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 Claims
The arguments filed on 02/24/2026 are acknowledged and have been fully considered. Claims 1-4 and 13-16 are now pending. Claim 1 is amended; claims 5-12 are cancelled.
Claims 1-4 and 13-16 will be examined on the merits herein.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/24/2026 has been entered.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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.
The factual inquiries 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 1-4 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over CA 2008143 A1 (Perner, 1990) in view of Champion (2007).
In regards to claim 1, Perner teaches a method of making a solution of polyglycerol maleate (see Perner, examples 1-3).
Perner is silent on the poly(glycerol maleate) being in the form of microparticles but does disclose spray drying the product in the examples (such as example 5).
In regards to claims 1-4 and 13-16, Champion teaches a method of drying polymer solutions, such as spray drying, to form spherical polymer micro- and nano- particles for use as drug carriers (i.e. a product) (see Champion, title, figures and paragraph bridging pages 1-2). As the solution is dried into particles, using the broadest reasonable interpretation, that these particles would be solid (i.e. having a solid structure). However, it is also noted that Champion teaches methods that product non-spherical solid particles as well (see Champion, page 3, paragraph 4).
Further in regards to the particle size limitation of the instant claims, Champion teaches that the particle size influences almost every aspect of particle function including degradation, flow properties, clearance and uptake mechanisms. It is noted that this is within a discussion of the importance of particle size and how it affects the degradation of the particles. As such, one with ordinary skill in the art reading Champion would understand that the particle size would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed particle size cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the particle size in Champion to obtain the desired balance between the degradability as taught by Champion (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[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.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
In regards to claims 1-4 and 13-16, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate a composition as instant claimed using the teachings of Perner and Champion as the methods of Champion are directed toward making polymer based microparticles and Perner is directed towards a polymer solution. Further, it is specifically taught that the polyglycerol aminocarboxylate that is formed by esterification using maleic anhydride (i.e. polyglycerol maleate) is known to have very good biodegrability (see Perner, page 4, lines 26-32). One with ordinary skill in the art would be motivated to combine the polyglycerol maleate solution of Perner with the teachings of Champion according to the method of forming microparticles (see Champion, paragraph bridging pages 1-2) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Further in regards to claims 1-2 and 13-14, specifically to the teaching of the polydispersity index and the degradability of the microparticle, as the combination of teachings of Perner and Champion renders it obvious to arrive at the composition instantly claimed. As the combined teachings of the prior art arrives at the composition as claimed, the properties applicant discloses and/or claims would necessarily follow absent evidence to the contrary.
Response to Arguments
Applicant's arguments filed 02/24/2026 have been fully considered but they are not persuasive.
First, examiner thanks Dr. Jane Wang for the declaration filed under 37 CFR 1.132. However as discussed below, it is not enough to establish unexpected results in order to overcome the rejection of record.
In regards to applicant’s arguments that the art does not teach the newly amended claimed range of grain size and the declaration of Dr. Jane Wang, it is noted that the prior art does not teach the claimed range. However, it is also pointed out that one with ordinary skill in the art reading Champion would understand that the particle size would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed particle size cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the particle size in Champion to obtain the desired balance between the degradability as taught by Champion (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[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.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). In order to overcome this, applicant has presented data in the form of a declaration, which is appreciated. It is noted that there is a difference between the mechanical strength of the larger particle sizes when compared to the smaller sizes. Unfortunately, the alleged unexpected results show that the mechanical strength difference is also present outside of the claimed range, specifically when looking at the 25µm particles. The mechanical strength of these microparticles is shown to be similar to those of the 105µm particles, but the claimed range is only from 26.3 micrometers. The data shown is not commensurate with the scope of the claims in this case. Applicant is reminded that whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
Further, applicant argues that the property of being degradable in seawater and freshwater cannot be expected based on the property of biodegradability, however it is pointed out that the rejection is not basing the reasoning on the biodegradability of the composition, rather that the claim is limiting the material in the microparticle to be poly(glycerol maleate) and the art teaches an identical microparticle. As such, it would be obvious to one with ordinary skill in the art that the properties that are claimed would necessarily follow absent evidence to the contrary.
In regards to applicant’s argument that Champion does not mention, teach, or imply the influence of the particle size on its mechanical strength. It is noted that the claims are not drawn to the mechanical strength of the microparticles either, only that they consist of PGM – a requirement that is met by the prior art. Champion does give other motivation to one with ordinary skill in the art to modify the particle size of the microparticles. The fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant also argues that Champion discourages particles with a size larger than 5 µm, however this is not the case. Champion simply mentions and discusses microparticles of the size range 1-5 µm (see Champion, page 3, first paragraph), however goes into a much deeper discussion about particle size and how it affects degradation of the particles. Specifically, it is taught that “Degradation of particles is size dependent” (see Champion, page 2, final paragraph).
Applicant’s arguments with respect to reference McDonough have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 EST.
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, Bethany Barham can be reached at 571-272-6175. 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.
/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611