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 reply to the Restriction Requirement, dated January 20, 2026, has been received. By way of this submission, Applicant has elected, without traverse, Group I: claims 1-6 and 14, and the species of SlyD as the chaperone species according to claim 3, SEQ ID NO: 8 as the SARS CoV-2 Corona nucleocapsid variant according to claim 4, and SEQ ID NO: 3 as the Corona antigen sequence according to claim 5.
Claims 7-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 January 20, 2026.
Claims 1-6 and 14 are currently under examination before the Office.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at page 17. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 1-6 and 14 are objected to because of the following informalities: The term "Corona virus" should be one word, and not capitalized. Likewise, the term "Corona antigen" should not be capitalized, and properly refer to "a coronavirus antigen". Appropriate correction is required.
For the purpose of claim construction, a "Corona antigen" is interpreted to mean an antigen from any member of the coronavirus family.
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 1-3, 6, and 14 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.
"[T]he purpose of the written description requirement is to 'ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.'" Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Regents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members. The Federal Circuit has cautioned that, for claims reciting a genus of antibodies with particular functional properties (e.g., high affinity, neutralization activity, competing with a reference antibody for binding), "[c]laiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described." Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011).
"[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A "representative number of species" means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) ("The '128 and '485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the 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 to provide a "representative number" of species.
The "structural features common to the members of the genus" needed for one of skill in the art to 'visualize or recognize' the members of the genus takes into account the state of the art at the time of the invention. For antibodies, the Federal Circuit has found that possession of a mouse antibody heavy and light chain variable regions provides a structural "stepping stone" to the corresponding chimeric antibody, but not to human antibodies. Centocor, 97 USPQ2d at 1875 ("[T]he application only provides amino acid sequence information (a molecular description of the antibody) for a single mouse variable region, i.e., the variable region that the mouse A2 antibody and the chimeric antibody have in common. However, the mouse variable region sequence does not serve as a stepping stone to identifying a human variable region within the scope of the claims."). A chimeric antibody shares the full heavy and light chain variable regions with the corresponding mouse antibody; that is, the structure shared between a mouse and chimeric antibody would generally be expected to conserve the antigen binding activity.
Lastly, even if a selection procedure is disclosed that was, at the time of the invention, sufficient to enable the skilled artisan to identify antibodies with the recited functional properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad, 94 USPQ2d at 1167; Centocor at 1876 ("The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.")
In Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad Pharms., Inc. v. Eli Lily & Co., 94 USPQ2d 1161 (Fed Cir. 2010), it is noted that to show invention, a patentee must convey in its disclosure that is "had possession of the claimed subject matter as of the filing date. Demonstrating possession "requires a precise definition" of the invention. To provide this precise definition" for a claim to a genus, a patentee must disclose "a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus" (see Amgen at page 1358).
Also, it is not enough for the specification to show how to make and use the invention, i.e., to enable it (see Amgen at page 1361).
An adequate written description must contain enough information about the actual makeup of the claimed products – "a precise definition, such as structure, formula, chemic name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials", which may be present in "functional terminology when the art has established a correlation between structure and function" (Amgen page 1361).
On 22 February 2018, the USPTO provided a Memorandum clarifying the Written Description Guide lines for claims drawn to antibodies, which can be found at www.uspto.gov/sltes/default/files/docurrienfcs/amgenJ22feb2018.pdf. That Memorandum indicates that, in compliance with recent legal decisions, the disclosure of a fully characterized antigen no longer is sufficient written description of an antibody to that antigen.
In the instant case, the claims are drawn to corona antigens suitable for detecting antibodies against a coronavirus in an isolated biological sample comprising a Corona nucleocapsid specific amino acid sequence according to SEQ ID NO: 1, or a variant thereof. The claims would encompass any variation on SEQ ID NO: 1 with the claimed property of detecting antibodies against a coronavirus in an isolated biological sample. However, the claims do not place any limitation of the structure of the variant. Applicant's specification at page 29 states that the variant may be as little as 95% homologous to SEQ ID NO: 1. This would result in a vast genus of possible antigens, not all of which would have the above claimed property. Applicant's specification discloses only a few such variants: SEQ ID NOs: 8, 10, 12, and 14. In contrast to Applicant's disclosure of the specific sequences above, the specification fails to disclose a representative number of species falling with the scope of the genus or structure common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus of the antigen.
A "representative number of species" means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The "structural features common to the members of the genus" needed for one of skill in the art to 'visualize or recognize' the members of the genus takes into account the state of the art at the time of the invention.
