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) 1-14 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Squitieri (USPGPub2014/0048081) in view of Karim et al. (USPGPub 2016/0166422).
Regarding claims 1-2, Squitieri teaches that it is known to provide a patient orienting device capable of mitigating localize pressure to areas of a patients body where the device comprises a plurality of chambers that may be inflated over time (abstract) which may include chambers having first, second and third interfaces wherein the second and third chambers reasonably envelop the first chamber (see Fig. 7). Squitieri fails to teach wherein a coating is applied to the device to aid in the attachment of the device to the underlying surface. However it is noted that Squitieri does show a desire for the device to be somewhat held in place because of the shown use of straps (see Fig. 3B). However, Karim shows that it is known to secure medical devices to underlying surfaces using adhesives such as silicone rubber so as to allow temporary attachment [0043]. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the adhesive of Karim in addition to or as a substitute for the straps of Squitieri to provide hold in a more specific location or better hold or in order to do away with the need for straps and unbuckling them wherein the use of adhesive in the place of straps would be both predictable and be expected to be functional for the intended use of Squitieri.
Regarding claim 3, Squitieri further teaches wherein the top layer may comprise a breathable fabric [0012] and the remainder of the device may be made from an impermeable material that provides air tight chambers [0103].
Regarding claim 4, the teachings of Squitieri in view of Karim are as shown above. Squitieri fails to teach wherein the periphery of the device is shaped as defined. However, the variation in claim language would be considered a mere change in shape of the periphery of the device of Squitieri wherein the Court has long held that in the absence of a new and unexpected results arising from a change in shape of a prior art product, changes in shape of prior art products are not capable of overcoming a prima facie case of obviousness. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 5, according to claim Fig. 7 the structure of Squitieri is generally symmetrical across a longitudinal axis and not across the latitudinal axis. However, the variation in shape between Squitieri and the current application would be considered a mere change in shape of the periphery of the device of Squitieri wherein the Court has long held that in the absence of a new and unexpected results arising from a change in shape of a prior art product, changes in shape of prior art products are not capable of overcoming a prima facie case of obviousness. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 6, the teachings of Squitieri in view of Karim are as shown above. Squitieri fails to show more than three chambers in the example cited above. However, the addition of chambers to the invention of Squitieri would be considered a mere duplication of parts wherein the Court has long held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See in reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Further modifying the arrangement of chambers would be considered a mere rearrangement of parts wherein the rearrangement of parts that would not have modified the fundamental operation of the device are held to be obvious matters of design choice. See in re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). See also in re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
Regarding claim 7, all chambers of Squitieri previously present function in the manner claimed.
Regarding claim 8, the interfaces of Squitieri are capable of being coupled in the manner claimed but it is noted that the current claim does not require them to be coupled but instead only requires them to be capable of being connected to tubing that is not necessarily part of the claimed device.
Regarding claim 9, as cited above as relates to a top breathable layer it is noted that the top breathable layer is part of a top layer that comprises a top breathable layer and a second impervious layer that is located between the breathable layer and the lower impervious layer forming the lower portion of the chambers.
Regarding claims 10 and 12-13, Squitieri teaches that it is known to provide a patient orienting device capable of mitigating localize pressure to areas of a patient’s body where the device comprises a plurality of chambers that may be inflated over time (abstract) which may include chambers having first, second and third interfaces wherein the second and third chambers reasonably envelop the first chamber (see Fig. 7). Squitieri fails to teach wherein a coating is applied to the device to aid in the attachment of the device to the underlying surface. However it is noted that Squitieri does show a desire for the device to be somewhat held in place because of the shown use of straps (see Fig. 3B). However, Karim shows that it is known to secure medical devices to underlying surfaces using adhesives such as silicone rubber so as to allow temporary attachment [0043]. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the adhesive of Karim in addition to or as a substitute for the straps of Squitieri to provide hold in a more specific location or better hold or in order to do away with the need for straps and unbuckling them wherein the use of adhesive in the place of straps would be both predictable and be expected to be functional for the intended use of Squitieri.
Regarding claim 11, the list of possible adhesives coatings provided by Karim includes several material that are generally considered to be liquid impervious.
