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 .
Withdrawn Rejection
The 35 U.S.C. §112, 2nd paragraph, rejection(s) of claim 11, made of record in the office action mailed 10/1/2025, page 2 have been withdrawn due to Applicant’s amendment in the response filed on 12/3/2025.
The 35 U.S.C. §103 rejection of claims 1-11 and 14-16 as over Currie et al. (WO 2018/025020) in view of Sauer et al. (US 2011/0186524), made of record in the office action mailed 10/1/2025, page 3 have been withdrawn due to Applicant’s amendment in the response filed on 12/3/2025.
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) 1-11 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Currie et al. (WO 2018/025020) in view of Sauer et al. (US 2011/0186524) and Harttig et al. (DE 19854973).
Regarding claims 1, 11 Currie discloses powder suitable for use in additive layer manufacturing (ALM). The powder comprises bioactive glass particles and particles of a polymeric binder material having a glass transition temperature (T.sub.g) of at least 30°C (abstract). Bioactive glasses have been widely used in biomedical applications. For example, bioactive glass has been employed in toothpastes for the treatment of hypersensitivity, in the manufacture of dental and orthopaedic implants, in bioactive coatings for metallic implants and prostheses and in synthetic bone grafting materials (page 1, lines 10-15).
While there is no disclosure that the powder composition comprising bioactive glass particles is a pH-switchable carrier composition as presently claimed, applicants attention is drawn to MPEP 2111.02 which states that “if the body of a claim fully and intrinsically sets forth all the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. Further, MPEP 2111.02 states that statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the purpose or intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the preamble does not state any distinct definition of any of the claimed invention’s limitations and further that the purpose or intended use, i.e. pH-switchable carrier composition, recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art Currie and further that the prior art structure which is a powder composition identical to that set forth in the present claims is capable of performing the recited purpose or intended use.
However, Currie fails to disclose that the bioactive glass particles can bind to a nucleic acid by non-covalanet bonding upon contact at pH in the range of about 7 to about 11 and exhibit controlled release of the nucleic acid compound at pH in the range of about 5 to about 6.
Whereas, Sauer discloses Porous, ferro- or ferrimagnetic, glass particles are described that selectively bind molecules of interest, especially nucleic acid molecules; under appropriate conditions (abstract). The porous, ferro- or ferrimagnetic, glass (silica) particles described herein have a relatively high binding capacity for various molecules, and especially nucleic acids, such that the particles are useful in isolating or separating molecules from a mixture in useful yields. The particles may be used in both analytical as well as preparative scale procedures. Particles having a particular porosity, binding capacity, and binding specificity are obtained by selectively changing various synthetic reaction parameters according to the invention (para 0023). The nucleic acid is selected from the group consisting of plasmid DNA, genomic DNA, cDNA, PCR DNA, linear DNA, RNA, ribozymes, aptamers, and chemically synthesized nucleic acids (claim 21).
Whereas, Harttig discloses preparation containing particles with a glass surface, more than 75% by weight these particles have a grain size of between 0.5 and 15 microns (claim 1) and purification of nucleic acids by non-covalent binding of the Nucleic acids from a sample of particles with a glass surface (claim 10).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to bind the bioactive glass particles of Currie bonded with nucleic acid by non-covalent bonding as taught by Sauer and Harttig motivated by the desire to have useful in isolating or separating molecules and remove unwanted components for end use of biomedical applications.
Regarding claims 2-3, Currie discloses a powder as claimed in claim 1 or 2 wherein the bioactive glass particles comprise a bioactive glass comprising: 0-60 wt% Si0.sub.2; 0-60 wt% B.sub.20.sub.3; 5-30 wt% CaO; 0-20 wt% K.sub.20; 0-10 wt% MgO; and 0-15 wt% P.sub.20.sub.5 (claims 2-5).
Regarding claims 4-5, as claims recites oxides in about 0 wt%, the claim limitation is met when they are absent from the bioactive glass particles.
