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 .
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.
No claim limitations are interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 28-29 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-11 of U.S. Patent No. 11,633,136 (the reference patent)(previously cited), in view of U.S. Patent No. 5,314,441 (Cusack)(previously cited).
Claims 10-11 of the reference patent include a casing having a lower surface and a blade pivotably coupled to the casing. Cusack teaches a pin 112 of a pivotable member 92 traveling within a guide channel 68 so as to focus the member’s path (FIGS. 3A-3B and 7A-7C and col. 8, line 52 to col. 10, line 20 of Cusack). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a guide channel in the casing and a pin coupled to the blade for insertion into the guide channel such that the pin follows the path of the guide channel since it better controls the intended path of the blade.
Claim 10 of the reference patent (as modified) includes all the features of claim 28 of the reference patent.
Claim 11 of the reference patent (as modified) includes all the features of claim 29 of the reference patent
Claims 21, 23, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 11,633,136 (the reference patent)(previously cited), in view of U.S. Patent Application Publication No. 2015/0080929 (Yi)(previously cited).
Claim 1 of the reference patent includes all the features of claim 21 of the reference patent except the base being configured to be positioned against skin of the subject and the release member being fixedly coupled to the base. Yi teaches a device for withdrawing bodily fluid from a subject, the device comprising: a housing including a base (the housing 2 of Yi including a bottom surface or base; paragraphs 0036 and 0053 of Yi) configured to be positioned against skin of the subject (paragraphs 0066 and 0069 of Yi) and members that extend out from the bottom surface of base being fixedly coupled to the bottom surface or base (see the rear member 36 and the cam element 40 of Yi). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the base being configured to be positioned against skin of the subject, as suggested by Yi, since it ensures the withdrawal of the bodily fluid from the skin. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to the have the release member being fixedly coupled to the base, as suggested by Yi, since it permits a firm construction.
Claim 1 of the reference patent (as modified) includes all the features of claim 26 of the present application.
Claim 9 of the reference patent includes all the features of claim 21 of the reference patent except the base being configured to be positioned against skin of the subject and the release member being fixedly coupled to the base. Yi teaches a device for withdrawing bodily fluid from a subject, the device comprising: a housing including a base (the housing 2 of Yi including a bottom surface or base; paragraphs 0036 and 0053 of Yi) configured to be positioned against skin of the subject (paragraphs 0066 and 0069 of Yi) and members that extend out from the bottom surface of base being fixedly coupled to the bottom surface or base (see the rear member 36 and the cam element 40 of Yi). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the base being configured to be positioned against skin of the subject, as suggested by Yi, since it ensures the withdrawal of the bodily fluid from the skin. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to the have the release member being fixedly coupled to the base, as suggested by Yi, since it permits a firm construction.
Claim 9 of the reference patent (as modified) includes all the features of claim 26 of the present application.
With respect to claim 23 of the present application, Yi teaches a device for withdrawing bodily fluid from a subject, the device comprising: a housing including a lumen (see the lumen of the housing 2 of Yi; paragraphs 0036 and 0053 of Yi). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the housing having a lumen with the components of the skin-piercing assembly positioned within the lumen since placement of the skin-piercing assembly inside the housing is required and Yi teaches such a structure that permits such a placement. Thus, claim 1 or 9 of the reference patent (as modified) includes all the features of claim 23.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 11,633,136 (the reference patent), in view of U.S. Patent Application Publication No. 2015/0080929 (Yi)(previously cited) and further in view of U.S. Patent No. 5,314,441 (Cusack)(previously cited).
Claim 1 or 9 of the reference patent (as modified) includes a biasing member. Cusack teaches that a torsion spring 122 is a suitable spring. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a torsion spring as the biasing member since a type of biasing member is required and Cusack teaches one such biasing member. Thus, claim 1 or 9 of the reference patent (as modified) includes all the features of claim 25.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 28-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2010/0081967 (Charlton)(previously cited).
