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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Election/Restrictions
Applicant’s election without traverse of Group 1 Species C in the reply filed on July 14, 2026 is acknowledged.
Claims 2-4 and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 14, 2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a urine measurement device” in claim 1 interpreted to be the elements as recited in claims 5-7 and equivalents thereof.
“a urine-clear device for clearing urine” in claim 16 interpreted to be the structure as in Paragraphs 0099-0100 of the specification and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
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) 1, 6-7, 11, and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blankenship et al. (US Patent No. 4658834) in view of Livengood et al. (US 2006/0163829).
Regarding claim 1, Blankenship teaches an automated urine-output-measurement system (Abstract), comprising:
a multi-use urine monitor (20; Column 3, Lines 48-49; “The apparatus 20 is comprised of a permanent reusable housing 24”) comprising:
a housing (24) having a cavity configured to encompass a drainage receptacle of a urine-collection system (Column 3, Lines 49-51; “a disposable container 26 adapted to cooperate with and be supported by the housing 24.”);
a urine measurement device (“electronic measurement subsystem 80”, “transducer 58”) configured to measure urine output into the drainage receptacle (Column 7, Lines 44-60); and
an integrated display screen (“digital display panel 34”) configured to display patient information including measurements of the urine output (Column 8, Lines 15-37).
Blankenship is silent on a housing having a cavity configured to completely encompass a drainage receptacle of a urine-collection system. Livengood teaches a housing having a cavity configured to completely encompass a drainage receptacle of a urine-collection system (Paragraph 0101; Figures 2-4).
It would have been obvious to one of ordinary skill in the art to have modified Blankenship with Livengood because it provides a support platform which provides a solution for healthcare facilities and nursing staff to address patient and staff safety, patient mobility, patient comfort, the availability of patient information, monitoring drugs and therapy provided, and controlling health care expenses (Abstract of Livengood).
Regarding claim 6, Blankenship teaches wherein the urine measurement device is a contactless ultrasonic liquid-level sensor for volume-based urine-output measurements (Column 12, Lines 8-17) but is silent on the placement being from above the drainage receptacle.
It would have been obvious to one of ordinary skill in the art to have modified Blankenship to use the ultrasonic liquid level sensor from above the drainage receptacle since it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C).
Regarding claim 7, Blankenship teaches wherein the urine measurement device is a contactless optical liquid-level sensor for volume- based urine-output measurements (Column 12, Lines 8-17) but is silent on the placement being from a side of the drainage receptacle.
It would have been obvious to one of ordinary skill in the art to have modified Blankenship to use the optical liquid level sensor from a side of the drainage receptacle since it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C).
Regarding claim 11, Blankenship teaches wherein the urine monitor further comprises lighting features configured to indicate a state of the urine monitor, indicate positive placement of the urine-collection system or a portion thereof, illuminate the drainage receptacle, indicate a urine-urine monitor alert, indicate a patient alert, or a combination thereof (Column 8, Lines 22-23).
Regarding claim 14, Blankenship teaches further comprising one or more rechargeable batteries configured to power the urine monitor (Column 8, Lines 46-48).
Regarding claim 15, Blankenship teaches further comprising a pole mount, a bed-rail mount, or a floor stand, the housing of the urine monitor having mounting interfaces to support the pole mount, the bed-rail mount, and the floor stand (Column 3, Line 65-Column 4, Line 1).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blankenship et al. (US Patent No. 4658834) in view of Livengood et al. (US 2006/0163829) and in further view of Luxon et al. (WO 2015/105916 A1).
Regarding claim 5, Blankenship is silent on the use of an in-line flow meter. Luxon teaches wherein the urine measurement device is an in-line flow meter for volume-based urine-output measurements (microfluidic flow detection chip; page 20). It would have been obvious to one of ordinary skill in the art to have modified Blankenship with Luxon because it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the urine measurement device of Blankenship with that of Luxon.
Claim(s) 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blankenship et al. (US Patent No. 4658834) in view of Livengood et al. (US 2006/0163829) and in further view of Chang et al. (US 2013/0304061).
Regarding claim 8, Blankenship teaches the urine monitor and urine-collection system (see rejection of claim 1 above) but is silent on the RFID elements. Chang teaches a monitor further including a radiofrequency identification ("RFID")-unit reader-writer configured to identify a presence of an RFID unit integrated into the system, read data from the RFID unit, and write data to the RFID unit (Paragraph 0032).
It would have been obvious to one of ordinary skill in the art to have modified Blankenship with Chang because it enables safety in ensuring the proper instruments are being used and allows for monitoring to update any procedures using the instruments (Paragraph 0032 of Chang).
