DETAILED ACTION
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/20/25 has been entered.
Response to Amendment
This office action is in response to the amendment filed 09/20/25. Claim(s) 30, 41-42, and 53 have been amended, no new claims have been added, and 1-29 have been cancelled. Thus, claims 30-53 are presently pending in this application.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 42, 44, 49, and 52 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schild (GB2285749).
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Annotated fig 3 of Schild.
With respect to claim 42, Schild discloses a compression therapy system (fig 1) comprising a compression bladder (1 and 2, fig 1) configured to apply pressure to a limb of a patient (see pg. 4) and a pump (compressor; 5, fig 1) fluidically coupled to the compression bladder (see pg. 4 and fig 1) configured to provide pressurized fluid to the compression bladder according to at least that has a beginning (see annotated fig 3 of Schild) and an end (see annotated fig 3 of Schild) and a second cycle (see annotated fig 3 of Schild) that is different than the first cycle (note the time for the first cycle is different than the second cycle in fig 3), that begins at the end of the first cycle, that has an end (see annotated fig 3 of Schild), and that does not overlap the first cycle (see annotated fig 3 of Schild); wherein the first cycle includes providing, at the beginning of the first cycle, the pressurized fluid to the compression bladder at a first high pressure for a first period (see annotated fig 3 of Schild) followed by a first low pressure a second period (see annotated fig 3 of Schild) that ends at the end of the first cycle; wherein the second cycle includes providing, at the end of the first cycle, the pressurized fluid to compression bladder at a second high pressure for a third period (see annotated fig 3 of Schild) followed by a second low pressure for a fourth period (see annotated fig 3 of Schild) that ends at the end of the second cycle; and wherein a sum of the third and fourth periods is greater than a sum of the first and second periods (see the time frame of the second cycle being longer than that of the first cycle in fig 3).
With respect to claim 44, Schild discloses the pump includes a pressurization pump (compressor; 5, fig 1 and pg. 4 (compressor is a source of pressurized air)) and a control circuit (controller; 3, fig 1).
With respect to claim 49, Schild discloses the pump is configured to apply the first cycle a first number of times (applied once at the beginning of the session as seen in annotated fig 3 of Schild) for a first portion of a therapy session (the beginning as seen in fig 3 of Schild) and to apply the second cycle a second number of times (once following the first cycle) for a second portion of the therapy session (the second part of the session as seen in annotated fig 3 of Schild, following the first cycle).
With respect to claim 52, Schild discloses the compression bladder comprises a first compression bladder (1, fig 2 of Schild) configured to apply compression to a calf (calf garment and seen in fig 2 of Schild); the compression therapy system further comprises a second compression bladder (2, fig 2 of Schild) configured to apply compression to a thigh (upper thigh garment; 2, fig 2 of Schild); and the first and second compression bladders are fluidically coupled to the pump independently of one another (see fig 1 and pg. 4 of Schild).
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.
Claim(s) 30-37, 41-49, and 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bemmelen (5,218,954) in view of Schild (GB2285749).
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Annotated fig 4 of Bemmelen; (note the fourth period and second cycle extend off the graph but last ~16.5 seconds according to col. 3, lines 60-65).