First Interpretation
With respect to claim 28, Charlton teaches or suggests a device for withdrawing bodily fluid from a subject, the device comprising:
a housing (the housing of the lancing device 120 of Charlton; the element A in the below annotated FIG. 3B of Charlton) including a base (the bottom surface of the housing of the lancing device 120 of Charlton; the element B in the below annotated FIG. 3B of Charlton) having an opening (the opening though which the lancet body 124 protrudes through in FIGS. 3B-3C of Charlton; the element C in the below annotated FIG. 3B of Charlton) extending therethrough, wherein the base is configured to be positioned adjacent skin of the subject (paragraphs 0027, 0033, 0041, 0046, and 0048 of Charlton); and
a skin-piercing assembly positioned at least partially within the housing, wherein the skin-piercing assembly includes-
a casing (the housing of the lancet body 124 of Charlton; the element D in the below annotated FIG. 3B of Charlton) having a lower surface (the lower surface of the housing of the lancet body 124 of Charlton; the element E in the below annotated FIG. 3B of Charlton), wherein the casing defines a track (the element F in the below annotated FIG. 3B of Charlton) extending at least partially therethrough;
a projection (the element G in the below annotated FIG. 3B of Charlton) constrained to move within the track; and
a blade (the lancet 122b of Charlton) coupled to the projection and configured to move relative to the lower surface when the projection moves within the track (compare FIGS. 3A-3F of Charlton; paragraphs 0040-0041 of Charlton); and
an actuator (the combination of the ring 146, the trigger 160, and the pin 140a, 140b of Charlton OR the combination of the ring 146, the trigger 160, the pin 140a, 140b, and the storage case 130 of Charlton) operably coupled to the skin-piercing assembly and movable relative to the housing, wherein-
the actuator is movable to a first position to drive the lower surface of the casing at least partially through the opening in the base and into contact with the skin (the ring 146 of Charlton operates with the downward movement of the lancet body 124 to drive the element E through the element C in the below annotated FIG. 3B of Charlton so as to go into the position in FIGS. 3B and 3C of Charlton; paragraphs 0040-0041 of Charlton); and
the actuator is movable to a second position to permit the blade to move along a path through the skin and relative to the lower surface of the casing (rotating the trigger 160 to eject the blade 122b into the skin relative to the element E in the below annotated FIG. 3B of Charlton; paragraphs 0040-0041 of Charlton).
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Annotated FIG. 3B of Charlton
With respect to claim 29, Charlton teaches that at least a portion of the lower surface of the casing has a curved shape (the element E in the above annotated FIG. 3B of Charlton is cylindrical which means it has a curved shape; paragraphs 0037-0041 of Charlton).
Second Interpretation
With respect to claim 28, Charlton teaches or suggests a device for withdrawing bodily fluid from a subject, the device comprising:
a housing (the housing of the lancing device 220 of Charlton; the element A in the below annotated FIG. 5B of Charlton) including a base (the bottom surface of the housing of the lancing device 220 of Charlton; the element B in the below annotated FIG. 5B of Charlton) having an opening (the opening though which the lancet body protrudes through in FIGS. 5B-5C of Charlton; the element C in the below annotated FIG. 5B of Charlton) extending therethrough, wherein the base is configured to be positioned adjacent skin of the subject (paragraphs 0027, 0033, 0041, 0046, and 0048 of Charlton); and
a skin-piercing assembly positioned at least partially within the housing, wherein the skin-piercing assembly includes-
a casing (the housing of the lancet body 224 of Charlton; the element D in the below annotated FIG. 5B of Charlton) having a lower surface (the lower surface of the housing of the lancet body 224 of Charlton; the element E in the below annotated FIG. 5B of Charlton), wherein the casing defines a track (the element F in the below annotated FIG. 5B of Charlton) extending at least partially therethrough;
a projection (the element G in the below annotated FIG. 5B of Charlton) constrained to move within the track; and
a blade (the lancet 222b of Charlton) coupled to the projection and configured to move relative to the lower surface when the projection moves within the track (compare FIGS. 5A-3D of Charlton; paragraphs 0042-0046 of Charlton); and
an actuator (the cam 228, the trigger 260, the pin 140a, 140b, and the storage case 130 of Charlton) operably coupled to the skin-piercing assembly and movable relative to the housing, wherein-
the actuator is movable to a first position to drive the lower surface of the casing at least partially through the opening in the base and into contact with the skin (the cam 228 moves to drive the element E through the element C in the below annotated FIG. 5B of Charlton so as to go into the position in FIGS. 5B and 5C of Charlton; paragraphs 0042-0046 of Charlton); and
the actuator is movable to a second position to permit the blade to move along a path through the skin and relative to the lower surface of the casing (rotating the trigger 260 to eject the blade 222b into the skin relative to the element E in the below annotated FIG. 5B of Charlton; paragraphs 0042-0046 of Charlton).
