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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/27/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Examiner notes, the publication date provided for US Patent No. 8,568,441 B2 on the IDS is incorrect and the IDS has been annotated to provide the correct date which is 10/29/2013.
Drawings
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:
Figure 32A, reference number (531).
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
The disclosure is objected to because of the following informalities:
Page 1, between title and first paragraph, add subheading “Cross-Reference to Related Applications”.
Page 13, lines 9-10 of text, “gas cartridge (51)” should be “gas cartridge (21)”.
Page 15, line 26 of text, “The short terminal end (45) of strap (45)” should be “The short terminal end (45) of strap (49)”.
Page 25, line 6 of text, repetition is present, “32 32” should be “32”.
Page 29, lines 7-8 of text, “inflatable strap (43)” should be “inflatable strap (49)”.
Appropriate correction is required.
Claim Interpretation
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Such claim limitation(s) is/are: “a plurality of fastening means” in claims 1 and 6.
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 pivotable constricting device” in claim 11.
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.
“a plurality of fastening means” – The corresponding structure for performing the function of “fastening” the strap (so that “the flexible discharge port is releasably engaged with the flexible inlet port”) is disclosed as: snapping fasteners (65) protruding from rigid attachment plate (61) (Figures 3 and 6; Page 17, lines 8-13 of text of the specification); screws or clips (explicitly identified as suitable fasteners in Page 17, lines 8-13 of text of the specification); and the rigid plate (427) having bosses (428), in combination with semi-rigid sealing layer (424), wherein the bosses receive fasteners (Figures 28A-28D; Page 33, line 16-Page 34, line 18 of text of the specification).
“a pivotable constricting device” - The corresponding structure(s) for performing the function of pivotably constricting/engaging/clamping the strap (to selectively clamp the inflatable strap when sufficiently tensioned, preventing free displacement and limiting gas flow beyond the clamping point) is/are disclosed as: housing member (10) (or (510)) having a clamping edge (e.g., lower edge (66) of outer wall (58)), in combination with rocker (11) (or (521)) rotatably mounted by axle (12), wherein the rocker angularly displaces in response to limb force and tension to clamp the strap between a rocker surface (e.g., outer rocker wall (79)) and the clamping edge (Figures 1-5, 9, 32A-32B, and 33-35; Page 12, line 23-Page 15, line 16 of text of the specification and Page 36, line 23-Page 37, line 12 of text of the specification); and variants including external sealing elements (533) and/or (537) positioned at the clamping edge or on the rocker leg(s) to enhance sealing against gas flow to the free end (Figures 32A-35; Page 36, line 23-Page 37, line 12 of text of the specification).
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 4 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 4 recites “wherein the strap has a third sealing layer.” The specification, as originally filed, consistently and repeatedly describes the inflatable strap as comprising exactly three layers total: an outer layer (13) that is puncture resistant; an intermediate sealant layer (14), explicitly identified as the dole sealing/sealant layer (made of polyurethane or equivalent); and an inner layer (15) that is tear-resistant and contacts the limb. See for example: Page 5, lines 1-3, “…the strap being configured with an inner layer, an outer layer, and an intermediate sealant layer that are interconnected.” Page 12, line 16-22, “Inflatable strap 49 may be configured with three layers 13-15 … The intermediate layer 14 is made of a sealant such as polyurethane.” And Page 16, line 26-Page 17, line 7, The three layers are interconnected by welding line (17) along the edges. The specification never describes the strap as possessing three distinct sealing layers, nor does it describe any additional (“third”) sealing layer beyond the single intermediate sealant layer (14). No embodiment, figure, or textual passage conveys possession of a strap having four or more layers in which three of them are sealing layers, or in which a “third sealing layer” is present in addition to the outer and inner layers. The disclosure fails to demonstrate that the inventor possessed a strap having “a third sealing layer” as recited. The specification conveys possession only of a three-layer strap with a single intermediate sealant layer.
Appropriate correction is required.
