DETAILED ACTION
Election/Restrictions
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 .
Election/Restrictions
2. Applicant's election with traverse of Group I in the reply filed on 9 June 2026 is acknowledged. The traversal is on the ground(s) that the claimed system is designed to carry out the claimed method methods and thus have the same technical feature. This is not found persuasive because, as noted in the previous Requirement of Restriction and reiterated below, the claimed technical feature is not a special technical feature, aa the limitations of the claimed system are taught by Huang as discussed therein and reiterated below.
The requirement is still deemed proper and is therefore made FINAL.
Claim 92 is therefore withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 9 June 2026.
3. Claims 1, 4, 6, 8, 11-12, 15, 17, 22-23, 25, 27, 31, 33, 37, 41, 42, 49, 54, 59, 73, 82, and 85 are under prosecution.
Notice to Comply with Requirements for Patent Applications Containing
Nucleotide Sequence And/Or Amino Acid Sequence Disclosure.
4. As noted in the Requirement for Restriction, this application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below.
Specifically, the application fails to comply with CFR 1.821(d), which states:
(d) Where the description or claims of a patent application discuss a sequence that is set
forth in the "Sequence Listing" in accordance with paragraph (c) of this section, reference
must be made to the sequence by use of the sequence identifier, preceded by "SEQ ID NO:" in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application.
5. The Specification discloses at least one nucleotide sequences on page 128.
However, the sequence is not identified by a SEQ ID NO.
6. For compliance with sequence rules, it is necessary to include the sequence in
the "Sequence Listing" and identify them with SEQ ID NO. In general, any sequence
that is disclosed and/or claimed as a string of particular bases or amino acids, and that otherwise meets the criteria of CFR 1.821(a), must be set forth in the "Sequence
Listing." See MPEP 2422.03.
7. While the Examiner has made every attempt to check the Specification for
sequence compliance, Applicant is required to carefully check the entire Specification
for any and all issues regarding sequence compliance.
8. For the response to this Office Action to be complete, Applicant is REQUIRED to comply with the Requirements for Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures. Failure to comply with the Requirements will be considered nonresponsive.
Drawings
9. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by:
I. The appropriate fee set forth in 37 CFR 1.17(h);
II. One set of color drawings or color photographs, as appropriate, if submitted via EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via EFS-Web; and, unless already present,
III. An amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
10. A statement from Applicant that there is no intention to have color drawings will result in acceptance of the drawings; otherwise, the conditions set forth above must be met in order for the color drawings to be accepted.
Information Disclosure Statement
11. The Information Disclosure Statements filed 27 June 2022, 18 April 2023, 4 March 2024, 3 June 2024, 23 September 2024, 4 February 2025, 30 June 2025, 19 September 2025, and 22 May 2026 are acknowledged and have been considered.
It is noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
12. The use of trade names or marks used in commerce (including but not necessarily limited to Cy3) has been noted in this application. Any trade names or marks should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
13. Claims 23, 27, 33, 37, 43, 54, 73, and 82 are objected to because of the following informalities, each of which appear to be typographical errors:
A. Claim 23 includes the text “configured to at least one of.”
B. Claim 27 includes the text at least one of at least one of.”
C. Claim 33 includes the text “at least some of the microstructures at least one of.”
D. Claim 37 included the text “at least some of microstructures” and “at least one electrode at least one of.”
E. Claim 43 includes the text “in different group.”
F. Claim 54 includes the text “the coating at least one of,” and is missing the article “a” in front of “self-assembled monolayer.”
G. Claim 73 includes the text “electronic processing devices at least one of.”
H. Claim 82 includes the text “is configured to at least one of.”
Appropriate correction is required.
Claim Interpretation
14. The claims are subject to the following interpretation:
A. The claims recite a “system.” The specification recites a “system” wherein the “system” is defined in terms of structural limitations. In addition, the claims recite structural limitations of the “system.” Thus, the “system” is interpreted to encompass any collection of reagents and parts used together that are not necessarily part of a completely integrated single unitary device. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation on the claimed subject matter.
