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 Rejections - 35 USC § 112
Note that dependent claims will have the deficiencies of base and intervening claims.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 19 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention. Claim 19 requires
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“Written description issues may also arise if the knowledge and level of skill in the art would not have permitted the ordinary artisan to immediately envisage the claimed product arising from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not necessarily constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967) . . . . [underlining added]” See MPEP 2163(I)(A).
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 13-17 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:
a) the method of independent claim 13 requires
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Claim 13 seems to claim that the sensor used in detecting CSF in a sample has the aptamer sequence diffused in solution, that is, not attached to the sensing area (but could be). However, from Applicant’s specification and drawings such a sensor is understood be an intermediate product (sensor), rather than a finished sensor ready for use. Moreover, it does seem not possible that the second end of the sequence, which is functionalized to attach to a surface of the sensor, can be attached to a sensor surface during measurement of the sample:
referring to Applicant’s pre-grant application publication, US 20214/0255462 A1 (hereafter “Applicant’s PG-PUB”),
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Applicant is requested to clarify whether he actually intends for the method of claim 13 to use a sensor that is from Applicant’s speciation and drawings an unfinished sensor.
b) claim 13 requires
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The scope of the term “sensing area” is not clear as there is no sensing feature (such as electrodes) within or associated to the sensing area nor is even the aptamer sequence associated with it as it is in solution and only may be attached to a surface of the sensor, which is not necessarily the sensing area.
c) claim 13 requires
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The clause “wherein the first end is functionalized by a redox agent to be sensitive to one or more molecules found in CSF, . . . .” could be interpreted to mean that the aptamer sequence makes the redox agent (which presumably may be methylene blue or ferrocene, see claim 19) sensitive to one or more molecules found in CSF, which is contrary to Applicant’s specification and drawings (see Applicant’s Figure 1C, paragraph [0033], Figure 6, and paragraph [0031] reproduced above). Applicant is requested to clarify how the clause “wherein the first end is functionalized by a redox agent to be sensitive to one or more molecules found in CSF, . . . .” is to be understood.
d) claim 18 requires
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The clause “wherein the first end is functionalized by a redox agent to be sensitive to one or more molecules found in cerebrospinal fluid (CSF), . . . .” could be interpreted to mean that the aptamer sequence makes the redox agent (which presumably may be methylene blue or ferrocene, see claim 19) sensitive to one or more molecules found in CSF, which is contrary to Applicant’s specification and drawings (see Applicant’s Figure 1C, paragraph [0033], Figure 6, and paragraph [0031] reproduced above). Applicant is requested to clarify how the clause “wherein the first end is functionalized by a redox agent to be sensitive to one or more molecules found in CSF, . . . .” is to be understood.
Allowable Subject Matter
Claims 1-12 are allowed.
Claim 13 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 14-18 and 20 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
a) in claim 1 the combination of limitations requires the following underlined features
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a)(i) Drucker et al. US 2011/0119086 A1 (hereafter “Drucker”) discloses a portable device (Figure 1 in its entirety. See also paragraph [0035].) for detection of glucose in a body fluid (see the Abstract and paragraph [0009]), the device comprising:
b. a sensor (test strip 8 in Figure 1. See also paragraph [0079].), the sensor comprising a sensing area (this sensing area is implied by the following, “When the test strip 8 is inserted into the slot 6, preferably blood such as whole blood, plasma and/or serum, and alternatively another body fluid such as interstitial fluid, sweat, urine, tears, saliva, dermal fluid, spinal fluid, etc., is applied to the strip 8 and the module 2 measures the glucose level of the body fluid applied to the strip 8. [italicizing by the Examiner]” See paragraph [0079]. Also, “At the point of the in vitro test strip slot 6 at the top of FIG. 2 is a strip interface 12 including circuitry for connecting to an in vitro test strip for passing a current through blood applied to the strip. Glucose measurement circuitry 14 is shown connected to the strip interface 12 for measuring one or more parameters indicative of a blood glucose level of the blood applied to the strip.[italicizing by the Examiner] “ See paragraph [0081].); and
c. an electrochemical detection component (hand-held processing
device 4 in Figure 1. See also paragraphs [0078] and [0036], and Figure 2.) operatively coupled to the sensor (see Figure 1, noting the arrow below test strip 8, and see the first sentence of paragraph [0079]);
wherein, when a sample containing an amount of the one or more molecules found in the body fluid is disposed on the sensing area of the sensor, the sensor is configured to generate a detection signal to be transmitted to the electrochemical detection component (this “wherein” limitation is implied by the following, “At the point of the in vitro test strip slot 6 at the top of FIG. 2 is a strip interface 12 including circuitry for connecting to an in vitro test strip for passing a current through blood applied to the strip. Glucose measurement circuitry 14 is shown connected to the strip interface 12 for measuring one or more parameters indicative of a blood glucose level of the blood applied to the strip.[italicizing by the Examiner] “ See paragraph [0081].).
Drucker, though, does not disclose, as claimed, that the portable device is “for detection of cerebrospinal fluid (CSF) in a sample,” “a. a substrate (110);”1 “wherein the sensor (120) further comprises one or more aptamers disposed on a surface of the sensor (120), wherein the one or more aptamers are configured to selectively bind to one or more molecules found in CSF;” and “wherein, when a sample containing an amount of the one or more molecules found in CSF is disposed on the sensing area of the sensor (120), the sensor (120) is configured to generate a detection signal to be transmitted to the electrochemical detection component (130).”
