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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 20th, 2025 has been entered.
Claims 1-10 and 12-17 are pending in the application.
Response to Arguments
Applicant’s arguments, filed October 20th, 2025, with respect to the rejections under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 and 12-17 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 term “resilient” in claims 1 (claims 2-10, 12-13, and 15-17 by virtue of dependency) and 14 is a relative term which renders the claim indefinite. The term “resilient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The limitation is suggested to recite “a first spring” and “a second spring”.
Claim 2 (Claims 3-4 by virtue of dependency) recites “a distal end of the pusher and a proximal end of the lancet holder”. It is unclear if this is referring to the same or different distal end of the pusher and proximal end of the lancet holder as recited in claim 1. The limitation is suggested to recite “the distal end of the pusher and the proximal end of the lancet holder”.
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.
Claims 1, 10, 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Harttig (US 20070293882 A1) in view of Vine (US 20130123824 A1), and further in view of Fowler (US 20060020228 A1).
Regarding claim 1, Harttig discloses an activation/retraction mechanism for a lancing device (Abstract, figs. 6-7B, para. [0082-0084]) comprising: a pusher (distal end 208, fig. 6); a first member (hinge pin 209, holding element 210, lever 202, figs. 6-7B, para. [0083]) arranged to displace the pusher in a distal direction (pricking direction 212, as seen in figs. 6-7B, “210 frees … buckling … turn about the hinge pin 209”, para. [0083]); a lancet holder (pricking element 204, fig. 6) comprising a lancet (tip 205, figs. 6-7B, “lancet”, para. [0018]) for penetrating the skin of a subject (“perforates”, para. [0018-0019, 0036]); and a second resilient member (return spring 207, figs. 6-7B) arranged to displace the lancet holder in a proximal direction (as seen in figs. 7A-7B, “retracted … into the housing 200”, para. [0082-0084]); wherein the lancet holder (204, figs. 6-7A) and the pusher (208, , figs. 6-7A) are arranged in a housing (housing 200) of the lancing device (“pricking device”, para. [0082-0084]) in such a way that a distal end of the pusher (distal end 208, figs. 6-7A) engages a proximal end of the lancet holder (contact surface 211, figs. 6-7A) to push the lancet holder from an initial position (“initial position”, para. [0054]) in a distal direction (pricking direction 212, as seen in figs. 6-7B) when the first member (hinge pin 209, holding element 210, lever 202, figs. 6-7B, para. [0083]) displaces the pusher distally (as seen in figs. 6-7B, para. [0082-0084]), wherein the distal end of the pusher (208, fig. 7B) and the proximal end of the lancet holder (211, fig. 7B) are arranged to disengage from each other when the pusher has been displaced distally a length from its initial position (as seen in figs. 7A-7B, “initial position to a locked position”; “208 … passed the edge 214 … no longer applies a force”, para. [0054, 0082-0084]), wherein the first member (hinge pin 209, holding element 210, lever 202, figs. 6-7B, para. [0083]) is arranged to maintain the pusher in a distal position after disengagement from the lancet holder (as seen in fig. 7B, “locked position”, para. [0083-0084]), wherein the second resilient member (return spring 207, fig. 7B) is configured to cause movement of the lancet holder toward the initial position after disengagement from the pusher (as seen in fig. 7B, “retracted”, para. [0082-0084]), wherein the activation/retraction mechanism (figs. 6-7B, para. [0082-0084]) is configured so that, after disengagement of the pusher from the lancet holder (as seen in fig. 7B), the pusher is in the distal position (“locked position”, para. [0083-0084]), in which the distal end of the pusher is positioned distally of the proximal end of the lancet holder (as seen in fig. 7B, para. [0083-0084]), and wherein an engagement surface of the proximal end of the lancet holder is perpendicular to a displacement direction of the lancet holder (unlabeled, but as seen in figs. 6-7B).
Harttig further discloses that the holding element 210 breaks, buckles, or frees the lever 202 such that the lever 202 turns about the hinge pin 209. Harttig does not disclose a first resilient member.
However, Vine directed to a lancet assembly discloses a first resilient member (drive spring 48 & mounting pin 46 & drive cam pin 43, figs. 2A-B), the first resilient member arranged to displace a pusher (pivotal drive cam 42 comprising cam lobe 44, figs. 2A-B) (“potential energy to be stored for pivoting the pivotal drive cam 42”, para. [0025], as seen in figs. 2A-B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig such that the activation/retraction mechanism for the lancing device comprises a first resilient member, in view of the teachings of Vine, as this would aid in storing potential energy for pivoting the lever in order to actuate the pricking device from the initial position to the locked position by combining the pin of Harttig with the spring of Vine.
