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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/18/2025 has been entered.
Response to Arguments
Applicant’s arguments, see pages 4-9, filed 11/18/2025, with respect to all previous rejections of the claims have been fully considered and are persuasive. All previous rejections have been withdrawn due to the cancellation of all previous claims.
Applicant’s arguments, see page 7, filed 11/18/2025, with respect to the rejection(s) of the claims under 35 U.S.C. § 103 have been fully considered and are persuasive, as Cunningham does not teach wherein the receptacle comprises a volume of at least 1 mL and is configured to remove at least 1 mL of blood from a blood draw location. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Cunningham, Burkholz, and Fujiwara.
Applicant's arguments filed 11/18/2025 have been fully considered but they are not persuasive.
Regarding the use of Fujiwara in the rejection of the claims under 35 U.S.C. § 103, the applicant has argued “The Office appears to have misconstrued the disclosure of Fujiwara and this may be due to the phrases "lancet" and "blood collection needle" being translated to English from Japanese (See Final Office Action at page 8). While Fujiwara allegedly discloses a lancet, there is no teaching or suggestion that the lancet of Fujiwara comprises multiple lancets configured to puncture the skin. While Fujiwara allegedly discloses a "blood collection needle", there is no teaching or suggestion that the blood collection needle of Fujiwara is hollow, and that the blood collection needle is a receptacle configured to store blood. Accordingly, Fujiwara fails to teach or suggest a blood sampling device comprising a receptacle comprising a lancet device disposed within and movable within the receptacle, where the receptacle comprises a volume of at least 1 mL and is configured to remove at least 1 ml of blood from a blood draw location”. However, Fujiwara was not relied upon to teach a lancet comprising multiple lancets in the previous Office Action, and it is the blood sensor 24, not the blood collection needle 26, that is considered the receptacle due to blood sensor 24 comprising storing part 49 (See Figs. 9A-9E and [0157] of Fujiwara). Blood sensor 24 is integrated with modular and removable blood sampling cartridge 22 (See [0079] of Fujiwara). Therefore, Fujiwara at least provides a teaching, suggestion, and motivation for making receptacle modular and removable from the housing as taught by feature (v) of pending Claim 41. Finally, it is Cunningham that is relied upon to teach a lancet device disposed within and movable within the receptacle, not Fujiwara.
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.
Claim 45 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 45 recites “wherein each of the multiple lancets have a gauge of 17 or 18”. This limitation is unclear because exact range of diameters claimed is unknown. The gauge system is a relative measure and the exact diameters of needle gauges can vary by manufacturer. For the purposes of substantive examination, any reference that recites a 17 gauge or 18 gauge needle, regardless of manufacturer, will be construed to read on this claim limitation.
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.
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 41 and 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over Cunningham et al (US 6063039 A, cited in applicant’s IDS, hereinafter Cunningham) in view of Burkholz et al (US 20140309551 A1, hereinafter Burkholz) and Fujiwara et al (US 20090281455 A1, hereinafter Fujiwara)
Regarding Claim 41, Cunningham discloses a blood sampling device (Element 10, Fig. 1) configured to draw and store blood for analysis (6:20-33), the device comprising:
a receptacle comprising a first end comprising an opening (“The end of the nosepiece 30 that contacts the skin is equipped with a seal 32…The seal 32 surrounds an opening 33 in the nosepiece 30”, 8:62-9:6), a second end that is sealed (See Fig. 1; in order for the vacuum to provide sufficient suction as taught in Cunningham(8:62-9:3), the end of receptacle 33 opposite opening 33 must be airtight and support reduced pressure), and a lancet device disposed within and movable within the receptacle (“After an appropriate period of time, which is typically pre-set by the programmer of the electronics, the lancing assembly 16 is triggered, thereby causing the lancet 36 to penetrate the skin that has risen up to the opening 33 and that is engorged with blood”, 9:21-25);
a vacuum device (Element 14, Fig. 1); and
a housing (Element 12, Fig. 1) operably connected to the receptacle and the vacuum device (See Fig. 1);
wherein
(i) the opening is configured to engage an area of skin at a blood draw location (“Referring now to FIGS. 1, 2 and 3, the nosepiece 30 of the lancing assembly 16 is applied to the surface of the skin”, 8:59-62),
(ii) the lancet device comprises multiple lancets configured to puncture the skin at the blood draw location (“Piercing devices suitable for this invention include, but are not limited to, mechanical lancing assemblies…Mechanical lancing assemblies are well-known in the art. These assemblies comprise include standard steel lancets, serrated devices, and multiple tip devices. The lancets can be made from metal or plastic. Multiple tip devices provide redundancy, which can reduce the number of failures and increase the volume of blood extracted”, 4:46-57; under broadest reasonable interpretation, each tip can be considered its own lancet), and
(iv) the vacuum device is configured to reduce a pressure within the receptacle (“The vacuum pump 14 is preferably capable of providing a pressure of down to about -14.7 psig, and is more preferably operated at from about -3.0 psig to about -10.0 psig.”, 7:11-14) prior to (“The period of vacuum application prior to forming the opening in the skin, i.e., for increasing the availability of blood to the application site, preferably ranges up to about 5 minutes, preferably from about 1 to about 15 seconds.”, 7:16-20), and during removal of the at least 1 ml of blood (“The period of vacuum application subsequent to forming the opening in the skin, i.e., for aiding in the extraction of blood from the unobstructed opening, preferably ranges up to about 5 minutes, preferably from about 1 to about 60 seconds”, 7:20-24).
