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.
Response to Arguments
Applicant's arguments filed December 16, 2025 have been fully considered but they are not persuasive.
Per the prior art rejection: The claim limitation recites: “the oxygen-sensing assembly comprising: a housing having a flow pathway extending between an inlet end and an outlet end thereof, the inlet end configured to be attachable to a device transmitting bodily fluids from a patient;”. Examiner notes as currently recited, the ‘device’ is not positively recited and is not part of the oxygen-sensing assembly. The language recites that the inlet end is configured to be attachable to a device, this under BRI means that the inlet end must merely be capable of being attached to a device. The claim doesn’t require any specific attachment nor does it require direct contact. One of ordinary skill in the art would recognize that a catheter can be attached to another catheter for transmitting bodily fluids, one of ordinary skill in the art would recognize that a catheter can be attached to a syringe for transmitting bodily fluids. One of ordinary skill in the art would recognize that a catheter, which has an inlet end, being attached to another structure at any other point on the catheter would still mean the inlet end is attached to that structure since it is part of the overall catheter. One of ordinary skill in the art would recognize the BRI of the claim language merely requires a housing that has an inlet end capable of being attached to a device that transmits bodily fluid from a patient. Therefore, Applicant’s arguments are not persuasive and the rejection stands.
Response to Amendment
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 device transmitting bodily fluids’ in claim 1 interpreted to be a catheter and equivalents thereof per the specification
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 § 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.
Claim(s) 1 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hunter (US 2017/0196478).
Regarding claim 1, Hunter teaches an assembly comprising an oxygen-sensing assembly (Abstract; Paragraph 0111), the oxygen-sensing assembly comprising:
a housing having a flow pathway extending between an inlet end and an outlet end thereof, the inlet end configured to be attachable to a device transmitting bodily fluids from a patient (Figure 3; Paragraph 0068; Examiner notes as currently recited, the ‘device’ is not positively recited and is not part of the oxygen-sensing assembly. The language recites that the inlet end is configured to be attachable to a device, this under BRI means that the inlet end must merely be capable of being attached to a device that transmits bodily fluid from a patient.); and
an oxygen sensor (Paragraphs 0018 and 0111) in operable communication with the flow pathway of the housing (chemical sensors can also be placed on and throughout; Figure 3; Paragraph 0068), the oxygen sensor configured to detect oxygen levels of a fluid flowing through the flow pathway (Paragraphs 0018 and 0111; Figure 3).
Regarding claim 10, Hunter teaches wherein the inlet end of the housing is configured to be attached to a catheter (Figure 3; Paragraph 0068).
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) 2 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (US 2017/0196478) in view of Rhea, Jr. (US Patent No. 5916153).
Regarding claim 2, Hunter is silent on the sensor having a fiber-optic. Rhea teaches wherein the oxygen sensor comprises a fiber-optic sensor (Column 3, Lines 9-26). It would have been obvious to one of ordinary skill in the art to have modified Hunter with Rhea 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 oxygen sensor of Hunter with the fiber optic oxygen sensor of Rhea.
Regarding claim 14, Hunter is silent on the sensor having an excitation portion, sensing portion, and optical module. Rhea teaches wherein the oxygen sensor comprises: an excitation portion configured to generate light; a sensing portion configured to receive the generated light from the excitation portion; and an optical module that receives the light from the sensing portion. (Column 3, Lines 9-18; Figure 4). It would have been obvious to one of ordinary skill in the art to have modified Hunter with Rhea 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 oxygen sensor of Hunter with the fiber optic oxygen sensor of Rhea.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (US 2017/0196478) in view of Luxon et al. (US 2016/0310711).
Regarding claim 13, Hunter is silent on the sensor being an electrochemical sensor. Luxon teaches wherein the oxygen sensor comprises an electrochemical sensor (Paragraph 0114). It would have been obvious to one of ordinary skill in the art to have modified Hunter 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 oxygen sensor of Hunter with the electrochemical oxygen sensor of Luxon.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (US 2017/0196478) in view of Rhea, Jr. (US Patent No. 5916153) and in further view of Elster et al. (US 2010/0182415).
Regarding claim 15, Hunter is silent on the analyzing of light to determine oxygen tension. Elster teaches further comprising a control system operably coupled to the sensing portion, the control system comprising at least one non-transitory computer-readable storage medium storing instructions thereon that (Paragraph 0029), when executed by at least one processor, cause the control system to:
receive the light from the sensing portion (Paragraphs 0019 and 0043);
analyze the light to determine a fluorescence; and based on the determined fluorescence (Paragraphs 0019 and 0043),
determine a measurement of oxygen tension of the fluid flowing through the flow pathway (Paragraphs 0019 and 0043).
