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 .
Benefit
The Application is a National Stage filing under 35 USC 371 of PCT/US2023/01849 (17 April 2023) which claims benefit to US Provisional 63/331380 (15 April 2022).
Formal Matters
Claims 1-20 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 15 October 2024 has been considered by the examiner. A signed copy is attached.
Drawings – Objections
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters “466” and “460” appear to label different components in FIGs 21-23. In FIG 23, callout 466 appears to identify the opening above springs 465, but in FIG 21 the same opening is labeled 460; FIG 22 labels the lower platform 460. Accordingly, it is difficult to discern which part is platform 466 and which part is receptacle 460. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
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 limitations are”
“An instruction portion” in claim 1, lines 13 and 15. The specification discloses an instruction portion that is configured to emit one of audible and visual instructions to a user (¶¶9, 24, 27). Visual instructions are broadly interpreted to include equivalents of printed matter and equivalents thereof.
“A first feature” in claim 2, line 2; claim 15, line 13; claim 20, line 2. The specification discloses a first feature on a spool shaft to prevent winding of the strap onto the spool shaft (¶¶10, 23, 27). However, the specification does not disclose any structure related to the first feature. Accordingly, a first feature will be defined according to the disclosed functions and any structures that are capable of performing these functions and equivalents thereof.
“A second feature” in claim 2, line 4; claim 3, line 2; claim 4, line 1; claim 15, line 15; claim 20, line 5. 1. The specification discloses a second feature on a spool shaft to prevent unwinding of the strap onto the spool shaft (¶¶10-12, 23, 28). However, the specification does not disclose any structure related to the second feature. Accordingly, a second feature will be defined according to the disclosed functions and any structures that are capable of performing these functions and equivalents thereof.
“An energy storage element” in claim 12, line 2. The specification discloses an “energy storage element” at ¶¶21 and 20, but does not describe a structure for the “energy storage element.” Accordingly, any structure that stores energy, including potential energy, such as a ratchet assembly, will be broadly interpreted as “an energy storage element” as defined by the function of storing energy and equivalents thereof.
“A platform energy storage element” in claim 14, lines 1 and 4. The specification discloses a “platform energy storage element” at ¶22, but does not describe a structure for the “platform energy storage element.” Instead the generic structure is recited only by the function of being compressible (¶22).
“A block” in claim 18, line 2. The specification discloses “a block 490” in FIG 22 (¶71). Block 490 is taught as being spring loaded, snapping into place, having a release mechanism, having a release tab 492 (FIG 22), being disengageable, and locking (¶72). However, the specification does not describe any specific structure for the block. Accordingly, a block will be defined according to the disclosed functions and associated functional structures and structures that are capable of performing these functions and equivalents thereof.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations 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 limitations recite sufficient structure to perform the claimed function so as to avoid 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(b) – Lack of Antecedent Basis
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 10 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 10 recites the limitation "second pawl" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 10 has been amended to depend from claim 8, which is dependent on claim 1. Neither of claims 1 and 8 provide antecedent basis for “second pawl”.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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 2-4, 12, 14, 15, 18, and 20 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.
Claim limitations “first feature”, “second feature”, and “energy storage element” 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.
“A first feature” is recited in claim 2, line 2; claim 15, line 13; claim 20, line 2. The specification discloses “a first feature” on a spool shaft to prevent winding of the strap onto the spool shaft (¶¶10, 23, 27). However, the specification does not disclose any structure related to the first feature.
“A second feature” is recited in claim 2, line 4; claim 3, line 2; claim 4, line 1; claim 15, line 15; claim 20, line 5. The specification discloses a second feature on a spool shaft to prevent unwinding of the strap onto the spool shaft (¶¶10-12, 23, 28). However, the specification does not disclose any structure related to the second feature. It is only taught functionally.
“An energy storage element” is recited in claim 12, line 2. The specification discloses an “energy storage element” at ¶¶21 and 20, but does not describe a structure for the “energy storage element.” Instead the generic structure is recited by function “configured to reduce the length of the strap extending outside the housing when energy stored in the energy storage element is released” (¶20).
“A platform energy storage element” is recited in claim 14, lines 1 and 4. The specification discloses a “platform energy storage element” at ¶22, but does not describe a structure for the “platform energy storage element.” Instead the generic structure is recited only by the function of being compressible (¶22).
“A block” in claim 18, line 2. The specification discloses “a block 490” in FIG 22 that is a generic structure that interferes with a cavity or aperture 324 in the buckle tongue 320, teeth, or serrations (¶71). Block 490 is taught as being spring loaded, snapping into place, having a release mechanism, having a release tab 492 (FIG 22), being disengageable, and locking (¶72). However, the specification does not describe any specific structure for the block. It is only taught functionally.
MPEP 2173.05(G) explains that a claim term is functional when it recites a feature "by what it does rather than by what it is" (e.g., as evidenced by its specific structure or specific ingredients). In re Swinehart, 439 F.2d 210, 212, 169 USPQ 226, 229 (CCPA 1971). There is nothing inherently wrong with defining some part of an invention in functional terms. Functional language does not, in and of itself, render a claim improper. Id. In fact, 35 USC 112(f) and pre-AIA 35 U.S.C. 112, sixth paragraph, expressly authorize a form of functional claiming (means- (or step-) plus- function claim limitations discussed in MPEP 2181 et seq.). Functional language may also be employed to limit the claims without using the means-plus-function format. See, e.g., K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 1363, 52 USPQ2d 1001, 1005 (Fed. Cir. 1999). Unlike means-plus-function claim language that applies only to purely functional limitations, Phillips v. AWH Corp., 415 F.3d 1303, 1311, 75 USPQ2d 1321, 1324 (Fed. Cir. 2005) (en banc) ("Means-plus-function claiming applies only to purely functional limitations that do not provide the structure that performs the recited function."), functional claiming often involves the recitation of some structure followed by its function.
Notwithstanding the permissible instances, the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008) (noting that the Supreme Court explained that a vice of functional claiming occurs "when the inventor is painstaking when he recites what has already been seen, and then uses conveniently functional language at the exact point of novelty") (quoting General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 371 (1938)); see also United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 234, 55 USPQ 381 (1942) (holding indefinite claims that recited substantially pure carbon black "in the form of commercially uniform, comparatively small, rounded smooth aggregates having a spongy or porous exterior"). Further, without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim. Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc).
