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 .
Drawings
The drawings are objected to because of the unlabeled rectangular box(es) shown in Figures 2, 3, and 6. The drawings should be provided with suitable descriptive legends. See: 37 CFR 1.84 (n) and (o).
The drawings are objected to because the drawings contain blank boxes and other shapes, which are not widely, recognized engineering symbols. Applicant must supply a suitable legend. A proposed drawing correction or corrected drawings are required in reply to the Office action to avoid abandonment of the application. The objection to the drawings will not be held in abeyance.
37 CFR 1.84(n) and (o) permit use of symbols which are not universally recognized, subject to approval by the Office, if they are not likely to be confused with existing conventional symbols, and if they are readily identifiable. In addition, suitable descriptive legends may be used subject to approval by the Office, or may be required by the examiner where necessary for understanding of the drawing. (Emphasis added). Thus the examiner may require, on a case-by-case basis, the use of descriptive legends where it is believed that such will facilitate a clear understanding of the drawings without undue reliance on the specification for understanding of the subject matter depicted therein. "When possible, a drawing should be so complete that the purpose and operation of the invention may be readily understood by one skilled in the art by means of a mere inspection of said drawing. The necessity of reading the specification in connection with the drawing should be avoided, if possible." See Ex Parte Hartley, 1901 C.D. 247 (Comm'r Pat. 1901).
In the instant case, Figures 2, 3, and 6 have boxes and other shapes with lines connecting the shapes together and the use of descriptive legends is necessary because it is believed that such will facilitate a clear understanding of the drawings without undue reliance on the specification for understanding of the subject matter depicted therein. It is clear that Figures 2, 3, and 6 are not “so complete that the purpose and operation of the invention may be readily understood by one skilled in the art by means of a mere inspection of said drawing” and that undue reliance on the specification is required for understanding of the subject matter depicted therein.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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, 5, 9-12, 15, and 19-20 are objected to because of the following informalities:
Regarding claim 1 line 5, claim 5 line 2, and claim 10 line 2, the term “the array of air pockets” should read --the array of selectively and sequentially inflatable and deflatable air pockets-- in order to remain consistent with the current language of claim 1 line 3.
Regarding claim 1 line 7 and claim 9 line 2, the term “the air pockets” should read --the array of selectively and sequentially inflatable and deflatable air pockets-- in order to remain consistent with the current language of claim 1 line 3.
Regarding claim 11 line 9 and 11, claim 12 line 2, claim 15 lines 2-3, and claim 19 line 2, the term “the array of air pockets” should read --the array of selectively inflatable and deflatable air pockets-- in order to remain consistent with the current language of claim 11 line 7.
Regarding claim 11 line 13 and claim 12 line 2, the term “the air pockets” should read --the array of selectively inflatable and deflatable air pockets-- in order to remain consistent with the current language of claim 11 line 7.
Regarding claim 20 line 5 and 11, the term “the array of air pockets” should read --the array of selectively inflatable and deflatable air pockets-- in order to remain consistent with the current language of claim 20 line 3.
Regarding claim 20 line 7, the terms “the air pockets” should read --the array of selectively inflatable and deflatable air pockets-- in order to remain consistent with the current language of claim 20 line 3.
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 4 and 11-19 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 4 lines 2-3, the term “a portion of a lower extremity of a bed-ridden patient” is unclear as to if the term “a portion” is the same or different than “a portion” of claim 1 line 8 and if “a bed-ridden patient” is the same or different than “a patient’s body” of claim 1 line 8.
Regarding claim 11 line 3, the term “a lower extremity” is unclear as to if the term is the same or different than claim 11 line 1 “the lower extremities”. In line 4, the term “a bed-ridden patient” is unclear as to if the term is the same or different than “a bed-ridden patient” of claim 11 line 1-2. In line 14, the term “the blood” is indefinite because it lacks proper antecedent basis.
Regarding claim 13 line 2, the term “a portion” is unclear as to if the term is the same or different than claim 11 line 3.
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 1-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Solana et al. (US 2022/0241137; hereinafter “Solana”).
Regarding claim 1, Solana discloses a pressure ulcer boot (pneumatic compression boot assembly 10) comprising:
a boot body formed from a layer of flexible material (inner layer 23 and outer layer 25; [0018] fabric boot portion);
an array of selectively and sequentially inflatable and deflatable air pockets mounted to a portion of the boot body (plurality of cells 21; [0040] inflatable sequentially (or in any other inflation pattern); [0005] “inflate the inflatable compartments (e.g., sequentially, individually, in sets, all at once or in any other combination)”);
an air pump in fluid communication with the array of air pockets (pump assembly 41 comprising pump(s) 12); and
a micro-processor operative to control the air pump to selectively inflate and deflate the air pockets and to apply pressure via the air pockets at regular intervals to increase circulation and relieve pressure in a portion of a patient’s body with which the pressure ulcer boot is in contact (control assembly 32; [0042] controlling the device (e.g., inflation and deflation cycles, etc.); pump assembly 41 operated by control assembly 32 to inflate sequentially, individually, etc. [0005 above]).
