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 .
Status of Claims
The present Office action is responsive to the application as filed on 05-21-2024. As directed, claims 1-19 are presently pending examination.
Drawings
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 distinct layers of claims 3-7 must be shown or the feature(s) canceled from the claim(s). 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. 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, 6-8, and 11-19 are objected to because of the following informalities:
At claim 1, lines 4, 7, and 10, it is suggested that “said first and second sheets” be replaced with “said first sheet and said second sheet” for clarity.
At claim 1, line 6, it is suggested that “said first and second base edges” be replaced with “said first base edge and said second base edge” for clarity.
At line 1 of each of claims 2-15, and line 2 of claim 16, “Claim” should be replaced with “claim” for consistency.
At claim 6, lines 1-2, it is suggested that “the internal layer” be replaced with an internal layer” as the claim limitation has not been previously introduced in this dependency chain.
At claim 7, lines 1-2, it is suggested that “an outer surface” be replaced with “the outer surface” as the limitation was previously introduced in claim 4.
At claim 8, line 1, it is suggested that “opposite” be added before “lateral edge” for consistency with claim 1, line 12.
At claim 8, line 2, it is suggested that “comprise” be replaced with “comprises” to correct a grammatical error.
At claim 8, line 3, it is suggested that “the” be added before “pouch” for clarity.
At claim 11, line 2, it is suggested that “base portion” be replaced with “base edge” for consistency with claim 1, line 5.
At claim 11, line 2, it is suggested that “the first or second sheet” be replaced with “the first sheet or the second sheet” for clarity.
At claim 12, line 2, it is suggested that “base portion” be replaced with “base edge” for consistency with claim 1, line 5.
At claim 12, line 2, it is suggested that “the first or second sheet” be replaced with “the first sheet or the second sheet” for clarity.
At claim 13, line 2, it is suggested that “the first and second sheet” be replaced with “the first sheet and the second sheet” for clarity.
At claim 14, line 2, it is suggested that “the first and second sheet” be replaced with “the first sheet and the second sheet” for clarity.
At claim 15, line 3, it is suggested that “an inflatable compression sleeve” be replaced with “the inflatable compression sleeve” as the limitation is introduced at claim 1, line 1.
At claim 15, line 4, it is suggested that “the pouch cavity” be replaced with “the cavity of the pouch” for consistency with claim 1, line 7.
At claim 15, lines 4-5, it is suggested that “the inflatable compression sleeve shape” be replaced with “the shape of the inflatable compression sleeve” for consistency.
At claim 15, line 5, it is suggested that “of” be added following “deflating” for clarity.
At claim 16, line 1, it is suggested that “a pouch” be replaced with “the pouch” as the pouch was previously introduced in claim 1.
At claim 16, line 2, it is suggested that “an inflatable compression sleeve” be replaced with “the inflatable compression sleeve” as the limitation is introduced at claim 1, line 1.
At claim 16, line 3, it is suggested that “the pouch cavity” be replaced with “the cavity of the pouch” for consistency with claim 1, line 7.
At claim 16, line 4, it is suggested that “the inflatable compression sleeve shape” be replaced with “the shape of the inflatable compression sleeve” for consistency.
At claim 16, line 7, it is suggested that “a user” be replaced with “the user” as the limitation is introduced at claim 1, line 14.
At claim 16, line 8, it is suggested that “a limb” be replaced with “the limb” as the limitation is introduced at claim 1, line 14.
At claim 17, lines 4-5, it is suggested that “said first and second faces” be replaced with “said first face and said second face” for clarity.
At claim 17, line 7, it is suggested that “plurality of adjacent” be added before “inflatable pockets” for consistency with lines 5-6.
At claim 18, line 3, it is suggested that “a limb of a user” be replaced with “the limb of the user” as the limitation was introduced in claim 17, line 11.
At claim 19, line 2, it is suggested that “an inflatable compression sleeve” be replaced with “the inflatable compression sleeve” as the limitation is introduced at claim 17, line 1.
At claim 19, lines 5, 8, and 11, it is suggested that “said first and second sheets” be replaced with “said first sheet and said second sheet” for clarity.
At claim 19, line 7, it is suggested that “said first and second base edges” be replaced with “said first base edge and said second base edge” for clarity.
At claim 19, line 3, it is suggested that “a limb of a user” be replaced with “the limb of the user” as the limitation was introduced in claim 17, line 11.