Harttig, as modified by Vine hereinabove, does not expressly disclose that the pusher is displaced a predetermined length from its initial position.
However, Fowler discloses that the pusher is displaced a predetermined length from its initial position (claim 17, “moving said lancet driver a predetermined distance”, para. [0052]). Fowler further discloses that a desired setting can be selected to determine the depth of penetration (para. [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig, as modified by Vine hereinabove, such that the pusher is displaced a predetermined length from its initial position, in view of the teachings of Fowler, in order to determine the depth of penetration of the lancet by selecting the desired settings (predetermined length) of the displacement of the pusher.
Regarding claim 10, Harttig, as modified by Vine and Fowler hereinabove, discloses the activation/retraction mechanism according to claim 1, wherein the first resilient member and/or second resilient member comprises a spring (Harttig, para. [0033, 0082-0084], “spring” & Vine, “spring”, para. [0025]).
Regarding claim 12, Harttig, as modified by Vine and Fowler hereinabove, discloses the activation/retraction mechanism according to claim 1, further comprising a releasable locking member (holding element 210, figs. 6-7B) arranged to retain the pusher and the first resilient member in a prestressed state (as seen in fig. 6, “secured”, para. [0082]).
Regarding claim 13, Harttig, as modified by Vine and Fowler hereinabove, discloses the activation/retraction mechanism according to claim 1. Harttig, as modified by Vine and Fowler hereinabove, does not disclose wherein the pusher is arranged at a distance from the lancet holder in an initial stage such that the distal end of the pusher is separated from the proximal end of the lancet holder.
However, Vine directed to a lancet assembly discloses wherein the pusher (cam lobe 44, fig. 2A) is arranged at a distance from the lancet holder in an initial stage (unlabeled, but as seen in fig. 2A, “cocked”, para. [0025]) such that the distal end of the pusher is separated from the proximal end of the lancet holder (unlabeled, but as seen in fig. 2A, “potential energy … pivoting … movable between a cocked, retracted position … fired, retracted position ... and an extending position”, para. [0025]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig, as modified by Vine and Fowler hereinabove, such that the pusher is arranged at a distance from the lancet holder in an initial stage such that the distal end of the pusher is separated from the proximal end of the lancet holder, in view of the teachings of Vine, as this would aid in driving the needle carriage to penetrate the tissue by using the pivotal drive cam that is moveable between a cocked position, fired position, and extended position.
Regarding claim 15, Harttig, as modified by Vine and Fowler hereinabove, discloses the activation/retraction mechanism according to claim 1, wherein the pusher (208, figs. 6-7B) is configured to remain in contact with the lancet holder from contact with the lancet holder until the disengagement between the distal end of the pusher and the proximal end of the lancet holder (as seen in figs. 6-7B, para. [0082-0084]).
Regarding claim 16, Harttig, as modified by Vine and Fowler hereinabove, discloses the activation/retraction mechanism according to claim 1. Harttig, as modified by Vine and Fowler hereinabove, does not disclose wherein the first resilient member is configured to resiliently deform to permit distal movement of the pusher.
However, Vine discloses wherein the first resilient member is configured to resiliently deform to permit distal movement of the pusher (unlabeled, but as seen in figs. 1A-C & 3A-3B, “potential energy for pivoting the pivotal drive cam 42”, para. [0023-0025]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig, as modified by Vine and Fowler hereinabove, such that the first resilient member is configured to resiliently deform to permit distal movement of the pusher, in view of the teachings of Fowler, as this would aid in pivoting the pivotal drive cam/lever by using potential energy stored in the drive spring.
