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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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Information Disclosure Statement
Applicants filed information disclosure statements (IDS) comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to 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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claims recite naturally occurring peptide which are not markedly different from the naturally occurring counterpart because it conveys the same structural and functional characteristics. This judicial exception is not integrated into a practical application for the reasons set forth below.
Claims are analyzed based on the guidance provided in the MPEP sections 2104, 2105 and 2106, also please see the flow chart(s) below.
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In the above flow chart, the Step 2A is further streamlined as shown below:
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Independent claim 1 is drawn to a pharmaceutical composition, with the recited intended use, comprising a peptide comprising an amino acid sequence represented by SEQ ID NO: 1, 2, 3, 4, 5 or a mixture thereof as an active agent.
Independent claim 4 is drawn to a health food, with the recited intended use, comprising a peptide comprising an amino acid sequence represented by SEQ ID NO: 1, 2, 3, 4, 5 or a mixture thereof as an active agent.
First, claims are interpreted as product claims, because the recited intended use does not structurally change peptide and also nothing is administered and so, no practical application. Second, the term “comprising” in the claim language does not exclude any other sequence in the claimed SEQ ID NOs:1-5. Accordingly, any known sequence comprising the claimed sequences reads applicants claimed subject matter.
The claimed SEQ ID NOs: 1-5 are part of naturally occurring peptide, as evidenced from the following document,
UNIPROT_1986 document [P01400.3NO2B_NAJME, Weak toxin S4C11] discloses sequence
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The above sequence is a natural product and present in Naja melanoleuca (Forest cobra).
In light of the term “comprising” in the claim language, the above sequence is identical to applicants claimed peptides.
Claims can also be analyzed based on The Myriad Supreme Court decision (Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 12-398 (2013)), which states that “Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together” (page 2 and 14). In the instant case, the claims are not saved by the fact that the peptide of the instant claims correspond to a fragment of a natural protein (the protein with severed bonds).
Further peptide is present in the cytoplasm of cell, and it is interpreted as a composition, which can be a nutrient etc. Dependent claims also do not recite additional elements, which change the structure of peptide and so, these are also interpreted as product claims.
Because there is no difference between the claimed and naturally occurring peptide, the claimed peptide does not have markedly different characteristics from what occurs in nature, and thus is a “product of nature” exception. Accordingly, the claim is directed to an exception (Step 1: YES). In relation to PRONG ONE of Step 2A, the answer is YES, because the peptide corresponds to natural product. In relation to PRONG TWO of Step 2A, the claim is drawn to a product and does not require any additional elements that apply the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Thus, the answer to PRONG TWO of Step 2A is NO. The claim does not recite any additional elements, so Step 2B is NO.
For these reasons, claims are rejected under 35 USC 101 as being directed to non-statutory subject matter.
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 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.
(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 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by UNIPROT_1986 document [P01400.3NO2B_NAJME, Weak toxin S4C11].
UNIPROT_1986 document discloses sequence
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In light of the term “comprising” in the claim language, which is an open language and does not exclude additional sequence in it, the above sequence is identical to applicants claimed peptides.
Also, claims are interpreted as product claims, because the recited intended use, either in the preamble or in the claim language, does not structurally change peptide(s), see MPEP 2111.02, and also nothing is administered.
Accordingly, claims are fully anticipated.
Nonstatutory Double Patenting Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
(i) Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US copending application 17/782,336.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
For claims 1-2:
Claim 1 or 4 of US copending application disclose a pharmaceutical composition for preventing or treating Behcet's disease or rheumatoid arthritis, comprising a peptide comprising an amino acid sequence represented by SEQ ID NO: 1, a peptide comprising an amino acid sequence represented by SEQ ID NO: 2, a peptide comprising an amino acid represented by SEQ ID NO: 3, a peptide comprising an amino acid represented by SEQ ID NO: 4, a peptide comprising an amino acid represented by SEQ ID NO: 5, or a mixture thereof as an active ingredient.
Claims in both cases are interpreted as product claims, because the recited intended use does not structurally change peptide and also nothing is administered, i.e., no practical application.
So, in both cases the product(s) are identical and accordingly, claim is anticipated.
For claim 3:
Claim 2 of US copending application disclose the pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a formulation selected from the group consisting of oral preparations, external preparations, suppositories, and injections.
For claim 4:
Claim 6 of US copending application disclose a health food for preventing or ameliorating rheumatoid arthritis, comprising a peptide comprising an amino acid sequence represented by SEQ ID NO: 1, a peptide comprising an amino acid sequence represented by SEQ ID NO: 2, a peptide comprising an amino acid represented by SEQ ID NO: 3, a peptide comprising an amino acid represented by SEQ ID NO: 4, a peptide comprising an amino acid represented by SEQ ID NO: 5, or a mixture thereof as an active ingredient.
Claims in both case are interpreted as product claim, because the recited intended use does not structurally change peptide and also nothing is administered, i.e., no practical application.
So, in both cases the product(s) are identical and accordingly, claim is anticipated.
(ii) Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US copending application 18/554,481.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
For claims 1-2:
Claims 1-2 and 10-11 of copending application disclose fragments represented by SEQ ID NOs: 1-3 and pharmaceutical composition.
Fragments represented by SEQ ID NOs:1-2 in the claim of copending application are identical to SEQ ID NOs:1-2 in the instant claims.
Fragment represented by SEQ ID NO: 3 in the claim of copending application is identical to SEQ ID NO:4 in the instant claims.
Claims in both cases are interpreted as product claims, because the recited intended use does not structurally change peptide and also nothing is administered, i.e., no practical application.
So, in both cases the product(s) are identical and accordingly, claim is anticipated.
For claim 3:
Claim 12 discloses a pharmaceutical composition of claim 10, wherein the pharmaceutical composition is any one selected from the group consisting of an oral agent, external agent, suppository, and injection agent.
For claim 4:
Claim 15 of US copending application discloses a health functional food composition for preventing or alleviating an inflammatory disease or autoimmune disease, comprising one or two or more selected from the group consisting of the peptide or fragment thereof according to claim 1.
Claims in both cases are interpreted as product claim, because the recited intended use does not structurally change peptide and also nothing is administered, i.e., no practical application.
So, in both cases the product(s) are identical and accordingly, claim is anticipated.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658