DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of t/e previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/15/2025 has been entered.
Status of Application
The Examiner acknowledges receipt of the amendments filed on 8/15/2025 wherein claim 61 has been amended.
Claims 61-68 are presented for examination on the merits. The following rejections are made.
Claim Objections
Claim 62 objected to because of the following informalities: claim 62 provides the abbreviated term “β-TCP” but this abbreviation is not defined by claim 62 (or 61). Appropriate correction is required.
Response to Applicants’ Arguments
Applicant’s amendment/argument filed 05/21/2025 render moot the rejection of claims 52-68 made by the Examiner under 35 USC 103 over Hunter et al. (US 2012/0063997) in view of Cooper et al. (US 5679723), Hao et al. (US 2007/0254035) and Zussman et al. (US 2010/0129656). This rejection has been withdrawn in view of a newly identified reference US2006/0204738.
Applicant’s approved terminal disclaimer filed 05/21/2025 overcomes the rejection of claims 52-68 made by the Examiner under nonstatutory double patenting over claims 1-35 of US 11904070. This rejection has been withdrawn.
New Rejections
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
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/KYLE A PURDY/Primary Examiner, Art Unit 1611