B.I. 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.
B.II. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A. The recitation “one or more processing devices…configured to” in each of claims 23 and 27;
B. The recitation “an actuator configured to…” in claim 59.
However, this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the specification contains no limiting definition of the corresponding structure for performing the claimed function, of equivalents thereof.
If Applicant does intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, Applicant may present a sufficient showing that the specification recites sufficient structure to perform the claimed function so as to warrant being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
15. 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.
16. Claims 1, 4, 6, 8, 11-12, 15, 17, 22-23, 25, 27, 31, 33, 37, 41, 42, 49, 54, 59, 73, 82, and 85 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. Claim 1 (upon which claims 4, 6, 8, 11-12, 15, 17, 22-23, 25, 27, 31, 33, 37, 41, 42, 49, 54, 59, 73, 82, and 85 depend) is indefinite in the recitation “the one or more microstructures include an aptamer.” It is unclear how more than one microstructure can comprise a single (i.e., “an”) aptamer.
For the purposes of examination, the claims are interpreted as each microstructure having at least one aptamer.
B. Claims 11 (upon which claim 12 depends), 31, 33, 37, and 41 are each indefinite in the recitation “the microstructure,” and claims 37, 43, and 54 are each indefinite in the recitation “microstructures,” each of which lacks antecedent basis in the previous recitation of “one or more microstructures.”
C. The term “small” in claim 15 is a relative term which renders the claim indefinite. The term “small” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
D. Claim 23 (upon which claim 25 depends) and claim 27 are each indefinite in the recitation “the one or more processing devices,” which lacks antecedent basis in the previous recitation of “one or more electronic processing devices.”
E. Claim 25 is indefinite in the recitation “stimulatory signals”, which is lacks antecedent basis in the previous recitation of “a” stimulatory signal.
F. Claim 27 is indefinite in the recitation “the switches,” which lacks antecedent basis in the previous recitation “one or more switches.”
G. Claim 31 is indefinite in the recitation ”substantially rounded rectangular shape.” It is unclear how a shape can be “substantially rounded” but still be rectangular.
H. Claim 33 is indefinite in each of the following:
I. The recitation “the subject,” which lacks antecedent basis in the previous recitation “the biological subject.”
II. The terms “similar” and “significantly” in claim 33 are relative terms which render the claim indefinite. The terms “similar” and “significantly” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
I. Claim 37 is indefinite in each of the following:
I. The reaction “the at least one electrode,” which lacks antecedent basis in the previous recitation of “an electrode.”
II. The recitation “the tip,” which lacks antecedent basis because there is no previous recitation of a “tip.”
J. Claim 43 is indefinite in the recitation “the group,” which lacks antecedent basis in the previous recitation of “groups.”
K. Claim 54 is indefinite in each of the following:
I. The recitation “the barrier,” which lacks antecedent basis in the previous recitation of “a functional barrier.”
II. The recitation “the subject,” which lacks antecedent basis in the previous recitation “the biological subject.”
L. Claim 73 is indefinite in each of the following:
I. The multiple recitations of “the subject,” which lacks antecedent basis in the previous recitation “the biological subject.”
II. The recitation “the indicator,” which lacks antecedent basis in the previous recitation “at least one indicator.”
M. Claim 82 is indefinite in the multiple recitations of “the indicator,” which lacks antecedent basis in the previous recitation “at least one indicator.
N. Claim 85 is indefinite in each of the following:
I. The recitation “the subject data” in part ii), as only part i) discusses subject data.
II. The recitation “the subject,” which lacks antecedent basis in the previous recitation “the biological subject.”
Claim Rejections - 35 USC § 103
17. 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.
18. 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.
