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 .
Response to Amendment
Examiner acknowledges applicants’ amendments to the claim 1 and 18 with claims 7, 16 and 17 canceled in prosecution and new claims 21-23 added. Claims 1-6, 8-15, 18-23 remain pending in the present application.
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.
Claim(s) 1-6, 8-16, 18-20, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panser (US Patent No 20150335470) in view of Anderson (US Patent No 20070093882).
Regarding claim 1, Panser teaches a warming device (warming device 20, [0021]) comprising: a clinical garment (garment 22, [0021]) comprising: a body portion adapted to cover a torso of a patient (see fig 5, portion covering patient), wherein the body portion comprises an inner surface for facing the patient (inside surface 43, [0022]), and an outer surface for facing away from the patient (see fig 2A for outside surface), a hemline (hems 45, [0022]) and sleeves extending from the body portion for receiving arms of the patient (sleeves 53 may be long or short and must give access for patient arms, [0022]); a pneumatic convective device (convective apparatus 60, [0023]) coupled to the inner surface (positioned to be facing the patient, [0023], therefore proximate and placed on the inner surface), wherein the pneumatic convective device has a first end proximate the sleeves (see peripheral diffusers 63 in fig 3A) and a second end (see fig 3A for the peripheral diffusers 63b extending downwards defining the second edge below) wherein a plurality of apertures is defined in the pneumatic convective device (air permeable wall 62, which reads on a plurality of apertures [0024]) wherein the pneumatic convective device includes a first section coupled to the clinical garment and a second section extend in a from the first section (see in which the convective apparatus 60 which is contained in the first section has diffusers 63 which are capable of being rolled or folded out into a second section, [0023], in which the convective apparatus is connected to the clinical garment, [0006]), wherein the second section is foldable relative to the first section between a folded state and a deployed state (wherein the diffusers can be folded or rolled into a retained or deployed state, [0006]) ; an inlet (see opening 29 in fig 1) for admitting a stream of pressurized warmed air into the pneumatic convective device (convective apparatus may be operated by receiving warmed, pressurized air from a heater/blower unit, [0021]), wherein the stream of pressurized air is to exit the pneumatic convective device via the plurality of apertures (see fig 3B, for air permeable layer 62 on outer surface in which the pressurized air is expelled, [0024]); and wherein in the deployed state the second end of the pneumatic device extends past the hemline (see fig 2b for convective device 60 surpassing the hemline 45), and the stream of pressurized air is to exit and provide warming to the patient (when member 61 is inflated resulting in the deployed state the pressurized air is expelled through air permeable layer 24, which is proximate to the sleeve edge, [0024]); and in a folded state a fold edge of the pneumatic convective device extends no greater than 3 inches past the hemline (the diffusers of the one pair of diffusers 63a may be folded, rolled or gathered in any way that achieves the desired length reduction and neat compaction useful for stowing and retention of the peripheral diffusers 63a, [0026], and therefore one can gather ore fold the device to be within 3 inches of the hemline)
Panser does not explicitly teach wherein, the stream of pressurized air is to exit the plurality of apertures between the first end and the fold edge to provide warming to the patient.
However, Panser does disclose that the diffusers 63 which contain the pair permeable wall 71, which deliver the stream of pressurized air to the body, when retained in a folded position still release a little bit of air flow to the extremities, [0029]. And furthermore, that there is still a little warming effect when retained in the folded position, [0033].
Therefore, even as it is not explicitly taught by Panser, it is still disclosed that warming and pressurized air are capable of being released through the extremity diffusers while they are retained in a folded state, and therefore under the broadest reasonable interpretation of the claim, the device disclosed by Panser is obvious and capable to when in the folded state, the stream of pressurized air is to exit the pneumatic convective device to provide warming to the patient from the first end proximate the sleeves to the fold edge.
Furthermore, Panser does not teach a fastener coupled to the pneumatic convective device, wherein the fastener is configured to interpose the first and second sections and fasten the first section to the second section.
However, the analogous convective warming device which is disclosed by Anderson does teach a fastener coupled to the pneumatic convective device (see in which the pneumatic convective device of Anderson contains an attachment mechanism, equated to the analogous fastener, in which the attachment mechanism is the form of double sided tape 66, [0049]), wherein the fastener is configured to interpose the first and second sections and fasten the first section to the second section (see in which Anderson discloses a first convective apparatus 60 and a second convective apparatus 70 seen as the first and second sections and wherein they are attached via the tape attachment 66 where they are interposed between the lower edge 65 of the first section and the upper edge 80 of the second section, [0058], see also fig 3B-3D).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the teachings of a pneumatic warming device disclosed by Panser with that of the specific fastening and attachment method taught by Anderson, as it would be an obvious method and structure to hold and maintain the two pneumatic convective sections together in both a deployed and retracted configuration as taught by Anderson, [0058].
