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 .
Detailed Action
Claims 1-26 are currently pending.
Election/Restriction
Applicant’s election of compound
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in the reply filed on 5/29/2026 is acknowledged. Because applicant did not distinctly and specifically point out the errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1-2, 8, 14-15, and 21 read on the elected species.
A search of the elected species of Claim 1 was conducted for both a block and random copolymers. The elected species was found to be free of the art and the search was expanded to polymers of Claim 1 as well as the copolymer compounds of Claims 4-7 and 10-13, which are not encompassed by Claim 1. The election of species requirement is withdrawn. All Claims 1-26 are examined on the merits hereinbelow.
Information Disclosure Statement
Two IDS forms are filed on 5/03/2023 with duplicate references cited. All copies of each references have been considered.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4-7, 10-13, 17-20, and 23-26 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
None of the cited claims depict a “N-(2-alkanoyloxyethyl)methacrylamide (AMA)” unit as required in independent Claim 1 or dependent Claim 14. Rather, each subgenus depicts compounds which fall outside of the permitted subunit definition required by the copolymer limitation of Claim 1. All rejected claims depend on the sole independent Claim 1. For example, Claim 12 depicts instead an aroyl group (encircled) rather than a “alkanoyl” as claimed:
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. Additionally, several subunit structures are not even methacrylamides. Instead, Claim 4, for example, depicts a methacrylate ester derivative wherein an oxygen atom is in place of the nitrogen of the Claim 1 subunit:
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. All such issues of dependency must be resolved.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
**Applicant is cautioned that search and examination was executed for the polymers encompassed by Claim 1 as written and the particular structures of the dependent claims as drawn. Search and consideration has not been extended beyond that which is claimed. Therefore, amending the scope of Claim 1 to include “aroyl” or “methacrylate” structures beyond those drawn may result in rejections over 35 USC 102(a)(1), 102(a)(2), and/or 103.**
Allowable Subject Matter
1) The closest prior art to the genus of Claim 1, “a copolymer of methacrylic acid (MAA) and N-(2-alkanoyloxyethyl)methacrylamide (AMA)” (the language of which does not restrict the scope to copolymers of only the two named subunits) is found in Duerr (DE1936830, Original German Language Document (OG) and Google Patent English Translation (ENG) cited throughout). Duerr teaches a self-gloss emulsion comprising a copolymer consisting of “a) 57 to 61[% by weight]…of ethyl acrylate, 30 to 34% by weight of methyl methacrylate, 5 to 8% by weight of methacrylic acid and 1 to 5% by weight of a Compound of the general formula consists,
[
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in which X is a hydroxyl group,…[alkylcarboxyl or methacrylamide or acrylamide radical] and Y denotes a hydrogen atom or a methyl group” (OG: Page 8; ENG: Abstract and Page 2, Claims). Preferred “suitable” compounds of the “general formula” component include “methacrylic acid or acrylic acid amide-N-methylol acetate”
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(OG: Page 3; ENG: Page 3), which differs from the claimed component N-(2-alkanoyloxyethyl)methacrylamide (AMA) in that the methylene of the Duerr subunit is ethylene in the claimed copolymer. Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09. Therefore, it would be obvious to substitute the methylene for the ethylene as claimed before the effective filing date of the claimed invention and expect success in doing so to form a “self-glossing emulsion” because the subunits “are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties”. Further, the language of examined Claim 1 is not limited to copolymers of only two subunits, but may include 3 or more like the copolymer component of the Duerr emulsion. The claimed genus only requires that the two named subunits be present. However, Duerr describes an emulsion composition of copolymers rather than a micelle as required by the independent claim of the examined invention (ENG: Abstract). Duerr does not suggest forming a micelle or teach a critical micelle concentration (CMC) of the described copolymer comprising various subunits. Duerr does not offer motivation for forming a micelle or provide a reasonable expectation of success that a micelle can be formed due to lack of suggestion and necessary parameters like CMC. Therefore, the micelle of Claim 1 is not taught by or obvious over Duerr.
2) The closest prior art to the particular copolymers of Claims 2-3 for example, reciting a block or random copolymer of two species of subunits, is found in Hubbell (US20200048390, 5/03/2026 IDS). Hubbell teaches copolymers as follow:
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(or random polymers thereof), wherein the HPMA (subunit encircled by “()a”) may instead be a “hydrophilic monomer [which] comprises a methacrylamide or methacrylate terminus” (Pages 17-18; Claims 1-3 and 17-18). The subunits described as having a methacrylate terminus throughout the disclosure are longer and heavier esters rather than a simple methacrylic acid residue (See particularly Page 17, Claim 2). Hubbell does not teach or suggest replacing the HPMA with methacrylic acid. The claimed polymers are not obvious.
3) The closest prior art to Claims 4-5, depicting a methacrylate (not methacrylamide) subunit, is found in Li (Journal of Bioactive and Compatible Polymers, Vol. 6-April 1991. 142-163). Li teaches a “Copolymer of (HEMA-ASA)-MA” wherein beta-(acetylsalicylyloxy)ethyl methacrylate is HEMA-ASA and MA is methacrylic acid (methacrylate):
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(Pages 143-144). Notwithstanding the cyano and sulfurous end groups of the claimed compounds, Li teaches ortho attachments on the aryl ring rather than para as claimed. It would not be obvious to reorient the attachment points on the phenylene because Li specifically teaches the polymers for delivering ASA, or acetylsalicylic acid or aspirin; “The main hydrolysis product was aspirin with minor amounts of salicylic acid.” (Title; Abstract). Therefore, one of skill in the art would not find it obvious to alter the therapeutic drug moiety of the polymer to arrive at the claimed copolymers because the same artisan would not seek to disrupt or destroy the active moiety of the Li copolymer. One would not expect successful delivery of ASA upon modification because said therapeutic drug would not exist in the modified polymer.
Conclusion
Claims 4-7, 10-13, 17-20, and 23-26 are rejected. Claims 1-3, 8-9, 14-16, and 21-22 are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
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