DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 08/25/2026.
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) 1-2, 4, 6, 8-19, and 21-22 is/are pending in the application.
Claim(s) 3, 5, 7, and 20 is/are canceled in the reply filed on 08/25/2026.
Claim(s) 1-2, 4, 6, 8-19, and 21-22 is/are examined on the merits.
Response to Arguments
Applicant’s arguments filed on 08/25/2026 have been fully considered.
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) 1-2 and 21 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-2 of U.S. Patent No. 11865296 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because patent claims 1-2 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 stop extends across a diameter of the catheter tube at a height smaller than a height of the ball and 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 a “species” of the “generic” invention of instant claims 1-2 and 21. 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 21, claim 1 of the reference patent discloses all the limitations of instant claim 21.
Claim(s) 4 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 8 of U.S. Patent No. 11865296 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because patent claim 8 contains 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: a one way check valve 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 having a closed position in which the bodily fluid cannot flow in an upstream direction from the distal end toward the proximal end, the check valve being positioned in the drainage lumen at the intermediate portion of the catheter tube such that the check valve is configured to be outside of and adjacent to the body of the subject when the proximal end opening is located in the fluid source in the body of the subject, 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 claim 8 a “species” of the “generic” invention of instant claim 4. 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 4, claim 8 of the reference patent discloses all the limitations of instant claim 4.
Claim(s) 10-12 and 22 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 and 13-14 of U.S. Patent No. 11865296 (reference patent) in view of Patel (US PAT 3943929).
Although the claims at issue are not identical, they are not patentably distinct from each other because patent claims 1 and 13-14 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 stop extends across a diameter of the catheter tube at a height smaller than a height of the ball, 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, and the valve body includes a proximal opening, a distal opening, and a port located between the proximal opening and the distal opening, and is thus more specific, in effect making the invention of patent claims 1 and 13-14 a “species” of the “generic” invention of instant claims 10-12 and 22. 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 10, claim 1 of the reference patent discloses all the limitations of instant claim 10 except a fluid sampling component in fluid communication with the distal end opening.
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), and 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) 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 instant claim 11, claim 13 of the reference patent discloses all the limitations of instant claim 11.
Regarding instant claim 12, claim 14 of the reference patent discloses all the limitations of instant claim 12.
Regarding instant claim 22, claim 1 of the reference patent discloses all the limitations of instant claim 22.
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 and in the Office Action filed on 02/25/2026 of the application 18/545736.
Claims 1-2, 4, 6, 8-19, and 21-22 contain allowable subject matter which is allowable over prior art; however, claims 1-2, 4, 10-12, and 21-22 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8, and 13-14 of U.S. Patent No. 11865296 (see Double Patenting section above). In order to overcome the nonstatutory double patenting rejection, Applicant's reply must include a terminal disclaimer over U.S. Patent No. 11865296.
The closest prior art of record is Austin (US PAT 5405336) and Patel (US PGPUB 3943929).
Regarding claim 1, Austin discloses a catheter system comprising a catheter tube, a one-way check valve wherein the check valve is a ball valve comprising a valve seat, a stop, and a ball. Austin fails to disclose 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. There are no teaching, suggestion, or motivation in Austin for changing the shape of the valve seat. While the modifications appear to be within one of ordinary skill in the art, there is no apparent/obvious reason/motivation for the modifications as the modifications increase the complexity of the catheter system in terms of structure, function, and design (See MPEP 2143.01 (IV)). In addition, Examiner did not find other prior art teaching the missing limitations.
Therefore, claim 1 and its dependent claims 2 and 21 are deemed novel and non-obvious over the prior art of record.
Regarding claim 4, Austin in view of Patel fail(s) to disclose or suggest the container includes a wall that partially separates the upstream portion and the downstream portion. There is no apparent teaching, suggestion, or motivation in Austin/Patel that would have prompted a person of ordinary skill in the art to modify the fluid sampling component of Austin in view of Patel to incorporate 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 4 and its dependent claims 6 and 8-9 are deemed novel and non-obvious over the prior art of record.
Regarding claim 10, Austin in view of Patel discloses a catheter system comprising a catheter tube, a one-way check valve wherein the check valve is a ball valve comprising a valve seat, a stop, and a ball; and a fluid sampling component. Austin/Patel fails to disclose the valve body has a tapered external shape surrounding the valve seat that gradually increases in diameter in the downstream direction. There are no teaching, suggestion, or motivation in Austin/Patel for changing the external shape of the valve body. While the modifications appear to be within one of ordinary skill in the art, there is no apparent/obvious reason/motivation for the modifications as the modifications increase the complexity of the catheter system in terms of structure, function, and design (See MPEP 2143.01 (IV)). In addition, Examiner did not find other prior art teaching the missing limitations.
Therefore, claim 10 and its dependent claims 11-19 and 22 are deemed novel and non-obvious over the prior art of record.
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 NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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/NHU Q. TRAN/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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