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 .
Response to Amendments
The Amendment filed 9/10/2025 has been entered. Claims 1-11 and 14-19 were amended, and claims 20-21 were new. Thus, claims 1-21 are pending in the application.
Drawing Objections
The drawings are objected to for the following informalities:
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following must be shown or the features canceled from the claims: (1) “a multi-compartment pneumatic device having fluid conduits between adjacent compartments” (claim 11, ln. 2-3); (2) “each more distal compartment” and “the adjacent proximal compartment” (claim 12, ln. 2-3); (3) and “each fluid conduit comprises a valve” (claim 13, ln. 1). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 3, 5, and 15-17 are objected to because of the following informalities:
Regarding claim 1, the limitation “for configured” (ln. 3) should read --configured-- in order to be grammatically correct.
Regarding claim 1, the limitation “the mammal’s cardiac cycle” (ln. 5) should read --a cardiac cycle of the mammal-- in order to ensure proper antecedent basis.
Regarding claim 3, the limitation “a mammalian limb” (ln. 2-3) should read --the limb of the mammal-- in order to ensure proper antecedent basis and to more clearly reference how the limitation was originally claimed.
Regarding claim 5, the limitation “a mammal’s limb” (ln. 3) should read --the limb of the mammal-- in order to ensure proper antecedent basis and to more clearly reference how the limitation was originally claimed.
Regarding claim 5, the limitation “the chamber” (ln. 4) should read --the double walled inflatable chamber-- in order to more clearly reference how the limitation was originally claimed.
Regarding claim 15, the limitation “a transduced signal” (ln. 2-3) should read --the transduced real time signal-- in order to ensure proper antecedent basis and to more clearly reference how the limitation was originally claimed.
Regarding claim 16, the limitation “the transduced signal” (ln. 2-3) should read --the transduced real time signal-- in order to more clearly reference how the limitation was originally claimed.
Regarding claim 17, the limitation “independent” (ln. 3) should read -- independently-- in order to be grammatically correct.
Regarding claim 17, the limitation “the most proximal compartment” (ln. 4-5) should read --a most proximal compartment-- in order to provide proper antecedent basis.
Regarding claim 17, the limitation “the organism’s limb” (ln. 6) should read --a limb of the vertebrate organism-- in order to ensure proper antecedent basis and to more clearly reference how the limitation was originally claimed.
Regarding claim 17, the limitation “most proximal compartment” (ln. 10) should read --the most proximal compartment-- in order to ensure proper antecedent basis.
Regarding claim 17, the limitation “the next compartment” (ln. 10) should read --a next compartment-- in order to provide proper antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-5, 7, 9, 12-15, 17, and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 3, the limitation “negative pressure” (ln. 2) is confusing, as it is unclear whether this limitation is meant to be the same as or different from “negative pressure” (claim 1). For the purposes of examination, they will be interpreted as the same limitation.
Regarding claim 7, the limitation “negative pressure” (ln. 2) is confusing, as it is unclear whether this limitation is meant to be the same as or different from “negative pressure” (claim 1). For the purposes of examination, they will be interpreted as the same limitation. Moreover, the limitation “the distal segment of the mammal’s limb” (ln. 2-3) is confusing, as it is unclear whether this limitation is meant to be the same as or different from “a distal portion of the limb” (claim 1). For the purposes of examination, they will be interpreted as the same limitation.
Claim 9 recites the limitation "the limb" (ln. 4). There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 12, the limitations “negative pressure” (ln. 2) and “such pressure” (ln. 2) are confusing, as it is unclear whether this limitation is meant to be the same as or different from “negative pressure” (claim 1). For the purposes of examination, they will be interpreted as the same limitations.
Regarding claim 17, the limitation “negative pressure” (ln. 6) is confusing, as it is unclear whether this limitation is meant to be the same as or different from “negative pressure” (claim 1). For the purposes of examination, they will be interpreted as the same limitation. Moreover, the limitation “the distal segment of the organism’s limb” (ln. 6) is confusing, as it is unclear whether this limitation is meant to be the same as or different from “a distal portion of the limb” (claim 1). For the purposes of examination, they will be interpreted as the same limitation.