With respect to claim 30, Bemmelen discloses a compression therapy system (10, fig 1) comprising a compression bladder (26, fig 1) configured to apply pressure to a limb of a patient (see col. 2, lines 43-45) and a pump (inflation system (compressor); 36, fig 1 and claim 2) fluidically coupled to the compression bladder (see col. 3, lines 14-15 and claim 2) configured to provide pressurized fluid to the compression bladder according to at least a first cycle (see annotated fig 4 of Bemmelen above) and a second cycle (see annotated fig 4 of Bemmelen above) that is different than the first cycle (see annotated fig 4 of Bemmelen above; where the first cycle is shorter in time than the second cycle) and does not overlap the first cycle (see annotated fig 4 of Bemmelen above; where the second cycle follows after the first cycle); wherein the first cycle includes providing the pressurized fluid to the compression bladder at a first high pressure (see annotated fig 4 of Bemmelen above; 80-160 mmHg, see col. 3, lines 49-50) for a first period (see annotated fig 4 of Bemmelen above) followed by a first low pressure of about 5-10 mmHg for a second period (see col. 3, lines 53-54 and annotated fig 4 of Bemmelen above); wherein the second cycle includes providing the pressurized fluid to compression bladder at a second high pressure for a third period (see annotated fig 4 of Bemmelen above; 80-160 mmHg, see col. 3, lines 49-50) followed by a second low pressure of about 5-10 mmHg (see col. 3, lines 53-54) for a fourth period (see annotated fig 4 of Bemmelen above; where the fourth period extends off of the graph as the therapy continues but lasts for 8-14 seconds (see col. 3, 64-64)); and wherein a sum of the third and fourth periods is greater than a sum of the first and second periods (see annotated fig 4 of Bemmelen above; where the first cycle is shorter in time than the second cycle as the second cycle lasts a total of 16.5 seconds (2.5 + 8-14 seconds according to col. 3, lines 60-65) which is longer than the first cycle annotated at 6 seconds); while Bemmelen discloses the treatment applications can be different time periods (see col. 3, lines 57-58), but lacks the first cycle has a beginning and an end and the second cycle, that begins at the end of the first cycle, that has an end, and wherein the second cycle includes providing, at the end of the first cycle, the pressurized fluid to compression bladder at the second high pressure for a third period followed by the second low pressure for the fourth period that ends at the end of the second cycle and the first and second period sum being less than the third and fourth period sum.
However, Schild teaches a compression system (fig 1) with compression bladders (1,2; fig 2); a pump (compressor; 6, fig 1) fluidically coupled to the compression bladder configured to provide pressurized fluid to the compression bladder (see translation pg. 4) according to at least a first cycle (see annotated fig 3 of Schild) that has a beginning (see annotated fig 3 of Schild) and an end (see annotated fig 3 of Schild) and a second cycle (see annotated fig 3 of Schild) that is different than the first cycle (note the time for the first cycle is different than the second cycle in fig 3), that begins at the end of the first cycle, that has an end (see annotated fig 3 of Schild), and that does not overlap the first cycle (see annotated fig 3 of Schild); wherein the first cycle includes providing, at the beginning of the first cycle, the pressurized fluid to the compression bladder at a first high pressure for a first period (see annotated fig 3 of Schild) followed by a first low pressure a second period (see annotated fig 3 of Schild) that ends at the end of the first cycle; wherein the second cycle includes providing, at the end of the first cycle, the pressurized fluid to compression bladder at a second high pressure for a third period (see annotated fig 3 of Schild) followed by a second low pressure for a fourth period (see annotated fig 3 of Schild) that ends at the end of the second cycle; and wherein a sum of the third and fourth periods is greater than a sum of the first and second periods (see the time frame of the second cycle being longer than that of the first cycle in fig 3 and pgs. 5-6 of Schild translation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first and second cycle of Bemmelen to be of various time periods and consecutive as taught by Schild so as to provide an alternative cycle time that would be able promote better blood flow towards the heart (Abstract of Schild translation).
With respect to claims 31 and 44, the modified Bemmelen shows that the pump includes a pressurization pump (compressor of inflation system, see claim 2) and a control circuit (means for controlling; claim 2).
With respect to claim 32, the modified Bemmelen shows that the first high pressure and the second high pressure are approximately the same (see annotated fig 4 of Bemmelen; where the first and second high pressures are 80-160 mmHg, see col. 3, lines 49-50).
With respect to claims 33 and 45, the modified Bemmelen shows that the first and second periods are each less than or equal to approximately 3 seconds io(see col. 3, lines 51-52 and annotated fig 4 of Bemmelen).
With respect to claims 34 and 46, the modified Bemmelen shows that the first high pressure and the second high pressure are each approximately 110 mmHg (see annotated fig 4 of Bemmelen and 80-160 mmHg, col. 3, lines 49-50).
With respect to claims 35 and 47, the modified Bemmelen shows that the first period is approximately 2 seconds (2-3 seconds in col. 3, lines 51-52 and annotated fig 4 of Bemmelen) and the second period is approximately 3 seconds (see annotated fig 4 of Bemmelen).
