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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claims 8-13) in the reply filed on 8/21/2026 is acknowledged.
Group I (claims 1-7 and 14) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 8/21/2026.
Specification
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some unclear, inexact or verbose terms used in the specification are:
The specification recites step A “a step of reacting a polymer represented by the following formula (32-I) … and a diethylenetriamine derivative represented by the following formula (5) … with a polymer represented by the following formula (33-I)”, and step B “a step of deprotecting the polymer represented by the aforementioned formula (33-I) obtained in the aforementioned step (A) to obtain a solution comprising a pH-responsive polymer represented by the aforementioned formula (I)” (e.g., [0103-0107 and 0177-0181 pgpub]). It is not clear if the polymer represented by formula (33-I) is a reactant in step A or a product of step A. When it recites step A of reacting a polymer represented by formula (32-I) … and a diethylenetriamine derivative represented by the following formula (5) … with a polymer represented by formula (33-I), the polymer represented by formula (33-I) is a reactant of step A. However, when it recites step B of deprotecting the polymer represented by the aforementioned formula (33-I) obtained in the aforementioned step (A), the polymer represented by formula (33-I) is a product of step A.
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 8-13 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 8 recites step A “a step of reacting a polymer represented by the following formula (32-I) … and a diethylenetriamine derivative represented by the following formula (5) … with a polymer represented by the following formula (33-I)”, and step B “a step of deprotecting the polymer represented by the aforementioned formula (33-I) obtained in the aforementioned step (A) to obtain a solution comprising a pH-responsive polymer represented by the aforementioned formula (I)” which leads the claim indefinite. It is not clear if the polymer represented by formula (33-I) is a reactant in step A or a product of step A. When it recites step A of reacting a polymer represented by formula (32-I) … and a diethylenetriamine derivative represented by the following formula (5) … with a polymer represented by formula (33-I), the polymer represented by formula (33-I) is a reactant of step A. However, when it recites step B of deprotecting the polymer represented by the aforementioned formula (33-I) obtained in the aforementioned step (A), the polymer represented by formula (33-I) is a product of step A. For the purpose of further examination, based on disclosure of the examples in the specification (e.g., Example 1 discloses reacting AZ-pBLG60 synthesized in Production Example 2 with DET-Car tBu (compound 3) synthesized in Production Example 1 to obtain tBu protected compound 7) [0433-0435 pgpub], the recited “a step of reacting a polymer represented by the following formula (32-I) … and a diethylenetriamine derivative represented by the following formula (5) … with a polymer represented by the following formula (33-I)” is interpreted as --a step of reacting a polymer represented by the following formula (32-I) … with a diethylenetriamine derivative represented by the following formula (5) … to obtain a polymer represented by the following formula (33-I)--.
Claims 9-13 are rejected likewise as depending on claim 8.
Allowable Subject Matter
Claims 8-13 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Independent claim 1 is directed to a method for producing a pH-responsive polymer represented by the following formula (I), comprising performing the following step (A), step (B), and step (C) in this order: [Step (A)] a step of reacting a polymer represented by formula (32-I) with a diethylenetriamine derivative represented by formula (5) to obtain a polymer represented by formula (33-I); [Step (B)] a step of deprotecting the polymer represented by the aforementioned formula (33-I) obtained in the aforementioned step (A) to obtain a solution comprising a pH-responsive polymer represented by the aforementioned formula (I); and [Step (C)] a step of purifying the solution comprising a pH-responsive polymer represented by the aforementioned formula (I) obtained in the aforementioned step (B) by crystallization or membrane purification.
There is no prior art that teaches or makes obvious the aforementioned limitations as claimed.
The closest prior art is the disclosure of Lee et al (US 20210238347 A1) and Nishiyama et al (US 20200069807 A1).
Lee teaches a polymer comprising a structure of Formula 1A [0162]:
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wherein R1 can be hydrogen, R2 can be hydrogen, R3b can be a ethylene group, R4 can be -COO-, R5 can be alkyl, R6 can be a C1-C12 alkyl, R13 can be hydrogen, m1, n1 and n2 can be zero, Y is optionally present and is a cleavable linker.
The examiner submits that when m1, n1 and n2 are zero, the above formula is substantially identical to the claimed formula (1), differing in that the R5 is alkyl instead of the claimed hydrogen. The recited Q2 is 100% of the four repeating units represented by m1, n1, m2 and n2.
Lee discloses an example of Polymer 33 synthesized by reacting compound 11 with compound 9 [Example 7: 0480-0482].
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and teaches that a similar procedure can be used to prepare other polymers of Formula 4 (e.g., polymers 30-32) [0483].
It can be seen that compound 9 is different from the claimed formula (5) without any carboxyl group attached. Michael addition reaction is needed to introduce the COOH group at the end of the side chain. This method is different from the claimed one wherein a diethylenetriamine derivative represented by formula (5) is used to react with a polymer similar to Lee’s compound 11 to form the claimed polymer represented by formula (33-I), followed by deprotecting the polymer represented by the aforementioned formula (33-I) to obtain the claimed pH-responsive polymer represented by the aforementioned formula (I).
According to the applicant, unlike Michael addition reaction approach, the claimed method produces a pH-responsive polymer represented by the aforementioned formula (I) with high purity, without the side products represented by formula (10), formula (11), formula (12) or formula (13) [0010-0012 pgpub].
Similarly, Nishiyama teaches the claimed pH-responsive polymer represented by the aforementioned formula (I) by introducing a carboxyl group at the end of the side chain by Michael addition reaction or a nucleophilic substitution reaction [0062, 0079].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANGTIAN XU whose telephone number is (571)270-1621. The examiner can normally be reached Monday-Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Jones can be reached on (571) 270-7733. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANGTIAN XU/Primary Examiner, Art Unit 1762
