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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 9, 2026, has been entered.
Election/Restrictions
Applicant's election with traverse of Group I (i.e., claims 1, 3-4, 6-10, 12, 14, 16-18, and 20-23 drawn to a peptide comprising an amino acid sequence as described in claim 1) in the reply filed on December 24, 2024, is acknowledged. The traversal is on the grounds that search and examination of all pending claims can be accomplished without serious burden on the Examiner (See Applicant’s Response received on 12/24/24, pg. 8). Moreover, no evidence was cited to show that any of the genus of peptides define din claim 1 was known in the prior art (See Applicant’s Response received on 12/24/24, pg. 9). Applicants assert that claim 1 defines the peptides by their chemical structure (i.e., amino acid sequence and net charge), and claim 16 recites at least one shared function (See Applicant’s Response received on 12/24/24, pg. 9).
Applicant’s argument regarding that no serious burden exists to search all claims, is not found persuasive because undue search and/or examination burden are not a criteria for election/restriction purposes under 35 USC §121 and 35 USC § 372. Please refer MPEP 1850 for details. Thus, Applicant’s argument is found unpersuasive.
Applicant’s argument regarding that lack of invention was not established in view of prior art, and where claim 1 provides a necessary structure and claim 16 provides at least one shared function, it is found unpersuasive. Pursuant to MPEP 1850(III)(B), the situation involving the so-called Markush practice wherein a single claim defines alternatives (chemical or non-chemical) is also governed by PCT Rule 13.2. In this special situation, the requirement of a technical interrelationship and the same or corresponding special technical features as defined in PCT Rule 13.2, shall be considered to be met when the alternatives are of a similar nature. As such, a Markush group is defined as where a single claim, i.e., instant claim 1, defines alternatives, i.e., peptides with varying amino acid sequence. Thus, contrary to Applicant’s argument, the Markish practice governed by PCT Rule 13.2 applies to the instantly claimed invention. Furthermore, Applicants have not established or clearly indicated what common structure is present that is a significant structural element recited in instant claim 1. The Examiner maintains that the peptide structure recited in instant claim 1, there is no required core sequence that each peptide must contain in order to constitute a significant structural element that is shared by all of the alternatives. Plus, there is no evidence provided that the peptides belong to a recognized class of chemical compounds. Therefore, contrary to Applicant’s argument, claim 1 fails to provide a necessary common structure that is a significant structural element shared by all alternatives.
The requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Claims 1-32 were originally filed on January 21, 2022.
The amendment received on January 21, 2022, canceled claims 2, 5, 11, 13, 15, 19, 24-25, 29-30, and 32; and amended claims 1, 3-4, 6-10, 12, 14, 16, 20-23, 26-28, and 31. The amendment received on June 20, 2025, canceled claims 1, 3-4, 6-10, and 12; and amended claims 14, 16, 20, 27, and 31. The amendment received on January 9, 2026, amended claims 14 and 16.
Claims 14, 16-18, 20-23, 26-28, and 31 are currently pending and claims 14, 16-18, 20, and 22-23 are under consideration as claims 26-28 and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, and claim 21 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 24, 2024.
Priority
The present application claims status as a 371 (National Stage) of PCT/SG2020/050424 filed July 22, 2020, and claims priority under 119(a)-(d) to Singapore Application No. 10201906759W filed on July 22, 2019.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) for Singapore Application No. 10201906759W, which papers have been placed of record in the file. Please note that the Singapore application is in English and therefore no further action is necessary.
Sequence Interpretation
Regarding claim 14, please note that the interpreting the scope of the claim as open-ended requiring 100% identity to elected SEQ ID NO: 10 with any N- and/or C-terminal additions. There is no evidence that a peptide consisting essentially of SEQ ID NO: 10 occurs naturally in nature since the C-terminus is amidated. Thus, SEQ ID NO: 10 is considered patent eligible subject matter. Note: determination of additional species have not been determined, and please note that the interpretation has been updated from closed-ended to open-ended.
Regarding claim 23, please note that the interpreting the scope of the claim as open-ended requiring 100% identity to either SEQ ID NO: 17 or 18 with any N- and/or C-terminal additions.
Response to Arguments
Applicant’s arguments, see Response, filed 6/20/25, with respect to the objection to the drawings have been fully considered and are persuasive. The objection of Figures 2A-C has been withdrawn.
Applicant’s arguments, see Response, filed 6/20/25, with respect to the objection to the specification have been fully considered and are persuasive. The objection of the specification has been withdrawn.
Applicant’s arguments, see Response, filed 6/20/25, with respect to the claim objections to the specification have been fully considered and are persuasive. The objection of claims 14 and 20 have been withdrawn.