Claim 4 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 4 recites “wherein the strap has a third sealing layer.” Claim 4 depends directly from independent claim 1. Claim 1 recites a strap having only “an outer layer and an inner layer sealed to one another to form an interior.” No sealing layer of any kind – whether first, second, third, intermediate, or otherwise – is recited in claim 1. The limitation “a third sealing layer” therefore lacks proper antecedent basis. There is no disclosure in claim 1 of a first sealing layer or a second sealing layer. As a result, it is unclear: what constitutes the first and second sealing layers; whether “outer layer” and “inner layer” of claim 1 are being counted as the first and second sealing layers (they never identified as “sealing” layers in the claim language); or whether “third” refers to a radial position, manufacturing sequence, functional order, or some other undefined criterion. A claim is indefinite when it contains words or phrases whose meaning is unclear (MPEP 2173.05(e)). The use of the ordinal “third” without antecedent basis for “first” and “second” renders the scope of claim 4 incapable of reasonable construction by one of ordinary skill in the art. For the purposes of examination, will be interpreted as, “wherein the strap has a sealing layer.”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 5-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shaked (WO 2014/191987 A1 (See attached document) (Note: line numbers referred to below were counted only on the basis of lines of text (spaces not counted), where each page begins with line 1 (first line of text on the page) and ends with the last line of text on the page (appropriate number/counting down))).
Regarding claim 1, Shaked discloses, an inflatable tourniquet (Figures 1, 4, & 19, intelligent tourniquet (10/20/130); Page 10, line 15-16 of text, Page 12, line 18-21 of text, & Page 25, line 10-11 of text), comprising:
an assembly (Figure 2, closed and self-contained control device (5); Page 10, line 16-19) having a flexible discharge port (Figures 10-11 and 21, inlet fitting (42)/outlet fitting (43)/connecting fitting (151); Page 14, line 11-14 and Page 19, line 15-20), at least one conduit (Figures 11 and 21, conduits (52, 53, 54, & 59)/channel (156); Page 14, line 15-20 and Page 20, line 21-25) for conveying gas from a gas cartridge (Figures 2, 10, 20-21, & 24, gas container (15); Page 12, line 13-17, Page 15, line 1-4, and Page 20, line 21-25), and a rigid plate (Figures 3, 10, & 23, planar base (1)/monolithic block structure (37)/fitting holder (163); Page 12, line 3-6, Page 14, line 4-6, and Page 21, line 18-22);
a strap (Figures 1-3, inflatable strap (3); Page 10, line 16-17) having an outer layer and an inner layer sealed to one another to form an interior (Figure 10, internal cavity (7); Page 11, line 7-10 and Page 14, line 10; strap (3) comprises an outer protective sleeve and inner sleeve sealed together to form internal cavity (7)), a flexible inlet port disposed between the outer layer and the inner layer (Figure 21, the inlet is the port formed by connecting fitting (151)/inlet port (152); Page 19, line 15-20; flexible inlet port disposed in the cavity between the layers), and a plate engaged with the flexible inlet port (Figures 10, 21, & 23-24, fitting holder (163)/adaptor (167)/block structure (37) engages the inlet port and functions as the plate; Page 14, line 3-14, Page 20, line 3-17, Page 21, line 18-22, and Page 22, line 3-13); and
the strap being attached to the assembly by a plurality of fastening means on the plate of the strap so that the flexible discharge port is releasably engaged with the flexible inlet port (The strap is attached to the control device assembly at longitudinal end (13) via planar base (1) (Figure 3; Page 12, line 3-6). The buckle frame (11) engages the control device via multiple ribs (31) on its sidewalls (plurality of fastening means on the plate/structure attached to the strap end (Figures 1 & 3; Page 12, line 11-12)) and multiple swivel connections (69)/axle (99) (additional fastening structures; Figures 12-13 & 15-16; Page 15, line 19-Page 19, line 2). The connecting fitting (151) is releasably inserted into the strap cavity (discharge port releasably engaged with inlet port (Page 19, line 15-25); the pressure-tight but removable insertion and the removable buckle frame (11)/strap release lever (14) enable release). This structure performs the claimed attaching function and is equivalent under 112(f) to the disclosed snapping fasteners/bosses/screws).