Regarding claim 19, the limitation “blood circulation” (ln. 6) is confusing, as it is unclear whether this limitation is meant to be the same as or different from “blood circulation” (ln. 1). For the purposes of examination, they will be interpreted as the same limitation.
Any remaining claims are rejected as being dependent upon a rejected base claim.
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.
Claims 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rastegar (2003/0216672).
Regarding claim 20, Rastegar discloses a method of treating a site of an injury or a wound of a vertebrate organism (abstract discloses treating “damages skin” of a patient; [0010] provides an example of a burn wound) comprising the steps of: (a) detecting cardiovascular activity of the organism to identify a diastolic phase (Fig. 1, [0075], sensor 180 detects the cardiac cycles of the user, which includes cardiac diastole); and (b) during the diastolic phase ([0075] discloses the enclosed chamber is pressurized with a positive pressure to assist the flow of blood out of the burned region, and blood flow out would occur during diastole), simultaneously applying negative pressure to a proximal portion of a body part of the organism and applying varying positive pressures to the site of the injury or the wound, wherein the site is located on a distal portion of the body part ([0038] discloses the positive pressure can be applied in a sequential manner, beginning at the most distal part of the injured area (which is the proximal portion of a body part) and then after applying a negative pressure there; after this, positive pressure is applied to the next area more proximal to the injured area (which is a portion of the body part more distal to the proximal portion of the body part), and the process is repeated sequentially until the most proximal portion of the injured area is reached (which is the most distal portion of a body part); therefore, a most proximal portion of the injured area (which is the most distal portion of a body part) would be under positive pressure while a more distal portion of the injured area (which is the proximal portion of a body part) is under negative pressure).
Regarding claim 21, Rastegar discloses a method for treating a target site on a body part of a vertebrate organism, the target site characterized by at least one of a wound, an injury, impaired microcirculation, or insufficient arterial perfusion (abstract discloses treating “damages skin” of a patient; [0010] provides an example of a burn wound, which has areas of coagulation to thereby impair microcirculation and/or arterial perfusion), the method comprising: (a) detecting a cardiac cycle of the organism, the cardiac cycle having a systolic phase (Fig. 1, [0075], sensor 180 detects the cardiac cycles of the user, which includes cardiac systole); and (b) applying a therapeutic pressure modulation to the body part in timed relation with the detected cardiac cycle to enhance blood circulation at the target site ([0075] discloses pressurization and vacuum cycles that are synchronized with the cardiac systole and diastole of the patient, thereby functioning to enhance blood circulation at the burned region), wherein the therapeutic pressure modulation is selected from the group consisting of: (i) applying varying negative pressure to the target site; and (ii) during the systolic phase, simultaneously applying positive pressure to a portion of the body part proximal to the target site and applying the varying negative pressure to the target site ([0038], [0077] the applied negative pressure to the injured area can be sequential and thus varied).
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 of this title, 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.
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.
Claims 1-2, 6-12, 14-15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Rastegar in view of Imai (WO 98/18424 A1, see attached translation).
Regarding claim 1, Rastegar discloses an apparatus for pulse cycle pressure modulation and negative pressure therapy treatment of a limb of a mammal (Fig. 1 depicts such an apparatus with Fig. 6 depicts a variation configured to be used with the overall system of Fig. 1 and designed to treat the foot of a human. See annotated Figs. 1 and 6 below for convenience) comprising a pneumatic system (Annotated Fig. 1 highlights the “pneumatic system” which includes a pressure and vacuum source 160, a control unit 170, and a tubing system 150 that leads to the chamber 102. Such an pneumatic system would also be used with the shell 202 in the variation of Fig. 6) for configured to exert pressure upon a tissue of the limb of the mammal, wherein the pressure is synchronized with a transduced real time signal representative of the mammal's cardiac cycle ([0075] discloses pressurization and vacuum cycles that are synchronized with the cardiac systole and diastole, which is detected by sensor 180); and wherein the pneumatic system is further configured to simultaneously apply positive pressure to a proximal portion of the limb and negative pressure to a distal portion of the limb ([0038] discloses positive pressure can be applied in a sequential manner, beginning at the most distal part of the injured area and then after applying a negative pressure there; after this, positive pressure is applied to the next area more proximal to the injured area, and the process is repeated sequentially until the most proximal portion is reached; therefore, a most proximal portion would be under positive pressure while a more distal portion is under negative pressure).
