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 the Application
Claims 1—15 have been examined in this application. This communication is the first action on merits. The Information Disclosure Statement (IDS) filed on 01/24/2025 has been acknowledged by the Office.
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 (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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 & 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S Patent Application 2014/0007346 A1 to Lachenbruch (Lachenbruch hereafter).
As per claim 1, Lachenbruch teaches
A controller (16—Fig.1; para [0047]) comprising: a structural body (10—Fig.1; para [0035]) that includes an egress interface (40—Fig.1; para [0035]) to which a pressure-mitigation apparatus (18 & 32—Fig.2; para [0038]) is fluidly coupled (para [0035]), wherein the pressure-mitigation apparatus includes a plurality of chambers (32—Fig.3 para [0038]) and is situated between a human body and a surface (Fig.4: pressure mitigation apparatus 18 positioned between human body and a surface); a sensor that is configured to output a signal that is indicative of a monitored characteristic of the human body (56—Fig.5; para [0048-49]); a processor (para [0053]); and a memory (72—Fig.5) that includes instructions for regulating a flow of fluid to inflate the
plurality of chambers of the pressure-mitigation apparatus in a controlled manner (72—Fig.5; para [0053]), wherein the instructions, when executed by the processor, cause the processor to: identify a programmed pattern that corresponds to the pressure-mitigation apparatus (para [0053]; claim 11), and cause the plurality of chambers to be inflated to varying degrees in accordance with the programmed pattern (para [0053]; claim 1), thereby shifting a force that is applied to the human body by the surface over time (para [0053]; claim 11).
As per claim 8, Lachenbruch teaches:
The controller of claim 1, wherein the instructions further cause the processor to: adjust the programmed pattern in response to a determination that the signal satisfies a predetermined criterion (para [0053]; claim 1).
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 (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.
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.
Claim(s) 2 & 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over in view of U.S Patent Application 2014/0007346 A1 to Lachenbruch in view of U.S Patent Application 2007/0239782 A1 to Schneider (Schneider hereafter) U.S Patent Application 2009/0287076 A1 to Boyden (Boyden hereafter).
As per claim 2, Lachenbruch teaches The controller of claim 1.
Lachenbruch does not teach, wherein the sensor is a vascular scanner that includes(i) an emitter operable to emit electromagnetic radiation into an anatomical region situated proximate to the vascular scanner and (ii) a detector operable to detect electromagnetic radiation reflected by physiological structures inside the anatomical region.
Schneider teaches, wherein the sensor is a vascular scanner (28-Fig.1; para [0036]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Lachenbruch (directed to a pressure mitigation system including a sensor configured to receive a patient input) and Schneider (directed to a system provided with a biometric authentication including a vascular scanner) and arrived at a pressure mitigation system including a sensor configured to receive a patient input provided with a biometric authentication including a vascular scanner. One of ordinary skill in the art would have been motivated to make such a combination to authenticate the identity of a test subject as taught in Schneider (para [0036]).
Lachenbruch (as modified) does not teach, [wherein the sensor is a vascular scanner]that includes(i) an emitter operable to emit electromagnetic radiation into an anatomical region situated proximate to the vascular scanner and (ii) a detector operable to detect electromagnetic radiation reflected by physiological structures inside the anatomical region.
Boyden teaches, wherein the includes(i) an emitter operable to emit electromagnetic radiation into an anatomical region situated proximate to the vascular scanner (106-Fig.1; para [0099]) and (ii) a detector (136-Fig.1; para [0117])operable to detect electromagnetic radiation reflected by physiological structures inside the anatomical region.
Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Lachenbruch (directed to a pressure mitigation system including a sensor configured to receive a patient input) and Schneider (directed to a system provided with a biometric authentication including a vascular scanner) and Boyden (directed to a method detect e-mag radiation reflected by tissue provided with an emitter and detector ) and arrived at a pressure mitigation system including a sensor configured to receive a patient input provided with a biometric authentication including a vascular scanner. One of ordinary skill in the art would have been motivated to make such a combination to compare the detected optical energy absorption profile of the biological subject as taught in Boyden (para [0251]).
