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 .
This office action is in response to preliminary amendment filed on 04/15/2024. As directed by the amendment, claim 16 was canceled, no claims were amended, and no claims were newly added. Thus, claims 1-15 and 17-18 are presently pending in this application.
Drawings
The drawings are objected to because Figures 6-7 illustrate graphs and flow charts that are blurry and unable to be read. A clear depiction of the Figures is necessary in order to accept the drawings.
The drawings are objected to because Figure 8 depicts a photograph of a view that is capable of being illustrated as a line drawing, see MPEP 37 CFR 1.84(b)(1).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference character “102g” in Figure 3.
The drawings are objected to because of the unlabeled rectangular box(es) shown in Figures 1, 3, and 4. 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 1, 3, and 4 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 1, 3, and 4 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.
Specification
The abstract of the disclosure is objected to because in line 1, the abstracts reads as “A portable, daily wearable, smart compression device The present invention relates to a compression therapy device (100) for promotion of venous and lymphatic flow and its method of use”. Examiner recommends using a period to separate the two statements, or remove the “A portable, daily wearable, smart compression device” from the abstract, as that appears to be the title of the invention.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1-5, 7, 10-11, and 13 are objected to because of the following informalities:
In claim 1 lines 3, 5, 7, 9, and 12 and claim 10 lines 4, 6, 8, 10, and 13, the terms “a.”, “b.”, “c.”, “d.”, and “e.” should read without the period at the end of the term. See MPEP 608.01(m) “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995).”
In claim 2 lines 4, 7, 9, 11, 13, and 15 and claim 11 lines 4, 7, 9, 11, 13, and 15, the terms “a.”, “b.”, “c.”, “d.”, “e.”, and “f.” should read without the period at the end of the term. See MPEP 608.01(m) “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995).”
In claim 1 lines 3, 5, 7, 9, and 12, claim 2 lines 4, 7, 9, 11, 13, and 15, claim 10 lines 4, 6, 8, 10, 13, and claim 11 lines 4, 7, 9, 11, 13, and 15, the terms “A” and “An” respectively should read --a-- and --an-- to remove improper capitalization in the body of the claim.
In claim 7 lines 3, 5, 7, 9, 11, 14, an 17, the terms “P”, “S”, “I” “C”, “S”, and “R” respectively should read --p--, --s--, --i--, --c--, --s--, and --r-- to remove improper capitalization in the body of the claim.
In claim 1 line 8 and 12, the term “the device” should read as --the smart compression device-- to remain consistent with claim 1 line 1.
In claim 2 lines 11-12, the term “characterized for characterized for” should read --characterized for-- to delete the repeated term.
In claim 3 lines 2-3 and claim 12 lines 3-4, the term “the innermost layer (101) comprises of breathable fabric” should read --the innermost layer (101) comprises breathable fabric-- for grammatical correctness.
In claim 4 lines 3, the term “selected from group of blends” should read --selected from a group of blends-- for grammatical correctness.
In claim 5 line 2, the term “( I02b)” should read --(102b)-- if the reference numbers are correctly listed in the claims.
In claim 7 line 9, the term “1-IOsec” should read --1-10 seconds-- for grammatical correctness.
In claim 10 line 9 and 13, the term “the device” should read --the smart compression device-- in order to remain consistent with language from line 1.
In claim 11 line 3, the term “comprising” should read --comprises-- for grammatical correctness.
In claim 11 line 11-12, the term “characterized for characterized for” should read --characterized for-- to delete the repeated term.
In claim 13 line 4-5, the term “selected from group of blends” should read --selected from a group of blends-- for grammatical correctness.
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 1-15 and 17-18 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 1 line 1-2, the term “the compressive pressure” is indefinite because it lacks proper antecedent basis. In line 3-4, the term “the human skin” is indefinite because it lacks proper antecedent basis. In line 5-6, the term “the plurality of technological components” is indefinite because it lacks proper antecedent basis. In line 7, the term “covenng” is unclear as to what term is intended to be written. Examiner interprets the term as “covering” for the purposes of rejection. In line 9-10, the term “the intermittent, sequenced, or continuous compression and relaxation” is indefinite because it lacks proper antecedent basis. In line 10-11, the term “the middle layer components” is indefinite because it lacks proper antecedent basis.
