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 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of Cheng et al. (U.S. Patent No. 12,128,188 B2) in view of Burnett et al. (Patent No. US 10,391,275 B2). The prior art reference of Cheng teaches a drainage system comprising a catheter, a drainage tube, a pump, a valved connector, and a control logic that is configured to measure a volume within the dependent loop after the application of an air bolus to move the dependent loop from a first position to a second position (see claim 1 of Cheng et al.). The claim 1 of Cheng does not discuss a urine drainage system with a urinary catheter.
However, Burnett teaches a urine drainage system with a urinary catheter (system comprising a Foley catheter 1000 for urine drainage; Figure 10A; Paragraphs 112-113).
Burnett and Cheng are both considered to be analogous to the claimed invention because they are in the same field of fluid drainage systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheng to incorporate the teachings of Burnett and have the drainage system with the catheter of Cheng to be a urine drainage system with a urinary Foley catheter, as taught by Burnett. This allows for urine drainage out of the user in an effective manner while allowing for the monitoring of urine volume and preventing air locks in the system (Burnett; Paragraphs 112-113).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the patented case in view of Burnett et al. recite the claim limitations required in the current application. The table below shows the mapping of the overlapping claims between the current application and the patented case in view of Burnett et al.
Instant claims
Claims of Patent No. US 12,128,188 B2 in view of Burnett et al. (Patent No. US 10,391,275 B2)
1
1
2
2
3
3
4
4
5
5
6
6
7
7
8
8
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.
Claims 1-8 are 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 1 recites the limitation "the distal meniscus" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Allowable Subject Matter
Claims 1-8 are rejected under non-statutory double patenting and 35 U.S.C. 112(b), as recited above, but would be allowable if the rejected claims under non-statutory double patenting and 35 U.S.C. 112(b) are overcome.
Reasons for Indicating Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: the prior art of the record, alone or in combination, fails to disclose all of the structural and functional limitations as described in the claims.
The invention is drawn to an urinary drainage system with a urinary catheter, a drainage tube, a pump, a valved connector, and a control logic that is configured to measure the volume of liquid within the drainage lumen in the dependent loop by providing an air displacement bolus, displacing a dependent loop, and measuring the air pressure between the distal connector and the distal meniscus. The closest prior art found is Burnett et al. (Patent No. U.S. 10,391,275 B2), Jacobson et al. (Publication No. US 2009/0157040 A1), and Diperna et al. (Publication No. US 2019/0009023 A1), with none of these references disclosing the required claim limitation of “a control logic configured to: i) provide an air displacement bolus to the drainage tube; ii) displace a dependent loop in the drainage tube from a first position to a second position, wherein the dependent loop has a distal meniscus height equivalent to a proximal meniscus height in the first position, and wherein the distal meniscus height differs from the proximal meniscus height in the second position; and iii) determine a volume of liquid in the drainage tube by measuring an air pressure between the valved connector and the distal meniscus in the second position” in claim 1.
Burnett discusses a drainage system (urinary drainage assembly with urine drainage tube 1001; Abstract; Column 14, lines 4-6; Figure 10A) that is connected between a catheter and a collection container (drainage tube is connected to opening 106 of catheter 1000 and urine reservoir/cassette 1022; Column 14, lines 11-13; Figure 10A) and has a control logic to provide an air displacement bolus to the drainage lumen (controller pump interface connects to pump 1134 to create a vacuum on urine drainage line; Column 14, lines 14-23) and displace a dependent loop by changing the position of the distal and proximal meniscuses from a neutral to displaced configuration (system is made to prevent and clear airlocks by applying pressure to drainage lumen to displace urine towards reservoir from a neutral position; Column 2, lines 54-58; Column 19; lines 48-59), however, Burnett does not teach the control logic configured to determine a volume of liquid within the drainage lumen by measuring an air pressure between the distal connector and the distal meniscus, after applying an air bolus to the dependent loop in a second position.
Jacobson discusses the control logic configured to determine a flow rate of liquid within the drainage lumen by measuring an air pressure between the distal connector and the distal meniscus (upstream pressure sensor 120 and downstream pressure sensor 122 in the sensor assembly 100 measures the air pressure in the assembly to calculate the flow rate of the displaced fluid, then the volume of fluid can be calculated through the output of the pressure readings by processor; Figure 4; Paragraph 0047-0049 and 0057), however, Jacobson does not teach the control logic configured to determine a volume of liquid within the drainage lumen by measuring an air pressure between the distal connector and the distal meniscus, after applying an air bolus to the dependent loop in a second position.
Diperna discusses the control logic configured to determine a volume of liquid by measuring an air pressure between the distal connector and the distal meniscus (air pressure is measured with pressure sensor 26 in the space between inlet and meniscus to measure volume of dispensed liquid through outlet conduit 46; Figure 1; Paragraph 0045 and 0049-0050), however, the control logic does not measure the entire volume of liquid in the system/lumen, after applying an air bolus to the dependent loop in a second position.
The closest is the disclosure of Diperna, however, the prior art, alone or in combination, does not provide a reasoning or teaching of having a control logic performing the steps of providing an air displacement bolus to displace a dependent loop from a first position to a second position and measuring the volume of liquid by measuring an air pressure. For these reasons, claims 1-8 are indicated as allowable subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lampotang et al. (Publication No. US 2018/0015251 A1) discusses a urinary drainage system (Paragraph 0026) with a dependent loop and vents that allow for the drainage of the urine through the dependent loops (Paragraphs 0090-0092; Figures 8A-8D).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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, Rebecca Eisenberg can be reached at (571) 270-5879. 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.
/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
Prosecution Insights