Appropriate correction is required.
Claim Interpretation
Examiner notes that the claimed “inflating device” is interpreted as a pump or other functionally equivalent device capable of inflation and deflation of a sleeve.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A/the “lateral edge fastening portion” in claims 1 and 19, which is interpreted relative to the instant specification at page 10 to include hook or loop fastener, hooks, buttons, snaps, zippers, latches, buckles, and functional equivalents thereof.
An/the “opposite lateral edge fastening portion” in claims 1 and 19, which is interpreted relative to the instant specification at page 10 to include hook or loop fastener, hooks, buttons, snaps, zippers, latches, buckles, and functional equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 18 is 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.
Claim limitation “releasable fastening means” in claim 18 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. While different releasable fasteners are mentioned with respect to a lateral edge fastening portion and an opposite lateral edge fastening portion at page 10, this portion of the disclosure is not directed to the “free of releasable fastening means” limitation of claim 18, and therefore it cannot be determined if the fastening portions recited at page 10 overlap in nature with the releasable fastening means or not. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
For the purposes of examination, the releasable fastening means will be interpreted as any reversible fastening attachment such as, but not limited to hook and loop fastener, hooks, buttons, snaps, zippers, latches, buckles, and functional equivalents thereof.
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Schirrmacher (US 2005/0256556) in view of Zeutzius (US 2019/0125619).
Regarding claim 1, Schirrmacher discloses a disposable pouch (104) for receiving an inflatable compression sleeve (102) for use in pneumatic compression therapy (paragraph 49, lines 15-17; paragraph 50, lines 3-9; paragraph 52, lines 1-4; Fig. 2), the pouch (104) comprising:
a first sheet (112) superposed to a second sheet (114) (paragraph 58, lines 1-8; Figs. 2-3),
said first and second sheets (112 and 114) each including a first base edge opposite a second base edge (see Figs. 2 and 3, where the second base edge is the top edge of each of 112 and 114, and the first base edge is the bottom edge of each of 112 and 114) (paragraph 58, lines 1-8, note that seam 116 forms the top and bottom edges; Figs. 2-3), the second base edge being longer than the first base edge (see Figs. 2 and 3, where the top edge is longer than the bottom by virtue of the upside-down trapezoid shape of the device) and lateral edges (see left and right sides of 112 and 114 in Figs. 2 and 3) joining said first and second base edges (top and bottom edges of sheets 112 and 114) (paragraph 58, lines 1-8, where seam 116 joins the entire perimeter of 112 and 114; Figs. 2-3);
said first and second sheets (112 and 114) being peripherally adjoined to form a cavity (interior of pouch 104) (paragraph 58, lines 1-8; paragraph 59, lines 1-7; Fig. 2) and an insertion slit (124) for allowing reversible insertion of the inflatable compression sleeve (102) into the cavity (interior of pouch 104) (paragraph 59, lines 1-7; Fig. 2);
a lateral edge fastening portion (130) of the first sheet (112) being configured to cooperate with an opposite lateral edge fastening portion (128) of the second sheet (114) when the pouch (104) is wrapped in a conoid configuration for allowing releasable attachment to a limb of a user (paragraph 61, lines 1-15 for hook and loop fastener; see Figs. 2-3 for portions 128 and 130, and note that the shape shown in these figures, when placed in the wrapped configuration in Fig. 1, would reasonably give way to a conoid shape due to the differences in length of the first and second base edges); and
a flap (126) configured to reversibly close the insertion slit (124) and secure the inflatable compression sleeve (102) when inserted into the cavity (interior of 104) (paragraph 59, lines 1-10).
Schirrmacher fails to explicitly disclose that the insertion slit is formed between the second base edges of the first and second sheets.
However, Zeutzius teaches a disposable pouch (120) for receiving an inflatable compression sleeve (110) for use in pneumatic compression therapy (paragraph 9, lines 1-10; paragraph 32, lines 1-11; Fig. 1A-C), including an insertion slit (see opening of pocket 126 in Fig. 1B) is formed between second base edges of analogous first and second sheets (paragraph 32, lines 5-11; paragraph 33, lines 5-10; Figs. 1A-C, note that the first and second sheets are the front and back portions of 120 that form the pocket 126, and the second base edges thereof are the topmost edges of each sheet that form the opening for pocket 126).
