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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/08/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 12/08/2025. As directed by the amendment: claims 1 and 13 have been amended, no claims have been cancelled, and claim 21 has been added. Thus, claims 1-21 are presently pending in this application, with claim 20 being withdrawn from consideration. The 112(f) interpretation is maintained.
Response to Arguments
Applicant' s arguments, see “Remarks”, filed 12/08/2025, with respect to the rejection(s) of claim(s) 1 and 13 under 103 over Lanigan in view of Danby embodiment of Fig. 7-8 in view of Kim have been fully considered and are persuasive, specifically in regards to the embodiment of Fig. 7-8 of Danby not teaching or disclosing the newly added claim limitation. Therefore, the rejection has been withdrawn. However, the 103 rejection over Lanigan in view of Danby embodiment of Fig. 11-13 in view of Kim has been maintained. Applicant provided no arguments against this rejection of record.
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.
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: “drop-off element” in claim 5
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.
Regarding “a drop-off element” in claim 5, the specification is referenced for the corresponding structure. Para. 0073 discloses the drop offs 1082 as forming paths or channels 1080 to cause the detent 1020 to only move in a desired direction and thereby preventing detent 1020 from touching an inner wall. Examiner is interpreting the drop off elements as a structure of the sloped channel of the V-feature of the fixed portion that prevent a degree of movement of the shaft/detent.
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 § 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) 1-4, 6-8, 11, 13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Lanigan et al. (U.S Patent Pub. No. 20140054883 A1, “Lanigan”) in view of Danby et al. (U.S Patent No. 4537387, “Danby”) in view of Kim et al. (U.S Patent No. 5622413, “Kim”).
Regarding claim 1, Lanigan discloses the limitations of (Claim 1) a fluid pump system for a wearable fluid delivery device (500, see Fig. 16-22 and para. 0483 and 0307 – infusion pump assembly 500 may be worn on the skin of a user or worn in a pocket of the user’s clothing and comprises the fluid pump system seen in Fig. 21), comprising:
a pump chamber (106B in Fig. 21) to store a fluid (see para. 0496 – pump assembly 106 comprises a fluid pump chambers 106B for storing infusible fluid);
a fluid path in fluid communication with the pump chamber (106B) and a reservoir (118 in Fig. 21, see para. 0496 – Fig. 21 illustrates a fluid path between reservoir 118 and pump chamber 106B);
a fluid path valve (614 in Fig. 21) operative to control a state of the fluid path (see para. 0496 – reservoir valve assembly 614 controls the state of the fluid path between reservoir 118 and pump chamber 106B),
an actuator (112 in Fig. 21, see para. 0494 – shape memory actuator 112 is attached to the valve actuator 614A for actuation of reservoir valve assembly 614).
However, Lanigan fails to disclose the limitations of (Claim 1) the fluid path valve comprising a fixed portion and a movable portion; and a shaft configured to move along the fixed portion to directly engage the movable portion responsive to a force imparted by an actuator, the movable portion comprising an offset to deflect a force of the shaft to cause the movable portion to pivot from one of a first position or a second position to the other of the first position or the second position responsive to being engaged by the shaft to change the state of the fluid path.
Danby teaches (Claim 1) the fluid path valve (Fig. 11-13) comprising a fixed portion (214 in Fig. 11) and a movable portion (210 in Fig. 11, see Col.6, lines 22-44 – valve assembly of Fig. 11-13 for changing the state of the fluid path between inlet passageway 202 and outlet passageway 208 comprises a backstop member 214 and a diaphragm element 210 which moves to change the state of the valve assembly); and
a shaft (218 in Fig. 11-12) configured to move along the fixed portion (214) to directly engage the movable portion (210) responsive to a force imparted by an actuator (226 in Fig. 11-12, see Col.6, lines 22-44– lever 218 is being interpreted as the shaft as it is configured to pivot about pin 220 and within the pivot holes 222 and 224 to directly engage the diaphragm element 210 in response to a force imparted by the manipulation arm 226, examiner notes the pivoting of lever 218 within hole 224 of backstop member 214 indicates that the lever 218 moves along and directly engages the backstop member 214), the movable portion (210) comprising an offset (222 in Fig. 11) to deflect a force of the shaft (218) to cause the movable portion (210) to pivot from one of a first position or a second position to the other of the first position or the second position responsive to being engaged by the shaft (218) to change the state of the fluid path (202 and 208, see Fig. 11-12 Col.6, lines 22-44 – manipulation arm 226 imparts a force onto the lever 228 causes it to pivot around pin 220 and within the hole 222 of diaphragm element 210 such that the hole 222 deflects a force of the lever 218 to cause the diaphragm element 210 to pivot the valve 212 to the closed position, examiner further notes the flexing of the diaphragm 210 between a downward and upward position is being interpreted as a pivot as the diaphragm 210 is secured on both ends and oscillates upward and downward in such a way that it pivots up and down).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reservoir valve assembly comprising a reservoir valve actuator and a reservoir valve taught by Lanigan to have the precision valve assembly with a shaft, fixed portion, and movable portion as taught by Danby to provide a compact, more precise control of fluid using a minimal amount of energy where a substantial movement of the actuator translates to a small valve movement and thus provides a major control advantage (see Col.1, lines 59-63 and Col. 5, lines 64-66).