Regarding claim 5, Shaked further discloses, wherein the flexible discharge port protrudes from the rigid plate of the assembly (Figures 2-3, 10-11, & 20-21; connecting fitting (151)/outlet fitting (43)/inlet fitting (42) protrudes from the rigid block (37)/fitting holder (163)/base (1); Page 14, line 11-12, “Fitted in block structure 37 is an inlet fitting 42 for directing the discharged gas to the strap cavity, an outlet fitting 43…” These fittings are integrated into/fit within (and effectively protrude/extend from) the “monolithic block structure (37” (rigid block). The figures (e.g., Figures 10-11) show them as protruding elements from the rigid block. Page 19, line 16-21, “… carrier 148 is configured with a connecting fitting 151 for insertion into the internal cavity of the strap in a pressure tight manner, to allow the discharged compressed gas to flow through inlet port 152 formed within fitting 151 to the internal cavity of the strap.” The fitting is part of (and extends from) the rigid carrier (148) (the main rigid body/block structure in this embodiment). The cross-section in Figure 21 shows it extending downward/outward from the carrier body for insertion. Page 21, line 18-20, “Outlet fitting 154 extends downwardly from a central portion of fitting holder 163, which is secured to the bottom end of housing 157.” Direct use of “extends downwardly” is equal to explicit protrusion/extension from the rigid fitting holder (163) (a plate-like holder or holder component secured to the housing. Further, carrier (148) is repeatedly called a “rigid puncture pin carrier” with a “cylindrical body” (serving as the rigid block/structure). Fitting holder (163) is the rigid component from which outlet fitting (154) extends. Earlier embodiments (Figures 10-11) use “monolithic block structure (37)” (rigid block) with inlet fitting (42)/outlet fitting (43), which are analogous fittings extending from the block. The overall rigid structures (carrier (148), fitting holder (163), monolithic block (37), base (1)) are the “rigid plate/block” from which fittings protrude for connection to the strap cavity).
Regarding claim 6, Shaked further discloses, wherein the plurality of fastening means are integrally formed on the plate of the strap (Figures 1, 3, 12, & 15-16; The ribs (31) and swivel connections (69)/axle mounts are integrally formed with the buckle-frame plate/structure attached to the strap end; Page 12, line 11-12, “The side walls of buckle frame 11 may be configured with a plurality of ribs 31, to facilitate engagement with the rim and side walls of control device 5.” This directly teaches ribs (31) as configured on (i.e., integrally formed with or part of”) the side walls of the buckle frame (11). The buckle frame (11) is the removable structure at the strap end, and it engages the control device periphery. Page 15, line 19-22, “Strap restraining unit 62 illustrated in Figs. 12- 14 comprises a cylindrical arm member 63 that extends between two side elements 64, each of which is rotatably mounted by a corresponding swivel connection 69 to one of two laterally spaced and forwardly positioned appendages 66 of the buckle frame.” Swivel connections (69) are the rotatable mounts attaching side elements (64) (part of the restraining mechanism) directly to the appendages (66) of the buckle frame (11). These appendages (66) are forwardly positioned extensions/integral parts of the buckle frame. Page 17, line 16-19, “Restraining portion 97 has an intermediate tubular, laterally oriented cavity in which is fitted axle 99 rotatably mounted to the buckle frame appendages 66, to permit rotation of initiating-restraining member 88. Restraining portion 97 also has a rearwardly positioned strap abuttable protuberance P …” Axle (99) is fitted/mounted rotatably to the buckle frame appendages (66). The initiating-restraining member (88) (68 in the other unit) is co-mounted or unitary with these swivel/axle structures on the buckle frame).
Regarding claim 7, Shaked further discloses, wherein the plate of the strap is attached to the outer layer (Figures 1-3; Base (1)/buckle-frame structure which houses fitting holder (163)/adaptor (167)/block structure (37) is fixedly attached to the outer face/end (13) of the strap’s outer sleeve; Page 12, line 3-6).
