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 1-21 are pending.
Election/Restrictions
Applicant’s election of the invention of Group I, claims 1-8, drawn to a method for preparing a biodegradable polymer, and the species of PLA and/or PLGA as the biodegradable polymer in the reply filed on 6/29/26 is acknowledged. Examination will be extended to both PLA and/or PLGA, however, if future claim sets diverge and require PLA and PLGA in separate claim trees, the election will comprise PLGA only.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 9-21 are withdrawn as being drawn to a nonelected invention.
Claims 1-8 are under consideration to the extent that the method comprises the elected species.
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 2/26/24. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
NPL references without provided copies have not been considered.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Claim Rejections - 35 USC § 112
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.
Claims 4-6 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 pre-AIA the applicant regards as the invention.
Claim 4 recites the limitation "the forming of microspheres" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite a step of “forming” so it is unclear which step is being referenced. If the claim is intended to describe a final product the following is suggested, “…wherein microspheres have a uniform particle size distribution within 30% of standard deviation in size.” Otherwise, a specific step in claim 1 should be referenced.
Claim 5 recites the limitation "the forming of microspheres" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite a step of “forming” so it is unclear which step is being referenced. If the claim is intended to describe a final product the following is suggested, “…wherein
Claim 6 recites the limitation "the forming of microspheres" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite a step of “forming” so it is unclear which step is being referenced. The following is suggested, “… wherein in the parallel-type continuous reaction membrane emulsification device, a membrane with different pores is used to adjust a microsphere size between 1 and 300 µm.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2020/0207930; hereafter Kim 2020) in view of Kim et al. (US 2014/0341997; hereafter Kim 2014).
Kim 2020 teaches a method for preparing biodegradable polymer microparticles (e.g. abstract). Kim 2020 teaches the method comprises:
-preparing a dispersion in which biodegradable polymers are dissolved;
-applying a pressure to the dispersion and slowly injecting the dispersion into an emulsion through a membrane to form microspheres;
-discharging a mixed solution in which the microspheres are mixed;
-receiving the discharged mixed solution to stabilize the microspheres; and
-washing and drying the stabilized microspheres (e.g. Claim 1; Example 1).
Kim 2020 teaches that the biodegradable polymer may be poly(lactic acid) and/or poly(lactic acid-co-glycolic acid) (e.g. Claim 12).
Kim 2020 does not teach the use of a parallel-type membrane or teach that the emulsion is continuously replaced and supplied. This is made up for by the teachings of Kim 2014.
Kim 2014 teaches a continuous process for preparing microspheres and microspheres prepared thereby, and in particular, a process for preparing microspheres comprising steps of injecting a first emulsion and a second emulsion at the same time to form microspheres instantaneously, applying high pressure to the microspheres formed, and injecting the microspheres into an agitator, wherein the steps can be carried out continuously, and microspheres prepared thereby (e.g. abstract). Kim 2014 teaches the polymer may be one or more selected from the group consisting of polylactide (PLA) and poly(lactide-co-glycolide) (PLGA) (e.g. paragraph 0027). Kim 2014 teaches that increasing from a laboratory scale to a pilot or production scale is very difficult and is very often the biggest cause for failure. In addition, particles prepared by a discontinuous process have a large particle size distribution, and the size distribution also varies depending on the scale, therefore, the output of a specific preparation is not reproducible (e.g. paragraph 0007). Kim 2014 teach that microspheres with a desired size such as a nano size can be reproducibly prepared by carrying out continuously (e.g. paragraph 0008).
Regarding Claim 1, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the process of Kim 2020 by incorporating a continuous method as in Kim 2014 using parallel membranes. The use of a known technique to improve similar devices (methods, or products) in the same way is obvious. One of ordinary skill in the art would have predicted success as both Kim 2020 and Kim 2014 are directed to the production of microspheres of PLA and/or PLGA. One of ordinary skill in the art would have been motivated to scale up production and improve reproducibility through a continuous process, as taught by Kim 2014.
Regarding Claim 2, Kim 2020 teaches that the polymers have a molecular weight of 10,000 to 1,000,000 g/mol, which overlaps with the claimed range (e.g. paragraph 0057). 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I).
Regarding Claim 3, Kim 2020 teaches that the solvent is methylene chloride (i.e. chlorinated hydrocarbon) and the polymer is present in 5 wt% (e.g. Example 1). More broadly, Kim 2020 teaches the concentration of biodegradable polymer dissolved in an organic solvent is preferably in a range of from 5 to 20% by weight (e.g. paragraph 0050).
Regarding Claim 4, Kim 2020 exemplifies 22.2% coefficient of variation (e.g. Table 1).
Regarding Claims 5 and 6, Kim 2020 teaches particle sizes of 10-200 µm (e.g. paragraphs 0035, 0036, 0040). Kim 2020 further teaches the membrane can have pores ranging from 10 to 30 μm (e.g. paragraph 0051).
Regarding Claim 7, Kim 2020 teaches polyvinyl alcohol as the preferred surfactant (e.g. paragraph 0053; Examples).
Regarding Claim 8, the claim is directed to an intended use of a resulting product from following the claimed method steps, and do not recite any additional ingredients or structure. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. However, Kim 2020 teaches that the microspheres can be used as a filler (e.g. paragraph 0003, Examples).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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