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 .
Status of Claims
Claim(s) 1-20 is/are pending in the application.
Claim(s) 1-20 is/are examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 08/01/2024 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have been considered by the examiner.
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.
Claim(s) 1-8, 11-16, and 18-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-2 and 29-35 of U.S. Patent No. 11878106 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because patent claims 1-2 and 29-35 contain the additional limitations of a catheter system configured for draining a bodily fluid from a fluid source in a body of a subject, the catheter system comprising: the check valve being a ball valve comprising a valve body having a valve seat, a stop, and a ball positioned between the valve seat and the stop, the ball sealing against the valve seat when the check valve is in the closed position, the stop restricting movement of the ball toward the distal end opening, wherein the stop extends across a diameter of the catheter tube at a height smaller than a height of the ball, wherein the valve seat extends through the valve body and has a tapered shape that, in the downstream direction, reduces in diameter to a minimum diameter and thereafter increases in diameter, the minimum diameter being smaller than the height of the ball; wherein the valve body includes a proximal opening, a distal opening, and a port located between the proximal opening and the distal opening and has a tapered external shape surrounding the valve seat that gradually increases in diameter in the downstream direction, and is thus more specific, in effect making the invention of patent claims 1-2 and 29-35 a “species” of the “generic” invention of instant claims 1-8, 11-16, and 18-20. 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 1, claim 1 of the reference patent discloses all the limitations of instant claim 1.
Regarding instant claim 2, claim 2 of the reference patent discloses all the limitations of instant claim 2.
Regarding instant claim 3, claim 1 of the reference patent discloses all the limitations of instant claim 3.
Regarding instant claim 4, claim 1 of the reference patent discloses all the limitations of instant claim 4.
Regarding instant claim 5, claim 30 of the reference patent discloses all the limitations of instant claim 5.
Regarding instant claim 6, claim 32 of the reference patent discloses all the limitations of instant claim 6.
Regarding instant claim 7, claim 29 of the reference patent discloses all the limitations of instant claim 7.
Regarding instant claim 8, claim 31 of the reference patent discloses all the limitations of instant claim 8.
Regarding instant claim 11, claim 34 of the reference patent discloses all the limitations of instant claim 11.
Regarding instant claim 12, claim 35 of the reference patent discloses all the limitations of instant claim 12.
Regarding instant claim 13, claim 30 of the reference patent discloses all the limitations of instant claim 13.
Regarding instant claim 14, claim 32 of the reference patent discloses all the limitations of instant claim 14.
Regarding instant claim 15, claim 29 of the reference patent discloses all the limitations of instant claim 7.
Regarding instant claim 16, claim 31 of the reference patent discloses all the limitations of instant claim 8.
Regarding instant claim 18, claim 33 of the reference patent discloses all the limitations of instant claim 18.
Regarding instant claim 19, claim 1 of the reference patent discloses all the limitations of instant claim 19.
Regarding instant claim 20, claim 1 of the reference patent discloses all the limitations of instant claim 20.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3 is/are rejected under 35 U.S.C 102(a)(1) as being anticipated by Austin (US PAT 5405336).
Regarding claim 1, Austin discloses a catheter system (a catheter system 10: Col. 4, Lines 15-35, and Fig. 1) for draining a bodily fluid from a fluid source in a body of a subject (Abstract), the catheter system (10) comprising:
a catheter tube (a catheter 12: Col. 4, Lines 15-35, and Fig. 1) having a proximal end (16), a distal end (19), and an intermediate portion between the proximal end and the distal end (an intermediate portion 30 between 16 and 19: Col 4, Lines 47-64, and Fig. 1), the catheter tube including a drainage lumen extending from a proximal end opening in the proximal end to a distal end opening in the distal end (the catheter tube 12 including an unlabeled drainage lumen extending from an unlabeled opening of the proximal end 16 to an unlabeled opening of the distal end 19: Fig. 1); and
a one way check valve (a check valve 130: Col. 7, lines 40-45 and Fig. 8) having an open position in which the bodily fluid can flow in a downstream direction from the proximal end toward the distal end (the check valve 130 having an unseat position of a ball 136 of the check valve in which the bodily fluid can flow in a downstream direction from 16 to 19: Col. 7, Lines 40-48 and Fig. 8; wherein, the unseat position of the ball reads on the opening position), the check valve having a closed position in which the bodily fluid cannot flow in an upstream direction from the distal end toward the proximal end (fluid flow in the reverse direction will be prevented by the check valve 130 at a seat position of the ball 136: Col. 7, Lines 32-37 and Fig. 8; wherein the seat position of the ball reads on the closed position),
the check valve being positioned in the drainage lumen at the intermediate portion of the catheter tube (the check valve is positioned in the drainage lumen of 30: Figs. 1 and 8) such that the check valve is outside the body of the subject when the proximal end opening is located in the fluid source in the body of the subject (Figs. 1 and 8).