Given that each of Schirrmacher and Zeutzius disclose/teach openings within a disposable pouch for compression therapy, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the placement of the insertion slit of Schirrmacher to be formed between the second base edges of the first and second sheets, as taught by Zeutzius, as an alternative placement for the insertion slit that would enable easier placement of the inflatable compression sleeve inside the pouch. Such a modification could be done with a reasonable expectation of success given that the function of both the Schirrmacher and Zeutzius insertion slits are for removably inserting the inflatable sleeve. Moving the insertion slit of Schirrmacher would not appear to render the Schirrmacher device unsuitable for its intended purpose.
Regarding claim 2, Schirrmacher in view of Zeutzius disclose the pouch according to claim 1, as discussed above.
Schirrmacher further discloses wherein the pouch (104) is configured for the first sheet (112) to contact the limb of the user (paragraph 58, lines 1-4; Figs. 1-3, note that the portion 120 shown in Fig. 1 is the same portion 120 seen in Fig. 2 as opposed to the portion 120 seen in Fig. 3, and thus 112 is shown to be interiorly oriented when in a wrapped configuration).
Regarding claim 3, Schirrmacher in view of Zeutzius disclose the pouch according to claim 1, as discussed above.
Schirrmacher further discloses wherein the first sheet (112) comprises an internal layer made of an impermeable material and wherein a border of the cavity (124) is defined by an inner surface of the internal layer (paragraph 64, lines 8-12, where the coating on the fabric constitutes the inner layer, and is described as being in contact with member 102, thus creating the interior border of cavity 124 on each of sheets 112 and 114).
Regarding claim 4, Schirrmacher in view of Zeutzius disclose the pouch according to claim 1, as discussed above.
Schirrmacher further discloses wherein the first sheet (112) comprises an external layer, an outer surface of the external layer being configured to contact the limb of the user (paragraph 58, lines 1-4; Figs. 1-3, note that the portion 120 shown in Fig. 1 is the same portion 120 seen in Fig. 2 as opposed to the portion 120 seen in Fig. 3, and thus 112 is shown to be interiorly oriented when in a wrapped configuration; paragraph 64, lines 8-12, where the coating on the fabric constitutes an inner layer and the underlying nylon constitutes an external layer, the inner layer is described as being in contact with member 102, thus the additional nylon on an outer surface of 104 that is uncoated and oriented on an opposite surface from the coated nylon would be expected to contact the limb).
Regarding claim 5, Schirrmacher in view of Zeutzius disclose the pouch according to claim 4, as discussed above.
Schirrmacher further discloses wherein the external layer of the first sheet (112) is made of water absorbing breathable material (paragraph 64, lines 8-12, see nylon, which is known to be moisture wicking and moderately breathable).
Regarding claim 6, Schirrmacher in view of Zeutzius disclose the pouch according to claim 4, as discussed above.
Schirrmacher further discloses wherein the external layer is adhered to the internal layer (paragraph 64, lines 8-12, where the coating on the fabric constitutes an internal layer and the underlying nylon constitutes an external layer, see “coating” for adherence).
Regarding claim 7, Schirrmacher in view of Zeutzius disclose the pouch according to claim 4, as discussed above.
Schirrmacher further discloses wherein the outer surface of the external layer is made of a material configured to releasably bind with a loop fastener (paragraph 64, lines 8-12, where the coating on the fabric constitutes an internal layer and the underlying nylon constitutes an external layer; note hook strip portion 130 in Fig. 3 and described at paragraph 61, lines 9-14).
Regarding claim 8, Schirrmacher in view of Zeutzius disclose the pouch according to claim 7, as discussed above.
Schirrmacher further discloses wherein the opposite lateral edge fastening portion (128) of the second sheet (114) comprises a loop fastener strip configured to bind with the outer surface of the external layer of the first sheet (112) when the pouch (104) is wrapped in the conoid configuration (paragraph 64, lines 8-12, where the coating on the fabric constitutes an internal layer and the underlying nylon constitutes an external layer; note loop strip portion 128 in Fig. 2 and described at paragraph 61, lines 1-4; see mating of the hook and loop fasteners 128 and 130 in Fig. 1 in the conoid configuration).
Regarding claim 9, Schirrmacher in view of Zeutzius disclose the pouch according to claim 1, as discussed above.
Schirrmacher further discloses wherein the flap (126) comprises a band portion (114A) folding over the insertion slit (124) (paragraph 59, lines 1-8; Fig. 2).
