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 .
DETAILED ACTION
This Non-Final Office Action is responsive to the communication received 3/30/2026.
Election/Restrictions
Applicant’s election without traverse in the Reply filed on 3/30/2026 of Group I, claims 15-23, 25, 31, 41, 73, 128 and 132-135 is acknowledged.
Applicant has elected without traverse in the Reply filed on 3/30/2026 the following species:
A. the MHC multimer is MHC Class I monomers (claim 17)
The Restriction/Election Requirements are deemed proper and are made FINAL.
Claims 15-23, 25, 31, 41, 73, 128 and 132-135 are pending.
Claim 18 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the Reply filed on 3/30/2026.
Claims 15-17, 19-23, 25, 31, 41, 73, 128 and 132-135 are under examination in this Office Action.
Claim Rejections - 35 USC § 112-1st paragraph (Written Description)
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.
The following is a quotation of the first paragraph of 35 U.S.C. 112 (pre-AIA ):
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 15-17, 19-23, 25, 31, 41, 73, 128 and 132-135 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention. Claims 16-17, 19-23, 25, 31, 41, 73, 128 and 132-135 depend directly or indirectly from claim 15.
The specification discloses chemicals, such as HLA-A2-DBCO-SAv-Az, HLA-A2-Az-SAv-DBCO and HLA-A2-Alk-SAv-Az which meet the written description and enablement provisions of 35 USC 112, first paragraph. However, claim(s) 15 is(are) directed to encompass barcode-labeled MHC multimers, which only correspond in some undefined way to specifically instantly disclosed chemicals. None of these barcode-labeled MHC multimers, meet the written description provision of 35 USC § 112, first paragraph, due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides insufficient written description to support the genus encompassed by the claim.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
With the exception of the above specifically disclosed chemical structures, the skilled artisan cannot envision the detailed chemical structure of the encompassed derivatives, analogs, etc., regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The chemical structure itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmacentical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood , 107 F.3d at 1572, 41 USPQ2d at 1966.
Therefore, only the above chemically structurally defined chemicals, but not the full breadth of the claim(s) meet the written description provision of 35 USC § 112, first paragraph. A search of the prior art fails to identify any examples of barcode-labeled MHC multimer. The species specifically disclosed are not representative of the genus because the genus is highly variant. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC § 112 is severable from its enablement provision. (See page 1115.)
Claim Rejections - 35 USC § 103(a)
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. § 103(a) 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.
5. Secondary considerations (objective evidence of nonobviousness): a) commercial success; b) long felt need; c) evidence of unexpected results; d) skepticism of experts; and e) copying.
Common Ownership of Claimed Invention Presumed
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the Examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the Examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 15-17, 19-23, 25, 31, 41, 73, 128 and 132-135 are rejected under 35 U.S.C. 103(a) as being unpatentable over Brix et al. (01/08/2009) PCT International Patent Application Publication WO 2009/003492 A1 cited in the 5/23/2023 IDS (hereinafter known as "Brix") in view of Bentzen et al. (2016) Nature Biotechnology volume 34 pages 1037 to 1045 and online methods cited in the 5/23/2023 IDS (hereinafter known as "Bentzen").
With regards to claims 15-17, 19-20, 22-23, 25, 31, 41, 73, 128 and 132-135, Brix teaches:
a) as in claims 15-17, 19-20, 22-23, 25, 31, 41, 73, 128 and 132-135, a labeled MHC multimer comprising: (a) two or more MHC monomers; (b) a multimerization domain comprising two or more subunits and having at least one non-covalent binding site; wherein each MHC monomers is bound to a subunit of the multimerization domain through a covalent linkage; and wherein the label is bound to the multimerization domain by non-covalent binding to the non-covalent binding site on the multimerization domain; which further comprises an MHC-binding peptide loaded onto each MHC monomer of the multimer (pMHC); wherein the MHC monomers are MHC Class I monomers; wherein the MHC multimer is a tetramer; wherein the multimerization domain is streptavidin; wherein the oligonucleotide label comprises a biotin moiety and is non-covalently bound to the biotin binding site on streptavidin; wherein each MHC monomer comprises a conjugation moiety X, and each subunit of the multimerization domain comprises a conjugation moiety Y, wherein (i) X is a terminal alkyne and Y is an azide; wherein the azide is a copper-chelating azide; wherein each MHC monomer and each subunit of the multimerization domain comprises a conjugation moiety, and wherein each conjugation moiety comprises a sortag motif; wherein each MHCI monomer comprises a human MHCI heavy chain polypeptide, and a human β2-microglobulin polypeptide; wherein each MHC monomer is a fusion protein comprising an MHCI heavy chain and β2-microglobulin; wherein the multimerization domain is a tetramer; a polypeptide library comprising a plurality of the peptide loaded MHC Class I (pMHCI) multimers, wherein each of the peptide loaded pMHCI multimers comprises two or more pMHCI monomers conjugated to a multimerization domain; comprising at least two MHC monomers; comprising at least three MHC monomers; wherein the copper-chelating azide is a picolyl azide; wherein each MHC monomer comprises a peptide linker between the MHCI heavy chain and the β2-microglobulin polypeptide (see pages 12 to 92 and 225 to 232).
Brix does not explicitly teach:
a) as in claims 15 and 21, a barcode-labeled polypeptide; an oligonucleotide barcode; ; and wherein the oligonucleotide barcode is bound to the polypeptide by non-covalent binding to the non-covalent binding site on the polypeptide; wherein the oligonucleotide barcode comprises a biotin moiety and is non-covalently bound to the biotin binding site on streptavidin.
With regards to claims 15 and 21, Bentzen teaches:
a) as in claim 15 and 21, a barcode-labeled polypeptide; an oligonucleotide barcode; ; and wherein the oligonucleotide barcode is bound to the polypeptide by non-covalent binding to the non-covalent binding site on the polypeptide; wherein the oligonucleotide barcode comprises a biotin moiety and is non-covalently bound to the biotin binding site on streptavidin (see entire document especially Figure 1, pages 1037 to 1040 and online methods).
One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have had a reasonable expectation of success in arriving at the Applicant's invention as claimed with the above cited references before them. One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have recognized the advantages of substituting Bentzen's barcode for Brix's florescent label because of the high number of unique barcodes available compared to unique florescent labels allows for the labeling of many more unique molecules in a library. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the time of the effective filing date of the claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Heather Calamita can be reached at 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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 .
/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684
Prosecution Insights