DETAILED ACTION
This action is in response to the Request for Continued Examination (RCE) filed 2/20/2025. Currently, claims 1-8 and 10-15 are pending in the application. Claims 1-5 and 15 are withdrawn and not examined at this point. Claim 9 is cancelled by Applicant.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/20/2025 has been entered.
Response to Arguments
Applicant’s amendment to claim 6 is sufficient to overcome the previous rejections of claims 6-8 and 10-14 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
Applicant’s amendment to claim 6 is sufficient to overcome the previous rejection of claims 6-8 and 10-14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Applicant's arguments filed 2/20/2025 have been fully considered but they are not persuasive.
In response to applicant's argument that Best is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Best is in the field of the inventor’s endeavor (inflatable devices positioned on a user’s body).
In response to applicant's argument that Rogmans is nonanalogous art, it has been held that a prior art reference must either be in the field of applicant’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Rogmans is in the field of applicant’s endeavor (inflatable therapeutic medical devices applied to the lower leg
In response to applicant's argument that Ravikumar is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Ravikumar is in the field of applicant’s endeavor (inflatable therapeutic medical devices applied to the lower leg).
In response to applicant's argument that Avitable et al. is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Avitable et al. is in the field of applicant’s endeavor (inflatable therapeutic medical devices applied to the lower leg).
In response to Applicant’s argument that Rogmans teaches away from applying pressure and compression, the examiner notes that Rogmans is not cited in the rejection(s) below to teach this feature. Further, the examiner reminds Applicant that simply that there are differences between two references is insufficient to establish that such references “teach away” from any combination thereof. In re Beattie, 974 F. 2d 1309, 1312-13, 24 USPQ2d, 1042 (Fed. Cir. 1992).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the Ravikumar and Best references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been obvious to one having ordinary skill in the art at the time of invention to modify the plurality of seams taught by the originally relied upon embodiment of Ravikumar as modified by the alternate embodiment of Ravikumar to be welds, the plurality of welds configured in the geometric placement having a higher number of plurality of welds located on the thinner inflated portion compared to a lower number of plurality of welds located on the thicker inflated portion as taught by Best because this element is known in the art to be an alternative configuration for attaching the first and second walls to form a tapered inflatable bladder, as Best teaches in Figures 1 and 4.
In response to applicant's argument that the cited prior art does not teach a compression apparatus configured to provide compression to the leg to treat chronic venous insufficiency and lymphedema including preventing swelling to the leg and foot, the examiner reminds Applicant that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the present case, [0050] of Ravikumar teaches that inflation/deflation of bladder 60 adjusts “cushioning pressure.” Thus, the bladder 60 of Ravikumar is capable of being positioned on the user’s leg and/or foot such that said pressure is capable of being directed inward against the user’s leg and/or foot to provide compression to the leg to treat chronic venous insufficiency and lymphedema including preventing swelling to the leg and foot.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s argument that the cited prior art does not teach an inflation inlet for inflation of the at least one bladder and a separate one-way valve to release air from the inflated bladder, the examiner respectfully disagrees. As detailed below, Ravikumar teaches in Figure 1A and [0034] an alternate embodiment wherein the at least one inflatable bladder (bladder 20) is inflated via an inflation inlet (lumen or tube 22; [0034] teaches “bladder 20 has a valve 24 through which air can be pumped to inflate the bladder, and, in this embodiment, valve 24 is coupled to bladder 20 via a lumen or tube 22”); and a separate (defined: distinct) one-way valve (valve 24; [0034] teaches “valve 24 may be a self-sealing, pressure-type valve that automatically seals upon removal of inflation pressure, and may additionally or alternatively provide for deflation without attaching a pumping mechanism for evacuation”) configured for releasing air from the inflated at least one inflatable bladder (bladder 20).
Claim Objections
Claim 6 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the inflated at least one inflatable bladder” should be amended to recite ---the at least one inflatable bladder when inflated---. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-8 and 10-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 6 recites “a separate one-way valve.” No support is provided for this claim limitation in Applicant’s disclosure as originally filed. Applicant’s specification does not provide a discussion of the one-way valve (48) being “separate,” as claimed. Further, Applicant’s drawings do not teach the one-way valve (48) being positioned apart from, or separate from, the remainder of the device. Rather, the one-way valve (48) is clearly taught in at least Applicant’s Figure 5 to be directly attached to (and not separate from) the bladder (22). Claims 7-8 and 10-14 depend on claim 6 and therefore, include the same error.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 6-8 and 11-13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ravikumar (US 2007/0095353), in view of Best (US 2007/0174970), in view of Avitable et al. (US 2008/0249441) and further in view of Rogmans (US 2012/0312310).