Accordingly, the claims are indefinite and 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.
Claims 1-14, 16, 19, and 20 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.
The instant claims are drawn to a tourniquet comprising an instruction portion that is claimed by way of function. This limitation recites steps that are drawn to a user-based method (process steps). See MPEP 2173.05(p)(II). The examiner has considered whether the recited method steps are user-involved or are functions of the apparatus and has determined, in the broadest reasonable interpretation of the claims, that the recited method steps are broadly drawn to end-user involved processes (e.g. “the emitting of a particular one of the instructions results from a user step being performed with the tourniquet” (claim 1, lines 14-15; claim 16, lines 3-4; claim 19, lines 16-17)). The functional language is expressly tied to the user involvement and the process is not directed to the product, but rather to the users actions, which would create confusion as to when direct infringement occurs. See, Katz, 639 F.3d at 1318, 97 USPQ2d at 1749 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005).
Claims 2-14 and 20 are rejected as being dependent on rejected base claims.
Applicant is advised that claims reciting device-state-triggered instructions can be amended to recite specific structures that show it is the function of the device and not the end-user’s actions that are the basis of the function.
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.
Claims 1, 5-9, 11, 12, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Dickinson et al., US 20150051638 (19 February 2015) in view of Lynch et al., US 20170273694 (28 September 2017).
Regarding independent claim 1, Dickinson teaches a tourniquet (FIG 1, tourniquet system 10; ¶17) for restricting flow of blood in a body part when a plurality of user steps is completed (¶3), the tourniquet comprising:
a strap (strap 1/strap 2, ¶18) configured to be wrapped around a portion of a body part, the strap having a first end and a second end (FIG 1);
a housing (12, ¶28) containing a winding mechanism (¶28), the first end of the strap (2, ¶28) being attached to a spool shaft (13) of the winding mechanism (¶28);
a buckle assembly (6) attached to the housing (12);
a buckle tongue (4) attached to the second end of the strap for releasably coupling the second end of the strap to the buckle assembly (FIG 2; ¶19);
a rotating handle (7) configured to transfer a rotation motion (FIG 3, arrow) of a user to the spool shaft (13);
a first portion (8) of the winding mechanism (¶28) configured to reduce a length of the strap (2) extending outside of the housing in response to the rotating handle being rotated (FIG 3; ¶20); and
the rotating handle (7) is initially decoupled from the first portion of the winding mechanism (¶28), and
rotation of the rotating handle (7) causes the rotating handle (7) to become mechanically coupled to the spool shaft (FIG 3, arrows; ¶20; ¶28).
Dickinson does not teach an instruction portion that is configured to emit one of audible and visual instructions to a user, wherein the emitting of a particular one of the instructions results from a user step being performed with the tourniquet.
Lynch teaches tourniquets comprising sensors 40 in the buckle assembly (FIG 5) and a triggering element (42, ¶49) that is a magnetic strip 42A (FIG 9) disposed at the surface and a magnetic switch (¶49) mounted in the buckle assembly (FIG 9) that determines whether the clasp is secured to the buckle (¶49). The sensor 40 can be a magnet sensor 40A (FIG 9, ¶50). First sensor 40 can initiate Trigger 1 (¶50). Trigger 1 is taught as confirmation of clasp TQ1 secured to the buckle B1 using sensor 40 (¶64).
Dickinson and Lynch both teach tourniquets. Although, Dickinson teaches the base tourniquet, Dickinson does not teach the tourniquet further comprising an instruction portion that is configured to emit one of audible and visual instructions to a user (BRI: an electronic component (indicators/speakers) actuated by sensors). Lynch’s magnet located on the buckle tongue and magnetic switch mounted in the buckle assembly are components actuated by sensors such that proximity of the magnet to the magnetic switch prompts the one of the instructions to be emitted.
Lynch specifically addresses a buckle assembly comprising a magnetic switch configured to communicate whether the clasp is secured using a magnetic sensor. Because Dickinson includes a claspable buckle assembly, a person of ordinary skill in the art, seeking to provide a confirmation that the buckle clasp is closed on Dickinson’s tourniquet architecture would reasonably consult Lynch’s magnetic switch clasp solution. Lynch’s magnetic clasp and switch can be incorporated alongside Dickinson’s tourniquet buckle assembly using known assembly methods without redesigning Dickinson’s core tourniquet and buckle assembly structure.
Because Dickinson and Lynch address the same engineering problem (tourniquets with buckle assemblies) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a magnetic switch and sensor to the buckle assembly), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. The level of ordinary skill in the art is someone that has a BS or ME or BME and 2-5 year of experience with mechanical medical devices/tourniquets.
Regarding the “instruction portion” of the claim, the “instruction portion” recitation in the claim must be interpreted in a bifurcated manner. If Applicant’s “instruction portion” reads on printed labels only, such as where visual instruction include printed matter, it is the position of the Office that the “instruction portion” is a set of instructions for applying the tourniquet and is printed matter.
Once it is determined that the limitation is directed to printed matter, the examiner must then determine whether the matter is functionally or structurally related to the associated physical substrate. MPEP 2111.05. See also, In re DiStefano, 808 F.3d 845, 117 USPQ2d 1267-1268 (Fed. Cir. 2015). If a new and unobvious functional relationship between the printed matter and the substrate does not exist, USPTO personnel need not give patentable weight to the printed matter. See In re Lowry, 32 F.3d 1579, 1583-84, 32 USPQ2d 1031, 1035 (Fed. Cir. 1994); In re Ngai, 367 F.3d 1336, 70 USPQ2d 1862 (Fed. Cir. 2004). Where a product merely serves as support for printed matter, no functional relationship exists. MPEP 2111.05(I)(B). These situations may arise where the claim as a whole is directed towards conveying a message or meaning to a human reader independent of the supporting product. Applicant’s attention is also directed to MPEP 2111.05(III).
