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 .
Claim Objections
Claim 8 is objected to because of the following informalities: line 24 of the claim has a typographical error in “wire or wirelessly”. Appropriate correction is required.
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 processor module in claim 8.
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.
Upon review of the disclosure, the Examiner has identified “one or more state machines and/or one or more processors to perform data analyses, trending and/or evaluations. The processor module may additional circuitry including circuitry to transmit the sensor data (e.g., raw data) and/or data of the analyses, trending and/or evaluations to other circuitry including data storage” as meeting the required disclosure for “processor module” interpreted under 112(f).
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.
(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) 1-5, 7-12, and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brownhill et al. (U.S. Patent Application Publication No. 2019/0290496) hereinafter referred to as Brownhill.
Regarding claim 1, Brownhill teaches a wound cover (Abstract) to, in operation, be disposed on or over a wound of a user (Fig. 2C, ¶[0038]) and temporarily affixed to a wound site, having the wound therein, of the user, the wound cover comprising:
a wound cover stack (Fig. 2C) having a plurality of layers formed in an integrated, unitary structure (Fig. 1A) including:
mesh pad layer (Fig. 2C, mesh layer element 105), having (i) an exposed, bottom surface that is configured to be placed over and/or in contact with at least a portion of the wound site that includes the wound (Fig. 2C, mesh layer 105, ¶[0078]) and (ii) a top surface that opposes the bottom surface of the mesh pad layer (Fig. 2C, mesh layer 105 has a bottom and top in orientation depicted, ¶[0078]);
a sensor layer (Figs. 3A-H), having a bottom surface and a top surface, wherein the bottom surface is disposed on the top surface of the mesh pad layer (¶¶[0085-0086] sensor integrated wound contact layer can either be directly in contact with the wound or in the next layer, therefore disposed on the top of the mesh pad layer), the sensor layer having a plurality of physiological sensors, configured to measure or detect physiological characteristics of the user and, in response, generate physiological data which are representative thereof (¶[0100]), including:
a thermocouple to detect a temperature of the wound site (¶[0101]), and
a communication layer (¶[0096]), disposed over the mesh pad layer (¶¶[0085-0086] sensor integrated wound contact layer can either be directly in contact with the wound or in the next layer, therefore disposed on the top of the mesh pad layer) and configured to wired and/or wirelessly output the physiological data measured or detected by the physiological sensors of the sensor layer to circuitry external to the wound cover (¶[0123]); and
an outer/adhesive layer (Fig. 2B, backing layer), having a bottom surface, a top surface and an adhesive edge which extends laterally beyond other layers the wound cover stack (Fig. 2B, extending beyond at least the absorbent and transmission layers), to, in operation, temporarily affix the wound cover to the wound site of the user (¶[0142]), wherein the bottom surface of the outer/adhesive layer is disposed over the mesh pad layer and the sensor layer of the wound cover stack (Fig. 2B, over element 222).
Regarding claim 2, Brownhill teaches the wound cover of claim 1.
Brownhill further teaches wherein: the plurality of physiological sensors of the sensor layer further includes: a chemical sensor to detect a pH of the wound site (¶[0098]).
Regarding claim 3, Brownhill teaches the wound cover of claim 1.
Brownhill further teaches wherein: the plurality of physiological sensors of the sensor layer further includes: a sensor to detect a blood flow in the wound site (¶[0113] pulsatile blood flow).
Regarding claim 4, Brownhill teaches the wound cover of claim 1.
Brownhill further teaches wherein: the plurality of physiological sensors of the sensor layer further includes: a bioimpedance sensor (¶[0111] conductivity or impedance sensor) to detect (i) a state of fluid in tissue of the wound site (¶[0111] exudate) and/or (ii) glucose metabolism of drainage of the wound (¶[0124] glucose levels, hydration).
Regarding claim 5, Brownhill teaches the wound cover of claim 1.
Brownhill further teaches wherein: the plurality of physiological sensors of the sensor layer further includes: a temperature sensitive strip (Fig. 3A, thermistor embedded in strip, see also Figs. 3B-H, ¶[0087]), operatively coupled to the wound site, to responsively output a temperature and/or changes in temperature of the wound site (¶[0101]).
Regarding claim 7, Brownhill teaches the wound cover of claim 1.
Brownhill further teaches wherein: the communication layer includes a connector or cabling (¶[0096]) configured to connect to the circuitry that is external to the wound cover (¶[0123]) and output the physiological data measured or detected by the physiological sensors of the sensor layer to the circuitry external to the wound cover (¶[0123]).
Regarding claim 8, Brownhill teaches a system to monitor the physiological conditions of a wound site, having the wound therein, of an animal (Abstract), the system including:
a wound cover (Abstract) to, in operation, be disposed on or over a wound of a user (Fig. 2C, ¶[0038]) and temporarily affixed to a wound site, having the wound therein, of the user, the wound cover comprising:
a wound cover stack (Fig. 2C) having a plurality of layers formed in an integrated, unitary structure (Fig. 1A) including:
mesh pad layer (Fig. 2C, mesh layer element 105), having (i) an exposed, bottom surface that is configured to be placed over and/or in contact with at least a portion of the wound site that includes the wound (Fig. 2C, mesh layer 105, ¶[0078]) and (ii) a top surface that opposes the bottom surface of the mesh pad layer (Fig. 2C, mesh layer 105 has a bottom and top in orientation depicted, ¶[0078]);
a sensor layer (Figs. 3A-H), having a bottom surface and a top surface, wherein the bottom surface is disposed on the top surface of the mesh pad layer (¶¶[0085-0086] sensor integrated wound contact layer can either be directly in contact with the wound or in the next layer, therefore disposed on the top of the mesh pad layer), the sensor layer having a plurality of physiological sensors, configured to continuously measure or detect physiological characteristics of the animal and, in response, generate physiological data which are representative thereof (¶[0100]); and
an outer/adhesive layer (Fig. 2B, backing layer), having a bottom surface, a top surface and an adhesive edge which extends laterally beyond other layers the wound cover stack (Fig. 2B, extending beyond at least the absorbent and transmission layers), to, in operation, temporarily affix the wound cover to the wound site of the user (¶[0142]), wherein the bottom surface of the outer/adhesive layer is disposed over the mesh pad layer and the sensor layer of the wound cover stack (Fig. 2B, over element 222); and
a processor module, configured to wire or wirelessly coupled to the wound cover (¶[0123] controller or control module), to receive, from the physiological sensors, the physiological data which are representative of the physiological characteristics of the animal and output a status of the wound (¶[0123]).