In regards to claim 6, Ravikumar teaches in Figures 5 and 6 and [0047-0048]
at least one inflatable bladder (bladder 60), wherein the at least one inflatable bladder (60) has
(a) a first ("inner surface”) and a second (“outer surface”) flexible (taught in [0047] to “have any varying degrees of elasticity,” and therefore, flexible) wall secured to one another about a plurality of peripheral edges thereof to form an air pocket (taught in [0047] to be “formed as an enclosed, inflatable member”),
(b) a plurality of seams (63, 65) provided in a predetermined (inasmuch as it was determined during the process of designing the bladder 60) location inward of the plurality of peripheral edges connecting the first ("inner surface”) and second (“outer surface”) flexible walls to one another to define a plurality of chambers (60a, 60b, 60c) within the air pocket and the plurality of seams are configured in a geometric (inasmuch as seams/baffles 63, 65 are formed as straight lines, which are simple rectilinear lines used in geometry; https://www.dictionary.com/browse/geometric) placement to form a predetermined (inasmuch as it was determined during the process of designing the bladder 60) gradient compression profile (said compression resulting from the pressure produced by the introduction of fluid/air into the bladder 60 that is directed toward and pressed against the user’s anatomy; [0050] teaches inflation/deflation of bladder 60 adjusts “cushioning pressure”) on the leg (capable of being positioned against the leg such that the bladder 60 provides a gradient pressure profile thereon) when the at least one inflatable bladder (60) is inflated (as shown in Figure 6) and secured on the leg (as shown in Figure 6) and configured to provide compression to the leg to treat chronic venous insufficiency and lymphedema including preventing swelling to the leg and foot ([0050] teaches inflation/deflation of bladder 60 adjusts “cushioning pressure;” the bladder 60 is capable of being positioned on the user’s leg and/or foot such that said pressure is capable of being directed inward against the user’s leg and/or foot to provide compression to the leg to treat chronic venous insufficiency and lymphedema including preventing swelling to the leg and foot) whereby the gradient compression profile created has a thinner inflated portion configured to be positioned toward the knee (as shown in Figure 6) compared to a thicker inflated portion configured to be positioned toward the ankle (as shown in Figure 6) compared to the thinner inflated portion (as shown in Figure 6, the bladder 60 is thinner at the end positioned toward the user’s knee and thicker at the end positioned toward the user’s ankle; the thicker end of the bladder 60 being configured to apply greater pressure/compression against the user’s anatomy since the thicker end includes a greater amount of air therein to press against the user’s anatomy), and
(c) at least one port in which is accommodated a valve (valve 62);
wherein the at least one inflatable bladder (60) is selected from the group consisting of a wedge-shaped bladder (taught in Figure 5 to be wedge-shaped) or a cone-shaped bladder.
The originally relied upon embodiment of Ravikumar does not teach that the at least one inflatable bladder is inflated via an inflation inlet; and a separate one-way valve configured for releasing air from the inflated at least one inflatable bladder.
However, Ravikumar teaches in Figure 1A and [0034] an alternate embodiment wherein the at least one inflatable bladder (bladder 20) is inflated via an inflation inlet (lumen or tube 22; [0034] teaches “bladder 20 has a valve 24 through which air can be pumped to inflate the bladder, and, in this embodiment, valve 24 is coupled to bladder 20 via a lumen or tube 22”); and a separate (defined: distinct) one-way valve (valve 24; [0034] teaches “valve 24 may be a self-sealing, pressure-type valve that automatically seals upon removal of inflation pressure, and may additionally or alternatively provide for deflation without attaching a pumping mechanism for evacuation”) configured for releasing air from the inflated at least one inflatable bladder (bladder 20).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the device of the originally relied upon embodiment of Ravikumar to include that the at least one inflatable bladder is inflated via an inflation inlet; and a separate one-way valve configured for releasing air from the inflated at least one inflatable bladder as taught by the alternate embodiment of Ravikumar because this element is known in the art to be an alternative for a bidirectional inflation/deflation valve, as Ravikumar teaches in [0034].
Ravikumar does not teach that the plurality of seams connecting the first and second walls is a plurality of spot welds, the plurality of spot welds configured in the geometric placement having a higher number of plurality of spot welds located on the thinner inflated portion compared to a lower number of plurality of spot welds located on the thicker inflated portion; and the at least one inflatable bladder being positioned within the compression apparatus such that the inflated at least one inflatable can be secured on the leg within the compression apparatus.