Regarding claim 2, Solana discloses the portion of the patient’s body with which the pressure ulcer boot is in contact includes an extremity area susceptible to ulcer formation (boot assembly 10; receives user’s leg and foot extremity).
Regarding claim 3, Solana discloses a plurality of straps and buckles ([0041] boot includes slot 26 for closing/opening in order for a user to insert their extremity; slot 26 closeable by zipper 28 or other closure mechanism such as snaps, latches, etc.).
Regarding claim 4, Solana discloses the boot body is configured to wrap around and be placed in contact with a portion of a lower extremity of a bed-ridden patient for whom increased circulation is desired ([0041] boot 10 slot 26 for inserting the foot/leg into the boot interior; boot 10 wraps around leg and foot such as in Fig. 2), and wherein the pressure ulcer boot is configured to be secured to the lower extremity with the plurality of straps and buckles ([0041] slot 26 closeable by zipper 28 or other closure mechanism such as snaps, latches, etc.).
Regarding claim 5, Solana discloses a plurality of air-flow tubes fluidly connecting the air pump to the array of air pockets ([0043] conduits 40 extend from pump(s) 12 to the compartments 21).
Regarding claim 6, Solana discloses one or more air-flow valves attached within one or more of the plurality of air-flow tubes ([0045] pump assembly 41 includes a valve system 56; plurality of valves route air into conduits 40).
Regarding claim 7, Solana discloses a source of power electrically connected to the micro-processor and to the air pump ([0045] battery 54).
Regarding claim 8, Solana discloses a source of power electrically connected to the micro-processor, the air pump, and to the one or more air-flow valves ([0045] battery 54).
Regarding claim 9, Solana discloses an air-flow control switch operative to control the flow of air to and from the air pockets via the air pump ([0042] control assembly 32 includes buttons 27 and switches for controlling the device (e.g., inflation and deflation cycles, etc.)).
Regarding claim 10, Solana discloses the boot body is formed from two layers of material between which the array of air pockets is mounted (Fig. 2 inner layer 23 and outer layer 25 hold compartments 21 between them).
Regarding claim 11, Solana discloses a method of increasing circulation in the lower extremities of a bed-ridden patient (pneumatic compression boot assembly 10; performs compression therapy), the method comprising:
placing a flexible pressure ulcer boot in contact with a portion of a lower extremity of a bed-ridden patient for whom increased circulation is desired (see Fig. 2 boot 10 on leg of patient; compression therapy increases circulation), the pressure ulcer boot including:
a boot body formed from a layer of flexible material (inner layer 23 and outer layer 25; [0018] fabric boot portion);
an array of selectively inflatable and deflatable air pockets mounted to a portion of the boot body (plurality of cells 21; [0040] inflatable sequentially (or in any other inflation pattern); [0005] “inflate the inflatable compartments (e.g., sequentially, individually, in sets, all at once or in any other combination));
an air pump in fluid communication with the array of air pockets (pump assembly 41 comprising pump(s) 12); and
a micro-processor operative to control the air pump (control assembly 32; [0042] controlling the device (e.g., inflation and deflation cycles, etc.); pump assembly 41 operated by control assembly 32 to inflate sequentially, individually, etc. [0005 above]);
wherein the array of air pockets is positioned on a posterior side of the portion of the lower extremity (see Fig. 2 compartments 21 located on posterior side of the leg); and
selectively inflating and deflating the air pockets in the array of air pockets, thus relieving pressure on the posterior side of the lower extremity and keeping the blood in the lower extremity moving (pump assembly 41 operated by control assembly 32 to inflate sequentially, individually, etc. [0005 above]).
Regarding claim 12, Solana discloses the step of inflating and deflating the air pockets in the array of air pockets further applies pressure at regular intervals to increase circulation and relieve pressure in the portion of the lower extremity with which the pressure ulcer boot is in contact ([0005] “inflate the inflatable compartments (e.g., sequentially, individually, in sets, all at once or in any other combination)”).
Regarding claim 13, Solana discloses the step of placing the flexible pressure ulcer boot in contact with a portion of the lower extremity includes wrapping the boot body around the portion of the lower extremity to place the flexible pressure ulcer boot in contact with the portion of the lower extremity ([0041] boot 10 slot 26 for inserting the foot/leg into the boot interior; boot 10 wraps around leg and foot such as in Fig. 2).