Regarding claim 6, Currie discloses silicate bioactive glass generally has a composition comprising sodium oxide, calcium oxide, phosphorus pentoxide and silica, such as a glass composition having about 45-60 mol % silica and a molar ratio of calcium to phosphate of 2-10: 1. Glass materials having this or a similar composition, demonstrate the formation of a hydroxyapatite film on the materials surface that readily bonds the glass material to bone (page 5, lines 34-page 6, lines 6).
Regarding claims 7-10, Currie discloses powder as claimed in any preceding claim wherein the polymeric binder material comprises one or more polymeric compounds having a molecular weight in the range of 200-175,000 g/mol and the polymeric binder material comprises a biocompatible polymer selected from polyvinylpyrrolidone, chitosan (claims 12-13), where the molecular weight 175000 g/mol is equal to 175 kDa which meets the limitation of claim 10. The powder of the present invention also contains particles of a polymeric binder material. The polymeric binder material is a polymeric material which, on activation, acts to bond (adhere) powder particles together (page 7, lines 17-20).
Regarding claim 14, As Currie discloses bioactive glass particles as presently claimed, it therefore would be obvious that unmodified glass particles would intrinsically have the claimed zeta-potential under neutral conditions.
Regarding claim 15, As Currie discloses modified bioactive glass particles with binder as presently claimed, it therefore would be obvious that modified glass particles would intrinsically have the claimed zeta-potential under neutral conditions.
Regarding claim 16, with respect to the concentration of the nucleic acid as claimed, It would have been obvious to one of ordinary skill in the art at the time of the invention to choose the instantly claimed ranges through process optimization motivated by the desire to have useful in isolating or separating molecules for end use of biomedical applications, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (MPEP 2144.05).
Claim(s) 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Currie et al. (WO 2018/025020) in view of Sauer et al. (US 2011/0186524) and Harttig et al. (DE 19854973) as applied to claim 1, further in view of Zimmer et al. (WO 2004/076369).
Regarding claims 12-13, Currie in view of Sauer and Harttig fails to disclose that the bioactive glass particles have a particle size of about 1 to about 5 microns.
Whereas, Zimmer discloses antibacterial borosilicate glass having the following composition in relation to an oxide base: 40-80 mass % SiO2, 5-40 mass % B2O3, 0-10 mass % AI2O3, 0 30 mass % P2O5, 0-25 mass % Li2O, 0-25 mass % Na2O, 0-25 mass % K2O, 0-25 mass % CaO (abstract). The size of the glass particles of the glass powder is on average less than 10 microns (claims 19-21).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to form bioactive glass particles of Currie having an average particle size of less than 10 microns as taught by Zimmer motivated by the desire to have biocidal characteristics.
Response to Arguments
Applicant’s arguments filed on 12/3/2025 has been fully considered, but they are not persuasive.
Applicant respectfully submits that no such reasonable expectation of success exists for binding the glass particles of Currie with nucleic acids as taught by Sauer to allegedly arrive at the claimed invention. Therefore, the combination of references do not support a conclusion of obviousness of the claimed invention as asserted by the Office. In this regard, Currie discloses powders for additive layer manufacturing, comprising bioactive Ca-P-Si glasses mixed with polymeric binder particles to facilitate sintering during 3D- printing (Currie, Abstract, pg. 1, lines 4-7; pg. 7, lines 16-25). Sauer, in contrast, describes porous, ferro- or ferrimagnetic glass particles comprising silica that are disclosed as being capable of binding nucleic acids. (Sauer 11[0008]-[0010], [0023]-[0026], [0044]). The only point of overlap between the systems is the presence of silica. The materials of Currie and Sauer are otherwise chemically and structurally distinct and designed for entirely different functions.
However, it should be noted that both Currie and Sauer are directed towards glass particles and are analogous art and it would be obvious to one of ordinary skill in the art at the time the application was filed to bind the bioactive glass particles of Currie bonded with nucleic acid as taught by Sauer motivated by the desire to have useful in isolating or separating molecules.
