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 03/22/2022, 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 1-5, 7-9 and 22-30, without traverse, in the reply filed on 11/03/2025 is acknowledged.
The examiner also acknowledges applicants response to election of species and providing a single species for the claimed compound.
Claims 15-16 and 21 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 1-5, 7-9 and 22-30 are examined on merits in this office action.
Claim objections
Claims 2 and 24-25 are objected to because of the following informalities:
In the recited motif, the variables n, m, o and p, and their corresponding values should be represented by subscripts. Appropriate correction is required.
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.
Claims 2-3 and 24-26 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 pre-AIA the applicant regards as the invention.
Claims recite “/” (slash) in the sequence, which is confusing because it is unclear whether the slash stands for “and” or “or” or “and/or”.
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 1-3, 7-9, 22-27 and 29-30 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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Loo discloses the following sequence:
QCKPN GAKCT EISIP PCCSN FCLRY AGQKS GTCAN R, which is extracted from Pereskia bleo of the Cactaceae family [see abstract and Fig. 2].
The above sequence is identical to applicants claimed SEQ ID NO:1.
So, claimed peptide is a natural product because it occurs in nature and exists in principle apart from any human action. 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 claims do not recite any additional elements that integrate the judicial exception into a practical application, so the Step 2B is NO.
Although claimed peptide is identified as ‘a recombinant peptide having EGFR-binding activity’, however, this observation does not, by itself render recited peptide patent eligible. Instead, the claimed peptide is analyzed to determine if separating the peptide from its surrounding material, either from recombinant technology or isolation from cells, has resulted in the purified peptide having markedly different characteristics from its naturally occurring counterpart. Based on the limited background information, there is no indication that recombinant or purified recited peptide has any characteristics (structural, functional, or otherwise) that are different from naturally occurring peptide. Claims therefore encompasses peptide that is structurally and functionally identical to naturally occurring peptide. 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.
So, claims recite naturally occurring protein, offer no differences, contain no practical applications, and do not recite any other elements that amount to significantly more than the judicial exception, the claims are rejected as being drawn to ineligible 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 1-3, 7-9, 22-27 and 29-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Loo (Frontiers in Plant Science, Dec 2017, vol.3, Article 2162, 1-13).
For claim 1:
Loo discloses the following sequence:
QCKPN GAKCT EISIP PCCSN FCLRY AGQKS GTCAN R [see Fig.2].
The above sequence is identical to applicants claimed SEQ ID NO:1.
With regard to preamble “recombinant”, the body of the claim does not depend on the preamble for completeness, but instead the structural limitations are able to stand alone. In other words, since the peptides are identical and so, ‘how the peptide is obtained or prepared’ is not relevant in this context.
With regard to recited property “having EGFR binding activity”, since the amino acid sequence is identical, and so the recited property is inherent to the peptide.
Accordingly, claim is fully anticipated.
For claims 2-3:
In the above sequence from Loo, Cys are present at positions 2, 9, 17, 18, 22 and 33.
In the claimed motif, C(X)nC(X)mCC(X)oC(X)pC, when n is 6, m is 7, o is 3 and p is 10, which is identical to motif 2-33 amino acid sequence of Loo.
In the claimed motif, YXGXK, when X is any amino acid, which is identical to motif 25-29 amino acid sequence of Loo.
For claim 7:
The peptide of Loo has 5 positively charged amino acids, viz., three Lys and two Arg, and one negatively charge amin acid Glu. So, peptide has a positive net charge.
For claim 8:
Loo discloses that their peptides has three disulfide bonds [see section NMR Structure of Bleogen pB1 and Fig.5].
For claim 9:
Loo discloses an amino acid sequence, which is identical to applicants claimed peptide, and so the recited property is inherent to the peptide.
For claims 22-23:
See For claim 1 above.
For claim 24:
See For claims 2-3 above.
For claim 25:
Loo discloses the following sequence:
QCKPN GAKCT EISIP PCCSN FCLRY AGQKS GTCAN R [see Fig.2].
In the above sequence, Cys are present at positions 2, 9, 17, 18, 22 and 33.
In the claimed motif, when n is 6, m is 7, o is 3 and the sequence in between Cys-22 and Cys-33 is LRYAGQKSGT, then claimed SEQ ID NO:4 is identical to motif 2-33 amino acid sequence of Loo.
For claim 26-27:
Loo discloses the following sequence:
QCKPN GAKCT EISIP PCCSN FCLRY AGQKS GTCAN R [see Fig.2].
In the above sequence, Cys are present at positions 2, 9, 17, 18, 22 and 33.
In the claimed motif, when X is any amino acid and when sequence in between Cys-2 and Cys-9 is KPNGAK, when sequence in between Cys-9 and Cys-17 is TEISIPP, when sequence in between Cys-18 and Cys-22 is SNF, and sequence in between Cys-22 and Cys-33 is LRYAGQKSGT, then claimed SEQ ID NOs: 5 and 6 are identical to motif represented by 2-33 amino acid sequence of Loo.
For claim 29:
Loo discloses that their peptides has three disulfide bonds, in between Cys-2 and Cys-18, Cys-9 and Cys-22, and Cys-17 and Cys-33 [see section NMR Structure of Bleogen pB1 and Fig.5].
For claim 30:
Loo discloses an amino acid sequence, which is identical to applicants claimed peptide, and so the recited property is inherent to the peptide.
Accordingly claims are fully anticipated.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7-9 and 22-30 are rejected under 35 U.S.C. 103 as being unpatentable over Loo (Frontiers in Plant Science, Dec 2017, vol.3, Article 2162, 1-13) in view of Feng (BioMol Concepts, 2016, 7(3), 179-187) and Sela (The FASEB Journal, May 1997, vol.11, 449-456).
For claims 1-3, 7-9, 22-27 and 29-30, see above 102 rejection.
For claims 4-5 and 28:
Loo is silent on D-amino acids in their peptide. However, the following art teaches advantages of D-amino acids over L-amino acids:
Feng teaches that D-amino acids enhance biostability of peptides [see sections D-amino acids enhancing biostability and Outlook].
Sela teaches that D-amino acids show high specificity towards immune response play dominant role, and states that D-amino acids may be an advantage in terms of both specificity and efficacy, the later because longer persistence, in an undigested form because they resist enzymatic degradation [see abstract].
Therefore, a skilled person in the art would be motivated to replace L-amino acid(s) with D-amino acid(s).
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants sequence and advantages of D-amino acids, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed product with a reasonable expectation of success.
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