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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/26/2022, 12/16/2022, and 04/04/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Claims 1-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/15/2025.
Claim Objections
Claims 20 and 21 objected to because of the following informalities:
Claims 20 and 21 recite the phrase “of from” in line 2. The examiner suggests amending the claim to remove the term “from”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 18-19, and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al (US 2014/0207248 A1).
Regarding claim 18, Wang discloses a hybrid fibrous scaffold (paragraph 0005), comprising:
a plurality of semi-stable fibers (Figure 17, see Wang, paragraph 0032 of Wang discloses the same polymers as the polymers discloses in paragraph 0065 of the applicant’s specification which are used to form the semi-stable fibers; the polymers of Wang are formed into fibers through electrospinning (paragraph 0031) including a plurality of bent fibers (see Wang, Figure 17, item 128; paragraph 0052) and a plurality of straight fibers (see Wang, Figure 17, items 122 and 124),
wherein the plurality of straight fibers are aligned to form a stacking grid geometry with a programmed grid spacing (Figure 17 depicts the straight fibers 122 and 124 aligned to form a stacking grid geometry) and the plurality of bent fibers extend across at least a portion of the programmed grid spacing (Figure 17, the bent fibers 128 are depicted as extending across at least a portion of the programmed grid spacing).
Regarding claim 19, Wang discloses wherein the hybrid fibrous scaffold (see Wang, paragraph 0002 discloses that the scaffolds can be used for tissue grafts) comprises a vascular graft hybrid fibrous scaffold (see Wang, Figure 19 depicts a tubular scaffold (paragraph 0060; paragraph 0042 discloses “In embodiments of the present invention, repair of soft tissue includes repair of skin, muscles, tendons, ligaments, cartilage, hernia, blood vessels, nerves, etc.”, repair of blood vessels would constitute a vascular graft).
Regarding claim 22, Wang discloses wherein the scaffold comprises one or more therapeutic agents (see Wang, paragraph 0042 “The selection of materials used to form the scaffolds allows control over the rate at which the scaffolds are degraded in vivo, and allows for the inclusion and controlled release of various large or small molecules (e.g., drugs, proteins, growth factors, minerals, buffers, or dyes).”).
Regarding claim 23, Wang discloses a method of promoting tissue regeneration (paragraph 0042 “Such scaffolds, which are also embodiments of the present invention, allow for the regeneration and repair of both soft tissue and hard tissue.”) or endothelialization in a subject, comprising:
providing a hybrid fibrous (Figure 17) scaffold comprising semi-stable fibers (Figure 17, see Wang, paragraph 0032 of Wang discloses the same polymers as the polymers discloses in paragraph 0065 of the applicant’s specification which are used to form the semi-stable fibers; the polymers of Wang are formed into fibers through electrospinning (paragraph 0031) 0including a plurality of bent fibers and a plurality of straight fibers;
and contacting the hybrid fibrous scaffold with tissue in the subject (paragraph 0002; paragraph 0042).
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 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (US 2014/0207248 A1) in view of D’Amore et al (US 2022/0259773 A1).
Regarding claim 20, Wang discloses the invention substantially as claimed.
However, Wang does not disclose wherein the hybrid fibrous scaffold comprises a permeability to 9.9 µm microspheres of from 150 microspheres/mm2 to 3000 microspheres/mm2.
D’Amore discloses a hybrid fibrous scaffold (see D’Amore, paragraph 0089; paragraph 0123) which can be formed of bent fibers (see D’Amore, paragraph 0095 “randomly-arranged”) and straight fibers (see D’Amore, paragraph 0095 “ordered”) wherein the pore size is between 0.1 and 100 microns (see D’Amore, paragraph 0157).
D’Amore does not disclose specifically wherein the permeability to 9.9 µm microspheres of from 150 microspheres/mm2 to 3000 microspheres/mm2, however, D’Amore does disclose that the hybrid fibrous scaffold is permeable to substances that are 9.9 µm and that the pore size or degree of porosity can be altered by varying the polymer concentration of the electrospinning solution, by varying the spinning distance from the nozzle to the target deposition axis, the polymer, the target—nozzle voltage gap, and/or any other factor that would after porosity during the electrodeposition process. Adjusting the pore size of the scaffold would adjust the permeability. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the scaffold of Wang by providing wherein the permeability to 9.9 µm microspheres of from 150 microspheres/mm2 to 3000 microspheres/mm2 as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 21, Wang discloses the invention substantially as claimed.
However, Wang does not disclose wherein the hybrid fibrous scaffold comprises a permeability to 97 µm microspheres of from 1 microspheres/mm2 to 5 microspheres/mm2.
D’Amore discloses a hybrid fibrous scaffold (see D’Amore, paragraph 0089; paragraph 0123) which can be formed of bent fibers (see D’Amore, paragraph 0095 “randomly-arranged”) and straight fibers (see D’Amore, paragraph 0095 “ordered”) wherein the pore size is between 0.1 and 100 microns (see D’Amore, paragraph 0157).
D’Amore does not disclose specifically wherein the permeability to 97 µm microspheres of from 1 microspheres/mm2 to 5 microspheres/mm2, however, D’Amore does disclose that the hybrid fibrous scaffold is permeable to substances that are 97 µm and that the pore size or degree of porosity can be altered by varying the polymer concentration of the electrospinning solution, by varying the spinning distance from the nozzle to the target deposition axis, the polymer, the target—nozzle voltage gap, and/or any other factor that would after porosity during the electrodeposition process. Adjusting the pore size of the scaffold would adjust the permeability. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the scaffold of Wang by providing wherein the permeability to 97 µm microspheres of from 1 microspheres/mm2 to 5 microspheres/mm2 as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA LYNEE ZIMMERMAN whose telephone number is (313)446-4864. The examiner can normally be reached Mon. 8:30 AM-6:30 PM, Tues. - Fri. 8:30-4:00 PM.
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/REBECCA LYNEE ZIMMERMAN/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774