Regarding claims 9-12 and 14, the claims are directed to a system comprising substantially the same subject matter as claims 2-5 and 7 and are rejected under substantially the same sections of Brownhill.
Regarding claim 15, Brownhill teaches the system of claim 8.
Brownhill further teaches wherein: wound cover stack of the wound cover further includes a communication layer to wirelessly connect to the processor module and output the physiological data measured or detected by the physiological sensors of the sensor layer to the processor module (¶[0123] wireless).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brownhill et al. (U.S. Patent Application Publication No. 2019/0290496) hereinafter referred to as Brownhill; in view of Hunt et al. (U.S. Patent Application Publication No. 2022/0031231) hereinafter referred to as Hunt.
Regarding claim 16, Brownhill teaches a system to monitor the physiological conditions of a wound site, having the wound therein, of an animal (Abstract), the system including:
a wound cover (Abstract) to, in operation, be disposed on or over a wound of a user (Fig. 2C, ¶[0038]) and temporarily affixed to a wound site, having the wound therein, of the user, the wound cover comprising:
a wound cover stack (Fig. 2C) having a plurality of layers formed in an integrated, unitary structure (Fig. 1A) including:
mesh pad layer (Fig. 2C, mesh layer element 105), having (i) an exposed, bottom surface that is configured to be placed over and/or in contact with at least a portion of the wound site that includes the wound (Fig. 2C, mesh layer 105, ¶[0078]) and (ii) a top surface that opposes the bottom surface of the mesh pad layer (Fig. 2C, mesh layer 105 has a bottom and top in orientation depicted, ¶[0078]);
a sensor layer (Figs. 3A-H), having a bottom surface and a top surface, wherein the bottom surface is disposed on the top surface of the mesh pad layer (¶¶[0085-0086] sensor integrated wound contact layer can either be directly in contact with the wound or in the next layer, therefore disposed on the top of the mesh pad layer), the sensor layer having a plurality of physiological sensors, configured to continuously measure or detect physiological characteristics of the animal and, in response, generate physiological data which are representative thereof (¶[0100]); and
an outer/adhesive layer (Fig. 2B, backing layer), having a bottom surface, a top surface and an adhesive edge which extends laterally beyond other layers the wound cover stack (Fig. 2B, extending beyond at least the absorbent and transmission layers), to, in operation, temporarily affix the wound cover to the wound site of the user (¶[0142]), wherein the bottom surface of the outer/adhesive layer is disposed over the mesh pad layer and the sensor layer of the wound cover stack (Fig. 2B, over element 222).
Brownhill does not teach a wound cover reader, configured to wirelessly couple to the wound cover, via NFC techniques/circuitry, when in operable proximity thereto, to receive, from the physiological sensors, the physiological data which are representative of the physiological characteristics of the animal.
Attention is drawn to the Hunt reference, which teaches a wound cover (dressing, element 22, ¶[0174]) reader, configured to wirelessly couple to the wound cover, via NFC techniques/circuitry (¶[0174] communication performed over wireless interface via NFC, RFID or the like), when in operable proximity thereto (¶[0174] placed in proximity), to receive, from the physiological sensors, the physiological data which are representative of the physiological characteristics of the animal. (¶[0174]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the wound cover system of Brownhill to include NFC, as taught by Hunt, because improving information gathering via wireless communication, as taught by Hunt, provides a benefit to “nearly all areas of medicine” (Hunt, ¶[0003]).
Regarding claims 17 and 19-20, the claims are directed to a system comprising substantially the same subject matter as claims 2 and 4 and are rejected under the same sections of Brownhill, as in the rejection above.
Regarding claim 18, Brownhill as modified teaches the system of claim 16.
Hunt further teaches wherein: at least one physiological sensor of the plurality of physiological sensors of the sensor layer of the wound cover is energized, via NFC techniques/circuitry, when the wound cover reader is in operable proximity to the wound cover (¶[0174] data is requested by reader when in proximity to sensor, energizing sensor for transfer of data).
Claim(s) 6 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brownhill as applied to claims 1 and 8 above, and further in view of Hyde et al. (U.S. Patent Application Publication No. 2017/0136265) hereinafter referred to as Hyde.
Regarding claims 6 and 14, Brownhill teaches the wound cover of claim 1/8.
Brownhill does not specifically teach an electrical power layer to power one or more of the physiological sensors of the plurality of physiological sensors of the sensor layer.
Attention is brought to the Hyde reference, which teaches an electrical power layer (¶[0080]) to power one or more physiological sensors of a plurality of physiological sensors of a sensor layer (¶[0086]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the layers of Brownhill to include a power layer, as taught by Hyde, for a functionality improvement such as wireless charging (Hyde ¶[0080]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2019/0082242 to Duesterhoft et al. teaches a wound dressing including NFC communication and sensors, in a layered unitary design.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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, Unsu Jung can be reached at (571) 272-8506. 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.
/AMANDA L STEINBERG/Examiner, Art Unit 3792