It is well-known in the art that antibodies have a large repertoire of distinct structures and that a huge variety of antibodies can be made to bind to a single epitope. For example, Lloyd et al. taught that over hundreds of functional antibody fragments can be isolated from an antibody library that bind to the same antigen wherein these antibodies have distinct heavy and light chain sequences (Protein Eng Des Sel. 2009 Mar;22(3):159-68; see page 159, right column, first paragraph: "Selection of such libraries to a given antigen can give rise to several hundreds to thousands of different antibodies.") The high degree of polymorphism in antibody generation evidences a lack of structure-function correlation for antibodies.
Given the well-known high level of polymorphism of antibodies and that Applicant has not defined anti particular coronavirus antibody, the skilled artisan would not have been in possession of the vast repertoire of antigens encompassed by the claimed invention; one of skill in the art would conclude that applicant was not in possession of the structural attributes of a representative number of species possessed by the members of the genus of coronavirus antigen variants broadly encompassed by the claimed invention. One of skill in the art would conclude that the specification fails to disclose a representative number of species to describe the claimed genera.
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.
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.
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.
Claims 1-3, 5-6, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (CN111220803B, machine translation attached) in view of Wu (WO2005081716A2) and Andres (US20140178393A1).
Wang teaches a SARS-CoV-2 nucleoprotein with a sequence identical to that of Applicant's SEQ ID NO: 1 (page 12).
Wang further teaches that SARS-CoV-2 nucleoprotein is useful for detecting SARS-CoV-2 antibodies (page 1, last paragraph and page 2, fourth paragraph).
However, Wang does not teach a chaperone protein.
Wu teaches a chimeric protein comprising a chaperone polypeptide and a SARS-CoV antigenic peptide (claim 31).
Wu further teaches that the antigenic peptide may be a SARS-CoV nucleocapsid protein (claim 34).
Wu further teaches that the antigenic peptide and the chaperone polypeptide may be connected by a linker (claim 35).
Wu further teaches that a chimeric polypeptide of a chaperone polypeptide and a SARS-CoV nucleocapsid protein are useful for generating an antibody response against the SARS-CoV nucleocapsid protein (Figure 2).
Andres teaches fusion polypeptides comprising an antigenic polypeptide and an FKBP family member (para. 0013). Andres further teaches that such polypeptides are useful for antibody screening (para. 0017).
Andres further teaches that the FKBP family member may be SlyD (para. 0019).
Andres further teaches that the fusion polypeptide may comprise more than one FKBP family member (para. 0001).
Andres further teaches FKBP family members such as SlyD are useful as chaperones in the recombinant expression of fusion polypeptides (para. 0008).
Andres further teaches linkers that connect the antigenic peptide to a SlyD sequence (para. 0140).
Andres further teaches a linker sequence of GGGSGGGSGGGSGGGSGGGSGGG (para. 0068).
Andres further teaches compositions of antigens and chaperone proteins (para. 0011), which is pertinent to claim 6.
Andres also teaches that SlyD has a sequence of SEQ ID NO: 12 (para. 0132).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Wang, Wu, and Andres to arrive at the claimed invention. Starting from Wang, the sequence of Applicant's SEQ ID NO: 1 was known in the art, and known to be useful for detecting SARS-CoV-2 antibodies without any other antigenic sequences. Combinations of coronavirus antigen and chaperone protein are taught by Wu, which provides motivation to combine the sequence of Wang with the SlyD sequence of Andres to arrive at the claimed invention. One of ordinary skill could combine the sequence of CN111220803 with the SlyD sequence and linker of Andres by known methods, and the combination would yield nothing more than predictable results.
While the references do not explicitly teach Applicant's SEQ ID NO: 3, this sequence consists of the antigenic sequence of SEQ ID NO: 1, the linker sequence GGGSGGGSGGGSGGGSGGGSGGG, and two copies of the SlyD sequence. As these sequences are taught by Wang and Andres, it would be well within the grasp of the ordinary artisan to assemble this sequence together to arrive at Applicant's SEQ ID NO: 3.
With regards to claim 14, it is well-settled law that combining printed instructions and an old product into a kit will not render the claimed invention non-obvious even if the instructions detail a new use for the product. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) and MPEP 2112.01(III).
Allowable Subject Matter
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 7:00 to 3:00.
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, Samira Jean-Louis can be reached at (571) 270-3503. 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.
/PETER JOHANSEN/Examiner, Art Unit 1644