Regarding claim 2, Panser teaches the warming device of claim 1, wherein the pneumatic convective device has a first internal volume when inflated in the folded state, and a second internal volume when inflated in the deployed state, the first internal volume is less than the second internal volume (wherein when in the deployed state, wherein the folded peripheral members and ducts expand in response to the pressurized airflow, [0024], and therefore by definition have an increased volume when in the deployed state).
Regarding claim 3, Panser teaches the warming device of claim 2, wherein, when the pneumatic convective device is in the folded state, the pneumatic convective device comprises a first fold section defined by the fold edge and at least one pneumatic edge portion (see fig 3b for pneumatic edge being the top edge portion of diffuser 63b connected to the ducts 65b, and the first fold section would comprise the bottom edge of the diffuser 63b when in folded state, see also [0027] for more detail).
Regarding claim 4, Panser teaches the warming device of claim 3, wherein the first internal volume is defined by a pneumatic edge portion and the fold edge (fig 3b), where the second internal volume is defined by a plurality of pneumatic edge portions (see fig 3A with the plurality of permeable walls 64b or pneumatic edge portions within the diffuser 63b, therefore when folded it would create a plurality of internal volumes).
Regarding claim 5, Panser teaches the warming device of claim 3, wherein, Panser does not explicitly teach wherein the fold edge is a first fold edge, and when in the folded state, the first pneumatic convective device further comprises a second fold section defined by a second fold edge portion.
However, Panser does teach elements of the convective apparatus 60 may be described as “folded” or in a “folded configuration;” which is also to include “rolled” or in a “rolled up configuration” or otherwise contracted configurations commonly known ([0023]) and further that as many rolls or folds may be done as necessary to fit the diffuser within the garment ([0026]).
Therefore, it would have been obvious and implicit to fold the known diffuser over a secondary time in order to compact it enough to fit within the parameters of the garment and in doing so would result in a second fold section and a second fold edge portion of the diffuser 63 taught by Panser.
Regarding claim 6, Panser teaches the warming device of claim 5,
Panser doesn’t explicitly teach wherein, when in the folded state, the pneumatic convective device further comprises a third fold section defined by the first fold edge, the second fold edge and at least one pneumatic edge portion.
However, it would be implicitly obvious to fold the convective device a third time which would result in a third fold section of the diffuser 63 defined by the first fold edge, second fold edge and pneumatic edge portion.
Regarding claim 8, Panser teaches the warming device of claim 3,
Panser doesn’t teach wherein the pneumatic convective device comprises a tab element extending past a pneumatic edge portion.
However, the analogous pneumatic warming garment of Anderson does teach an analogous grasping target 88 (also seen in FIGS. 3B-3E), or a tab, not shown, may be provided on a free upper edge of the head drape 87 so that the drape may be grasped for deployment ([0067]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the warming convective device of Panser to have the tab element of Anderson to provide easy deployment of the convective device as disclosed by Anderson [0067].
Regarding claim 9, Panser teaches the warming device of claim 3,
Panser doesn’t explicitly state wherein, when in a partially deployed state, the pneumatic convective device has a third internal volume in between the first internal volume and the second internal volume.
However, Panser does disclose a partially deployed state ([0026]) in which there were three implicitly obvious folds within the diffuser 63 that would result in a third internal volume between the first internal volume and the second internal volume.
Regarding claim 10, Panser teaches the warming device of claim 1, wherein the pneumatic convective device comprises a first sheet that is air-permeable and sealed to the clinical garment except at an unsealed portion, wherein the pneumatic convective device comprises a second sheet that is air-impermeable, the second sheet is attached to the first sheet of material at most of the unsealed portion (the inflatable convective device 60 may be made include two or more sheets of flexible material that are brought together and bonded, joined, or sealed at a periphery to form inflatable space. Within the peripheral seals, the shapes and airflow characteristics of the inflatable space are established by stake points, and/or elongate seals. The sheets of material of which these elements are formed may be made of synthetic or natural materials, or a natural/synthetic blend. The sheet or sheets forming one side of an inflatable structure are made, or processed, to form an inflatable structure having an air-permeable wall with a surface through which pressurized air that inflates the structure, circulates, passes or exits toward the body of a person clothed in the clinical garment, [0030]).
Regarding claim 11, Panser teaches the warming device of claim 10, wherein the second sheet faces the inner surface (wherein the air flow faces the patient, [0030], therefore the impermeable sheet must face the inner surface).
Regarding claim 12, Panser teaches the warming device of claim 10, wherein the second sheet is attached to the inner surface (apparatus 60 is formed or assembled separately from the clinical garment and then attached to its inside surface, [0030]).