Kim teaches a valve assembly (100 in Fig. 2) comprising a lever (64 in Fig. 2) pivoted around pin (68 in Fig. 2), wherein pivoting of lever (64) changes the state of the valve (100) and pivoting of the lever (64) is controlled by actuation of a shape memory alloy wire (S2 in Fig. 2) coupled to one end of the lever (64, see Fig. 2 and Col.6, lines 51-67 and Col.7, 20-31).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape memory actuator of modified Lanigan to be the shape memory wire taught by Kim as Kim teaches an improved shape memory alloy actuator that is promptly operated and freely and accurately controlled in either an open or close operation (see Col.2, lines 32-61). In combination, the shape memory alloy (112) of Lanigan would be substituted for the shape memory wire of Kim such that it is coupled to the shaft (218) to control pivoting of the shaft (218) and thus change the state of the precision valve assembly of Fig. 11-13 of Danby.
Regarding claim 2, modified Lanigan discloses the system of claim 1, as discussed above. In modified Lanigan, Lanigan discloses (Claim 2) the wearable fluid delivery device (500 in Fig. 16) configured to deliver a medicament to a patient, the medicament comprising insulin (see para. 0289 – reservoir 118 of infusion pump assembly 500 may comprise insulin as the fluid for drug delivery).
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Regarding claim 3, modified Lanigan discloses the system of claim 1, as discussed above. In modified Lanigan, Danby discloses (Claim 3) the fixed portion (214 in Fig. 11) comprising a V-feature having a substantially V-shape (see annotated Danby drawing 1 below – the bottom surface of fixed portion 214 forms a substantial V-shape interpreted as the V-feature).
Regarding claim 4, modified Lanigan discloses the V-shape of claim 3, as discussed above. In modified Lanigan, Danby discloses (Claim 4) the V-feature comprising at least one channel (230 in Fig. 12) for the shaft (218 in Fig. 12) to travel during operation of the fluid path valve (see annotated Danby drawing 1 above and Fig. 12 and Col.6, lines 41-49).
Regarding claim 6, modified Lanigan discloses the system of claim 1, as discussed above. In modified Lanigan, Danby discloses the limitation (Claim 6) the movable portion (210 in Fig. 11-12).
However, Danby fails to disclose (Claim 6) the movable portion comprising a bistable mechanism.
Kim discloses (Claim 6) comprising a bistable mechanism (examiner notes a bistable mechanism is being interpreted as a system having two stable states, see Fig. 2-3 and Col.7, lines 6-31 – the plate spring 62 can be pivoted upwards or downwards through engagement with lever 64 actuated by shape memory wire S2 such that the valve 100 comprises a bistable mechanism through the actuation of wire S2).
In modified Lanigan, Lanigan is modified to have the movable portion, fixed portion, and shaft of the valve mechanism of Danby with the shape memory alloy wire of Kim substituted for the shape memory actuator of Lanigan. Thus, the shape memory alloy wire of Kim is capable of actuating between two stable states indicating that the shaft (218) of Danby would be actuated to pivot movable portion (210) between two stable states, wherein the movable portion (210) is fully deformed to close the valve or fully undeformed to open the valve.
Regarding claim 7, modified Lanigan discloses the system of claim 1, as discussed above. In modified Lanigan, Lanigan discloses (Claim 7) the state of the fluid path comprising one of a fluid delivery state to deliver the fluid to the patient from the pump chamber (106B in Fig. 21) or a fluid fill state to fill the pump chamber (106B) from the reservoir (118 in Fig. 21, see para. 0496 – Fig. 21 illustrates a fluid path between reservoir 118 and pump chamber 106B, the reservoir valve assembly 614 may be actuated to close valve 614B and activate pump assembly 106 to place the fluid path in a delivery state where infusible fluid is delivered to the patient or the valve assembly 614 may be open which places the fluid path in a fill state with pump chamber 106B and reservoir 118 in fluid communication).