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Annotated FIG. 5B of Charlton
With respect to claim 29, Charlton teaches that at least a portion of the lower surface of the casing has a curved shape (the element E in the above annotated FIG. 5B of Charlton is cylindrical which means it has a curved shape; paragraphs 0037-0041 of Charlton).
Third Interpretation
With respect to claim 28, Charlton teaches or suggests a device for withdrawing bodily fluid from a subject, the device comprising:
a housing (the housing of the lancing device 320 of Charlton; the element A in the below annotated FIG. 7B of Charlton) including a base (the bottom surface of the housing of the lancing device 320 of Charlton; the element B in the below annotated FIG. 7B of Charlton) having an opening (the opening though which the lancet body protrudes through in FIGS. 7B-7C of Charlton; the element C in the below annotated FIG. 7B of Charlton) extending therethrough, wherein the base is configured to be positioned adjacent skin of the subject (paragraphs 0027, 0033, 0041, 0046, and 0048 of Charlton); and
a skin-piercing assembly positioned at least partially within the housing, wherein the skin-piercing assembly includes-
a casing (the housing of the lancet body 324 of Charlton; the element D in the below annotated FIG. 7B of Charlton) having a lower surface (the lower surface of the housing of the lancet body 324 of Charlton; the element E in the below annotated FIG. 7B of Charlton), wherein the casing defines a track (the element F in the below annotated FIG. 7B of Charlton) extending at least partially therethrough;
a projection (the element G in the below annotated FIG. 7B of Charlton) constrained to move within the track; and
a blade (the lancet 322b of Charlton) coupled to the projection and configured to move relative to the lower surface when the projection moves within the track (compare FIGS. 7A-7D of Charlton; paragraphs 0047-0049 of Charlton); and
an actuator (the cam 328 and the firing mechanism 330 of Charlton) operably coupled to the skin-piercing assembly and movable relative to the housing, wherein-
the actuator is movable to a first position to drive the lower surface of the casing at least partially through the opening in the base and into contact with the skin (the cam 328 moves to drive the element E through the element C in the below annotated FIG. 7B of Charlton so as to go into the position in FIGS. 7B and 7C of Charlton; paragraphs 0047-0049 of Charlton); and
the actuator is movable to a second position to permit the blade to move along a path through the skin and relative to the lower surface of the casing (the cam 328 and the firing mechanism 330 are moved to eject the blade 322b into the skin relative to the element E in the below annotated FIG. 7B of Charlton; paragraphs 0047-0049 of Charlton).
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Annotated FIG. 7B of Charlton
With respect to claim 29, Charlton teaches that at least a portion of the lower surface of the casing has a curved shape (the element E in the above annotated FIG. 7B of Charlton is cylindrical which means it has a curved shape; paragraphs 0037- 0041 of Charlton).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 35-36 and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2005/0125018 (Galloway)(previously cited), in view of U.S. Patent No. 5,314,441 (Cusack)(previously cited).
Galloway teaches a carriage 58 of Galloway pivotably coupled to the blade 38 via a pivot point 108 inserted into a retaining hole 78 of the blade (paragraph 0059 of Galloway). The cam 64 guides the outward movement of the blade 38 from the slot 36 and from the pre-actuated position shown in FIG. 3 (paragraph 0058 of Galloway). The cam 64 causes a horizontal movement of the blade 38 after the outward movement by slidably contacting a surface 104 of the cam 64 against the bottom surface of the guide member 15 of the casing 12 (paragraph 0058 and FIG. 4 of Galloway). The cam 64 also guides an inward movement of the blade 38 toward the slot 36 to the post-actuated position of FIG. 5 (paragraph 0058 of Galloway). The cam 64 typically has a curved shape rotatable around the pivot pin 108 attached to the blade 38 (paragraph 0058 of Galloway). The motions shown in FIGS. 3-5 of Galloway indicate a specific path for the cam 64 and the blade 38, and by extension the pivot pin 108, during operation. Cusack teaches a pin 112 of a pivotable member 92 traveling within a guide channel 68 so as to focus the member’s path (FIGS. 3A-3B and 7A-7C and col. 8, line 52 to col. 10, line 20 of Cusack). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a guide channel in the casing 12 of Galloway into which the pivot point 108 is extended such that the pivot point 108 follows the path of the guide channel since it better controls the intended path of the cam 64 and the blade 38.