Modified Cunningham discloses the claimed invention except for expressly disclosing the receptacle comprising a volume of at least 1 mL;
(iii) the receptacle is configured to remove at least 1 ml of blood from the blood draw location, and
(v) the receptacle is modular and removable from the housing.
However, Burkholz, which also discloses a blood sampling device (Element 10, Fig. 1) configured to draw and store blood for analysis (“The blood sampling device 110 is configured as part of a larger extravascular system 10, and is configured to receive the fluid sample from a separate vascular access device 12”, [0033]; this means the extravascular system 10, which can be thought of as one combined device, both draws and stores blood for analysis) teaches the receptacle comprising a volume of at least 1 mL (“The reservoir 118 is enclosed within the housing body 114 and includes an internal volume sufficient to contain enough blood for use in a diagnostic test, for example, an internal volume of between about 0.1 mL and about 10 mL”, [0038]; this range overlaps the required range of at least 1 mL); and
(iii) the receptacle is configured to remove at least 1 ml of blood from the blood draw location (“Because different blood tests require different quantities of blood, in some embodiments, the reservoir 118 is sized to retain a quantity of blood needed for a specific test”, [0038]; an interval volume of 0.1 mL to 10 mL also means the receptacle is configured to remove at least 1 mL from the blood draw location at vascular access device 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the receptacle of Cunningham to comprise a volume of at least 1 mL, wherein the receptacle is configured to remove at least 1 ml of blood from the blood draw location, because this can account for blood tests that need at least 1 mL of blood (“Because different blood tests require different quantities of blood, in some embodiments, the reservoir 118 is sized to retain a quantity of blood needed for a specific test”, [0038] of Burkholz).
Fujiwara teaches wherein (v) the receptacle (“Blood sensor 24 has: a base plate; a storing part provided on the base plate…”, [0112]; “The blood flowing out from the skin punctured with blood collection needle 26 is brought to storing part 49.”, [0157]) is modular and removable from the housing (“a blood test apparatus wherein a holder, a lancet, a blood collection needle and a blood sensor are united together as a blood sampling cartridge that is detachably mounted to the apparatus body”, Abstract; “blood test apparatus 20 has blood sampling cartridge 22 that is integrated with built-in lancet 25 with blood collection needle 26 attached and built-in blood sensor 24, and blood sampling cartridge 22 can be attached to and removed from attaching part 21a”, [0079]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Cunningham such that the receptacle is modular and removable from the housing, as suggested by Fujiwara, for the advantage of replacing these components in a simple manner, as taught by Fujiwara ([0079]).
Regarding Claim 47, modified Cunningham discloses the device of claim 41. Modified Cunningham discloses the claimed invention except for expressly disclosing the device wherein the receptacle comprises a volume of at least 1.5 mL and is configured to remove at least 1.5 ml of blood from the blood draw location. However, Burkholz teaches wherein the receptacle comprises a volume of at least 1.5 mL (“The reservoir 118 is enclosed within the housing body 114 and includes an internal volume sufficient to contain enough blood for use in a diagnostic test, for example, an internal volume of between about 0.1 mL and about 10 mL”, [0038]; this range overlaps the required range of at least 1.5 mL) and is configured to remove at least 1.5 ml of blood from the blood draw location (“Because different blood tests require different quantities of blood, in some embodiments, the reservoir 118 is sized to retain a quantity of blood needed for a specific test”, [0038]; an interval volume of 0.1 mL to 10 mL also means the receptacle is configured to remove at least 1.5 mL from the blood draw location at vascular access device 12). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to further modify Cunningham such that the receptacle comprises a volume of at least 1.5 mL and is configured to remove at least 1.5 ml of blood from the blood draw location, because this can account for blood tests that need at least 1.5 mL of blood (“Because different blood tests require different quantities of blood, in some embodiments, the reservoir 118 is sized to retain a quantity of blood needed for a specific test”, [0038] of Burkholz). Furthermore, it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP 2144.05.II.