Applicant’s arguments, see Response, filed 6/20/25, with respect to the 102(a)(1) rejection have been fully considered and are persuasive. The rejection of claims 1, 3, 7, 12, 16, and 22 as being anticipated by Obika et al. US Publication No. 2013/0172402 A1 published on July 4, 2013 has been withdrawn.
Applicant’s arguments, see Response, filed 6/20/25, with respect to the 103(a) rejection have been fully considered and are persuasive. The rejection of claims 16-18 as being unpatentable over Obika et al. US Publication No. 2013/0172402 A1 published on July 4, 2013 has been withdrawn.
Maintained/Modified Rejections Necessitated by Amendment
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 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 pre-AIA 35 U.S.C. 103(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
103 - KSR Examples of 'Rationales' Supporting a Conclusion of Obviousness(Consistent with the "Functional Approach" of Graham)
Further regarding 35 USC 103(a) rejections, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) (KSR) 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.
Also, a reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976).
Claims 14, 16-18, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Anson et al. WO 2013/072686 A2 published on May 23, 2013 in view of Betts et al., “Chapter 14: Amino Acid Properties and Consequences of Substitutions,” Bioinformatics for Geneticists, Barnes, et al., eds., John Wiley & Sons Ltd, pgs. 289-316 (2003), and Adessi et al., Curr. Med. Chem. 9:963-978 (2002). Please note that the rejection has been updated.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
For claim 14, it is noted that “consisting essentially of” will be construed as “comprising”. Pursuant to MPEP 2111.03, the transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original). "A ‘consisting essentially of’ claim occupies a middle ground between closed claims that are written in a ‘consisting of’ format and fully open claims that are drafted in a ‘comprising’ format." PPG Industries v. Guardian Industries, 156 F.3d 1351, 1354, 48 USPQ2d 1351, 1353-54 (Fed. Cir. 1998). See also Atlas Powder v. E.I. duPont de Nemours & Co., 750 F.2d 1569, 224 USPQ 409 (Fed. Cir. 1984); In re Janakirama-Rao, 317 F.2d 951, 137 USPQ 893 (CCPA 1963); Water Technologies Corp. vs. Calco, Ltd., 850 F.2d 660, 7 USPQ2d 1097 (Fed. Cir. 1988). For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355 ("PPG could have defined the scope of the phrase ‘consisting essentially of’ for purposes of its patent by making clear in its specification what it regarded as constituting a material change in the basic and novel characteristics of the invention."). See also AK Steel Corp. v. Sollac, 344 F.3d 1234, 1240-41, 68 USPQ2d 1280, 1283-84 (Fed. Cir. 2003) (Applicant’s statement in the specification that "silicon contents in the coating metal should not exceed about 0.5% by weight" along with a discussion of the deleterious effects of silicon provided basis to conclude that silicon in excess of 0.5% by weight would materially alter the basic and novel properties of the invention. Thus, "consisting essentially of" as recited in the preamble was interpreted to permit no more than 0.5% by weight of silicon in the aluminum coating.); In re Janakirama-Rao, 317 F.2d 951, 954, 137 USPQ 893, 895-96 (CCPA 1963). In the instant case, since the specification or claims do not clearly indicate what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising”.
Anson et al. teaches peptide-based hydrogels where peptide coalesce such that they ‘self-assemble’ to form a hydrogel (See Anson specification, pg. 1, 1st paragraph). Anson et al. teaches a pharmaceutical composition comprising at least one pharmaceutically active compound and at least one peptide having 2-20 amino acids that is capable of mediating self-assembly (See Anson specification, pg. 2, 2nd paragraph). Preferably, the peptide has 6-12 amino acids, and more preferably the peptide has 8 amino acids (See Anson specification, pg. 2, 3rd paragraph; pg. 4, 5th paragraph). Preferably the one or more amino acids are selected from Phe, Val, Arg, Lys, Leu, Ile, Asp, and Glu (See Anson specification, pg. 2, 4th paragraph; pg. 4, 4th paragraph). Preferably the peptides comprise at least one amino acid having a hydrophobic side chain (a hydrophobic amino acid), and at least one amino acid having a hydrophilic side chain (a hydrophilic amino acid) (See Anson specification, pg. 2, 5th paragraph; pg. 4, 6th paragraph). Typically the peptides comprises an amino acid sequence in which the amino acids alternate between hydrophilic amino acids and hydrophobic amino acids (See Anson specification, pg. 2, 6th paragraph; pg. 4, last paragraph). The hydrophobic amino acids are selected from Phe, Val, Leu, and Ile, and the hydrophilic amino acids are selected from Arg, Lys, Asp, and Glu (See Anson specification, pg. 2, 7th paragraph; pg. 5, 1st paragraph). Specific peptide amino acid sequences include Val-Glu-Val-Glu-Val-Lys-Val-Lys, Val-Glu-Val-Lys-Val-Glu-Val-Lys, Phe-Glu-Phe-Glu-Phe-Arg-Phe-Lys, or Phe-Glu-Phe-Arg-Phe-Arg-Phe-Lys (See Anson specification, pg. 2, last paragraph to pg. 3, 3rd paragraph; pg. 5, 2nd to 5th paragraphs). Thus, Anson’s peptide constitutes a peptide comprising an amino acid sequence of alternating hydrophobic and hydrophilic amino acids where each hydrophobic amino acid is selected from Ile, Val, and Leu, and each hydrophilic amino acid is selected from Arg, Lys, Glu, and Asp, at least one hydrophilic amino acid is selected from Arg and Lys, at least one hydrophilic amino acid is selected from Glu and Asp.