Regarding claim 14, Harttig discloses a lancing device comprising an activation/retraction mechanism (Abstract, figs. 6-7B, para. [0082-0084]), the activation/retraction mechanism comprising: a pusher (distal end 208, fig. 6); a first member (hinge pin 209, holding element 210, lever 202, figs. 6-7B, para. [0083]) arranged to displace the pusher in a distal direction (pricking direction 212, as seen in figs. 6-7B, “210 frees … buckling … turn about the hinge pin 209”, para. [0083]); a lancet holder (pricking element 204, fig. 6) comprising a lancet (tip 205, figs. 6-7B, “lancet”, para. [0018]) for penetrating skin of a subject (“perforates”, para. [0018-0019, 0036]); and a second resilient member (return spring 207, figs. 6-7B) arranged to displace the lancet holder in a proximal direction from an initial position (as seen in figs. 7A-7B, “initial position”; “retracted … into the housing 200”, para. [0054, 0082-0084]); wherein the lancet (204, figs. 6-7A) and the pusher (208, , figs. 6-7A) are arranged in a housing (housing 200) of the lancing device (“pricking device”, para. [0082-0084]) in such a way that a distal end of the pusher (distal end 208, figs. 6-7A) engages a proximal end of the lancet holder (contact surface 211, figs. 6-7A) to push the lancet holder in a distal direction (pricking direction 212, as seen in figs. 6-7B) when the first member (hinge pin 209, holding element 210, lever 202, figs. 6-7B, para. [0083]) displaces the pusher distally (as seen in figs. 6-7B, para. [0082-0084]), wherein the distal end of the pusher (208, fig. 7B) and the proximal end of the lancet holder (211, fig. 7B) are arranged to disengage from each other when the pusher has been displaced distally a length from its initial position (as seen in figs. 7A-7B, “initial position to a locked position”; “208 … passed the edge 214 … no longer applies a force”, para. [0054, 0082-0084]), wherein the first member (hinge pin 209, holding element 210, lever 202, figs. 6-7B, para. [0083]) is arranged to maintain the pusher in a distal position after disengagement from the lancet holder (as seen in fig. 7B, “locked position”, para. [0083-0084]), wherein the second resilient member is configured to cause movement of the lancet holder toward the initial position after disengagement from the pusher (as seen in fig. 7B, “retracted”, para. [0082-0084]), wherein the activation/retraction mechanism (figs. 6-7B, para. [0082-0084]) is configured so that, after disengagement of the pusher from the lancet holder, the pusher is in the distal position (“locked position”, para. [0083-0084]), in which the distal end of the pusher is positioned distally of the proximal end of the lancet holder (as seen in fig. 7B, para. [0083-0084]), and wherein an engagement surface of the proximal end of the lancet holder is perpendicular to a displacement direction of the lancet holder (unlabeled, but as seen in figs. 6-7B).
Harttig further discloses that the holding element 210 breaks, buckles, or frees the lever 202 such that the lever 202 turns about the hinge pin 209. Harttig does not disclose a first resilient member.
However, Vine directed to a lancet assembly discloses a first resilient member (drive spring 48 & mounting pin 46 & drive cam pin 43, figs. 2A-B), the first resilient member arranged to displace a pusher (pivotal drive cam 42 comprising cam lobe 44, figs. 2A-B) (“potential energy to be stored for pivoting the pivotal drive cam 42”, para. [0025], as seen in figs. 2A-B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig such that the activation/retraction mechanism for the lancing device comprises a first resilient member, in view of the teachings of Vine, as this would aid in storing potential energy for pivoting the lever in order to actuate the pricking device from the initial position to the locked position by combining the pin of Harttig with the spring of Vine.
Harttig, as modified by Vine hereinabove, does not expressly disclose that the pusher is displaced a predetermined length from its initial position.
However, Fowler discloses that the pusher is displaced a predetermined length from its initial position (claim 17, “moving said lancet driver a predetermined distance”, para. [0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig, as modified by Vine hereinabove, such that the pusher is displaced a predetermined length from its initial position, in view of the teachings of Fowler, in order to determine the depth of penetration of the lancet by selecting the desired settings (predetermined length) of the displacement of the pusher.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Harttig in view of Vine and Fowler, as applied to claim 1 above, and further in view of Simons (US 6036924 A).
Regarding claim 2, Harttig, as modified by Vine and Fowler hereinabove, discloses the activation/retraction mechanism according to claim 1, wherein a distal portion of the pusher and a proximal portion of the lancet holder have a combined cross-sectional area smaller than a cross- sectional area of the housing (unlabeled, but as seen in figs. 6-7B) such that the distal portion of the pusher and the proximal portion of the lancet holder are free to move in relation to each other when the distal end of the pusher is disengaged from the proximal end of the lancet holder (as seen in figs. 6-7B, “slides”, para. [0082-0084]).