Regarding claim 14, the teachings of Squitieri in view of Karim are as shown above. Squitieri in view of Karim fails to teach the use of a temporary cover provided over the adhesive present until an intended time of use. However, the examiner is taking Official Notice to inform the applicant that it is generally known in the field of adhesives to provide temporary covers for adhesives so as to preserve their tack until a time of use. This is known to be done in product such as Band-aids, wall-hangers, tapes (both one and two sided), stickers, decals 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 provide a temporary covering for the exterior of the adhesive coating of Squitieri in view of Karim in order to allow maintenance of the adhesive quality of the coating until the intended time of use.
Regarding claim 16, as shown in Fig. 7, the chambers are generally intertwined allowing for the operation claimed.
Regarding claim 17, Squitieri further teaches wherein the top of the apparatus is provided with an adhesive coating the would presumably function as claimed (see Fig. 5).
Regarding claim 18, the teachings of Squitieri in view of Karim are as shown above. Squitieri in view of Karim is silent regarding the use of antibacterial coatings. However, the examiner is taking Official Notice to inform the applicant that the use of antibacterial coatings especially in hospitals and locations wherein doctors see patients are highly prevalent. These coatings include temporary coatings such as cleaners and antibacterial reagents as well as longer term coatings such as hydrophobic coatings that resist bacteria as well as coatings containing active ingredients such as silver nanoparticles or drugs. The benefits of these coatings are very logical as well in that they prevent disease especially in those people present in hospital or other locations likely there already due to medical issues wherein additional infection would be particularly devastating to human health. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to antibacterial coatings in any fashion on any surface of a medical device, especially those for treating patients directly in order to reduce the risk of infectious disease.
Regarding claims 19-20, Squitieri teaches that it is known to provide a patient orienting device capable of mitigating localize pressure to areas of a patient’s body where the device comprises a plurality of chambers that may be inflated over time (abstract) which may include chambers having first, second and third interfaces wherein the second and third chambers reasonably envelop the first chamber (see Fig. 7). Squitieri fails to teach wherein a coating is applied to the device to aid in the attachment of the device to the underlying surface. However it is noted that Squitieri does show a desire for the device to be somewhat held in place because of the shown use of straps (see Fig. 3B). However, Karim shows that it is known to secure medical devices to underlying surfaces using adhesives such as silicone rubber so as to allow temporary attachment [0043]. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the adhesive of Karim in addition to or as a substitute for the straps of Squitieri to provide hold in a more specific location or better hold or in order to do away with the need for straps and unbuckling them wherein the use of adhesive in the place of straps would be both predictable and be expected to be functional for the intended use of Squitieri. The teachings of Squitieri in view of Karim are as shown above. Squitieri in view of Karim fails to teach the use of a temporary cover provided over the adhesive present until an intended time of use. However, the examiner is taking Official Notice to inform the applicant that it is generally known in the field of adhesives to provide temporary covers for adhesives so as to preserve their tack until a time of use. This is known to be done in product such as Band-aids, wall-hangers, tapes (both one and two sided), stickers, decals 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 provide a temporary covering for the exterior of the adhesive coating of Squitieri in view of Karim in order to allow maintenance of the adhesive quality of the coating until the intended time of use.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Squitieri (USPGPub2014/0048081) in view of Karim et al. (USPGPub 2016/0166422) and applied to claims 1-14 and 16-20 above and further in view of Squitieri (USPGPub2016/0193090)(referred to herein as SQ2).
Regarding claim 15 the teachings of Squitieri in view of Karim are as shown above. Squitieri further teaches wherein the upper material is more porous than other materials (claim 5) but fails to teach wherein the material is necessarily porous or perforated to the point such that it would allow flow of fluid into the device. However, SQ2 teaches that it is known to provide inflatable devices for the support of patients with perforations for the purpose of providing “low air loss” which keeps the patient in contact with the device “cool and dry” [0031]. 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 the apparatus of Squitieri in view of Karim with the low air loss perforations of SQ2 in order to allow patients in contact with the surface of the device to remain cool and dry.
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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