However, Anson et al. does not teach a specific species of peptide amino acid sequence of instant SEQ ID NO: 10 where the C-terminus is amidated as recited in instant claim 14.
Betts et al. teaches lysine can be substituted by arginine (See Betts article, pg. 304, 3rd paragraph). Although Betts et al. teaches that arginine and lysine are not necessarily a neutral substitution, Betts et al. teaches that arginine most prefers to substitute for the other positively-charged amino acid, lysine (See Betts article, pg. 303, 3rd paragraph). Thus, given that Anson teaches that the hydrophilic amino acids are selected from Arg, Lys, Asp, and Glu, and given that lysine and arginine are known to be substituted for each other, an ordinary skilled artisan would be motivated with a reasonable expectation to substitute one of the two lysine amino acids in Anson’s amino acid sequence of Val-Glu-Val-Glu-Val-Lys-Val-Lys thereby resulting in an amino acid sequence of Val-Glu-Val-Glu-Val-Arg-Val-Lys.
Furthermore, Betts et al. teaches that isoleucine, leucine and valine can be substituted by other hydrophobic, particularly aliphatic amino acids (See Betts article, pg. 300, 5th paragraph to pg. 301, 5th paragraph). Betts et al. teaches that aliphatic means that the side chain contains only hydrogen and carbon atoms (See Betts article, pg. 298, 4th paragraph). The amino acids with aliphatic side chains are alanine, isoleucine, leucine proline and valine (See Betts article, pg. 298, 4th paragraph). The unifying theme is that they contain largely non-reactive and flexible side chains that are ideally suited for packing in the protein interior (See Betts article, pg. 298, 4th paragraph). Thus, given that Anson teaches that the hydrophobic amino acids are selected from Phe, Val, Leu, and Ile, and given that valine and isoleucine are known to be substituted for each other, an ordinary skilled artisan would be motivated, at a minimum, to try to substitute two of the four valine amino acids in Anson’s amino acid sequence of Val-Glu-Val-Glu-Val-Lys-Val-Lys thereby resulting in an amino acid sequence of Ile-Glu-Val-Glu-Ile-Arg-Val-Lys. Therefore, when considering the teachings of Anson in view of Betts et al., an ordinary skilled artisan would be motivated, at a minimum, to try to utilize a pharmaceutical composition comprising at least one pharmaceutically active compound and at least one peptide having an amino acid sequence of instant SEQ ID NO: 10, Ile-Glu-Val-Glu-Ile-Arg-Val-Lys, that is capable of mediating self-assembly.
Regarding the C-terminus being amidated, Adessi et al. teaches that chemical modifications of peptides introduced strategically at potential enzymatic cleavage sites can dramatically increase the in vivo stability of peptide drugs (See Adessi article, pg. 965, col. 2, 1st paragraph). Adessi et al. teaches a number of peptide modifications where the nature of the peptide backbone is not altered (See Adessi article, pg. 966, col. 2, last paragraph; Figure 1A). One of these peptide modifications is where the free carboxyl group at the C-terminus is amidated (See Adessi article, pg. 967, col. 1, last paragraph). In serum and plasma, many small peptides are degraded primarily by exopeptidases (See Adessi article, pg. 967, col. 1, last paragraph). Most L-amino acid peptides with free N- and C-termini are degraded rapidly (See Adessi article, pg. 967, col. 1, last paragraph). Some hormones and neuropeptides are naturally end-protected such as by amino-acetylation and carboxy-amidation (See Adessi article, pg. 967, col. 1, last paragraph). The end-protection strategy has been widely used to improve enzymatic stability in peptide drug development (See Adessi article, pg. 967, col. 1, last paragraph). Therefore, the teachings of Adessi et al. suggest chemically modifying the C-termini of a peptide in order to improve enzymatic stability of the peptide.