Harttig, as modified by Vine and Fowler hereinabove, does not disclose wherein a distal portion of the pusher and a proximal portion of the lancet holder have complementary cross-sections.
However, Simons directed to a cassette of lancet cartridges for sampling blood discloses a distal portion and a proximal portion (“opposite surfaces”, col. 5 lines 42-44) having complementary cross-sections (“opposite surfaces each having a cross section that is curved … to match the other surface”, col. 5 lines 42-44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig, as modified by Vine and Fowler hereinabove, such that a distal portion of the pusher and a proximal portion of the lancet holder have complementary cross-sections, in view of the teachings of Simons, as this would aid in providing the sliding engagement of the distal end of the lever with the contact surface of the pricking element by forming the distal end surface and contact surface with matching cross sections.
Regarding claim 3, Harttig, as modified by Vine, Fowler, and Simons hereinabove, discloses the activation/retraction mechanism according to claim 2, wherein the pusher and the lancet holder are arranged at a non-zero angle to each other (unlabeled, but as seen in fig. 6) such that the distal end of the pusher moves laterally in relation to the proximal end of the lancet holder (as seen in figs. 6-7B, “laterally”, para. [0082-0084]) when the first resilient member displaces the pusher distally until they disengage from each other (as seen in figs. 6-7B, para. [0082-0084]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Harttig in view of Vine in view of Fowler and Simons, as applied to claim 2 above, and further in view of Keil (US 20130085517 A1), and further in view of Leong (US 20110029006 A1).
Regarding claim 4, Harttig, as modified by Vine, Fowler, and Simons hereinabove, discloses the activation/retraction mechanism according to claim 2. Harttig, as modified by Vine, Fowler, and Simons hereinabove, does not disclose wherein the pusher comprises an external helical groove or ridge arranged to cooperate with a guide projection arranged in the housing to rotate the pusher when the first resilient member displaces the pusher distally, such that the distal end of the pusher rotates in relation to the proximal end of the lancet holder until they disengage from each other.
However, Keil directed to a lancing device with automatic disengagement discloses wherein the pusher (drive rotor (50) that can be rotated, para. [0126-0127]) comprises an external helical groove or ridge para. [0057, 0126], control track (72, 73); the rotary/sliding transmission may have a recess that can be rotated with the drive rotor into which a matching guide pin engages) arranged to cooperate with a guide projection (para. [0126, 0057], control cam (71); the rotary/sliding transmission may have a recess that can be rotated with the drive rotor into which a matching guide pin engages) to rotate the pusher when the first resilient member displaces the pusher distally (para. [0010, 0057, 0126], a cam control comprising a recess forming a guide curve that can be rotated together with the drive rotor into which a matching guide pin engages where at least a part of the puncturing and return movement is determined by a relative movement between the guide pin and the recess which the guide pin makes when it travels through the guide curve formed by the recess; control cam (71) which is mounted such that it can be moved along a control track (72, 73), where the control track or the control track part (72, 73) is attached to the rotatable drive rotor (50) of the rotary/sliding transmission).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig, as modified by Vine, Fowler, and Simons hereinabove, such that the pusher comprises an external helical groove or ridge arranged to cooperate with a guide projection to rotate the pusher when the first resilient member displaces the pusher distally, in view of the teachings of Keil, in order to determine the puncturing and return movement by a relative movement between the guide pin and recess by incorporating the guide curve and guide pin of Keil.
Harttig, as modified by Vine, Fowler, Simons, and Keil hereinabove, does not disclose that the guide projection is arranged in the housing and that the distal end of the pusher rotates in relation to the proximal end of the lancet holder until they disengage from each other.
However, Leong directed to lancet device with lance retraction, discloses a guide projection arranged in the housing (para. [0079, 0082], interior wall 22 may have a set of guide rails 94, 96 for engaging the feet 86 of slider 14 and for guiding the arms 60 of needle holder 16; ridges 102 provide abutment surface for flanges 84 of slider 14 and arms 60 of needle holder 16) and that the distal end of the pusher rotates in relation to the proximal end of the lancet holder until they disengage from each other (para. [0044, 0059, 0081, 0090], axial movement includes any movement of the slider 14 and the needle holder 16 relative to each other, including axial and/or rotational movement of either element or both elements with respect to the general length of hollow housing 11; Needle holder 16 is adapted for longitudinal and rotational movement within hollow housing 11 and is sequentially movable from an initial position with the puncture end 58 within the proximal end 18 of hollow housing 11, to an disengagement position where biasing assembly 12 is compressed and needle holder disengages from slider 14; “moment of disengagement”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig, as modified by Vine, Fowler, Simons, and Keil hereinabove, such that the guide projection is arranged in the housing and that the distal end of the pusher rotates in relation to the proximal end of the lancet holder until they disengage from each other, in view of the teachings of Leong, in order to guide the rotational and axial movement of the needle holder and the pusher with respect to the interior wall of the housing to define the moment of disengagement.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Harttig in view of Vine and Fowler, as applied to claim 1 above, further in view of Karbowniczek (US 20090036915 A1), and further in view of Kitamura (US 20090275969 A1).