Regarding claim 2 line 2, the term “a body parts” is unclear as to if the term is the same or different than “body parts” in claim 1 line 2. In line 3, the term “compnsmg” is unclear as to what term is intended to be written. Examiner interprets the term as “comprising” for the purposes of rejection. In line 5, the term “the shape memory alloy” is indefinite because it lacks proper antecedent basis. In line 5, the term “the contraction” is indefinite because it lacks proper antecedent basis. In line 6, the term “the body part” is indefinite because it lacks proper antecedent basis. In line 8, the term “contraction” is unclear as to if the term is the same or different than “the contraction” of line 5. In line 10, the term “the shape memory alloys” is unclear as to if the term is the same or different than claim 2 line 5 given the plurality. Are there multiple shape memory alloys? In line 12, the term “sensmg” is unclear as to what term is intended to be written. Examiner interprets the term as “sensing” for the purposes of rejection. In line 15-16, the term “the technology components” is indefinite because it lacks proper antecedent basis.
Regarding claim 3 line 2, the term “body parts” is unclear as to if the term is the same or different than “body parts” in claim 1 line 2. In line 6, the term “particularly” is indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 4 line 2, the term “a body parts” is unclear as to if the term is the same or different than “body parts” in claim 1 line 2. In line 2, the term “outer layer” is unclear to if the term is the same or different than “An outer layer” of claim 1 line 7. In line 4, the term “particularly” is indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 5 line 2, the term “a body parts” is unclear as to if the term is the same or different than “body parts” in claim 1 line 2. In line 2-3, the term “the shape memory alloy ( I02b) is in the form of wire, foil, stents, helical springs, flat springs, tubes, mesh” is unclear as to how the shape memory alloy is in all of those forms. Should the claim read --, or mesh--? Examiner interprets the form listings as a group with an “or” statement. In line 3, the term “particularly” is indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 6 line 2, the term “a body parts” is unclear as to if the term is the same or different than “body parts” in claim 1 line 2. In line 4, the term “- I 90°C” is unclear as to what is meant by the term. Examiner interprets the term as “-190°C” for the purposes of rejection. In line 5, the term “particularly” is indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 7 lines 1, the term “the compressive pressure” is indefinite because it lacks proper antecedent basis. In line 3, the terms “the compression device” and “the affected body part” are indefinite because they respectively lack proper antecedent basis. In line 4, the terms “the help” and “the fastening means” are indefinite because they respectively lack proper antecedent basis. In line 5, the terms “the power” and “the plurality of shape memory alloy units” are indefinite because they respectively lack proper antecedent basis. In line 6, the term “the controller” is indefinite because it lacks proper antecedent basis. In line 7, the term “In case where” is unclear as to what is meant by the phrasing, and the term is indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. Are limitations following “In case where” optional to a specific case? See MPEP § 2173.05(d). In line 7, the term “shape memory alloy” is unclear as to if the term is the same or different than the term “the plurality of shape memory alloy units” of claim 7 line 5. In line 13, the term “the circumference of the swollen extremity” is indefinite because it lacks proper antecedent basis. In line 17, the term “Shape memory alloy” is unclear as to if the term is the same or different than “the plurality of shape memory alloy units” of claim 7 line 5 or “shape memory alloy” of claim 7 line 7.
Regarding claim 8 and claim 9 lines 1-2, the term “The method for applying the compressive pressure on a body parts as claimed in claim 5” is unclear as to how the method claim is dependent from the apparatus claim of claim 5. Examiner interprets the term as “as claimed in claim 7” since the preamble of claim 7 matches the lines 1-2 of claims 8 and 9 for the purposes of examination.
Regarding claim 8 line 1, the term “a body” is unclear as to if the term is the same or different than “body parts” of claim 1 line 2, “a body parts” of claim 5 line 2, or “a body” of claim 7 line 1. In line 2, the term “the swollen area” is indefinite because it lacks proper antecedent basis.