As per claim 4, Lachenbruch teaches: The controller of claim 2.
Boyden teaches, wherein the instructions further cause the processor to: generate a digital image based on the detected electromagnetic radiation, and store the digital image in the memory as a reference template for vasculature in the anatomical region (para [0039]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Lachenbruch (directed to a pressure mitigation system including a sensor configured to receive a patient input) and Boyden (directed to a method detect e-mag radiation reflected by tissue provided with an emitter and detector) and arrived at a pressure mitigation system including a sensor configured to receive a patient input provided with a biometric authentication including a vascular scanner. One of ordinary skill in the art would have been motivated to make such a combination to compare the detected optical energy absorption profile of the biological subject as taught in Boyden (para [0251]).
Claim(s) 6 &7 is/are rejected under 35 U.S.C. 103 as being unpatentable over in view of U.S Patent Application 2014/0007346 A1 to Lachenbruch in view of U.S Patent 9,700,247 B2 to Dixon et. al (Dixon hereafter).
As per claim 6, Lachenbruch teaches The controller of claim 1.
Lachenbruch does not teach, wherein the sensor is a pulse oximeter that is operable to infer oxygen saturation in an anatomical region situated proximate to the pulse oximeter from analysis of peripheral oxygen saturation readings.
Dixon teaches, wherein the sensor is a pulse oximeter (700-Fig.7; Col 3 lines 1—23) that is operable to infer oxygen saturation in an anatomical region situated proximate to the pulse oximeter from analysis of peripheral oxygen saturation readings (Col 3 lines 1—23).
Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Lachenbruch (directed to a pressure mitigation system including a sensor configured to receive a patient input) and Dixon (directed to a patient support provided with a pulse oximeter operable to infer oxygen saturation) and arrived at a pressure mitigation system including a sensor configured to receive a patient input provided with a biometric authentication including a vascular scanner with a pulse oximeter operable to infer oxygen saturation. One of ordinary skill in the art would have been motivated to configure the display according to the needs of a particular healthcare environment or healthcare situation, in a similar fashion as discussed above as taught in Dixon (Col 9 Lines 45—50).
As per claim 7, Lachenbruch teaches The controller of claim 1.
Lachenbruch does not teach, further comprising: a display mechanism on which information is displayable; wherein the instructions further cause the processor to: compute, in an ongoing manner, values for a vital sign based on an analysis of the signal, and cause display of the values on the display mechanism.
Dixon teaches, further comprising: a display mechanism on which information is displayable (724-Fig.7; Col 3 lines 1—23); wherein the instructions further cause the processor to: compute, in an ongoing manner, values for a vital sign based on an analysis of the signal, and cause display of the values on the display mechanism (728-Fig.7; Col 3 lines 1—23).
Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Lachenbruch (directed to a pressure mitigation system including a sensor configured to receive a patient input) and Dixon (directed to a patient support provided with a pulse oximeter operable to infer oxygen saturation) and arrived at a pressure mitigation system including a sensor configured to receive a patient input provided with a biometric authentication including a vascular scanner with a pulse oximeter operable to infer oxygen saturation. One of ordinary skill in the art would have been motivated to configure the display according to the needs of a particular healthcare environment or healthcare situation, in a similar fashion as discussed above as taught in Dixon (Col 9 Lines 45—50).
Allowable Subject Matter
Claim 3 & 5 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: dependent claims 3 & 5 respectfully recite:
wherein the instructions further cause the processor to: generate a digital image based on the detected electromagnetic radiation, compare the digital image against a reference template for vasculature in the anatomical region, and determine whether to authorize use of the controller based on whether the digital image matches the reference template
wherein the emitter is further operable to emit, at a
given time, electromagnetic radiation into the anatomical region after an interval of time has elapsed, and wherein the instructions further cause the processor to: generate a second digital image based on the electromagnetic radiation as detected by the detector at the given time, and compare the second digital image against the digital image to establish changes, if any, in the vasculature in the anatomical region over the interval of time.