Regarding claim 8, modified Lanigan discloses the system of claim 1, as discussed above. In modified Lanigan, Lanigan discloses (Claim 8) the actuator (112 in Fig. 21) comprising a shape memory alloy (see para. 0282 – shape memory actuator 112 may be a shape memory wire).
Kim discloses an evidentiary teaching for how a shape memory alloy can be coupled to a lever shaft for actuating a valve mechanism. Kim discloses a valve assembly (100 in Fig. 2) comprising a lever (64 in Fig. 2) pivoted around pin (68 in Fig. 2), wherein pivoting of lever (64) changes the state of the valve (100) and pivoting of the lever (64) is controlled by actuation of a shape memory alloy wire (S2 in Fig. 2) coupled to one end of the lever (64, see Fig. 2 and Col.6, lines 51-67 and Col.7, 20-31). In combination, the shape memory alloy (112 in Fig. 21) of Lanigan would be coupled to the manipulate arm (226 in Fig. 11) of the shaft (218) of Danby to control pivoting of the shaft (218) thus change the state of the precision valve assembly of Fig. 11-13 of Danby.
Regarding claim 11, modified Lanigan discloses the system of claim 1, as discussed above. In modified Lanigan, Danby discloses (Claim 11) the shaft (218) comprising a detent arm (228, examiner notes a detent arm is being interpreted as an arm-like structure capable of limiting rotation, see Fig. 11-12 and Col.6, lines 22-44 – lever 218 comprises a projection or slide 228 interpreted as the detent arm as it is a projecting structure of lever 218 that limits the pivoting of lever 218 through engagement with the arcuate path 230).
Regarding claim 13, Lanigan discloses the limitations of (Claim 13) a wearable fluid delivery device (500, see Fig. 16-22 and para. 0483 and 0307 – infusion pump assembly 500 may be worn on the skin of a user or worn in a pocket of the user’s clothing and comprises the fluid pump system seen in Fig. 21), comprising:
a reservoir (118 in Fig. 21) to store a fluid (see para. 0496),
a needle (138 in Fig. 21) to infuse the fluid into a patient (see para. 0503 – assembly 500 comprises a needle or disposable cannula 138 to infuse the fluid to the patient),
a fluid pump (106 in Fig. 21) to pump the fluid through the needle (138, see para. 0495 – assembly 500 comprises a pump assembly 106 to pump infusible fluid from fluid path to the user through needle 138), the fluid pump (106) comprising:
a pump chamber (106B in Fig. 21) to store a fluid (see para. 0496 – pump assembly 106 comprises a fluid pump chamber 106B for storing infusible fluid);
a fluid path in fluid communication with the pump chamber (106B) and the reservoir (118, see Fig. 21 and para. 0496 – Fig. 21 illustrates a fluid path between reservoir 118 and pump chamber 106B);
a fluid path valve (614 in Fig. 21) operative to control a state of the fluid path (see para. 0496 – reservoir valve assembly 614 controls the state of the fluid path between reservoir 118 and pump chamber 106B),
an actuator (112, see para. 0494 – shape memory actuator 112 is attached to the valve actuator 614A for actuation of reservoir valve assembly 614).
However, Lanigan fails to disclose the limitations of (Claim 13) the fluid path valve comprising a fixed portion and a movable portion; and a shaft configured to move along the fixed portion to engage the movable portion responsive to a force imparted by an actuator, the movable portion comprising an offset to deflect a force of the shaft to cause the movable portion to pivot from one of a first position or a second position to the other of the first position or the second position responsive to being engaged by the shaft to change the state of the fluid path.