Regarding claim 9 lines 1, the term “a body” is unclear as to if the term is the same or different than “body parts” of claim 1 line 2, “a body parts” of claim 5 line 2, or “a body” of claim 7 line 1. In line 3, the term “particularly” is indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 10 line 2-3, the term “the compressive pressure” is indefinite because it lacks proper antecedent basis. In line 4-5, the term “the human skin” is indefinite because it lacks proper antecedent basis. In line 6-7, the term “the plurality of technological components” is indefinite because it lacks proper antecedent basis. In line 8, the term “covenng” is unclear as to what term is intended to be written. Examiner interprets the term as “covering” for the purposes of rejection. In line 10, the term “managmg” is unclear as to what term is intended to be written. Examiner interprets the term as “managing” for the purposes of rejection. In line 10-11, the term “the intermittent, sequenced, or continuous compression and relaxation” is indefinite because it lacks proper antecedent basis. In line 11-12, the term “the middle layer components” is indefinite because it lacks proper antecedent basis.
Regarding claims 11-15 lines 1-3, the term “The smart compression device (100) for treatment of venous and arterial diseases, lymphedema and other related edemas by applying the compressive pressure on a body parts as claimed in claim 1” is unclear as to how the claims are each dependent from claim 1 when the claim preambles and subsequent limitations do not match. Examiner interprets the term as “…as claimed in claim 10” since the preamble of claim 10 matches the lines 1-3 of claims 11-15 for the purposes of examination.
Regarding claim 11 line 3, the term “a body parts” is unclear as to if the term is the same or different than “body parts” in claim 10 line 3. In line 5, the term “the shape memory alloy” is indefinite because it lacks proper antecedent basis. In line 5, the term “the contraction” is indefinite because it lacks proper antecedent basis. In line 6, the term “the body part” is indefinite because it lacks proper antecedent basis. In line 8, the term “contraction” is unclear as to if the term is the same or different than “the contraction” of line 5. In line 10, the term “the shape memory alloys” is unclear as to if the term is the same or different than claim 2 line 5 given the plurality. Are there multiple shape memory alloys? In line 12, the term “sensmg” is unclear as to what term is intended to be written. Examiner interprets the term as “sensing” for the purposes of rejection. In line 15-16, the term “the technology components” is indefinite because it lacks proper antecedent basis.
Regarding claim 12 line 3, the term “body parts” is unclear as to if the term is the same or different than “body parts” in claim 10 line 3. In line 6, the term “particularly” is indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 13 line 3, the term “a body parts” is unclear as to if the term is the same or different than “body parts” in claim 10 line 3. In line 3, the term “outer layer” is unclear to if the term is the same or different than “An outer layer” of claim 1 line 7 or claim 7 line 8. In line 5, the term “particularly” is indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 14 line 3, the term “a body parts” is unclear as to if the term is the same or different than “body parts” in claim 10 line 3. In line 3-4, the term “the shape memory alloy (102b) is in the form of wire, foil, stents, helical springs, flat springs, tubes, mesh” is unclear as to how the shape memory alloy is in all of those forms. Should the claim read --, or mesh--? Examiner interprets the form listings as a group with an “or” statement. In line 4, the term “particularly” is indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 15 line 3, the term “a body parts” is unclear as to if the term is the same or different than “body parts” in claim 10 line 3. In line 5, the term “- I 90°C” is unclear as to what is meant by the term. Examiner interprets the term as “-190°C” for the purposes of rejection. In line 6, the term “particularly” is indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 17 and 18 lines 1-3, the term “The method for treatment of venous and arterial diseases, lymphedema and other related edemas by applying the compressive pressure on a body parts as claimed in claim 5” is unclear as to how the claims are each dependent from claim 5 when the claim preambles and subsequent limitations do not match. Examiner interprets the term as “… as claimed in claim 7” since claim 7 is the only independent claim claiming a method for the purposes of rejection.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 17-18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 17, the claim limitations do not specify a further limitation of the subject matter claimed. As indicated above, Examiner interprets the claim 17 as dependent from independent claim 7. Thus, the claim limitations from claim 17 do not further limit the limitations from claim 8.
Regarding claim 18, the claim limitations do not specify a further limitation of the subject matter claimed. As indicated above, Examiner interprets the claim 18 as dependent from independent claim 7. Thus, the claim limitations from claim 18 do not further limit the limitations from claim 9.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-2, 5-6, 10-11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Pamplin et al. (US 9,271,890; hereinafter “Pamplin”) in view of Atkinson et al. (US 2006/0287621; hereinafter “Atkinson”), as best understood.