Regarding claim 2, Austin discloses all the limitations as discussed above for claim 1.
Austin further discloses wherein the check valve is positioned at the intermediate portion adjacent to the proximal end (Col. 7, Lines 40-45, Figs. 1 and 8).
Regarding claim 3, Austin discloses all the limitations as discussed above for claim 1.
Austin further discloses wherein the check valve is a ball valve comprising a valve body having a valve seat, a stop, and a ball positioned between the valve seat and the stop (the check valve 130 is a ball valve comprising a valve body 132 having a valve seat 134, a stop/spring 140 and a ball 136 positioned between 134 and 140: Col. 7, Lines 40-48, and Fig. 8), the ball sealing against the valve seat when the check valve is in the closed position (Col. 7, Lines 40-48, and Fig. 8), the stop restricting movement of the ball toward the distal end opening (Col. 7, Lines 40-48, and Fig. 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 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(s) 4-6, 10, and 18-20 is/are rejected under 35 U.S.C 103 as being unpatentable over Austin (US PAT 5405336) in view of Patel (US PAT 3943929).
Regarding claims 4-6, Austin discloses a catheter system (a catheter system 10: Col. 4, Lines 15-35, and Fig. 1) for draining a bodily fluid from a fluid source in a body of a subject (Abstract), the catheter system (10) comprising:
a catheter tube (a catheter 12: Col. 4, Lines 15-35, and Fig. 1) having a proximal end (16), a distal end (19), and an intermediate portion between the proximal end and the distal end (an intermediate portion 30 between 16 and 19: Col 4, Lines 47-64, and Fig. 1), the catheter tube including a drainage lumen extending from a proximal end opening in the proximal end to a distal end opening in the distal end (the catheter tube 12 including an unlabeled drainage lumen extending from an unlabeled opening of the proximal end 16 to an unlabeled opening of the distal end 19: Fig. 1).
Austin does not disclose a fluid sampling component in fluid communication with the distal end opening; the fluid sampling component includes a container having an upstream portion in fluid communication with the distal end opening, a downstream portion in fluid communication with the upstream portion, and a sampling port in fluid communication with the downstream portion; the downstream portion is in fluid communication with a fluid collection bag.
In an analogous art for being directed to solve the same problem, draining fluids out of the body, Patel discloses a multi-chamber container comprising a plurality of liquid drainage tubes (Abstract). Patel further discloses fluid sampling component includes containers (compartments 80/82/280: Figs. 1 and 6) having an upstream portion in fluid communication with the distal end opening (the proximal end 54 of the ureteral catheter 24 is connected to the upstream end 56 of the drainage tube 26 by the connector 58, while the proximal end 38 of the Foley catheter 22 is connected to the upstream end 44 of the drainage tube 28: Col. 4, Lines 38-42, Figs. 1 and 6), a downstream portion in fluid communication with the upstream portion (a second connector 258 connecting a downstream end 254 of the ureteral catheter 224 to an upstream end 256 of a third drainage tube 226, with a downstream end 262 of the drainage tube 226 being connected to a third connector or drip chamber 266: Col. 5, Lines 6-12, Figs. 1 and 6); a sample port in fluid communication with the downstream portion (a second connector 258 in fluid communication with the downstream portion 254: Fig. 6), and the downstream portion is in fluid communication with a fluid collection bag (a drainage bag or receptacle 30: Col. 5, lines 5-15; Figs. 1 and 6) for the benefit of having separated upstream and downstream drainage tubes connected to compartments to prevent retrograde bacterial movement from said compartments (Col. 3, Lines 1-7) and providing means for collecting urine (Col. 1, lines 18-22).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the catheter system of Austin in view of Patel by incorporating a fluid sampling component as claimed, in order to have separated upstream and downstream drainage tubes connected to compartments to prevent retrograde bacterial movement from said compartments, as suggested in Col. 3, Lines 1-7 of Patel.