Regarding claim 13, Panser teaches the warming device of claim 10, wherein the inlet is proximate to a fold edge portion (see fig 3b for inlet port 67 which is proximate to the fold edges of 63b) and disposed on the second sheet (inlet is disposed on outer surface and therefore must be on the second sheet, [0029]), when in the folded state, the inlet does not extend past the hemline, and when in the deployed state, the inlet extends past the hemline (see difference between fig 3B in the folded state and fig 5 in the deployed state at which inlet 67 extends past the hemline 45).
Regarding claim 14, Panser teaches the warming device of claim 10, wherein the pneumatic convective device has a perimeter defined by sealing together the first sheet and the second sheet (the inflatable convective device 60 may be made include two or more sheets of flexible material that are brought together and bonded, joined, or sealed at a periphery to form inflatable space, [0030]).
Regarding claim 15, Panser teaches the warming device of claim 1, wherein the pneumatic convective device is a first pneumatic convective device and the inlet is a first inlet, and wherein the warming device.
Panser does not teach further comprising: a second pneumatic convective device fixedly attached to the inner surface, wherein the first pneumatic convective device is releasably attached to the second pneumatic convective device. wherein the second pneumatic convective device comprises a second inlet for admitting a stream of pressurized, warmed air into the second pneumatic convective device.
However, Anderson teaches a second pneumatic convective device (second convective apparatus 70, [0051]) fixedly attached to the inner surface (see fig 3F), wherein the first pneumatic convective device is releasably attached to the second pneumatic convective device (convective units are releasably attached, [0064]). wherein the second pneumatic convective device comprises a second inlet for admitting a stream of pressurized, warmed air into the second pneumatic convective device (see fig 3D, for second inlet 85 for second convective device).
Therefore, it would have been obvious for one skilled in the art to combine the warming garment of Panser to have two convective units taught by Anderson in order to adapt the garment to have differing therapy temperatures as well as more control over the distribution of pressurized air.
Regarding claim 18, the combination teaches a method comprising; allowing a patient to wear the warming device of claim 1 in a first configuration (Panser, first mode fig 3B) within 2 hours before anesthesia during a preoperative period and in a first location (from Anderson, a few hours prior to the operation, [0022]); changing the warming device to a second configuration (Panser, second mode fig 5) within 5 minutes before anesthesia of a patient at a second location (from Anderson, a few minutes around the time of the operation, [0022]); applying heat via a pneumatic convective device to the patient during an operative period (from Anderson, a person may be warmed for comfort before surgery and warmed therapeutically during and after surgery, [0025]).
Regarding claim 19, the combination teaches the method of claim 18, wherein the first configuration of the warming device is in a folded state with the pneumatic convective device worn by the patient (in the perioperative state the convective device retains its folded configuration and provide a little warming effect, Panser, [0033]).
Regarding claim 20, the combination teaches the method of claim 19, wherein the second configuration of the warming device is a deployed state (during the preinduction phase the peripheral diffusers can be deployed and the warming will increase, Panser, [0033]).
Regarding claim 22, Panser teaches a warming device (warming device 20, [0021]), comprising: a clinical garment (garment 22, [0021]), comprising: a body portion to cover a torso of a patient (see fig 5, portion covering patient), wherein the body portion comprises an inner surface for facing the patient (inside surface 43, [0022]), an outer surface for facing away from the patient (see fig 2A for outside surface), and a hemline (hems 45, [0022]); and sleeves extending from the body portion for receiving arms of the patient (sleeves 53 may be long or short and must give access for patient arms, [0022]); a pneumatic convective device (convective apparatus 60, [0023]) coupled to the inner surface (positioned to be facing the patient, [0023], therefore proximate and placed on the inner surface), wherein the pneumatic convective device has a first end proximate the sleeves (see peripheral diffusers 63 in fig 3A) and a second end (see fig 3A for the peripheral diffusers 63b extending downwards defining the second edge below), wherein a plurality of apertures is defined in the pneumatic convective device (air permeable wall 62, which reads on a plurality of apertures [0024]), wherein the pneumatic convective device includes a first section coupled to the clinical garment and a second section extending from the first section (see in which the convective apparatus 60 which is contained in the first section has diffusers 63 which are capable of being rolled or folded out into a second section, [0023], in which the convective apparatus is connected to the clinical garment, [0006]), and wherein the second section is foldable relative to the first section between a folded state and a deployed state (wherein the diffusers can be folded or rolled into a retained or deployed state, [0006]); and an inlet (see opening 29 in fig 1) for admitting a stream of pressurized, warmed air into the pneumatic convective device (convective apparatus may be operated by receiving warmed, pressurized air from a heater/blower unit, [0021]), wherein the stream of pressurized air is to exit the pneumatic convective device via the plurality of apertures (see fig 3B, for air permeable layer 62 on outer surface in which the pressurized air is expelled, [0024]); wherein: in the deployed state, the second end of the pneumatic device extends past the hemline (see fig 2b for convective device 60 surpassing the hemline 45) and the stream of pressurized air is to exit the plurality of apertures between the first end and the second end to provide warming to the patient (when member 61 is inflated resulting in the deployed state the pressurized air is expelled through air permeable layer 24, which is proximate to the sleeve edge, [0024]); and in the folded state, a fold edge of the pneumatic convective device extends no greater than 3 inches past the hemline (the diffusers of the one pair of diffusers 63a may be folded, rolled or gathered in any way that achieves the desired length reduction and neat compaction useful for stowing and retention of the peripheral diffusers 63a, [0026], and therefore one can gather ore fold the device to be within 3 inches of the hemline).
