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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 6/29/2026 is acknowledged. Accordingly, claims 19, 20 and 22-35 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 6 is objected to because of the following informalities: The recitation of “first and second filter membranes” in claim 6 and “at least one filter membrane” in claim 1 would normally render the claims indefinite because it would not be clear if the “first and second” membranes were part of the “at least one” membrane. However, since references characters 120a and 120b are used to designate both the “first and second membranes” and the “at least one” membrane, it is apparent to the examiner that they are intended to be the same. In order to make this clear, it is suggested to amend claim 6 to recite “wherein the at least one filter membrane includes first and second filter membranes”. 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 9 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 9 recites “an internal stop against which a tube may be abutted”. The phrase “may be” renders the claim indefinite as it is unclear whether or not the internal stop and the tube are required to be abutted. For the sake of examination, the two are interpreted as being required to abut. According, it is suggested to amend claim 9 to recite “an internal stop configured to abut a tube
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, 10-14, 16-18, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8, 10-14, 17 and 18 of copending Application No. 18/710,712 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the present claims is fully disclosed in the copending claims. Specifically, the subject matter of present claim 1 is fully disclosed in copending claim 1, the subject matter of present claim 2 is fully disclosed in copending claim 2, the subject matter of present claim 3 is fully disclosed in copending claim 3, the subject matter of present claim 4 is fully disclosed in copending claim 4, the subject matter of present claim 10 is fully disclosed in copending claim 8, the subject matter of present claim 11 is fully disclosed in copending claim 8, the subject matter of present claim 12 is fully disclosed in copending claim 10, the subject matter of present claim 13 is fully disclosed in copending claim 11 (wherein the “cap” of the copending claim is the same as a “lid”),the subject matter of present claim 14 is fully disclosed in copending claim 12, the subject matter of present claim 16 is fully disclosed in copending claim 13, the subject matter of present claim 17 is fully disclosed in copending claim 14, the subject matter of present claim 18 is fully disclosed in copending claim 17, and the subject matter of present claim 21 is fully disclosed in copending claim 18 (although a “body” is not recited in copending claim 18, a structure that can be considered a “body” must be present in order for the filter membrane to be present).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
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 1, 8-16, 18 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Norman et al. (PG PUB 2020/0086028).
Re claim 1, Norman discloses a peritoneal dialysis ("PD") system 10 (Fig 1) comprising: a PD machine 20 (Fig 1); a patient line (not labeled in Fig 1 but seen extending proximally from filter set 100 and through occluder 26; labeled 50 in Fig 3 and extending directly from port 114) extending from the PD machine (as seen in Fig 1); and a filter set 100 (Fig 1,3-6; it is noted that all reference characters referring to structures of the filter set 100 are seen in Fig 3-6 unless otherwise noted) in fluid communication with the patient line (as seen in Fig 3), the filter set including at least one filter membrane (140,142 (Para 97,106) positioned and arranged such that fresh PD fluid flows through the at least one filter membrane prior to exiting the filter set (as seen in Fig 3, Para 100), the filter set further including a used PD fluid tube (forming pathway 118) positioned and arranged to carry used PD fluid past the at least one filter membrane without contacting the at least one filter membrane (as seen in Fig 3; Para 100).
Re claim 8, Norman discloses that the filter set includes a transfer set-side port 106 within which fresh and used PD fluid flows (Para 98), the used PD fluid tube extending into the transfer set-side port (as seen in Fig 3, highlighted in Fig A below).
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Re claim 9, Norman discloses that the transfer set-side port defines an internal stop (labeled in Fig A above) against which a tube 50 (two tubes 50 are shown in Fig 3; it is the tube on the left that is this “tube”) may be abutted (as seen in Fig 3), the internal stop spaced from an end of the used PD fluid tube extending into the transfer set-side port (as seen in Fig 3 and Fig A above).
Re claim 10, Norman discloses that the filter set includes at least one outer compartment 116 sized to displace the fresh PD fluid across an upstream side of the at least one filter membrane (Para 96,97).
Re claim 11, Norman discloses that the at least one filter membrane is a flat sheet filter membrane (as seen in Fig 5).
Re claim 12, Norman discloses that the filter set includes a deflecting wall (labeled in annotated Fig B below) positioned and arranged to displace incoming fresh PD fluid towards the at least one outer compartment (as seen by the dashed arrow pointing left in Fig 3).
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Re claim 13, Norman discloses that the filter set includes at least one lid 112 (incorrectly labeled in Fig 3, but correctly labeled in Fig 4) cooperating with the at least one filter membrane to form the at least one outer compartment (as seen in Fig 3,4).
Re claim 14, Norman discloses that the at least one lid includes at least one vent opening (seen but not labeled in Fig 3,4; labeled in Fig B above) and at least one hydrophobic membrane 152 (seen but not labeled in Fig 4) sealingly covering the at least one vent opening (as seen in Fig 4, Para 105).
Re claim 15, Norman discloses that the filter set includes at least one sidewall 104, wherein the at least one lid is sealed to an outer portion (labeled in Fig B above) of the at least one sidewall (Para 96), and wherein the least one filter membrane is sealed to an inner portion of the at least one sidewall (as seen in Fig 4, all components of the filter set are “sealed to” each other either directly or indirectly).
Re claim 16, Norman discloses that the filter set is configured to connect directly to a patient's transfer set, or wherein the filter set includes a flexible tube 50 (as seen in Fig 3, there are two tubes 50; the tube 50 on the left is the “flexible tube”) configured to connect to the patient's transfer set (as seen in Fig 1, Para 85).
