DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 4/17/2026 wherein claims 61 and 62 have been amended.
Claims 61-68 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s amendment filed 4/17/2026 amending claims 61 and 62 overcomes the objection to claim 62.
Applicant’s arguments filed 4/17/2026 regarding the rejection of claims 61, 63, 64, 66-68 made by the Examiner under 35 USC 103 over Dubrow et al. (US 2006/0204738) in view of Zussman et al. (US 2010/0129656) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 1/22/2026.
Applicant’s arguments filed 4/17/2026 regarding the rejection of claims 62 and 65 made by the Examiner under 35 USC 103 over Dubrow et al. (US 2006/0204738) in view of Zussman et al. (US 2010/0129656) further in view of Cooper et al. (US 5679723) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 1/22/2026.
In regards to the 103 rejections, Applicant asserts the following:
A) Dubrow is directed to a technology fundamentally different and not relevant to the present invention. Dubrow is directed to surface modified metallic implant to improve osteoblast adhesion and not about free-standing particulate scaffolds for tissue repair or replacement. Moreover, the coating of Dubrow and the non-polymer particles of 61 are two different things.
In response to A, if the scaffold is to be free-standing, then the claims should state as much. As of now, the only requirement is that the scaffold be solid, be used for tissue repair or replacement and comprise a plurality of hollow polymer pellets having an open hollow extending through the pellet. Dubrow is directed to medical applications using polymeric nanostructured scaffolds comprising nanotubes having an open hollow extending through the tube. The fact that Dubrow describes the composition as a ‘scaffold’ indicates overlap with the ‘scaffold’ of the prior art. The intention of Dubrow’s composition being for treating bone by improving osteoblast adhesion is not considered mitigating because it is ultimately an intention for how the composition is to be used. Moreover, the purpose of Dubrow is not seen as significantly different from the present invention as the present invention is also intended for the treatment and repair of bone.
The argument that Dubrow does not describe non-polymer particles is not persuasive. Dubrow teaches that their mineral, e.g. hydroxyapatite, coating is applied to the scaffold surface via sol-gel deposition process. Sol-gel process are known to be for the synthesis of particles (see evidence to Tseng et al. (Materials Science and Engineering, 2009, 29, 819-822). Thus, Dubrow’s process would result in a mineral coating wherein the mineral coating is in the form of deposited particles (via sol-gel).
Maintained Rejections, of Record
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 61, 63, 64 and 66-68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dubrow et al. (US 2006/0204738) in view of Zussman et al. (US 2010/0129656; of record)
Dubrow is directed to medical applications using polymeric nanostructured scaffold compositions wherein the composition comprises a plurality of nanotubes (see [0006, 0015, 0023, 0215])). The composition is to be used in bone repair compositions such as implants and replacements (see [0021]).
The polymeric nanotubes are to be hollow through the core of the nanotube, wherein the diameter of the hollow core can be modulated by synthetic techniques to increase the diameter (to increase release rate) or narrow the diameter (to restrict release) of the material contained within the nanotube (see [0215]). The nanotube is to have an aspect ratio of greater than 1 (see [0273]) wherein the dimension of the nanotube are such that the diameter can comprise, e.g., from about 5 nm up to about 1 micron or more (e.g., 5 microns); from about 10 nm to about 750 nanometers or more; from about 25 nm to about 500 nanometers or more; from about 50 nm to about 250 nanometers or more, or from about 75 nm to about 100 nanometers or more, while the lengths of the nanotube can comprise, e.g., from about 2 microns (e.g., 0.5 microns) up to about 1 mm or more; from about 10 microns to about 500 micrometers or more; from about 25 microns to about 250 microns or more; or from about 50 microns to about 100 microns or more (see [0310]). One of ordinary skill in the art would be capable of modulating the length and width of the nanotubes within the dimensions suggested by the prior and if such a manipulation resulted in an aspect ratio which overlapped that claimed, then that would have been the product of ordinary skill and common sense. Again, it is noted that at a minimum, Dubrow suggests an aspect ratio of above 1 which overlaps with that presently claimed (see instant claims 63 and 64).
Exemplified polymers for constructing the hollow nanotube include PLGA and PLA (see [0137]) (see instant claim 68).
The material loaded into the nanotube (i.e. encapsulated within) may be a drug (see [0219]) (see instant claim 66).
The nanofiber may be coated with a substance to encourage bio-compatibility/biointegration such as hydroxyapatite (see [0375, 0376]) (see instant claim 61).
Dubrow fails to teach their hollow microtubes as having a hollow volume that is at least 20% of each hollow polymer pellet.
Zussman describes biocompatible microtubes made from polymers such as PLGA and polyethylene glycol (see [0010]). The microtubes may be used for drug release (see [0001]). The microtube is to have an internal diameter of 200 nm to 50 um and an outer diameter of 0.5 um to 100 um (see [0048]). A microtube, for example, having an internal diameter of 50 um and an outer diameter of 100 um would result in a hollow lumen volume of 50% ((50um/100um)*100). Thus, as Dubrow describes hollow microtubes but is silent regarding the hollow volume thereof, one of ordinary skill in the art would seek to identify a hollow volume useful for the retention and release of drugs once applied to a subject in need thereof.
Regarding the requirement that “the hollow polymer pellets are non-uniformly orientated relative to each other”, this would be expected to follow from the combination of references in that Dubrow describes the microtubes as being random oriented (see [0339]) and the Figures of Zussmann demonstrate that the microtubes are randomly orientated (see Figure 3a).
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.
Claims 62 and 65 rejected under 35 U.S.C. 103 as being unpatentable over Dubrow et al. (US 2006/0204738) in view of Zussman et al. (US 2010/0129656; of record) as applied to claims 61, 63, 64 and 66-68 above, and further in view of Cooper et al. (US 5679723; of record).
Dubrow and Zussman fails to teach their scaffold as comprising non-polymer particles, the non-polymer particles comprise or consist of calcium phosphate, a-tricalcium phosphate, b-tricalcium phosphate or hydroxyapatite.
Cooper is directed to hard tissue bone cements comprising a first polymeric phase and a second resorbable phase comprising hard tissue osteoconductive compounds such as hydroxyapatite and beta-tricalcium phosphate (“β-TCP”) (see claim 1(b)) (see instant claims 61, 62 and 65). It is taught that compounds such as hydroxyapatite are critical in regenerating bone (see column1, lines 15-22). Cooper teaches that the osteoconductive material is to be included in the bone cement composition in an amount between 10-50% of the composition weight (see claim 2) (see instant claim 62).
Given that Dubrow is broadly directed to osteoconductive compositions, it would have been obvious to identify specific osteoconductive materials, such as hydroxyapatite and β-TCP, and include them in Dubrow’s microtube scaffold composition with a reasonable expectation for success in providing bone regeneration benefit. See MPEP 2144.07 which states that the selection of a known material based on its suitability for its intended purpose is supportive of obviousness.
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
THIS ACTION IS MADE FINAL. 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 mailing 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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