Regarding claim 1, Pamplin discloses a smart compression device for applying the compressive pressure on body parts (see Pamplin compression garment apparatus 10), comprising:
a. An innermost layer, characterized for contacting with the human skin (see Pamplin flexible backing 13; Fig. 2 contacting the skin);
b. A middle layer, characterized for enclosing the plurality of technological components (see Pamplin flex frames 20a-d with shape memory alloy 40, such as in Fig. 3A).
Pamplin is silent as to An outer layer, characterized for covenng, protection, and aesthetic appearance of the device. However, Atkinson teaches An outer layer, characterized for covenng, protection, and aesthetic appearance of the device (see Atkinson compression device 10; [0019] outer layer 13 of cover may be elastic (e.g. silicone, latex, polyurethane)). 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 outside of the device of Pamplin with the addition of an outer layer cover as taught by Atkinson so as to protect the components on the inside of the compression device.
Modified Pamplin discloses
d. A controller (see Pamplin controller 50), characterized for managing the intermittent, sequenced, or continuous compression and relaxation of the middle layer components (see Pamplin Abstract “A controller can be connected to the terminals applying current to the shape memory alloy at defined intervals providing intermittent, sequenced, or continuous compression therapy”), and
e. A fastening means, characterized for tightening the device, uniformly placed at different locations (see Pamplin attaching means 16a-g; Col. 4 lines 63-67 attaching means “is used to connect the flexible backing to the body part and provide tensioning and closing of the apparatus around the body part”; such as Velcro straps).
Regarding claim 2, modified Pamplin discloses the middle layer compnsmg;
a. An elastic base structure (see Pamplin tensioners 18a-g), characterized for supporting and disposing the shape memory alloy (see Pamplin Col. 11 lines 50-54 tensions serve to tension the shape memory alloy), augmenting the contraction (see Pamplin Col. 8 lines 56-64 tensions provide “pretension the shape memory alloy prior to applying current to the shape memory alloy”), acting as a tensioner (see Pamplin tensioner 18a-g), applying pull back force (see Pamplin Col. 8 lines 56-64 above), and a baseline pressure to the body part (see Pamplin Col. 9 lines 57-58 “a tensioner can be secured to the flexible backing for applying a baseline pressure to the body part”);
b. A shape memory alloy, characterized for application of contraction (see Pamplin shape memory alloy 40);
c. A plurality of anchor points, characterized for attachments of the shape memory alloys (see Pamplin first and second terminals 30, 32 attach shape memory alloy 40’s first and second ends 41, 42);
d. A temperature sensor, characterized for characterized for sensmg and controlling temperature of the shape memory alloy (see Pamplin sensor 90; Col. 3 lines 19-21 “a temperature sensor that can automatically shut off the system if the temperature of the patents skin rises above a specified benchmark”);
e. A pressure sensor, characterized for sensing and controlling pressure of the shape memory alloy (see Pamplin sensor 90; Col. 4 lines 21-24 “The amount of compression can be controlled by several methods including but not limited to a pressure sensor”).
Modified Pamplin is silent as to a plurality of temperature and pressure sensors. However, 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 sensor of Pamplin with a plurality of sensors, both temperature and pressure as disclosed in Pamplin, as the plurality of sensors is a mere duplication of parts with no new or unexpected results produced from the modification. See MPEP 2144.04(VI)(B), In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Modified Pamplin discloses f. A resistive material layer, characterized for encasing the technology components and for thermal, electrical and water insulation (see Pamplin fabric covers 14a-g attached to flex frames 20a-g; Col. 5 lines 61-67 fabric cover can be electrically or heating insulating).
Regarding claim 5, modified Pamplin discloses the shape memory alloy is in the form of wire (see Pamplin Col. 2 lines 51-64 shape memory alloy 40 is in the form of a wire) particularly anchored in waveform, dual waveform (see Pamplin Fig. 3A two waves of shape memory alloy wire 40 in a helical waveform shape).