Rastegar does not disclose wherein the pneumatic system is further configured to simultaneously apply positive pressure to a proximal portion of the limb and negative pressure to a distal portion of the limb during a systolic phase of the cardiac cycle.
However, Imai teaches a stimulator to promote blood circulation via a physical stimulus such as mechanical pressure (Imai translation [0002], [0013]) wherein the pneumatic system is further configured to apply positive pressure during a systolic phase of the cardiac cycle (Imai translation [0088], positive pressure is applied during systole).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Rastegar pneumatic system to be configured to apply positive pressure during a systolic phase of the cardiac cycle, as taught by Imai, for the purpose of enabling the system to be capable of maintaining cerebral circulation during heart failure (Imai translation [0088]).
With this modification, the modified Rastegar would thus teach wherein the pneumatic system is further configured to simultaneously apply positive pressure to a proximal portion of the limb and negative pressure to a distal portion of the limb during a systolic phase of the cardiac cycle (Imai translation [0088], the positive pressure is applied during systole; Rastegar [0038] discloses when positive pressure is applied, it is applied in a sequential manner beginning at the most distal part of the injured area and then after applying a negative pressure there; after this, positive pressure is applied to the next area more proximal to the injured area, and the process is repeated sequentially until the most proximal portion is reached; therefore, a most proximal portion would be under positive pressure while a more distal portion is under negative pressure).
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Regarding claim 2, the modified Rastegar teaches the apparatus is configured to alternately apply negative pressure to improve arterial blood flow and positive pressure to increase venous blood flow (Rastegar [0075] discloses negative pressure while blood is being pumped into the injured region (which occurs in the arteries) and positive pressure as blood is being pumped out of the injured region (which occurs in the veins)) and the apparatus comprises a transducer for signal input of the cardiac cycle (Rastegar Fig. 1, sensor 180), a microcontroller-based control module and an associated computing system (Rastegar Fig. 1, control unit 170 is equipped with a microcomputer to regulate the supply of pressurized air and vacuum to the chamber; see [0072]), an air compressor (Rastegar Fig. 2, compressor 161), an air reservoir (Rastegar Fig. 2, pressure tank 163 and vacuum tank 164 are both air reservoirs), one or more inflation valves (Rastegar Fig. 2, valve unit 172), conduits (Rastegar Fig. 1, tubing system 150), electronic circuitry for controlling the inflation valves (Rastegar Fig. 12, solenoid valves 402 are part of the valve unit 172, wherein solenoid valves require electronic circuitry to operate); see [0077]), and one or more inflation air cells adapted to compress tissue (Rastegar Fig. 1, enclosed chamber 102 and Fig. 6, shell 202 are “inflation air cells” in the same manner as applicant’s embodiment of Fig. 2 is an “inflation air cell”).
Regarding claim 6, the modified Rastegar teaches the pneumatic system is configured to vary the negative pressure is varied in timed relation to a transduced signal that is indicative of cardiovascular activity (Rastegar [0075] discloses applying negative pressure as dependent upon the cardiac cycle as indicated by sensor 180).
Regarding claim 7, as best understood, the modified Rastegar teaches the pneumatic system is configured to exert negative pressure at the distal segment of the mammal's limb (Rastegar Fig. 6 depicts pressure exerted at the foot, which is the distal end of a human’s leg).
Regarding claim 8, the modified Rastegar teaches the pneumatic system is configured to vary the negative pressure in timed relation to inflation of an immediately proximal one of the one or more inflation air cells (Rastegar [0038], [0077] discloses sequential negative pressurization application after a positive pressurization application within the enclosure).
Regarding claim 9, as best understood, the modified Rastegar teaches a method for pulse cycle pressure modulation and negative pressure therapy, the method comprising one or more of the following steps: (i) simultaneously applying positive pressure to a proximal portion of the limb and negative pressure to a distal portion of the limb during a systolic phase of a detected cardiac cycle; (ii) applying negative pressure at a wound site during systole; and (iii) applying positive pressure at a tissue site on the limb during diastole (Rastegar [0075] discloses applying negative pressure to the wound site as blood is being pumped to the wound site, which occurs during systole; Imai translation [0088] has the positive pressure applied during systole, and was previously combined with Rastegar [0038] such that a most proximal portion would be under positive pressure while a more distal portion is under negative pressure).
