DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 112
3. 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.
4. Claims 15, 16, 17, 19, 20, 21, 27, 28, 29, as well as claim 30 based on its dependency to the former claims, 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.
5. Claim 15 recites the limitation "at least one of the electrodes" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 15 is dependent from Claim 1. Claim 1 recites “two or more electrodes”, therefore, it is unclear whether “at least one of the electrodes” recited in Claim 15 refers to an electrode of the two or more electrodes, or if this refers to another electrode. For examination purposes, Claim 15 will be interpreted as follows: “wherein at least one of the two or more electrodes”. Proper correction is required.
6. Claim 16 recites the limitation "each of the electrodes" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 16 is dependent from Claim 1. Claim 1 recites “two or more electrodes”, therefore, it is unclear whether “each of the electrodes” recited in Claim 16 refers to both electrodes of the two or more electrodes, or if this refers to another electrode. For examination purposes, Claim 16 will be interpreted as follows: “each of the two or more electrodes”. Proper correction is required.
7. Claim 17 recites the limitation "one electrode" in line 2 as well as “the other” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 17 is dependent from Claim 16 and Claim 1. Claim 1 recites “two or more electrodes”, therefore, it is unclear whether “one electrode” and “the other” recited in Claim 17 refers to the two or more electrodes, or if this refers to another electrode. For examination purposes, Claim 17 will be interpreted as follows: “one electrode of the two or more electrodes terminates more distally to the mounting portion than the other electrode of the two or more electrodes”. Proper correction is required.
8. Claim 19 recites the limitation "each electrode from each other electrode" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 19 is dependent from Claim 16 and Claim 1. Claim 1 recites “two or more electrodes”, therefore, it is unclear whether “each electrode from each other electrode” recited in Claim 19 refers to the two or more electrodes, or if this refers to another electrode. For examination purposes, Claim 19 will be interpreted as follows: “each electrode of the two or more electrodes from the other electrode of the two or more electrodes”. Proper correction is required.
9. Claim 20 recites the limitation "the electrodes" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 20 is dependent from Claim 16 and Claim 16 and Claim 1. Claim 1 recites “two or more electrodes”, therefore, it is unclear whether “the electrodes” recited in Claim 20 refers to the two or more electrodes, or if this refers to another electrode. For examination purposes, Claim 20 will be interpreted as follows: “wherein the two or more electrodes”. Proper correction is required.
10. Claim 21 recites the limitation "the electrode" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 21 is dependent from Claims 20, 16, 1. Claim 1 recites “two or more electrodes”, therefore, it is unclear whether “the electrode” recited in Claim 21 refers to one of the two or more electrodes, or if this refers to another electrode. Proper correction is required.
11. Claim 27 recites the limitation "each of the electrodes" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 27 is dependent from Claim 1. Claim 1 recites “two or more electrodes”, therefore, it is unclear whether “the electrodes” recited in Claim 27 refers the two or more electrodes, or if this refers to another electrode. For examination purposes, Claim 27 will be interpreted as follows: “each of the two or more electrodes”. Proper correction is required.
12. Claim 28 recites the limitation "the electrodes" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 28 is dependent from Claim 27 and Claim 1. Claim 1 recites “two or more electrodes”, therefore, it is unclear whether “the electrodes” recited in Claim 28 refers to the two or more electrodes, or if this refers to another electrode. For examination purposes, Claim 28 will be interpreted as follows: “hold the two or more electrodes”. Proper correction is required.
13. Claim 29 recites the limitation "at least one of the electrodes" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 29 is dependent from Claim 1. Claim 1 recites “two or more electrodes”, therefore, it is unclear whether “at least one of the electrodes” recited in Claim 29 refers to one of the two or more electrodes, or if this refers to another electrode. For examination purposes, Claim 29 will be interpreted as follows: “at least one of the two or more electrodes”. Proper correction is required.
Claim Rejections - 35 USC § 102
14. 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.
15. Claims 1-5, 15, 16, 27, 28, 108, 110, and 111 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levinson U.S. 2011/0125058 (herein referred to as “Levinson”).