Re claim 18, Norman discloses that the at least one filter membrane is a bacteria reduction filter membrane or a sterilizing grade filter membrane (Para 85).
Re claim 21, Norman discloses a filter set 100 (Fig 1,3-6; it is noted that all reference characters cited below refer to Fig 3-6 unless otherwise noted) comprising: a body 104; at least one filter membrane 140,142 positioned and arranged within the body such that fresh peritoneal dialysis ("PD") fluid flows through the at least one filter membrane prior to exiting the filter set (as seen in Fig 3; Para 100); and a used PD fluid tube (forming pathway 118) positioned and arranged within the body to carry used PD fluid past the at least one filter membrane without contacting the at least one filter membrane (as seen in Fig 3; Para 100).
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.
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Norman et al. (PG PUB 2020/0086028) in view of Work et al. (PG PUB 2003/0069534).
Re claim 2, Norman discloses that the patient line is in fluid communication with the used PD fluid tube (as seen in Fig 3, Para 100) but does not disclose that the patient line is a dual lumen patient line including a fresh PD fluid lumen and a used PD fluid lumen with the used PD fluid lumen placed in fluid communication with the used PD fluid tube. Work, however, teaches using a dual-lumen patient line (extending to the right of connector 50 in Fig 6A) including a fresh PD fluid lumen 12 (Fig 6A,6B) and a used PD fluid lumen 14 (Fig 6A,6B) in peritoneal dialysis (Para 13) for the purpose of allowing simultaneous use of both lumen (Para 39). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Norman to include the patient line as a dual-lumen patient line, as taught by Work, for the purpose of allowing simultaneous use of both lines (Para 39).
Re claim 3, Norman as modified by Work in the rejection of claim 2 above discloses all the claimed features with Work teaching that the use of a dual-lumen tube requires the use of a dual-lumen connector 50 that includes a fresh PD fluid port 52 (Fig 6A) for fluid communication with the fresh PD fluid lumen (as seen in Fig 6A) and a used PD fluid port 54 (Fig 6A) for fluid communication with the used PD fluid lumen (as seen in Fig 6A) (Para 61). Therefore, it would have been obvious to modify connector 106 of Norman to include two ports instead of single port 108, as taught by Work. The motivation cited in the rejection of claim 2 also applies to this claim.
Re claim 4, Norman as modified by Work in the rejection of claims 2 and 3 above disclose all the claimed features with Work teaching that the used PD fluid tube is in fluid communication with the used PD fluid port when the dual-lumen connector 50 is used (as seen in Fig 6A) (Para 61). The motivation cited in the rejection of claim 2 also applies to this claim.
Re claim 5, Norman discloses that the filter set includes a compressible gasket (formed by port 114 itself, Para 96) configured to seal the port 114 to a patient line connector (the distal end of the right-most tube 50 in Fig 50) located at an end of the patient line. When modified by Work in the rejection of claim 3 above to include two fluid ports instead of one fluid port, the compressible gasket (forming the ports themselves) will work in the same way.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Norman et al. (PG PUB 2020/0086028) in view of Kirsch et al. (US Pat 6,503,225).
Re claim 6, Norman discloses that the filter set includes first and second filter membranes 140,142 (Para 106) separated by an inner compartment 126 (as seen in Fig 6) into which fresh PD fluid is filtered by the first and second filter membranes (Para 97), but does not disclose that the used PD fluid tube extends through the inner compartment. Kirsch, however, teaches a filter set 10 (Fig 2) comprising a tube 72 (Fig 2) that extends through an inner compartment 66 (Fig 2) of filter body 20 (Fig 2) in which filter membranes 50 (Fig 2) are arranged coaxially around the tube, wherein the tube is fluidically isolated from the filter membranes (Col 5, Lines 40-42) for the purpose of providing a more compact design that if the tube were outside the compartment (as seen in Fig 2). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Norman to locate the used PD fluid tube within the inner compartment, as taught by Kirsch, for the purpose providing a more compact design than that of Norman whose tube is outside the compartment (as seen in Fig 2).
Re claim 7, Norman discloses at least one rib 136 located within the inner compartment for supporting the first and second filter membranes (Para 108).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Norman et al. (PG PUB2020/0086028) in view of Burbank et al. (PG PUB 2014/0018727).
Re claim 17, Norman discloses all the claimed features except that the PD machine includes a pressure sensor positioned and arranged to sense the pressure of fresh PD fluid downstream from the at least one filter membrane during a patient fill. Burbank, however, teaches providing a PD machine with a pressure sensor positioned and arranged to sense pressure of a fresh PD fluid downstream during a patient fill (Para 55 – “pressures at each end of the fill/drain line 306 may be determined by a controller at all times during operation of the PD cycler 318 and applied as continuous input signals to the controller during fill and drain operations”) for the purpose of detecting flow restrictions and kinks in the line and allow regulation of flow (Para 55). therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Norman to include the PD machine with a pressure sensor, as taught by Burbank, for the purpose of detecting flow restrictions and kinks in the line and allow regulation of flow (Para 55).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. PG PUB 2002/0123715 to Sorenson et al., PG PUB 2005/0077225 to Usher et al., PG PUB 2021/0046243 to Guala, PG PUB 2021/0379298 to Kim each discloses filter sets relevant to the presently claimed filter set. PG PUB 2015/0250945 to Kim and PG PUB 2018/0147359 to Seok et al. each disclose a return lumen coaxially arranged within a filter-covered delivery lumen.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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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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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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