Regarding Claim 48, modified Cunningham discloses the device of claim 41. Modified Cunningham discloses the claimed invention except for expressly disclosing the device wherein the receptacle comprises a volume of at least 2.0 mL and is configured to remove at least 2.0 ml of blood from the blood draw location. However, Burkholz teaches wherein the receptacle comprises a volume of at least 2.0 mL (“The reservoir 118 is enclosed within the housing body 114 and includes an internal volume sufficient to contain enough blood for use in a diagnostic test, for example, an internal volume of between about 0.1 mL and about 10 mL”, [0038]; this range overlaps the required range of at least 2.0 mL) and is configured to remove at least 2.0 ml of blood from the blood draw location (“Because different blood tests require different quantities of blood, in some embodiments, the reservoir 118 is sized to retain a quantity of blood needed for a specific test”, [0038]; an interval volume of 0.1 mL to 10 mL also means the receptacle is configured to remove at least 2.0 mL from the blood draw location at vascular access device 12). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to further modify Cunningham such that the receptacle comprises a volume of at least 2.0 mL and is configured to remove at least 2.0 ml of blood from the blood draw location, because this can account for blood tests that need at least 2.0 mL of blood (“Because different blood tests require different quantities of blood, in some embodiments, the reservoir 118 is sized to retain a quantity of blood needed for a specific test”, [0038] of Burkholz). Furthermore, it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP 2144.05.II.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Cunningham in view of Burkholz and Fujiwara, and further in view of Li et al (US 20130289265 A1, hereinafter Li).
Regarding Claim 42, modified Cunningham discloses the device of claim 41. Modified Cunningham discloses the claimed invention except for expressly disclosing wherein the receptacle further comprises a substrate configured to stabilize nucleic acids. However, Li teaches a substrate configured to stabilize nucleic acids (“The present disclosure generally relates to solid matrices for the extraction, stabilization, and storage of nucleic acids, particularly RNA, in a dry format under ambient conditions for a prolonged period of time”, Abstract; “Biological samples may be obtained by an individual undergoing a self-diagnostic test (e.g., blood glucose monitoring)”, [0018]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the stabilization matrix of Li to the receptacle of modified Cunningham such that the receptacle further comprises a substrate configured to stabilize nucleic acids, because nucleic acids can be a bio-marker of interest in medical diagnostics.
Claim 43, 46, and 50-51 are rejected under 35 U.S.C. 103 as being unpatentable Cunningham in view of Burkholz and Fujiwara, and further in view of Bernstein et al (US 20120271125 A1, cited in applicant’s IDS, hereinafter Bernstein).
Regarding Claim 43, modified Cunningham discloses the device of claim 41. Modified Cunningham discloses the claimed invention except for expressly disclosing wherein the receptacle further comprises a substrate configured to absorb blood. However, Bernstein, which also discloses a device configured to draw and store blood for analysis (“the device contains a vacuum chamber that is also used as a storage chamber to receive blood, interstitial fluid, or other fluid withdrawn from the skin and/or beneath the skin of the subject into the device”, [0139]), teaches the receptacle further including a blood storage substrate configured to absorb blood from the punctured skin (“a storage chamber for receiving a fluid withdrawn from the subject via the fluid transporter. In some instances, the storage chamber further comprises an agent able to stabilize a protein in the fluid withdrawn from the skin. In certain embodiments, the storage chamber further comprises an agent able to stabilize a nucleic acid in the fluid withdrawn from the skin”, [0032]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the blood storage substrate of Bernstein to the receptacle of Cunningham, for the additional benefit of stabilizing proteins and nucleic acids from stored blood, as taught by Bernstein ([0032]).
Regarding Claim 46, modified Cunningham discloses the device of claim 41. Modified Cunningham discloses the claimed invention except for expressly disclosing the device wherein at least a portion of the lancet device is coated with an anticoagulant. However, Bernstein teaches wherein at least a portion of the lancet device is coated with an anticoagulant (“In one set of embodiments, the needles (or microneedles) may be coated. For example, the needles may be coated with a substance that is delivered when the needles are inserted into the skin. For instance, the coating may comprise…an anticoagulant…”, [0116]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add an anticoagulant coating to the lancet device of modified Cunningham, to assist with the flow of blood from the skin of the subject, as taught by Bernstein ([0116]).
