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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/27/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 2 is objected to because of the following informalities: the phrase “for accepting a blood sample” in line 2 should be amended to read –configured for accepting a blood sample--. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: the phrase “for pricking skin” in line 3 should be amended to read –configured for pricking skin--. Appropriate correction is required.
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.
Claim(s) 2-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roe et al (US 2011/0178435).
As to claim 2, Roe teaches a strip-lancet apparatus (integrated lancing test strip or device 20, abstract, par.47, fig.1-6 and 15-18) comprising:
a first layer comprising a testing strip for accepting a blood sample (test strip layer 26 for acquiring a body fluid from the incision, par.47, fig.1-6); and
a second layer comprising a lancing needle for pricking skin at a measurement site (lancet layer 30 forming an incision 136 in the tissue 134, wherein lancet 30 is layered adhered to test strip layer 26, par.48 and par.53, fig.1-6 and fig.17).
As to claim 3, Roe teaches a strip-lancet apparatus, wherein the first layer is configured to move relative to the second layer (the test strip 20 contacts the body part 134, the frictional forces that caused the test strip 26 to move with the holder 90 are unable to move the test strip 26 any further so that the test strip 26 rests against the tissue 134. Although the test strip 26 stops moving, the lancet 30 continues to move because of the engagement of the lancet 30 with the cam arm 94 of the still moving holder 90. Consequently, upon contacting the tissue 134, the test strip 26 is pushed back, and the tip 38 of the lancet 30 is exposed such that the tip 38 penetrates the tissue 134, test strip 26 does not contact the skin during lancing par.66) (the Examiner respectfully notes that test strip 26 moves relative to lancet 30, and lancet 30 moves relative to lancet strip 26, as best seen in fig,15-18).
As to claim 4, Roe teaches a strip-lancet apparatus, wherein in a first configuration the lancing needle is exposed to a user (the configuration in fig.17, wherein lancet 30 continues to move because of the engagement of the lancet 30 with the cam arm 94 of the still moving holder 90 and the tip 38 of the lancet 30 is exposed such that the tip 38 penetrates the tissue 134, par.66), and wherein in a second configuration the lancing needle is isolated from the user (the configuration in fig.15, 16 and 18, wherein lancet 30 is retracted away from the user’s skin, the firing mechanism 63 retracts the holder 90, which in turn retracts the lancet 30 as well as the rest of the integrated lancing test strip 20 to its initial position, par.66).
As to claim 5, Roe teaches a strip-lancet apparatus, wherein to transition from the first configuration to the second configuration, the first layer is shifted relative to the second layer (the test strip 26 stops moving, the lancet 30 continues to move because of the engagement of the lancet 30, upon contacting the tissue 134, the test strip 26 is pushed back, and the tip 38 of the lancet 30 is exposed such that the tip 38 penetrates the tissue 134,par.66, when lancet 30 is exposed to prick the user’s skin/first configuration, the test strip layer 26 is offset/shifted relative to lancet 30, as best seen in fig.17, par.66-67).
As to claim 6, Roe teaches a strip-lancet apparatus, wherein the strip-lancet apparatus transitions from the second configuration to the first configuration responsive to force applied on the first layer by a launching mechanism (firing button 76 of the firing mechanism 63 to initiate lancing, par.57 and par.66-67, fig.12 and 15-18).
As to claim 7, Roe teaches a strip-lancet apparatus, wherein the strip-lancet apparatus transitions from the first configuration to the second configuration responsive to force applied on the first layer by a recoil mechanism (spring-powered type firing mechanism in firing mechanism 63, par.57, concentric return spring, par.62, and/or spring that rests against the connector block 102 of the firing mechanism 63 retracts the holder 90, which in turn retracts the lancet 30 as well as the rest of the integrated lancing test strip 20 to its initial position, par.66).
As to claim 8, Roe teaches a strip-lancet apparatus, wherein in a first configuration the first layer is offset from the second layer (the test strip 26 stops moving, the lancet 30 continues to move because of the engagement of the lancet 30, par.66, when lancet 30 is exposed to prick the user’s skin/first configuration, the test strip layer 26 is offset/not aligned with lancet 30, as best seen in fig.17), and wherein in a second configuration the first layer is aligned with the second layer (retracts the lancet 30 as well as the rest of the integrated lancing test strip 20 to its initial position, par.66, when lancet 30 is retracted away from the user’s skin/second configuration, lancet 30 is retracted with test strip layer 26 to initial position, wherein in initial position test strip 26 is aligned with lancet 30, as best seen in fig.18).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
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