Regarding claim 5, Harttig, as modified by Vine and Fowler hereinabove, discloses the activation/retraction mechanism according to claim 1, wherein the pusher comprises at least one pusher arm (distal end 208, figs. 6-7B) extending in the distal direction (as seen in figs. 6-7B), wherein a distal end of the at least one pusher arm comprises an engagement surface (unlabeled, but as seen in figs. 6-7B) arranged to engage the proximal end of the lancet holder (as seen in figs. 6-7B, para. [0082-0084]). Harttig, as modified by Vine and Fowler hereinabove, does not disclose a camming surface, wherein the camming surface is arranged to come into contact with an abutment in the housing arranged in a position corresponding to the predetermined length from the initial position of the pusher and adapted to deflect the at least one pusher arm laterally to disengage the at least one pusher arm from the proximal end of the lancet holder when the pusher is urged against the abutment in the distal direction.
However, Karbowniczek discloses a camming surface, wherein the camming surface (para. [0137, 0147], rim 148 is provided as a contact structure or surface) is arranged to come into contact with an abutment in the housing (paragraph [0137], rim 148 is provided as a contact structure or surface on lancet 70d for engagement by tab member 134 to cause actuation of lancet device 10d) and adapted to deflect the at least one pusher arm laterally to disengage the at least one pusher arm from the proximal end of the lancet holder when the pusher is urged against the abutment in the distal direction (figs. 19-20, para. [0140], downwardly directed force on lever 132 pivotally connected to main body 20d, causing lever 132 to depress into internal cavity 28d of main body 20d; tab member 134 interacts with rear rim 148 on carrier body 76d; carrier body 76d will substantially simultaneously pivot about posts 150 in main channel 140 of guide channels 138). Karbowniczek further discloses that the actuating member may comprise a cam element with a cam surface and the rotation element may comprise a guide plate defining a cam guide recess for receiving the cam element, such that axial movement of the shield into the housing causes the cam surface to engage the cam guide recess an impart rotational motion to the guide plate (para. [0022]), initial or pre-actuated state where upon compressing or "loading" the drive spring 92a, the lancet device 10a is placed into an armed or loaded state ready for a puncturing procedure (para. [0100]), and the force required to axially compress drive spring 92a between proximal spring guide 86a and rear cap 24a a pre-selected distance (para.[0107]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig, as modified by Vine and Fowler hereinabove, such that the camming surface is arranged to come into contact with an abutment in the housing arranged in a position corresponding to the predetermined length from the initial position of the pusher and adapted to deflect the at least one pusher arm laterally to disengage the at least one pusher arm from the proximal end of the lancet holder when the pusher is urged against the abutment in the distal direction, in view of the teachings of Karbowniczek, as this would aid in allowing drive spring to propel carrier body through main body until the puncturing end of lancet projects through front opening in main body by incorporating the tab/cam surface such that as rear rim of carrier body moves downward in internal cavity of main body, the carrier body will substantially simultaneously pivot about posts in main channel of guide channels, align the guide tabs with the main channel, and will move carrier body from a first state of being dynamically balanced to a second state of being dynamically unbalanced (Karbowniczek, para. [0135, 0140-0141]).
Harttig, as modified by Vine, Fowler, and Karbowniczek hereinabove, does not disclose the abutment in the housing arranged in a position corresponding to the predetermined length from the initial position of the pusher.