16. Regarding Claim 1, Levinson teaches a method for producing an electrochemical aptamer-based sensor apparatus (para 0238, 0241), the method comprising assembling two or more electrodes (para 0130; 0211; Fig. 2C, ref num 505) of an electrochemical aptamer-based sensor (Fig. 2C, ref num 510) with an apparatus for contacting the two or more electrodes to the skin of a subject (para 0068-0069; para 0211, “the signal structure or generator may be integral with the device (e.g., integrally connected with a support structure for application to the skin of the subject, e.g., containing a fluid transporter such as one or more needles or microneedles)…”).
17. Regarding Claim 2, Levinson teaches at least one of the two or more electrodes is a working electrode configured to specifically detect an analyte (para 0068, “Upon determination of the fluid and/or an analyte present or suspected to be present within the fluid, a microprocessor or other controller may display on display 525 a suitable signal”; para 0072, “ The device, or a portion thereof, may then be processed to determine the fluid and/or an analyte within the fluid, alone or with an external apparatus. For example, fluid may be withdrawn from the device, and/or the device may contain sensors or agents able to determine the fluid and/or an analyte suspected of being contained in the fluid”; para 0205).
18. Regarding Claim 3, Levinson teaches at least two of the two or more electrodes is each a working electrode configured to specifically detect an analyte (para 0130 describes the electrodes being an anode and a cathode, which indicates they are both working electrodes; para 0205).
19. Regarding Claim 4, Levinson teaches each of the two or more working electrodes comprises a different aptamer species, each of the different aptamer species configured to specifically detect different analytes or the same analyte (para 0225, 0238),
20. Regarding Claim 5, Levinson teaches the two of more electrodes are fixed in a mutual spaced relationship (para 0101-0102; Figs. 11-13).
21. Regarding Claim 15, Levinson teaches at least one of the electrodes is a wire, a needle, or a microneedle (Fig. 2C, ref num 505 are needles).
22. Regarding Claim 16, Levinson teaches the assembling comprises mounting each of the electrodes on a mounting portion (Fig. 2C, ref num 2C has ref nums 5085 mounted thereon).
23. Regarding Claim 27, Levinson teaches each of the electrodes is obtained by removed an electrode from a group of electrodes of the same analyte specificity, dimension, material, or function (para 0104-0105).
24. Regarding Claim 28, Levinson teaches the group of electrodes is held in a holder configured to releasably hold the electrodes (para 0095).
25. Regarding Claim 108, Levinson teaches a system for producing an electrochemical aptamer-based sensor apparatus (Fig 2C; para 0238, 0241), the system comprising a library of two or more working electrodes of an electrochemical aptamer-based sensor apparatus (para 0130 describes the electrodes being an anode and a cathode, which indicates they are both working electrodes; para 0205; Fig. 2C, ref num 505), a mounting portion (see Fig. 2C) configured to mount the two or more working electrodes in a fixed mutual spaced relationship (para 0101-0102; Figs. 11-13), wherein each working electrode comprises a different aptamer species (para 0225, 0238).
26. Regarding Claim 110, Levinson fails to teach the electrode library comprises working electrodes comprising at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 different aptamer species (para 0110).
27. Regarding Claim 111, Levinson teaches the working electrodes comprising the same aptamer species are grouped into a discrete holder, or grouped into a region of a single holder (see Fig. 2D, each same species in discrete holders, ref nums 152).
28. Claims 1, 25, 29, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cho U.S. 2016/0278672 (herein referred to as “Cho”).
29. Regarding Claim 1, Cho teaches a method for producing an electrochemical aptamer-based sensor apparatus (para 0108, 0114-0120), the method comprising assembling two or more electrodes (para 0140, “a working electrode and a counter electrode”; ref num 151) of an electrochemical aptamer-based sensor (Fig. 5, ref num 105) with an apparatus for contacting the two or more electrodes to the skin of a subject (para 0106-0107).
