DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Per preliminary amendment dated 8/5/24, claims 1, 2, 8-12, 15-20, 23, 24, 27-31 are currently pending in the application.
Election/Restrictions
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1. In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
i. Group I, claim(s) 1, 2, 8-12, 15, 16 and 29, drawn to a composition;
ii. Group II, claim(s) 17-20, 23, 24, 27 and 28; drawn to a method of preparing the composition; and
iii. Group III, claim(s) 30 and 31, drawn to a composition.
The inventions listed as Groups I to III do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: The technical feature that is common to Groups I to III is a composition comprising a polyhydroxyalkanoate, and a stabilizer comprising or more of the claimed species in an amount of about 0.0001 to about 10 percent by weight or less based on the weight of the polyhydroxyalkanoate and the stabilizer. Regarding this feature, the prior art to Schmid et al. (US 2008/0142023 A1) teaches an antimicrobial composition comprising an aliphatic polyester, such a poly(lactic acid) (reads on polyhydroxyalkanoate), in an amount of at least at 50 wt.% of the composition, and an enhancer, such as a a-hydroxy acid, e.g., lactic acid, citric acid, malic acid, tartaric acid etc. (read on stabilizer), in an amount of greater than 0.1 wt.% and not greater than 10 wt.%, based on the total weight of the composition (Ab., [0011], [0078]-[0084], ref. claims 1-8).
Although the prior art is silent on a composition comprising claimed components in one single embodiment as claimed, it would have been obvious to one of ordinary skill in the art, as of the effective filing date of the claimed invention, to prepare a composition of overlapping scope comprising claimed components (elaborated further in the rejection below). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP § 2144.05.
Given that the common technical feature of presently cited claims in Groups I to III fails to define a contribution over cited art, the common technical feature does not amount to a special technical feature.
In light of above, there is lack of unity between the cited groups.
During a telephone conversation with Mr. Norman Sims on 1/16/26, a provisional election was made with traverse to prosecute the invention of Group I, claims 1, 2, 8-12, 15, 16 and 29. Affirmation of this election must be made by applicant in replying to this Office action. Claims 17-20, 23, 23, 27, 28, 30 and 31 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 102 and 103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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, 2, 8, 9, 11, 12, 15, 16 and 29 are rejected under 35 U.S.C. 102(a)(1) as being by Masaki et al. (US 2015/0051119 A1).
Regarding claims 1, 16, 29, Masaki teaches a resin composition comprising 100 parts by mass of a polyester resin having at least 50 % by glycolic acid resin, i.e., a glycolic acid resin, and from 0.5 to 50 parts by mass of a carboxylic acid anhydride (Ab., claim 1). Masaki teaches that the glycolic acid resin may consist of only glycolic acid units, i.e., a polyhydroxyalkanoate/homopolymer/polyglycolic acid PGA, and preparable from a glycolide by ring-opening polymerization [0021]-[0034], or by polycondensation [0034]-[0037].
Disclosed Example 7 is drawn to a composition comprising polyglycolic acid PGA (100 parts by mass) and phthalic anhydride (5 parts by mass).
It is noted Masaki teaches that glycolic acid resins, such as PGA of example 8, may be either ring opening polymerization or by polycondensation. That is, Masaki teaches only two methods for preparing polyglycolic acid PGA, and therefore, a polyglycolic acid PGA formed from the ring opening of a lactone is taught with sufficient specificity. Moreover, the recitation “polyhydroxyalkanoate formed by ring opening of a lactone” in claim 1 defines the process by which the polyhydroxyalkanoate is made. However, product-by-process claims are not limited to the manipulations of the recited steps, only to the structure implied by the steps. If the product in a product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the product was made by a different process. See MPEP 2113(I).
Regarding claims 2, 8, 9, 11, 12, 15, it is noted that the claimed limitation does not necessarily limit the scope of claim 1 given that the at least one stabilizer in claim 1 may be a cyclic anhydride, and Masaki teaches a cyclic anhydride.
Given that the claimed compositional limitations are fully met by Masaki, the presently cited claims are anticipated by the reference.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over prior art to Masaki et al. (US 2015/0051119 A1).
The discussion on Masaki from paragraph 7 above is incorporated herein by reference. It is further noted that the disclosed genus of carboxylic acid anhydrides include maleic anhydride and phthalic anhydride (read on a cyclic anhydride) [0057].
Masaki is silent on a composition comprising a polyhydroxyalkanoate and an anhydride as claimed
Given the teaching on maleic anhydride and phthalic anhydride as carboxylic acid anhydrides, i.e., equivalence thereof, it would have been obvious for one of ordinary skill in the art, as of the effective filing date of the claimed invention, to prepare a composition as in Masaki’s Example 7, by substituting phthalic anhydride with maleic anhydride, including a composition comprising a PGA prepared from glycolide by ring opening polymerization.
Claims 1, 2, 8-12, 15, 29 are rejected under 35 U.S.C. 103 as being unpatentable over the prior art to Schmid et al. (US 2008/0142023 A1).
Regarding claims 1, 2, 8, 9, 15, 29, Schmid teaches an antimicrobial composition comprising an aliphatic polyester, an antimicrobial component and an enhancer (Ab.). Disclosed genus of aliphatic polyesters include homo- and copolymers of poly(hydroxyalkanoates), including those derived by ring-opening polymerization, and may be present in an amount of at 50 % by weight of the composition [0032]-[0034], [0047].
Disclosed genus of enhancers include a-hydroxy acids, such as citric acid, malic acid etc. (read on stabilizer/aliphatic carboxylic acid having at least one hydroxyl group in a-position), in an amount of greater than 0.1 wt.% and not greater than 10 wt.%, based on the total weight of the composition (Ab., [0011], [0078]-[0084], ref. claims 1-8).
Schmid is silent on a composition comprising claimed components in one single embodiment as claimed.
As stated in paragraph 2 above, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
Given the teaching in Schmid on suitable aliphatic polyesters and enhancers for preparing antimicrobial compositions, it would have been obvious to one of ordinary skill in the art, as of the effective filing date of the claimed invention, to prepare compositions comprising any of the poly(hydroxyalkanoate)s, and citric acid or malic acid, including those within the scope of the present invention. Additionally, noting that Schmid’s poly(hydroxyalkanoates) encompass those derived by ring-opening polymerization, the discussion on product-by-process claims from paragraph 7 above is incorporated herein by reference.
Regarding claims 10-12, it is noted that the claimed limitation does not necessarily limit the scope of claim 1, given that the at least one stabilizer in claim 1 may be an aliphatic carboxylic acid having a hydroxyl group and Schmid teaches a-hydroxy acids of the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Satya Sastri at (571) 272 1112. The examiner can normally be reached Monday-Friday, 9 AM - 5 PM EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Mr. Robert Jones can be reached at (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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/Satya B Sastri/
Primary Examiner, Art Unit 1762