Regarding claim 6, modified Pamplin discloses the shape memory alloy is in waveform arrangement (see Pamplin Fig. 3A two waves of shape memory alloy wire 40 in a helical waveform shape), selected from a composite of two or more metal ions particularly, Ni, Ti, Cu (see Pamplin Col. 7 lines 31-38 shape memory alloy can be nickel or copper alloys including but not limited to: copper-aluminum-nickel alloys and nickel-titanium (NiTi) alloys, etc…) with operating temperatures between -190°C to 220°C (see Pamplin materials claimed are disclosed in Pamplin and thus can operate at this temperature range; also see Figs. 5a-5b with operating temperatures below 40 to over 110°C), more particularly Nitinol (see Pamplin nickel-titanium (NiTi) alloys).
Regarding claim 10, Pamplin discloses a smart compression device for treatment of venous and arterial diseases, lymphedema and other related edemas by applying the compressive pressure on body parts (see Pamplin compression garment apparatus 10; Col. 2 lines 31-40 people who would benefit from this invention include patients with peripheral edema; compartment syndrome; poor circulation; etc.), comprising:
a. An innermost layer, characterized for contacting with the human skin (see Pamplin flexible backing 13; Fig. 2 contacting the skin);
b. A middle layer, characterized for enclosing the plurality of technological components (see Pamplin flex frames 20a-d with shape memory alloy 40, such as in Fig. 3A).
Pamplin is silent as to An outer layer, characterized for covenng, protection, and aesthetic appearance of the device. However, Atkinson teaches An outer layer, characterized for covenng, protection, and aesthetic appearance of the device (see Atkinson compression device 10; [0019] outer layer 13 of cover may be elastic (e.g. silicone, latex, polyurethane)). 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 outside of the device of Pamplin with the addition of an outer layer cover as taught by Atkinson so as to protect the components on the inside of the compression device.
Modified Pamplin discloses
d. A controller (see Pamplin controller 50), characterized for managing the intermittent, sequenced, or continuous compression and relaxation of the middle layer components (see Pamplin Abstract “A controller can be connected to the terminals applying current to the shape memory alloy at defined intervals providing intermittent, sequenced, or continuous compression therapy”), and
e. A fastening means, characterized for tightening the device, uniformly placed at different locations (see Pamplin attaching means 16a-g; Col. 4 lines 63-67 attaching means “is used to connect the flexible backing to the body part and provide tensioning and closing of the apparatus around the body part”; such as Velcro straps).
Regarding claim 11, modified Pamplin discloses the middle layer comprising:
a. An elastic base structure (see Pamplin tensioners 18a-g), characterized for supporting and disposing the shape memory alloy (see Pamplin Col. 11 lines 50-54 tensions serve to tension the shape memory alloy), augmenting the contraction (see Pamplin Col. 8 lines 56-64 tensions provide “pretension the shape memory alloy prior to applying current to the shape memory alloy”), acting as a tensioner (see Pamplin tensioner 18a-g), applying pull back force (see Pamplin Col. 8 lines 56-64 above), and a baseline pressure to the body part (see Pamplin Col. 9 lines 57-58 “a tensioner can be secured to the flexible backing for applying a baseline pressure to the body part”);
b. A shape memory alloy, characterized for application of contraction (see Pamplin shape memory alloy 40);
c. A plurality of anchor points, characterized for attachments of the shape memory alloys (see Pamplin first and second terminals 30, 32 attach shape memory alloy 40’s first and second ends 41, 42);
d. A temperature sensor, characterized for characterized for sensmg and controlling temperature of the shape memory alloy (see Pamplin sensor 90; Col. 3 lines 19-21 “a temperature sensor that can automatically shut off the system if the temperature of the patents skin rises above a specified benchmark”);
e. A pressure sensor, characterized for sensing and controlling pressure of the shape memory alloy (see Pamplin sensor 90; Col. 4 lines 21-24 “The amount of compression can be controlled by several methods including but not limited to a pressure sensor”).
Modified Pamplin is silent as to a plurality of temperature and pressure sensors. However, 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 sensor of Pamplin with a plurality of sensors, both temperature and pressure as disclosed in Pamplin, as the plurality of sensors is a mere duplication of parts with no new or unexpected results produced from the modification. See MPEP 2144.04(VI)(B), In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Modified Pamplin discloses f. A resistive material layer, characterized for encasing the technology components and for thermal, electrical and water insulation (see Pamplin fabric covers 14a-g attached to flex frames 20a-g; Col. 5 lines 61-67 fabric cover can be electrically or heating insulating).