Panser does not explicitly teach wherein, the stream of pressurized air is to exit the plurality of apertures between the first end and the fold edge to provide warming to the patient.
However, Panser does disclose that the diffusers 63 which contain the pair permeable wall 71, which deliver the stream of pressurized air to the body, when retained in a folded position still release a little bit of air flow to the extremities, [0029]. And furthermore, that there is still a little warming effect when retained in the folded position, [0033].
Therefore, even as it is not explicitly taught by Panser, it is still disclosed that warming and pressurized air are capable of being released through the extremity diffusers while they are retained in a folded state, and therefore under the broadest reasonable interpretation of the claim, the device disclosed by Panser is obvious and capable to when in the folded state, the stream of pressurized air is to exit the pneumatic convective device to provide warming to the patient from the first end proximate the sleeves to the fold edge.
Furthermore, Panser does not teach that the inlet is provided on the second section.
However, the analogous convective warming device which is taught by Anderson does disclose that the inlet is provided on the second section (see from figure 3D in which an inlet port 74 is configured on the secondary convective section 70, [0052]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the convective warming device taught by Panser with that of the air inlet portion found on a second section as disclosed by Anderson, as having the inlet on the second section is a simple design choice to one skilled in the art and it also provides warm air intake to the body on sections father away than the explicit convective device output as taught by Anderson, [0052].
Claim(s) 21 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panser (US Patent No 20150335470) in view of Anderson (US Patent No 20070093882) further in view of Van Duren (US Patent No 20060184217).
Regarding claim 21 and 23, the combination of Panser and Anderson teach the warming device of claim 1 and 22.
The previous combination does not teach wherein a uniform array of apertures is defined in the pneumatic convective device from the first end to the second end.
However, the analogous convective warming device disclosed by Van Duren does teach wherein a uniform array of apertures is defined in the pneumatic convective device from the first end to the second end (see [0041] which discloses how the thermal blanket used as the pneumatic convective device and contains a uniform array of apertures 55. Furthermore, it can be seen that this blanket is uniform from the proximal sleeve area all the way to the bottom of the gown, and thereby teaches the uniformity from first end to second end seen in figures 5A and 5B).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine pneumatic convective device garment of Panser in combination with Anderson with the teachings of a uniform aperture array for delivering treatment fluid defined by Van Duren in order to effectively deliver treatment in a full and uniform way to the body of the patient as disclosed by Van Duren, [0041].
Response to Arguments
Applicant’s arguments, see remarks, filed 07/14/2025, with respect to the rejection(s) of claim(s) 1 under Panser in view of Van Duren have been fully considered and are persuasive as agreed upon in the interview with applicant which took place on 07/10/2025. Therefore, the rejection has been withdrawn. However, upon further search and consideration as necessitated by the amended claim language, a new ground(s) of rejection is made in view of Panser in view of Anderson.
As discussed in the interview which took place on 7/10/2025, Examiner agrees that the prior art of record of Panser in view of Van Duren does not solely teach the limitation of the amended claim 1 stating that there is a “fastener which is configured to interpose the first and second sections and fasten the first section to the second section” of the present application. However, upon further search and consideration it has been found that the analogous art of Anderson in paragraph [0058] discloses how there is an attachment device 66 which is equated to an analogous fastener which maintains the connection between a first convective device or section 60 and a second convective device or section 70. This attachment connection can also be seen illustrated in figures 3B to 3D of the prior art Anderson. Therefore, as it has been taught and obvious in the prior art, the new amended claim 1 remains rejected under the new prior art of record of Panser in view of Anderson set forth in the present rejection.
As the claim limitation of claim 1 was amended this necessitated further search and consideration regarding the amended claim language in which the prior art of record of Panser in view of Anderson was found to teach the amended limitations. Regarding claims 2-6, 8-15, 18-21, as they are dependent on the rejected claim 1, they remain rejected under the new prior art of record rejection.
Furthermore, as the new claims 21-23 do not contain any new structural limitations over the previous claims they too remain rejected under the new prior art of record rejection of Panser in view of Anderson.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/KYLE M. BROWN/Examiner, Art Unit 3794