With respect to claim 35, the combination teaches or suggests a skin-piercing assembly configured to be positioned at least partially in a device (the cover 16 of Galloway) for withdrawing bodily fluid from a subject, the skin-piercing assembly comprising:
a casing (the casing 12 of Galloway) including a trigger portion (the portion A of the casing outside the triangle B in the below annotated Figure of the casing 12 of Galloway) and a blade holder portion (the portion of the casing inside the triangle B in the below annotated Figure of the casing 12 of Galloway), wherein the trigger portion includes a first end portion fixedly coupled to the blade holder portion (the portions D of the casing at the sides of the triangle B in the below annotated Figure of the casing 12 of Galloway) and a second end portion (the guide member 15 of Galloway) spaced apart from the blade holder portion, wherein the second end portion of the trigger portion includes a first retaining feature (the guide member 15 of Galloway), wherein the blade holder portion includes a lower surface (the bottom surface 14 of Galloway), and wherein the blade holder portion defines a track (the cam guide channel of Cusack) extending at least partially therethrough (the portion of the casing inside the triangle B in the below annotated Figure of the casing 12 of Galloway includes the cam guide channel suggested by Cusack);
a drive member (the carriage 58 of Galloway) having a projection (the pivot point 108 of Galloway) constrained to move within the track (the cam guide channel suggested by Cusack) such that the drive member is pivotably coupled to the blade holder portion of the casing pivotably coupled to the blade holder portion of the casing (the portion of the casing inside the triangle B in the below annotated Figure of the casing 12 of Galloway), wherein the drive member includes a second retaining feature (the cam 64 of Galloway);
a blade (the razor blade 38 of Galloway) carried by the drive member; and
a biasing member (the leaf spring 45 of Galloway) operably coupled between the drive member and the casing, wherein-
in a pre-deployed position, the second retaining feature is configured to engage the first retaining feature to maintain the biasing member in a loaded configuration (FIG. 3 of Galloway; paragraphs 0050-0054 of Galloway); and
in a deployed position, the second retaining feature is configured to disengage the first retaining feature to permit the biasing member to pivot the blade at least partially past the lower surface of the blade holder portion (FIG. 4 of Galloway; paragraphs 0050-0054 of Galloway).
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With respect to claim 36, the combination teaches or suggests that the trigger portion (the portion A of the casing outside the triangle B in the above annotated Figure of the casing 12 of Galloway) and the blade holder portion (the portion of the casing inside the triangle B in the above annotated Figure of the casing 12 of Galloway) are integrally formed.
With respect to claim 38, the combination teaches or suggests that the casing is movable along a longitudinal axis from the pre-deployed position to the deployed position (see the movement of the casing 12 of Galloway relative to the cover 16 of Galloway in FIGS. 3-5 of Galloway).
With respect to claim 39, the combination teaches or suggests that at least a portion of the lower surface of the casing has a curved shape (the portions E of the casing in the above annotated Figure of the casing 12 of Galloway).
Claims 35-36 and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2013/0172698 (Reynolds)(previously cited), in view of U.S. Patent Application Publication No. 2009/0036915 (Karbowniczek)(previously cited), and further in view of U.S. Patent No. 5,314,441 (Cusack)(previously cited).
Reynolds teaches a skin-piercing assembly comprising a needle 304 carried by a hub 820. Karbowniczek teaches a blade edge is a suitable substitute for a needle (paragraph 0098 of Karbowniczek). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a blade edge in place of the needle of Reynolds since it is a simple substitution of one known element for another to obtain predictable results.
Reynolds teaches the hub 820 pivotably coupled to the cartridge cell 802 via a pivot point (paragraphs 0102-0104 and FIGS. 8A-8C of Reynolds). The hub 820 guides the outward movement of the blade to the aperture 814 (paragraphs 0102-0104 and FIGS. 8A-8C of Reynolds). Cusack teaches a pin 112 of a pivotable member 92 traveling within a guide channel 68 so as to focus the member’s path (FIGS. 3A-3B and 7A-7C and col. 8, line 52 to col. 10, line 20 of Cusack). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a guide channel in the cartridge cell 802 of Reynolds and a pin in the hub 820 designed to travel along the guide channel so that since it better controls the intended path of the hub 820.
