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 § 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) 1-3, 8-11, 13-14, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent NO. 7971292 issued to Sithian over U.S. Patent No. 6415466 issued to Laios.
Regarding claim 1,
Sithian discloses a method for using a patient positioning and support system, (Sithian: FIGS. 1-4 (12, 14) see abstract “A bedsheet, a system, and a method for use thereof for elevating at least one leg or heel of the patient lying on a mattress is disclosed.”) the method comprising: placing a patient above a first sheet such that a … region of the patient is proximate to a first pocket, (Sithian: FIG. 1 (12) has a first sheet (16) that a patient lies upon, see also FIG. 2B (34) and col. 3 lines 54-65 “It will be appreciated that the first and second sheets 16, 24 of the bedsheet 12 together define an expandable first pocket 34 (FIG. 2B)) the first sheet being of the patient positioning and support system that includes a second sheet that cooperates with the first sheet and a first stitched region to define the first pocket, the first sheet coupled to the second sheet along the first stitched region; (Sithian: col. 3 lines 39-50 first and second sheets (16, 24) define a first pocket 34, (24) being attached to (16) via stitching) and inserting a first portion of a first support device in the first pocket (Sithian: FIG. 2B (14) and col. 3 lines 60-67 talk about a pillow (14) being inserted into the first pocket (34)) thereby elevating the …. region while supporting a sacral region of the patient and a leg region of the patient. (Sithian: FIG. 2B pillow (14) forms an elevated surface (39) that elevates the body region while the remaining body regions rest upon and are supported by the sheet (12) the examiner notes that depending on the dimension of the patient the sacral region may also be supported by the other pockets.)
Sithian does not appear to disclose elevating a head region.
However, Laiso discloses elevating a head region. (Laiso: FIG. 1 (12) elevates the head region of a patient via pillow (15) see col. 3 lines 30-42)
It would have been obvious for a PHOSITA before the effective filing date of the claimed invention to modify Sithina by positioning the first pocket of Sithian’s bedsheet so as to receive the first support device beneath, and thereby elevate, the head region of the patient, as taught by Laiso, while the sacral and leg regions remain supported by the first sheet. One of ordinary skill in the art would have been motivated to make this modification since Sithian identifies elevation of the patient’s head with pillows as a conventional and desirable caregiving practice (Sithian: background) and selecting the head as the region to be elevated amounts to applying Sithian’s own pocket-and-pillow technique to one of a finite number of body regions a caregiver would predictably wish to elevate.
Regarding claim 2,
Sithian in view of Laiso discloses the method of claim 1, wherein inserting the first portion of the first support device further comprises securing the first support device to an interior of the first pocket, the first support device including a first engagement region and the interior of the first pocket including a first pocket engagement region, the first engagement region engaging with the first pocket engagement region engaging to secure the first support device. (Sithian: col. 5 lines 40-56 talk about using hook and loop fasteners/buttons to secure pillows to the pockets)
Regarding claim 3,
Sithian in view of Laiso discloses the method of claim 1, further comprising: inserting a second portion of the first support device in the first pocket, such that the first support device is enclosed in the first pocket. (Sithian: col. 5 lines 40-56 talk about using hook and loop fasteners to secure pillows into the pockets)
Regarding claim 8,
Sithian in view of Laiso discloses the method of claim 1, further comprising: subsequent to inserting the first portion of the first support device in the first pocket, inserting a first portion of a second support device in a second pocket (Sithian: FIGS 1- 4B see col. 2 lines 15-21 which discloses a plurality of pockets (34, 36, 46) which all receive a pillow and teaches positioning a pillow in a pocket depending on what portion of the patient is to be elevated, thus Sithian discloses inserting a first portion of a second pillow into the second pocket 36 after the first pillow has been inserted into the first pocket 34) thereby elevating the sacral region while the second sheet supports the head region and the leg region, (The examiner notes that the combination of Sithian and Lasio read on this limitation since Lasio provides the teaching of the pocket for the head region and Sithian provides the teaching of multiple pockets in the leg region which depending on dimensions could be used to support the sacral region of a patient) the second sheet cooperating with the first sheet and a second stitched region to define the second pocket, the first sheet coupled to the second sheet along the second stitched region. (Sithian: col 3 lines 45-50 “The second and third sheets 24, 26 are both attached to the first sheet at the seams 30, 32.”)