With respect to claims 36 and 48, the modified Bemmelen shows that the third period is approximately 3 seconds (2-3 seconds in col. 3, lines 51-52 and annotated fig 4 of Bemmelen) and the fourth period is approximately 17 seconds (see annotated fig 4 of Bemmelen where the fourth period extends past the end of the graph and lasts approximately 17 seconds (see col. 3, lines 54-55))(note the modification by Schild allows the periods of the first and second cycle to be adjusted to different times and end at the end of the second cycle).
With respect to claims 37 and 49, the modified Bemmelen shows that the controller is configured to apply the first cycle the first number of times for a 15first portion of a therapy session and to apply the second cycle the second number of times for a second portion of the therapy session, note the treatment is repetitive for 60-120 min (see col. 3, lines 55-57) therefore, the first cycle is applied for a first amount of time for a first portion followed by the second cycle for a second portion.
With respect to claims 41 and 53, the modified Bemmelen shows that the pressure within the bladder increases from about 5-10 mmHg (see annotated fig 4 of Bemmelen; where the pressure begins at 5-10 mmHg to the high pressure of 80-160 mmHg) to the first high pressure during the first period (see annotated fig 4 of Bemmelen).
With respect to claim 42, Bemmelen shows a compression therapy system (10, fig 1) comprising a compression bladder (26, fig 1) configured to apply pressure to a limb of a patient (see col. 2, lines 43-45) and a pump (inflation system (compressor); 36, fig 1 and claim 2) fluidically coupled to the compression bladder (see col. 3, lines 14-15 and claim 2) configured to provide pressurized fluid to the compression bladder according to at least a first cycle (see annotated fig 4 of Bemmelen above) and a second cycle (see annotated fig 4 of Bemmelen above) that is different than the first cycle (see annotated fig 4 of Bemmelen above; where the first cycle is shorter in time than the second cycle) and does not overlap the first cycle (see annotated fig 4 of Bemmelen above; where the second cycle follows after the first cycle); wherein the first cycle includes providing the pressurized fluid to the compression bladder at a first high pressure (see annotated fig 4 of Bemmelen above; 80-160 mmHg, see col. 3, lines 49-50) for a first period (see annotated fig 4 of Bemmelen above) followed by a first low pressure for a second period (see annotated fig 4 of Bemmelen above); wherein the second cycle includes providing the pressurized fluid to compression bladder at a second high pressure for a third period (see annotated fig 4 of Bemmelen above; 80-160 mmHg, see col. 3, lines 49-50) followed by a second low pressure (see col. 3, lines 53-54) for a fourth period (see annotated fig 4 of Bemmelen above; where the fourth period extends off of the graph as the therapy continues but lasts for 8-14 seconds (see col. 3, 64-64)); and wherein a sum of the third and fourth periods is greater than a sum of the first and second periods (see annotated fig 4 of Bemmelen above; where the first cycle is shorter in time than the second cycle as the second cycle lasts a total of 16.5 seconds (2.5 + 8-14 seconds according to col. 3, lines 60-65) which is longer than the first cycle annotated at 6 seconds) but lacks the first cycle has a beginning and an end and the second cycle, that begins at the end of the first cycle, that has an end, and wherein the second cycle includes providing, at the end of the first cycle, the pressurized fluid to compression bladder at the second high pressure for a third period followed by the second low pressure for the fourth period that ends at the end of the second cycle and the first and second period sum being less than the third and fourth period sum.