Insofar as the claims may also read on the “instruction portion” comprising electronics (indicators/speakers), the elements are given patentable weight and are rejected as being obvious under the prior art teachings of Dickinson in combination with Lynch, as set forth above.
Where claimed and prior art products/apparatus/devices are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Accordingly, as long as the prior art teaches the claimed structural components, the claims are anticipated and/or rendered obvious by the prior art. See, In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See also, MPEP 2111, MPEP 2113, MPEP 2173, and MPEP 2112.01.
Regarding claim 5, Dickinson modified by Lynch teaches the tourniquet of claim 1, as set forth above.
Dickinson does not teach wherein each of the instructions corresponds to a different user step.
Lynch teaches tourniquets comprising sensors 40 in the buckle assembly (FIG 5) and a triggering element (42, ¶49) that is a magnetic strip 42A (FIG 9) disposed at the surface and a magnetic switch (¶49) mounted in the buckle assembly (FIG 9) that determines whether the clasp is secured to the buckle (¶49). The sensor 40 can be a magnet sensor 40A (FIG 9, ¶50). First sensor 40 can initiate Trigger 1 (¶50). Trigger 1 is taught as confirmation of clasp TQ1 secured to the buckle B1 using sensor 40 (¶64).
Regarding the “instruction portion” of the claim, the “instruction portion” is interpreted as set forth above.
Regarding claim 6, Dickinson modified by Lynch teaches the tourniquet of claim 1, as set forth above.
Dickinson does not teach wherein coupling the buckle to the buckle assembly prompts one of the instructions to be emitted.
Lynch teaches tourniquets comprising sensors 40 in the buckle assembly (FIG 5) and a triggering element (42, ¶49) that is a magnetic strip 42A (FIG 9) disposed at the surface and a magnetic switch (¶49) mounted in the buckle assembly (FIG 9) that determines whether the clasp is secured to the buckle (¶49). The sensor 40 can be a magnet sensor 40A (FIG 9, ¶50). First sensor 40 can initiate Trigger 1 (¶50). Trigger 1 is taught as confirmation of clasp TQ1 secured to the buckle B1 using sensor 40 (¶64).
Regarding the “instruction portion” of the claim, the “instruction portion” is interpreted as set forth above.
Regarding claim 7, Dickinson modified by Lynch teaches the tourniquet of claim 6, as set forth above.
Dickinson does not teach the tourniquet further comprising a magnet located on the buckle tongue; and a magnetic switch mounted in the buckle assembly, wherein a proximity of the magnet to the magnetic switch prompts the one of the instructions to be emitted.
Lynch teaches tourniquets comprising sensors 40 in the buckle assembly (FIG 5) and a triggering element (42, ¶49) that is a magnetic strip 42A (FIG 9) disposed at the surface and a magnetic switch (¶49) mounted in the buckle assembly (FIG 9) that determines whether the clasp is secured to the buckle (¶49). The sensor 40 can be a magnet sensor 40A (FIG 9, ¶50). First sensor 40 can initiate Trigger 1 (¶50). Trigger 1 is taught as confirmation of clasp TQ1 secured to the buckle B1 using sensor 40 (¶64).
Regarding claim 8, Dickinson modified by Lynch teaches the tourniquet of claim 1, as set forth above, further comprising an input shaft (annotated FIG 8) that is rotationally coupled to the spool shaft (13) and through which the rotation motion of the user is transferred to the spool shaft (FIGs 3, 8;¶28).
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Regarding claim 9, Dickinson teaches the tourniquet of claim 8, as set forth above, wherein the input shaft (annotated FIG 8) is not parallel to the spool shaft (13) in a strap unwinding state (¶28), and the input shaft is parallel to the spool shaft in a strap winding state (¶28).
Regarding claim 11, Dickinson modified by Lynch teaches the tourniquet of claim 1, as set forth above, further comprising a torque limiter (tension cords 8) that couples the rotating handle to the spooling shaft (¶¶20, 28) such that torque above a threshold torque applied to the rotating handle causes the rotating handle to rotate without rotating the spool shaft without destroying the torque limiter (¶28).
As set forth above, “a torque limiter” in claim 11, lines 2 and 4, is broadly interpreted under 35 USC 112(f). The specification discloses that a torque limiter couples the rotating handle to the spooling shaft such that torque applied above a threshold torque applied to the rotating handle causes the rotating handle to rotate without rotating the spool shaft without destroying the torque limiter (¶19). Example of twisting knob 220 may be a torque limiter (¶65). The specification discloses that the torque limiter is part of 14 (¶65). However, the specification does not describe any specific structure for the torque limiter. Accordingly, “a torque limiter” will be defined according to these function and structure that are capable of performing those functions and equivalents thereof.
Regarding claim 12, Dickinson modified by Lynch teaches the tourniquet of claim 1, as set forth above, further comprising an energy storage element (ratcheting assembly 14; ¶28) configured to reduce the length of the strap extending outside the housing when energy stored in the energy storage element (14) is released (¶28).
As set forth above, “an energy storage element” in claim 12, line 2 is broadly interpreted under 112(f) and equivalents thereof. The specification discloses an “energy storage element” at ¶¶21 and 20, but does not describe a structure for the “energy storage element.” Accordingly, any structure that stores energy, including potential energy, such as a ratchet assembly, will be broadly interpreted as “an energy storage element”, and equivalents thereof.
Regarding independent claim 19, Dickinson teaches a tourniquet (FIG 1, tourniquet system 10; ¶17) for restricting flow of blood in a body part when a plurality of user steps is completed, the tourniquet comprising:
a strap (strap 1/strap 2, ¶18) configured to be wrapped around a portion of a body part, the strap having a first end and a second end (FIG 1);
a winding mechanism (¶28), the first end of the strap (1/2) being attached to a spool shaft (13) of the winding mechanism (¶28);
a buckle assembly (6) attached to the winding mechanism (¶28);
a buckle tongue (4) attached to the second end of the strap for releasably coupling the second end of the strap to the buckle assembly (FIG 2; ¶19);
a rotating handle (7) configured to transfer a rotation motion (FIG 3, arrow) of a user to the spool shaft (13);
a first portion (8) of the winding mechanism (¶28) configured to reduce a length of the strap (2) extending outside of the housing in response to the rotating handle being rotated (FIG 3; ¶20).