Danby teaches (Claim 13) the fluid path valve (Fig. 11-13) comprising a fixed portion (214 in Fig. 11) and a movable portion (210 in Fig. 11, see Col.6, lines 22-44 – valve assembly of Fig. 11-13 for changing the state of the fluid path between inlet passageway 202 and outlet passageway 208 comprises a backstop member 214 and a diaphragm element 210 which moves to change the state of the valve assembly); and
a shaft (218 in Fig. 11-12) configured to move along the fixed portion (214) to directly engage the movable portion (210) responsive to a force imparted by an actuator (226 in Fig. 11-12, see Col.6, lines 22-44– lever 218 is being interpreted as the shaft as it is configured to pivot about pin 220 and within the pivot holes 222 and 224 to directly engage the diaphragm element 210 in response to a force imparted by the manipulation arm 226, examiner notes the pivoting of lever 218 within hole 224 of backstop member 214 indicates that the lever 218 moves along and directly engages the backstop member 214), the movable portion (210) comprising an offset (222 in Fig. 11) to deflect a force of the shaft (218) to cause the movable portion (210) to pivot from one of a first position or a second position to the other of the first position or the second position responsive to being engaged by the shaft (218) to change the state of the fluid path (202 and 208, see Fig. 11-12 Col.6, lines 22-44 – manipulation arm 226 imparts a force onto the lever 228 causes it to pivot around pin 220 and within the hole 222 of diaphragm element 210 such that the hole 222 deflects a force of the lever 218 to cause the diaphragm element 210 to pivot the valve 212 to the closed position, examiner further notes the flexing of the diaphragm 210 between a downward and upward position is being interpreted as a pivot as the diaphragm 210 is secured on both ends and oscillates upward and downward in such a way that it pivots up and down).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reservoir valve assembly comprising a reservoir valve actuator and a reservoir valve taught by Lanigan to have the precision valve assembly with a shaft, fixed portion, and movable portion as taught by Danby to provide a compact, more precise control of fluid using a minimal amount of energy where a substantial movement of the actuator translates to a small valve movement and thus provides a major control advantage (see Col.1, lines 59-63 and Col. 5, lines 64-66).
Kim teaches a valve assembly (100 in Fig. 2) comprising a lever (64 in Fig. 2) pivoted around pin (68 in Fig. 2), wherein pivoting of lever (64) changes the state of the valve (100) and pivoting of the lever (64) is controlled by actuation of a shape memory alloy wire (S2 in Fig. 2) coupled to one end of the lever (64, see Fig. 2 and Col.6, lines 51-67 and Col.7, 20-31).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape memory actuator of modified Lanigan to be the shape memory wire taught by Kim as Kim teaches an improved shape memory alloy actuator that is promptly operated and freely and accurately controlled in either an open or close operation (see Col.2, lines 32-61). In combination, the shape memory alloy (112) of Lanigan would be substituted for the shape memory wire of Kim such that it is coupled to the shaft (218) to control pivoting of the shaft (218) and thus change the state of the precision valve assembly of Fig. 11-13 of Danby.
Regarding claim 15, modified Lanigan discloses the device of claim 13, as discussed above. In modified Lanigan, Lanigan discloses (Claim 15) the state of the fluid path comprising one of a fluid delivery state to deliver the fluid to the patient from the pump chamber (106B in Fig. 21) or a fluid fill state to fill the pump chamber (106B) from the reservoir (118 in Fig. 21) in fluid communication with the fluid path (see para. 0496 – Fig. 21 illustrates a fluid path between reservoir 118 and pump chamber 106B, the reservoir valve assembly 614 may be actuated to close valve 614B and activate pump assembly 106 to place the fluid path in a delivery state where infusible fluid is delivered to the patient or the valve assembly 614 may be open which places the fluid path in a fill state with pump chamber 106B and reservoir 118 in fluid communication).
Regarding claim 16, modified Lanigan discloses the device of claim 13, as discussed above. In modified Lanigan, Lanigan discloses (Claim 16) the actuator (112 in Fig. 21) comprising a shape memory alloy (see para. 0282 – shape memory actuator 112 may be a shape memory wire).
Kim discloses an evidentiary teaching for how a shape memory alloy can be coupled to a lever shaft for actuating a valve mechanism. Kim discloses a valve assembly (100 in Fig. 2) comprising a lever (64 in Fig. 2) pivoted around pin (68 in Fig. 2), wherein pivoting of lever (64) changes the state of the valve (100) and pivoting of the lever (64) is controlled by actuation of a shape memory alloy wire (S2 in Fig. 2) coupled to one end of the lever (64, see Fig. 2 and Col.6, lines 51-67 and Col.7, 20-31). In combination, the shape memory alloy (112 in Fig. 21) of Lanigan would be coupled to the manipulate arm (226 in Fig. 11) of the shaft (218) of Danby to control pivoting of the shaft (218) thus change the state of the precision valve assembly of Fig. 11-13 of Danby.