Regarding claim 10, Schirrmacher in view of Zeutzius disclose the pouch according to claim 7, as discussed above.
Schirrmacher further discloses wherein the flap (126) comprises a band portion (114A) folding over the insertion slit (124) (paragraph 59, lines 1-8; Fig. 2).
While Schirrmacher indicates that any suitable fastening means can be used to close the insertion slit (124) (paragraph 59, lines 8-10), Schirrmacher fails to explicitly disclose wherein said band portion includes a second hook or loop fastener strip configured to bind with the outer surface of the external layer of the first sheet.
However, Zeutzius further teaches a flap (128) including a band portion (see surface of 128 shown in Fig. 1A), wherein said band portion (see surface of 128 shown in Fig. 1A) includes a hook or loop fastener strip configured to bind with an outer surface of an external layer of the first sheet in order to secure the inflatable sleeve (110) (paragraph 33, lines 12-19; Figs. 1A-B, note that the fist sheet, and I particular its outer surface, is the surface of 120 that can be seen in Fig. 1A, and external layer is interpreted to include strips 130).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified said band portion of modified Schirrmacher to further include a second hook or loop fastener strip configured to bind with the outer surface of the external layer of the first sheet, as further taught by Zeutzius, in order to secure the inflatable sleeve within the pocket during use.
Regarding claim 11, Schirrmacher in view of Zeutzius disclose the pouch according to claim 9, as discussed above.
Modified Schirrmacher further discloses wherein the band portion (114A) extends from the second base edge (top edges of 112 and 114 in Shirrmacher’s Figs. 2-3) of the first or second sheet (112 or 114 of Schirrmacher) (note Schirrmacher’s Figs. 2-3, and Zeutzius’ Fig. 1A, as modified, the insertion slit and flap have been moved such that the cavity is formed between second base edges of the first and second sheets, this modification means that flap 126 in Schirrmacher’s Fig. 2 would extend from the top surface of one of the second base edges, similar to what is shown in Zeutzius’ Fig. 1A).
Regarding claim 12, Schirrmacher in view of Zeutzius disclose the pouch according to claim 10, as discussed above.
Modified Schirrmacher further discloses wherein the band portion (114A) extends from the second base edge (top edges of 112 and 114 in Shirrmacher’s Figs. 2-3) of the first or second sheet (112 or 114 of Schirrmacher) (note Schirrmacher’s Figs. 2-3, and Zeutzius’ Fig. 1A, as modified, the insertion slit and flap have been moved such that the cavity is formed between second base edges of the first and second sheets, this modification means that flap 126 in Schirrmacher’s Fig. 2 would extend from the top surface of one of the second base edges, similar to what is shown in Zeutzius’ Fig. 1A).
Regarding claim 13, Schirrmacher in view of Zeutzius disclose the pouch according to claim 1, as discussed above.
Schirrmacher further discloses a tubular opening extending from the first base edges (in Schirrmacher’s Figs. 2 and 3, the bottom edges of 112 and 114) of the first and second sheets (112 and 114) and configured to allow passing of a tubing braid (110) (see Figs. 2-3, where an opening is seen in 104 for surrounding and allowing the passage of 110 at the first base edge region).
Regarding claim 14, Schirrmacher in view of Zeutzius disclose the pouch according to claim 1, as discussed above.
Schirrmacher further discloses wherein the first and second sheets (112 and 114) have a substantially trapezoid shape (see Figs. 2-3, where 112 and 114 are shown in a substantially upside-down trapezoid shape).
Regarding claim 15, Schirrmacher in view of Zeutzius disclose the pouch according to claim 1, as discussed above.
Schirrmacher further discloses wherein the pouch (104) constitutes a part of a system (100) for pneumatic compression therapy, said system (100) at least when in use, comprising at least said pouch (104) and an inflatable compression sleeve (102) having substantially a trapezoid shape and the pouch cavity (124) being shaped to match the inflatable compression sleeve shape while allowing inflating and deflating the inflatable compression sleeve (102) (paragraph 50, lines 1-7; paragraph 52, lines 1-6; paragraph 59, lines 1-3; Figs. 1-3, see that the shapes of 102 and 104 are complementary/matched).
Regarding claim 16, Schirrmacher in view of Zeutzius disclose the pouch according to claim 1, as discussed above.