However, Schild teaches a compression system (fig 1) with compression bladders (1,2; fig 2); a pump (compressor; 6, fig 1) fluidically coupled to the compression bladder configured to provide pressurized fluid to the compression bladder (see translation pg. 4) according to at least a first cycle (see annotated fig 3 of Schild) that has a beginning (see annotated fig 3 of Schild) and an end (see annotated fig 3 of Schild) and a second cycle (see annotated fig 3 of Schild) that is different than the first cycle (note the time for the first cycle is different than the second cycle in fig 3), that begins at the end of the first cycle, that has an end (see annotated fig 3 of Schild), and that does not overlap the first cycle (see annotated fig 3 of Schild); wherein the first cycle includes providing, at the beginning of the first cycle, the pressurized fluid to the compression bladder at a first high pressure for a first period (see annotated fig 3 of Schild) followed by a first low pressure a second period (see annotated fig 3 of Schild) that ends at the end of the first cycle; wherein the second cycle includes providing, at the end of the first cycle, the pressurized fluid to compression bladder at a second high pressure for a third period (see annotated fig 3 of Schild) followed by a second low pressure for a fourth period (see annotated fig 3 of Schild) that ends at the end of the second cycle; and wherein a sum of the third and fourth periods is greater than a sum of the first and second periods (see the time frame of the second cycle being longer than that of the first cycle in fig 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first and second cycle to be of various time periods as taught by Schild so as to promote better blood flow towards the heart (Abstract of Schild translation).
With respect to claim 43, the modified Bemmelen shows that the first low pressure and the second low pressure are each about 5-10 mmHg (see col. 3, lines 53-54 and annotated fig 4 of Bemmelen).
Claims 38 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bemmelen and Schild as applied to claim 30 above, further in view of Denson (2015/0374571).
With respect to claims 38 and 50, the modified Bemmelen shows that the controller is configured to apply a third cycle (since the high and low pressures repeat sequentially anything after the first and second cycles can be defined as a third cycle) different and separate from the 20first and second cycles (cycles are sequential, see claim 30 above).
However, Bemmelen does not explicitly disclose that the third cycle is different from the first and second cycles in a period.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify a period of Bemmelen from between 2-3 secs and 8-14 secs to anything different from those defined by the first and second cycles, as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
However, if there is any question Denson teaches a compression garment (10, fig 1) with a controller (5, fig 1) configured to apply multiple cycles (13a-c pf fig 4; three cycles) different and separate from the 20first and second cycles (cycles are sequential, and differ in high pressure see fig 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure profile of the Bemmelen to include three cycles as taught by Denson so as to provide cyclical inflation of the compression garment enhances blood circulation and decreases the likelihood of deep vein thrombosis (see [0001] of Denson).
Claim 39 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Bemmelen and Schild as applied to claim 30 and 42 above, and further in view of Kivisto (2007/0239087).
With respect to claims 39 and 51, the modified Bemmelen shows high pressure in the cycles (see claim 30 above) but lacks a pressure pulse superimposed on the pressure.
However, Kivisto teaches a system which applies pressure pulses superimposed over a static pressure (see [0046], lines 3-6 of Kivisto).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the high pressure of Bemmelen to include pressure pulses as taught by Kivisto so as to adjust the therapy delivered dependent on the needs of the particular patient (see [0004], lines 1-3 of Kivisto).
Claim 40 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Bemmelen and Schild as applied to claims 30 and 42 above, and further in view of Wasowski (10,357,421).
With respect to claims 40 and 52, the modified Bemmelen that the compression bladder (cuff; 12, fig 1 of Logan) is configured for applying 30compression to a calf (see [0019], lines 5-7 of Logan) but lacks a second bladder configured for applying compression to a thigh.
However, Wasowski teaches a compression system (400, fig 4A of Wasowski) with a first compression bladder (408, fig 4A of Wasowski) and a second compression bladder (406, fig 4A of Wasowski) configured for applying compression to a thigh (thigh calf; see col. 8, line 17 of Wasowski).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Bemmelen to include the thigh cuff as taught by Wasowski so as to provide simulate the backpressure of gravity on the venous valves in a gravity environment, thereby providing enhanced venous return blood flow and improve circulation (see col. 8, lines 49-52 of Wasowski).
Claim(s) 30-32, 37, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schild (GB2285749) in view of Bemmelen (5,218,954).
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Annotated fig 3 of Schild.