Regarding claim 14, modified Pamplin discloses the shape memory alloy is in the form of wire (see Pamplin Col. 2 lines 51-64 shape memory alloy 40 is in the form of a wire) particularly anchored in waveform, dual waveform (see Pamplin Fig. 3A two waves of shape memory alloy wire 40 in a helical waveform shape).
Regarding claim 15, modified Pamplin discloses the shape memory alloy is in waveform arrangement (see Pamplin Fig. 3A two waves of shape memory alloy wire 40 in a helical waveform shape), selected from a composite of two or more metal ions particularly, Ni, Ti, Cu (see Pamplin Col. 7 lines 31-38 shape memory alloy can be nickel or copper alloys including but not limited to: copper-aluminum-nickel alloys and nickel-titanium (NiTi) alloys, etc…) with operating temperatures between -190°C to 220°C (see Pamplin materials claimed are disclosed in Pamplin and thus can operate at this temperature range; also see Figs. 5a-5b with operating temperatures below 40 to over 110°C), more particularly Nitinol (see Pamplin nickel-titanium (NiTi) alloys).
Claims 3 and 12 rejected under 35 U.S.C. 103 as being unpatentable over Pamplin in view of Atkinson as applied to claim 1 and 10 respectively above, and further in view of Cleveland (US 2014/0289924) and Berthet (US 2023/0018250), as best understood.
Regarding claim 3, modified Pamplin discloses the innermost layer comprises of breathable fabric with high moisture regain (see Pamplin Col. 6 lines 21-24 flexible backings can be made from cotton, linen), tensile strength (see Pamplin Col. 6 lines 18-24 flexible backing is a non-woven material or any combination of natural and synthetic fabrics, all of which would have a tensile strength), selected from the group of natural fibers, Synthetic fibers particularly polyester (see Pamplin Col. 6 lines 18-24 flexible backing is a combination of natural and synthetic fibers; polyester, parachute material).
Modified Pamplin is silent as to the innermost layer comprises anti-microbial property, anti- fungal property. However, Cleveland teaches a fabric comprising anti-microbial property, anti- fungal property (see Cleveland [0032] compression sock made of materials that are actively anti-microbial to provide anti-fungal benefits). 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 innermost layer fabric of modified Pamplin with the addition of anti-microbial, anti-fungal properties as taught by Cleveland so as to prevent fungal or antimicrobial growth in the device, and as this would have been an obvious substitution for one known type of fabric for another and would yield predictable results, i.e. a fabric with properties, now including anti-fungal and anti-microbial.
Modified Pamplin is silent as to the innermost layer comprises a thickness ranging in between 0.5-2.0mm. However, Berthet teaches a layer comprises a thickness ranging in between 0.5-2.0mm (see Berthet title “Pressure application garment”; [0052] the fabric layer has a thickness between 0.5mm and 25mm, specifically 2mm mentioned). 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 thickness of the innermost layer of modified Pamplin with the thickness as taught by Berthet since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 105 USPQ 233), and as this would have been an obvious substitution for one known type of fabric thickness for a compression garment layer for another and would yield predictable results, i.e. layer as a fabric within the garment for wearing.
Regarding claim 12, modified Pamplin discloses all of the claimed structures, see rejection to claim 3 above.
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Pamplin in view of Atkinson as applied to claim 1 and 10 respectively above, and further in view of Berthet, as best understood.
Regarding claim 4, modified Pamplin discloses outer layer comprises of breathable fabric selected from group of blends of Shape Memory Polyurethane (SMPU) with thermal sensitivity (see modification in claim 1 with Atkinson over cover 13; [0019] outer layer 13 may be elastic, such as latex or polyurethane; polyurethane is heat sensitive).
Modified Pamplin is silent as to the outer layer comprises thickness ranging between 0.5-2.5mm. However, Berthet teaches a layer comprises a thickness ranging in between 0.5-2.0mm (see Berthet title “Pressure application garment”; [0052] the fabric layer has a thickness between 0.5mm and 25mm, specifically 2mm mentioned). 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 thickness of the outer layer of modified Pamplin with the thickness as taught by Berthet since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 105 USPQ 233), and as this would have been an obvious substitution for one known type of fabric thickness for a compression garment layer for another and would yield predictable results, i.e. layer as a fabric within the garment for wearing.