However, Kitamura directed to a lancet assembly discloses an opening on the side surface arranged in a position corresponding to the predetermined length from the initial position of the pusher (para. [0028-0029], the distance, between the front-end portion of the trigger and the front-end wall that defines the opening on the side surface that are separated from each other …trigger can be moved … launch the lancet body … pricking element is exposed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig, as modified by Vine, Fowler, and Karbowniczek hereinabove, such that the abutment in the housing is arranged in a position corresponding to the predetermined length from the initial position of the pusher, in view of the teachings of Kitamura, in order to move the trigger forward to launch the lancet body to expose the pricking element.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Harttig in view of Vine, Fowler, Karbowniczek, and Kitamura, as applied to claim 5 above, and further in view of Stout (US 20070185515 A1).
Regarding claim 6, Harttig, as modified by Vine, Fowler, Karbowniczek, and Kitamura hereinabove, discloses the activation/retraction mechanism according to claim 5. Harttig, as modified by Vine, Fowler, Karbowniczek, and Kitamura hereinabove, does not expressly disclose wherein the pusher comprises two pusher arms.
However, Stout directed to a lancing device discloses wherein the pusher comprises two pusher arms (pressing member 28 with two resilient lancet control fingers 32, para. [0012, 0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig, as modified by Vine, Fowler, Karbowniczek, and Kitamura hereinabove, such that the pusher comprises two pusher arms, in view of the teachings of Stout, in order to provide cooperating releasable engagement structures that store a charge until they are disengaged to disable the lancing device from reuse.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Harttig in view of Vine, Fowler, Karbowniczek, and Kitamura, as applied to claim 5 above, and further in view of Huang (CN 201098127 Y English Translation).
Regarding claim 7, Harttig, as modified by Vine, Fowler, Karbowniczek, and Kitamura hereinabove, discloses the activation/retraction mechanism according to claim 5. Harttig, as modified by Vine, Fowler, Karbowniczek, and Kitamura hereinabove does not disclose a safety assembly comprising a lancet guard integrally formed with a distal end of the lancet holder by means of a frangible portion adapted to break when the lancet guard is displaced in relation to the lancet holder.
However, Huang directed to a safe blood sampling needle discloses a safety assembly comprising a lancet guard integrally formed with a distal end of the lancet holder by means of a frangible portion adapted to break when the lancet guard is displaced in relation to the lancet holder (para. [0060, 0066], protective rod 125 is provided with the inner edge 123; and is provided with a pair of fastening parts 122 on both sides above it to fasten with a pair of perforations 15 provided in the main housing 11 to form a safety lancet; break the protective rod 125. at this time, the protective rod 125 will be broken from the inner edge 123 of the outlet 121).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig, as modified by Vine, Fowler, Karbowniczek, and Kitamura hereinabove, to further comprise a safety assembly comprising a lancet guard integrally formed with a distal end of the lancet holder by means of a frangible portion adapted to break when the lancet guard is displaced in relation to the lancet holder, in view of the teachings of Huang, as this would aid in forming a safety lancet by incorporating the protective rod (Huang, para. [0060, 0066]).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Harttig in view of Vine, Fowler, Karbowniczek, and Kitamura, and Huang, as applied to claim 7 above, and further in view of Ghesquiere (US 20090270765 A1).
Regarding claim 8, Harttig, as modified by Vine, Fowler, Karbowniczek, Kitamura, and Huang hereinabove, discloses the activation/retraction mechanism according to claim 7. Harttig, as modified by Vine, Fowler, Karbowniczek, Kitamura, and Huang hereinabove, does not disclose wherein the lancet holder further comprises one or more projections arranged to cooperate with corresponding recesses in the housing which allow rotation of the lancet holder within a predetermined angular range.
However, Huang discloses directed to a safe blood sampling needle discloses wherein the lancet holder further comprises one or more projections (para. [0063], second sliding block 4 is a round rod with a flange 42 and a pair of sliding feet 41 extends axially on both sides of the flange 42) arranged to cooperate with corresponding recesses in the housing (para. [0060], on the inner wall of the main housing 11 a pair of chute seats 14 is provided) which allow rotation of the lancet holder (para. [0013, 0067], the second spring prompts the second sliding block to rotate at an angle; inclined surfaces 311 and 411 of each sliding foot 31 and 41 prompt the second sliding block 4 to rotate, and the rebound force of the second spring 22 is exerted on the second sliding block 4, when the second sliding block 4 is rotating; Return its sliding feet 41 to the internal space of the shell). Huang further discloses that the needle is automatically withdrawn and the safety blood collection needle is taken away (para. [0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig, as modified by Vine, Fowler, Karbowniczek, Kitamura, and Huang hereinabove, such that the lancet holder further comprises one or more projections arranged to cooperate with corresponding recesses in the housing which allow rotation of the lancet holder, in view of the teachings of Huang, as this would aid in automatically withdrawing the needle by rotating the sliding block such that the pricking element returns to the internal space of the shell.