Regarding claim 10, the modified Rastegar teaches the pneumatic system is configured to apply progressively decreasing negative pressure to the limb (Rastegar [0078] discloses exhausting air before switching phases, which would thereby decrease negative pressure as the valves open and pressure is released).
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Regarding claim 11, the modified Rastegar teaches wherein the apparatus further comprises a multi-compartment pneumatic device having fluid conduits between adjacent compartments (Rastegar Fig. 10 depicts an embodiment of the shell 202 that has a plurality of compartments or “bubbles” that are connected to one another via fluid conduits; see annotated Fig. 10 below).
Regarding claim 12, as best understood, the modified Rastegar teaches the fluid conduits are sized to provide progressive changes in negative pressure within each more distal compartment when such pressure is changed in the adjacent proximal compartment (Rastegar [0077] discloses sequential negative pressure, whereby the fluid conduits running between the bubbles 251 would act to provide “progressive changes in negative pressure” within each more distal compartment).
Regarding claim 14, the modified Rastegar teaches the pressure, flow rate, flow volume, and timing of fluid flows are selectively controllable (Rastegar [0072], control unit 171 would control all of these parameters. Rastegar [0078] additionally explicitly discloses pressure control with feedback from pressure sensors 416).
Regarding claim 15, the modified Rastegar teaches the pressure, flow rate, flow volume, and timing of fluid flows are configured to be varied in timed relation to a transduced signal that is indicative of cardiovascular activity (Rastegar [0075] discloses applying positive/negative pressure as dependent upon the cardiac cycle as indicated by sensor 180, wherein application of the positive/negative pressure includes control over the claimed parameters).
Regarding claim 17, as best understood, the modified Rastegar teaches a method of treating a vertebrate organism using the apparatus of claim 1, the method comprising independent varying: (a) delay in time from largest detected signal of cardiac activity at which time the most proximal compartment inflation begins (Rastegar [0072], sensors 180 are used to sense blood flow to synchronize the pressurization cycles of the enclosed chamber 102; Rastegar [0075], the sensed blood flow includes cardiac systole and diastole, either of which can be the largest cardiac activity detected; Rastegar [0077], controller is programmable to operate a desired timing of the air compressor for enclosure pressurization; Rastegar [0079], [0081] outer shell 202 of enclosure 100 can be made of one or more segments attached together, and so would be adjacent to each other; Rastegar [0038] the positive pressurization can be sequential such that the most proximal portion to the injured area is positively pressurized last, and thus being delayed); (b) exerting negative pressure at the distal segment of the organism's limb (Rastegar [0038], [0077] the exerted negative pressure to the distal portion of the injured area can be sequential and thus varied); (c) maximal pressure in one or more compartments (Rastegar [0076], the amount of required pressure may be within a range of an air flow generation device; Rastegar, para. [0091] the applied pressure by the enclosure can vary in a range from -25 mm Hg to +300 mm Hg); (d) duration of compartment inflation (Rastegar [0077], controller is programmable to operate a desired timing of the air compressor and vacuum pump for enclosure positive and negative pressurization; Rastegar [0038] the positive pressurization can be sequential and thus have a duration that can be controlled as desired); (e) time after inflation of most proximal compartment when the next compartment inflation begins (Rastegar [0079], [0081] outer shell 202 of enclosure 100 can be made of one or more segments attached together, and so would be adjacent to each other; Rastegar [0038], the applied positive pressure to the injured area can be sequential from a more distal portion to a more proximal portion and thus varied over time; Rastegar [0077], controller is programmable to operate a desired timing of the air compressor and vacuum pump for enclosure positive and negative pressurization); (f) pressure of each successive compartment, relative to its most immediate neighboring proximal compartment (Rastegar [0079], [0081] outer shell 202 of enclosure 100 can be made of one or more segments attached together, and so would be adjacent to each other; Rastegar [0038], [0077] the applied positive and/or negative pressure to the injured area can be varied sequentially such that a more distal portion of the enclosure is pressurized first and then the next more proximal portion in the sequence); and (g) duration of treatment (Rastegar [0077], controller is programmable to operate a desired operation sequence and timing of the air compressor, vacuum pump, and valves used for the treatment to apply the positive and negative pressurization).