Regarding dependent claims 3 & 5, The closest prior art of record U.S Patent Application 2014/0007346 A1 to Lachenbruch teaches a pressure mitigation system including a controller, sensor, processor and memory including instructions to regulate flow in the inflatable chambers of the pressure mitigation system. The processor is configured to identify a programmed pattern based on output signals of a characteristic of the human body. Lachenbruch fails to teach wherein the sensor is a vascular scanner and the output signal is the detected electromagnetic radiation reflected by physiological structures inside the anatomical region.
U.S Patent Application 2007/0239782 A1 to Schneider discloses systems and methods of conducting clinical research. Schneider teaches wherein a sensor is a vascular sensor, however the reference fails to teach wherein [the sensor is a vascular scanner]that includes(i) an emitter operable to emit electromagnetic radiation into an anatomical region situated proximate to the vascular scanner and (ii) a detector operable to detect electromagnetic radiation reflected by physiological structures inside the anatomical region.
U.S Patent Application 2009/0287076 A1 to Boyden a monitoring device capable of real time imaging of biological tissue. Modifying the sensor of Lachenbruch produces a vascular scanner of Schneider and further modified by Boyden’s emitter and detector operable to emit and detect electromagnetic radiation reflected by physiological structure inside an anatomical region. However the combination of Lachenbruch and Schneider and Boyden fail to produce a controller configured to:
cause the processor to: generate a digital image based on the detected electromagnetic radiation, compare the digital image against a reference template for vasculature in the anatomical region, and determine whether to authorize use of the controller based on whether the digital image matches the reference template
nor does modified Lachenbruch teach:
wherein the emitter is further operable to emit, at a
given time, electromagnetic radiation into the anatomical region after an interval of time has elapsed, and wherein the instructions further cause the processor to: generate a second digital image based on the electromagnetic radiation as detected by the detector at the given time, and compare the second digital image against the digital image to establish changes, if any, in the vasculature in the anatomical region over the interval of time.
The examiner submits that while incorporating a vascular scanner to the pressure mitigation system may considered an obvious modification in view of the prior art. The examiner holds that integrating instructions to inflate bladders of the pressure mitigation system based on compared electromagnetic radiation images obtained by the emitter and detector units may be considered non-obvious combination. Therefor upon exhausting the art, it is concluded by the examiner for those reasons stated above that inconsideration with deficiencies of the prior art, that applicant' s invention would be considered non-obvious in light of the prior art.
Claim 9—15 allowed.
The following is an examiner’s statement of reasons for allowance:
Independent claims 9 & 14, are allowed for the analysis provided of claims 3 and 5 above.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S Patent Application 2014/0290670 A1 to Squitieri (Squitieri hereafter) teaches a pressure-mitigating contact portion of the contact surface includes a plurality of independently pressurized chambers configured in a specific geometric pattern that is designed to mitigate contact pressure between a support surface (e.g., bed or chair) and a specific anatomic region of a patient's body when the specific anatomic region of the patient's body is oriented over an epicenter of the geometric pattern.
U.S Patent Application 2018/0296103 A1 to Rege et. al teaches a vascular imaging system, comprising: One or more illumination modules configured to generate at least one type of coherent light to illuminate the target tissue; One or more camera modules, comprising at least one camera sensor or image acquisition device, configured to capture light that is reflected or scattered by the target tissue
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Deborah T Gedeon whose telephone number is (571)272-8863. The examiner can normally be reached Mon - Fri 8:30am to 4:30pm EST.
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/D.T.G./Examiner, Art Unit 3673 05/16/2026
/JUSTIN C MIKOWSKI/Supervisory Patent Examiner, Art Unit 3673
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