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 .
DETAILED ACTION
Responsive to communication entered 06/17/2025.
Priority
This application, filed 11/13/2024, Pub. No. US 2025/0110119 A1, published 04/03/2025, is a § 371 National Stage of International Patent Application No. PCT/US2024/017641, filed 02/28/2024, Pub. No. WO 2024/186532, published 09/12/2024, which claims priority to US provisional applications Nos 63/449,765, filed 03/03/2023 and 63/522,580, filed 06/22/2023.
A request for acceleration under the Patent Prosecution Highway based upon the Written Opinion of the International Searching Authority in application PCT/US2024/017641 has been filed 11/13/2024 and granted 12/06/2024.
Status of Claims
Claims 1-9 and 11-22 are currently pending. Claims 1-22 have been originally filed. Claim 10 has being canceled, and Claims 1 and 11 have being amended, as set forth in Applicant’s Preliminary amendment filed 11/13/2024. Claims 1-9 and 11-22 have been subject to restriction/election requirement mailed 03/14/2025. Claim 8 has been amended, as set forth in Applicant’s Amendment filed 06/17/2025. Claims 7 and 15-22 are withdrawn from further consideration. Claims 1-6, 8, 9 and 11-14 are examined.
Manner of Making Amendments to Claims
Although the amendment filed on 06/17/2025 is entered, it is considered non-compliant because it has failed to meet the requirements of 37 CFR 1.121 or 1.4. Specifically, with regard to Claims 7 and 15-22, the correct status identifier is (Withdrawn). See MPEP 714.II.(C):
(A) Status Identifiers: The current status of all of the claims in the application, including any previously canceled or withdrawn claims, must be given. Status is indicated in a parenthetical expression following the claim number by one of the following status identifiers: (original), (currently amended), (previously presented), (canceled), (withdrawn), (new), or (not entered). The status identifier (withdrawn – currently amended) is also acceptable for a withdrawn claim that is being currently amended. See paragraph (E) below for acceptable alternative status identifiers. Emphasis added.
Withdrawn Objections/Rejections
Any objection or rejection not reiterated herein has been withdrawn.
The rejection of Claim 8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of Applicant’s amendment of the claim.
Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-6, 8, 9 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Zuk et al., WO 2023/205609 A1, published 10/26/2023 (PTO-892 mailed 05/14/2025), in view of AAV Capsid Ratio - Additional Data Document, author unknown, known at least as early as March 2, 2023, 2 pages (IDS submitted 11/13/2024); Examples of Charged Biopolymers Document, author unknown, known at least as early as March 2, 2023, 1 page (IDS submitted 11/13/2024); and Arugula et al., “Architectures of nano-biointerfaces: relevance to future biosensing, environment and energy applications,” Internl. J. Parallel, Emergent Distributed Systems, 2016, 15 pages (IDS submitted 11/13/2024).
This rejection is maintained from the previous Office Action.
The Examiner notes that the Zuk et al. reference is a proper reference under 102(a)(2):
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With regard to Claims 1, 3, 4, 6, 8, 9, 11, and the elected species (1), (2), (6), Zuk et al., throughout the publication, and, for example, in the claims, teach:
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Emphasis added.
With regard to Claim 2, Zuk et al. teach:
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Page 12; Emphasis added.
With regard to Claims 11-14, Zuk et al. teach:
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Pages 9-10; Emphasis added.
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Page 16; Emphasis added.
With regard to Claim 5, Zuk et al. teach a biosensor containing a core component comprising aminopropylsilane:
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Page 26; Emphasis added.
Although Zuk et al. do not teach the elected species (3) epoxypropylsilane, one of skill in the art would have known that it is a type of silane coupling agent that is used to modify surfaces:
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Accordingly, it would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have made and used a biosensor containing a core component comprising epoxypropylsilane.
Zuk et al. do not teach a biosensor containing a negatively charged biopolymer bound to an external surface of the core component and the positively charged biopolymer bound to an external surface of the negatively charged biopolymer.