With respect to claim 30, Schild discloses a compression therapy system (fig 1) comprising a compression bladder (1 and 2, fig 1) configured to apply pressure to a limb of a patient (see pg. 4) and a pump (compressor; 5, fig 1) fluidically coupled to the compression bladder (see pg. 4 and fig 1) configured to provide pressurized fluid to the compression bladder according to at least that has a beginning (see annotated fig 3 of Schild) and an end (see annotated fig 3 of Schild) and a second cycle (see annotated fig 3 of Schild) that is different than the first cycle (note the time for the first cycle is different than the second cycle in fig 3), that begins at the end of the first cycle, that has an end (see annotated fig 3 of Schild), and that does not overlap the first cycle (see annotated fig 3 of Schild); wherein the first cycle includes providing, at the beginning of the first cycle, the pressurized fluid to the compression bladder at a first high pressure for a first period (see annotated fig 3 of Schild) followed by a first low pressure a second period (see annotated fig 3 of Schild) that ends at the end of the first cycle; wherein the second cycle includes providing, at the end of the first cycle, the pressurized fluid to compression bladder at a second high pressure for a third period (see annotated fig 3 of Schild) followed by a second low pressure for a fourth period (see annotated fig 3 of Schild) that ends at the end of the second cycle; and wherein a sum of the third and fourth periods is greater than a sum of the first and second periods (see the time frame of the second cycle being longer than that of the first cycle in fig 3); but lacks the first low pressure of about 5-10 mmHg and the second low pressure of about 5-10 mmHg.
However, Bemmelen teaches a compression therapy system (10, fig 1) comprising a compression bladder (26, fig 1) configured to apply pressure to a limb of a patient (see col. 2, lines 43-45) and a pump (inflation system (compressor); 36, fig 1 and claim 2) fluidically coupled to the compression bladder (see col. 3, lines 14-15 and claim 2) configured to provide pressurized fluid to the compression bladder according to at least a first cycle (see annotated fig 4 of Bemmelen above) and a second cycle (see annotated fig 4 of Bemmelen above) wherein the first cycle includes providing the pressurized fluid to the compression bladder at a first high pressure (see annotated fig 4 of Bemmelen above) for a first period (see annotated fig 4 of Bemmelen above) followed by a first low pressure of about 5-10 mmHg for a second period (see col. 3, lines 53-54 and annotated fig 4 of Bemmelen above); wherein the second cycle includes providing the pressurized fluid to compression bladder at a second high pressure for a third period (see annotated fig 4 of Bemmelen above) followed by a second low pressure of about 5-10 mmHg (see col. 3, lines 53-54) for a fourth period (see annotated fig 4 of Bemmelen above; where the fourth period extends off of the graph as the therapy continues but lasts for 8-14 seconds (see col. 3, 64-64)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first and second low pressures to be about 5-10 mmHg as taught by Bemmelen so as maintain a residual low pressure to allow for an easy rise back up to high pressure.
With respect to claim 31, the modified Schild shows the pump includes a pressurization pump (compressor; 5, fig 1 and pg. 4 (compressor is a source of pressurized air)) and a control circuit (controller; 3, fig 1).
With respect to claim 32, the modified Schild shows the first high pressure and the second high pressure are approximately the same (see the pressure in annotated fig 3 of Schild where the high pressures are approximately the same).
With respect to claim 37, the modified Schild shows the pump is configured to apply the first cycle a first number of times (applied once at the beginning of the session as seen in annotated fig 3 of Schild) for a first portion of a therapy session (the beginning as seen in fig 3 of Schild) and to apply the second cycle a second number of times (once following the first cycle) for a second portion of the therapy session (the second part of the session as seen in annotated fig 3 of Schild, following the first cycle).
With respect to claim 40, the modified Schild shows the compression bladder comprises a first compression bladder (1, fig 2 of Schild) configured to apply compression to a calf (calf garment and seen in fig 2 of Schild); the compression therapy system further comprises a second compression bladder (2, fig 2 of Schild) configured to apply compression to a thigh (upper thigh garment; 2, fig 2 of Schild); and the first and second compression bladders are fluidically coupled to the pump independently of one another (see fig 1 and pg. 4 of Schild).
Response to Arguments
The arguments to the newly added claim limitations in claims 30-53 have been addressed in the above rejections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY E BALLER whose telephone number is (571)272-8153. The examiner can normally be reached Monday - Friday 8 AM - 4 PM.
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/KELSEY E BALLER/Examiner, Art Unit 3785
/TU A VO/Primary Examiner, Art Unit 3785