For claim 16, as discussed supra for claim 14, Anson et al. teaches a pharmaceutical composition comprising at least one pharmaceutically active compound and at least one peptide having 2-20 amino acids that is capable of mediating self-assembly (See Anson specification, pg. 2, 2nd paragraph). Moreover, as discussed supra, the combination of Anson et al. and Betts et al. suggest a peptide comprising SEQ ID NO: 10. Anson et al. also teaches a hydrogel/viscous liquid comprising more than one of the peptides wherein the more than one peptides form a matrix that is hydrated to form the gel/viscous liquid (See Anson specification, pg. 5, last paragraph to pg. 6, 1st paragraph; pg. 6, last paragraph; pg. 7, 6th paragraph). The matrix can be in the form of a beta-sheet (See Anson specification, pg. 6, 1st paragraph). By hydrating the matrix necessarily correlates to where the matrix is combined with water. Thus, the teachings of Anson et al. satisfy the claim limitations as recited in instant claim 16.
For claims 17-18, Anson et al. teaches that the peptide concentration in the composition can be 0.1-10% w/w (See Anson specification, pg. 2, 7th paragraph). Typically, the concentration is 0.5-5% w/w, and more typical concentration is 1-3% w/w (See Anson specification, pg. 2, 7th paragraph). However, Anson et al. does not teach the peptide concentration in % w/v.
With respect to the concentration of the plurality of peptides in the composition, the concentration of the plurality of peptides in the composition is clearly a result specific parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal concentration of the plurality of peptides in the composition needed to achieve the desired results. Thus, an ordinary skilled artisan would have been motivated to adjust the units the concentration of the plurality of peptides is measured in from w/w to w/v for delivering a pharmaceutically active compound in light of the teachings of Anson et al. to obtain various concentration parameters with a reasonable expectation of success. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the concentration of the plurality of peptides in the composition would have been obvious at the time of applicant's invention. Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, because the combined teachings of the prior art are fairly suggestive of the claimed invention.
For claim 20, Anson et al. teaches that in preparing a homogenous composition comprising the peptide, water and a pharmaceutically active compound, e.g., lidocaine HCl monohydrate, the samples were vortexed and sonicated immediately after the active loading, then maintained at room temperature for ~ 12 hours to allow them to settle plurality of peptide (See Anson specification, pg. 7, last paragraph to pg. 8, 1st paragraph). The final pH of the sample can be adjusted to pH 4-7 using NaOH solutions after ~ 6 hours (See Anson specification, pg. 8, 1st paragraph). As such, a sodium salt is added to the composition in order to adjust the pH of the composition. Thus, the teachings of Anson et al. satisfy the claim limitation as recited in instant claim 20.
For claim 22, Anson et al. teaches that the peptide-based hydrogels can be used to deliver pharmaceutically active compounds through mucosal tissue (See Anson specification, pg. 1, 1st paragraph). The at least pharmaceutically active compound can be flurbiprofen, lidocaine, and benzocaine (See Anson specification, pg. 3, last paragraph to pg. 4, 1st paragraph). Thus, the teachings of Anson et al. satisfy the claim limitation with respect to where the composition comprises a therapeutic agent as recited in instant claim 22.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.012)
Anson et al. does not expressly teach a specific species of peptide consisting essentially of an amino acid sequence of instant SEQ ID NO: 10 where the C-terminus is amidated as recited in instant claim 14. However, the teachings of Anson et al. and Adessi et al. cure these deficiencies by constituting an "Obvious to try" rationale - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success and/or 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 pursuant to KSR.
Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-4143)
With respect to a specific species of peptide consisting essentially of an amino acid sequence of instant SEQ ID NO: 10 as recited in instant claim 14, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to follow the teachings of Anson et al. and modify the peptide amino acid sequence of Val-Glu-Val-Glu-Val-Lys-Val-Lys such that the Val residue at position 1 is substituted with Ile, the Val residue at position 3 is substituted with Ile, the Lys residue at position 6 is substituted with Arg, and the C-terminus is amidated in order for the peptide to deliver a pharmaceutically active compound and to improve the peptide' s enzymatic stability. One of ordinary skill in the art at the time the invention was made would have been motivated to, at a minimum, try do so because lysine was known to be substituted with arginine, because arginine was known to preferably be substituted with lysine, and because valine was known to be substituted with other aliphatic amino acids including isoleucine as taught by Betts et al. thereby constituting a finite number of possible substituted combinations of Arg for Lys, and a finite number of possible substituted combinations of Ile for Val; and because chemically modifying the free hydroxyl group at the C-terminus with NH2 of a small peptide was known to improve the peptide' s enzymatic stability resulting from the amidation of the free hydroxyl group at the C-terminus as taught by Adessi et al.