Regarding claim 9,
Sithian in view of Laios discloses the method of claim 8, wherein: inserting the first portion of the first support device further comprises securing the first support device to an interior of the first pocket, (Sithian: col. 5 see FIG. 1 “various securement devices may alternatively or additionally be used to secure the pillow 14 within a given pocket” including hooks and fastener strips 50 provided to the inside of the pocket and to the pillow 14 to secure the pillow within one of the pockets 34, 36, 46) the first support device including a first engagement region and the interior of the first pocket including a first pocket engagement region, (Sithian: FIG. 1 fastener strip 50 or button 54 carried on the pillow 14 is a first engagement region, and the mating fastener strip 50 or slot 52 on the interior of the first pocket 34 is a first pocket engagement region) the first engagement region engaging with the first pocket engagement region engaging to secure the first support device; (Sithian: FIG. 1 see col. 5 and 2 complementary fasteners engage one another to secure the pillow 14 within the pocket, “at least one fastener is provided which is preferably positioned within at least one of the pockets for fastening the pillow”)) and inserting the first portion of the second support device further comprises securing the second support device to an interior of the second pocket, the second support device including a second engagement region and the interior of the second pocket including a second pocket engagement region, the second engagement region engaging with the second pocket engagement region engaging to secure the second support device. (The examiner notes that the combination of Laios and Sithian discloses this since Laios discloses a pocket in the head region and the teaching of inserting pillows into pockets simultaneously and Sithian discloses the engagement features)
Regarding claim 10,
Sithian in view of Laios discloses the method of claim 8, further comprising: subsequent to inserting the first portion of the second support device in the second pocket, inserting a first portion of a third support device in a third pocket (Sithian: col. 4-5 FIGS. 4A-4B discloses a plurality of pockets including third pocket 46, the pillow 14 being insertable into the third pocket 46 through its open end 46a thus Sithian discloses inserting a first portion of a third pillow into the third pocket 46 after a pillow has been inserted into the second pocket 36) thereby elevating the leg region while the second sheet supports the head region and the sacral region, the second sheet cooperating with the first stitched region and the second stitched region to define the third pocket. (Sithian: FIGS. 4A-4B see col. 5 “the third pocket 46 may be disposed under the upper leg of the patient” whereby the leg region is elevated while the remaining head and sacral regions rest upon and are supported by the sheets. Examiner notes that 30, 32 define first and second stitched regions)
Regarding claim 11,
Sithian in view of Laios discloses the method of claim 10, wherein: inserting the first portion of the first support device further comprises securing the first support device to an interior of the first pocket, (Sithian: col. 5 see FIG. 1 “various securement devices may alternatively or additionally be used to secure the pillow 14 within a given pocket” including hooks and fastener strips 50 provided to the inside of the pocket and to the pillow 14 to secure the pillow within one of the pockets 34, 36, 46) the first support device including a first engagement region and the interior of the first pocket including a first pocket engagement region, (Sithian: FIG. 1 fastener strip 50 or button 54 carried on the pillow 14 is a first engagement region, and the mating fastener strip 50 or slot 52 on the interior of the first pocket 34 is a first pocket engagement region) the first engagement region engaging with the first pocket engagement region engaging to secure the first support device; (Sithian: FIG. 1 see col. 5 and 2 complementary fasteners engage one another to secure the pillow 14 within the pocket, “at least one fastener is provided which is preferably positioned within at least one of the pockets for fastening the pillow”)) and inserting the first portion of the second support device further comprises securing the second support device to an interior of the second pocket, the second support device including a second engagement region and the interior of the second pocket including a second pocket engagement region, the second engagement region engaging with the second pocket engagement region engaging to secure the second support device; and inserting the first portion of the third support device further comprises securing the third support device to an interior of the third pocket, the third support device including a third engagement region and the interior of the third pocket including a third pocket engagement region, the third engagement region engaging with the third pocket engagement region engaging to secure the third support device. (The examiner notes that the combination of Laios and Sithian discloses this since Laios discloses a pocket in the head region and the teaching of inserting pillows into pockets simultaneously and Sithian discloses the engagement features)
