DETAILED ACTION
Non-Final Rejection
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims Status
Claims 1-27, 34-36, and 43 are cancelled. Claims 28 and 38 are amended. Claims 28-33, 37-42, and 44-57 remain pending.
Response to Arguments
The objection to claim 28 is withdrawn in view of the amendments to the claim.
The objection to claim 38 is withdrawn in view of the amendments to the claim.
The 35 U.S.C. § 112(b) or 35 U.S.C. § 112, 2nd paragraph rejection of claim 28 in section 5.b of the previous Office Action is withdrawn in view of the amendment to the claim, but a new rejection is set forth below.
The 35 U.S.C. § 112(b) or 35 U.S.C. § 112, 2nd paragraph rejection of claim 38 in section 5.c of the previous Office Action is withdrawn in view of the amendment to the claim.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 28-33, 37-42, and 44-57 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Broadest reasonable interpretation to one of ordinary skill in the art for claims 28 and 38 indicate that sensing system may include a mix of RF sensors and ultrasound sensors. The Office could not find support in the application as originally filed that provide written description support for this feature. It appears that only multiple sensors of one type is contemplated (i.e. all RF or all ultrasound). The Office requests applicants identify the portion of the specification that support the claimed feature.
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 28-33, 37, and 48 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 28 recites a method of measuring the formation of pressure ulcers at a target location of a patient’s skin in the preamble. Steps for emitting and measuring reflecting signals are recited followed by determining sub-epidermal moisture levels at the locations where reflection occurs using the reflected signals. No steps are recited that connect the sub-epidermal moisture levels to the measurement of the formation of pressure ulcers at a target location (i.e. are the sub-epidermal moisture levels determined at the locations where reflection occurs related to formation of a pressure ulcer at the recited target location? How do the reflection locations relate to the target location?).
Claim 38 recites a system to indicate a likelihood of a presence or development of a skin ulcer in the preamble. Claim 38 recites the emission of a plurality of signals and the reception of a plurality of the signals reflected back to the sensor from different depths within the skin of a subject. Interface electronics are configured to identify SEM values indicative of a likelihood of the presence or development of a skin ulcer. However, it is unclear how the sub-epidermal moisture values relate to the reflected signals that are received.
Claim 48 states that the depths are selected based on 1+ characteristics. It is unclear what is performing the selecting.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 28-33, 37-40, 44, 45, 47-49, and 52 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Quintavalle et al. (Use of High-Resolution, High-Frequency Diagnostic Ultrasound to Investigate the Pathogenesis of Pressure Ulcer Development, Advances in Skin & Wound Care 19(9):p 498-505, November 2006) in view of Haim et al. (US 2006/0184034).
Regarding claim 28, Quintavalle et al. disclose a method of measuring formation of pressure ulcers at a target location of a patient’s skin (see highlighted portions of the Abstract on page 1) comprising:
emitting a first signal into a subject’s skin at a first location using a first sensor; measuring a first reflected signal of said first signal from said subject’s skin using said first sensor; emitting a second signal into said subject’s skin at a second location using said first sensor; measuring a second reflected signal of said second signal from said subject’s skin using said first sensor; and wherein said first sensor comprise a radiofrequency (RF) sensor, or an ultrasound sensor, wherein said first reflect signal and said second reflected signal are reflected from different target depths within said subject’s skin; and indicating a sub-epidermal moisture of said subject’s skin at said first location or said second location based at least in part on said first reflected signal or said second reflected signal (the highlighted portions on pages 499-501 substantially disclose the claimed features of using an ultrasound sensor to probe subepidermal moisture, because the sensor disclosed by Quintavalle can collect B-mode scans, the data necessarily includes several readings, the target depths are whatever locations the operator chooses to examine in the B-mode scan).
In the above cited portions, the Office stated that Quintavalle substantially disclosed the claimed features. However, the use of two sensors is not disclosed. Quintavalle discloses the use of one ultrasound sensor to probe different target sites, but does not expressly disclose that the ultrasound sensor comprises two sensors. However, Haim et al. teach an ultrasonic probe for medical applications (see [0002]-[0003]). Haim discloses that known prior art ultrasound probes includes ones with linear array probe for producing rectangular image of the tissue under examination ([0021]). Haim also teaches an ultrasound sensor that is comprised of multiple ultrasound sensing arrays used to collect data on tissue (see at least [0030]). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Quintavalle to use multiple ultrasound sensors, as taught by Haim, for probing tissue moisture because it can allow faster data collection over an area of the skin. There would have been a reasonable expectation of success given the demonstrated utility by Haim in diagnosing tissue.
Regarding claim 29, Quintavalle et al. disclose wherein said first sensor and said second sensor are positioned external to a surface of said subject's skin (the disclosed ultrasound sensor does this, see Diagnostic Ultrasound section on pg. 499, where it discloses sound waves transmitted into the body by the sensor).