One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success given that a peptide of Anson et al. comprises an amino acid sequence containing alternating hydrophilic amino acids selected from Arg, Lys, Glu, and Asp and hydrophobic amino acids selected from Phe, Val, Leu, and Ile where a specific peptide amino acid sequence is Val-Glu-Val-Glu-Val-Lys-Val-Lys. Therefore, substituting the Val residue at position 1 with Ile, the Val residue at position 3 with Ile, and the Lys residue at position 6 with Arg, and amidating the C-terminus of the peptide would support the formation of a peptide-based hydrogel comprising the amino acid sequence of instant SEQ ID NO: 10, Ile-Glu-Val-Glu-Ile-Arg-Val-Lys-NH2 with improved enzymatic stability by constituting an "Obvious to try" rationale - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success and/or 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 pursuant to KSR.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 16 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Anson et al. WO 2013/072686 A2 published on May 23, 2013 in view of Betts et al., “Chapter 14: Amino Acid Properties and Consequences of Substitutions,” Bioinformatics for Geneticists, Barnes, et al., eds., John Wiley & Sons Ltd, pgs. 289-316 (2003), as applied to claim 16 above, and further in view of Yang et al. WO 2014/035345 A1 published on March 6, 2014.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
For claim 16, please see discussion of Anson and Betts supra.
For claim 23, as discussed supra, Anson et al. teaches that the peptide-based hydrogels can be used to deliver pharmaceutically active compounds through mucosal tissue (See Anson specification, pg. 1, 1st paragraph). Anson et al. also teaches that the pharmaceutically active compound can be anti-cancer agents, antibacterial agents, antifungal/yeast agents, antimicrobial peptides, anti-inflammatory agents, and antiseptic agents (See Anson specification, pg. 3, 4th paragraph). However, Anson et al. does not teach where the therapeutic agent is a second peptide of instant SEQ ID NO: 17 or instant SEQ ID NO: 18 as recited in instant claim 23.
Yang et al. teaches an amphiphilic peptide for used as a medicament to treat bacterial infection, a viral infection, a fungal infection, or a proliferative disease (See Yang specification, [008]-[0015]). These amphiphilic peptides exhibit less haemolytic activity while possessing comparable antimicrobial activities to their alpha-helical counterparts of equal charge and hydrophobicity (See Yang specification, [0045]). Specific species of these amphiphilic peptides include IRIKIRIK (SEQ ID NO: 17) or irikirik (SEQ ID NO: 21) where all the residues of SEQ ID NO: 21 are in the D-conformation (See Yang specification, [0060]). Yang et al. found that SEQ ID NO: 17 exhibited antimicrobial activity (See Yang specification, [00108]-[00110]). Thus, when combining the teachings of Anson et al. with Yang et al., an ordinary skilled artisan would be motivated to substitute instant SEQ ID NO: 17 or 18 as the therapeutic agent of Anson as further articulated below.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.012)
Anson et al. does not expressly teach where the composition further comprises a second peptide of SEQ ID NO: 17 or 18 as recited in instant claim 23. However, the teachings of Yang et al. cure this deficiency by constituting a simple substitution of one known element for another to obtain predictable results and/or 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 pursuant to KSR.
Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-4143)
With respect to where the composition further comprises a second peptide of SEQ ID NO: 17 or 18 as recited in instant claim 23, it would have been prima facie obvious to one of ordinary skill in the art as of the effective filing date of the instant application to modify the teachings of Anson et al. and substitute instant SEQ ID NO: 17 or 18 as the pharmaceutically active compound in a pharmaceutical composition comprising a peptide of instant claim 1 as described supra where such peptide forms a beta-sheet conformation and where the composition forms a hydrogel once water is added in order for the composition to be used to treat bacterial infections. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because instant SEQ ID NOs: 17 and 18 were known to treat bacterial infections as taught by Yang et al. One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success given that a pharmaceutical composition of Anson et al. comprises peptide-based hydrogels that can be used to deliver pharmaceutically active compounds such as antibacterial agents, and therefore, substituting instant SEQ ID NO: 17 or 18 as the pharmaceutically active compound would support the treatment of bacterial infections by constituting a simple substitution of one known element for another to obtain predictable results and/or 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 pursuant to KSR.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Applicants’ Arguments
Applicants contend that the claimed invention is nonobvious because (1) an ordinary skilled artisan would not have found the claimed invention to be prima facie obvious with a reasonable expectation of success from the disclosures of the cited references (See Applicant’s Response received on 1/9/26, pg. 7-8) given that the Office Action has failed to state any acceptable technical reason why an ordinary skilled artisan would have made the required amino acid substitutions resulting in instant SEQ ID NO: 10, and in particular, there is a lack of motivation to make the specific amino acid substitutions at positions 1 and 5-6, and thus, could only have been made using impermissible hindsight (See Applicant’s Response received on 1/9/26, pg. 9); (2) there is not a finite number of possible combinations, but rather, at least 431 total possible combinations in light of Betts, and thus, it can be hardly obvious with a reasonable expectation of success for an ordinary skilled artisan to make all of the possible peptides and to test them functionally for the ability to form a hydrogel (See Applicant’s Response received on 1/9/26, pg. 10); and (3) the ability of a peptide having a particular amino acid sequence to form a hydrogel, especially since SEQ ID NO: 8 does not form a hydrogel and SEQ ID NO: 9 only forms a hydrogel at a higher concentration and requires a longer time, and thus, an ordinary skilled artisan cannot predict with a reasonable expectation of success how the needed amino acid substitutions can affect the peptide’s ability to form a hydrogel (See Applicant’s Response received on 1/9/26, pg. 10-11).
