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 17 March, 2026. Claims 1-16 are pending in the instant application. Applicant’s election of Group III (claims 2-8, 10, and 12-14) without traverse is noted. Claims 1, 9, 11, 15, and 16 stand withdrawn from further consideration by the Examiner, pursuant to 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention.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 20197898.8, filed 23 September, 2020. A copy of the foreign priority document submitted under 35 U.S.C. § 119(a)-(d), has been received and placed of record in the file.
37 C.F.R. § 1.98
The information disclosure statements filed 19 June, 2023 (2), have been placed in the application file and the information referred to therein has been considered.
37 C.F.R. § 1.84
The drawings filed 21 March, 2023, have been reviewed and are acceptable.
37 C.F.R. § 1.75(c)
Claims 2-8, 10, 12, and 13 are objected to under 37 C.F.R. § 1.75(c), as being of improper dependent form for failing to further limit the subject matter of a previous claim. The claims fail to reference a previous claim since they are dependent from claim 14. Applicant is required to cancel the claim(s), or amend the claim(s) to place the claim(s) in proper dependent form, or rewrite the claim(s) in independent form.
35 U.S.C. § 112(b)
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.
Claims 2-8, 10, and 12-14 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Two separate requirements are set forth under this statute: (1) the claims must set forth the subject matter that applicants regard as their invention; and (2) the claims must particularly point out and distinctly define the metes and bounds of the subject matter that will be protected by the patent grant.
The claims are directed toward a method of sequestering one or more antibodies present in a subject comprising: obtaining a pharmaceutical composition comprising administering a compound and a pharmaceutically acceptable excipient, wherein the compound comprises a biopolymer scaffold and a first peptide of the formula P(-S-P)(n-1) and a second peptide of the formula P(-S-P)(n-1), wherein independently P is a peptide of 6-13 amino acids and S is a non-peptide spacer, wherein independently n is an integer of at least 1, wherein each of the peptide n-mers is bound to the biopolymer scaffold, wherein independently P comprises an amino acid sequence comprising a fragment of at least six amino acids of a viral capsid, wherein at most three amino acids of the fragment sequence are independently substituted by any other amino acid, wherein the composition is non-immunogenic in the subject and one or antibodies present in the individual bind to P.
The claims are vague and indefinite because the precise nature of the compound linkage and actual composition are not readily manifest. For example, it is not readily manifest how many peptides are actually being conjugated. If n-1 equals 100, does that mean that 100 peptides (P) have been conjugated to the original peptide P? Alternatively, does it mean that the peptide has the formula P-S-P-S-P-S…-P100? Is the first peptide a linear peptide (e.g., P-S-P-S-P-S-P-S-P) or is it branched (e.g., are multiple S-P units attached to a single peptide)? The same limitations extend to the second peptide as well. It is also not readily manifest how the first or second peptide are conjugated to the scaffold. Is a single linear peptide (e.g., P-S-P-S-P-S-P) conjugated at one location on the biopolymer scaffold? Alternatively, are multiple peptides conjugated to multiple locations on the scaffold? Applicant should clearly identify the number and nature of the linkage between the first/second proteins, as well as, the number and nature of their linkage to the biopolymer scaffold.
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 2-8, 10, and 12-14 stand 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).
As previously set forth, 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 a method of sequestering one or more antibodies present in a subject comprising: obtaining a pharmaceutical composition comprising administering a compound and a pharmaceutically acceptable excipient, wherein the compound comprises a biopolymer scaffold and a first peptide of the formula P(-S-P)(n-1) and a second peptide of the formula P(-S-P)(n-1), wherein independently P is a peptide of 6-13 amino acids and S is a non-peptide spacer, wherein independently n is an integer of at least 1, wherein each of the peptide n-mers is bound to the biopolymer scaffold, wherein independently P comprises an amino acid sequence comprising a fragment of at least six amino acids of a viral capsid, wherein at most three amino acids of the fragment sequence are independently substituted by any other amino acid, wherein the composition is non-immunogenic in the subject and one or antibodies present in the individual bind to P.
The claims encompass an inordinate number of biopolymer scaffolds, first peptide, and second peptide. Biopolymeric scaffolds encompass a large and diverse genus of molecules with disparate structures, physicochemical properties, and functions (Abdul Khalil et al., 2020; Santhamoorthy and Kim, 2025). For example, biopolymeric hydrogel scaffolds may take many forms including cellulose-based, chitosan-based, sodium alginate-based, and gelatin-based. Moreover, despite their potential, biopolymer hydrogel scaffolds have various difficulties that prevent broad clinical implementation. Key difficulties include the challenge of balancing mechanical strength and flexibility to meet the needs of various tissues, managing degradation rates to line up with tissue regeneration, and assuring large-scale manufacturing while retaining scaffold uniformity and quality. Furthermore, fostering appropriate vascularization and cell infiltration in larger tissues remains a significant challenge for optimal tissue integration and function. Perusal of the specification only identified a limited number of biopolymer scaffolds based on murine immunoglobulin (Ig) or murine serum albumin (MSA). No other examples were provided. Moreover, the claims are not limited to the sequestration of any particular antibody species nor do they utilize any specific viral capsid protein.
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 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, Michael Allen, Ph.D., can be reached at (571) 270-3497. 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
Prosecution Insights