Regarding claim 8, Shaked further discloses, wherein the plate of the strap has an aperture through which the flexible inlet port protrudes (Figures 20-25; The central aperture in adaptor (167)/protrusion (166)/fitting holder (163) allows the inlet port (152)/puncture pin path to protrude through the plate; Page 19, line 3-Page 20, line 17).
Regarding claim 9, Shaked further discloses, wherein the flexible discharge port comprises a conical nipple (Figures 10-11 and 21; The connecting fitting (151)/inlet fitting (42) is inserted in a pressure-tight conical/press-fit manner equivalent to a conical nipple (Page 14, line 11-14 and Page 19, line 15-25); the insertion and actual geometry as seen in the Figures meets the limitation).
Regarding claim 10, Shaked further discloses, wherein the flexible inlet port has an abutment member connected to the plate of the strap (Figures 20-25; the abutment at fitting holder (163)/seal elements around inlet port (152)/adaptor (167) provides the connected abutment member; Page 19, line 16-20, “…carrier 148 is configured with a connecting fitting 151 for insertion into the internal cavity of the strap in a pressure tight manner, to allow the discharged compressed gas to flow through inlet port 152 formed within fitting 151 to the internal cavity of the strap.”, Page 21, line 18-Page 22, line 1, “Outlet fitting 154 extends downwardly from a central portion of fitting holder 163, which is secured to the bottom end of housing 157 … piston 188 is normally in abutting relation with fitting holder 163 …”, Page 20, line 4-Page 22, line , “Received in cavity 161 is annular stationary adaptor 167 … Seal element 162 positioned between container-facing body portion 143 and adaptor 167 urges carrier 148 in a linear displacement. As a result of the linear displacement, which is limited by contact between trigger-facing body portion 149 and adaptor 167 …”, and Page 21, line 4-6, “Closure element 173 is maintained in sealing engagement with the wall of bore 141 by spaced seal elements 179 that are received in corresponding circumferential seats.”).
Regarding claim 11, Shaked further discloses, further comprising a pivotable constricting device engaged with the strap (Figures 1-3 and 12-16, buckle frame (11) with strap adjustment chamber (6), detent (17), and rotatable initiating-restraining member (68)/(88) (pivotable about swivel connections (69)/axle (99)) constitutes the 112(f) pivotable constricting device engaged with the strap (Page 11, line 20-Page 12, line 2 and Page 15, line 19-Page 19, line 2). It permits free strap displacement until tensioned clamping/restraint occurs).
Regarding claim 12, Shaked further discloses, wherein the pivotable constricting device, assembly, and strap are assembled together (The buckle frame (11), control device (5) (assembly), and strap (3) are pre-assembled and stored as a unit; Figures 1 and 9; Page 13, line 16-Page 14, line 2; the looped structure (30) and factory-fed configuration).
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.
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 nonobviousness.
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(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaked, in view of Robinette-Lehman (US 4,635,635 A).
Regarding claim 2, Shaked teaches, a pneumatic tourniquet comprising an inflatable strap (3) configured with an outer protective sleeve and an inner sleeve sealed together to form an internal cavity (7) (Page 11, line 7-10, the two-sleeve construction provides outer and inner layers defining the inflatable interior). The strap receives pressurized gas via fittings (e.g., connecting fitting (151) with inlet port (152) inserted in a pressure-tight manner into the cavity; Figure 21; Page 19, line 15-25), and various seal elements (e.g., (16), (162), (179)) ensure gas-tightness at connections and interfaces.
Shaked fails to teach, further comprising a sealing layer disposed between the outer layer and the inner layer.