Regarding claim 13, modified Pamplin discloses all of the claimed structures, see rejection to claim 4 above.
Claims 7-9 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Pamplin in view of Farrow et al. (US 2012/0209153; hereinafter “Farrow”), as best understood.
Regarding claim 7, Pamplin discloses a method for applying the compressive pressure on a body (see Pamplin Figs. 7a-b method of make and use of compression garment apparatus 10), comprising steps of
a. Placing the compression device on the affected body part with the help of the fastening means (see Pamplin attaching means 16a-g for attaching compression garment apparatus 10);
b. Supplying the power to the plurality of shape memory alloy units through the controller (see Pamplin Col. 11 lines 31-33 shape memory alloy 40 controlled and provided current by controller 50);
c. In case where no current is passing, shape memory alloy is in a detwinned martensite phase (see Pamplin shape memory alloy 40 when no current is passing would naturally be in detwinned martensite phase (cool/room temperature));
d. Passing the current of 0.IA - IA, 9V - 24V for 1-IOsec (see Pamplin Col. 10 lines 34-36, 38-40, and 63-65 where current to create compression therapy is set at 1 A, for a preset time of 6 seconds, where the current can be from 3-48 Volts), heats the shape memory alloy by Joule's heating to 45-90°C (see Pamplin Col. 10 lines 66-67, Col. 11 lines 1-3 shape memory alloy raises temperature between 40-110°C) and raising the shape memory alloy temperature to Austenite final temperature which causes contraction in the Shape memory alloy (see Pamplin shape memory alloy temperature raised between 40-110°C; highest temperature shortens at this deformable final temperature), which results in contraction of fabric closer to each other and generation of pressure against the circumference of the swollen extremity (see Pamplin Col. 11 lines 1-3 shape memory alloy raises temperature between 40-110°C to shorten or lengthen the shape memory alloy);
e. Cooling of the Shape memory alloy at -50°C-50°C for 20-90 sec. to Martensite final temperature range (Mf) relaxing it back to its original length, releasing the pressure application (see Pamplin Col. 5 lines 30-38 “cooling phase” cools from 0.1 seconds to 10 minutes, or 3 seconds to 3 minutes to a target transition temperature; Col. 11 lines 1-3 shape memory alloy raises temperature between 40-110°C, encompassing a “coolest” temperature of 40°C within the range to original length, such as in Fig. 3a).
Pamplin is silent as to repeating the contraction and the relaxation of Shape memory alloy after every 60-80sec. However, Farrow teaches repeating the contraction and the relaxation of Shape memory alloy after every 60-80sec (see Farrow compression therapy device 10; [0007] “A preferred rest time is approximately 60 seconds between cycles for each output”). 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 method of controlling the shape memory alloy of Pamplin with the addition of rest and repeat of contraction and relaxation as taught by Farrow so as to prevent over-compression of the user.
Regarding claim 8, modified Pamplin discloses the pressure applied throughout the swollen area is adjusted in the range of 25 - 120 mmHg (see Pamplin Col. 4 lines 2-4 compression sleeve able to reach 30 mmHg).
Regarding claim 9, modified Pamplin discloses the compression device is placed on the affected body parts, particularly hand, arm, feet, ankle and leg swollen due to oedema (see Pamplin Col. 5 lines 3-6 the term “body part” can refer to legs, arms, hands, heads, necks or other body parts of a human in need of compression therapy; Col. 2 lines 31-40 people who would benefit from this invention include patients with peripheral edema; compartment syndrome; poor circulation; etc.).
Regarding claim 17, modified Pamplin discloses all of the claimed structures, see rejection to claim 8 above.
Regarding claim 18, modified Pamplin discloses all of the claimed structures, see rejection to claim 9 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to the applicant' s disclosure.
Brown (US 2008/0245361), Ramanan et al. (US 2020/0113773), Wright et al. (US 2015/0224012), and Walter et al. (US 2010/0249637) are cited to show a controller operated compression device.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GWYNNETH L HOWELL/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
Prosecution Insights