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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites the limitation "extending along the side of the foot" in line 4, “extending along the heel” in line 5, “adjacent to the patient’s foot” in line 8, and “adjacent the patient’s heel” in line 12.
Claim 2 recites the limitation “positioned immediately below the patient’s heel” in lines 1-2.
Claim 13 recites the limitation “positioned below the sole” in line 3, "extending along the side of the foot" in line 4, “extending along the heel” in line 5, and “securing the heel protector to the patient’s foot” in line 7.
Claim 15 recites the limitation “adjacent to the patient’s foot” in line 2.
Claim 18 recites the limitation “positioned below the sole” in line 3, "extending along the side of the foot" in line 4, “extending along the heel” in line 5, and “adjacent to the patient’s foot” in line 7.
These limitations are positive recitations of a human organism. Language such as “configured to extend…” or “configured to be adjacent to…” is suggested.
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) 1-3 and 5-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riesinger (10,470,933) in view of Wong et al. (9,291,589).
With respect to claim 1, Riesinger discloses a heel protector comprising a boot shaped portion, as shown in figure 21, comprising a lower portion positioned below the sole of the foot, side portions extending along the side of the foot over the ankle, and a rear portion extending along the heel, as shown in figure 22. The rear portion is fully capable of cushioning the heel from contact with a patient support surface. A strap is provided to secure the heel protector to the foot, as disclosed in column 9, lines 34-42. An inner liquid permeable layer 14 comprises a first side and a second side, as shown in figure 1.
Riesinger discloses all aspects of the claimed invention with the exception of a first sensor adjacent the inner liquid permeable layer second side. Wong teaches providing a sensor 350 adjacent the second side of a liquid permeable layer 322 of an absorbent article, as shown in figure 3, to indicate to a patient or caregiver when the article is damp without needing to inspect the article, as disclosed in column 1, lines 13-21. It would therefore have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the heel protector of Riesinger with a first sensor adjacent the inner liquid permeable layer second side, as taught by Wong, to allow a patient or caregiver to know when the article is damp without needing inspection.
With respect to claim 2, Wong teaches sensors extending the length of the article, as shown in figure 1, and therefore when Riesinger is modified to comprise a first sensor running the length of the article, as taught by Wong, a portion of the first sensor will be positioned immediately below the patient’s heel during use of the article of Riesinger.
With respect to claim 3, the first sensor is a moisture sensor, as taught by Wong.
With respect to claim 5, the first sensor is a moisture sensor, as taught by Wong, and therefore indicates that fluid has reached the sensor.
With respect to claim 6, the first sensor indicates that fluid has penetrated a first distance (i.e. the distance from the first side of the inner permeable layer and the location of the first sensor).
With respect to claim 7, Riesinger further discloses an absorbent layer 13 adjacent the inner permeable layer 14, as shown in figure 1.
With respect to claim 8, Wong teaches the first sensor 350 is adjacent a first side of the absorbent layer 326 and positioned between the absorbent layer 326 and the inner liquid permeable layer 322, as shown in figure 3.
With respect to claims 9-11, Wong further teaches a second fluid sensor 352 positioned adjacent a second side of the absorbent layer 326 opposite the first sensor 350, as shown in figure 3.
With respect to claim 12, the second sensor indicates that fluid has penetrated a second distance (i.e. the distance from the first side of the inner permeable layer and the location of the second sensor). Wong teaches that the second distance is greater than the first distance because the second sensor is located further from the first side of the inner permeable layer, as shown in figure 3.
With respect to claim 13, Riesinger discloses a heel protector comprising a boot shaped portion, as shown in figure 21, comprising a lower portion positioned below the sole of the foot, side portions extending along the side of the foot over the ankle, and a rear portion extending along the heel, as shown in figure 22. The rear portion is fully capable of cushioning the heel from contact with a patient support surface. A strap is provided to secure the heel protector to the foot, as disclosed in column 9, lines 34-42.
Riesinger discloses all aspects of the claimed invention with the exception of a first sensor positioned on an inside surface. Wong teaches providing a sensor 350 positioned on an inside surface of an absorbent article, as shown in figure 3, to indicate to a patient or caregiver when the article is damp without needing to inspect the article, as disclosed in column 1, lines 13-21. It would therefore have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the heel protector of Riesinger with a first sensor positioned on an inside surface, as taught by Wong, to allow a patient or caregiver to know when the article is damp without needing inspection.
With respect to claim 14, Riesinger further discloses an inner liquid permeable layer 14, as shown in figure 1.
With respect to claim 15, the inner liquid permeable layer 14 comprises a first side adjacent to the patient and a second side, as shown in figures 1 and 22.
With respect to claim 16, Wong teaches positioning the first sensor 350 adjacent the first side of inner liquid permeable layer 322, as shown in figure 3.
With respect to claim 17, Wong teaches positioning the first sensor 350 adjacent the second side of inner liquid permeable layer 322, as shown in figure 3.
With respect to claim 18, Riesinger discloses a heel protector comprising a boot shaped portion, as shown in figure 21, comprising a lower portion positioned below the sole of the foot, side portions extending along the side of the foot over the ankle, and a rear portion extending along the heel, as shown in figure 22. The rear portion is fully capable of cushioning the heel from contact with a patient support surface. An inner liquid permeable layer 14 comprises a first side and a second side, as shown in figure 1. An absorbent layer 13 is positioned adjacent to the inner liquid permeable layer second side, as shown in figure 1.
Riesinger discloses all aspects of the claimed invention with the exception of a first sensor positioned between the inner liquid permeable layer and the absorbent layer and a second sensor positioned adjacent a second side of the absorbent layer. Wong teaches providing a first sensor 350 between a liquid permeable layer 322 and an absorbent layer 326 of an absorbent article, and a second sensor 352 adjacent a second side of the absorbent layer 326 opposite the first sensor 350, as shown in figure 3. Wong teaches that the first and second sensors indicate to a patient or caregiver when the article is damp without needing to inspect the article, as disclosed in column 1, lines 13-21. It would therefore have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the heel protector of Riesinger with a first sensor positioned between the inner liquid permeable layer and the absorbent layer and a second sensor positioned adjacent a second side of the absorbent layer, as taught by Wong, to allow a patient or caregiver to know when the article is damp without needing inspection.
With respect to claim 19, the first sensor indicates that fluid has penetrated a first distance (i.e. the distance from the first side of the inner permeable layer and the location of the first sensor).
With respect to claim 20, the second sensor indicates that fluid has penetrated a second distance (i.e. the distance from the first side of the inner permeable layer and the location of the second sensor). Wong teaches that the second distance is greater than the first distance because the second sensor is located further from the first side of the inner permeable layer, as shown in figure 3.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riesinger (10,470,933) in view of Wong et al. (9,291,589), and further in view of Chen et al. (11,229,553).
With respect to claim 4, modified Riesinger discloses all aspects of the claimed invention with the exception of the first sensor comprising an RFID tag. Chen teaches the use of an RFID tag in a fluid sensor for use in an absorbent article in order to provide an alert from the sensor, as disclosed in column 2, lines 33-48. It would therefore have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the first sensor of modified Riesinger with an RFID tag, as taught by Chen, to provide a signal to alert a caregiver when the sensor senses fluid.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patents and Publications 7,458,948; 9,615,658; 10,195,087; and 2019/0262180 disclose bandages or protectors for heels.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNNE ANDERSON whose telephone number is (571)272-4932. The examiner can normally be reached Monday-Friday 10-6.
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/CATHARINE L ANDERSON/ Primary Examiner, Art Unit 3781