Harttig, as modified by Vine, Fowler, Karbowniczek, Kitamura, and Huang hereinabove, does not expressly disclose rotation of the lancet holder within a predetermined angular range.
However, Ghesquiere directed to the field of medical diagnostic devices discloses rotation of the lancet holder within a predetermined angular range (para. [0115], STRIPLETTM … oriented in a second direction for testing, rotated approximately 180 degrees or another angle equal to the angular displacement of the lancet).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig, as modified by Vine, Fowler, Karbowniczek, Kitamura, and Huang hereinabove, such that the lancet holder rotates within a predetermined angular range, in view of the teachings of Ghesquiere, in order to orient the lancet holder in a second direction for testing by rotating at an angle equal to the angular displacement of the lancet.
Regarding claim 9, Harttig, as modified by Vine, Fowler, Karbowniczek, Kitamura, and Huang hereinabove, discloses the activation/retraction mechanism according to claim 7. Harttig, as modified by Vine, Fowler, Karbowniczek, Kitamura, and Huang hereinabove, does not disclose wherein the safety assembly further comprises a guide rod rigidly connected to or integrally formed with the proximal end of the lancet holder, wherein the pusher comprises a through- going hole adapted to the shape of the guide rod such that rotation of the lancet holder a predetermined angle in relation to the pusher brings the guide rod into alignment with the hole to allow the pusher to be displaced distally along the guide rod.
However, Karbowniczek discloses wherein the safety assembly further comprises a guide rod rigidly connected to or integrally formed with a proximal end of the lancet holder (para. [0135], guide tabs 78d on carrier body 76d), wherein the pusher comprises a through-going hole adapted to the shape of the guide rod (para. [0152], transverse cross-sectional shape of the carrier body 76e defined at the location of rear rim 174 and guide tabs 78e on carrier body 76e matches the corresponding profile of keyhole 166) such that rotation of the lancet holder in relation to the pusher brings the guide rod into alignment with the hole to allow the pusher to be displaced distally along the guide rod (figs. 19-20, para. [0140-0141], as rear rim 148 of carrier body 76d moves downward in internal cavity 28d of main body 20d, the carrier body 76d will substantially simultaneously pivot about posts 150 in main channel 140 of guide channels 138; moving carrier body 76d from a first state of being dynamically balanced to a second state of being dynamically unbalanced, thereby allowing drive spring 92d to propel carrier body 76d through main body 20d until the puncturing end 74d of lancet 72d projects through front opening 30d in main body 20d; guide tabs 78d align with main channel 140 of guide channels 138 and are free to move forward therein under the biasing force of drive spring 92d).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig, as modified by Vine, Fowler, Karbowniczek, Kitamura, and Huang hereinabove, such that the safety assembly further comprises a guide rod rigidly connected to or integrally formed with a proximal end of the lancet holder, wherein the pusher comprises a through-going hole adapted to the shape of the guide rod such that rotation of the lancet holder in relation to the pusher brings the guide rod into alignment with the hole to allow the pusher to be displaced distally along the guide rod as disclosed by Karbowniczek, as this would aid in allowing drive spring to propel carrier body through main body until the puncturing end of lancet projects through front opening in main body by incorporating guide tabs such that as rear rim of carrier body moves downward in internal cavity of main body, the carrier body will substantially simultaneously pivot about posts in main channel of guide channels, align the guide tabs with the main channel, and will move carrier body from a first state of being dynamically balanced to a second state of being dynamically unbalanced (Karbowniczek, para. [0135, 0140-0141]).
Harttig, as modified by Vine, Fowler, Karbowniczek, Kitamura, and Huang hereinabove, does not expressly disclose rotation of the lancet holder within a predetermined angular range.
However, Ghesquiere directed to the field of medical diagnostic devices discloses rotation of the lancet holder a predetermined angle in relation to the pusher (para. [0115], STRIPLETTM … oriented in a second direction for testing, rotated approximately 180 degrees or another angle equal to the angular displacement of the lancet).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig, as modified by Vine, Fowler, Karbowniczek, Kitamura, and Huang hereinabove, such that the lancet holder rotates within a predetermined angular range, as disclosed by Ghesquiere, in order to orient the lancet holder in a second direction for testing by rotating at an angle equal to the angular displacement of the lancet.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Harttig in view of Vine and Fowler, as applied to claim 1 above, further in view of Kan (US 20140088633 A1), and further in view of Ranalletta (US 4892097 A).