Dickinson does not teach an instruction portion that is configured to emit one of audible and visual instructions to a user, wherein the instructions comprise a plurality of different instructions, and each of the plurality of instructions corresponds to one of a different one of a plurality of user steps.
Lynch teaches tourniquets comprising sensors 40 in the buckle assembly (FIG 5) and a triggering element (42, ¶49) that is a magnetic strip 42A (FIG 9) disposed at the surface and a magnetic switch (¶49) mounted in the buckle assembly (FIG 9) that determines whether the clasp is secured to the buckle (¶49). The sensor 40 can be a magnet sensor 40A (FIG 9, ¶50). First sensor 40 can initiate Trigger 1 (¶50). Trigger 1 is taught as confirmation of clasp TQ1 secured to the buckle B1 using sensor 40 (¶64).
Dickinson and Lynch both teach tourniquets. Although, Dickinson teaches the base tourniquet, Dickinson does not teach the tourniquet further comprising an instruction portion that is configured to emit one of audible and visual instructions to a user (BRI: an electronic component (indicators/speakers) actuated by sensors). Lynch’s magnet located on the buckle tongue and magnetic switch mounted in the buckle assembly are components actuated by sensors such that proximity of the magnet to the magnetic switch prompts the one of the instructions to be emitted.
Lynch specifically addresses a buckle assembly comprising a magnetic switch configured to communicate whether the clasp is secured using a magnetic sensor. Because Dickinson includes a claspable buckle assembly, a person of ordinary skill in the art, seeking to provide a confirmation that the buckle clasp is closed on Dickinson’s tourniquet architecture would reasonably consult Lynch’s magnetic switch clasp solution. Lynch’s magnetic clasp and switch can be incorporated alongside Dickinson’s tourniquet buckle assembly using known assembly methods without redesigning Dickinson’s core tourniquet and buckle assembly structure.
Because Dickinson and Lynch address the same engineering problem (tourniquets with buckle assemblies) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a magnetic switch and sensor to the buckle assembly), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. The level of ordinary skill in the art is someone that has a BS or ME or BME and 2-5 year of experience with mechanical medical devices/tourniquets.
Regarding the “instruction portion” of the claim, the “instruction portion” recitation in the claim must be interpreted in a bifurcated manner. If Applicant’s “instruction portion” reads on printed labels only, such as where visual instruction include printed matter, it is the position of the Office that the “instruction portion” is a set of instructions for applying the tourniquet and is printed matter.
Once it is determined that the limitation is directed to printed matter, the examiner must then determine whether the matter is functionally or structurally related to the associated physical substrate. MPEP 2111.05. See also, In re DiStefano, 808 F.3d 845, 117 USPQ2d 1267-1268 (Fed. Cir. 2015). If a new and unobvious functional relationship between the printed matter and the substrate does not exist, USPTO personnel need not give patentable weight to the printed matter. See In re Lowry, 32 F.3d 1579, 1583-84, 32 USPQ2d 1031, 1035 (Fed. Cir. 1994); In re Ngai, 367 F.3d 1336, 70 USPQ2d 1862 (Fed. Cir. 2004). Where a product merely serves as support for printed matter, no functional relationship exists. MPEP 2111.05(I)(B). These situations may arise where the claim as a whole is directed towards conveying a message or meaning to a human reader independent of the supporting product. Applicant’s attention is also directed to MPEP 2111.05(III).
Insofar as the claims may also read on the “instruction portion” comprising electronics (indicators/speakers), the elements are given patentable weight and are rejected as being obvious under the prior art teachings of Dickinson in combination with Lynch, as set forth above.
Where claimed and prior art products/apparatus/devices are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Accordingly, as long as the prior art teaches the claimed structural components, the claims are anticipated and/or rendered obvious by the prior art. See, In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See also, MPEP 2111, MPEP 2113, MPEP 2173, and MPEP 2112.01.
Claims 2-4, 10, 15-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dickinson et al., US 20150051638 (19 February 2015) in view of Dimino et al., US 20210204962 (8 July 2021) and further in view of Boney et al., US 20160058130 (3 March 2016).
Regarding claim 2, Dickinson teaches the tourniquet of claim 1, as set forth above, further comprising a first pawl (14; ¶28), wherein the first pawl (14) mechanically engages a first feature (toothed gear; ¶28) on the spool shaft (13) to prevent winding of the strap (2) onto the spool shaft (13) and allow unwinding of the strap (2) from the spool shaft (13).
Dickinson does not teach a second pawl or wherein the second pawl mechanically engages a second feature to prevent unwinding of the strap from the spool shaft and allow winding of the strap onto the spool shaft.
Dimino specifically addresses tourniquets comprising two pawls (FIG 33, 202A, 202B) (¶96). Dimino teaches that the two pawls allow for the slow, gradual release of pressure without the total loss of pressure or tension by having two separate and independently operable levers with pawls to allow one pawl to lock the ratchet while the other pawl is released to allow for a gradual step-by-step release of the tension (¶99).
Dimino teaches the second pawl (202B) mechanically engages a second feature (ladder strap 204) to prevent unwinding of the strap from the spool shaft and allow winding of the strap onto the spool shaft (¶98).
Boney teaches a multi-purpose closure system comprising a knob member 218 attached to a spool housing 220 comprising one or more pawls 236 mechanically engage ratchet teeth 224 to prevent unwinding from the spool shaft and allow winding of the strap onto the spool shaft (¶37). Boney teaches tourniquets comprising the multi-purpose closure system at FIGs 5 and 17 (¶40).
Dickinson and Dimino teach in the field of medical tourniquets. Boney teaches in the field of multi-purpose closure systems and specifically teaches medical tourniquets as being applicable for the closure device. All of Dickinson, Dimino, and Boney use pawls for tensioning mechanisms in tourniquets.