However, Best teaches in Figures 1 and 4 and [0028] an analogous device wherein the plurality of seams connecting the first and second walls (“two flexible, air-impermeable sheets 28 superimposed over each other and welded together,” taught in [0028]) is a plurality of welds ([0028] teaches that the two flexible, air-impermeable sheets 28 are welded together around the perimeter of cushion 22, arms 24 and joiner 26; the weld(s) at the perimeter of each element are each individual welds), the plurality of welds ([0028] teaches that the two flexible, air-impermeable sheets 28 are welded together around the perimeter of cushion 22, arms 24 and joiner 26; the weld(s) at the perimeter of each element are each individual welds) configured in the geometric placement (placement of welds shown in Figure 1) having a higher number of plurality of welds (6 welds form the perimeter(s) of arms 24 and joiner 26) located on the thinner inflated portion (arms 24 and joiner 26; Figure 4 teaches arms 24 and joiner 26 being thinner than cushion 22 when inflated) compared to a lower number of plurality of welds (4 welds form the perimeter(s) of cushion 22) located on the thicker inflated portion (cushion 22; Figure 4 teaches cushion 22 being thicker than arms 24 and joiner 26 when inflated).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the plurality of seams taught by the originally relied upon embodiment of Ravikumar as modified by the alternate embodiment of Ravikumar to be welds, the plurality of welds configured in the geometric placement having a higher number of plurality of welds located on the thinner inflated portion compared to a lower number of plurality of welds located on the thicker inflated portion as taught by Best because this element is known in the art to be an alternative configuration for attaching the first and second walls to form a tapered inflatable bladder, as Best teaches in Figures 1 and 4.
Ravikumar and Best do not teach that the welds are a plurality of spot welds (note: Best teaches in [0028] that the sheets 28 can be welded together “in a way that is known to those skilled in the art”); and the at least one inflatable bladder being positioned within the compression apparatus such that the inflated at least one inflatable can be secured on the leg within the compression apparatus.
However, Avitable et al. teaches in [0050] an analogous device in which the welds (92) connecting the first (12) and second (16) walls are a plurality of spot welds.
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the welds taught by the originally relied upon embodiment of Ravikumar as modified by the alternate embodiment of Ravikumar and Best to be a plurality of spot welds as taught by Avitable et al. because this element is known to be an alternate means in the art to connect the first and second walls that functions to prevent the chambers from substantially shifting relative to the first and second walls while still providing the at least one inflatable bladder with substantial flexibility, as Avitable et al. teaches in [0050].
Ravikumar, Best and Avitable et al. do not teach the at least one inflatable bladder being positioned within the compression apparatus such that the inflated at least one inflatable can be secured on the leg within the compression apparatus.
However, Rogmans teaches in Figures 4A-4D and [0049-0050] an analogous device (the abstract teaches “a heel protection device for protecting a heel against damage or irritation, such as decubitus symptoms”) with the at least one inflatable bladder (air cushions 73, 74) being positioned within the compression apparatus (encasing body 2; [0049] teaches “this encasing body 2 comprises integrated therein the different chambers for holding the buffer members or air cushions 71-79;” encasing body 2 can be considered a compression apparatus inasmuch as it surrounds and therefore, produces a compressing force against, the user’s lower leg/foot) such that the inflated (as shown in Figures 4C and 4D) at least one inflatable (air cushions 73, 74) can be secured on the leg (as shown in Figures 4A-4D) within the compression apparatus (encasing body 2).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the at least one inflatable bladder of the originally relied upon embodiment of Ravikumar as modified by the alternate embodiment of Ravikumar, Best and Avitable et al. to be positioned within the compression apparatus such that the inflated at least one inflatable can be secured on the leg within the compression apparatus as taught by Rogmans because this element is known to provide the at least one inflatable bladder in a more close fitting relation to the part of the body to be protected from damage which makes the device suitable for long-term use, wherein the protection is precisely defined, as Rogmans teaches in [0020].
In regards to claim 7, Ravikumar, Best, Avitable et al. and Rogmans teach the apparatus of claim 6. Ravikumar teaches in Figure 5 that the at least one inflatable bladder (60) is wedge-shaped.
In regards to claim 8, Ravikumar, Best, Avitable et al. and Rogmans teach the apparatus of claims 6 and 7. Ravikumar teaches in Figures 4-6 and [0045] that the wedge-shaped at least one inflatable bladder (60) has three sides configured to define a pyramidal shape when inflated, with one (51) of the three sides being rigid (backing 51 is taught in [0045] to be made of PVC, which is a rigid material) to prevent distension thereof in a direction away from a treatment area which is a leg when operatively disposed in the compression apparatus (inasmuch as the bladder 60 is capable of being positioned on a user in this manner), and having a thinner portion (the bottom half of the bladder 60 having a smaller, thinner width) configured to be positioned toward the knee and a thicker end (the top half of the bladder 60 having a larger, thicker width) configured to be positioned toward the ankle (inasmuch as the bladder 60 is capable of being positioned on a user in this manner).
