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 .
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.
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.
Claim(s) 1 – 7, 9, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over US 5858531 to Chenite et al. hereinafter “Chenite” and as evidenced by the NPL titled Microspheres: Medical and Biological Applications, Rembaum et al., CRC Press, 1988, page 4.
Chenite is directed to a method of preparation of poly microparticles free of organic solvents (1: 5 – 10).
Regarding claims 1 – 4 and 9, Chenite teaches a process for producing polymer microparticles in claim 12 reproduced below.
PNG
media_image1.png
200
400
media_image1.png
Greyscale
PNG
media_image2.png
200
400
media_image2.png
Greyscale
Steps a) - c) of Chenite is equivalent to step a) of claim 1.
Step e) of Chenite is equivalent to step b) of claim 1. The solvent used is water which washes out the dispersed polymer from the mixture by simple dissolution of the matrix in water (4: 60 – 65). The polymer beads can be made from PCL, PLA, PLGA and the like (3: 45 – 57). The dispersed polymers can include PEG and PPG (4: 60 – 67).
Steps f – g) of Chenite are equivalent to step c) of claim 1. Therefore, it would have been obvious to one of ordinary skill to produce polymer microparticles as claimed as the process is directly taught by Chenite using more specific and narrower combinations of steps.
Chenite teaches that the microparticles may be spheroids, ellipsoids, platelets and fibrils (3: 20 – 25). The particle sizes range from 50 – 150 microns for PCL, 100 to 180 microns for PBA and 50 to 120 microns for PS (5: 55 – 60).
Regarding the particle sizes of the polymeric microparticles, “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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). MPEP 2144.05
As to claims 5 – 7, Chenite is silent as to the aspect ratios of the polymer microparticle however, the microparticles shown in Figures 3a, 3b and 3c are spherical particles. Therefore the aspect ratio length : diameter is equal to 1 as the particles are spheres. Therefore, it would have been obvious to one of ordinary skill to have particles with an aspect ratio of 1 (1:1) as the particles are spheres.
Regarding claims 11 – 12, the NPL to Rembaum, listed at (1: 19 – 25) in Chenite, teaches that microparticles are used in the biotechnical field as carrier matrices for drug delivery and other applications. Rembaum teaches the binding of monoclonal antibodies to polymer microspheres at page 4. Monoclonal antibodies are used in antimicrobial treatments. See Is monoclonal antibody an antimicrobial? - Search
Allowable Subject Matter
Claims 8, 10, 13 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER A. SALAMON whose telephone number is 571-270-3018. The examiner can normally be reached M-F: 9AM - 6PM.
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, Curtis Mayes can be reached at 571-272-1234. 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.
PAS 4/2/26
/PETER A SALAMON/Primary Examiner, Art Unit 1759