Regarding claim 30, Quintavalle et al. disclose wherein said different target depths within said subject's skin are selected based on one or more characteristics of said subject (pg. 500, left col., 1st paragraph -anatomic sites predisposed to pressure ulcer development were selected; examples are provided in pg. 500, left col., 2nd – 3rd paragraphs), wherein said first sensor or said second sensor are selected to measure said different target depths. (pg. 500, left col., second paragraph – “The ultrasound gain (amplification), depth, and time/gain compensation were standardized for each anatomic site to ensure consistent results”).
Regarding claim 31, Quintavalle et al. disclose wherein said one or more characteristics of said subject comprise age, region of said subject to be measured, or skin anatomy (see claim 30 rejection where sites were selected based on region of said subject to be measured as well as skin anatomy).
Regarding claim 32, Quintavalle et al. do not disclose the method further comprising selecting a different first sensor or a different second sensor to reach a different target depth within said subject's skin. As noted in the claim 28 rejection, Quintavalle et al. appear to use a single ultrasound sensor to generate B-mode scans (scan of tissue along a single path). However, the Quintavalle was modified in view of the Haim reference to substitute Quintavalle’s sensor for Haim’s ultrasound sensor array in the claim 28 rejection. Haim teaches the use of multiple ultrasound sensor arrays operating independently to interrogate tissue (see at least [0030]). This teaching coupled with the discussion in the claim 30 rejection discussing Quintavalle’s depth of penetration would yield the claimed limitations. The rationale for modifying remains the same.
Regarding claim 33, Quintavalle et al. do not disclose wherein said first sensor is independently operated from said second sensor. However, the previously cited Haim reference teaches this (see at least [0030] where multiple sensing ultrasound sensing arrays maybe operated independently). The rationale for modifying remains the same.
Regarding claim 37, Quintavalle et al. discloses wherein said non-planar sensing surface comprises a body curvature or bony prominence (see pg. 500, left col., 1st paragraph where the scanned area including regions located over bony prominences).
Regarding claim 38, Quintavalle et al. disclose a system to indicate a likelihood of a presence or development of a skin ulcer (see Abstract where an ultrasound sensor was applied to determine how well it could be used to observing the pathogenesis of pressure ulcers in soft tissue) comprising:
an ultrasound sensor (Methods section starting on page 499 of Quintavalle disclose the use of an ultrasound sensor);
interface electronics coupled to said sensor (Methods section disclose that the ultrasound sensor is connected to custom ultrasound A-D board and a portable computer with operating software); wherein said interface electronics coupled to said sensor is configured to control:
emission of a plurality of signals from said sensor; and reception of a plurality of reflected signals from said subject’s skin (this is inherent in the disclosed ultrasound sensing system in Quintavalle operating to collect a B-mode scan), wherein said plurality of reflected signals are reflected from a plurality of depths within said subject’s skin (pg. 499, right col., 3rd paragraph discussion of ultrasound tissue depth sensing; see also pg. 500, left col., first paragraph discussion of sensor signal penetration depth); and wherein said interface electronics are further configured to (i) receive said plurality of reflected signals (the previously cited hardware is configured to receive the reflected ultrasound sensor data, see the Diagnostic Ultrasound discussion on pg. 499).
Quintavalle et al. do not disclose that the sensor is an array of sensors. However, this limitation is rejected in view of the Haim teachings as argued in the claim 28 rejection above.
Quintavalle et al. also do not disclose that the interface electronics are configured to identify sub-epidermal moisture (SEM) values indicative of a likelihood of the presence or development of a skin ulcer. Quintavalle. Quintavalle disclosed the examination of the ultrasound data by qualified experts who were trained to identify scans indicative of edema/moisture order to ascertain. Quintavalle et al. disclose that ultrasound imaging data provided readily identifiable patterns related to abnormal skin and tissue indicative (weak reflective patterns) indicative of increased fluid content or edema in tissue (see at least pg. 500, right col., last paragraph to pg. 501, left col., first paragraph). While trained nurses were able to identify such patterns and demonstrate the utility of ultrasound for detecting pressure ulcer pathogenesis patterns, an automated application of this identification process was not disclosed. However, MPEP 2144.04(III) states that “broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.” Further modifying Quintavalle to provide such an automated feature by the interface electronics would have been obvious in view of this section of the MPEP.
Regarding claim 39, Quintavalle et al. do not disclose wherein a sensor of said array of sensors is independently coupled to said interface electronics. However, this limitation follows from the independent operation argument cited in the claim 33 rejection in view of Haim. The rationale for modifying remains the same.
Regarding claim 40, Quintavalle et al. as modified in view of Haim teach wherein said array of sensors are configured to be positioned external to a surface of said subject's skin (Haim was used to substitute Quintavalle’s single ultrasound sensor for an array of ultrasound sensors, Quintavalle disclose that the ultrasound sensors are positioned external to the skin as noted in the Diagnostic Ultrasound section. The rationale for modifying remains the same.
Claim 44 is rejected using the same argument for claim 33 (Haim’s teaching of operating each array of sensors independently).
Claim 45 is rejected using the same argument for claim 33 (Haim’s teaching of operating each array of sensors independently).
