Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claims 1-6 are pending and under examination.
Claim Objections
Claims 1-4 are objected to because of the following informalities: the claims contain grammatical errors, redundant, and convoluted language.
Claim 1 also recites MOG35-55, which is an acronym, but does not recite what the acronym stands for.
See suggested amendment on starting on page 8 of this Office action. Appropriate correction is required.
Claim Rejections - 35 USC § 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.
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.
Claims 1-6 are 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.
Claims 1-6 recite a recombinant protein capable of resisting multiple sclerosis. It is unclear what the phrase “capable of resisting multiple sclerosis” means. It is unclear if the claim means that the protein is capable of treating multiple sclerosis, or if the claim means something else.
Regarding claim 1, "i.e.," renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 1 also recites: wherein a sequence of the recombinant protein is SEQ ID NO:1. Because the claim recites “a sequence”, it is unclear if the claim requires a fragment of the amino acid sequence of SEQ ID NO:1 or if the claim requires the full-length amino acid sequence of SEQ ID NO:1.
Claims 2-6 are also rejected as they depend from claim 1.
Claim 2 recites: building a recombinant plasmid…to obtain engineering bacteria having the recombinant plasmid. However, building a recombinant plasmid does not result in the development of engineered bacteria. Therefore, the claim language is scientifically incorrect.
Claim 4 recites the limitation "the target protein" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101 and 35 USC § 112(b)
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.
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.
MPEP § 2173.05(q) “Use” Claims, states:
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph...
"Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961) ("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid."
Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim.
It is appropriate to reject a claim that recites a use but fails to recite steps under 35 U.S.C. 101 and 35 U.S.C. 112(b) if the facts support both rejections.
“An application of” is considered to be synonymous with “use of”.
Claims 5 and 6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are “use” claims that do not purport to claim a process, machine, manufacture, or composition of matter. As noted above, MPEP § 2173.05(q) states that "use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101.
Claims 5 and 6 are also 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. Claims 17 and 18 are indefinite because they are “use” claims that attempt to claim a process without setting forth any steps involved in the process. As noted above, MPEP § 2173.05(q) states that attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Pertinent Prior Art
The closest prior art references are that of Rezende et al., (Hsp65-producing Lactococcus lactis prevents experimental autoimmune encephalomyelitis in mice by inducing CD4+LAP+ regulatory T cells; J Autoimmun. 2013 February; 40: 45–57) Sahin et al., (WO 2018/189193 A1; cited in the IDS filed 12/28/2023), Siegel et al., (US 6,495,347 B1).
Rezende teaches that administration of Hsp65 prevented experimental autoimmune encephalomyelitis (EAE), which is a rodent model for multiple sclerosis, in mice (Abstract). Rezende teaches that EAE was induced using MOG35-55 (p. 3, para. 3). Rezende does not teach an Hsp65- MOG35-55 fusion protein, or teach a 6-segment tandem repeat of MOG35-55.
Sahin teaches non-immunogenic RNA for the treatment of autoimmune diseases (Abstract) and teaches that said RNA forms the basis for the development of therapeutic agents for inducing tolerance towards an autoantigen (p. 1, para. 1). Sahin teaches that the T cells may be autoreactive with the autoantigen and teaches that the autoimmune disease may be Multiple Sclerosis (p. 3, para. 5). Sahin teaches that the autoantigen may be Myelin Oligodendrocyte Glycoprotein (MOG) comprising amino acids 35-55 of MOG (p. 5, para. 3). Sahin does not teach: heat shock proteins, a MOG fusion protein, a 6-segment tandem repeat of MOG35-55, or a sequence with any sequence similarity to SEQ ID NO:1.
Siegel teaches fusion proteins that elicit a Th1-like response wherein said fusion protein comprises at least a portion of a heat shock protein (Abstract). Siegel teaches that the fusion protein can contain the full-length amino acid sequence of Hsp65 (col. 2, para. 1). Siegel teaches a sequence that shares 78.1% sequence identity with instant SEQ ID NO:1, which is the closest prior art sequence (see alignment below). Siegel does not teach an Hsp65-MOG35-55 fusion protein, or teach a 6-segment tandem repeat of MOG35-55.
Thus, there are no prior art references that teach an Hsp65-MOG35-55 fusion protein, a 6-segment tandem repeat of MOG35-55, or a sequence that shares 100% sequence identity to instant SEQ ID NO:1.
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Examiner Comment
To obviate the objections and rejections presented in this Office action, Applicant may consider the following amendment, which has been drafted by the Examiner:
Claim 1. A recombinant fusion protein a 6-segment tandem repeat of myelin oligodendrocyte glycoprotein epitope (6MOG35-55), 35-55 are connected through an Ala-Ser-Ala linkerthefusion protein is SEQ ID NO.1.
Claim 2. A method of preparingfusion protein
(1) transforming bacterial cells with a recombinant pET28a plasmid comprising the gene encoding the recombinant fusion protein of claim 1 fused to a His taged
(2) culturing the engineeredinuntil the bacteria reach a logarithmic growth period[[,]]; adding a sterile lactose solution of 0.5 mol/L to reachlactose concentration ofing the bacteriaadditional hours[[,]]; and, collecting the bacteria;
(3) separating recombinant fusion protein from
Claim 3. The
inserting the 6MOG35-55 gene into a pET-28a(+) vector to obtain a35-55 plasmid; conducting PCR amplification on a template of the 35-55 plasmid to obtain a target gene segment 35-55
ngwith NheI and HindIII restriction enzymes to obtain a linearized cloning vector;
recombining the target gene segment 35-55 ed
Claim 4. The comprises:
lysing collected bacteria on ice to obtain inclusion bodies comprising therecombinant fusion proteinies, purifying the recombinant fusion a Ni-NTA agarose gel column to obtain the recombinant fusion protein comprising His-HSP65-6MOG35-55.
Cancel claims 5 and 6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL EMILY MARTIN whose telephone number is (703)756-1416. The examiner can normally be reached M-Th 8:30-16:00, F 8:30-10:00 EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657