Although, Dickinson teaches the base tourniquet, Dickinson does not teach a second pawl or wherein the second pawl mechanically engages a second feature to prevent unwinding of the strap from the spool shaft and allow winding of the strap onto the spool shaft. Dimino specifically addresses tourniquets comprising two pawls, with the rationale that the two pawls allow for the slow, gradual release of pressure without the total loss of pressure or tension by having two separate and independently operable levers with pawls to allow one pawl to lock the ratchet while the other pawl is released to allow for a gradual step-by-step release of the tension (¶99). Dimino also teaches the second pawl (202B) mechanically engages a second feature (ladder strap 204) to prevent unwinding of the strap from the spool shaft and allow winding of the strap onto the spool shaft (¶98).
Boney specifically addresses a structure comprising a knob member attached to a spool housing comprising one or more pawls that mechanically engage ratchet teeth to prevent unwinding from the spool shaft and allow winding of the strap onto the spool shaft (¶37).
Because Dickinson’s base device includes a rotatable handle, like Boney’s knob member, and spool shaft similar to Boney’s spool housing, and teaches one pawl with a ratcheting assembly to control tension, a person of ordinary skill in the art, seeking to more precisely control tension in Dickinson’s architecture would reasonably consult Dimino’s dual pawl solution. Dimino teaches that the two pawls allow for the slow, gradual release of pressure without the total loss of pressure or tension by having two separate and independently operable levers with pawls to allow one pawl to lock the ratchet while the other pawl is released to allow for a gradual step-by-step release of the tension (¶99). Dimino’s dual pawl solution can be incorporated alongside Dickinson’s single pawl solution (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Dickinson’s core device structure.
Boney expressly discloses a multi-pawl spool housing similar to Dickinson’s that can be used to control one or more pawls that mechanically engage ratchet teeth to prevent unwinding from the spool shaft and allow winding of the strap onto the spool shaft. All three references use pawls as tensioning mechanisms for tourniquets. A person of ordinary skill in the art attempting to provide better tension adjustment and release control of Dickinson’s rotatable handle tourniquet would look for established pawl designs to avoid creating a novel tension interfaces. Dimino’s dual pawl system and Boney’s dual pawl spool housing are modular and can be adapted Dickinson’s device to enable more effective tensioning as motivated by the teachings of Dimino.
Because the references address the same engineering problem (the need for controlled tensioning in tourniquet devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a dual pawl system within a central spool housing), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. The level of ordinary skill in the art is someone that has a BS or ME or BME and 2-5 year of experience with mechanical medical devices/tourniquets.
Regarding claim 3, Dickinson modified by Dimino and Boney teach the tourniquet of claim 2, as set forth above.
Boney teaches wherein the first pawl engages the spool shaft in a first state while the second pawl is disengaged from the second feature (¶37). Additionally, Dimino teaches specific engagement of either the first pawl or the second pawl while the first pawl or the second pawl is disengaged from the ratcheting mechanism in order to allow for a graduate step by step release of the tension (¶¶98, 99). Further, Dimino teaches the second pawl (202B) mechanically engages a second feature (ladder strap 204) to prevent unwinding of the strap from the spool shaft and allow winding of the strap onto the spool shaft (¶98).
Regarding claim 4, Dickinson modified by Dimino and Boney teach the tourniquet of claim 3, as set forth above.
Boney teaches that the knob teeth can be configured to mate with the spool teeth in either a loosening or tightening direction and include one or more pawls that can be biased radially outwardly to mate with ratchet teeth such that the pawls and the ratchet teeth can be configured so that the ratchet teeth can displace the pawls radially inwardly when the knob member is in the tightening direction thereby allowing knob member to rotate in the tightening direction or they may be configured so that they engage one another when force is applied in the loosening direction thereby preventing knob member from rotating in a loosening direction (¶37). Additionally, Dimino teaches specific engagement of either the first pawl or the second pawl while the first pawl or the second pawl is disengaged from the ratcheting mechanism in order to allow for a graduate step by step release of the tension (¶¶98, 99).
Regarding claim 10, Dickinson teaches the tourniquet of claim 8, as set forth above.
Dickinson does not teach wherein the tourniquet further comprises an opening in a portion of the housing, wherein a delay between when the first pawl becomes disengaged and when second pawl becomes engaged is caused by an end of the input shaft moving within the opening.
Dimino specifically addresses tourniquets comprising two pawls (FIG 33, 202A, 202B) (¶96). Dimino teaches that the first pawl 202A and second pawl 202B rest inside of a strap groove (broadly interpreted as an opening) (¶98). Dimino teaches that the second pawl 202B may not be positioned inside the same groove 208 as the first pawl 202A but on the top ledge 221 of a ridge 201 (i.e. or at least partially inside another groove 208) with a tip thereof spaced from the groove 208 in which the first pawl 208A resides and the tip of the first pawl 202A (¶98). Dimino also teaches that the two pawls allow for the slow, gradual release of pressure without the total loss of pressure or tension by having two separate and independently operable levers with pawls to allow one pawl to lock the ratchet while the other pawl is released to allow for a gradual step-by-step release of the tension (¶99).
Boney teaches a multi-purpose closure system comprising a knob member 218 attached to a spool housing 220 comprising one or more pawls 236 mechanically engage ratchet teeth 224 to prevent unwinding from the spool shaft and allow winding of the strap onto the spool shaft (¶37). Boney teaches tourniquets comprising the multi-purpose closure system at FIGs 5 and 17 (¶40).
Dickinson and Dimino teach in the field of medical tourniquets. Boney teaches in the field of multi-purpose closure systems and specifically teaches medical tourniquets as being applicable for the closure device. All of Dickinson, Dimino, and Boney use pawls for tensioning mechanisms in tourniquets.
Although, Dickinson teaches the base tourniquet, Dickinson does not teach a second pawl or wherein the tourniquet further comprises an opening in a portion of the housing, wherein a delay between when the first pawl becomes disengaged and when second pawl becomes engaged is caused by an end of the input shaft moving within the opening. Dimino specifically addresses tourniquets comprising two pawls, with the rationale that the two pawls allow for the slow, gradual release of pressure without the total loss of pressure or tension by having two separate and independently operable levers with pawls to allow one pawl to lock the ratchet while the other pawl is released to allow for a gradual step-by-step release of the tension (¶99). Dimino also teaches an opening (BRI: groove) where one pawl resides but the other does not. Because the engagement structure comprising two pawls of Dimino is axial, Boney specifically addresses a structure comprising a knob member attached to a spool housing comprising one or more pawls that mechanically engage ratchet teeth to prevent unwinding from the spool shaft and allow winding of the strap onto the spool shaft (¶37).
