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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 71-88 & 95) in the reply filed on 07 August 2025 is acknowledged.
Claims 89 & 91-94 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07 August 2025.
Applicant’s election without traverse of:
1) Linker: Functional group 1-amine and Functional Group 2-carboxylic group; Linker embodiment PAM (4-hydroxymethylphenylacetamidomethyl;
2) Cationic Amino residue: Lysine;
3) Functional groups of the linker: Amine + carboxylic acid;
4) Polymer-polystyrene in the reply filed on 07 August 2025 is acknowledged.
No claims are withdrawn as a result of this election. Election was made without traverse in the reply filed on 07 August 2025.
Claim Status
Applicant’s claim amendments and arguments in the response filed 07 August 2025 are acknowledged.
Claims 71-89 & 91-95 are pending.
Claims 1-70 & 90 are cancelled.
Claim 95 is new.
No claims are amended.
Claims 89 & 91-94 are withdrawn.
Claims 71-88 & 95 are under consideration.
Drawings
The drawings were received on 08 August 2022. These drawings are accepted.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 17 November 2022 has been fully considered by the examiner. A signed and initialed copy of each IDS is included with the instant Office Action.
Claim Objections
Claims 90 & 95 are objected to because of the following informalities:
Claim 90 is not compliant with 37 CFR 1.121 because it contains struck-through text and the status identifier of “Cancelled”. No text should be present for cancelled claims.
Applicant should consider whether deleting all struck through text such that the claim listing appears as “90. (Cancelled)” would obviate the objection.
Claim 95 is objected to because it defines that PAM is 4-hydroxymethylphenylacetamidomethyl again. 4-hydroxymethylphenylacetamidomethyl (PAM) was already defined as PAM in claim 81.
Applicant may wish to consider whether a claim 95 amendment to recite only PAM would obviate the objection.
Claim 95 is also objected to because the “first functional groups” is not conjugated correctly in line 2.
Applicant may wish to consider whether than amendment to recite “first functional group” would obviate the objection.
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 74-81 & 84-88 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 74-79 recites the limitation "the peptides" in line 2. There is insufficient antecedent basis for this limitation in the claims.
Applicant may wish to consider whether an amendment to recite “the synthetic peptides” would obviate the rejection.
Claims 80 & 81 are rejected under 35 USC 112 (b) because they ultimately depend from indefinite claim 79, but do not clarify the issue.
Claim 84 recites the limitation "the peptides" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Applicant may wish to consider whether an amendment to recite “the synthetic peptides” would obviate the rejection.
Claim 84 also recites the limitation "the plurality of peptides" in the second to the last line. There is insufficient antecedent basis for this limitation in the claim.
Applicant may wish to consider whether an amendment to recite “the plurality of synthetic peptides” would obviate the rejection.
Claim 85 recites the limitation "the peptides" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Applicant may wish to consider whether an amendment to recite “the synthetic peptides” would obviate the rejection.
Claim 86 recites the limitation "the peptide" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Applicant may wish to consider whether an amendment to recite “the synthetic peptides” would obviate the rejection.
Claims 87 & 88 are rejected under 35 USC 112(b) because it ultimately depends from indefinite claim 84 and does not clarify the issue.
Claim Rejections - 35 USC § 103
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, 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 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.
Claims 71-88 & 95 are rejected under 35 U.S.C. 103 as being unpatentable over Hayouka (J. Am. Chem. Soc. 2013, 135, 11748−11751; IDS- 11/17/2022) in view of Chemfiles (https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/300/807/al_chemfile_v3_no4.pdf?srsltid=AfmBOoqgfRb8i_0Pgs2xgldB7CdE38OZbXrRasPsDS7RTAYVihSTzG9u; Published: 2003) and Tovi (US 2011/0160431; Published: 06/30/2011).
With regard to claims 71-77, 84, 84 & 95, Hayouka teaches an 20 mer peptide sequence consisting of lysine as the cationic residue and leucine as the hydrophobic residue in a ratio of 48:52 (1:1.08; i.e. about 1:1; Table 1- pg. 11749). With regard to claims 77, 84, 85 & 95, Hayouka considers this ratio to be 1:1 by teaching the 1:1 20-mer mixtures generated from L-Lys with either L-Leu or L-Phe proved to be highly hemolytic for the investigated pathogenic bacteria (pg. 11749). With regard to claims 71, 84 & 95, Hayouka teaches the sequence is random (title). Hayouka teaches they used solid phase peptide synthesis resin to build their peptide sequences using Standard Fmoc-based solid-phase synthesis methods (Figure 1-pg. 11748). With regard to claims 71, 84 & 95, Hayouka in the Figure 1 legend teaches the bead of the sold support bears many growing chains of different sequences (pg. 11748). Hayouka also examined the effect of stereochemistry/chirality of the peptide mixtures on antimicrobial activity (pg. 11750). D-leucine and D-lysine achieved the lowest MIC for the examined pathogenic bacteria (Table 2-pg. 11750). Hayouka warns “the results highlight the importance of controlling the stereochemistry to achieve an optimal profile (i.e., selectivity for prokaryotic cells), at least among binary subunit combinations” (pg. 11750).
Hayouka does not teach the sequences are attached to a the water-insoluble polymer via a linker.
With regard to claims 71, 89-82, 86, 87 & 95, Chemfiles teaches a series of proteinaceous amino acid derivatives linked to (4-hydroxymethylphenyl)acetamidomethyl polystyrene (PAM) resin and catalog number 51591 teaches Boc-Gly-PAM resin (i.e. the linker comprises a carboxylic acid group and an amine group from the attached glycine; pg. 9). With regard to claims 71, 89-82, 86, 87 & 95, Chemfiles teaches the Boc-Gly-PAM resin to be among those that make it an ideal choice for larger peptides and among those that result in higher yield and purities (pg. 9). With regard to claim 78 & 79, the Gly-PAM linker is approximately 21.13 angstroms based upon the radius of the atoms in PAM and glycine after the BOC protecting group is removed with trifluoromethanesulfonic acid (i.e. about 20 angstroms; TFMSA; pg. 5). With regard to claim 83, 88 & 95, Chemfiles teaches their polystyrene resins are beads (pg. 3).
In the same field of solid state synthesis which may use BOC as the protecting group, Tovi teaches glycine has no chiral atoms and therefore its introduction into the peptide sequence is free from racemization ([0014], [0071] & [0075]). Tovi teaches BOC to be a protecting group for all other amino acids except for arginine [0075].
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Here, at least rationale (B) may be employed in which it would have been prima facie to the ordinary skilled artisan before the effective filing date to have substituted Hayouka’s generically taught solid phase peptide synthesis resin bead with the Boc-Gly-PAM resin bead commercially marketed by Chemfiles in order to higher yield and purities of the 20-mer sequence without introducing unintended racemates through the use of glycine as suggested by the combined teachings of Chemfiles and Tovi. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, because Chemfiles teaches the Boc-Gly-PAM resin to be among those that make it an ideal choice for larger peptides and Hayouka’s peptide is a large peptide of 20 amino acids.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORI K MATTISON whose telephone number is (571)270-5866. The examiner can normally be reached 9-7 (M-F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David J Blanchard can be reached at 5712720827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LORI K MATTISON/ Examiner, Art Unit 1619
/NICOLE P BABSON/ Primary Examiner, Art Unit 1619