19. Claims 1, 11-12, 15, 17, 22, 31, 49, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015).
Regarding claims 1 and 49, Huang teaches a substrate comprising a microstructure, in the form of a transdermal microneedle array patch (Title), wherein a microneedle surface is modified to include an aptamer (paragraph 0040). Huang also teach a sensor, in the form of an electrode, connected to the microneedle (Abstract), and a signal processing unit that receives concentration data of target molecule (paragraph 0028) from a subject (i.e., patient; paragraph 0042).
In addition, it is noted that the courts have held that “while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). In addition, “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). Therefore, any uses recited in the claims fail to define additional structural elements of the claimed systems. Because the cited art teaches the structural elements of the claim, the claim is obvious. See MPEP § 2114.
It is also noted that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device (In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)). See MPEP §2144.04.
MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, counsel’s mere arguments cannot take the place of evidence in the record.
Regarding claims 11-12, the system of claim 1 is discussed above. Huang teaches the aptamer comprises a biotin moiety for immobilization on the surface (i.e., a streptavidin coated electrode; paragraph 0041).
Regarding claims 15 and 17, the system of claim 1 is discussed above.
It is noted that the claims are drawn to the analyte, which is not actually part of the claimed system.
In addition, Huang teaches the analyte (i.e., target molecule) is a hormone, in the form of cortisol, or a small molecule, in the form of glucose (i.e., claim 15; paragraph 0039).
Regarding claim 22, the system of claim 1 is discussed above. Huang teaches the system is a transdermal patch (Abstract), sand is therefore wearable.
Regarding claim 31, the system of claim 1 is discussed above. Hung teaches the microstructures are tapered (e.g., Figure 10).
In addition, it is noted that the courts have found that changes in shape are obvious (In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)). Thus, the claimed shapes are an obvious variant of the cited prior art. See MPEP 2144.04 IV B.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 54, the system of claim 1 is discussed above. Huang teaches at least one microstructure includes multiple coatings; namely, a combination of aptamer, antibody, and carbohydrate is coated on the microneedle (paragraph 0040). In an alternative embodiment, Huang teaches the at least one microneedle has different coatings on different parts; e.g., the aptamer is a sensing polymer coated on the inner face of a barbule in the microneedle, and an anti-irritation coating is on the outer face of the barbule (paragraph 0045).
20. Claims 4, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015) as applied to claim 1 above, and further in view of Ferguson et al. (U.S. Patent Application Publication No. US 2016/0166186 A1, published 16 June 2016).
Regarding claims 4, 6, and 8, the system of claim 1 is discussed above in Section 19.
Huang teaches the system has the added advantage of being manufactured with standard semiconductor processes (paragraph 0007). Thus, Huang teaches the known techniques discussed above.
Huang does not teach the aptamer is labeled or undergoes a conformational change.
However, Ferguson et al. teach systems (Abstract) utilizing aptamers that undergo conformational changes upon target binding (i.e., claim 4; paragraph 008). The aptamer is labeled with a redox moiety (i.e., claim 6) in the form of methylene blue (i.e., claim 8; paragraph 0233), and that the systems have the added advantage of allowing real-time in vivo monitoring of analyte concentrations (Abstract). Thus, Ferguson et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Huang and Ferguson et al. to arrive at the instantly claimed systems with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in systems having the added advantages of utilizing standard semiconductor processes as explicitly taught by Huang (paragraph 0007) and allowing real-time monitoring of analyte concentration as explicitly taught by Ferguson et al. (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result molecules useful for detecting analytes.
21. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015) as applied to claim 1 above, and further in view of Leung et al. (U.S. Patent No. 8,748,104, issued 10 June 2014).
It is noted that while claim 17 is rejected as described above, the claim is also obvious using the interpretation outlined below.
Regarding claim 17, the system of claim 1 is discussed above in Section 19.
Huang teaches the system has the added advantage of being manufactured with standard semiconductor processes (paragraph 0007). Thus, Huang teaches the known techniques discussed above.
Huang does not teach the aptamer is for troponin.