Regarding claims 10 and 18, Austin discloses a catheter system (a catheter system 10: Col. 4, Lines 15-35, and Fig. 1) for draining a bodily fluid from a fluid source in a body of a subject (Abstract), the catheter system (10) comprising:
a catheter tube (a catheter 12: Col. 4, Lines 15-35, and Fig. 1) having a proximal end (16), a distal end (19), and an intermediate portion between the proximal end and the distal end (an intermediate portion 30 between 16 and 19: Col 4, Lines 47-64, and Fig. 1), the catheter tube including a drainage lumen extending from a proximal end opening in the proximal end to a distal end opening in the distal end (the catheter tube 12 including an unlabeled drainage lumen extending from an unlabeled opening of the proximal end 16 to an unlabeled opening of the distal end 19: Fig. 1);
a one way check valve (a check valve 130: Col. 7, lines 40-45 and Fig. 8) having an open position in which the bodily fluid can flow in a downstream direction from the proximal end toward the distal end (the check valve 130 having an unseat position of a ball 136 of the check valve in which the bodily fluid can flow in a downstream direction from 16 to 19: Col. 7, Lines 40-48 and Fig. 8; wherein, the unseat position of the ball reads on the opening position), the check valve having a closed position in which the bodily fluid cannot flow in an upstream direction from the distal end toward the proximal end (fluid flow in the reverse direction will be prevented by the check valve 130 at a seat position of the ball 136: Col. 7, Lines 32-37 and Fig. 8; wherein the seat position of the ball reads on the closed position), the check valve being positioned in the drainage lumen at the intermediate portion of the catheter tube (the check valve is positioned in the drainage lumen of 30: Figs. 1 and 8) such that the check valve is outside the body of the subject when the proximal end opening is located in the fluid source in the body of the subject (Figs. 1 and 8).
Austin does not disclose a fluid sampling component in fluid communication with the distal end opening; and the fluid sampling component includes an inlet that interfaces with the distal proximal end.
Patel further discloses fluid sampling component includes containers (compartments 80/82/280: Figs. 1 and 6) having an upstream portion in fluid communication with the distal end opening (the proximal end 54 of the ureteral catheter 24 is connected to the upstream end 56 of the drainage tube 26 by the connector 58, while the proximal end 38 of the Foley catheter 22 is connected to the upstream end 44 of the drainage tube 28: Col. 4, Lines 38-42, Figs. 1 and 6), a downstream portion in fluid communication with the upstream portion (a second connector 258 connecting a downstream end 254 of the ureteral catheter 224 to an upstream end 256 of a third drainage tube 226, with a downstream end 262 of the drainage tube 226 being connected to a third connector or drip chamber 266: Col. 5, Lines 6-12, Figs. 1 and 6); and an inlet that interfaces with the distal end (opening 112/114/312: Figs. 1 and 6) for the benefit of having separated upstream and downstream drainage tubes connected to compartments to prevent retrograde bacterial movement from said compartments (Col. 3, Lines 1-7).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the catheter system of Austin in view of Patel by incorporating a fluid sampling component as claimed, in order to have separated upstream and downstream drainage tubes connected to compartments to prevent retrograde bacterial movement from said compartments, as suggested in Col. 3, Lines 1-7 of Patel.
Regarding claim 19, Austin/Patel discloses all the limitations as discussed above for claim 10.
Austin further discloses the check valve is positioned at the intermediate portion adjacent to the proximal end (Col. 7, Lines 40-45, Figs. 1 and 8).
Regarding claim 20, Austin/Patel discloses all the limitations as discussed above for claim 10.
Austin further discloses the check valve is a ball valve comprising a valve body having a valve seat, a stop, and a ball positioned between the valve seat and the stop (the check valve 130 is a ball valve comprising a valve body 132 having a valve seat 134, a stop/spring 140 and a ball 136 positioned between 134 and 140: Col. 7, Lines 40-48, and Fig. 8), the ball sealing against the valve seat when the check valve is in the closed position (Col. 7, Lines 40-48, and Fig. 8), the stop restricting movement of the ball toward the distal end opening (Col. 7, Lines 40-48, and Fig. 8).
Claim(s) 11-14 is/are rejected under 35 U.S.C 103 as being unpatentable over Austin in view of Patel, as applied to claim 10 above, and further in view of Theriault (GB 2472407).
Regarding claim 11, Austin/Patel discloses all the limitations as discussed above for claim 10.
Austin further discloses a balloon (14) positioned at the proximal end of the catheter tube (Fig. 1).
Austin/Patel does not disclose the drainage lumen includes a second proximal end opening in the proximal end, and the balloon is positioned between the opening at the proximal end of the catheter tube and the second proximal end opening in the proximal end of the catheter tube.
