Detailed Office 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 .
Status of the Claims
Acknowledgement is hereby made of receipt and entry of the communication filed 05 February, 2026. Claims 1-10, 12, 13, 15, 16, 19, 20, 26-28, and 33 are pending in the instant application. Applicants’ election of Group I (claims 1-10, 12, 13, 15, and 16) without traverse is noted. Claims 19, 20, 26-28, and 33 are withdrawn from further consideration by the Examiner, pursuant to 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention.
35 U.S.C. § 119
Acknowledgment is hereby made of Applicants’ claim for foreign priority based on EP 21315057 filed 30 March, 2021. It is noted, however, that applicant has NOT filed a certified copy AND English translation of this application as required by 35 U.S.C. § 119(b)(3). Accordingly, the foreign priority claim has NOT been entered.
37 C.F.R. § 1.84
The drawings filed 05 April, 2023, have been reviewed and are objected to. Applicants are reminded that color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 C.F.R. § 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 C.F.R. § 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via EFS-Web, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 C.F.R. § 1.84(b)(2).
37 C.F.R. § 1.98
The information disclosure statements filed 29 June, 2023, 22 July, 2025, and 10 September, 2025, have been placed in the application file and the information referred to therein has been considered.
Marks Used in Commerce
The use of the term DENGVAXIA®, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. See M.P.E.P. § 608.01(v).
35 U.S.C. § 112(a)
The following is a quotation 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.
Written Description
Claims 1-10, 12, 13, 15, and 16 are rejected under 35 U.S.C. § 112(a), 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, at the time the application was filed, had possession of the claimed invention. Amgen, Inc. v. Sanofi, 872 F.3d 1367, 124 U.S.P.Q.2d 1354 (Fed. Cir. 2017). AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 111 U.S.P.Q.2d 1780 (Fed. Cir. 2014). Univ. of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 920, 69 U.S.P.Q.2d 1886, (Fed. Cir. 2004). Enzo Biochem, Inc. v. Gen-Probe, Inc., 296 F.3d 1316, 63 U.S.P.Q.2d 1609, (Fed. Cir. 2002). Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 U.S.P.Q.2d 1398, (Fed. Cir. 1997). Fiers v. Revel Co., 984 F.2d 1164, 25 U.S.P.Q.2d 1601, (Fed. Cir. 1993). Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 U.S.P.Q.2d 1016, (Fed. Cir. 1991). In re Rasmussen, 650 F.2d 1212, 211 U.S.P.Q. 323 (C.C.P.A. 1981). In re Wertheim, 541 F.2d 257, 191 U.S.P.Q. 90 (C.C.P.A. 1976).
The crux of the statutory requirement governing written description is whether one skilled in the art, familiar with the practice of the art at the time of the filing date, could reasonably have found the later claimed invention in the specification as filed. In re Kaslow, 707 F.2d 1366, 1375, 217 U.S.P.Q. 1089, 1096 (Fed. Cir. 1983). In re Wilder, 736 F.2d 1516, 1520 222 U.S.P.Q. 349, 372 (Fed. Cir. 1984, cert. denied, 469 U.S. 1209 (1985). Texas Instruments, Inc. v. International Trade Comm’n, 871 F.2d 1054, 1063, 10 U.S.P.Q.2d 1257, 1263 (Fed. Cir. 1989). Moreover, the courts have stated that the evaluation of written description is highly fact-specific, and that broadly articulated rules are inappropriate. In re Wertheim, 541 F.2d 257, 263, 191 U.S.P.Q. 90, 97 (C.C.P.A. 1976). In re Driscoll, 562 F.2d 1245, 1250, 195 U.S.P.Q. 434, 438 (C.C.P.A. 1977). It is also important to remember that the true issue in question is not whether the specification enables one of ordinary skill in the art to make the later claimed invention, but whether or not the disclosure is sufficiently clear that those skilled in the art will conclude that the applicant made the invention having the specific claim limitations. Martin v. Mayer, 823 F2d 500, 505, 3 U.S.P.Q.2d 1333, 1337 (Fed. Cir. 1987).
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor has possession of the claimed invention. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 U.S.P.Q.2d at 1116. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 U.S.P.Q.2d 1961, 1966 (Fed. Cir. 1997). The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 U.S.P.Q.2d 1895, 1905 (Fed. Cir. 1996).