Regarding claim 10, Blankenship teaches the urine monitor (see rejection of claim 1 above) but is silent on the RFID elements.
Chang teaches wherein the housing of the monitor has an RFID-unit receptacle including the RFID-unit reader-writer (Paragraphs 0031-0032 of Chang). It would have been obvious to one of ordinary skill in the art to have modified Blankenship with Chang because it enables safety in ensuring the proper instruments are being used and allows for monitoring to update any procedures using the instruments (Paragraph 0032 of Chang).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blankenship et al. (US Patent No. 4658834) in view of Livengood et al. (US 2006/0163829) and Chang et al. (US 2013/0304061) and in further view of LaBorde (US Patent No. 9848827).
Regarding claim 9, Blankenship is silent on the RFID elements. LaBorde wherein the RFID unit is a bead around a length of drainage tubing connected to the drainage receptacle (Column 2, Lines 25-35). It would have been obvious to one of ordinary skill in the art to have modified Blankenship with LaBorde because it allows for removal of errors thus improving the safety of the patient (Column 1, Line 60-Column 2, Line 7 of LaBorde).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blankenship et al. (US Patent No. 4658834) in view of Livengood et al. (US 2006/0163829) and in further view of Ribble et al. (US 2016/0136356).
Regarding claim 12, Blankenship teaches the urine monitor further including an embedded system comprising a microcontroller configured to process urine-measurement data corresponding to the urine output into the drainage receptacle, a graphics controller configured to render on the integrated display screen the patient information including the measurements of the urine output (Column 7, Lines 61-Column 8, Line 37; Figures 11A-11B), but is silent on the communication to a companion wireless device. Ribble teaches one or more wireless communication modules configured to wirelessly communicate the patient information including the urine output to a companion wireless device when paired therewith (Paragraph 0013, 0019, 0038, 0045, 0047, and 0049). It would have been obvious to one of ordinary skill in the art to have modified Blankenship with Ribble because Ribble teaches this as being known in the art (Paragraphs 0047 and 0049 of Ribble) and thus would yield predictable results.
Regarding claim 13, Blankenship is silent on the communication to a companion wireless device. Ribble teaches further comprising a companion tablet computer configured to wirelessly communicate with the urine monitor and one or more networked computers to update electronic medical records with the patient information including the urine output or retrieve historical patient information from the electronic medical records (Paragraph 0013, 0019, 0038, 0045, 0047, and 0049). It would have been obvious to one of ordinary skill in the art to have modified Blankenship with Ribble because Ribble teaches this as being known in the art (Paragraphs 0047 and 0049 of Ribble) and thus would yield predictable results.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blankenship et al. (US Patent No. 4658834) in view of Livengood et al. (US 2006/0163829) and in further view of Feneley (US 2004/0176747).
Regarding claim 16, Blankenship is silent on the urine-clearing device. Feneley teaches further comprising a urine-clearing device for clearing urine from drainage tubing connected to the drainage receptacle (Paragraph 0014 and 0011). It would have been obvious to one of ordinary skill in the art to have modified Blankenship with Feneley because cleaning tubing would be known to those of ordinary skill in the art as cleaning medical devices is conventional and standard, thus providing a clearing device would yield predictable results of cleaning the interior of a catheter (Paragraph 0014 of Feneley).
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 and 5-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11911160. Although the claims at issue are not identical, they are not patentably distinct from each other because see the chart below. The difference between the rejected claims of the instant application and patented claims of the patent lies in the fact that the patented claims are more specific. Thus, the invention of patented claims is in effect a “species” of the “generic” invention of rejected claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since rejected claims are anticipated by patented claims, it is not patentably distinct from patented claims.
Instant Application 18/538,136
Conflicting US Patent No. 11911160
1. (Original) An automated urine-output-measurement system, comprising:
a multi-use urine monitor comprising:
a housing having a cavity configured to completely encompass a drainage receptacle of a urine-collection system;
a urine measurement device configured to measure urine output into the drainage receptacle; and
an integrated display screen configured to display patient information including measurements of the urine output.
1. An automated urine-output-measurement system, comprising:
a) single-patient equipment including:
a urinary catheter; and
a urine-collection system including drainage tubing and a drainage receptacle; and
b) multi-patient equipment including:
a urine monitor including:
a housing having a cavity configured to house an entirety of the drainage receptacle;
a urine-measurement means for measuring urine output into the drainage receptacle; and
an integrated display screen configured to display patient information including measurements of the urine output.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Burnett et al. (US 2013/0030262)
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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