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
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.
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.
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) 1, 4-7 and 9-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Squitieri et al. (USPGPub 2013/0255699) in view of Newkirk et al. (USPGPub2008/0235872).
Regarding claims 1, 7 and 9, Squitieri teaches that it is known to provide a pressure mitigation apparatus comprising providing a first sheet comprising a “soft, low sheer, breathable fabric” which is implicitly at least air permeable wherein that first sheet is further lined with an impervious lining [0106] wherein the first sheet it attached to a lower sheet through interconnections between the first sheet and the lower sheet (abstract)(Fig. 2, 4b and 5) along the periphery and in the interior body of the sheet thereby creating cavities between the first and lower sheets where the shape of the cavities may be considered as an intertwined geometric pattern wherein an adhesive may be applied to the first sheet [0124](Fig. 5) to thereby provide tackiness to the pressure mitigation apparatus. Squitieri fails to teach application of an antimicrobial coating to the medical device. Further the examiner is taking Official Notice to inform the applicant that is in known to coat most surfaces in the medical field with antimicrobial coatings at least in the form of cleaning and decontamination agents as infections in hospitals are a major health concern. Additionally it is well known to provide coatings that may continue to inhibit bacterial growth such as those containing antibiotics, antifungals such as silver acetate and etc. In a broadest reasonably interpretation the applicants’ recitation reads upon the use of a antibacterial cleaning agent, the use of said agents is widespread in hospitals and doctors’ offices on most surfaces that patients may come in contact with. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide an antibacterial coating to the surfaces of Squitieri in order to prevent bacterial infection associated with contact from the first layer as is known by those of ordinary skill in the art. Squitieri fails to teach applying an adhesive to the underside surface of the pressure mitigation apparatus in order to attach it to the apparatus to an underlying substrate. Squitieri instead uses straps (Fig. 1). However, Newkirk teaches that in the patient support field straps and adhesives are generally considered to be functional equivalents described as mechanical couplings [0075]. Further, the mechanical couplings of Newkirk would all reasonably be described as temporary means in at least some version or one reading Newkirk would reasonably envisage at least temporary means. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute or combine the straps of Squitieri with a temporary adhesive as a simple substitution of one known mechanical attachment means for another in the patient orientation field wherein the results of said substitution or combination would have been predictable based upon the teachings of Newkirk.
Regarding claims 4 and 10-11, the device of Squitieri may be polyurethane [0106], including the body and liner, as is also used in the current application. Further it is noted that tackiness is a material quality of a given material and the use of a material to “naturally limit movement” is a recitation of intended use of the material of the prior art without an active step of “limiting movement”. Therefore this recitation is considered to be a mere recitation of intended use wherein so long as the prior art product is capable of being used as claimed, it necessarily would meet the limitations of the claims with regards to at least some undisclosed “underlying surface” that is generally claimed without limits.
Regarding claim 5, the teachings of Squitieri in view of Newkirk are a shown above. Squitieri in view of Newkirk fails to teach wherein the interconnections are formed via heat or melting. However, the examiner is taking Official Notice that it is known to heat bond plastic parts together, especially layers such as polyurethane in the prior art, as a known and common method of bond plastics together. This process is not limited to the pressure mitigation apparatus field or even the medical field. This process is known in most fields of manufacture including the manufacture of blow up toys and blow up beds and heating pads manufacture and etc. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to bond the layers of Squitieri in view of SQ2 by heat bonding or melting as a use of known bonding technique applied to a known device ready for improvement wherein the results of the use of said technique would be predictable based on the known predictability of using such techniques to those of ordinary skill in the art.
Regarding claim 6, the teachings of Squitieri in view of Newkirk are a shown above. Squitieri in view of Newkirk fails to teach wherein the interconnections are formed via an adhesive. However, the examiner is taking Official Notice that it is known to heat bond plastic parts together using glue or an adhesive as a known and common method of bond plastics together. This process is not limited to the pressure mitigation apparatus field or even the medical field. This process is known in most fields of manufacture including the manufacture of blow up toys and blow up beds and heating pads manufacture and etc. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to bond the layers of Squitieri in view of Newkirk by using an adhesive as a use of known bonding technique applied to a known device ready for improvement wherein the results of the use of said technique would be predictable based on the known predictability of using such techniques to those of ordinary skill in the art.
Regarding claim 12, Fig. 2 of Squitieri shows a plurality of areas that may read upon the longitudinally opposing chambers referenced herein with two sections specifically being labeled as “side supports” that are exemplary.
Regarding claim 13, air reads upon a “pliable material”.