However, Leung et al. teach aptamers for detecting troponin I, which have the added advantage of being useful as diagnostics of skeletal muscle damage (column 1, lines 45-55). Thus, Leung et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Huang and Leung et al. to arrive at the instantly claimed systems with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in systems having the added advantages of utilizing standard semiconductor processes as explicitly taught by Huang (paragraph 0007) and being useful as diagnostics of skeletal muscle damage as explicitly taught by Leung et al. (column 1, lines 45-55). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result molecules useful for detecting analytes associated with medical conditions.
22. Claims 23, 25, 27, 33, 73, 82, and 85 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015) as applied to claim 1 above, and further in view of Chiou et al. (U.S. Patent Application Publication No. US 2008/0009763 A1, published 10 January 2008).
Regarding claims 23, 25, 27, 33, 73, 82, and 85, the system of claim 1 is discussed above in Section 19.
Huang teaches the system has the added advantage of being manufactured with standard semiconductor processes (paragraph 0007). Thus, Huang teaches the known techniques discussed above.
Huang also teaches the system is a transdermal patch (Title) and has a signal generator, in the form of a power source for the electrodes (Abstract), and that the processing unit generates a signal (paragraph 0028). Thus, it would have been obvious to have the signal generator (i.e., power source) be controlled by the processing device because the processing device generates the signal, and needs power to do so (i.e., claim 23). Huang further teaches electrical connections for receiving signals (i.e., claim 25), and that the system is a continuous monitoring system used for diagnosis (paragraphs 0047-0048) by tracking the current physiological condition of the user (i.e., claim 85; paragraph 0028).
Huang does not explicitly teach penetration of the stratum corneum, applying a stimulatory signal, switches, the dimensions of the microstructures, or that the monitoring system receives and analyzes data.
However, Chiou et al. teach an array of microstructures (i.e., microprobes; Abstract) which penetrate the stratum corneum (paragraph 0009) and have lengths of 500 micrometers and widths (i.e., radii) of 200 micrometers, which is less that the width (i.e., claim 33; paragraph 0027).
Chou et al also teach the electrodes are used as stimuli by conducting voltages or currents into them (i.e., claim 23; paragraph 0043), that leads are connected to the electrodes to receive signals (i.e., claim 25; paragraph 0036).
Chiou et al. further teach switches, in the form of layers, coatings, and leads that allow for individually addressable microstructures (i.e., the selective connection of the signal generator and sensor of claim 27; paragraph 0042).
Chiou et al. teach the device comprises a wearable monitoring device (i.e., a watch; paragraph 0036) which comprises terminal to analyze and display signals relative to a medical condition (i.e., claims 73, 82 and 85; paragraph 0036) and that the devices have the added advantage of allowing both form measurement and stimulus (Abstract). Thus, Chiou et al. teach the known techniques discussed above.
In addition, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found 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). See MPEP 2144.05 II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
It is also reiterated that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device. Thus, any arrangement of the switches in an obvious rearrangement of the structures taught by the cited prior art.
It is further noted that the courts have held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958)). See MPEP 2144.04 III.
Thus, automating the determination of a health condition is obvious.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Huang and Chiou et al. to arrive at the instantly claimed systems with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in systems having the added advantages of utilizing standard semiconductor processes as explicitly taught by Huang (paragraph 0007) and along both stimulus and measurement as explicitly taught by Chiou et al. (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result molecules useful for detecting conditions in a patient.
23. Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015) as applied to claim 1 above, and further in view of Hashimoto et al. (U.S. Patent Application Publication No. US 2002/0039743 A1, published 4 April 2002).
It is noted that while claim 27 is rejected as described above, the claim is also obvious using the interpretation outlined below.
Regarding claim 27, the system of claim 1 is discussed above in Section 19.
Huang teaches the system has the added advantage of being manufactured with standard semiconductor processes (paragraph 0007). Thus, Huang teaches the known techniques discussed above.