30. Regarding Claim 25, Cho teaches assembling at least 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 electrodes (Figs. 44 and 45, ref nums 811a-811g).
31. Regarding Claim 29, Cho teaches at least one of the electrodes is a working electrode, and the working electrode(s) are selected from an electrode library comprising at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 working electrodes each of which comprises a different aptamer species (Figs. 44 and 45, ref nums 811a-g; para 0188).
32. Regarding Claim 30, Cho teaches working electrodes comprising the same aptamer species are grouped into a discrete holder, or grouped into a region of a single holder (see Figs. 44 and 45)
Claim Rejections - 35 USC § 103
33. 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.
34. Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Cho.
35. Regarding Claim 16, Cho teaches another embodiment wherein the assembling comprises mounting each of the electrodes on a mounting portion (Figs. 44-45, ref num 811a-g are mounted on unit ref num 811). These embodiments may be combined by one of ordinary skill in the art (para 0336), therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined multiple embodiments of Cho as they produce the same expected result.
36. Regarding Claim 17, Cho teaches the sensor apparatus is assembled (Fig. 44 and 45), one electrode terminates distally to the mounting portion than the other (para 0188, “the micro needles 811a, 811b, 811c, 811d, 811e, 811f, and 811g may include different lengths”).
37. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Levinson and in view of Windmiller U.S. 2022/0031244 (herein referred to as “Windmiller”).
38. Regarding Claim 19, Levinson fails to teach the mounting portion electrically insulates each electrode from each other electrode.
Windmiller teaches a method of analogous art (Figs. 3A-5B; abstract), wherein the method comprises assembling electrodes on a mounting portion (Fig. 5A, ref num 510 on ref num 502), such that the mounting portion electrically insulates each electrode from each other electrode (para 0089, “the microneedle array 500 may include a plurality of microneedles that are insulated such that the electrode on each microneedle in the plurality of microneedles is individually addressable and electrically isolated from every other electrode on the microneedle array”). This configuration allows for each electrode to be individually addressable (para 0009, 0089) in order to enable greater control of each electrode’s function (para 0089). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Levinson to have the electrodes be insulated from one another in order to improve the control over each electrode.
39. Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Levinson and in view of Pushpala U.S. 2021/0321942 (herein referred to as “Pushpala”).
40. Regarding Claims 20 and 21, Levinson fails to teach the electrodes and/or mounting portion are configured to form a watertight seal at a junction formed therebetween, such that the watertight seal is formed by way of a press fit, snap fit or friction fit between the electrode and the mounting portion; or by way of a flexible seal, or a curable sealant applied to or about the junction; or by way of a threaded connection between the electrode and the mounting portion.
Pushpala teaches a method of analogous art (Figs. 3A-3I), such that the method comprises assembling electrodes on a mounting portion (Fig. 3D, ref num 306 mounted to ref num 302) wherein there is a watertight seal at a junction formed therebetween (para 0093, “the seal 358 can contact a corresponding region 360 (FIG. 3F) on the electronics substrate 308 of the patch 302 to create a watertight seal”). The watertight seal is formed by way of a press fit, snap fit or friction fit between the electrode and the mounting portion; or by way of a flexible seal, or a curable sealant applied to or about the junction; or by way of a threaded connection between the electrode and the mounting portion (para 0093). This prevents moisture from reaching the electrical pins connecting the electrodes (para 0093). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Levinson to have provided a watertight seal between the electrodes and mounting portion, as this prevents inadvertent damage to the device (para 0090).
41. Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Levinson and in view of Pierart U.S. 2021/0353229 (herein referred to as “Pierart”).
42. Regarding Claim 24, Levinson teaches at least one of the electrodes comprises an expanded region configured to contact a surface of the mounting portion.
Pierart teaches a method of analogous art (Figs. 1-6), wherein the electrodes comprise an expanded region to contact a surface of the mounting portion (para 0065; see shape of electrodes in Figs. 3 and 6). It would have been an obvious matter of design choice to make the different portions of the electrode whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Conclusion
43. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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