In regards to claim 11, Ravikumar, Best, Avitable et al. and Rogmans teach the apparatus of claim 6. Ravikumar teaches on Figure 5 and [0048] that the at least one inflatable bladder (60) includes a plurality of fluid chambers (60a, 60b, 60c).
In regards to claims 12 and 13, Ravikumar, Best, Avitable et al. and Rogmans teach the apparatus of claim 6. Ravikumar and Best do not explicitly teach an inflation device for inflating the air pocket through the inflation inlet which is provided in the first flexible wall; wherein the inflation device is detachable from the inflation inlet.
However, Avitable et al. teaches in Figures 1-4 and [0047] an analogous device with an inflation device (“source of compressed fluid”) for inflating the air pocket (bladders 24a, 24b, 24c) through the inflation inlet (26a, 26b, 26c, 30; [0047] teaches “each tube 26a, 26b, 26c is disposed between the intermediate layers 14, 16 and secured to the respective bladder 24a, 24b, 24c” and “the opposite ends of the tubes 26a, 26b, 26c are grouped together using a second connector 30 (FIGS. 1 and 2) that is adapted to fluidly connect the tubes to the source of compressed fluid”) which is provided in (at cutout 27) the first flexible (taught in [0044] to be elastic and pliable and therefore, flexible) wall (16); wherein the inflation device (“source of compressed fluid”) is detachable (shown to be detached in Figures 1-4, but taught in [0047] to be connectable) from the inflation inlet (26a, 26b, 26c, 30).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the device taught by the originally relied upon embodiment of Ravikumar as modified by the alternate embodiment of Ravikumar, Best, Avitable et al. and Rogmans to include an inflation device for inflating the air pocket through the inflation inlet which is provided in the first flexible wall; wherein the inflation device is detachable from the inflation inlet as taught by Avitable et al. because this element is known to provide a controlled means of inflation of the air pocket, as Avitable et al. teaches in [0047].
Claims 10 and 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ravikumar (US 2007/0095353), in view of Best (US 2007/0174970), in view of Avitable et al. (US 2008/0249441), in view of Rogmans (US 2012/0312310) and further in view of Ravikumar (US 2004/0193084).
In regards to claim 10, Ravikumar (US 2007/0095353), Best, Avitable et al. and Rogmans teach the apparatus of claim 6. Ravikumar (US 2007/0095353), Best, Avitable et al. and Rogmans do not teach a pressure gauge coupled to the at least one inflatable bladder.
However, Ravikumar (US 2004/0193084) teaches in Figures 1 and 2, [0020] and [0026] an analogous device with a pressure gauge (pressure gauge 22) coupled to the at least one inflatable bladder (air bladder chambers(s) 14).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the at least one inflatable bladder of the originally relied upon embodiment of Ravikumar (US 2007/0095353) as modified by the alternate embodiment of Ravikumar (US 2007/0095353), Best, Avitable et al. and Rogmans to include a pressure gauge coupled to the at least one inflatable bladder as taught by Ravikumar (US 2004/0193084) because this element is known to provide a visual indication of the pressure level therein, as Ravikumar (US 2004/0193084) teaches in [0020] and [0026].
In regards to claim 14, Ravikumar, Best, Avitable et al. and Rogmans teach the apparatus of claims 6 and 12. Ravikumar, Best, Avitable et al. and Rogmans do not explicitly teach at least one pressure valve operatively associated with the inflation device for controlling an amount of pressure within the air pocket.
However, Ravikumar (US 2004/0193084) teaches in Figure 1, [0026] and [0035] an analogous device with at least one pressure valve (20) operatively associated with the inflation device (18) for controlling an amount of pressure within the air pocket (14).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the inflation device taught by the originally relied upon embodiment of Ravikumar (US 2007/0095353) as modified by the alternate embodiment of Ravikumar (US 2007/0095353), Best, Avitable et al. and Rogmans to include at least one pressure valve operatively associated with the inflation device for controlling an amount of pressure within the air pocket as taught by Ravikumar (US 2004/0193084) because this element is known to provide a means a regulate the pumping of air into the air pocket, as Ravikumar (US 2004/0193084) teaches in [0026].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA H FISHER whose telephone number is (571)270-7033. The examiner can normally be reached M-TH 6:00AM-4:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached on (571) 270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 3/5/2025