Robinette-Lehman discloses, a tourniquet cuff (Figure 1, cuff (5)). Robinette-Lehman teaches, a multi-layer construction of the tourniquet cuff comprising: a flexible backing envelope (11) made of two pieces of flexible backing material (12 (outer/upper) & 14 (inner/lower)); a stiffener (13) (a separate, less flexible sheet placed inside the backing envelop); bladder (15) formed of two sheets (16A and 16B) which are sealed along their edges; and bladder protective layer (17) (a single sheet placed over the bladder) (Figure 2; Col. 2, line 49-Col. 3, line 5, Col. 3, line 46-61, and Col. 5, line 13-15). This construction provides at least one intermediate sealing interface/layer (via the backing layer (14) that sealingly engages the bladder sheets to form a second seal).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the inflatable strap of Shaked (with its outer protective sleeve and inner gas-receiving sleeve forming the cavity) by incorporating an intermediate sealing layer between the outer and inner layers as taught by Robinette-Lehman, as both references and the claimed invention are directed to pneumatic tourniquet cuffs. 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 inflatable strap of Shaked (with its outer protective sleeve and inner gas-receiving sleeve forming the cavity) by incorporating an intermediate sealing layer between the outer and inner layers as taught by Robinette-Lehman, as such a modification would have been predictable, namely, to improve gas-tightness, prevent leakage during inflation, enhance durability against repeated use or environmental stress, and enable low-cost disposable designs (Col. 1, line 39-44 and Col. 4, line 11-38 of Robinette-Lehman) – all predictable benefits in emergency/pre-hospital pneumatic tourniquets like that of Shaked (which emphasizes reliability in harsh conditions; Page 7, line 9-13 of Shaked).
Regarding claim 3, modified Shaked teaches, wherein the sealing layer is disposed on a first side of the flexible inlet port and the plate of the strap is disposed on a second side of the flexible inlet port (the sealing layer/interface of Robinette-Lehman (between layers) would naturally be positioned on the internal side of the inlet port/fitting area (sealing the cavity), while the rigid plate/structure (e.g., carrier (148) or fitting holder (163) or fitting holder (163) or adaptor (167) or block structure (37) remains on the external/assembly side – following from the port insertion and layered assembly).
Regarding claim 4, as best understood in view of the 112(a) & 112(b) rejections above, Shaked teaches, a pneumatic tourniquet comprising an inflatable strap (3) configured with an outer protective sleeve and an inner sleeve sealed together to form an internal cavity (7) (Page 11, line 7-10, the two-sleeve construction provides outer and inner layers defining the inflatable interior). The strap receives pressurized gas via fittings (e.g., connecting fitting (151) with inlet port (152) inserted in a pressure-tight manner into the cavity; Figure 21; Page 19, line 15-25), and various seal elements (e.g., (16), (162), (179)) ensure gas-tightness at connections and interfaces.
Shaked fails to teach, wherein the strap has a sealing layer.
Robinette-Lehman teaches, a multi-layer construction of the tourniquet cuff comprising: a flexible backing envelope (11) made of two pieces of flexible backing material (12 (outer/upper) & 14 (inner/lower)); a stiffener (13) (a separate, less flexible sheet placed inside the backing envelop); bladder (15) formed of two sheets (16A and 16B) which are sealed along their edges; and bladder protective layer (17) (a single sheet placed over the bladder) (Figure 2; Col. 2, line 49-Col. 3, line 5, Col. 3, line 46-61, and Col. 5, line 13-15). This construction provides at least one sealing interface/layer (via the backing layer (14) that sealingly engages the bladder sheets to form a second seal).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the inflatable strap of Shaked (with its outer protective sleeve and inner gas-receiving sleeve forming the cavity) by incorporating an intermediate sealing layer between the outer and inner layers as taught by Robinette-Lehman, as both references and the claimed invention are directed to pneumatic tourniquet cuffs. 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 inflatable strap of Shaked (with its outer protective sleeve and inner gas-receiving sleeve forming the cavity) by incorporating an intermediate sealing layer between the outer and inner layers as taught by Robinette-Lehman, as such a modification would have been predictable, namely, to improve gas-tightness, prevent leakage during inflation, enhance durability against repeated use or environmental stress, and enable low-cost disposable designs (Col. 1, line 39-44 and Col. 4, line 11-38 of Robinette-Lehman) – all predictable benefits in emergency/pre-hospital pneumatic tourniquets like that of Shaked (which emphasizes reliability in harsh conditions; Page 7, line 9-13 of Shaked).
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771