Regarding claim 47, Quintavalle et al. as modified by Haim et al. teach wherein a first sensor of said array of sensors and a second sensor of said array of sensors interrogate said subject's skin at different depths (see the claim 30 rejection above).
Claim 48 is rejected using the same argument as found in claim 30 regarding characteristics.
Claim 49 is rejected using the same argument as claim 31.
Regarding claim 52, Quintavalle et al. disclose wherein said interface electronics are further configured to correlate said reflected signals with locations on said subject's skin (see at least Fig. 1A and 1B where the ultrasound data can be used to identify different skin regions).
Claims 41 and 42 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Quintavalle et al. in view of Haim et al. as applied to claim 38 above, and further evidenced by Episcan I-200 website (see attached printout of Longport website which manufacturers the scanner).
Regarding claim 41, Quintavalle et al. do not expressly disclose wherein said array of sensors are configured to conform to a non-planar sensing surface of said subject's skin. Quintavalle et al. disclose the use of an Episcan I-200 ultrasound scanner. The device is shown in the attached photo taken from the manufacturer’s website. As can be seen in the photo, the tip of the scanner itself is curved and would be able to conform to a variety of non-planar sensing surfaces on the skin of the subject.
Regarding claim 42, Quintavalle et al. discloses wherein said non-planar sensing surface comprises a body curvature or bony prominence (see pg. 500, left col., 1st paragraph where the scanned area including regions located over bony prominences).
Claim 46 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Quintavalle et al. in view of Haim et al. as applied to claim 38 above, and further in view of Tanaka et al. (US 2009/0301200).
Regarding claim 46, Quintavalle and Haim et al. do not disclose wherein a first sensor of said array of sensors and a second sensor of said array of sensors are insulated from each other. However, insulating ultrasonic transducers was known in the art at the time of the invention. Tanaka et al. teach an ultrasonic transducer probe and imaging device (see Abstract). The transducer comprises an array of ultrasonic sensors that are insulated (see at least [0010], [0103], and [0127]-[0128] which discusses the use of insulating material in the array). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to further modify Quintavalle et al. to insulate ultrasonic transducers from each other as taught by Tanaka et al. because it is the use of known technique to improve similar devices (methods or products) in the same way. The claim would have been obvious because the technique for improving a particular class of devices was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
Claim 50 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Quintavalle et al. in view of Haim et al. as applied to claim 38 above, and further in view of Smith et al. (US 6646556).
Regarding claim 50, Quintavalle et al. do not disclose the system further comprising a camera. However, Smith et al. teach an apparatus for preventing the formation of pressure ulcers (see Abstract). The device includes a video camera for capturing the position of the patient (see col. 14, 3rd paragraph). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to further modify Quintavalle to include a camera as taught by Smith et al. for measuring patient position because it can help prevent the formation of pressure ulcers.
Claim 51 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Quintavalle et al. in view of Haim et al. as applied to claim 38 above, and further in view of Larson et al. (US 2011/0263950). Quintavalle et al. do not disclose the system further comprising a radio frequency (RF) scanner, wherein said subject is identified via a RF identification. However, Larson et al. teach a system for preventing, detecting, and treating pressure ulcers (see Abstract). Larson et al. teach that the system may include RFID sensing capabilities (see [0051]). Larson et al. teach that it can be used to identify the patient (see [0134]). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to further modify Quintavalle et al. to include an RF scanner such as that taught by Larson et al. for RF identification purposes because it amounts to combining prior art elements according to known methods to yield predictable results. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claims 53-55 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Quintavalle et al. in view of Haim et al. as applied to claim 38 above, and further in view of the Office taking Official Notice. Quintavalle et al. do not disclose wherein said electronics package is configured to transfer said SEM values and said locations to a remote device, wherein said remote device is a computer, and wherein said SEM values and said locations are transferred via wireless communication. However, the Office takes Official Notice that transferring medical data to a remote device wirelessly is well known in the art (e.g. transferring data to a server for storage).
Claims 56-57 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Quintavalle et al. in view of Haim et al. as applied to claim 38 above, and further in view of the Office taking Official Notice as applied to claim 55 and further evidenced by Episcan I-200 website (see attached printout of Longport website which manufacturers the scanner).
Regarding claim 56, Quintavalle disclose that SEM data can be displayed as a map (see 2D image of data shown at least in Figs. 2A and 2B), but does not disclose that the data display is on a remote computer. However, the ultrasound system disclosed by Quintavalle et al. is an Episcan I-200. The website for the Episcan is included in this Office Action. One can see that the displays shown in Quintavalle are those found on a computer that is separate from the sensor system.
Regarding claim 57, Quintavalle disclose wherein said computer is configured to display a plot of changes in SEM values over time (Figs. 3A-3C show a progression of pressure ulcer development over time).
Conclusion
Claims 28-33, 37-42, and 44-57 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tho Q. Tran whose telephone number is (571)270-1892. The examiner can normally be reached 7-5.
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, Jacqueline Cheng can be reached at 5712725596. 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.
/THO Q TRAN/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791