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 .
Election/Restrictions
Claims 11, 20 – 22 and 24 – 30 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/5/2025.
Response to Arguments
Applicant's arguments, filed 2/26/2026, regarding the rejection of newly amended claim 10 under 35 U.S.C. 102(a)(2) as being anticipated by Xu et al. et al. (US 2022/0390408 A1; hereinafter “Xu”) have been fully considered, but they are not persuasive. Applicant alleges that Xu does not teach or suggest the claimed invention of sole independent claim 10. Examiner respectfully disagrees. Applicant alleges that Xu does not teach a graphene sensitive film. The features at issue are that claim 10 is essentially drawn to a sealing structure applied to a chemical sensor that is already known in the prior art, that is altered by the mere inclusion of a graphene sensitive layer and a protective film comprising polyvinyl alcohol. However, Xu clearly teaches the protective film comprising polyvinyl alcohol as claimed. Xu teaches a protective film (porous protective layer 14) that covers the surface of the sensitive film (conductive polymer layer 12 including immobilized antibody layer 13) as shown in figure 1. Xu explicitly teaches that the protective film is formed of polyvinyl alcohol (paragraphs 18, 77 and 90). Now the facts themselves show that there is no difference between the claimed subject matter and the prior art, but for the mere incorporation of the graphene sensitive film. However, Xu does indicate that the sensitive film can comprise graphene incorporated within an electrode material. Therefore, a sensitive film comprising graphene is implicitly taught as an alternative embodiment of the immunoelectrode chemical sensor structure (paragraphs 4 and 5). Furthermore, the newly cited reference to Claussen specifically teaches electrochemical sensing circuits on a substrate for a biosensing apparatus comprising antibodies immobilized via attachment onto graphene surfaces via EDC/NHS chemistry (paragraph 444). The use of graphene surfaces with immobilized antibodies for biosensing is well known in the art as evidenced by Claussen. There is no reason to suggest to a person of ordinary skill in the art that including the graphene sensitive film as known by Claussen with the sensor element taught by Xu would not have been suitable or not predictable. The Applicant has not shown objective factual evidence that this change would have yielded an unexpected result or was beyond the skill of, or uniquely challenging to, a person of ordinary skill in the art. An argument does not replace evidence, where evidence is necessary (see MPEP § 2145). The Courts have held that the arguments of counsel cannot take the place of evidence in the record. See In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); & In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). Moreover, this position is merely attorney argument lacking evidentiary support. See Gemtron Corp. v. Saint-Gobain., 572 F.3d 1371, 1380 (Fed. Cir. 2009) (noting that “unsworn attorney argument … is not evidence”). In addition, the Examiner recognizes that obviousness can only be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988) and In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). The Applicant is further advised that the recent Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) forecloses the argument that a specific teaching, suggestion or motivation is required to support a finding of obviousness. See Ex parte Smith, USPQd, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007). In addition, the Supreme Court noted in KSR that although the test “captured a helpful insight,” an obviousness analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person or ordinary skill in the art would employ.” See 127 S. Ct. at 1741, 82 USPQd at 1396. The Courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. Id. at 1366, 80 USPQ2d at 1649. Therefore, the invention of claim 10 is anticipated by Xu individually or rendered obvious by the teachings of Xu in view of Claussen.
These rejections are maintained.
Applicant canceled claims 12 – 19 and 23.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 10 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Xu et al. et al. (US 2022/0390408 A1; hereinafter “Xu”).
Regarding claim 10, Xu teaches a sealing structure applied to a chemical sensor (microfluidic detection chip; paragraphs 106 and 69; figures 1 – 9) that includes: a sensor element (immunoelectrode; figure 9; paragraph 69), the sensor element including:
a substrate (base layer 10);
a graphene sensitive film (conductive polymer layer 12 comprising antibody layer 13; paragraphs 69 and 90; figure 9; Xu specifically teaches that the sensitive film can comprise graphene incorporated within an electrode material, therefore, a sensitive film comprising graphene is implicitly taught as an alternative embodiment of the immunoelectrode chemical sensor structure disclosed here; paragraphs 4 and 5) that is provided on the substrate;
and a probe molecule (immobilized antibodies in layer 13) for capturing a target substance that is immobilized on a surface of the graphene sensitive film, the sealing structure of the sensor element comprising a protective film (porous protective layer 14; paragraph 69; figure 9) that covers the surface of the sensitive film on which the probe molecule is immobilized and is formed of polyvinyl alcohol (paragraphs 18, 77 and 90).
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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) 10 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. et al. (US 2022/0390408 A1; hereinafter “Xu”) in view of Claussen et al. (US 2021/0215636 A1; hereinafter “Claussen”).
Regarding claim 10, Xu teaches a sealing structure applied to a chemical sensor (microfluidic detection chip; paragraphs 106 and 69; figures 1 – 9) that includes: a sensor element (immunoelectrode; figure 9; paragraph 69), the sensor element including:
a substrate (base layer 10);
a sensitive film (conductive polymer layer 12 comprising antibody layer 13; paragraphs 69 and 90; figure 9) that is provided on the substrate;
and a probe molecule (immobilized antibodies in layer 13) for capturing a target substance that is immobilized on a surface of the sensitive film, the sealing structure of the sensor element comprising a protective film (porous protective layer 14; paragraph 69; figure 9) that covers the surface of the sensitive film on which the probe molecule is immobilized and is formed polyvinyl alcohol (paragraphs 18, 77 and 90).
Xu does not explicitly teach that the sensitive film comprises graphene in the embodiment described in Example 1 (paragraph 69). Xu does indicate that the sensitive film can comprise graphene incorporated within an electrode material (paragraphs 4 and 5).
Claussen specifically teaches electrochemical sensing circuits on a substrate for a biosensing apparatus comprising antibodies immobilized via attachment onto graphene surfaces via EDC/NHS chemistry (e.g., paragraph 444). The use of graphene surfaces with immobilized antibodies for biosensing is well known in the art as evidenced by Claussen. Consequently, the incorporation of a sensitive film comprising graphene would have been considered to be suitable and predictable to a person of ordinary skill in the art. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.07). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide that the sensitive film comprises graphene as claimed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
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, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796