Hashimoto et al. teach detection systems (paragraph 0021) comprising arrays of electrodes wherein the electrodes have nucleic acid probes attached thereon (paragraph 0012), and wherein the electrodes are attached toa plurality of switching elements for applying signals to specific electrodes, which as the added advantage of allowing independent operation of each electrode (i.e., cell; paragraphs 0044 and 0038) Thus, Hashimoto et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Huang and Hashimoto et al. to arrive at the instantly claimed systems with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in systems having the added advantages of utilizing standard semiconductor processes as explicitly taught by Huang (paragraph 0007) and allowing independent operation of each electrode as explicitly taught by Hashimoto et al. (paragraphs 0044 and 0038). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result electrodes useful for detecting analytes.
24. Claims 37 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015) as applied to claim 1 above, and further in view of Imran (U.S. Patent Application Publication No.2010/0331759 A1, published 30 December 2010).
Regarding claims 37 and 41, the system of claim 1 is discussed above in Section 19.
Huang teaches the system has the added advantage of being manufactured with standard semiconductor processes (paragraph 0007). Thus, Huang teaches the known techniques discussed above.
While Huang also teaches the system delivers medication (paragraph 0042) and electrodes (Abstract), Huang does not teach the electrode is at a distal end of the microstructure or an insulating layer.
However, Imran teaches systems (claim 27 of Imran) comprising transdermal patches for delivering medication (paragraph 0024) comprising microneedle 30 having electrode 40 at the distal end (i.e., claim 37; Figure 8 and paragraphs 0043-0044). Imran also teaches insulating layer 14 on part of a surface of the microstructure (i.e., claim 41; Figure 9 and paragraph 0044), and that the devices have the added advantage of having corrosion resistant electrodes (Abstract). Thus, Imran teaches the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Huang and Imran to arrive at the instantly claimed systems with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in systems having the added advantages of utilizing standard semiconductor processes as explicitly taught by Huang (paragraph 0007) and having corrosion resistant electrodes as explicitly taught by Imran (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result electrodes useful with transdermal patches.
25. Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015) as applied to claim 1 above, and further in view of King et al. (U.S. Patent Application Publication No. US 2008/0004674 A1, published 3 January 2008).
Regarding claim 43, the system of claim 1 is discussed above in Section 19.
Huang teaches the system has the added advantage of being manufactured with standard semiconductor processes (paragraph 0007). Thus, Huang teaches the known techniques discussed above.
While Huang teaches groups of electrodes (e.g., Figure 4 and paragraph 0016), Huang does not teach different groups apply different stimulation.
However, King et al. teach systems (paragraph 0034) comprising groups of electrodes that provide different stimulations, which has the added advantage of decreasing the amount of time a clinician must invest to select an effective electrode combination for a patient (paragraph 0026). Thus, King et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Huang and King et al. to arrive at the instantly claimed systems with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in systems having the added advantages of utilizing standard semiconductor processes as explicitly taught by Huang (paragraph 0007) and decreasing the amount of time a clinician must invest to select an effective electrode combination for a patient as explicitly taught by King et al. (paragraph 0026). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result electrodes useful with for clinical applications.
26. Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015) as applied to claim 1 above, and further in view of Yeshurun (U.S. Patent Application Publication No. US 2008/0004674 A1, published 3 January 2008).
Regarding claim 59, the system of claim 1 is discussed above in Section 19.
Huang teaches the system has the added advantage of being manufactured with standard semiconductor processes (paragraph 0007). Thus, Huang teaches the known techniques discussed above.
While Huang also teaches the system is a transdermal patch (Title) and that the system delivers medication (paragraph 0042) Huang does not teach an actuator.