AAV Capsid Ratio Document teaches the use of a negatively charged biopolymer bound to an external surface of the core component (“alginic acid surface”) and the positively charged biopolymer polyethylenimine (PEI), the elected species (5), bound to an external surface of the negatively charged biopolymer:
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Examples Document teaches:
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Arugula et al., throughout the publication, and, for example, in Abstract, teach a layer-by-layer (LbL) technology to generate multi-functional protein-based biointerfaces for construction of novel bioelectronic devices for biomedical, environment and energy applications, and that LbL is considered as an effective, simple and well suited technique for fabrication of unique functional biointerfaces.
It would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have made and used a negatively charged biopolymer bound to an external surface of the core component and the positively charged biopolymer bound to an external surface of the negatively charged biopolymer, taught by Examples Document, in a method, taught by Zuk et al.
One of ordinary skill in the art would have been motivated to have made and used a negatively charged biopolymer bound to an external surface of the core component and the positively charged biopolymer bound to an external surface of the negatively charged biopolymer, taught by Examples Document, in a method, taught by Zuk et al., because layer-by-layer (LbL) technology is considered as an effective, simple and well suited technique for fabrication of unique functional biointerfaces, as taught by Arugula et al.
One of ordinary skill in the art would have had a reasonable expectation of success in making and using a negatively charged biopolymer bound to an external surface of the core component and the positively charged biopolymer bound to an external surface of the negatively charged biopolymer, taught by Examples Document, in a method, taught by Zuk et al., because the use of a negatively charged biopolymer bound to an external surface of the core component (“alginic acid surface”) and the positively charged biopolymer polyethylenimine (PEI) bound to an external surface of the negatively charged biopolymer, was known in the art, as taught by AAV Capsid Ratio Document.
With regard to the elected species (4), dextran as a negatively charged biopolymer, it is noted that one of skill in the art would have known that dextran, in its basic form, is a polysaccharide composed of glucose units and does not inherently carry a strong negative charge, while dextran sulfate is designed to be negatively charged due to the presence of sulfate groups:
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Dextran can also be modified with other groups, like carboxylic acid groups, which can also give it a negative charge:
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Emphasis added.
Declaration Under 37 CFR § 1.132 of Ling Zang
The declaration under 37 CFR § 1.132 of Ling Zang filed 06/17/2025, is insufficient to overcome the 103 rejection of Claims 1-6, 8, 9 and 11-14 under 35 U.S.C. 103 as being unpatentable over Zuk et al., in view of AAV Capsid Ratio - Additional Data Document; Examples of Charged Biopolymers Document; and Arugula et al., because the declaration fails to disqualify the submitted references NPL3 and NPL4 as prior art.
Specifically, with regard to AAV Capsid Ratio - Additional Data Document and Examples of Charged Biopolymers Document, the declaration is limited to an ambiguous statement that “at least some of the material included in NPL3 and NPL4 have not otherwise been made publicly available” leading to confusion what material included in NPL3 and NPL4 has been made publicly available and what material included in NPL3 and NPL4 has not been made publicly available:
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Emphasis added.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Response to Arguments
Applicant's arguments filed 06/17/2025 have been fully considered but they are not persuasive.
Claim Rejections - 35 USC § 103
At pages 8-9 of Remarks, Applicant argues that:
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The Examiner respectfully disagrees because, as indicated above, the declaration under 37 CFR § 1.132 of Ling Zang, filed 06/17/2025, fails to disqualify the submitted references NPL3 and NPL4 as prior art.
Further, Applicant is reminded that MPEP § 2155 requires the use of 37 CFR § 1.130 Declaration for the AIA applications:
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Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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 GALINA M YAKOVLEVA whose telephone number is (571)270-3282. The examiner can normally be reached on M-F 8:30 AM-5:00 PM.
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, GREGORY S EMCH can be reached on (571)272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GALINA M. YAKOVLEVA/Primary Examiner, Art Unit 1678
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