Schirrmacher further discloses a method of pneumatic compression therapy using a system (100) that includes the pouch (104) of claim 1 and an inflatable compression sleeve (102) (paragraph 50, lines 1-7; paragraph 52, lines 1-6), the inflatable compression sleeve (102) having substantially a trapezoid shape and the pouch cavity (124) being shaped to match the inflatable compression sleeve shape while allowing inflating and deflating the inflatable compression sleeve (102) (paragraph 50, lines 1-7; paragraph 52, lines 1-6; paragraph 59, lines 1-3; Figs. 1-3, see that the shapes of 102 and 104 are complementary/matched), the method further comprising:
(a) inserting the inflatable compression sleeve (102) into the disposable pouch (104) (paragraph 59, lines 1-6; Figs. 1-3 and 4);
(b) releasably attaching the disposable pouch (104) to a user by wrapping the disposable pouch (104) into the conoid configuration around a limb of the user (see Figs. 1 and 7A-C; paragraph 61, lines 1-15 for releasable connection; paragraph 66, lines 1-11);
(c) connecting a connector (110) of the inflatable compression sleeve (102) to an inflating device (180) (paragraph 52, lines 11-19 and “A fluid circulation control unit as diagrammatically represented in FIG. 7B and generally designated with reference numeral 180 is coupled to manifold 110 with tubing to fluidly communicate the therapy fluids to bladders 106 and 108”; Figs. 3 and 7A-C).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Schirrmacher (US 2005/0256556) in view of Malhi (US 2013/0085427).
Regarding claim 17, Schirrmacher discloses an inflatable compression sleeve (102) for use in pneumatic compression therapy, (paragraph 50, lines 1-7; paragraph 52, lines 1-6), the inflatable compression sleeve (102) having substantially a trapezoid shape and the pouch cavity (124) being shaped to match the inflatable compression sleeve shape while allowing inflating and deflating the inflatable compression sleeve (102) (paragraph 50, lines 1-7; paragraph 52, lines 1-6; paragraph 59, lines 1-3; Figs. 1-3, see that the shapes of 102 and 104 are complementary/matched), and comprising:
(a) a first face (152) superimposed to a second face (150) each made of airtight material, said first and second faces (150 and 152) being adjoined to form an inflatable pocket (106A) extending transversely across the inflatable compression sleeve (102) (paragraph 51, lines 10-13; paragraph 53, lines 5-21; Fig. 2, see 106/106A; Fig. 6);
(b) a tube coupled at a first end to the inflatable pocket (106A) and at a second end to an inflating device connector (110) configured to be connected to an inflating device (180) (paragraph 52, lines 11-19 and “ A fluid circulation control unit as diagrammatically represented in FIG. 7B and generally designated with reference numeral 180 is coupled to manifold 110 with tubing to fluidly communicate the therapy fluids to bladders 106 and 108”);
the inflatable compression sleeve (102) being further configured to be received within a pouch (104) and to be attached to a limb of the user by means of said pouch (104) (paragraph 59, lines 1-8; Figs. 1-3 and 7A-C).
Schirrmacher fails to disclose a plurality of adjacent inflatable pockets extending transversely across the inflatable compression sleeve, and each pocket connected to one of a plurality of tubes.
However, Malhi teaches an inflatable compression sleeve (22) fashioned to be palced within a pouch (20) (paragraph 21, lines 1-5; paragraph 26, lines 1-8; Fig. 1), wherein the inflatable compression sleeve (22) includes a plurality of adjacent inflatable pockets (30A-C) extending transversely across the inflatable compression sleeve (22), and each pocket (30A-C) connected to one of a plurality of tubes (34A-C) (paragraph 23, lines 1-11; Fig. 3), and Malhi further indicates that it is known to vary the configuration of pockets within the inflatable compression sleeve (22) (paragraph 24, lines 18-25).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inflatable compression sleeve of Schirrmacher to include a plurality of adjacent inflatable pockets extending transversely across the inflatable compression sleeve, and each pocket connected to one of a plurality of tubes, as taught by Malhi, as it is known to vary the configuration of pockets within the inflatable compression sleeve, and doing this would allow for several independently inflatable pockets.
Regarding claim 18, Schirrmacher in view of Malhi disclose the inflatable compression sleeve according to claim 17, as discussed above.
Schirrmacher further discloses the compression sleeve (102) being free of releasable fastening means for releasably fastening the inflatable compression sleeve (102) to a limb of a user (note paragraph 61 and Figs. 1-3, where the only releasable fastening means, 128 and 130, are provided on pouch 104 as opposed to sleeve 102).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Schirrmacher (US 2005/0256556) in view of Malhi (US 2013/0085427), as applied to claim 17 above, in further view of Zeutzius (US 2019/0125619).
