD fluid tube is in fluid communication with a port 150b (fig. 3; page 8, para. 0098), and wherein the used PD fluid tube 118 is positioned and arranged to carry used PD fluid past the filter membrane without contacting the filter membrane (fig. 3; page 8, para. 0099).
PNG
media_image2.png
859
861
media_image2.png
Greyscale
Regarding claim 5, Norman discloses that the port 150b extends from the used PD fluid tube 118 (fig. 3).
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 110 (page 8, para. 0097), the filtered fluid compartment including an outlet to a used PD fluid tube 118 (see fig. 3 annotated above); wherein the used PD fluid tube 118 in fluid communication with the port (fig. 3), the used PD fluid tube is 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2-4 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).
Allowable Subject Matter
Claims 6, 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.
Claim 19 is allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 19, the prior art fails to teach or fairly suggest the step of directing the fresh PD fluid from the filtered fluid compartment of the filter set through an outlet to a used PD fluid tube of the filter set, wherein the used PD fluid tube is in fluid communication with a port of the filter set, in combination with the features of the invention, substantially as claimed.
See prior office action for additional reasons for allowance.
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 LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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, 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.
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.
LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