Response to Arguments
Applicant's arguments filed 1/9/26 have been fully considered but they are not persuasive for the following reasons.
In response to Applicants’ first and second arguments, they are found unpersuasive. As stated in the Action mailed on 10/9/25, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as discussed supra in the 103 rejection, the teachings of Anson and Betts are suggestive of a peptide comprising the amino acid sequence of SEQ ID NO: 10. Anson expressly teaches an exemplary peptide sequence comprising the amino acid sequence of VEVEVKVK. However, Anson also further broadly teaches peptide-based hydrogels where peptide coalesce such that they ‘self-assemble’ to form a hydrogel where the peptide capable of mediating self-assembly typically comprise an amino acid sequence in which the amino acids alternate between hydrophilic amino acids selected from Arg, Lys, Asp, and Glu and hydrophobic amino acids selected from Phe, Val, Leu, and Ile. As such, the question is whether an ordinary skilled artisan would be motivated with a reasonable expectation of success to substitute the Val residues at positions 1 and 5 of Anson’s exemplary peptide sequence with another preferred hydrophobic amino acid taught by Anson, i.e., Phe, Leu or Ile, and to substitute the Lys residue at position 6 of Anson’s exemplary peptide sequence with another preferred hydrophilic amino acid taught by Anson, i.e., Arg, Asp, and Glu. The Examiner maintains that the answer to the question is yes in light of the teachings of Betts. Thus, the teachings of Anson and Betts provide the “why” an ordinary skilled artisan would select Ile as the hydrophobic amino acid to be substituted for Val, and Arg as the hydrophilic amino acid to be substituted for Lys, i.e., because arginine was known to preferably be substituted with lysine, and because valine was known to be substituted with other hydrophobic, aliphatic amino acids including isoleucine.
Notably, the rejection is not asserting that any amino acid can be substituted with any other amino acid, or that each residue is to be substituted. Rather, the question is whether an ordinary skilled artisan would be motivated to select another preferred hydrophobic and hydrophilic amino acid taught by Anson. The teachings of Anson in combination with Betts provide the requisite motivation to select specific preferred hydrophobic and hydrophilic amino acid taught by Anson. Moreover, it is noted that the number of potential substitutions for Lys, i.e., Arg, Asp, and Glu, and the number of potential substitutions for Val, i.e., Phe, Leu, and Ile, taught by Anson are independently a finite number. Thus, when considering the teachings of Betts in combination of with Anson, an ordinary skilled artisan would be motivated to select Arg as a conservative substitution for Lys and not Asp or Glu given that the Lys and Arg are known to exhibit similar properties, e.g., both positively charged, as suggested by Betts. Similarly, an ordinary skilled artisan would be motivated to select Phe, Leu or Ile as a conservative substitution for Val given that these residues are known to exhibit similar properties as suggested by Betts. Although, Val can equally be substituted with Phe or Leu, the Examiner maintains that an ordinary skilled artisan would at least be motivated to try substituting Ile for Val given the finite number of potential substitutions. Furthermore, it is noted that Anson’s peptide sequence length is 8 amino acids where there are two lysine residues and four valine residues. Thus, the Examiner maintains that an ordinary skilled artisan would at least be motivated to try to substitute the Val residues at positions 1 and 5 and the lysine residue at position 6 given the finite number of residues that can be substituted.
Additionally, pursuant to MPEP 2144.07, the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol. “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” 325 U.S. at 335, 65 USPQ at 301.). See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious); Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988) (Claimed agricultural bagging machine, which differed from a prior art machine only in that the brake means were hydraulically operated rather than mechanically operated, was held to be obvious over the prior art machine in view of references which disclosed hydraulic brakes for performing the same function, albeit in a different environment.). In the instant case, although the Examiner does not consider the list of hydrophobic and hydrophilic residues that can be substituted taught by Anson to be an extensive “laundry list”, similar rationale applies. Anson teaches that a peptide capable of mediating self-assembly typically comprise an amino acid sequence in which the amino acids alternate between hydrophilic amino acids selected from Arg, Lys, Asp, and Glu and hydrophobic amino acids selected from Phe, Val, Leu, and Ile thereby constituting a list of hydrophobic and hydrophilic residues that are interchangeable such that the resulting peptide would be capable of mediating self-assembly. This expectation is supported by the teachings of Betts in that the hydrophobic residues: Phe, Val, Leu, and Ile, would exhibit similar properties, and the hydrophilic residues: Arg and Lys, would exhibit similar properties since both have positively charged side chains. As such, although it is acknowledged that the combination of references do not expressly suggest that the Val at positions 1 and 5 should be substituted for Ile for reason X and the Lys at position 6 should be substituted for Arg for reason Y, an ordinary skilled artisan would read Anson in view of Betts and understand that substituting Ile in place of Val and Arg in place of Lys would result in peptides capable of mediating self-assembly. Therefore, contrary to Applicant’s argument, the combination of Anson and Betts provides the requisite motivation to render the claimed invention obvious.
