DETAILED ACTION
Claims 1-24 have been canceled. Claims 25-46 are newly added and currently under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 26, 27, 29, 30, 31, 35, 36, 42 and 46 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.
Claims 26, 27, 31, 35 and 26 recite the limitation "the binding module". There is insufficient antecedent basis for this limitation in the claim. Claim 25 recites a “binding molecule” not a “binding module”. Claims 31, 35 and 36 suffer similar deficiencies.
Claim 29 requires that “the antibody” be coupled to the main body in a particular way. Claim 26, however, permits the binding molecule [sic] to be “at least one antibody or antibody fragment.” It is unclear whether claim 29 intends to limit its scope to antibodies per se. Claim 30 suffers similar deficiencies.
Claim 42 contains the trademark/trade name WHEATSTONE. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a Wheatsone measurement bridge and, accordingly, the identification/description is indefinite.
Claim 46 recites the limitation "the medium" in line 4 e.g. There is insufficient antecedent basis for this limitation in the claim. Claim 25 does not recite a “medium.” Claim 46 therefore lacks clear antecedent basis in claim 25. It later refers to “the medium to be tested” (lines 9-10), but it does not refer to such a medium in the preamble or anywhere else. This issue would be resolved by amending the preamble of claim 46 to refer to “the presence of an analyte in a medium.”
Claim 46 refers to “the binding of an analyte, preferably of antigens.” (Lines 7-8.) Preferences within a claim render it indefinite when it is unclear whether they are examples or actual limitations. MPEP 2173.05(d). Such is the case here.
Claim Rejections - 35 USC § 112
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.
Claims 25-46 are 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(s) 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 inventor(s), at the time the application was filed, had possession of the claimed invention
The claims describe a device and device element for the detection of an analyte as well as a method of detecting the analyte. The specification describes a device with a spring like element for the detection of SARS-CoV-2 virus. The specification does not describe the use of the device for detection of just any analyte or even for any other viral antigens.
MPEP § 2163 states: "The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice reduction to drawings or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. In unpredictable arts a widely variant genus cannot be represented by only one species. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A 'representative number of species' means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. Furthermore, establishment of a 'reasonable structure-function correlation' can also describe a genus and may be established 'by the inventor as described in the specification,' or "known in the art at the time of the filling date.' See MPEP 2163 (II)(A)(3)(a)(ii) and Abb Vie Deutschland GmbH & Co., KG V. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that 'only describe[d] one type of structurally similar antibodies' that 'are not representative of the full variety or scope of the genus.')."
Applicant discloses no specific examples indicating that any SARS-CoV-2 antigens could be detected using the claimed device. While there is disclosure of the structure of the device, there is no indication that the device actually functions to detect any analyte.
"A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) (Claims directed to PTFE dental floss with a friction-enhancing coating were not supported by a disclosure of a microcrystalline wax coating where there was no evidence in the disclosure or anywhere else in the record showing applicant conveyed that any other coating was suitable for a PTFE dental floss.). In the instant application there is no correlation between structure and function of the device and the detection of any analytes. Thus claims 25-46 are rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaya (WO 2007088018, 8/9/2007, as cited on the IDS filed 9/21/23) in view of BelBruno (US 11680921, issued 6/20/2023). BelBruno was effectively filed on 10/18/18 and names inventors other than those on the examined application, so it is prior art under 35 U.S.C. 102(a)(2).
Kaya teaches a miniaturized spring element with a bendable (flexible) main body that deforms or deflects in response to an externally acting mechanical force. (Page 1.) Kaya teaches that the spring element is useful as a sensor element in biosensor technology. (Page 1.) Kaya also teaches that the spring element is useful for measuring gas concentrations. (Page 5.) Kaya teaches that the conductivity of the spring is determined by measuring tunnel current (electronic tunneling), ion, or hopping process. (Page 3.) Kaya teaches that the locally changing zones of the spring are formed by composite systems comprising conductive nanocrystallites (nanoparticles). (Page 3.) Kaya teaches that the nanoparticles within the detector zone have higher electrical conductivity compared to the matrix material of the detector zone. (Page 3.) Kaya teaches that the detector zone can be a spring with a coating. (Pages 4, 11-12.)
Kaya does not teach that the coating contains a binding molecule that binds to an analyte in a sample. This deficiency is made up for in the teachings of BelBruno.
BelBruno teaches a biosensor for detecting diols and triols (analytes) comprising a conductive nanoparticle-containing coating disposed on a substrate, wherein the coating has affinity for binding diols and triols. (Abstract; claim 18.) BelBruno teaches that the biosensor probes conductivity changes in the coating to detect the diols and triols in air (a sample) from a reduction in the conductivity. (Abstract.)
It would have been obvious to select BelBruno’s nanoparticle-containing coating as the spring coating in Kaya’s system because BelBruno teaches that the coating is conductive and permits quantification of analyte binding. Furthermore, Kaya teaches that the spring system is useful as a biosensor and for detecting concentrations within gases (of which air is one). Combining the teachings of the references in this way would have constituted following the express suggestion of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNE M. GUSSOW whose telephone number is (571)272-6047. The examiner can normally be reached Monday to Friday 7am to 4pm, alternate Fridays off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yvonne Eyler can be reached at 571-272-1200. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
Prosecution Insights