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 .
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 20 January 2026.
ELECTION
Applicant’s election of claims 53-58 drawn to a method of manufacturing a soft tissue device in the reply filed on 20 January 2026 is acknowledged. The response does not clearly state the election is with or without traverse. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). Burden was established in the restriction mailed on 18 January 2025. The requirement is still deemed proper and is therefore made FINAL. Claims 39-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
CLAIMS UNDER EXAMINATION
Claims 53-58 have been examined on their merits.
PRIORITY
Provisional Application 62669287, filed on 09 May 2018, is acknowledged.
OBJECTIONS
Regarding claim 58: the claim contains two periods (a period before “cosmetic procedure” and after “disorder or condition”). The claim should be rewritten to recite one sentence.
REJECTIONS
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 53-58 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding step b of claim 53: The step recites “reacting or stabilizing hydrogel material with polymeric fibers”. It is unclear if the step is referring to the same hydrogel material and polymeric fibers recited in step a. The metes and bounds of the claim are unclear. Appropriate correction is required. All dependent claims are included in this rejection.
Claim 55 recites “the hyaluronic network”. There is a lack of antecedent basis for a hyaluronic network in the base claim. The metes and bounds of the claim are unclear. Appropriate correction is required.
Claim 56 recites “the pores”. There is a lack of antecedent basis for pores in the base claim. The metes and bounds of the claim are unclear Appropriate correction is required.
Regarding claim 57: The preamble of the claim recites “the device of claim 53”. Claim 53 is directed to a method, not a device. The metes and bounds of the claim are unclear. If the claim is further limiting the device manufactured by the method of claim 53, the claim should be rewritten to recite “The method of claim 53, wherein the device”. Appropriate correction is required. Claim 58 is included in this rejection because it depends from claim 57.
Claim 58 recites “using the soft tissue device”. The claim is indefinite because it attempts to claim a process without setting forth any steps involved in the process. It merely recites a use without any active, positive steps delimiting how this use is actually practiced. See MPEP 2173.05. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 53-58 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (Composite material for tissue restoration. WO2016025945A1) in view of Birch et al. (Microcarriers for stem cell culture and fabrication thereof US20160083690A1) and Zussman et al. (Fiber-reinforced hydrogel composites and methods of forming fiber-reinforced hydrogel composites
US20150105863).
Jiang teaches a method for preparing an implant for tissue or cartilage repair. Because it us used for soft tissue repair (Abstract), it is interpreted to be a soft tissue device. The method comprises (page 4, lines 25-30):
providing a three-dimensional scaffold comprising polymeric fibers oriented to produce a plurality of pores;
disposing a composition that includes hydrogel material on the polymeric fibers to form a complex; and
reacting or stabilizing the complex to form a stabilized implant wherein at least a portion of the polymeric fibers are cross-linked to the hydrogel material.
A scaffold comprising polymeric fibers reads on a plurality of polymeric fibers. The art teaches polymeric fiber and hydrogel are mixed (page 50, lines 27-29). Therefore a bulk composite is formed.
The scaffold complex further includes a crosslinking moiety present in an amount effective to introduce bonding between polymer fiber and hydrogel material (page 3, lines 18-20; page 17 lines 5-10).The art teaches 5.0 mg/ml PEGDA (a crosslinking agent) is added for crosslinking (page 52, line 18). Crosslinking reads on reacting or stabilizing to form a stabilized bulk composite.
The art teaches forming a precursor solution (hence, a bulk composite) in a cylindrical mold(see last line of page 50 bridging through line 1 of page 51). The art teaches composites are formed. This is interpreted to be a physical modulation. The art teaches multiple composites are formed in molds (see page 51, line 27). Therefore a population of non-spherical composites is formed.
The art teaches illustrates a non-spherical composite is formed (see Figure 1C and Figure 6, cylindrical). Figure 6 discloses a cylindrical (non-spherical) composite.
The specification does not define a bead. Therefore the non-spherical composite is broadly interpreted to read on a bead.
The art seeds the composite with cells (a biological material (see Example 8 on page 59). Cells are a biologically active material. The art teaches cells migrate inside the composites (see line 15 on page 59). Therefore the composition encapsulates the biologically active material.
The following is also taught:
The art teaches hyaluronic acid as a hydrogel material (page 25, line 24). The art teaches polylactic acid and poly(lactic-co-glycolic acid) as polymeric fibers (see page 2, lines 30-31).
The deficiencies are:
The art does not explicitly teach microbeads of the claimed size and stability.
The art is silent regarding the mean length for the polymeric fibers.
Birch et al. teach a microcarrier comprising polycaprolactone for cell culture (Abstract). The microcarriers comprise a hydrogel ([0049 [0124]). The microcarriers can have a mean diameter of about 150 to 200 microns ([0029]). The particle can be a microbead with a mean diameter of 50-150 microns ([0293]). The particle can be ellipsoid or granular (hence, non-spherical) ([0296]), a cube, a cone, a cylinder or a polyhedron ([0303]). The particle can be porous ([0320]). The particle size allows aggregation of stem cells and allows continuous growth ([0233] [0312]).
Zussman teaches a fiber-reinforced hydrogel composite (Abstract). The length of each plurality of fibers can be about 100 μm to about 300 μm ([0031]). This is interpreted to be less than “about” 200 micrometers. By embedding short-length fibers, wherein length of each fiber is less than about 1,000 μm, in a hydrogel, properties of the resultant composite may be improved due to structural reinforcement of the hydrogel by the fibers ([0021]). This may be attributed to the short length of the reinforcing fibers, which facilitate dispersion of the fibers within the hydrogel and injectability of the resultant composite. The hydrogel, on the other hand, retains its properties as a tunable matrix for various applications ([0021]).
It would have been obvious to form a microbead 50-200 micrometers. One would have been motivated to do so since Jiang teaches a bead for cell culture and Birch teaches microbeads of the claimed size allows for cell aggregation and continuous growth. One would have had a reasonable expectation of success since Birch teaches microbeads of the claimed size can successfully culture cells. One would have expected similar results since both references are directed to cell carriers.
It would have been obvious to use fibers with a mean length of less than about 200 micrometers to form the composite taught by Jiang. One would have been motivated to do so since Zussman teaches by embedding short-length fibers in a hydrogel, properties of the resultant composite may be improved due to structural reinforcement of the hydrogel by the fibers. One would have had a reasonable expectation of success since Zussman teaches fibers of the claimed size can be used to form a hydrogel composition. One would have expected similar results since both references are directed to composites comprising fibers and hydrogel. Because steps a-c are rendered obvious, the resultant microbeads would be expected to have the claimed stability.
Therefore claim 53 is rendered obvious as claimed.
Regarding claim 43: The art teaches a scaffold complex that includes a polymeric fiber (page 2, lines 19-20). The fiber is covalently linked to a hydrogel material (page 2, line 21). Therefore claim 54 is included in this rejection.
Regarding claim 55: The art teaches the composite comprises pores through which cells grow (supra). Therefore claim 55 is included in this rejection.
Regarding claim 56: The art teaches the scaffold complex includes a plurality of pores present on or within a surface of the scaffold complex, where the pores are present at a concentration of at least about 50 pores per cm2 of the surface, and where at least 80% of the pores have an average pore diameter on the surface is at least about 5 microns. Therefore claim 56 is included in this rejection.
Regarding claim 57: The art teaches not teach further coating the composite. Therefore claim 57 is included in this rejection.
The art teaches the composition is used to treat a soft tissue defect (Abstract). This reads on a reconstructive procedure. Therefore claim 58 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 270-8439.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
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