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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on April 22, 2024 and May 14, 2024 have been considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because no specific active step of “using” is recited.
Claim Rejections - 35 USC § 112
Claims 1-10 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.
In claim 1, in the R1 embodiment wherein “NR2aR2b together form a C5-C6-cycloalkylenamino or a 1-imidazole group”, it is unclear what the term “together” refers to.
In claim 2, given that the group of formula (II) is linked to the N-atom of polymer (A), it is unclear whether said group is in place of, or in addition, to the R1 group defined in claim 1. In this regard, if said group replaces the R1, then it is unclear how such further limits the polymer (A) per claim 1 which requires the R1 group. On the other hand, if said group is in addition to the R1 group, the location of its attachment on the polymer is unclear.
In claim 2, it is unclear how the NR2aR2b group of formula (III) would form a 1-imidazole group per claim 1, which contains two nitrogen atoms.
In claim 8, line 3, there is no express antecedent basis for the composition containing 4,4’-dichloro 2-hydroxydiphenyl ether.
In claim 8, line 4, it is unclear whether the “composition” refers to the composition with or without 4,4’-dichloro 2-hydroxydiphenyl ether.
Claim 9 is indefinite in that no active specific “using” step is recited.
Claim 10 is indefinite in that it is unclear whether the added polymer (A) (line 2) is defining the polymer (A) already present in the composition per claim 1. That is, it is unclear how the added polymer (A) distinguishes over the polymer (A) already present in the composition per claim 1.
In claim 10, there is no express antecedent basis for the lipase and/or protease.
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 (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.
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 4 are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0131951 (Langer).
Langer discloses a poly(beta-amino ester) having the repeating unit
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inclusive of those wherein R1 is a (substituted) C2-C4-alkyl, R3 and R6 are hydrogen or methyl, R4, R5, R7 and R8 are hydrogen and the linker B is a C2-C6-alkylene or ethoxy or propoxy (meets Applicants’ formula (I) wherein X1 is O) (e.g., abstract, [0063-0064]. The poly(beta-amino-ester) is prepared by reacting a bis(acrylate ester) [0065] with an amine [0067]. Particular examples of the poly(beta-amino ester) [0069] include the expressly depicted polymers B14, G5, A14, C5 and G10 (each meets Applicants’ formula (I)).
In essence, Langer differs from claim 1 in not expressly setting forth a composition comprising the poly(beta-amino ester) and an anionic surfactant. Langer, however, discloses that the poly(beta-amino ester) can be further combined with excipients such as sodium lauryl sulfate [0108] (falls within Applicants’ anionic surfactant per specification [0047]). Accordingly, it would have been within the purview of Langer’s inventive disclosure, and obvious to one having ordinary skill in the art, to formulate a composition comprising a poly(beta-amino ester) (meets Applicants’ formula (I)) and sodium lauryl sulfate (meets Applicants’ anionic surfactant) in accordance with the desired characteristics and with the reasonable expectation of success.
As to claim 3, it is within the purview of Langer’s inventive disclosure, and obvious to one having ordinary skill in the art, to produce a poly(beta-amino-ester) obtained from the bis(acrylate ester) E [0065]
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(meets Applicants’ formula (I) wherein A1 is (AO)2 consisting of ethylene oxide).
As to claim 4, Langer’s poly(beta-amino-ester) preferably has a molecular weight from 5,000 to 100,000 g/mol [0054].
Claims 2 and 5-10 have not been included in this rejection because it is not seen that Langer discloses or suggests the additional claimed features.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ana L Woodward whose telephone number is (571)272-1082. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heidi Kelley can be reached at 571-270-1831. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANA L. WOODWARD/Primary Examiner, Art Unit 1765
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