Allowable Subject Matter
Claims 5, 9-10, 12, 14, and 17-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 21 is allowed.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Danby (U.S Patent No. 4537387) and Cornelia (EP Patent No. 3047873).
Danby discloses several embodiments of a precision valve assembly comprising a backstop member, a pivoting diaphragm element, and an actuation mechanism. In the embodiment of Fig. 7, the movable portion (132) is actuated by a wheel (140) with a shaft (148) that travels along a sloped surface (142) of a fixed portion (136) to apply a force to pivot the movable portion (132) to close the fluid pathway (see Fig. 7-8 and Col.5, lines 24-66). The embodiment of Fig. 7 of Danby fails to disclose the shaft (148) directly engaging the movable portion (132) and rather only discloses an indirect engagement. The embodiment of Fig. 7 of Danby cannot be modified to have a shaft directly engaging the movable portion as this would render its valve mechanism inoperably for its intended operation.
In the embodiment of Fig. 11-13 of Danby, the movable portion (210) is actuated by a shaft (218) that pivots about a pin (220) and within holes (222) and (224) to apply a force to the movable portion (210) to close the fluid pathway (see Fig. 11-13 and Col.6, lines 22-44). Regarding claims 5 and 14, while Fig. 11-13 of Danby disclose the fixed portion (214) having a substantially V-shape as seen in the annotated Danby drawing 1 above, and the V-shape of the fixed portion (214) comprising a channel (230) for the shaft (218) to travel which is a sloped channel (see Col.6, lines 22-44), the channel (230) does not comprise at least one drop-off element to prevent the shaft (218) from engaging an inner wall of the movable portion (210) when traveling toward a central V-section of the V-shaped fixed portion (214). Instead, the shaft (218) travels the entire channel (230) unimpeded and engages the movable portion (210) in each position. Thus, Danby fails to disclose the limitations of claims 5 and 14, and there is no reference that teaches a sloped channel comprising a drop-element to modify Danby with to disclose said limitations. Regarding claims 9, 17, and 21, while the embodiment of Fig. 11-13 of Danby discloses the offset (222) in the form of a pivot hole in the movable portion (210), Danby fails to disclose the offset comprising a substantially triangular projection extending from the movable portion. The pivot hole (222) cannot be modified to have a triangular projection extending therefrom as this would render the pivot hole inoperable for its intended operation. Thus, Danby fails to disclose the limitations of claims 9, 17, and 21, and there is no reference that teaches an offset in the movable portion comprising a substantially triangular projection to modify Danby with to disclose said limitations. Regarding claims 12 and 19, the embodiment of Fig. 11-13 of Danby fails to disclose a magnet associated with the movable portion (210), and there is no reference to modify the diaphragm element of Danby to be associated with a magnet that is attracted to the backstop member. Thus, Danby fails to disclose the limitations of claims 12 and 19.
Kim discloses a valve assembly (100 in Fig. 2) comprising a shaft (64 in Fig. 2) pivoted around pin (68 in Fig. 2), wherein pivoting of shaft (64) changes the state of the valve (100) by deflecting a movable portion (62 in Fig. 2). The pivoting of the shaft (64) is controlled by actuation of a shape memory alloy (S2 in Fig. 2) coupled to one end of the shaft (64, see Col.6, lines 51-67 and Col.7, 20-31). Regarding claims 10 and 18, while Kim discloses a spring (66) configured to bias the shaft (64) in the absence of the force of the actuator (S2), Kim fails to disclose the spring biasing the shaft in a direction toward the movable portion. Instead, Kim discloses the spring (66) biasing the shaft in a direction away from the movable portion (62) as the actuation mechanism causes the movable portion (62) to deflect upward for closing the valve and the spring (66) biases the valve open again (see Col. 6, lines 44-50). Thus, there is no reference that teaches the limitations of claims 10 and 18 with a spring that biases the shaft in a direction toward the movable portion, and Kim cannot be modified to operate in such a manner as this would render Kim inoperably for its intended operation.
Cornelia discloses a valve control member for a catheter comprising a lever 3 with a bottom portion 14 magnetically affected by magnets A and B such that actuation of the magnets A and B pivots the lever 3 between positions I, II, and III. Cornelia fails to disclose the movable portion and fixed portion of claims 13 and 14. Further, there is no motivation to use Cornelia as a teaching reference as it comprises a significantly different structure from the embodiments of Danby.
Therefore there is no reference that discloses or teaches the limitations of claims 5, 9-10, 12, 14, 17-19, and 21.
Conclusion
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783 /COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783