Regarding claim 18, Rastegar discloses a method of treating a site of an injury or a wound of a vertebrate organism (Rastegar abstract discloses treating “damages skin” of a patient. Rastegar [0010] provides an example of a burn wound) comprising the steps of: (a) detecting cardiovascular activity of the organism to identify a systolic phase (Rastegar Fig. 1, [0075], sensor 180 detects the cardiac cycles of the user, which includes cardiac systole); (b) during the systolic phase, simultaneously applying positive pressure to a proximal portion of a body part of the organism and applying varying sub-atmospheric pressures to the site of the injury or the wound, wherein the site is located on a distal portion of the body part (Imai translation [0088], the positive pressure is applied during systole; Rastegar [0038] discloses when positive pressure is applied, it is applied in a sequential manner beginning at the most distal part of the injured area and then after applying a negative pressure there; after this, positive pressure is applied to the next area more proximal to the injured area, and the process is repeated sequentially until the most proximal portion is reached; therefore, a most proximal portion would be under positive pressure while a more distal portion is under negative pressure; Rastegar [0077] the applied negative pressure can be sequential and thus varied).
Regarding claim 19, as best understood, Rastegar discloses a method for therapeutically enhancing blood circulation at a target somatic site on a human, the site being characterized by at least one of impaired microcirculation or insufficient arterial perfusion (Rastegar [0010] provides an example of a burn wound, which has areas of coagulation to thereby impair microcirculation and/or arterial perfusion), the method comprising the steps of: (a) detecting cardiovascular activity of the human (Rastegar Fig. 1, sensor 180 detects the cardiac cycles of the user; see [0075]) and (b) applying varying sub-atmospheric pressures to the target somatic site in timed relation with the detected cardiovascular activity to thereby enhance blood circulation at the site (Rastegar [0075] discloses pressurization and vacuum cycles that are synchronized with the cardiac systole and diastole of the patient, thereby functioning to enhance blood circulation at the burned region).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Rastegar in view of Imai, as applied to claim 2 above, in view of Loori et al (2006/0185670).
Regarding claim 3, as best understood, the modified Rastegar teaches the one or more inflation cells comprising a chamber for exerting negative pressure on a mammalian limb (Rastegar Fig. 6 depicts a chamber formed by shell 202 for exerting negative pressure on the foot of a limb of a human).
The modified Rastegar does not teach the one or more inflation air cells comprising inflatable double walled chambers.
However, Loori teaches a hyperbaric device for treating the foot of a user comprising a collapsible bag formed of an inflatable double walled chamber (Loori Figs. 2-3 enclosure 12 is a collapsible bag formed of an outer sheet 24 and an inner sheet 26 that is inflated when gas filled the space 25 between the two sheets). Loori teaches that the bag transitions into a “rigid state” when gas is delivered between the sheets 24 and 26 ([0022])
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the foot chamber of Rastegar to comprise an inflatable double wall as taught by Loori. Having the chamber be an inflatable double wall allows it to collapse for easier storage and transport.
Regarding claim 4, the modified apparatus of Rastegar has the double walled chambers each comprising inner and outer inflatable shells (Loori annotated Fig. 3 above), and a valve on the outer shell configured to introduce a fluid between the inner inflatable shell and the outer inflatable shell (Rastegar Figs. 2 and 12, [0077], solenoid valve 402 on the outer wall of the enclosure 100 via piping 406 to control the flow of pressurized air into the enclosure 100; Rastegar enclosure 100 was previously modified by Loori to have an outer shell, in which air is delivered between the inner and outer shells for inflating the enclosure, see Loori [0022]), such that the double walled chamber is configured to resist deformation during subsequent inflation or suction (Loori, [0022], discloses that the bag transitions into a “rigid state” when gas is delivered between the sheets 24 and 26. Finally, once Loori’s double walled chamber is in its rigid state, it resists deformation to the inflation or suction that would occur within the chamber in the modified device of Rastegar).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Rastegar in view of Imai and Loori, as applied to claim 3 above, in view of Whalen et al. (US 2011/0098615 A1).