Because Dickinson’s base device includes a rotatable handle, like Boney’s knob member, and spool shaft similar to Boney’s spool housing, and teaches one pawl with a ratcheting assembly to control tension, a person of ordinary skill in the art, seeking to more precisely control tension in Dickinson’s architecture would reasonably consult Dimino’s dual pawl solution. Additionally, one of ordinary skill in the art would reasonably understand that two pawls may comprise two different grooves or tracks in order to hold or main tension on one when the other is released or tightened. Dimino expressly teaches that the two pawls allow for the slow, gradual release of pressure without the total loss of pressure or tension by having two separate and independently operable levers with pawls to allow one pawl to lock the ratchet while the other pawl is released to allow for a gradual step-by-step release of the tension (¶99). Dimino’s dual pawl solution comprising different grooves for the pawls can be incorporated alongside Dickinson’s single pawl solution (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Dickinson’s core device structure.
Boney expressly discloses a multi-pawl spool housing similar to Dickinson’s that can be used to control one or more pawls that mechanically engage ratchet teeth to prevent unwinding from the spool shaft and allow winding of the strap onto the spool shaft. All three references use pawls as tensioning mechanisms for tourniquets. A person of ordinary skill in the art attempting to provide better tension adjustment and release control of Dickinson’s rotatable handle tourniquet would look for established pawl designs to avoid creating a novel tension interfaces. Dimino’s dual pawl system and dual groove system for each of the two pawls and Boney’s dual pawl spool housing are modular and can be adapted Dickinson’s device to enable more effective tensioning as motivated by the teachings of Dimino.
Because the references address the same engineering problem (the need for controlled tensioning in tourniquet devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a dual pawl system within a central spool housing), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. The level of ordinary skill in the art is someone that has a BS or ME or BME and 2-5 year of experience with mechanical medical devices/tourniquets.
Regarding independent claim 15, Dickinson teaches a tourniquet (FIG 1, tourniquet system 10; ¶17) for restricting flow of blood in a body part when a plurality of user steps is completed (¶3), the tourniquet comprising:
a strap (strap 1/strap 2, ¶18) configured to be wrapped around a portion of a body part, the strap having a first end and a second end (FIG 1);
a housing (12, ¶28) containing a winding mechanism (¶28), the first end of the strap (2, ¶28) being attached to a spool shaft (13) of the winding mechanism (¶28);
a buckle assembly (6) attached to the housing (12);
a buckle tongue (4) attached to the second end of the strap for releasably coupling the second end of the strap to the buckle assembly (FIG 2; ¶19);
a rotating handle (7) configured to transfer a rotation motion (FIG 3, arrow) of a user to the spool shaft (13);
a first portion (8) of the winding mechanism (¶28) configured to reduce a length of the strap (2) extending outside of the housing in response to the rotating handle being rotated (FIG 3; ¶20);
first pawl (14; ¶28) that mechanically engages a first feature (toothed gear; ¶28) on the spool shaft (13) to prevent winding of the strap (2) onto the spool shaft (13) and allow unwinding of the strap (2) from the spool shaft (13).
Dickinson does not teach a second pawl that mechanically engages a second feature to prevent unwinding of the strap from the spool shaft and allow winding of the strap onto the spool shaft.
Dimino specifically addresses tourniquets comprising two pawls (FIG 33, 202A, 202B) (¶96). Dimino teaches that the two pawls allow for the slow, gradual release of pressure without the total loss of pressure or tension by having two separate and independently operable levers with pawls to allow one pawl to lock the ratchet while the other pawl is released to allow for a gradual step-by-step release of the tension (¶99). Dimino teaches the second pawl (202B) mechanically engages a second feature (ladder strap 204) to prevent unwinding of the strap from the spool shaft and allow winding of the strap onto the spool shaft (¶98).
Boney teaches a multi-purpose closure system comprising a knob member 218 attached to a spool housing 220 comprising one or more pawls 236 mechanically engage ratchet teeth 224 to prevent unwinding from the spool shaft and allow winding of the strap onto the spool shaft (¶37). Boney teaches tourniquets comprising the multi-purpose closure system at FIGs 5 and 17 (¶40).
Dickinson and Dimino teach in the field of medical tourniquets. Boney teaches in the field of multi-purpose closure systems and specifically teaches medical tourniquets as being applicable for the closure device. All of Dickinson, Dimino, and Boney use pawls for tensioning mechanisms in tourniquets.
Although, Dickinson teaches the base tourniquet, Dickinson does not teach a second pawl or wherein the second pawl mechanically engages a second feature to prevent unwinding of the strap from the spool shaft and allow winding of the strap onto the spool shaft. Dimino specifically addresses tourniquets comprising two pawls, with the rationale that the two pawls allow for the slow, gradual release of pressure without the total loss of pressure or tension by having two separate and independently operable levers with pawls to allow one pawl to lock the ratchet while the other pawl is released to allow for a gradual step-by-step release of the tension (¶99). Dimino also teaches the second pawl (202B) mechanically engages a second feature (ladder strap 204) to prevent unwinding of the strap from the spool shaft and allow winding of the strap onto the spool shaft (¶98).
Boney specifically addresses a structure comprising a knob member attached to a spool housing comprising one or more pawls that mechanically engage ratchet teeth to prevent unwinding from the spool shaft and allow winding of the strap onto the spool shaft (¶37).
Because Dickinson’s base device includes a rotatable handle, like Boney’s knob member, and spool shaft similar to Boney’s spool housing, and teaches one pawl with a ratcheting assembly to control tension, a person of ordinary skill in the art, seeking to more precisely control tension in Dickinson’s architecture would reasonably consult Dimino’s dual pawl solution. Dimino teaches that the two pawls allow for the slow, gradual release of pressure without the total loss of pressure or tension by having two separate and independently operable levers with pawls to allow one pawl to lock the ratchet while the other pawl is released to allow for a gradual step-by-step release of the tension (¶99). Dimino’s dual pawl solution can be incorporated alongside Dickinson’s single pawl solution (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Dickinson’s core device structure.
