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 .
Priority
Support for “receptor test region” and “receptor to the antigenic protein” is not seen in the provisional application so Priority only goes back to 8 March 2022.
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 1-28 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 require receptors that have the function of binding to neutralizing epitopes
and antigens that have the function of inducing neutralizing binding partners, so anything that binds to the epitope and neutralizes the pathogen and includes antibodies and anything else that has the same function.
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by 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 genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Fri. January 5, 2001, see especially page 1106 column 3).
The specification does not provide adequate written description of the claimed invention. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention of the claimed invention, the genus of antibodies and of neutralzing epitopes. The the genus of antibodies and of neutralzing epitopes are claimed by function, the ability to bind to bind neutralizing epitopes and having neutralizing epitopes. The specification does not disclose any antibodies that is capable of these functions. The Federal Circuit addressed the application of the written description requirement to DNA-related inventions in University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). The court stated that “[a] written description of an invention involving a chemical genus, like a description of a chemical species, requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” Id. At 1567, 43 USPQ2d at 1405. The court concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” Id.
The Federal Circuit clarified that a molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ....i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “ Id. At 1324, 63 USPQ2d at 1613 (emphasis omitted, bracketed material in original).
Furthermore The Board in Ex Parte Kubin found that the written description of 35 USC 112 was not met, stating that
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
The Board in Ex Parte Kubin further stated on page 16 that
Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
The court in In re Alonso (Fed. Cir. 2008) citing In re Enzo, Enzo, 323 F.3d at 969 stated that
[F]or purposes of satisfying the written description requirement, it is not enough merely to disclose a method of making and identifying compounds capable of being used to practice the claimed invention.
In this case, the specification does not appear to describe the genus of antibodies and of neutralzing epitopes and thus does not satisfy either the Lilly nor Enzo standards.
There are insufficient structural features common to all members of the the genus of antibodies and of neutralzing epitopes The Board in Kubin indicated that possession may not be shown by merely describing how to obtain possession of members of the claimed genus. The autoantibodies are claimed by function, the ability to bind to csPCNA but not to nmPCNA. However, the specification does not disclose sufficient information on the structural function relationship to identify the claimed genus of autoantibodies. One of ordinary skill in the art would not be able to identify the broad claimed the genus of antibodies and of neutralizing epitopes that are capable of binding to that are able to bind neutralizing epitopes and the neutralizing epitopes themselves.
Thus, the specification does not provide an adequate written description of the genus of antibodies and of neutralizing epitopes that are capable of binding to that are able to bind neutralizing epitopes and the neutralizing epitopes themselves that is required to practice the claimed invention. Applicants have not described the broad genus sufficiently to show they had possession of the claimed genus. Since the disclosure fails to provide sufficient relevant identifying characteristics, and because the genus is highly variant, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
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 3, 8, 9, 11, 17-19, 25, and 27 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.
Claim 3 uses the term “for example” in three places and includes specific members of the group in parentheses). It is not clear if the material in parentheses is part of the claim and if the examples are limiting. The claim is treated as the parenthetical items are not limitations.
For claim 8, it is not clear if the full-length protein is required or is it just the neutralizing epitope portion.
Claims 9, 19, and 27 contain the term “preferably” and it is not clear if the limitation/s that follow or are required of the claim. They are treated as not required.
Claim 11 recites the limitation of two complexes in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. They appear to refer to claim 10 (full length antigenic protein) but no complexes are made in the claim. The claim is not treated further.
For claims 17-18, it is not clear if the sequential epitope test regions refer to the epitope present (different epitopes) or if it is multiple sequential regions on the test strip. The claims are not further treated.
Claim 25 is not clear if “when used” is intended use or if the parts A-D are method steps/result indicators. Also, it is not clear if A-D is one group and all happen in the method or if it is some kind if selection. There is no conjunction between C and D. The claim is not further treated.
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(s) 1-10, 11-16, 19-24, and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Gerhold et al. (poster, March 2021 Buhlmann Laboratory, from IDS) and Li et al. (WO2021216276).
For claims 1, 15 and 25, Gerhold et al. teach a lateral flow assay (LFA) for detecting Sars-Cov-2 neutralizing antibodies in a sample comprising a solid support comprising a sample receiving region, a conjugate pad comprising mobilizable RBD antigen conjugated to a label, a test line comprising immobilized unlabeled RBD antigen and a control line (see abstract and figures with the titles: "Extended RBD as Antigen" and "Principle of the assay").
For claim 3, the sample can be from serum (methods). For claims 4-5, the assay can be qualitative and the signal will develop over time (in the objective section). For claims 6-7, the assay can show kinetics of binding and show correlation to neutralizing antibodies (title and assay performance section).
For claim 8-9 and 26, the RBD fragment used is within a full-length protein (Extended RBD as antigen section shows RBD as part of whole spike). For claim 27, readers can be used to detect the detectable label (lower center shows detector machine).
Gerhold et al. does not teach receptor test region.
For claims 1, 19-20, and 23, Li et al. teach a SARS-CoV-2 neutralizing antibody LFA that contains a receptor bound to it (claim 1) and use the ACE-2 receptor that the SARS-CoV-2 RBD binds to. For claim 4, the assay can be qualitative (Figure 1).
For claim 10, one of ordinary skill in the art before the effective filing date would have known the RBS epitope can be in a fragment or the whole protein. For claim 12-14, one of ordinary skill in the art could choose to use different epitope test regions and proteins including fragments and whole protein and been motivated to use different labels to be able to differentiate what one reacted. For claim 16, Li et al. teach gold nanoparticle (figure 7a).
For claim 21, a control line can be used (claim 1). For claims 22 and 24, one of ordinary skill in the art would be motivated to choose to detect multiple strains at one time as multiple strains circulated and be motived to assay for different virus as respiratory illness is caused by more than one pathogen. One would have the expectation of success knowing that the LFA is well known and used routinely.
One of ordinary skill in the art would be motivated to detect neutralizing antibodies as it is taught in the prior art and been able to choose from epitope binding region and receptor binding region to make an assay to detect neutralizing antibodies and have the expectation of success as both were known and used in the art.
Thus, it would have been prima facie obvious before the effective filing date to modify the LFA of Gerhold et al. with the receptor test region of Li et al. with the expectation of success knowing both are used to detect neutralizing antibodies.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached Mon-Fri.
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, Michael Allen can be reached at 571-270-3497. 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.
MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671