However, Yeshurun teaches systems (Title) comprising devices for transporting fluids through a biological barrier (paragraph 0011) having microneedles that penetrate the stratum corneum (paragraph 0084). The devices further comprises an actuator, either vibrational or piezoelectrical, which applied a vibratory force, which has the added advantage of increasing efficiency of injection (paragraph 0118). Thus, Yeshurun teaches the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Huang and Yeshurun to arrive at the instantly claimed systems with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in systems having the added advantages of utilizing standard semiconductor processes as explicitly taught by Huang (paragraph 0007) and increasing injection efficiency as explicitly taught by Yeshurun (paragraph 0026). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result systems useful for administering reagents to a patient.
Double Patenting
27. 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.
28. Claims 1, 11-12, 15, 17, 22, 31, 37, 41, 43, 49, and 54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 8-9, 17, 20, 22, 24, 26, 28, 31, 35, and 55 of copending Application No. 17/282,292 in view of Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015).
Both sets of claims are drawn to systems comprising electrodes, plate microstructures, coatings, switches, etc. Any additional limitations of the ‘292 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘292 claims do not require an aptamer.
However, Huang teaches the aptamer, as well as the other limitations of the claims and the rationale for combining as discussed above.
This is a provisional nonstatutory double patenting rejection.
29. Claims 4 and 6-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 8-9, 17, 20, 22, 24, 26, 28, 31, 35, and 55 of copending Application No. 17/282,292 in view of Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015) as applied to claim 1 above, and further in view of Ferguson et al. (U.S. Patent application Publication No. US 2016/0166186 A1, published 16 June 2016) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
30. Claim 17 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 8-9, 17, 20, 22, 24, 26, 28, 31, 35, and 55 of copending Application No. 17/282,292 in view of Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015) as applied to claim 1 above, and further in view of Leung et al. (U.S. Patent No. 8,748,104, issued 10 June 2014) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
31. Claims 23, 25, 27, 33, 73, 82, and 85 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 8-9, 17, 20, 22, 24, 26, 28, 31, 35, and 55 of copending Application No. 17/282,292 in view of Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015) as applied to claim 1 above, and further in view of Chiou et al. (U.S. Patent Application Publication No. US 2008/0009763 A1, published 10 January 2008) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
32. Claim 59 is are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 8-9, 17, 20, 22, 24, 26, 28, 31, 35, and 55 of copending Application No. 17/282,292 in view of Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015) as applied to claim 1 above, and further in view of Yeshurun (U.S. Patent Application Publication No. US 2008/0004674 A1, published 3 January 2008) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
33. Claims 1, 4, 11-12, 15, 17, 22-23, 25, 27, 31, 33, 37, 41, 43, 49, 54, 59, 73, 82, and 85 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 8, 11, 15, 18, 20, 25, 27, 29, 33, 35, 39, 43, 45, 51, 56, 61, 75, 81, and 87 of copending Application No. 17/765,753 in view of Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015).
Both sets of claims are drawn to systems comprising electrodes, plate microstructures, coatings, switches, etc. Any additional limitations of the ‘753 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘753 claims do not require an aptamer.
However, Huang teaches the aptamer, as well as the other limitations of the claims and the rationale for combining as discussed above.
This is a provisional nonstatutory double patenting rejection.
34. Claims 6 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 8, 11, 15, 18, 20, 25, 27, 29, 33, 35, 39, 43, 45, 51, 56, 61, 75, 81, and 87 of copending Application No. 17/765,753 in view of Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015) as applied to claim 1 above, and further in view of Ferguson et al. (U.S. Patent application Publication No. US 2016/0166186 A1, published 16 June 2016) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
35. Claims 1, 11-12, 15, 17, 22, 27, 31, 33, 37, 41, 43, 49, 54, and 73 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-8, 13-15, 17, 22, 25-27, 29, and 31-35 of copending Application No. 18/286,739 in view of Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015).
Both sets of claims are drawn to systems comprising electrodes, plate microstructures, coatings, switches, etc. Any additional limitations of the ‘739 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘738 claims do not require an aptamer.
However, Huang teaches the aptamer, as well as the other limitations of the claims and the rationale for combining as discussed above.
This is a provisional nonstatutory double patenting rejection.