Regarding claim 5, the modified Rastegar teaches the double walled inflatable chamber configured to be positioned over the mammal's limb (Rastegar, Fig. 6, depicts the chamber positioned over the foot of the user. The modified apparatus would use the double-walled structure of Loori for its chamber), and comprises a padding of a material for sealing the chamber to the mammal’s limb (Rastegar, [0080], discloses a soft sealing material 212 that is considered both “padding” and a “seal” used with medical adhesive tape 208).
The modified Rastegar does not teach the material is a curable material.
However, Whalen teaches a differential air pressure system (Whalen, abstract) wherein the material used to anchor a user to a seal is a curable material (Whalen, [0098] has a curing epoxy as a suitable alternative to adhesive tape).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Rastegar apparatus by substituting the medical adhesive tape for a curing epoxy, such that the material is a curable material, as taught by Whalen, for the purpose of providing the apparatus with a specific suitable alternative adhesive mechanism to anchor a user to a seal which one of ordinary skill in the art could feasibly expect to perform reasonably well (Whalen, [0098]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Rastegar and Imai, as applied to claim 12 above, in view of Mansur et al (2014/0276294).
Regarding claim 13, Rastegar discloses a desire to have pressure applied in a sequential manner ([0038] and [0077]).
The modified Rastegar does not teach each fluid conduit comprising a valve.
However, Masur teaches a pressure treatment garment comprising a plurality of inflatable bladders that are connected to one another via fluid conduits containing valves (Figs. 4-5, air chambers 110, 112, and 114 are connected to one another via pressure resistive valves 116 and 118). Use of this conduit and valve configuration between bladders ensures a progressively distal-to-proximal force application within the limb ([0022]).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the chamber of Rastegar to have valves within the fluid conduits connecting the plurality of compartments as taught by Masur to ensure a progressive/sequential pressurization of the chamber to assist in blood flow within the limb.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Rastegar in view of Imai, as applied to claim 1 above, in view of Kamm et al (2003/0009119).
Regarding claim 16, the modified Rastegar does not teach the apparatus includes a pulse oximeter configured to generate the transduced signal.
However, Kamm teaches a wound healing device that applies external compression that is synchronized with the cardiac cycle of the patient ([0011]). Kamm detects the cardiac cycle by using a pulse oximeter ([0050]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the cardiac sensor of Rastegar a pulse oximeter as taught by Kamm. Such a sensor would be an easy and non-invasive way to determine the patient’s cardiac cycle.
Response to Arguments
Applicant's arguments filed 9/10/2025 have been fully considered but they are not persuasive.
On page 10 in the first paragraph of the Applicant’s remarks, the Applicant argues that the drawings have been amended to overcome the drawing objections of the previous office action. The Examiner partially agrees, and has thus withdrawn those drawing objections which were addressed. However, the drawing objections which were not addressed are being maintained as detailed above.
On page 10 in the “Claim Objection Overcome” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the claim objections of the previous office action. The Examiner agrees, and has thus withdrawn those claim objections. However, the newly amended claims have raised new claim objections as detailed above.
On pages 10-11 in the “Discussion of the Claim Rejections under 35 USC 112(b)” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the 35 U.S.C. 112(b) rejections of the previous office action. The Examiner partially agrees, and has thus withdrawn those 35 U.S.C. 112(b) rejections which were addressed. However, the 35 U.S.C. 112(b) rejections which were not addressed are being maintained along with new claim 35 U.S.C. 112(b) rejections raised by the newly amended claims as detailed above.
On page 11 in the “Discussion of the Claim Rejections under 35 USC 101” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the 35 U.S.C. 101 rejections of the previous office action. The Examiner agrees, and has thus withdrawn those 35 U.S.C. 101 rejections.
Applicant’s arguments on pages 12-13 in the “Independent Claims 1, 9, 17, 18, and 19 are patentable” section of the Applicant’s remarks with respect to the newly amended independent claims have been considered but are moot in view of new grounds of rejection with new additional Imai reference being used in the current rejection as discussed above.
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 JACQUELINE M PINDERSKI whose telephone number is (571)272-7032. The examiner can normally be reached Monday-Friday 7:00-4:00.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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