Regarding claim 14, the teachings of Squitieri in view of Newkirk are as shown above. Squitieri in view of Newkirk fails to teach filling the fixed portions of his side supports with any of the pliable materials listed. However, the examiner is taking Official Notice to inform the applicant that along with air as is used by Squitieri, it is known to fill closed cushion portions of devices with cotton for example as a soft pliable material providing cushion. This practice is not limited to the pressure mitigation apparatus field or even the medical field. Pillows are frequently filled with cotton as are furniture items such as chairs and couches as well as stuffed animals and etc. Cotton stuffing is a well-known technique for filling of closed chambers intended for providing cushioning. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to fill the pliable section of Squitieri in view of Newkirk with cotton as a use of a known pliable filling material to improve similar cushioning devices in the same way.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Squitieri et al. (USPGPub 2013/0255699) in view of Newkirk et al. (USPGPub2008/0235872) as applied to claim 1 above and further in view of Squitieri (USPGPub 2016/0193090)(referred to herein as SQ2) .
Regarding claim 2, the teachings of Squitieri in view of Newkirk are as shown above. Squitieri in view of Newkirk as described above fails to teach providing perforations in the first sheet in order to allow for the passage of liquids into the chambers during use. However, SQ2 further teaches a pressure mitigation device wherein the top is provided with orifices so as to cause the patient in contact with the surface to be cool and dry, presumably by providing some air flow near the patient. Further although it is not stated that the intent of the orifices is to allow for the passage of liquid into the chamber, because the orifices are literally holes in the surface of the substrate that are “pin-sized”, the holes of SQ2 would seemingly allow for the passage of liquid into the device during use in the same manner claimed. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include the orifices of SQ2 into the invention of Squitieri in view of Newkirk in order to allow the patient to be cool and dry in the invention of Squitieri in view of Newkirk as was done in SQ2. Further, the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).
Regarding claim 3, Squitieri in view of SQ2 as described above fails to teach providing perforations in the second sheet in order to allow for the passage of liquids into the chambers during use. However, SQ2 further teaches that the first layer of the invention may further be provided with orifices so as to cause the patient in contact with the surface to be cool and dry, presumably by providing some air flow near the patient. Reasonably this logic would also apply to the second sheet of SQ2 wherein dissipating more air from the device would reasonably cool and dry the patient further as described above. Further although it is not stated that the intent of the orifices is to allow for the passage of liquid out of the chamber, because the orifices are literally holes in the surface of the substrate that are “pin-sized”, the holes of SQ2 would seemingly allow for the passage of liquid out of the device during use in the same manner claimed. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include the orifices of SQ2 into the invention of Squitieri in view Newkirk and SQ2 in the second sheet in order to allow the patient to be further cooled and dried in the invention of Squitieri in view of Newkirk and SQ2 as was done in SQ2. Further, the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Squitieri et al. (USPGPub 2013/0255699) in view of Lafleche et al. (USPGPub 2014/0059781).
Regarding claims 15, Squitieri teaches that it is known to provide a pressure mitigation apparatus comprising providing a first sheet comprising a “soft, low sheer, breathable fabric” which is implicitly at least air permeable wherein that first sheet is further lined with an impervious lining [0106] wherein the first sheet it attached to a lower sheet through interconnections between the first sheet and the lower sheet (abstract)(Fig. 2, 4b and 5) along the periphery and in the interior body of the sheet thereby creating cavities between the first and lower sheets where the shape of the cavities may be considered as an intertwined geometric pattern forming at least three chambers wherein an adhesive may be applied to the first sheet [0124](Fig. 5) to thereby provide tackiness to the pressure mitigation apparatus. Squitieri fails to teach the use of valves associated with the chambers for controlling the flow air to said chambers individually. However, Lafleche teaches that it is known to use valves to inflate and vary pressure within chambers of inflatable devices employed to prevent problems associated with pressure applied to the skin of a patient by said devices (see abstract and [0051-0064]). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to control the inflation of the chambers of the device of Squitieri using valves as described by LaFleche as a use of a known air control means in a similar device in the same way.