With respect to claim 35, the combination teaches or suggests a skin-piercing assembly configured to be positioned at least partially in a device for withdrawing bodily fluid from a subject, the skin-piercing assembly comprising:
a casing including a trigger portion (the element A in the below annotated FIG. 8A of Reynolds) and a blade holder portion (the element B in the below annotated FIG. 8A of Reynolds), wherein the trigger portion includes a first end portion (the element C in the below annotated FIG. 8A of Reynolds) fixedly coupled to the blade holder portion and a second end portion (the element D in the below annotated FIG. 8A of Reynolds) spaced apart from the blade holder portion, wherein the second end portion of the trigger portion includes a first retaining feature (the retaining feature at the element D in the below annotated FIG. 8A of Reynolds), wherein the blade holder portion includes a lower surface (the element E in the below annotated FIG. 8A of Reynolds), and wherein the blade holder portion defines a track (the guide channel suggested by Cusack in the cartridge cell 802 of Reynolds) extending at least partially therethrough;
a drive member (the hub 820 of Reynolds) having a projection (the pin suggested by Cusack in the hub 820) constrained to move within the track (the guide channel suggested by Cusack in the cartridge cell 802 of Reynolds) such that the drive member is pivotably coupled to the blade holder portion of the casing, wherein the drive member includes a second retaining feature (the latch 818 of Reynolds);
a blade (the blade edge of Karbowniczek; paragraph 0098 of Karbowniczek) carried by the drive member (the hub 820 of Reynolds); and
a biasing member (the torsion spring of Reynolds; FIGS. 8A-8C of Reynolds) operably coupled between the drive member and the casing, wherein-
in a pre-deployed position, the second retaining feature is configured to engage the first retaining feature to maintain the biasing member in a loaded configuration (FIGS. 8A-8B of Reynolds); and
in a deployed position, the second retaining feature is configured to disengage the first retaining feature to permit the biasing member to pivot the blade at least partially past the lower surface of the blade holder portion (paragraph 0102 of Reynolds).
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Annotated FIG. 8A of Reynolds
With respect to claim 36, the combination teaches or suggests that the trigger portion and the blade holder portion are integrally formed (the elements A and B in the above annotated FIG. 8A of Charlton are integrally formed).
With respect to claim 39, the combination teaches or suggests that at least a portion of the lower surface of the casing has a curved shape (the element E in the above annotated FIG. 8A of Charlton has a rounded corner).
With respect to claim 40, the combination teaches or suggests that the biasing member is a torsion spring (the torsion spring of Reynolds; FIGS. 8A-8C of Reynolds).
Allowable Subject Matter
Claims 22, 24, and 27 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, 23, and 25-26 would be allowable if a terminal disclaimer is filed to overcome the double patenting rejections.
Claim 37 is allowed.
The following is an examiner’s statement of reasons for allowance.
With respect to claim 21, this claim is allowable for the reasons provided in the Office Action mailed on 2/25/2026.
Claims 22-27 are allowable over the prior art by virtue of their dependence from claim 21.
With respect to claim 37, this claim is allowable for the reasons provided in the Office Action mailed on 2/25/2026.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
The Applicant’s arguments filed 5/1/2026 have been fully considered.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 5/1/2026, the claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been withdrawn.
Double patenting rejections
The Applicant asserts:
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This non-argument is not persuasive. The Examiner cannot find a reason to withdraw the double patenting rejections. Therefore, the double patenting rejections of claims 21, 23, and 25-26 are maintained.
With respect to the double patenting rejection of claims 28-29, there are new grounds of rejection that were necessitated by the claim amendments filed on 5/1/2026.
Prior art rejection based on Charlton
The Applicant asserts:
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This argument is not persuasive. In particular, there are new grounds of rejections based on new interpretations of Charlton that were necessitated by the claim amendments filed on 5/1/2026. Charlton teaches the claimed track and projection constrained to move within the track in the form of the elements F and G in the above annotated FIG. 3B of Charlton, the elements F and G in the above annotated FIG. 5B of Charlton, and the elements F and G in the above annotated FIG. 7B of Charlton.
Prior art rejection based on Galloway
The Applicant asserts:
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This argument is not persuasive. FIG. 3 of Galloway clearly shows that the second retaining feature (the cam 64 of Galloway) is engaged with the first retaining feature (the guide member 15 of Galloway) in the pre-deployed position as indicated in the below figure.
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Blow Up FIG. of FIG. 3 of Galloway
The arguments related to Galloway not disclosing the claimed track are rendered moot because there are new grounds of claim rejections that were necessitated by the claim amendments filed on 5/1/2026.
Prior art rejections based on Reynolds and Karbowniczek
The arguments related to the rejection of Reynolds and Karbowniczek are rendered moot because there are new grounds of claim rejections that were necessitated by the claim amendments filed on 5/1/2026.
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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