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 .
Election Acknowledged
Applicants’ election without traverse the invention of Group I encompassing claims 1-10 is acknowledged. The restriction is made final 1-10 traverse.
Claims 1-10 are pending and presented for examination on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/7/2024 and 3/5/2025 have been considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: missing an “a” in front of “boron complex” in the preamble (“lyophilized powder containing boron complex, comprising…)
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 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shull et al. (US 6169076) in view of Musunuri et al. (US 7276359).
Shull is directed to p-boronophenylalanine (BPA) complexes carbohydrates and polyols.
Shull teaches that BPA is useful compound in boron neutron capture therapy for the treatment of gliomas and other cancer types wherein the boron captures a neutron which results in the release of ionizing helium and lithium ions that are highly damaging and lethal to the host cell (see column 1, lines 36-65). BPA, however, suffers from poor water solubility and so novel water-soluble forms of BPA are needed for successful delivery of the compound. Complexation of BPA with polyols, such as mannitol, xylitol and sorbitol, are contemplated to overcome the issue of poor solubility (see column 4, lines 57-67; see instant claims 1 and 3). The BPA-sugar alcohol complexes are prepared as a lyophilized (freeze-fried) product (see column 13, lines 39-42) which refers to a method of dehydration wherein the mixture is frozen and then placed under vacuum so that water vaporizes without melting leaving non-volatile components behind. Example 7 provides a method for preparing a BPA-mannitol complex via a freeze-drying process so as to produce a lyophilized product (see column 17, lines 45-60; see instant claim 1). The solution of the BPA-sugar alcohol is taught to have a pH of between 7.3-7.5 (see claim 1; see instant claim 9).
Regarding instant claim 4, mixtures of lyophilized BPA and sugar alcohol preparations, e.g. BPA-sorbitol, BPA-mannitol and BPA-xylitol, would have been obvious as each are separately described by Liu as useful for improving the water-solubility of the poorly soluble BPA. Thus, mixtures thereof would be reasonable expected to perform similarly absent evidence otherwise. As to the molar ratios of the various complexes to one another described by instant claim 5 (e.g. BPA-sorbitol:BPA-xylitol, etc), these are considered obvious as the general framework is already set forth by the prior art and where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Shull teaches that the process of producing PBA-polyol complex does not yield complete complexation and that the ratio of free BPA to BPA-carbohydrate of the resulting mixture can be determined by integration of the aromatic protons resonance wherein the free BPA has resonance signals of 7.73 and 7.33 ppm and the complexed BPA has resonance of 7.2 ppm and 7.5 ppm (see column 7, lines 60-65; see instant claims 6-8). The proton resonance described by Shull is overlapping or sufficiently close to that of instant claims 6-8. See MPEP 2144.05(I)(A).
Shull fails to teach the lyophilized materials as being in the form of a powder and comprising a sugar acid (e.g. sialic acid, neuraminic acid, glucuronic acid and/or mannuronic acid).
Musunuri is directed to lyophilized polynucleotide compositions in the form of a powder having an average particle size of less than 100 microns (see abstract and column 9, lines 5-13; see instant claims 1 and 10). It is taught that the lyophilized compositions are to include a cryoprotectant, such as mannuronic acid or neuraminic acid. Musunuri taches that cryoprotectants are important in stabilizing the composition during and after lyophilization (see column 6, lines 26-65; see instant claim 2). One of ordinary skill in the art would be motivated to modify Shull’s lyophilized composition so as to be in the form of a powder and include a cryoprotectant, such as mannuronic acid, with a reasonable expectation for success in protecting the composition during and after the lyophilization process.
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
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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