In the same field of endeavor, catheters, Theriault discloses a catheter comprising a shaft with lumen for drainage of waste material from a body (Abstract). Theriault further discloses a balloon (8) positioned between a first opening (7) in a proximal end and a second proximal end opening (pinhole 13 and/or slit valve 14) in the proximal end of the catheter tube (abstract and Figs. 10-12) for the benefits of providing a slow/intermittent drain and preventing urine from stagnating at the base of the bladder (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the catheter system of Austin in view of Theriault by incorporating a second proximal end opening in the proximal end and repositioning the balloon, in order to provide a slow/intermittent drain and prevent urine from stagnating at the base of the bladder, as suggested in Abstract of Theriault and as it has been held that a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art. One would have been motivated to rearrange the balloon between the opening at the proximal end of the catheter tube and the second proximal end opening in the proximal end of the catheter tube for the purpose of providing a slow/intermittent drain and preventing urine from stagnating at the base of the bladder. See MPEP § 2144.04 (VI) (C).
Regarding claim 12, Austin/Patel/Theriault discloses all the limitations as discussed above for claim 11.
Austin further discloses the catheter tube includes an inflation lumen (a Y-site or port 18: Col. 1, lines 30-35; Col. 4, lines 20-25, and Fig. 1) in fluid communication with the balloon for inflating the balloon (Col. 1, lines 30-35; Col. 4, lines 20-25, and Fig. 1).
Regarding claims 13-14, Austin/Patel/Theriault discloses all the limitations as discussed above for claim 12.
Austin/Theriault does not disclose a fluid sampling component in fluid communication with the distal end opening; the fluid sampling component includes a container having an upstream portion in fluid communication with the distal end opening, a downstream portion in fluid communication with the upstream portion, and a sampling port in fluid communication with the downstream portion; the downstream portion is in fluid communication with a fluid collection bag.
Patel further discloses fluid sampling component includes containers (compartments 80/82/280: Figs. 1 and 6) having an upstream portion in fluid communication with the distal end opening (the proximal end 54 of the ureteral catheter 24 is connected to the upstream end 56 of the drainage tube 26 by the connector 58, while the proximal end 38 of the Foley catheter 22 is connected to the upstream end 44 of the drainage tube 28: Col. 4, Lines 38-42, Figs. 1 and 6), a downstream portion in fluid communication with the upstream portion (a second connector 258 connecting a downstream end 254 of the ureteral catheter 224 to an upstream end 256 of a third drainage tube 226, with a downstream end 262 of the drainage tube 226 being connected to a third connector or drip chamber 266: Col. 5, Lines 6-12, Figs. 1 and 6); a sample port in fluid communication with the downstream portion (a second connector 258 in fluid communication with the downstream portion 254: Fig. 6), and the downstream portion is in fluid communication with a fluid collection bag (a drainage bag or receptacle 30: Col. 5, lines 5-15; Figs. 1 and 6) for the benefit of having separated upstream and downstream drainage tubes connected to compartments to prevent retrograde bacterial movement from said compartments (Col. 3, Lines 1-7) and providing means for collecting urine (Col. 1, lines 18-22).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the catheter system of Austin/Patel/Theriault in view of Patel by incorporating a fluid sampling component as claimed, in order to have separated upstream and downstream drainage tubes connected to compartments to prevent retrograde bacterial movement from said compartments and provide means for collecting urine, as suggested in Col. 3, Lines 1-7 and Col. 1, lines 18-22 of Patel.
Allowable Subject Matter
The reasons for indicating allowable subject matter are the same as those presented by Examiner in the Office Action filed on 09/23/2022 of the parent application 16/337378.
Claims 7-9 and 15-17 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 7, the prior arts of record, alone or in combination, fail(s) to discloses or suggest the container includes a wall that partially separates the upstream portion and the downstream portion. There is not an apparent/obvious reason/motivation for incorporating a wall that partially separates the upstream portion from the downstream portion as this modification increases the complexity of the system in the prior art in terms of structure, function, and design (See MPEP §2143.01 (IV)).
Therefore, claim 7 and its dependent claims 8-9 are deemed novel and non-obvious over the prior art of record.
Regarding claim 15, the prior arts of record, alone or in combination, fail(s) to discloses or suggest the container includes a wall that partially separates the upstream portion and the downstream portion. There is not an apparent/obvious reason/motivation for incorporating a wall that partially separates the upstream portion from the downstream portion as this modification increases the complexity of the system in the prior art in terms of structure, function, and design (See MPEP §2143.01 (IV)).
Therefore, claim 15 and its dependent claims 16-17 are deemed novel and non-obvious over the prior art of record.
Conclusion
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/NHU Q. TRAN/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781