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
Applicant’s election without traverse of Group III, claims 24-29 in the reply filed on 3/10/26 is acknowledged.
Claims 1-23, 32 and 36-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/10/26.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The IDS filed on 2/10/23 and 12/4/24 have been fully considered except where references have been lined through.
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 24-30, and 33-35 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.
Claim 24 requires a generic target and responsive protein. One of ordinary skill in the arts understands that there is nearly an unlimited number of proteins and modified proteins that exist naturally or could be manufactured in a lab that could serve as targets and responsive proteins. Likewise, the target could be essentially an unlimited number of proteins, molecules, pH shifts, or heat shifts that would lead to a conformational change in a protein. Thus, the claims recite a large and varied genus of potential targets/responsive proteins.
To show possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus (MPEP 2163). The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species sufficient to show the applicant was in possession of the claimed genus (Id.). A “representative number of species” means that the species which are adequately described are representative of the entire genus (Id.).
Instant specification describes only SARS-Voc-2 and ACE2, and thus fails to describe representative species showing possession of the claimed genus. Moreover, there is no structure-function relationship provided in the specification that would allow one of ordinary skill in the art to identify additional target and responsive protein pairs. Therefore, applicants are not in possession of the entire claimed genus.
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.
Claim 26 and 33-34 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.
Regarding claim 26, the claim requires “shape and or a size that resemble a host cell”. This is a term of degree and it is unclear what degree of similarity is sufficient or how one of ordinary skill in the arts would determine whether a particular size/shape meets the claim limitation. Moreover, it is unclear how the limitations found in claims 33-34 limit the shape of the assembly/proteins - e.g., it is unclear what type of structure would be implied by the shape being "based on surface proteins" in claim 33, and it is unclear what the "the shape of the responsive proteins contain a plurality of copies of a binding site" requires in claim 34 (e.g., are multiple copies of a binding site sufficient, or does the claim require some corresponding "shape").
Claim Rejections - 35 USC § 102
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)(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.
Claims 24, 26-27, 29-30, 33 and 34 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Oh (US20220034884A1). While Oh was published after the filing dare of instant application, Oh claims priority to 8/3/20 and therefore is valid prior art under 35 USC 102(a)(2).
Regarding claims 24, and 29-31, Oh teaches labeled quantum dots for detection of SARS-COV-2 (abstract). Oh teaches the dots can comprise ACE2 (protein sensors bound to substrate) ([0030]). Oh teaches that upon binding of an antigen to ACE2, the protein undergoes an energy shift allowing detection of the virus (responsive protein) (abstract). Oh teaches ACE2 is a host cell receptor (host cell decoy) ([0004]). Oh teaches the quantum dots can have fluorescent properties ([0029]). Oh teaches ACE2 is added to the particles at targeted ratios (desired density/substrate). Oh teaches their composition is useful in identifying therapeutics ([0003]).
Regarding claim 26 and 33, the limitation of “shape and/or size that resemble a host cell” can be construed so broadly as to be similar in any aspect to any hypothetical host cell, and the spherical QD of Oh would meet this limitation.
Regarding claim 27, Oh teaches oligomers of proteins can be used (fig 8a).
Regarding claim 34, Oh teaches the dots contain multiple copies of the proteins that comprise multiple binding sites (fig 1)
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, 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.
Claim 25, 28 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Oh (US20220034884A1), as applied to claims 24, 26-27, 29-30, 33 and 34 above, and further in view of Wang, (Chapter Fourteen - Single-Molecule Fluorescence Studies of Fast Protein Folding, Editor(s): Maria Spies, Yann R. Chemla, Methods in Enzymology,Academic Press, Volume 581,2016,Pages 417-459)
Regarding claim 25, Oh teaches that the protein can comprise a donor acceptor pair ([0032]). Oh teaches the biosensors can be FRET ([0029]).
Oh does not specifically teach a downhill folding protein or the conformational change.
Wang studies downhill folding FRET proteins (6. A CASE EXAMPLE: ONE-STATE DOWNHILL FOLDING). Wang teaches these proteins can be coupled to donors and acceptors and respond to targets of denaturing chemicals (conformational change) (fig 11). Wang teaches that these FRET proteins can provide highly sought after microsecond resolution (7. CONCLUSION).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a downhill folding protein of Wang in the composition of Oh. One of ordinary skill in the art would be motivated to do so because Wang teaches these proteins provide very fast resolution. Further, one of ordinary skill in the art would be motivated to do so because these downhill fluorescent proteins have been successfully used to provide rapid response to targets, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. There would be a reasonable expectation of success as Oh, and Wang are in the same field of endeavor of fluorescence.
Regarding claim 28, Wang teaches that the protein is folded before contacting denaturing chemicals and unfolds upon contacting the target denaturing chemical.
Regarding claim 35, Wang teaches that fluorescence can shift depending on whether the protein is bound to the target or not (fig 11).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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/TREVOR KANE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
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