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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Response to Amendment
The amendment filed April 1, 2026 has been entered. Claims 1 and 3 have been amended. Claim 4 remains withdrawn due to being drawn to a non-elected invention. Claims 7-15.
Applicants amendments to the claims have overcome the objections and rejections previously set forth in the Non-Final Office action mailed December 17, 2025. Applicant’s cancellation of claims 7-15 have rendered the corresponding rejections moo. Thus these rejections and objections are hereby withdrawn. New rejections necessitated by Applicants amendments are addressed below.
Claims 1-6 are pending in this application.
Priority
This application is a national stage filing under 35 U.S.C. § 371 of PCT Application No. PCT/JP2019/027455, filed on July 11, 2019, which claims priority of Japanese Application No. 2018-131529, filed on July 11, 2018. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been received
Election
Applicant’s election of the polymer of formula 4 and a peptide/protein drug of claim 6 in the reply filed on April 10, 2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant elected the polymer of formula 4 as shown on page 15 of the instant specification that has the following formula:
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(Chem. 4). The elected species was not taught or suggested by the prior art. The search was extended to include additional species of polymers of formula (4) comprising four arginine residues (basic peptide of chain length of 4, wherein the basic peptide is arginine) as was previously encompassed by instant claim 1. The amendment entered November 25, 2025 removed a polymer comprising one arginine or four arginine residues from the claims, thus the search was extended to include additional species of polymers of formula (4) comprising five or six arginine residues and was further expanded to include hyaluronic acid as a polymer comprising five or six arginine residues. The amendment filed April 1, 2026 removed a polymer comprising 5 or 6 arginine residues from the claims, thus the search was extended to wherein the main chain is hyaluronic acid, wherein said end comprises a basic peptide of RRR.
Applicant has indicated in the remarks that the elected species would encompass claims 1-6. The Examiner notes that claim 4 is limited to a polymer wherein the basic peptide is consisting of arginine and glycine. Formula 4 does not comprise or allow for the incorporation of any glycine molecules. Thus, claim 4 is not encompassed by the elected species and is withdrawn due to being drawn to a non-elected invention.
Claims 1-3 and 5-6 are examined herein
Claim Interpretation
According to the instant specification, the term “end of the side chain” means a terminal part of a branched chain which branches off from the main chain and does not re-bond to the main chain (pg. 8, para. 0020). The specification continues, “The side chain containing one arginine at the end thereof…. can contain any chain on the main chain side of one arginine. The any chain is not particularly limited, but, for example, includes a linker peptide” (pg. 8, para. 0020). Thus the broadest reasonable interpretation of the claim includes a peptide than ends in an three arginine residues (For example: QQQQQQRRR).
The phrase “side chain” as recited by instant claim 1 is interpreted to mean a group that branches off from the polymer backbone (arrow):
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.
The phrase “main chain” as recited by instant claim 2 is interpreted to refer to the polymer backbone (arrow):
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With respect to instant claim 5 which are directed to an agent and recites the phrase ““for promoting introduction of compound into cells”. The Examiner notes that it is well settled that “intended use” of a composition or product, e.g., “for promoting introduction”, will not further limit claims drawn to a composition, so long as the prior art discloses the same composition comprising the same ingredients (See MPEP 2111.02 (II)). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. According to the instant specification, “The agent for promoting introduction of compound of the present invention comprises the polymer compound of the present invention” (pg. 10, para. 0024). The broadest reasonable interpretation of the claimed agent is just the polymer itself.
New 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.
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Sakuma (WO 2016/136707, IDS filed January 8, 2021) in view of Stalmans (J. Pharmaceutical and Biomedical Analysis, 2016, cited on PTO-892). The English translation relied upon has been provided by the Examiner in a previous action.
Regarding claims 1-3, 5-6: Sakuma teaches the following polysaccharide derivative:
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wherein the main chain is hyaluronic acid, b is 0, X1 represents an octaarginine residue with terminal amino group and a terminal carboxyl group removed, and X3 represents an amino group (English translation, pg. 10, production example 1, pg. 7, structural formula 3). The average molecular weight is 5,000 to 50 million and the d/(c+d) is 0.002 to 1 (English Translation, pg. 7, para. 2). In a specific embodiment the ratio of d/(c+d) is 0.29 and the weight was 220,000 (pg. 10, production example 1). Sakuma teaches using the polysaccharide derivatives as an introduction agent for introducing a low membrane-permeable compound in to cells, such as insulin (English Translation, pg. 8, para. 3). Sakuma teaches alternative membrane permeable peptides can be utilized instead of oligoarginine (English translation, pg. 5, second to last para.). Sakuma teaches alternative membrane permeable peptides can be utilized instead of oligoarginine (English translation, pg. 5, second to last para.) teaches Tat peptide can be utilized as the cell permeable peptide (English translation, pg. 5, second to last para.).
Sakuma does not teach a polymer wherein the basic peptide comprises arginine at a chain length of 3 (RRR) as claimed. Sakuma does not explicitly teach wherein said end has one arginine or wherein said polymer comprises a guanidino group originating from arginine of 0.5 to 20 mmol/g as claimed.
However, Stalmans teaches cell penetrating peptides are a particular group of peptides being able to cross cellular barriers without causing significant membrane damage (pg. 289, col. 2, last para.). Stalmans teaches R9 (nonaarginine) and Tat47-57-NH2 are both known cell-penetrating peptides known In the art (pg. 290, table 1). Stalmans teaches Tat47-57-NH2 has the following structure:
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(pg. 290, table 1).
According to the instant specification, the basic peptide may contain amino acids other than arginine as long as it is basic as a whole, and glutamine is a neutral amino acid (pg. 5, para. 0013). According to the instant specification, the term “end of the side chain” means a terminal part of a branched chain which branches off from the main chain and does not re-bond to the main chain (pg. 8, para. 0020). The specification continues, “The side chain containing one arginine at the end thereof…. can contain any chain on the main chain side of one arginine. The any chain is not particularly limited, but, for example, includes a linker peptide” (pg. 8, para. 0020). Thus the broadest reasonable interpretation of the claim includes a peptide than ends in an three arginine residues (For example: QQQQQQQQRRR), such as the TAT peptide of Stalmans.
Taken together it would have been prima facie obvious to one of ordinary skill in the art to modify the polymer of Sakuma such that the oligoarginine is replaced with Tat47-57 as taught by Stalmans. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the art establishes TAT peptides and oligoarginines are both cell permeating peptides and Sakuma teaches alternative cell permeable peptides, including a TAT peptide, can be used in place of oligoarginine. Wherein Tat47-57 and oligoarginines are both cell permeable peptides, it is prima facie obvious to substitute equivalents known for the same purpose (See MPEP 2144.06 (II)). Additionally, wherein Sakuma teaches that the ratio of d/(c+d) can be as low as 0.02 and the molecular weight can be 5,000, this equates to a guanidine molar amount of 16.667 mmol/g using the taught peptide (1/(0.002x5g/mmolx6arginine)=16.667 mmol/g). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05 (I)).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s reply is considered to be a bona fide attempt at a response and is being accepted as a complete response. The 35 USC § 103 rejections are maintained for reason of record and foregoing discussion.
Conclusion
No claims are allowed in this action.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/S.L.G./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693
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