Regarding claim 13,
Sithian in view of Laios discloses the method of claim 1, wherein placing the patient above the first sheet further comprises: placing the patient above the first sheet such that the sacral region is proximate to a second pocket, (Sithian: FIGS. 2A, 3A and col. 4-5 Sithian discloses placing the bedsheet 12 on the mattress and positioning the patient thereon relative to the pockets, the patient being placed such that the body region to be supported is proximate to the pocket used for that region) the second sheet cooperating with the first sheet and a second stitched region to define the second pocket, the first sheet coupled to the second sheet along the second stitched region. (Sithian: FIG. 1 (30, 32))
Regarding claim 14,
Sithian in view of Laios discloses the method of claim 13, wherein placing the patient above the first sheet further comprises: placing the patient above the first sheet such that the leg region is proximate to a third pocket, the second sheet cooperating with the first stitched region and the second stitched region to define the third pocket. (Sithian: FIG. 1 (30, 32) examiner notes that third pocket 46 is close to the leg region)
Regarding claim 19,
Sithian in view of Laios discloses the method of claim 1, further comprising:removing the first portion of the first support device from the first pocket thereby lowering the head region while supporting the sacral region and the leg region. (The examiner notes that Sithian and Laios both disclose removable pillows and simultaneous support of head and body regions by inserting pillows at the same time)
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent NO. 7971292 issued to Sithian over U.S. Patent No. 6415466 issued to Laios further in view of U.S. Publication NO. 20120073056 issued to Freund.
Regarding claim 4,
Sithian in view of Laiso discloses the method of claim 3.
Sithian does not appear to disclose further comprising: subsequent to inserting the second portion of the first support device in the first pocket, inserting a second support device in the first pocket, such that the first support device and the second support device are enclosed in the first pocket.
However, Freund discloses further comprising: subsequent to inserting the second portion of the first support device in the first pocket, inserting a second support device in the first pocket, such that the first support device and the second support device are enclosed in the first pocket. (Freund: FIG. 2 see [0021] “FIG. 2 shows the adjustable pillow with the three (3) inserts placed in the stretchable cover to provide an initial height, overall firmness and surface firmness. “)
It would have been obvious for a PHOSITA before the effective filng date of the claimed invention to insert a second support device into the first pocket of Sithian in view of Laiso as taught by Freund in order to permit a caregiver to adjust and tailor the elevation provided at the pocket to the head region of the patient.
Regarding claim 5,
Sithian in view of Laiso in view of Freund discloses the method of claim 4, wherein inserting the second support device further comprises securing the first support device and the second support device to an interior of the first pocket, the first support device including a first engagement region, the second support device including a second engagement region, the interior of the first pocket including a first pocket engagement region, the first engagement region and the second engagement region engaging with the first pocket engagement region to secure the first support device and the second support device. (The examiner notes that Sithian already discloses the engagement system (see claim 3) via hook and loop system (50) and/or buttons. When Freund is combined the engagement system would be applied to the second pillow inserted within the pocket)
Claim(s) 6-7, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent NO. 7971292 issued to Sithian over U.S. Patent No. 6415466 issued to Laios further in view of U.S. Publication NO. 5274862 issued to Palmer.
Regarding claim 6,
Sithian in view of Laiso discloses the method of claim 1.
Sithian in view of Laiso does not appear to disclose further comprising: prior to inserting the first portion of the first support device in the first pocket, rotating the patient from a supine position to a prone position.
