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 .
Status of the Application
1. Claims 1-12 are pending and subject to examination on the merits.
Election/Restrictions
2. The applicant selected Group II (claims 3-12) without traverse. However, the applicant amended claims 1 and 2 to depend on claim 3 and are therefore included in the elected group. However, the restriction requirement on 08 June 2026 remains in place. Claims 1-12 are examined below
Priority
3. Acknowledgement is made of applicant’s claim for foreign priority based on an application filed in Korea (KR10-2021-0187341) on 24 December 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
4. The information disclosure statements (IDS) submitted on 07 June 2024, 30 October 2025, and 16 March 2026 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
Claim Rejections - 35 USC § 112(b)
5. 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.
6. Claims 1-12 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.
7. Independent claim 3 recites the limitation "the cells" in line 4. There is insufficient antecedent basis for this limitation in the claim, since there is no previous reference to cells or a cell. Claims 1-2 and 4-12 are included in the instant rejection, since they do not mitigate the issue.
8. Claim 4 recites the limitations "the initially set pressure," “the high-pressure homogenizer,” and “the number of crushing treatments” in lines 5-6. There is insufficient antecedent basis for this limitation in the claim, since there is no previous reference to set pressure, homogenizer, or crushing treatments.
9. Claim 5 recites the limitations “the crushing pressure,” “the high-pressure homogenizer,” and “the number of crushing treatments” lines 5-6. There is insufficient antecedent basis for this limitation in the claim, since there is no previous reference to crushing pressure, homogenizer, or crushing treatments. Claim 10 is included in the instant rejection, since it does not mitigate the issue.
10. Claim 6 recites the limitation "the crushed product solution" in line 2, “the crushing pressure,” “the high-pressure homogenizer,” and “the number of crushing treatments” in lines 5-6. There is insufficient antecedent basis for this limitation in the claim, since there is no previous reference to crushing pressure, homogenizer, or crushing treatments.
11. Claim 7 recites the limitation "the crushing pressure" in line 4. There is insufficient antecedent basis for this limitation in the claim, since there is no previous reference to crushing pressure.
12. Claim 8 recites the limitation “the crushing pressure,” “the high-pressure homogenizer,” and “the number of crushing treatments” in lines 5-6 and lines 10-11 and “the crushed product solution” in line 9. There is insufficient antecedent basis for this limitation in the claim, since there is no previous reference to crushing pressure, homogenizer, crushing treatments, or crushed product solution. Claim 12 is included in the instant rejection, since it does not mitigate the issue.
Claim Rejections - 35 USC § 102
13. 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.
14. 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.
15. Claim 3 and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thorsten et al (Thorsten et al., 1998, DE19633475A 1—cited on the IDS dated 30 October 2025 and provided previously as an English translation). Regarding claim 3, drawn to a method for producing a polyhydroxyalkanoate, which comprises: preparing a culture medium with PHA, preparing a feed solution with culture medium, crushing the cells in the feed solution, and analyzing a morphological parameter of the cells before, during, or after the crushing step, Thorsten et al. teaches a process to obtain PHAs from a cell mass of microorganisms or plant biomass, which accumulate intracellularly (abstract), where specifically, microorganism are cultivated through a growth phase with accumulation of polyhydroxybutyric acid in the cell, where cells are then disrupted in a high-pressure homogenizer, where the cell fragments are separated out, and the particle diameter is then measured (Paragraph 0024). Regarding claims 6-7, drawn to the method of claim 3, and the method comprises quantifying the analyzed morphological parameter to detect a degree of crush; and determining the crushing pressure of the high-pressure homogenizer, which is between 300-1500 bar (claim 7), or the number of crushing treatments according to crush as a first re-determination step of crushing conditions, Thorsten et al. teaches Example 1, where after culturing Methylobacterium rhodesianum, cell disruption was accomplished via a high-pressure homogenizer at 850 bar for 2 passes, at the end of the cellular crushing (homogenization) step, the particle diameter (morphological parameter) was measured as 1.34 µm (paragraph 0018).