Regarding claim 19, Schirrmacher in view of Malhi disclose the inflatable compression sleeve according to claim 17, as discussed above.
Schirrmacher further discloses wherein said pouch is constituted by a disposable pouch (104) for receiving an inflatable compression sleeve (102) for use in pneumatic compression therapy (paragraph 49, lines 15-17; paragraph 50, lines 3-9; paragraph 52, lines 1-4; Fig. 2), the pouch (104) comprising:
a first sheet (112) superposed to a second sheet (114) (paragraph 58, lines 1-8; Figs. 2-3),
said first and second sheets (112 and 114) each including a first base edge opposite a second base edge (see Figs. 2 and 3, where the second base edge is the top edge of each of 112 and 114, and the first base edge is the bottom edge of each of 112 and 114) (paragraph 58, lines 1-8, note that seam 116 forms the top and bottom edges; Figs. 2-3), the second base edge being longer than the first base edge (see Figs. 2 and 3, where the top edge is longer than the bottom by virtue of the upside-down trapezoid shape of the device) and lateral edges (see left and right sides of 112 and 114 in Figs. 2 and 3) joining said first and second base edges (top and bottom edges of sheets 112 and 114) (paragraph 58, lines 1-8, where seam 116 joins the entire perimeter of 112 and 114; Figs. 2-3);
said first and second sheets (112 and 114) being peripherally adjoined to form a cavity (interior of pouch 104) (paragraph 58, lines 1-8; paragraph 59, lines 1-7; Fig. 2) and an insertion slit (124) for allowing reversible insertion of the inflatable compression sleeve (102) into the cavity (interior of pouch 104) (paragraph 59, lines 1-7; Fig. 2);
a lateral edge fastening portion (130) of the first sheet (112) being configured to cooperate with an opposite lateral edge fastening portion (128) of the second sheet (114) when the pouch (104) is wrapped in a conoid configuration for allowing releasable attachment to a limb of a user (paragraph 61, lines 1-15 for hook and loop fastener; see Figs. 2-3 for portions 128 and 130, and note that the shape shown in these figures, when placed in the wrapped configuration in Fig. 1, would reasonably give way to a conoid shape due to the differences in length of the first and second base edges); and
a flap (126) configured to reversibly close the insertion slit (124) and secure the inflatable compression sleeve (102) when inserted into the cavity (interior of 104) (paragraph 59, lines 1-10).
Schirrmacher fails to explicitly disclose that the insertion slit is formed between the second base edges of the first and second sheets.
However, Zeutzius teaches a disposable pouch (120) for receiving an inflatable compression sleeve (110) for use in pneumatic compression therapy (paragraph 9, lines 1-10; paragraph 32, lines 1-11; Fig. 1A-C), including an insertion slit (see opening of pocket 126 in Fig. 1B) is formed between second base edges of analogous first and second sheets (paragraph 32, lines 5-11; paragraph 33, lines 5-10; Figs. 1A-C, note that the first and second sheets are the front and back portions of 120 that form the pocket 126, and the second base edges thereof are the topmost edges of each sheet that form the opening for pocket 126).
Given that each of Schirrmacher and Zeutzius disclose/teach openings within a disposable pouch for compression therapy, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the placement of the insertion slit of Schirrmacher to be formed between the second base edges of the first and second sheets, as taught by Zeutzius, as an alternative placement for the insertion slit that would enable easier placement of the inflatable compression sleeve inside the pouch. Such a modification could be done with a reasonable expectation of success given that the function of both the Schirrmacher and Zeutzius insertion slits are for removably inserting the inflatable sleeve. Moving the insertion slit of Schirrmacher would not appear to render the Schirrmacher device unsuitable for its intended purpose.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Parker (US 2020/0121545) is cited for its disposable pouch and sleeve as shown in Figures 52-56.
Ravikumar (US 2011/0087142) is cited for its multi-sheet bladder configuration with breathable and moisture wicking material as discussed in paragraph 53.
Brown (US 2014/0257154) is cited for its construction of a bladder as shown in Figure 3.
Souney (US 2004/0039317) is cited for its pouch for receiving an inflatable bladder as shown in Figures 1A-C.
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/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785
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