In response to Applicant’s argument regarding impermissible hindsight, as stated in the Action mailed on 10/9/25, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Here, as discussed supra in response to Applicant’s first argument, the Examiner maintains that the combination of Anson, Betts, and Adessi are suggestive of a peptide comprising instant SEQ ID NO: 10. This determination is based on the combined teachings of Anson, Betts, and Adessi as discussed supra and utilizing an obvious-to-try rationale. It is further noted that the Examiner has not excluded other substitutions, e.g., Val to Phe or Leu. The rejection acknowledges that Anson teaches multiple hydrophobic and hydrophilic residues, but an ordinary skilled artisan would at least be motivated to try to substitute Arg for Lys and Ile for Val in light of Betts’ teachings, especially for the reasons set forth in response to Applicant’s first argument. Moreover, it appears that Applicant’s determination that there would be at least 431 total possible number of substituted peptides is based on each of the Val and Lys residues in the peptide. However, the total possible number of substituted residues would be based on two Val residues and one Lys residue since there are only 3 of the 8 residues in the peptide that need to be substituted. Thus, although the total number of possible substituted peptides may appear high, albeit, less than 431, when considering that the possible hydrophobic residues would exhibit similar properties and the possible hydrophilic residues would exhibit similar properties as suggested by Anson and Betts, the Examiner maintains that an ordinary skilled artisan would have the requisite motivation with the requisite expectation of success of arriving at a peptide consisting essentially of instant SEQ ID NO: 10.
Furthermore, regarding the peptides exhibiting the ability to form a hydrogel, as discussed supra in the rejection, Anson expressly teaches that the peptides exhibit the ability to ‘self-assemble’ to form a hydrogel. Although Anson does not reduce-to-practice every species encompassed by the discussed broader genus, does not per se preclude a finding of obviousness. Pursuant to MPEP 2152.02(b), in order for a prior art document to describe a claimed invention under AIA 35 U.S.C. 102(a)(1) or (a)(2), the prior art document need only describe and enable one skilled in the art to make a single species or embodiment of the claimed invention. See Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991). As such, Anson expressly teaches peptides that encompass the amino acid sequence of instant SEQ ID NO: 10 and Betts provides the motivation and reasonable expectation of success that the substitutions of V1I, V5I, and K6R would result in a peptide with the similar properties including the ability to form a hydrogel. Plus, as long as the combination of cited reference suggest the claimed structure, i.e., SEQ ID NO: 10, then the structure would necessarily exhibit the claimed property. Properties are the same when the structure and composition are the same. Thus, burden shifts to applicant to show unexpected results, by declaration or otherwise. In re Fitzgerald, 205 USPQ 594. In the alternative, the claimed properties would have been present once the composition was employed in its intended use. In re Best, 195 USPQ 433. Therefore, contrary to Applicant’s argument, the Examiner has not utilized impermissible hindsight to render the claimed invention obvious, but rather an ordinary skilled artisan would be motivated with a reasonable expectation of success in light of the teachings of Anson, Betts and Adessi.
In response to Applicant’s third argument, it is found unpersuasive. Pursuant to MPEP 2143.02(II), obviousness does not require absolute predictability, however, at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). In the instant case, as discussed supra and in the Action mailed on 10/9/25, Anson expressly teaches peptide-based hydrogels where peptide coalesce such that they ‘self-assemble’ to form a hydrogel including a peptide with the sequence of VEVEVKVK. As discussed supra, the question is whether an ordinary skilled artisan would be motivated with a reasonable expectation of success to substitute the Val residues at positions 1 and 5 of Anson’s exemplary peptide sequence with another preferred hydrophobic amino acid taught by Anson, i.e., Phe, Leu or Ile, and to substitute the Lys residue at position 6 of Anson’s exemplary peptide sequence with another preferred hydrophilic amino acid taught by Anson, i.e., Arg, Asp, and Glu. Given that Betts demonstrates that isoleucine, leucine and valine can be substituted by other hydrophobic, particularly aliphatic amino acids, and lysine can be substituted by arginine, an ordinary skilled artisan would have the requisite expectation of success, albeit, not an absolute expectation of success. This requisite expectation of success is because (1) Anson expressly suggests that Val, Phe, Leu, or Ile are preferred hydrophobic residues and that Arg, Lys, Asp, or Glu are preferred hydrophilic residues to be used in a peptide-based hydrogels; and (2) Betts expressly suggests that lysine can be substituted with arginine and valine can be substituted with isoleucine or leucine. There is no indication in Anson that Arg and Lys or Val and Ile would function in a distinct manner, and thus, an ordinary skilled artisan would not have an expectation that a Lys to Arg substitution and a Val to Ile substitution would be detrimental in forming peptide-based hydrogels. Plus, Applicants have not provided any evidence that such a substitution would be detrimental Therefore, contrary to Applicant’s argument, an ordinary skilled artisan would have the requisite expectation of success to substitute the Val residues at positions 1 and 5 with isoleucine and the Lys residue at position 6 with arginine without evidence to the contrary.
