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
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.
Response to Restriction
Applicant's response to restriction requirement and election of group I corresponding to claims 44-51 and 57, with traverse, in the reply filed on 06/15/2026 is acknowledged.
Applicants traversal of restriction is on the grounds that all of the claims of Groups I-III are linked by a common inventive concept, namely the polypeptide claimed in Group I, which is encoded by the nucleic acid of Group II, and used in the treatment method of Group III. Therefore, all of claims 44-63 have unity of invention.
Polypeptide is totally different from nucleic acid and cell etc, at least based on its structure and function. These are also belongs to different classification. Accordingly, there is no common technical feature among the groups I-III.
The examiner also acknowledges applicants election of SEQ ID NO:1 as a species for the claimed polypeptide. Claims 44-50 and 57 encompass the elected species.
Claims 51-56 and 58-63 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
The claims 44-50 and 57 are examined, in light of elected SEQ ID NO:1, on merits in this office action.
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 47 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 pre-AIA the applicant regards as the invention.
Claim 47 recites claimed polypeptide does not comprise an amino acid sequence according to SEQ ID NO:2.
Claimed SEQ ID NO:1 is part of SEQ ID NO:2 and cannot be excluded. So, it is not clear what applicants intend to exclude. Intend to exclude other than SEQ ID NO:1? Therefore, it is impossible under understand the metes and bounds of claimed subject matter. Accordingly, claim is rendered indefinite.
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 44-51 and 57 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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The claims recite and involve the judicial exception of natural products. The claims are directed to naturally-occurring products which encompass naturally occurring protein and do not recite something significantly different from the naturally occurring products. The claims as a whole do not recite or include elements to the judicial exception of naturally occurring protein that practically apply the products in a significant way by adding significantly more than the natural product and do not recite features that are markedly different from what exists in nature.
The claims are drawn to a peptide comprising or consisting of an amino acid sequence according to general formula (IIa): SCFFX3 YLX4RX6 GX8X9KG SRX10C, wherein X3 is I or deleted, X4 is P or D, X6 is Q or deleted , X8 is T or Y, X9 is K or Q, and X10 is S or G.
The elected species is represented by the following sequence:
KKGSR SCFFI YLDRG TKKGS RSCFF YLP [SEQ ID NO:1.
Applicants acknowledged that the following sequence [SEQ ID NO:2] is microbiota protein:
AFLFTSTGVPKKAAEAAFFLYLNKGTKKGSRSCFFIYLDRGTKKGSRSCF FYLPRQGYQKGSRGCFFIYLDRGTKKGSRGCFFIYLDCEKRAGNVCIRKC RGRYLHKKTPRRYRNAEATCS
So, the above sequence is naturally occurring protein and elected SEQ ID NO:1 [underlined] is part of natural product.
Claimed polypeptide “comprises” elected sequence, since “comprises” is open language, so, it reads SEQ ID NO:2.
Claimed polypeptide consisting of elected sequence, so, it is part of naturally occurring protein. However, mere cleavage of peptide bonds is insufficient to demonstrate a difference from the full-length protein, similar to isolated DNA ruled to be ineligible in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589-91, 106 USPQ2d 1972, 1978-79 (2013). There is no indication from the claims that any function is found in claimed sequences that is distinct from the full-length protein.
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 judicial exception is not integrated into a practical application because there are no applications claimed, in other words 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.
The pharmaceutical composition language itself implies no application, and no further limitations or dependent claims offers any particular application of the claimed polypeptide.
For these reasons, claims are rejected under 35 USC 101 as being directed to non-statutory subject matter.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
Prosecution Insights