It would have been obvious to one of ordinary skill in the art to have modified Hunter with Elster because Elster teaches the use of fluorescence as being known in the art (Paragraph 0010 of Elster) and thus the modification would yield predictable results and it allows for easy identification of areas of interest (Paragraph 0014 of Elster).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (US 2017/0196478) in view of Rhea, Jr. (US Patent No. 5916153) and Elster et al. (US 2010/0182415) and in further view of Chin et al. (US 2005/0137459).
Regarding claim 16, Hunter is silent on the barrier member. Chin teaches further comprising a barrier member between the sensing portion and the excitation portion to prevent contact between the excitation portion and the fluid flowing through the flow pathway (Paragraph 0023). It would have been obvious to one of ordinary skill in the art to have modified Hunter with Chin to prevent bodily fluids from contacting the light source (Paragraph 0025 of Chin).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (US 2017/0196478) in view of Rhea, Jr. (US Patent No. 5916153) and Elster et al. (US 2010/0182415) and in further view of Taboas et al. (US 2009/0215104).
Regarding claim 17, Hunter in view of Rhea and Elster is silent on the dye-impregnanted material. Taboas teaches wherein the sensing portion comprises a dye-impregnated material exhibiting a fluorescence based on an oxygen tension of a fluid to which it is exposed (Paragraphs 0033 and 0064). It would have been obvious to one of ordinary skill in the art to have modified Hunter in view of Rhea and Elster with Taboas because it enables non-invasive monitoring of oxygen tension (Paragraph 0033 of Taboas).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (US 2017/0196478) in view of Westphal et al. (US Patent No. 5769087).
Regarding claim 18, Hunter is silent on the determination of temperature differences. Westphal further comprising a control system configured to determine a difference in a temperature of the fluid in a patient and a temperature of the fluid in the flow pathway (Column 10, Line 61-Column 11, Line 15; body temperature is temperature of fluid in the patient and is continuously monitored/displayed along with urine temperature thus constituting a comparison). It would have been obvious to one of ordinary skill in the art to have modified Hunter with Westphal because it enables automation and continuous monitoring of the patient’s fluid levels (See description of Westphal).
Claim(s) 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (US 2017/0196478) in view of Kumhyr (US 2008/0249388).
Regarding claim 22, Hunter is silent on the optical module. Kumhyr teaches further comprising a control system in operable communication with the oxygen-sensing assembly, the control system comprising:
an optical module coupled to the oxygen-sensing assembly (Paragraph 0021; Figure 3; optical fibers); and
a communication interface coupled to the optical module (Figure 3; transmitter 309).
It would have been obvious to one of ordinary skill in the art to have modified Hunter with Kumhyr because it allows for continuous, precise data detection (Paragraphs 0005-0010 of Kumhyr).
Regarding claim 23, Hunter is silent on the use of the oxygen, flowrate, and temperature to qualify the oxygen level with bladder/kidney/flowpath oxygen levels. Kumhyr teaches further comprising a control system (304) in operable communication with the oxygen sensor (Paragraphs 0021 and 0025), the control system comprising at least one non-transitory computer-readable storage medium (306) storing instructions thereon that, when executed by at least one processor (304; Paragraph 0025), cause the control system to:
based at least partially on at least one of a detected oxygen level of the fluid in the flow pathway, a detected flowrate of the fluid in the flow pathway, and a detected temperature of the fluid in the flow pathway, determine an oxygen level of the fluid in a bladder or a kidney of a patient (Paragraph 0025).
It would have been obvious to one of ordinary skill in the art to have modified Hunter with Kumhyr because it allows for continuous, precise data detection (Paragraphs 0005-0010 of Kumhyr).
Regarding claim 24, Hunter is silent on the use of the oxygen, flowrate, and temperature to qualify the oxygen level with bladder/kidney/flowpath oxygen levels. Kumhyr teaches further comprising a control system (204) in operable communication with the oxygen sensor (Paragraphs 0021 and 0025), the control system comprising at least one non-transitory computer-readable storage medium (206) storing instructions thereon that, when executed by at least one processor (304; Paragraph 0025), cause the control system to:
based at least partially on at least one of a detected oxygen level of the fluid in the flow pathway, a detected flowrate of the fluid in the flow pathway, data from a flowrate sensor, and a detected temperature of the fluid in the flow pathway, qualify the at least one detected oxygen level to determine a relevance of the at least one detected oxygen level to one or more of a bladder oxygen tension, a kidney oxygen tension, and an oxygen level of the fluid in the flow pathway (Paragraph 0025).
It would have been obvious to one of ordinary skill in the art to have modified Hunter with Kumhyr because it allows for continuous, precise data detection (Paragraphs 0005-0010 of Kumhyr).
Allowable Subject Matter
Claim 5 (and subsequently claims 4, 6, 11-12, and 19-21) are allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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 PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791