Additionally, with respect to the data provided in Table 2 in the instant specification, as stated in the Action mailed on 10/9/25, it is acknowledged that SEQ ID NO: 8 that contains two differences relative to instant SEQ ID NO: 10 (i.e., an Arg residue at position 2 and a Glu residue at position 6), did not form a hydrogel. However, a substitution based on Arg to Glu and Glu to Arg is not necessary to render the claimed invention obvious. Although Anson teaches that the hydrophilic amino acids can be Arg, Lys, Asp or Glu, a substitution between Arg and Glu is not considered a conservative substitution that an ordinary skilled artisan would expect similar properties. The teachings of Betts support this rationale as there is no indication that arginine and glutamate would be considered a conservative substitution. As such, although Applicants demonstrate that SEQ ID NO: 8 does not form a hydrogel, such evidence does not preclude the finding of obvious when combining the teachings of Anson and Betts because such a substitution is not necessary to arrive at a peptide comprising instant SEQ ID NO: 10. Rather, the substitution is based on Val to Ile and Lys to Arg. Therefore, contrary to Applicant’s argument, the fact that SEQ ID NO: 8 did not form a hydrogel, does not demonstrate the unpredictability in light of the teachings of the cited references.
Additionally, although instant SEQ ID NO: 9 has not yet been examined, it is noted that if SEQ ID NO: 9 requires a specific concentration in order to form a hydrogel as stated by Applicants, then it is possible that the scope of claim 16 and its dependent claims fail the enablement requirement. However, a determination of the patentability of SEQ ID NO: 9 has not yet been performed.
Accordingly, the rejections of claims 14, 16-18, 20, and 22-23 are maintained as Applicants’ arguments are found unpersuasive.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 14 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 15 of copending Application No. 18/684,884 (Lee et al. 2024/0352093 A1) in view of Anson et al. WO 2013/072686 A2 published on May 23, 2013, and Yang et al. WO 2014/035345 A1 published on March 6, 2014. Please note that the rejection has been updated in light of Applicants’ amendments.
Lee et al. claims:
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(See Lee claims 1-8). It is noted that Lee’s SEQ ID NO: 2 is 100% identical to instant SEQ ID NO: 10. Moreover, Lee claims a kit comprising the peptide and gelatin recited in Lee’s claim 1 (See Lee claim 15). Thus, Lee’s claimed invention anticipates instant claim 14. Therefore, the Lee’s ‘884 claimed invention is not patentably distinct from the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection.
Applicants’ Arguments
Applicants contend that the obviousness-type double patenting rejection is overcome because (1) the ‘884 claims require gelatin whereas the instant claimed invention excludes gelatin; and (2) the ‘884 application has a later effective filing date compared to the instant application, and thus, pursuant to MPEP 804, the rejection should be withdrawn in the application with the earlier effective filing date if the provisional nonstatutory double patenting rejection is the only rejection remaining in the application having the earlier effective filing date (See Applicant’s Response received on 1/9/26, pg. 12-13).
Response to Arguments
Applicant's arguments filed 1/9/26 have been fully considered but they are not persuasive for the following reasons.
In response to Applicant’s first argument, it is found unpersuasive as it pertains to instant claim 14. It is noted that Applicant’s argument is persuasive for instant claims 16-18, 20, and 22-23 as gelatin is expressly excluded. However, instant claim 14 does not recite the same negative provision. Thus, since the ‘884 claimed invention still encompasses a peptide consisting essentially of SEQ ID NO: 10, the ‘884 claimed invention anticipates instant claim 14.
In response to Applicant’s second argument, it is found unpersuasive. It is acknowledged that the ‘884 application has a later effective filing date, is still pending, and the nonstatutory double patenting rejection was the only remaining rejection, the rejection would be withdrawn. However, the nonstatutory double patenting rejection is not the only remaining rejection. Thus, rejection of claim 14 is maintained as Applicant’s argument is found unpersuasive.
Conclusion
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/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654