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
The information disclosure statement (IDS), dated 05/19/2022, 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 1-2 and 6-10, with traverse, in the reply filed on 06/10/2026 is acknowledged.
Applicants’ traversal of restriction is on the ground(s) that USPTO fails to properly assert why and/or how the pending claims lack unity a priori and unity a posteriori. Therefore, the instant Unity of Invention Requirement is procedurally deficient and all claims/asserted Groups should be concurrently examined.
In fact, restriction requirement explained the reasons for lack of unity. For example, as explained previously, in group I, X3 is Ala or Gly, whereas in group II, X3 is positively charged amino acid, so both are different. Similarly, nucleic acid in group VII and antibody in group VIII are totally different from the remaining product claims. Accordingly, there is no common technical feature connecting all the groups.
The examiner also acknowledges applicants response to election of species and providing a single species, viz., SEQ ID NO:1, for the claimed oligopeptide, which reads claims 1-2 and 6-7.
Claims 3-5, 8-10 and 12-21 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 1-2 and 6-7 are examined, in light of elected SEQ ID NO:1, on merits in this office action.
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.
(i) Claims 1-2 and 6-7 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 an oligopeptide has a length of 3 to 7 amino acids, represented by THGRGFI.
The above sequence is part of the following naturally occurring protein [see US2010/0203060A1]:
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[see SEQ ID NO:1 in pages 35-36].
In the above sequence is positions from 73 to 79 amino acids are identical to applicants elected species, 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.
For these reasons, claims are rejected under 35 USC 101 as being directed to non-statutory subject matter.
(ii) Claims 1-2 and 6-7 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.
---See the Charts in the above 101 rejection---
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 an oligopeptide has a length of 3 to 7 amino acids, represented by THGRGFI.
The above 7 amino acid sequence is a naturally occurring product, as evidence from the following GenBank: AAB20171.1, which discloses same sequence THGRGFI, and its source is from Papio (baboons), see below:
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Further, 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.
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 1-2 and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prolactin_1993 [see GenBank: AAB20171.1, 1993].
Prolactin_1993 discloses following sequence, see at the bottom of the page:
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Above sequence is identical to applicants elected species. Accordingly, claims are fully 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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