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
Claims 1-12 are pending. Claims 1-12 are examined on the merits.
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, 2, 5-9, and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
First, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101 defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. The latter three categories define "things" or "products" while the first category defines "actions" (i.e., inventions that consist of a series of steps or acts to be performed). See 35 U.S.C. 100(b) ("The term ‘process’ means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material."). See MPEP § 2106.03 for detailed information on the four categories.
Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called "judicially recognized exceptions" or simply "exceptions") are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). See MPEP § 2106.04 for detailed information on the judicial exceptions.
Claim(s) 1, 2, 5-9, and 12 is/are directed to a pharmaceutical composition for treating or preventing graft-versus-host disease containing: (i) a therapeutically effective amount of a TLR5 agonist derived from flagellin; and (ii) a pharmaceutically acceptable carrier.
Analysis of the flowchart:
Step 1, is the claim directed to a process, machine, manufacture or composition of matter?
Yes. The claim is directed to a composition of matter.
Step 2A. Prong one: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
Yes, the claims are directed to nature based components, a TLR5 agonist derived from flagellin, which is a family of proteins present in flagellated bacteria, because there is no indication that extraction has caused flagellin derivative that comprises the claimed compositions to have any characteristics that are different from the naturally occurring flagellin in flagellated bacteria.
Step 2A. Prong two: Does the claims recite additional elements that amount to significantly more than the judicial exception?
No. The claim(s) of 1, 2, 5-9, and 12 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Regarding claims 1, 2, 5-9, and 12, since there is no absolute amounts of the active ingredients are claimed as compared to the whole composition, the claimed composition encompasses embodiments where the active ingredients are in such small amounts that none of them impart any characteristic or markedly different characteristic. Also, this is a product claim and since there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
Regarding claims 1, 2, 5-9, and 12, the presence of a pharmaceutically acceptable carrier (which reads on water) in the claimed composition does not result in a markedly different characteristic for the claimed composition because flagellated bacteria already comprises water and thus have that same characteristic.
Regarding claims 8, 9, and 12, a functional food composition that is taking orally does not result in a markedly different characteristic because a TLR5 agonist derived from flagellin already have the characteristic of being in a form suitable for oral consumption (see below 102 rejection for details).
Step 2B. If additional elements of the claim provide an inventive concept (Step 2B) (also called "significantly more" than the recited judicial exception).
No, no non-nature based components were recited in the claims.
For the reasons described above, the claimed compositions are not markedly different from their closest naturally occurring counterparts and thus are product of nature judicial exceptions.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements beyond the claimed compositions themselves. Also, this is a product claim and since there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
Claim Rejections –35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 5-9, and 12 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Hossain et al (US 8486408 B2).
Hossain et al teach methods are disclosed for treating or preventing graft versus host disease in a subject. The methods include selecting a subject in need of treatment for graft versus host disease; and administering to the subject a therapeutically effective amount of a TLR5 agonist such as a flagellin polypeptide (thus claim 1 (i) is met, thus a pharmaceutical composition; thus has a linker peptide), or a polynucleotide encoding the flagellin, thereby treating or preventing graft versus host disease in the subject. Methods are also disclosed for reducing susceptibility to an opportunistic infection in a subject who is a bone marrow transplant recipient. The methods include selecting a subject who has had a bone marrow or hematopoietic stem cell transplant; and administering to the subject a therapeutically effective amount of a TLR5 agonist such as a flagellin polypeptide or a polynucleotide encoding the polypeptide, and administering to the subject an effective amount antigen of the opportunistic infection, thereby reducing the susceptibility to the opportunistic infection in the subject (see Abstract).
Hossain et al teach FIG. 1 is a schematic diagram of flagellin, a TLR5 agonist (molecular size 100-150 kDa). The D0, D1, D2 and D3 domains are shown, along with the location of the N-terminal and C-terminal regions for TLR5 signaling. The D0 domain (thus claim 2 is met) consists of approximately 50 amino acid residues within the N- and C-termini, form the inner core of the flagellin protein and is responsible for flagellin's ability to polymerize into a filament. D1 domain (thus claim 2 is met) is primarily alpha-helical and highly conserved region and is required for signaling. D2 and D3 are mostly beta-strand hypervariable domains and bind with the TLR5 (col 2, lines 57-67).