The claims are directed toward an immunodiagnostic device for the detection of dengue virus (DENV)-specific antibodies. The device comprises DENV1, DENV2, DENV3, and DENV4 envelope (E) peptides. In particular, claim 1 references a DENV antigen that comprises at least 90% sequence identity with SEQ ID NO.: 1 (DENV1 E) and upwards of four amino acid substitutions with respect toe SEQ ID NO.: 2 (DENV2 E). Additional claims reference DENV antigenic peptides that comprise at least 90% sequence identity to SEQ ID NO.: 3 (DENV3 E) and SEQ ID NO.: 4 (DENV4 E). The claimed DENV E antigenic peptides vary in length between 390 to 394 amino acids. A representative sequence (SEQ ID NO.: 1) follows:
RCVGIGNRDF VEGLSGGTWV DVVLEHGSCV TTMAKDKPTL DIELLKTEVT NPAVLRKLCI
EAKISNTTTD SRCPTQGEAT LVEEQDANFV CRRTFVDRGW GNGCGLFGKG SLITCAKFKC
VTKLEGKIVQ YENLKYSVIV TVHTGDQHQV GNETTEHGTI ATITPQAPTS EIQLTDYGAL
TLDCSPRTGL DFDEMVLLTM KEKSWLVHKQ WFLDLPLPWT SGASTPQETW NREDLLVTFK
TAHAKKQEVV VLGSQEGAMH TALTGATEIQ TSGTTKIFAG HLKCRLKMDK LTLKGMSYVM
CTGSFKLEKE VAETQHGTVL VQVKYEGTDA PCKIPFSTQD EKGVTQNGRL ITANPIVTDK
EKPVNIEAEP PFGESYIVVG AGEKALKLSW FKKG (394 aa).
At 10% amino acid sequence variation, this would encompass upwards of ~3 x 10106 variant antigenic sequences.1 The sequence variability allows for amino acid insertions, deletions, or replacements at any location in the antigenic peptide. The claims are not limited to any particular epitope or structural feature. Thus, the claim language clearly encompasses an inordinate number of variant antigenic sequences.
It has been well-documented that even single amino acid substitutions can abrogate antigen-antibody binding interactions (Hiramatsu et al., 1996; Roehrig et al., 2004; Costin et al., 2013; Ye et al., 2013). Hiramatsu and colleagues demonstrated that amino acid substitutions at positions 383, 384, or 385 abrogate DENV2 E antigen-antibody binding. Costin and associates reported that single amino acid substitutions at residues 101, 107, and 109 significantly reduced antibody binding to the Env. Roehrig and colleagues demonstrated that structural alterations distal from an epitope can also abrogate antigen-antibody binding interactions. Moreover, the specification fails to disclose the preparation, isolation, and antigenic characterization of a single DENV variant. Single representative envelopes were provided from DENV1-4. However, no other variant sequences were generated. The specification also failed to identify any specific regions within E that should be targeted for modification and that can tolerate amino acid replacements without inhibiting antigen-antibody binding interactions.
Accordingly, when all the aforementioned factors are considered in toto, the skilled artisan would reasonably conclude that Applicants were not in possession of a sufficient number of variant DENV E species to support the full breadth of the patent protection desired.
Correspondence
Any inquiry concerning this communication should be directed to Jeffrey S. Parkin, Ph.D., whose telephone number is (571) 272-0908. The Examiner can normally be reached Monday through Friday from 10:00 AM to 6:00 PM. A message may be left on the Examiner's voice mail service. 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 are unsuccessful, the Examiner's supervisor, Janet L. Andres, Ph.D., can be reached at (571) 272-0867. Direct general status inquiries to the Technology Center 1600 receptionist at (571) 272-1600.
Information regarding the status of an application may be obtained from the Patent Center. Status information for published applications may be obtained from the Patent Center. Status information for unpublished applications is available through the Patent Center for authorized users only. Should you have questions about access to Patent Center, 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.
Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671 04 April, 2026
1 These calculations were performed as follows: TV=(NY)(X!)/(Y!)((X-Y-1)!), wherein, TV=the total number of variant sequences, N=the number of amino acids or nucleotides that can be substituted (i.e., if any of the 20 naturally occurring amino acids can be substituted, N=19; if any of the four naturally occurring nucleotides can be substituted, N=3), Y=the number of amino acids/nucleotides in the parent sequence that can be substituted (i.e., if the amino acid sequence is 100 aa in length and 10% genetic variation is allowed, Y=10 [100@10%]), and X=the total sequence length of the sequence of interest.
Prosecution Insights