Regarding claim 16, the teachings of Squitieri in view of Lafleche are as shown above. Squitieri in view of Lafleche is silent with regards to the location of the valves. However, it should first be noted that reasonably, if the valves are fed by a single air source, it would be logical to provide valves pointing in the direction of the source of air which may be located beside the device on a single side as in shown by the air intake in Squitieri. However, further the apparatus of Squitieri in view of Lafleche would necessarily comprise an arrangement of valves wherein aligning the valves in a particular manner in the absence of a new and unexpected result would not support patentability of the claimed rearrangement over the prior art arrangement. Reasonably any arrangement provided would be considered an obvious matter of design choice for one of ordinary skill in the art to adjust the valve locations according to a variety of desired outcomings and structural limitations. See in re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) and in re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Squitieri et al. (USPGPub 2013/0255699) in view of Lafleche et al. (USPGPub 2014/0059781) as applied to claims 15-16 above and further in view of Newkirk et al. (USPGPub2008/0235872).
Regarding claims 17-18 , the teachings of Newkirk are reasonably applicable to the teachings of Squitieri in view of LaFleche in the same manner that they are applicable to the teachings of Squitieri alone in the rejection of claims 1, 4-7 and 9-14 above.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Squitieri et al. (USPGPub 2013/0255699) in view of Newkirk et al. (USPGPub2008/0235872) as applied to claims 1, 4-7 and 9-14 above and further in view of Carey Stachowski et al. (USPGPub 2012/0216949)
Regarding claim 19, Squitieri teaches that it is known to provide a pressure mitigation apparatus comprising providing a first sheet comprising a “soft, low sheer, breathable fabric” which is implicitly at least air permeable wherein that first sheet is further lined with an impervious lining [0106] wherein the first sheet it attached to a lower sheet through interconnections between the first sheet and the lower sheet (abstract)(Fig. 2, 4b and 5) along the periphery and in the interior body of the sheet thereby creating cavities between the first and lower sheets where the shape of the cavities may be considered as an intertwined geometric pattern wherein an adhesive may be applied to the first sheet [0124](Fig. 5) to thereby provide tackiness to the pressure mitigation apparatus. Squitieri fails to teach application of an antimicrobial coating to the medical device. Further the examiner is taking Official Notice to inform the applicant that is in known to coat most surfaces in the medical field with antimicrobial coatings at least in the form of cleaning and decontamination agents as infections in hospitals are a major health concern. Additionally it is well known to provide coatings that may continue to inhibit bacterial growth such as those containing antibiotics, antifungals such as silver acetate and etc. In a broadest reasonably interpretation the applicants’ recitation reads upon the use of a antibacterial cleaning agent, the use of said agents is widespread in hospitals and doctors’ offices on most surfaces that patients may come in contact with. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide an antibacterial coating to the surfaces of Squitieri in order to prevent bacterial infection associated with contact from the first layer as is known by those of ordinary skill in the art. Squitieri fails to teach applying an adhesive to the underside surface of the pressure mitigation apparatus in order to attach it to the apparatus to an underlying substrate. Squitieri instead uses straps (Fig. 1). However, Newkirk teaches that in the patient support field straps and adhesives are generally considered to be functional equivalents described as mechanical couplings [0075]. Further, the mechanical couplings of Newkirk would all reasonably be described as temporary means in at least some version or one reading Newkirk would reasonably envisage at least temporary means. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute or combine the straps of Squitieri with a temporary adhesive as a simple substitution of one known mechanical attachment means for another in the patient orientation field wherein the results of said substitution or combination would have been predictable based upon the teachings of Newkirk. The teachings of Squitieri in view of Newkirk are as shown above. Squitieri in view of Newkirk fails to teach the composition of the adhesive. However, Carey Stachowski teaches that silicone rubber is known to be used as an adhesive for the bonding of medical devices (claim 14) to surfaces (claim 11). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the silicone rubber Carey Stachowski for the adhesive of Squitieri in view of Newkirk as simple substitution of one adhesive material employed for the attachment of medical devices to surface for another wherein the substitution would have been predictable based upon the collective teachings of Newkirk and Carey Stachowski.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Squitieri et al. (USPGPub 2013/0255699) in view of Newkirk et al. (USPGPub2008/0235872) and Carey Stachowski et al. (USPGPub 2012/0216949) as applied to claim 19 above and further in view of Squitieri (USPGPub 2016/0193090)(referred to herein as SQ2).
Regarding claim 20, the teachings of SQ2 are applicable to the teachings of Squitieri in view of Newkirk and Carey Stachowski in the same manner that they are applicable to the teachings of Squitieri in view of Newkirk as applied to claims 2-3 above.
Response to Arguments
The applicants’ are generally moot in view of new grounds of rejection based on the current claim amendments that were not previously addressed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J BOWMAN whose telephone number is (571)270-5342. The examiner can normally be reached Mon-Sat 5:00AM-11:00AM.
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/ANDREW J BOWMAN/Examiner, Art Unit 1717
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