Hossain et al teach in general, the nature of the carrier (thus claim 1 (ii) is met) will depend on the particular mode of administration being employed. For instance, parenteral formulations usually comprise injectable fluids that include pharmaceutically and physiologically acceptable fluids such as water, physiological saline, balanced salt solutions, aqueous dextrose, glycerol or the like as a vehicle. For solid compositions (such as powder, pill, tablet, or capsule forms), conventional non-toxic solid carriers can include, for example, pharmaceutical grades of mannitol, lactose, starch, or magnesium stearate (col 13, lines 3-13).
Hossain et al teach suitable routes of administration include intramuscular, intraperitoneal, subcutaneous, or intravenous injection, but even oral (thus a functional food composition, thus claims 8 and 9 are met), nasal, transdermal, inhalation or anal administration is contemplated (col 28, lines 3-8).
The intended use of the composition was analyzed for patentable weight. It is deemed that the preamble ‘breathes life’ into the claims in that the prior art product must not be precluded for use to promote production of IL-22 and IL23 derived from a host, to increase graft-versus tumor effect, to suppress a decrease in intestinal stem cells of a host, to alleviate graft-versus-host disease. It is deemed that the composition disclosed by the cited reference is not precluded for carrying out the intended function of the claims.
Therefore, the reference is deemed to anticipate the instant claim above.
Claims 1, 3-8, and 10-12 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Zhang et al (US 2016/0060305 A1).
Zhang et al teach the application of flagellin derivative CZLC31 from Salmonella in preparation of medicines for preventing and treating inflammatory bowel disease (IBD) (thus pharmaceutical, thus claims 1, and 4-7 are met) is introduced in this invention. The CZLC331 protein has a good preventive and therapeutic effect for IBD, such as ulcerative colitis (UC) and Crohn's disease (CD) in this invention. Therefore, this protein can be prepared into the drug for prevention and treatment of IBD. It has been found that the bad efficacy, slow onset, long course of treatment, side effects can be significantly avoided for existing clinical IBD drugs, it can reduce the patient's pain during the treatment in this invention. The rehabilitation and quality of life of the patients have been largely improved. The drug will play an important role in the prevention and treatment of IBD in this invention, and has broad application prospects (see Abstract).
Zhang et al teach sequence No. 3 (col 7-8) has a 100% query match with the claimed SEQ ID No. 1 in claims 3 and 10 (thus amino acid sequence, thus claims 3 and 10 are met).
Zhang et al teach sequence No. 4 (col 8-9) has a 100% query match with the claimed SEQ ID No. 2 in claims 4 and 11 (thus amino acid sequence, thus claims 4 and 11 are met).
Zhang et al teach the drug containing CZLC331 protein can be prepared into injection, oral (thus a functional food composition, thus claims 8, 11, and 12 are met) enema, capsules (thus a carrier, thus claims 1(ii) and 8 (ii) is met), enteric-coated tablets, powders or tablets, and the better is injection, enema, or enteric-coated tablets in this invention [0017].
The intended use of the composition was analyzed for patentable weight. It is deemed that the preamble ‘breathes life’ into the claims in that the prior art product must not be precluded for use to treat or prevent graft-versus-host, to promote production of IL-22 and IL23 derived from a host, to increase graft-versus tumor effect, to suppress a decrease in intestinal stem cells of a host, to alleviate graft-versus-host disease. It is deemed that the composition disclosed by the cited reference is not precluded for carrying out the intended function of the claims.
Therefore, the reference is deemed to anticipate the instant claim above.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIUWEN MI whose telephone number is (571)272-5984. The examiner can normally be reached on Monday-Friday 8:30 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655