Boney expressly discloses a multi-pawl spool housing similar to Dickinson’s that can be used to control one or more pawls that mechanically engage ratchet teeth to prevent unwinding from the spool shaft and allow winding of the strap onto the spool shaft. All three references use pawls as tensioning mechanisms for tourniquets. A person of ordinary skill in the art attempting to provide better tension adjustment and release control of Dickinson’s rotatable handle tourniquet would look for established pawl designs to avoid creating a novel tension interfaces. Dimino’s dual pawl system and Boney’s dual pawl spool housing are modular and can be adapted Dickinson’s device to enable more effective tensioning as motivated by the teachings of Dimino.
Because the references address the same engineering problem (the need for controlled tensioning in tourniquet devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a dual pawl system within a central spool housing), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. The level of ordinary skill in the art is someone that has a BS or ME or BME and 2-5 year of experience with mechanical medical devices/tourniquets.
Regarding claim 16, Dickinson modified by Dimino and Boney teach the tourniquet of claim 15, as set forth above.
Dimino teaches an instruction portion that is configured to emit one of audible and visual instructions to a user, wherein the emitting of a particular one of the instructions results from a user step being performed with the tourniquet (¶17).
Regarding the “instruction portion” of the claim, the “instruction portion” recitation in the claim must be interpreted in a bifurcated manner. If Applicant’s “instruction portion” reads on printed labels only, such as where visual instruction include printed matter, it is the position of the Office that the “instruction portion” is a set of instructions for applying the tourniquet and is printed matter.
Once it is determined that the limitation is directed to printed matter, the examiner must then determine whether the matter is functionally or structurally related to the associated physical substrate. MPEP 2111.05. See also, In re DiStefano, 808 F.3d 845, 117 USPQ2d 1267-1268 (Fed. Cir. 2015). If a new and unobvious functional relationship between the printed matter and the substrate does not exist, USPTO personnel need not give patentable weight to the printed matter. See In re Lowry, 32 F.3d 1579, 1583-84, 32 USPQ2d 1031, 1035 (Fed. Cir. 1994); In re Ngai, 367 F.3d 1336, 70 USPQ2d 1862 (Fed. Cir. 2004). Where a product merely serves as support for printed matter, no functional relationship exists. MPEP 2111.05(I)(B). These situations may arise where the claim as a whole is directed towards conveying a message or meaning to a human reader independent of the supporting product. Applicant’s attention is also directed to MPEP 2111.05(III).
Insofar as the claims may also read on the “instruction portion” comprising electronics (indicators/speakers), the elements are given patentable weight and are rejected as being obvious under the prior art teachings of Dickinson in combination with Dimino, as set forth above.
Where claimed and prior art products/apparatus/devices are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Accordingly, as long as the prior art teaches the claimed structural components, the claims are anticipated and/or rendered obvious by the prior art. See, In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See also, MPEP 2111, MPEP 2113, MPEP 2173, and MPEP 2112.01.
Regarding claim 17, Dickinson modified by Dimino and Boney teaches the tourniquet of claim 15, as set forth above.
Dickinson teaches that the rotating handle (7) is initially decoupled from the first portion of the winding mechanism (¶28). Additionally, Boney teaches wherein the rotating handle (216) is initially decoupled from the first portion of the winding mechanism, and rotation of the rotating handle (218) causes the rotating handle to become mechanically coupled to the spool shaft (¶36).
Regarding claim 18, Dickinson modified by Dimino and Boney teaches the tourniquet of claim 15.
Dickinson teaches the tourniquet further comprising a block (FIG 9, stab-lock style buckle) that retains the buckle tongue (male connector 17) in the buckle assembly (female connector 16) in an at rest secured position under tension from the strap; and
a retainer (release tabs 15) that requires the buckle tongue (17) to be pressed farther into the buckle assembly than in the at rest secured position in order to remove the buckle from the buckle assembly (¶36).
As set forth above, the specification discloses “a block 490” in FIG 22 (¶71). Block 490 is taught as being spring loaded, snapping into place, having a release mechanism, having a release tab 492 (FIG 22), being disengageable, and locking (¶72). However, the specification does not describe any specific structure for the block. Accordingly, a block will be defined according to the disclosed functions and associated functional structures and structures that are capable of performing these functions and equivalents thereof.
Regarding claim 20, Dickinson teaches the tourniquet of claim 19, as set forth above.
Dickinson also teaches a first pawl (14; ¶28).
Dickinson does not teach a second pawl wherein the second pawl mechanically engages a second feature to prevent unwinding of the strap from the spool shaft and allow winding of the strap onto the spool shaft.
Dimino specifically addresses tourniquets comprising two pawls (FIG 33, 202A, 202B) (¶96). Dimino teaches that the two pawls allow for the slow, gradual release of pressure without the total loss of pressure or tension by having two separate and independently operable levers with pawls to allow one pawl to lock the ratchet while the other pawl is released to allow for a gradual step-by-step release of the tension (¶99). Dimino also teaches the second pawl (202B) mechanically engages a second feature (ladder strap 204) to prevent unwinding of the strap from the spool shaft and allow winding of the strap onto the spool shaft (¶98).
Boney teaches a multi-purpose closure system comprising a knob member 218 attached to a spool housing 220 comprising one or more pawls 236 mechanically engage ratchet teeth 224 to prevent unwinding from the spool shaft and allow winding of the strap onto the spool shaft (¶37). Boney teaches tourniquets comprising the multi-purpose closure system at FIGs 5 and 17 (¶40).
Dickinson and Dimino teach in the field of medical tourniquets. Boney teaches in the field of multi-purpose closure systems and specifically teaches medical tourniquets as being applicable for the closure device. All of Dickinson, Dimino, and Boney use pawls for tensioning mechanisms in tourniquets.