Regarding Claim 50, modified Cunningham discloses the device of claim 41. Modified Cunningham discloses the claimed invention except for expressly disclosing the device further comprising an analog indicator and/or an electronic sensor configured to convey information of a quantity of blood in the receptacle. However, Bernstein teaches an analog indicator and/or an electronic sensor configured to convey information of a quantity of blood in the receptacle (“In some embodiments, the flow of blood (or other fluid, e.g., interstitial fluid) into the storage chamber may be controlled using a flow controller. The flow controller may be manually and/or automatically controlled to control the flow of blood. The flow controller may activate or deactivate when a certain amount or volume of fluid has entered the storage chamber in certain cases. For instance, the flow controller may stop blood flow after a predetermined amount or volume of blood has entered the storage chamber”, [0143]; therefore, the flow controller stopping blood flow conveys information that there is a predetermined volume of blood in the receptacle). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the electronic sensor of Bernstein to the receptacle of modified Cunningham, for the advantage of sampling only a desired amount of blood.
Regarding Claim 51, modified Cunningham discloses the device of claim 41. Modified Cunningham discloses the claimed invention except for expressly disclosing the device further comprising a button configured to initiate action of the vacuum device to reduce pressure in the receptacle. However, Bernstein teaches a button configured to initiate action of the vacuum device to reduce pressure in the receptacle (“One category of self-contained vacuum or pressure regulators of the invention includes self-contained assisted regulators. These are regulators that, upon actuation (e.g., the push of a button, or automatic actuation upon, e.g., removal from a package or urging a device against the skin), a vacuum or pressure associated with the device is formed where the force that pressurizes or evacuates a chamber is not the same as the actuation force”, [0133]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the button of Bernstein to the device of Cunningham, to allow for greater user control of when the vacuum initiates.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable Cunningham in view of Burkholz and Fujiwara, and further in view of De Vaughn (US 5662127 A, hereinafter De Vaughn).
Regarding Claim 44, modified Cunningham discloses the device of claim 41. Modified Cunningham discloses the claimed invention except for expressly disclosing wherein the vacuum device is removable from the housing. However, DeVaughn, which also discloses a blood sampling device (Element 20, Fig. 2) configured to draw and store blood for analysis (See Abstract), teaches wherein the vacuum device (Element 30, Fig. 2) is removable from the housing (See Fig. 2; “It will be appreciated that suction mechanism 30 may be provided by a mechanical vacuum pump or the like (not shown) removably coupled to connector 96”, 11:66-12:1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Cunningham with the removably coupled vacuum device of De Vaughn, because this would make the vacuum device reusable, as taught by DeVaughn (10:65-11:8).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Cunningham in view of Burkholz and Fujiwara, and further in view of Stone et al (US 20170340352 A1, hereinafter Stone).
Regarding Claim 45, modified Cunningham discloses the device of claim 41. Modified Cunningham discloses the claimed invention except for expressly disclosing the device wherein each of the multiple lancets have a gauge of 17 or 18. However, Stone, which also discloses a lancet device (Fig. 10), teaches wherein the lancet device includes a 17 gauge lancet or an 18 gauge lancet (“Five biopsy needle assembly designs were tested: 1) an 18 gauge lancet-tip mandrel/needle and complimentary cannula used with the Bard® Monopty® device…”, [0052]; see the rejection of this claim under 35 U.S.C. § 112(b) above). As both the multiple lancets of modified Cunningham and the 18 gauge lancet in Stone are both known devices, one of ordinary skill in the art could have combined known elements by known teaches, and the results of the substitution would have been predictable (a usable lancet device). All of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Cunningham in view of Burkholz and Fujiwara, and further in view of Somack et al (US 20030098271 A1, cited in applicant’s IDS, hereinafter Somack).
Regarding Claim 49, modified Cunningham discloses the device of claim 41. Modified Cunningham discloses the claimed invention except for expressly disclosing the device wherein the receptacle is configured to receive a cap that removably couples with the first end of the receptacle and is configured to prevent blood from escaping from the receptacle when the receptacle is removed from the housing. However, Somack teaches wherein the receptacle (Element 10, Fig. 1) is configured to receive a cap (Element 16, Fig. 1) that removably couples with the first end of the receptacle and is configured to prevent blood from escaping from the receptacle when the receptacle is removed from the housing (See Fig. 1; “A removable sealing end cap 16 is provided for attaching to the second end 21 of the tubular body 10 and sealing the second end opening 18”, [0067]). It would have been obvious to add the cap of Somack to the device of modified Cunningham, for the advantages of having a removable sealing system.