Regarding claim 14, Solana discloses the pressure ulcer boot further includes a plurality of straps and buckles ([0041] boot includes slot 26 for closing/opening in order for a user to insert their extremity; slot 26 closeable by zipper 28 or other closure mechanism such as snaps, latches, etc.), wherein the boot body is configured to wrap around and be placed in contact with the portion of the lower extremity ([0041] boot 10 slot 26 for inserting the foot/leg into the boot interior; boot 10 wraps around leg and foot such as in Fig. 2), and wherein the pressure ulcer boot is secured to the lower extremity with the plurality of straps and buckles ([0041] snaps and latches above).
Regarding claim 15, Solana discloses the pressure ulcer boot further includes a plurality of air-flow tubes fluidly connecting the air pump to the array of air pockets ([0043] conduits 40 extend from pump(s) 12 to the compartments 21).
Regarding claim 16, Solana discloses the pressure ulcer boot further includes one or more air-flow valves attached within one or more of the plurality of air-flow tubes ([0045] pump assembly 41 includes a valve system 56; plurality of valves route air into conduits 40).
Regarding claim 17, Solana discloses the pressure ulcer boot further includes a source of power electrically connected to the micro-processor and to the air pump ([0045] battery 54).
Regarding claim 18, Solana discloses the pressure ulcer boot further includes a source of power electrically connected to the micro-processor, the air pump, and to the one or more air-flow valves ([0045] battery 54).
Regarding claim 19, Solana discloses the boot body is formed from two layers of material between which the array of air pockets is mounted (Fig. 2 inner layer 23 and outer layer 25 hold compartments 21 between them).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Solana in view of Bongers (US 2019/0297991).
Regarding claim 20, Solana discloses a pressure ulcer boot (see Solana pneumatic compression boot assembly 10) comprising:
a boot body formed from two layers of flexible material (see Solana inner layer 23 and outer layer 25; [0018] fabric boot portion).
Solana is silent as to flexible foam material. However, Bongers teaches a boot body formed of flexible foam material (see Bongers Figs. 6a-c boot 110 made of layers [0090] second layer 147 consists of a foam material). 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 layers material of Solana with the foam layer material as taught by Bongers as this would have been an obvious substitution for one known type of material for another and would yield predictable results, i.e. form the boot body, and since such a modification would have involved a mere change in the form (material) of a component. A change in form is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Modified Solana discloses an array of selectively inflatable and deflatable air pockets mounted between the two layers of flexible foam material (plurality of cells 21; [0040] inflatable sequentially (or in any other inflation pattern); [0005] “inflate the inflatable compartments (e.g., sequentially, individually, in sets, all at once or in any other combination)”);
an air pump in fluid communication with the array of air pockets (pump assembly 41 comprising pump(s) 12); and
a micro-processor operative to control the air pump to selectively inflate and deflate the air pockets and to apply pressure via the air pockets at regular intervals to increase circulation and relieve pressure in a portion of a patient’s body to which the pressure ulcer boot is in contact (control assembly 32; [0042] controlling the device (e.g., inflation and deflation cycles, etc.); pump assembly 41 operated by control assembly 32 to inflate sequentially, individually, etc. [0005 above]);
wherein the boot body is configured to wrap around the portion of the patient’s body such that the array of air pockets is positioned on a posterior side of the portion of the patient’s body ([0041] boot 10 slot 26 for inserting the foot/leg into the boot interior; boot 10 wraps around leg and foot such as in Fig. 2); and
wherein the pressure ulcer boot is configured to be secured to the portion of the patient’s body with at least one fastening strap ([0041] boot includes slot 26 for closing/opening in order for a user to insert their extremity; slot 26 closeable by zipper 28 or other closure mechanism such as snaps, latches, etc.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to the applicant’s disclosure.
Davis et al. (US 2013/0310719), Logan et al. (US 2020/0368100), Wersland et al. (US 2022/0192914), Arkans (US 6,358,219), and Wild et al. (US 2005/0107725) are cited to show a compressive therapeutic boot.
Kloecker et al. (US 2010/0042026), Ramakrishna et al. (US 2016/0361224), Perry et al. (US 2005/0222526), Eddy (US 2010/0137764), Barak et al. (US 7,591,796), Meyer et al. (US 2009/0062703), and Zeutzius et al. (US 2019/0374424) cited to show a pneumatic compression device wrapped around the lower leg.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GWYNNETH L HOWELL whose telephone number is (703)756-4742. The examiner can normally be reached 8:30-4:30 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tim Stanis can be reached at (571) 272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GWYNNETH L HOWELL/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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