Although, Dickinson teaches the base tourniquet, Dickinson does not teach a second pawl or wherein the second pawl mechanically engages a second feature to prevent unwinding of the strap from the spool shaft and allow winding of the strap onto the spool shaft. Dimino specifically addresses tourniquets comprising two pawls, with the rationale that the two pawls allow for the slow, gradual release of pressure without the total loss of pressure or tension by having two separate and independently operable levers with pawls to allow one pawl to lock the ratchet while the other pawl is released to allow for a gradual step-by-step release of the tension (¶99). Dimino also teaches the second pawl (202B) mechanically engages a second feature (ladder strap 204) to prevent unwinding of the strap from the spool shaft and allow winding of the strap onto the spool shaft (¶98).
Boney specifically addresses a structure comprising a knob member attached to a spool housing comprising one or more pawls that mechanically engage ratchet teeth to prevent unwinding from the spool shaft and allow winding of the strap onto the spool shaft (¶37).
Because Dickinson’s base device includes a rotatable handle, like Boney’s knob member, and spool shaft similar to Boney’s spool housing, and teaches one pawl with a ratcheting assembly to control tension, a person of ordinary skill in the art, seeking to more precisely control tension in Dickinson’s architecture would reasonably consult Dimino’s dual pawl solution. Dimino teaches that the two pawls allow for the slow, gradual release of pressure without the total loss of pressure or tension by having two separate and independently operable levers with pawls to allow one pawl to lock the ratchet while the other pawl is released to allow for a gradual step-by-step release of the tension (¶99). Dimino’s dual pawl solution can be incorporated alongside Dickinson’s single pawl solution (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Dickinson’s core device structure.
Boney expressly discloses a multi-pawl spool housing similar to Dickinson’s that can be used to control one or more pawls that mechanically engage ratchet teeth to prevent unwinding from the spool shaft and allow winding of the strap onto the spool shaft. All three references use pawls as tensioning mechanisms for tourniquets. A person of ordinary skill in the art attempting to provide better tension adjustment and release control of Dickinson’s rotatable handle tourniquet would look for established pawl designs to avoid creating a novel tension interfaces. Dimino’s dual pawl system and Boney’s dual pawl spool housing are modular and can be adapted Dickinson’s device to enable more effective tensioning as motivated by the teachings of Dimino.
Because the references address the same engineering problem (the need for controlled tensioning in tourniquet devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a dual pawl system within a central spool housing), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. The level of ordinary skill in the art is someone that has a BS or ME or BME and 2-5 year of experience with mechanical medical devices/tourniquets.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Dickinson et al., US 20150051638 (19 February 2015) in view of Pienkowski et al., US 20100234877 (16 September 2010).
Regarding claim 13, Dickinson teaches the tourniquet of claim 1, as set forth above, further comprising a platform (5) pivotably coupled to the buckle assembly (¶32-33) and configured to contact the body part (¶26).
Dickinson does not teach an indicator element that moves relative to a force applied to the body part by the platform, the indicator element indicating to the user when to stop rotating the rotating handle.
Pienkowski teaches electromechanical tourniquet (10) comprising an indicator element (FIG 1, 32) that moves relative to a force applied (50) to the body part by the platform (¶34; FIG 3), the indicator element (32) indicating to the user when to stop (¶34).
Pienkowski does not teach rotating a rotating handle.
Dickinson teaches a rotatable handle (7).
Dickinson and Pienkowski teach in the same field of endeavor adjustable tourniquets. Although Dickinson teaches the base tourniquet comprising a platform (9) pivotably coupled to the buckle assembly (¶20) and configured to contact the body part (FIG 8; ¶¶29-31) as well as a rotatable handle (7), Dickinson does not teach an indicator element that moves relative to a force applied to the body part by the platform, the indicator element indicating to the user when to stop rotating the rotating handle.
Pienkowski specifically addresses a tourniquet comprising an indicator element that moves relative to the force applied to the body part by the tourniquet platform where the indicator indicates to the user when to stop tightening the strap (¶34). Pienkowski uses a micro-controller 38 to activate the pressure LED 32 in a manner to cause it to blink red. If the force is greater than or equal to the desired baseline or threshold value, the microcontroller activates the pressure LED 32 to illuminate green (¶39). If the applied pressure falls below the threshold pressure at any time, the micro-controller 38 causes the pressure LED 32 to blink red (¶41).
Because Dickinson’s tourniquet includes a rotatable handle to increase pressure, a person of ordinary skill in the art, seeking to monitor force or occlusive pressure in Dickinson’s architecture would reasonably consult Pienkowski’s force sensor and LED indicator element to solution. Pienkowski’s force sensor and indicator solution can be incorporated alongside Dickinson’s rotatable handle (same general location and interaction with the tightening of the knob) using known assembly methods without redesigning Dickinson’s core tourniquet design.
Because the references address the same engineering problem (tourniquets with adjustable occlusive force) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a force sensor and indicator element to the base tourniquet), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. The level of ordinary skill in the art is someone that has a BS or ME or BME and 2-5 year of experience with mechanical medical devices/tourniquets.
Regarding claim 14, Dickinson modified by Pienkowski teaches the tourniquet of claim 13, as set forth above.
Dickinson teaches the tourniquet further comprising a platform energy storage element (ratcheting arrangement 14), wherein tightening the tourniquet by rotating the rotating handle (7) increases the force applied to the body part (¶28), which causes the platform (5) to pivot relative to the buckle assembly (¶¶32-33) and compresses the platform energy storage element (¶26).
As set forth above, “an energy storage element” in claim 12, line 2 is broadly interpreted under 112(f) and equivalents thereof. The specification discloses an “energy storage element” at ¶¶21 and 20, but does not describe a structure for the “energy storage element.” Accordingly, any structure that stores energy, including potential energy, such as a ratchet assembly, will be broadly interpreted as “an energy storage element”, and equivalents thereof.
Conclusion
No claim is allowed.
The prior art made of record and not presently relied upon is considered pertinent to applicant's disclosure:
Olbu et al., US 20170100131 (13 April 2017) teaches a flywheel tourniquet system comprising two ratcheting gear locks.
Peters et al., US 20220313275 (6 October 2022, benefit to 1 April 2021) teaches a ratchet tourniquet.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
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/CHERIE M POLAND/Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771