Regarding claim 17, Harttig, as modified by Vine and Fowler, hereinabove, discloses the activation/retraction mechanism according to claim 1.
Harttig, as modified by Vine and Fowler, hereinabove, does not disclose wherein the first resilient member comprises a spiral wound torsion spring arranged in a proximal end of the housing with its axis of rotation substantially perpendicular to the longitudinal extension of the housing, wherein a free end of the torsion spring extends a predetermined length from the axis of rotation and is arranged to act as the pusher, wherein rotation of the torsion spring causes the free end to engage the proximal end of the lancet holder and displace the lancet holder distally, wherein the housing comprises a recess arranged to receive the free end of the torsion spring when the free end reaches its distalmost position in such a way that the free end is disengaged from the proximal end of the lancet holder.
However, Kan directed to a lancing device discloses wherein the first resilient member comprises a spiral wound torsion spring (drive torsion spring 80, figs. 7-8, para. [0040]) arranged in a proximal end (unlabeled, but as seen in figs. 7-8) of the housing (housing 12, fig. 1, para. [0041]) with its axis of rotation substantially perpendicular (unlabeled, but as seen in figs. 7-10, “clockwise … transversely”, para. [0042, 0056]) to the longitudinal extension of the housing (“linear stroke axis (see axial centerline in FIG. 7), para. [0034] (Examiner note: the drive spring 80 has an axis of rotation that is perpendicular to the linear stroke axis as seen in figs. 7-8)), wherein a free end of the torsion spring (leg 81, figs. 7-8) extends a length from the axis of rotation (as seen in figs. 7-8) and is arranged to act as the pusher (“leg 81 … engages the drive contact surface 34 of the … drive element 41 … drives the lancet 30”, para. [0029, 0040, 0055]), wherein rotation of the torsion spring (as seen in figs. 7-10) causes the free end to engage the proximal end of the lancet holder and displace the lancet holder distally (“engagement”; “propels the lancet carrier forward toward its extended position”, para. [0029, 0040, 0055], figs. 7-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig, as modified by Vine and Fowler, hereinabove, such that the first resilient member comprises a spiral wound torsion spring arranged in a proximal end of the housing with its axis of rotation substantially perpendicular to the longitudinal extension of the housing, wherein a free end of the torsion spring extends a length from the axis of rotation and is arranged to act as the pusher, wherein rotation of the torsion spring causes the free end to engage the proximal end of the lancet holder and displace the lancet holder distally, in view of the teachings of Kan, for the obvious advantage of providing a charged drive mechanism to propel the lancet carrier through the lancing stroke.
Furthermore, upon the incorporation of the torsional spring having the leg of Kan, Harttig, as modified by Vine, Fowler, and Kan hereinabove, discloses wherein the housing comprises a recess (unlabeled, but as seen in figs. 6-7B, the space between the inside wall 216 of the housing 200 and the second guide surface 215, para. [0084]) arranged to receive the free end of the torsion spring when the free end reaches its distalmost position in such a way that the free end is disengaged from the proximal end of the lancet holder (as seen in fig. 7B, “locked position … fixed between the inside wall 216 of the housing and the second guide surface 215”, para. [0084]).
Harttig, as modified by Vine, Fowler, and Kan hereinabove does not disclose the free end of the torsion spring extending a predetermined length.
However, Ranalletta directed to a disposable lancet assembly having a torsion spring 56 discloses the free end of the torsion spring (66, 68, figs. 2-3) extending a predetermined length (“pretensioned torsion spring … overall operational length dimension”, claim 1, figs. 2-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harttig, as modified by Vine, Fowler, and Kan hereinabove, such that the free end of the torsion spring extending a predetermined length, in view of the teachings of Ranalletta, in order to provide an overall operational length dimension for engaging and driving the lancet carrier.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Saeki (WO 2011158669 A1) directed to a lancet and puncture device; Smith (US 5514152 A) directed to a two part lancing device including a pre-cocked torsion spring and forming the torsion spring, lancet shaft, and lancet tip from a single length of spring wire
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791