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Cunningham in view of Burkholz and Fujiwara, and further in view of Christensen (US 20140323915 A1, cited in applicant’s IDS, hereinafter Christensen).
Regarding Claim 52, modified Cunningham discloses the device of claim 41. Modified Cunningham discloses the claimed invention except for expressly disclosing the device further comprising an LED indicator device coupled with the housing, the LED indicator device configured to indicate a quantity of blood in the receptacle. However, Christensen teaches the device (Element 210, Fig. 10A) further comprising an LED indicator device coupled with the housing, the LED indicator device configured to indicate the quantity of blood in the receptacle (“the reusable module 210 can include a display monitor 218 supported by the reusable module housing 212 and configured to display the measured property. The display monitor 218 can be a LCD panel or LED or similar display device that can display the measured property and/or other relevant information”, [0054]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the LED indicator device of Christensen to the device of modified Cunningham, for the advantage of displaying information to the user.
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Cunningham in view of Burkholz and Fujiwara, and further in view of McCullough et al (US 20180036476 A1, hereinafter McCullough).
Regarding Claim 53, modified Cunningham discloses the device of claim 41. Modified Cunningham discloses the claimed invention except for expressly disclosing the device further comprising a pressure sensor configured to generate output signals that convey information related to a pressure within the receptacle, the pressure sensor being disposed within the receptacle; and a controller configured to, responsive to the pressure in the receptacle breaching a threshold level, cause the lancet device to puncture the skin at the blood draw location. However, McCullough teaches the device (Element 10-6, Fig. 11) further comprising a pressure sensor (Element 126, Fig. 11) configured to generate output signals that convey information related to a pressure within the receptacle (“In block 304, the vacuum pressure sensor monitors vacuum between the device and the body tissue of the patient”, [0222]), the pressure sensor being disposed within the receptacle (See Fig. 11; element 126 is within receptacle 12); and a controller (Element 17, Fig. 11) configured to, responsive to the pressure in the receptacle breaching a threshold level (“In block 306 a determination is made as to whether the vacuum pressure is at or above a predetermined vacuum pressure threshold”, [0222]), cause the lancet device to puncture the skin at the blood draw location (“If the vacuum pressure is determined to be at or above the predetermined vacuum pressure threshold, the device will automatically commence or allow manual activation of needle insertion”, [0222]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the pressure sensor and pressure sensor configuration of McCullough to the system of modified Cunningham for the advantage of determining whether there is proper attachment between the lancet injector and the skin before commencing needle injection, as taught by McCullough (Abstract, [0222]).
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Cunningham in view of Burkholz and Fujiwara, and further in view of Cavanaugh, II (US 8133211 B2, cited in applicant’s IDS, hereinafter Cavanaugh).
Regarding Claim 54, modified Cunningham discloses the device of claim 41. Modified Cunningham discloses the claimed invention except for expressly disclosing the device further comprising a comfort pad coupled with a first surface of the housing, the first surface of the housing facing the area of skin at the blood draw location while blood is removed. However, Cavanaugh teaches the device (Element 910, Fig. 13) further comprising a comfort pad (Element 970, Fig. 14) coupled with a first surface of the housing, the first surface of the housing facing the area of skin at the blood draw location (“A comfort layer 970, which has a first side 972 and a second, inward-facing side 974, may be coupled, e.g., by a heat bond 976 or any other technique, to the second side 936 of the flexible dressing bolster 932”, 11:34-38) while blood is removed (“The comfort layer 970 may be any material that helps prevent skin irritation and discomfort while allowing fluid transmission through the comfort layer 970”, 11:39-41). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a comfort pad to the system of device Cunningham for the advantage of preventing skin irritation and discomfort, as taught by Cavanaugh (11:39-40).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Davis et al (US 20110009717 A1), which discloses a receptacle comprising a volume of at least 1 mL ([0049]).
See Kowarski (US 3908657 A), which discloses a receptacle configured to remove at least 1 ml of blood from the blood draw location (4:7-11).
See Hayakawa et al (US 20140228709 A1), which discloses a receptacle comprising a volume of at least 1 mL ([0027])
See Boeker et al (US 20030199896 A1), which discloses a receptacle comprising a volume of at least 1 mL ([0049]) ([0163]).
See Faurie et al (US 20150351676 A1), which discloses a receptacle comprising a volume of at least 1 mL ([0037]).
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791