DETAILED ACTION
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Matsumoto et al., “Dynamic Changes of Intracellular Monomer Levels Regulate Block Sequence of Polyhydroxyalkanoates in Engineered Escherichia coli”.
Regarding claims 1 and 2: Matsumoto et al. teaches a copolymer (abstract) comprising a 2-position hydroxycarboxylic acid/2-hydroxybutyrate and 3-hydroxybutyrate (abstract), which is the monomer from a hydroxycarboxylic acid having a hydroxy group at a position other than a 2-position. There is a homopolymer segment of one of the two monomer and a copolymer segment of at least two of the monomers:
PNG
media_image1.png
197
301
media_image1.png
Greyscale
The weight average about 0.6-3.0 x 105, which overlaps the claimed range (figure 2). In the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists (MPEP 2144.05 I). Before the effective filing date of the claimed invention a person having ordinary skill in the art would have found it obvious to use an overlapping molecular weight and would have been motivated to do so since Matsumoto et al. teaches it is achievable by the disclosed copolymer synthesis method.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Matsumoto et al., “Dynamic Changes of Intracellular Monomer Levels Regulate Block Sequence of Polyhydroxyalkanoates in Engineered Escherichia coli” as applied to claim 1 set forth above and in view of in view of Skraly et al. (US 2008/0275208).
Regarding claim 3: Matsumoto et al. teaches 2-hydroxybutyric acid and 3-hydroxybutyrate (abstract). As shown in the diagram above, either block of the copolymer segment can be considered the homopolymer segment, while the entire polymer can be considered the copolymer segment.
Matsumoto et al. does not teach 3-hydroxyhexanoic acid. However, Skraly et al. teaches a similar copolymer using 3-hydroxyhexanoate (abstract). Matsumoto et al. and Skraly et al. are analogous art since they are both concerned with the same field of endeavor, namely polyhydroxyalkanoate copolymers. Before the effective filing date of the claimed invention a person having ordinary skill in the art would have found it obvious to add 3-hydroxyhexanoate of Skraly et al. to the copolymer of Matsumoto et al. and would have been motivated to do so since they can be produced by biological systems through genetic engineering.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Matsumoto et al., “Dynamic Changes of Intracellular Monomer Levels Regulate Block Sequence of Polyhydroxyalkanoates in Engineered Escherichia coli” as applied to claim 1 set forth above and in view of Hermes et al. (U.S. Pat. 5,256,762).
Regarding claim 4: Matsumoto et al. teaches 2-hydroxybutyric acid and 3-hydroxybutyrate (abstract). As shown in the diagram above, either block of the copolymer segment can be considered the homopolymer segment, while the entire polymer can be considered the copolymer segment.
Matsumoto et al. does not disclose 2-hydroxyacetic acid. However, Hermes et al. teaches glycolic acid/2-hydroxyacetic acid with β-hydroxybutyric acid/3-hydroxybutyric acid (col. 4 lines 44-55). Matsumoto et al. teaches the desire to incorporate other monomers into the polymers (pg. 662 column 1). Matsumoto et al. and Hermes et al. are analogous art since they are both concerned with the same field of endeavor, namely PHAs. Before the effective filing date of the claimed invention a person having ordinary skill in the art would have found it obvious to add the 2-acetic acid of Hermes et al. into the polymer of Matsumoto et al. and would have been motivated to do so since Matsumoto et al. teaches the desire to experiment with different PHA monomers to serve as biodegradable alternatives to petroleum derived plastic (pg. 662 column 1).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Matsumoto et al., “Dynamic Changes of Intracellular Monomer Levels Regulate Block Sequence of Polyhydroxyalkanoates in Engineered Escherichia coli” as applied to claim 1 set forth above and in view of Hermes et al. (U.S. Pat. 5,256,762) and Skraly et al. (US 2008/0275208).
Regarding claim 5: Matsumoto et al. teaches 2-hydroxybutyric acid and 3-hydroxybutyrate (abstract). As shown in the diagram above, either block of the copolymer segment can be considered the homopolymer segment, while the entire polymer can be considered the copolymer segment.
Not disclosed is 2-hydroxyacetic acid or 3-hydroxyhexamonic acid. However, Hermes et al. teaches glycolic acid/2-hydroxyacetic acid with β-hydroxybutyric acid/3-hydroxybutyric acid (col. 4 lines 44-55). Matsumoto et al. teaches the desire to incorporate other monomers into the polymers (pg. 662 column 1). Before the effective filing date of the claimed invention a person having ordinary skill in the art would have found it obvious to add the 2-acetic acid of Hermes et al. into the polymer of Matsumoto et al. and would have been motivated to do so since Matsumoto et al. teaches the desire to experiment with different PHA monomers to serve as biodegradable alternatives to petroleum derived plastic (pg. 662 column 1).
Matsumoto et al. also does not teach 3-hydroxyhexanoic acid. However, Skraly et al. teaches a similar copolymer using 3-hydroxyhexanoate (abstract). Before the effective filing date of the claimed invention a person having ordinary skill in the art would have found it obvious to add 3-hydroxyhexanoate of Skraly et al. to the copolymer of Matsumoto et al. and would have been motivated to do so since they can be produced by biological systems through genetic engineering.
Response to Arguments
Applicant's arguments filed January 26, 2026 in the remarks and declaration have been fully considered but they are not persuasive.
A) The amendment to the claims overcome the previous rejection, but a rejection is now made in view of Matsumoto et al. Arguments that still pertain to the above rejection, however, are addressed.
B) Applicant’s argument that Hermes et al. is directed toward chemical synthesis and not biosynthesis is not persuasive since the claims are directed to the product itself and the method of making the product does not materially affect the basic characteristics of the copolymer.
C) Applicant’s argument that Hermes et al. discloses the concept of obtaining a copolymer having a continuous sequence of the same monomers by using multiple types of hydroxy acid, and does not disclose or suggest a copolymer having homopolymerized segments and randomly copolymerized segments can be produced by the same chemical method is not persuasive. In the broadest reasonable interpretation of the claim language, there is no limitation requiring a “randomly copolymerized segment”, but instead “a copolymer segment containing at least two hydroxycarboxylic acids.
Conclusion
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Megan McCulley whose telephone number is (571)270-3292. The examiner can normally be reached Monday - Friday 9-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mark Eashoo can be reached at 571-272-1197. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MEGAN MCCULLEY/
Primary Examiner, Art Unit 1767
Prosecution Insights