36. Claims 4 and 6-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-8, 13-15, 17, 22, 25-27, 29, and 31-35 of copending Application No. 18/286,739 in view of Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015) as applied to claim 1 above, and further in view of Ferguson et al. (U.S. Patent application Publication No. US 2016/0166186 A1, published 16 June 2016) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
37. Claim 17 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-8, 13-15, 17, 22, 25-27, 29, and 31-35 of copending Application No. 18/286,739 in view of Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015) as applied to claim 1 above, and further in view of Leung et al. (U.S. Patent No. 8,748,104, issued 10 June 2014) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
38. Claims 23, 25, 82, and 85 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-8, 13-15, 17, 22, 25-27, 29, and 31-35 of copending Application No. 18/286,739 in view of Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015) as applied to claim 1 above, and further in view of Chiou et al. (U.S. Patent Application Publication No. US 2008/0009763 A1, published 10 January 2008) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
39. Claim 59 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-8, 13-15, 17, 22, 25-27, 29, and 31-35 of copending Application No. 18/286,739 in view of Huang (U.S. Patent Application Publication No. US 2015/0208985 A1, published 30 July 2015) as applied to claim 1 above, and further in view of Yeshurun (U.S. Patent Application Publication No. US 2008/0004674 A1, published 3 January 2008) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 101
40. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
41. Claims 1, 4, 6-8, 11-12, 15, 17, 22-23, 25, 27, 31, 33, 37, 41, 43, 49, 54, 59, 73, 82, and 85 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
A two-step procedure is used to determine if the claimed subject matter is a judicial exception. First it is determined whether the claimed subject matter is directed to a law of nature, a natural phenomenon, or an abstract idea. If the claimed subject matter recites an abstract idea it is determined whether the claimed subject matter is instead directed to an improvement to a technology. If the claimed subject matter recites a law of nature it is determined whether the claimed subject matter is instead directed to a patent-eligible application of the law of nature. A claim is not directed to a natural phenomenon that is a nature-based product if the product limitation is markedly different from what occurs in nature.
The claims are drawn to a judicial exception of performing an abstract idea that can be performed as a mental step; i.e., determining a signal and performing an analysis to at least partially indicate analyte presence, absence, or level of concentration, which is similar to the abstract idea of comparing information of a sample or test subject to a control or target data at issue in Univ. of Utah Research Found. v. Ambry Genetics Corp., 774 F.3d 755, 113 USPQ 2d 1241 (Fed, Cir. 2014)) and the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group. LLC. v. Alstom (830 F3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016).
In the second step it is determined whether the claimed subject matter includes significantly more than a judicial exception by comprising an additional element or a combination of additional elements that are not routine or conventional.
The additional elements of the claims recite well known and generic steps utilizing well known and generic devices. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the remaining limitations refer to microstructures on a substrate, operatively coupled sensors, and processing devices.
The claimed subject matter comprises an abstract idea that is computer mediated. Performing an abstract idea on a generic computer is not an additional element that is significantly more than the abstract idea itself. In Alice Corp. Pty. Ltd. v. CLS Bank Int'l (573 U.S. 134 S.Ct. 2347, 110 USPQ2d 1976 (2014)) the Supreme Court reviewed the prior Benson, Flook, and Diehr decisions regarding claims directed to an abstract idea that include a step of using computers:
These cases demonstrate that the mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention. Stating an abstract idea “while adding the words ‘apply it’” is not enough for patent eligibility. Mayo, supra, at ___ (slip op., at 3). Nor is limiting the use of an abstract idea “‘to a particular technological environment.’” Bilski, supra, at 610–611. Stating an abstract idea while adding the words “apply it with a computer” simply combines those two steps, with the same deficient result. Thus, if a patent’s recitation of a computer amounts to a mere instruction to “implemen[t]” an abstract idea “on…a computer,” Mayo, supra, at ___ (slip op., at 16), that addition cannot impart patent eligibility. This conclusion accords with the pre-emption concern that undergirds our §101 jurisprudence. Given the ubiquity of computers, see 717 F. 3d, at 1286 (Lourie, J., concurring), wholly generic computer implementation is not generally the sort of “additional featur[e]” that provides any “practical assurance that the process is more than a drafting effort designed to monopolize the [abstract idea] itself.” Mayo, 566 U. S., at ___ (slip op., at 8–9).