Applicant argues that Currie discloses powders for additive layer manufacturing, comprising bioactive Ca-P-Si glasses mixed with polymeric binder particles to facilitate sintering during 3D- printing (Currie, Abstract, pg. 1, lines 4-7; pg. 7, lines 16-25). Sauer, in contrast, describes porous, ferro- or ferrimagnetic glass particles comprising silica that are disclosed as being capable of binding nucleic acids. (Sauer 11[0008]-[0010], [0023]-[0026], [0044]). The only point of overlap between the systems is the presence of silica. The materials of Currie and Sauer are otherwise chemically and structurally distinct and designed for entirely different functions. Nothing in Currie suggests that its Ca-P-Si bioactive glass compositions, which may contain substantial amounts of CaO, Na₂O, K2O, and P₂O₅ (Currie, pg. 6, lines 7-14), would behave like Sauer's porous ferro- or ferrimagnetic silica-based particles that are designed and used for nucleic-acid binding. Nor does Sauer suggest that its binding mechanism, which is disclosed in the context of porous, ferro- or ferrimagnetic silica-containing glass beads for nucleic-acid capture and elution, could be transferred to a bioactive glass formulated for structural and biomedical implant applications.
However, Sauer is only used as teaching reference in order to teach nucleic acid bonded to a glass particle. It is noted that the "test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference... Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art", In re Keller, 642 F.2d 413,208 USPQ 871,881 (CCPA 1981) and that "combining the teachings of references does not involve an ability to combine their specific structures", In re Nievelt, 482 F.2d 965, 179 USP 224, 226 (CCPA).
Applicant argues that the references operate with completely different glass-based materials, a person of ordinary skill in the art would have had no reasonable expectation of success that the bioactive glass particles of Currie would have any nucleic-acid binding capabilities. As a result, one of ordinary skill in the art would have not have combined Currie and Sauer in the manner asserted by the Office.
However, both Currie and Sauer are directed towards glass particles and are analogous art and it would be obvious to bind the bioactive glass particles of Currie bonded with nucleic acid, absent evidence to the contrary as taught by Sauer motivated by the desire to have useful in isolating or separating molecules. If Applicant does not believe that nucleic acid of Sauer can be bonded on to glass particles of Currie, a declaration or an Affidavit is requested to support these arguments.
Applicant also offers the following additional information regarding the context and benefits of the presently claimed invention. The claimed pH-switchable carrier composition comprising bioactive glass particles with nucleic acids non-covalently bound to their surfaces offers distinct advantages not disclosed or suggested in the cited prior art. As detailed in the Application, the bioactive glass particles are described as "tunable" or "switchable" carriers that bind nucleic acids at neutral to basic pH and release them at mildly acidic pH (Application, ПТ[0029], [0031], [0032], [0083], FIG. 6). For example, the Application demonstrates that nucleic acids can be bound at pH 7-11 and subsequently released in the pH range of 5-6, with elution occurring within approximately 30 minutes (Application ||[0060]). These functional advantages are directly attributable to the pH-responsive properties of the disclosed bioactive glass particles with nucleic acids non- covalently bound to their surfaces. Neither Currie nor Sauer recognizes or suggests a system capable of neutral to basic pH nucleic acid compound binding coupled with controlled release triggered by mildly acidic pH, as demonstrated in the present Application.
The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed.Cir. 2006); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662,1685 (Fed. Cir. 2005); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991)
“obviousness under 103 is not negated because the motivation to arrive at the claimed invention as disclosed by the prior art does not agree with appellant’s motivation”, In re Dillon, 16 USPQ2d 1897 (Fed. Cir. 1990), In re Tomlinson, 150 USPQ 623 (CCPA 1966).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/RONAK C PATEL/Primary Examiner, Art Unit 1788