However, Palmer discloses rotating the patient from a supine position to a prone position. (Palmer: col. 2 lines 64-67 “For the turning device 50 to turn a patient 60 from the supine position to a face down position middle section 52 should be approximately the width of or less than the width of the patient's torso 62.” And col. 1 lines 39-43 “Thus the age old tradition of turning over a patient every two hours by hand prevails and decubitus management for the immobile patient remains a serious problem.”)
It would have been obvious for a PHOSITA before the effective filing dateo f the claimed invention to rotate the patient of Sithian in view of Laiso from a supine position to a prone position prior to inserting the first support device, as taught by Palmer, in order to relieve pressure on the patient’s posterior and sacral surfaces and to manage decubitus formation by turning the immobile patient off of his or her back, consistent with turning practice.
Regarding claim 7,
Sithian in view of Laiso discloses the method of claim 1.
Sithian in view of Laiso does not appear to disclose further comprising: prior to inserting the first portion of the first support device in the first pocket, rotating the patient from a prone position to a supine position.
However, Palmer discloses rotating the patient from a supine position to a prone position. (Palmer: col. 2 lines 64-67 “For the turning device 50 to turn a patient 60 from the supine position to a face down position middle section 52 should be approximately the width of or less than the width of the patient's torso 62.” And col. 1 lines 39-43 “Thus the age old tradition of turning over a patient every two hours by hand prevails and decubitus management for the immobile patient remains a serious problem.” See claims 3 and 4 which talk about doing the reverse action i.e. supine to prone.)
It would have been obvious for a PHOSITA before the effective filing date of the claimed invention to rotate the patient of Sithian in view of Laiso from a prone position to a supine position prior to inserting the first support device, as taught by Palmer, in order to relieve pressure on the patient’s head stomach and thighs in order to manage decubitus formation by turning the immobile patient off of his or her back, consistent with turning practice.
Regarding claim 15,
Sithian in view of Laios discloses the method of claim 1, wherein placing the patient above the first sheet further comprises placing the patient in a … position such that a stomach region of the patient is proximate to a second pocket, (Sithian: FIGS. 2A, 3A col. 4 – 5 discloses placing the patient relative to the pockets such that body regions are supported by the pocket used for that region) the second sheet cooperating with the first sheet and a second stitched region to define the second pocket, the first sheet coupled to the second sheet along the second stitched region, (Sithian: FIG. 1 (30, 32)) and subsequent to inserting the first portion of the first support device in the first pocket, inserting a first portion of a second support device in the second pocket thereby elevating the stomach region while the second sheet supports the head region and the leg region. (The combination of Sithian and Laios discloses inserting a second pillow into the second pocket 36 after a pillow has been inserted into the first pocket, see FIGS. 3A and 3B of sithian. Examiner notes that Laios teaches inserting pillow simultaneously and Sithian teaches a 3 pocket region in the lower body area.)
Neither reference suggest the orientation of the patient.
However, Palmer discloses a prone position (Palmer: col. 2 lines 64-67 “For the turning device 50 to turn a patient 60 from the supine position to a face down position middle section 52 should be approximately the width of or less than the width of the patient's torso 62.” And col. 1 lines 39-43 “Thus the age old tradition of turning over a patient every two hours by hand prevails and decubitus management for the immobile patient remains a serious problem.”)
It would have been obvious for a PHOSITA before the effective filing dateo f the claimed invention to rotate the patient of Sithian in view of Laiso from a supine position to a prone position or vice versa prior to inserting the first support device, as taught by Palmer, in order to relieve pressure on the patient’s posterior and sacral surfaces and to manage decubitus formation by turning the immobile patient off of his or her back, consistent with turning practice.
Allowable Subject Matter
Claims 12, 16-18, 20 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM C ORTIZ whose telephone number is (303)297-4378. The examiner can normally be reached Monday - Friday 7:30 am-3:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justin C. Mikowski can be reached at 571-272-8525. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM C ORTIZ/Primary Examiner, Art Unit 3673
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