Regarding claims to computers and computer-readable media that execute an abstract idea, the court further stated:
Petitioner’s claims to a computer system and a computer-readable medium fail for substantially the same reasons. Petitioner conceded below that its media claims rise or fall with its method claims. En Banc Response Brief for Defendant-Appellant in No. 11–1301 (CA Fed.) p. 50, n. 3. As to its system claims, petitioner emphasizes that those claims recite “specific hardware” configured to perform “specific computerized functions.” Brief for Petitioner 53.But what petitioner characterizes as specific hardware-a “data processing system” with a “communications controller” and “data storage unit,” for example, see App. 954,958, 1257-is purely functional and generic. Nearly every computer will include a “communications controller” and “data storage unit” capable of performing the basic calculation, storage, and transmission functions required by the method claims. See 717 F. 3d, at 1290 (Lourie, J., concurring). As a result, none of the hardware recited by the system claims “offers a meaningful limitation beyond generally linking ‘the use of the [method] to a particular technological environment,’ that is, implementation via computers.” Id., at 1291 (quoting Bilski, 561 U. S., at 610–611). Put another way, the system claims are no different from the method claims in substance. The method claims recite the abstract idea implemented on a generic computer; the system claims recite a handful of generic computer components configured to implement the same idea. This Court has long “warn[ed] . . . against” interpreting §101 “in ways that make patent eligibility ‘depend simply on the draftsman’s art.’” Mayo, supra, at ___ (slip op., at 3) (quoting Flook, 437 U. S., at 593); see id., at 590 (“The concept of patentable subject matter under §101 is not ‘like a nose of wax which may be turned and twisted in any direction . . . ’”). Holding that the system claims are patent eligible would have exactly that result.
Because petitioner’s system and media claims add nothing of substance to the underlying abstract idea, we hold that they too are patent ineligible under §101.
Evidence for the conventional nature of the limitations is provided by the prior art rejections presented cited above.
The subject matter of the claims is therefore a computer-mediated process directed to a judicial exception. There is no limitation in the claims that the claimed computer-mediated process utilizes anything other than a generic computer (i.e., “electronic processing devices”). Therefore the subject matter of the claims is without limitations that indicate that the claims are different than the steps of the process claims in substance.
The subject matter of the instant claims is therefore a judicial exception and the claims are patent-ineligible.
42. One way to overcome a rejection for non-patent-eligible subject matter is to persuasively argue that the claimed subject matter is not directed to a judicial exception. Another way for the applicants to overcome the rejection is to persuasively argue that the claims as a whole are directed to an improvement to a technology instead of an abstract idea, or are directed to a patent-eligible application of a law of nature instead of the law of nature itself, or are directed to a product that is markedly different from that which occurs in nature instead of a natural phenomenon. Persuasive evidence for an improvement to a technology could be a comparison of results of the claimed subject matter with results of the prior art, or arguments based on scientific reasoning that the claimed subject matter inherently results an improvement over the prior art. Applicant should show why the claims require the improvement in all embodiments. Another way for the applicants to overcome the rejection is to persuasively argue that the claims contain elements in addition to the judicial exception that either individually or as an ordered combination are not well understood, routine, or conventional. See the May 2016 guidance at
http://www.uspto.gov/patent/laws-and-regulations/examination-policy/2014-interim-guidance-subject-matter-eligibility-0
Conclusion
43. No claim is allowed.
44. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30.
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/Robert T. Crow/Primary Examiner, Art Unit 1683
Robert T. Crow
Primary Examiner
Art Unit 1683
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