As for the limitation “a. a substrate (110);” although Drucker does not specifically disclose a substrate and so also does not disclose that the sensor (implied as disclosed above) is disposed on the substrate, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide these features because (1) Drucker implicitly discloses that the sensor is part of an electrochemical test strip (see Drucker paragraph [0133]), which typically have a sensor on a substrate, and, more importantly, (b) Drucker incorporates by reference many documents for detailed descriptions of contemplated embodiments (see Drucker paragraphs [0060]-[0077]). Most notably, for details about the test strip Drucker refers to U.S. Patent application Ser. No. 09/413,565 (see Drucker paragraph [0079]), which issued as U.S. patent no. 6,299,757 B1 (hereafter “Feldman”), and U.S. Patent application Ser. No. 09/434,026 (see Drucker paragraph [0133]), which issued as U.S. patent no. 6,616,819 B1 (hereafter “Liamos”). In the various test strips embodiments illustrated by the figures in Feldman and Liamos the test strip comprises a sensor (comprising electrodes) disposed on a substrate. See, for example, Feldman Figures 3-5, 18A-C,19A-C, 20A-C,21A-C, 22A-C, and 23A-C; and in Liamos see Figures 1-4,5A-C,6A-C7A-C, 8A-C, 9A-Cand 10A-C.
As for Applicant’s claim 1 limitation “wherein, when a sample containing an amount of the one or more molecules found in CSF is disposed on the sensing area of the sensor (120), the sensor (120) is configured to generate a detection signal to be transmitted to the electrochemical detection component (130)…”, It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have the portable device of Drucker as modified by Feldman and Liamos be configured to be able to perform this function because
Drucker clearly envisions that the device be used on any body fluid and, moreover, alludes to cerebrospinal fluid, if not implies it, by listing “spinal fluid” as a body fluid:
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; and
Feldman, which is one of the main documents Drucker refers to for detail about the sensor, discloses actually testing a sensor embodiment to measure glucose in artificial cerebrospinal fluid. See Feldman col. 54:9-16.
As for Applicant’s claim 1 preamble recitation “A portable device (100) for detection of cerebrospinal fluid (CSF) in a sample, [italicizing by the Examiner]” and the claim 1 limitation “wherein the sensor (120) further comprises one or more aptamers disposed on a surface of the sensor (120), wherein the one or more aptamers are configured to selectively bind to one or more molecules found in CSF; . . . . [italicizing by the Examiner]”, neither Drucker nor Feldman, nor Liamos disclose detection of cerebrospinal fluid (CSF) in a sample, although they do disclose detection of an analyte (glucose) in CSF (see above). Xian et al., “Digital biosensor for human cerebrospinal fluid detection with single-use sensing strips,” J. Vac. Sci. Technol. B 40, 023202 (2022)2 (hereafter “Xian”) and Carey IV et al., “Fast Cerebrospinal Fluid Detection Using Inexpensive Modular Packaging with Disposable Testing Strips,” Journal of The Electrochemical Society, 166 (8) B708-B712 (2019) (hereafter “Carey”) each disclose a device that uses an electrochemical test strip for detection of CSF in a sample. See in Xian the title, Abstract, and Figure 1; and in Carey see the title, abstract, and Figure 1. Xian, in fact, adapted a disposable glucose test strip. See in Xian the first sentence of II. Material And Method, which is on page 023202-2, and Figure 1(b). Even if it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to adapt as taught by Xian or Carey the device of portable device of Drucker as modified by Feldman and Liamos to be able to detect CSF in a sample, because of the medical importance of such detection (see the first of paragraph of I. Introduction in Xian and the first paragraph of Carey, after the abstract ) the sensor of the resulting device would not comprise one or more aptamers disposed on a surface of the sensor (120), wherein the one or more aptamers are configured to selectively bind to one or more molecules found in CSF. Instead, the sensor would comprise beta-2-transferrin antibody. See in Xian the Abstract, the second paragraph of I. Introduction, and the first sentence of II. Material And Method; in Carey see the abstract, and the first paragraph of Experimental.
b) claims 2-12 depend directly or indirectly from allowable claim 1.
c) in independent claim 13 the combination of limitations requires the following underlined features
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The discussion above regarding the allowability of claim 1 applies to claim 13 also.
d) claims 2-12 depend directly or indirectly from allowable claim 1.
e) in independent claim 18 the combination of limitations requires the following underlined feature
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e)(i) Deng et al., ‘An electrochemical aptasensor for amyloid-β oligomer based on double-stranded DNA as “conductive spring” ‘ , Microchimica Acta (2020) 187: 239 (hereafter “Deng”) discloses an aptamer otherwise the same as that claimed except for not having a required sequence. See in Deng the Abstract, the first paragraph of Introduction, Figure 1, and Table 1.
f) claim 20 depends from allowable claim 18.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER STEPHAN NOGUEROLA whose telephone number is (571)272-1343. The examiner can normally be reached on Monday - Friday 9:00AM-5:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached on 571 272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER S NOGUEROLA/Primary Examiner, Art Unit 1795
1 “Reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims. The reference characters, however, should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. Generally, the presence or absence of such reference characters does not affect the scope of a claim. [italicizing by the Examiner]” See MPEP 608.01(m).
2 Published online: 1 February 2022
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