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 .
Status of the application
Receipt of applicant’s remarks and claim amendments filed on 04/21/2026 are acknowledged.
In light of claim amendments, previous 101 and 102 rejections are withdrawn.
However, applicants’ arguments for the previous 103 rejection are found not persuasive. Accordingly, the previous rejection is maintained and modified to address claim amendments.
In addition, a new Claim Objections is made.
Response to Arguments
Applicants’ main argument is that Loo fails to disclose, teach, or suggest that bleogen pB 1 has EGFR binding activity and that the YXGXK/R (SEQ ID NO:3) motif plays a role in such activity. Loo also fails to disclose substitutions with D-amino acids in this motif at specific positions may increase the peptides EGFR binding affinity. Loo merely refers to bleogen pB 1 having heparin binding activity and utility as an antimicrobial peptide.
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, absent evidence to the contrary.
In addition, the following case laws support the above reasoning:
A compound and all of its properties are generally inseparable. In re Papsech, 315 F2d. 381, 137 USPQ 43, (CCPA 1963).
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
Claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
“Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning tending to show inherency, the burden shifts to the applicant to show an unobvious difference.”
“[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).” (MPEP 2112 V) (MPEP 2100-48).
With regard to D-amino acids, as explained in the rejection, cited Feng and Sela teach advantages of D-amino acids over L-amino acids. Therefore, a skilled person in the art would be motivated to replace L-amino acid(s) with D-amino acid(s).
Feng and Sela broadly and non-specifically generally refer to D-amino acids and their impact on biostability of therapeutic peptides. Feng and Sela fail to refer to the bleogen pB 1 peptide or its ability to bind to EGFR, let alone suggest or provide any guidance to the skilled person as to which amino acid residue or combination of residues that may be substituted with D- amino acids or why, with any reasonable expectation or anticipation of the effects attained thereof in regards to binding affinity to EGFR. A person skilled in the art, reading Feng and Sela therefore fail to provide any motivation or reasonable expectation of success for substituting residues 25 or 29 to modulate EGFR binding.
Purpose of Feng and Sela is to show the advantages of D-amino acids over L-amino acids in the peptides or proteins. Moreover, such replacements are well known and common practice in the art and so, can be applicants to divergent peptides.
If applicants think (i) such modifications are not possible for the claimed sequence, and (ii) replacement of L-amino acids with D-amino acids at specific positions have advantage, then applicants need to provide comparative data to prove the evidence.
Applicants argue that Loo, Feng, and Sela, alone or in combination, all fail to disclose the listed distinguishing features in the claims for the claimed peptide.
Applicants show how each cited reference differ from the instant invention, but the obviousness test under 35 U.S.C. 103 is whether the invention would have been obvious in view of the prior art taken as a whole. In re Metcalf et al. 157 U.S.P.Q. 423.
Applicant is reminded that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, all the art rejections are under 35 USC 103, which relies on the combination of the references together.
Claim objections
Claim 1 is objected to because of the following informalities: in SEQ ID NO:3, X is not defined. Appropriate correction is required.
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 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.
In the above sequence, Cys are present at positions 2, 9, 17, 18, 22 and 33.
In the claimed motif, YXGXK, when X is any amino acid, then is identical to motif 25-29 amino acid sequence of Loo.
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, then it is identical to 2-33 amino acid sequence of Loo.
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.
Difference is that Loo is silent on D-amino acids at 25 and 29th position in the peptide. This can be cured with the following art, which 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].
If applicants think D-amino acids at specific positions have advantage, then comparative data is required to show the evidence.
Therefore, a skilled person in the art would be motivated to replace L-amino acid(s) with D-amino acid(s).
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 1-3 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 28:
See For claim 1 above.
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.
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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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