DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 4/30/2026 wherein claim 1 has been amended.
Claims 1-4 and 6 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s approved terminal disclaimer filed 4/30/2026 overcomes the rejection of claims 1-4 and 6 made by the Examiner under non-statutory double patenting over application 17/762701. This rejection is withdrawn.
Applicant’s amendments/arguments filed 4/30/2026 renders moot the rejection of claims 1-4 and 6 made by the Examiner under 35 USC 103 over Kim et al. (WO 2019/078583) in view of Berkland et al. (J Controlled Release, 73, 2001, 59-74) as the claims no longer require a particle distribution width of 35 microns, a feature taught by Berkland. Therefore, the rejection has been withdrawn.
Allowable Subject Matter
Claim 6 is 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.
New Rejections, Necessitated by Amendment
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.
Claims 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (WO 2019/078583; of record; translation provided) in view of Lee et al. (US 2020/0101054) and Srinivas et al. (US 2008/0226742).
Kim describes a sustained release microparticle containing a polymer such as PLGA (see page 4) (see instant claims 1 and 4) and a drug such as donepezil (see page 4) (see instant claim 1) wherein the microparticles contains the polymer and drug in a weight ratio of 2:1 to 9:1 (see page 7) (see instant claim 3). 2:1 to 9:1 equates to 66% to 90% polymer (math not shown). This range overlaps with the claimed range of 60-97% by weight (see instant claim 2). See MPEP 2144.05(I) regarding obviousness of overlapping ranges.
The microparticle’s of Kim are to be smooth (see Figures 2 and 3) and be capable of sustained release for a period of time of one week to three months (see page 2) (see instant claim 1). Kim teaches that the microparticles are to be smooth and have a spherical shape (see page 4) and that the drug is uniformly distributed within the microparticle (see page 4) (see instant claim 1). The microparticles are to have a diameter of between 20-70 microns (see page 4) (see instant claim 1), wherein the microparticles are prepared by using a microchannel having a cross section of 0.7-1.3 with respect to the diameter of the microparticles thereby ensuring a homogenous particle distribution (see page 4). Kim teaches that particles having a size below 20 microns results in predation by macrophages post injection, possibly affecting absorption whereas particles with a size above 70 microns increase foreign body sensation and pain when administered (see page 8).
Figure 7 demonstrate the release characteristics of drug from the microparticle where it is observed that no initial excessive release of drug is observed (see instant claim 1).
Regarding instant claim 6, this is an intended use limitation in that it defines an initial blood concentration to maximum blood concentration. A blood concentration, however, would require that the particles be administered and a blood concentration be subsequently measured. The blood concentration is related to the act of administering the composition rather than to any structural feature of the composition claimed. See 2112.02 regarding statements of intended use.
Kim fails to teach their microparticles have a D90-D10 particle size of 25 microns or less, a (D90-D10)/D50 ratio of 0.35 and a specific surface area per mass unit of 0.75x10-1 to 2.0x10-1 m2/g.
Lee, like Kim, is directed to sustained-release donepezil microparticles comprising a polymer, e.g. polylactide acid, and donepezil (see claim 1). Lee’s particles are to have a uniform particle size with an average particle size of between 40-130 microns (see [0021]) and possess a Span index (D90-D10)/D50) of 1.2 or less (see [0024]) with specific examples having a Span value of 0.57 (see Table 2). It is taught that compositions comprising such uniform therapeutic microparticles effectively maintains effective blood concentration thereby improving patient compliance and maximizing therapeutic outcome (see [0015]). Although Lee does not teach a D90-D10 range as being 25 microns or less, one of ordinary skill in the art would desire to minimize the particle size distribution so as to produce a microparticle best capable of providing therapeutic benefit. Given that the prior art, Kim and Lee, desires uniform monodisperse donepezil microparticles, one of ordinary skill in the art would seek to minimize the size variance. If such an undertaking resulted in a D90-D10 range of 25 microns or less, then this would have been a product of ordinary skill in the art, rather than one of innovation. It is noted that the size distribution is controlled by modulating the pore size of the separating membrane which one of ordinary skill in the art would be capable of performing (see [0117]). Regarding the Span value being less than 0.35, this is obvious in view of Lee as the general feature of a homogenous particle distribution is taught as desired for donepezil microparticles. Lee’s teaching that the Span value be less than 1.2 overlaps with the 0.35 as well. See MPEP 2144.05(I). In any regard, reducing the distribution in particle size would necessarily result in reducing the Span value as the Span value is a measure of size distribution, i.e. the more narrow the distribution the smaller the Span value. See MPEP 2144.05.02 which states that where the general conditions of a claim are described by the prior art, it is not inventive to discover optimum ranges by routine experimentation. Such is relevant here as the basic framework is provided by the prior art and carrying forward the desires of the prior art forward so as to arrive at microparticles having the physical properties so claimed would have been an obvious manipulation.
Srinivas is directed to compositions for drug delivery the composition being in the form of polymeric microparticles. Srinivas teaches that their microparticles may possess particle size of between 0.01 microns to 1 mm and possess a surface area of 0.01-500 m2g (see [0046] and claim 2). As the property of specific surface area is understood to be tunable to a desired outcome, one of ordinary skill in the art would have been motivated to identify a surface area which best resulted in a microparticle capable of excellent therapeutic benefit. Moreover, the property of specific surface area as claimed would be expected to flow from the obvious PLGA donepezil particles resulting from Kim and Berkland because the resulting particles would have the same composition and physical dimensions with that claimed and would therefore be reasonably expected to possess such a physical property.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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