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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 5-10, 22 in the reply filed on 08-12-2025 is acknowledged.
Claims 13-16, 18, 21, 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 08-12-2025.
Applicant further indicates an election of species with traverse. Examiner notes that no election “B.)” is provided for Group I election (particular SEQ ID NO: ) . Examiner will Examine SEQ ID NO: 1 with respect to the Group I invention election.
Regarding the indicated elections, Applicant states that the excipient of claim 7-8 are fully substitutable for each other and well known. Likewise Applicant argues that the election of claim 9-10 are well known existing treatments for rheumatoid arthritis. In reply Examiner withdraws the species elections above. Examiner provides rejections based on the original elected species as indicated below.
Therefore Claims 1, 5-10, 22 are examined on the merits below.
Claim Rejections - 35 USC § 112
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.
Claim 10 is 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.
The instant claim 10 describes that immunomodulatory composition are selected from the group consisting of a variety of additional agents. However nested within the claim are “including” phraseology after “DMARDs” and (TNF)-alpha inhibitors. While Applicant describes a subset of particular inhibitors within the claim , one does not know the limitations of the claim as to what other DMARDs or TNF-alpha inhibitors for example, Applicant might consider to be encompassed by the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 5, 6, 7-8, 22 rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Instant claim 1 describes a composition comprising one or more peptides which have at least 90% or at least 95% sequence identity to the provided sequences. Claim 5 indicates an immunomodulatory composition which comprises APC which are loaded with one or more peptide as presented in claim 1. Claim 6 describes that the APC are “tolerogenic dendritic cells”. Claims 7-8 describe that the composition comprises additional generic buffering agent for example, as a saline, PBS or Ringer-lactate solution (claim 8). Claim 22 describes that the composition may comprise for example serum or “autologous serum”.
Regarding the instant claims rejected for instance Applicant in the specification describes that the peptide sequences which were identified and presented in claim 1 were isolated through a protocol ,wherein in particular embodiments, MHC molecules comprising loaded peptides were isolated from dendritic cells naturally occurring or pulsed with synovial flued from rheumatoid arthritis subjects utilizing mass spectrometry. The peptides were then sequenced through routine methods. Thus regarding the instant claims 1, 5, 6 the Applicant has simply isolated the peptides which were found naturally occurring as in particular instances as surface expressed MHC-peptide complexes on dendritic cells. Applicant simply applied known routine and conventional mass spectrometry method to isolate the claimed sequences found naturally occurring as processed and presented on the cell surface by an APC such as a dendritic cell. Further supporting the presence of the claimed sequences as naturally occurring peptide, the disclosure of Klareskog (WO2012138294A1 of record) provides “novel peptide” which bind to class II MHC and their use in diagnosis and treatment of rheumatoid arthritis (0023-0027). Klareskog discloses a peptide as SEQ ID NO: 61 derived from vimentin-1 (table 3) which is greater than 90% similar to the instant claimed sequence ID number 1 with only a single amino acid appearing at the N terminal region of the instant SEQ ID NO:1 .
RESULT 1
US-17-638-770A-1
Query Match 94.5%; Score 69; DB 1; Length 15;
Best Local Similarity 100.0%;
Matches 14; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 FRQDVDNASLARLD 14 SEQ ID NO: 61 WO2012138294A1
||||||||||||||
Db 2 FRQDVDNASLARLD 15 SEQ ID NO: 1 17638770
Furthermore regarding claim 6 Klareskog describes that tolerogenic dendritic cells are known in the art and that peptides which are discovered may be linked for example to the dendritic cells , as cells which are expressing the peptide in complex with MHC CII molecules would qualify (0080).
Instant claims 7, 8, 22 involve additional formulation of the composition wherein the composition comprises additional relatively generic components such as for example , a diluent or “buffering agents” (claim 7), as sterile saline solution , with additional components as “autologous serum” for instance. Regarding the claim 7, 8, 22 for instance, the analysis to be performed is whether the additional claim elements rise to the level of providing a composition which has markedly different characteristics compared to naturally occurring tolerogenic dendritic cells. Comparing the composition of claim 7, 8 for example as a “buffering agent” for example one may find that a naturally occurring tolerogenic dendritic cell comprised in a subject would be found for example in lymphoid organs, peripheral blood or other immunological tissues. Such a cell would naturally be exposed to a solution such as lymph fluid or peripheral blood which comprise naturally occurring buffering agents such as the bicarbonate buffered system. Additionally regarding claim 8 the blood naturally comprises sodium chloride (“saline solution”) and is typically “sterile”. Regarding the claim 22 and the additional component of serum for instance, serum may be isolated from the peripheral blood naturally , therefore a tolerogenic dendritic cell would naturally be expected to be found in a composition which comprises autologous serum. Therefore as indicated above none of the additional components of claims 7, 8, 22 rise to the level of providing a composition which has markedly different characteristics compared to the naturally occurring dendritic cell which may present the claimed peptide in combination with MHC class II molecules on its surface.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 5, 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Klareskog (WO2012138294A1 of record).