Claim Rejections - 35 USC § 103
16. 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.
17. Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Thorsten et al (Thorsten et al., 1998, DE19633475A 1—cited on the IDS dated 30 October 2025 and provided previously as an English translation) as applied to claims 3 and 6-7 above, and further in view of Choi et al (Choi et al., 2021, PNAS—cited on the IDS dated 07 June 2024).
The teachings of Thorsten et al. are discussed above and incorporated into the instant rejection.
Thorsten et al. does not teach three-dimensional image analysis (claim 1) to determine the morphological parameter such as length, sphericity, volume, and surface area (claim 2). Choi et al. teaches optical diffraction tomography for visualizing individual cells and in vivo PHB granules and quantifying their physical properties such as weight, volume, density, and localization by measuring 3D refractive index distributions (p. 1, Significance).
Therefore, it 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 combine the teachings of Thorsten et al. and Choi et al. to utilize 3D image analysis to visualize the morphological features of PHAs to determine granule formation and distribution as taught by Choi et al (p. 2, paragraph 1). One would be motivated to combine these teachings to arrive at the instant claims to produce PHAs as an alternative to synthetic plastics, since PHAs are biodegradable as taught by Choi et al. (p. 1, paragraph 1). There would be a reasonable expectation of success, yielding no surprising results when combining the teachings of Thorsten et al. and Choi et al. to measure the morphological features of PHAs, since Choi et al. utilized 3D imaging to determine the physical properties PHAs.
18. Claims 4-5 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Thorsten et al (Thorsten et al., 1998, DE19633475A 1—cited on the IDS dated 30 October 2025 and provided previously as an English translation) and Choi et al (Choi et al., 2021, PNAS—cited on the IDS dated 07 June 2024) as applied to claims 1-3 and 6-7 above, and further in view of Dimopoulos et al. (Dimopoulos et al., 2020, Innovative Food Science and Emerging Technologies—cited herein).
The teachings of Thorsten et al. and Choi et al. are discussed above and incorporated into the instant rejection.
Thorsten et al. and Choi et al. do not teach utilizing the quantified morphological feature to determine the degree of high-pressure homogenization (crushing) and/or the number of passes. Dimopoulos et al. teaches the utilization of high-pressure homogenization for the autolysis of S. cerevisiae cells and recovery of beta-glucan (abstract). High-pressure homogenization was performed for 1-3 passes at 200-800 bar, where the lysis efficiency and protein release were measured l to determine the optimal conditions of high-pressure homogenization (Table 1, Figure 1). While Dimopoulos et al. does not explicitly teach the optimization of high-pressure homogenization after determining the rate of autolysis, routine optimization to determine the optimal working conditions of an invention is not non-obvious. The MPEP states, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP Section 2144.05.
Therefore, it 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 combine the teachings of Thorsten et al., Choi et al., Dimopoulos et al., and routine optimization to produce PHA with a first and second analysis steps to determine the crushing conditions of the high-pressure homogenizer to enhance PHA production because they are a promising alternative to synthetic plastics, as taught by Choi et al (paragraph 1). One would be motivated to combine these teachings to arrive at the instant claims to produce PHA with an optimized method utilizing a first and second analysis step to determine high-pressure homogenization conditions to optimize the production of PHA as substitutes for petroleum-based plastics, as taught by Choi et al (abstract). There would be a reasonable expectation of success, yielding no surprising results when combining the teachings of Thorsten et al., Choi et al., Dimopoulos et al., and routine optimization to devise a method for producing PHA with a first and second analysis steps to determine the crushing conditions of the high-pressure homogenizer, since Dimopoulos et al. teaches the utilization high-pressure homogenization in multiple passes to release proteins to determine the optimal conditions of protein production.
Conclusion
19. All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIARA A MCKNIGHT whose telephone number is (703)756-4791. The examiner can normally be reached M-F 8:00am-4:30pm.
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/CIARA A MCKNIGHT/Examiner, Art Unit 1656
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656
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