As described above the instant claim 1 provides an immunomodulatory composition comprising one or more peptides having an amino acid sequence 90% identical to “an amino acid sequence” of for example SEQ ID NO: 1 (SFRQDVDNASLARLD) which is derived from vimentin-1 protein. Anticipating claim 1, as provided above the disclosure of Klareskog relates to among other proteins, vimentin peptide which are useful in the treatment of autoimmune disease such as rheumatoid arthritis (0079). The peptide of the disclosure include the amino acid sequence of SEQ ID NO: 61 which has at least 90% homology to the claimed peptide sequence and 100% homology over 14 amino acid length which may be expected to be responsible to binding to a peptide-MHC class II antigen binding cleft/groove (table 3). The disclosure describes peptide between 8 and 20 amino acid which comprise at least 8 consecutive amino acid residues with a sequence present in SEQ ID NO: 61. Thus the extra N terminal S (SEQ ID NO:1) may be accounted for as well as the C terminal T of the SEQ ID NO: 61 of Klareskog (“claims”, p64 claim 1).
Regarding claims 5, 6 and wherein tolerogenic dendritic cells are loaded with peptide SEQ ID NO: 1 for example, the disclosure of Klareskog describes that immunomodulatory composition are contemplated as comprising peptide, for example SEQ ID NO: 1 thereby “linked to tolerogenic dendritic cells” (0080) for the purposes of administration to a subject.
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) 7-10, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Klareskog as applied to claim 1, 5, 6 above, and further in view of Thomas (WO2013138871A1).
Claim 7 and 8 describe an immunomodulatory composition which further comprises a pharmaceutically acceptable excipient (claim 7) as potentially phosphate buffered saline (claim 8). The disclosure of Klareskog provides tolerogenic dendritic cells which comprise peptide that are 90% identical to the SEQ ID NO:1 for example for administration to human subjects. The disclosure of Klareskog does not provide the particular additional components as in claim 7 and 8. However the disclosure of Thomas (WO2013138871A1) relates to in particular embodiments treatment of subjects with manufactured and purified tolerogenic dendritic cells which are loaded with antigen involved in the etiology of rheumatoid arthritis (p136-137). Vimentin antigenic peptide are particularly indicated as desirable peptide for use in production of tolerogenic dendritic cells (0289, 0008, Table 5). The disclosure of Thomas further describes that produced tolerogenic dendritic cells of the invention may be formulated as compositions which comprise buffering media such as phosphate buffered saline (p136, 5-10) or Ringer’s solution (p137, 1-15). It therefore would be obvious to provide the cells of Klareskog in a formulation which comprises acceptable additional components as provided by Thomas for the purposes of maintaining cellular health and viability.
Regarding claim 22 and the additional component of serum or autologous serum added to the pharmaceutical composition , the disclosure of Thomas describes that appropriate pharmaceutical carrier of the invention for use in cellular compositions may comprise the growth media in which the cells were grown (p136, 5-10). The disclosure further indicates that composition of the invention such as peripheral blood mononuclear cells which may comprise dendritic cells as APC were cultured in RPMI and 10% human serum from healthy or allogeneic donors (0306). It would thereby be obvious to utilize serum (autologous or heterologous) in a composition comprising tolerogenic dendritic cells of Klareskog for example as a previously disclosed composition known to provide appropriate conditions for cell health and viability.
Claims 9 and 10 describe that cells of the composition may be administered as a composition which comprises an additional active pharmaceutical ingredient (claim 9) and particularly DMARDs including methotrexate as one example. Regarding claims 9 and 10 the disclosure of Thomas indicates that cellular composition of the invention may be administered as a stand-alone therapy or in conjunction with other therapeutics such as methotrexate (p136, 5-13). It would therefore be obvious to utilize the cells of Klareskog in combination with methotrexate as disclosed by Thomas for the purposes of providing additional treatment modality for rheumatoid arthritis as disclosed by Thomas as known in the art.
Conclusion
Summary: No claims are allowed.
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/BRIAN HARTNETT/ Examiner, Art Unit 1644
/JANET L ANDRES/ Supervisory Patent Examiner, Art Unit 1671