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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-6 in the reply filed on 6/25/26 is acknowledged.
Claims 7-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6/25/26.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 6 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because "use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 ").
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 6 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.
Claim 6 is rejected as being indefinite for failing to particularly point out and distinctly claim the subject matter because it is drawn to a use claim.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Mavely et al (US 2021/0252182 A1).
Regarding claims 1-3 and 6, Mavely teaches a composite dressing used to repair or reinforce soft tissue and organs comprising a non-woven fabric substrate and a porous matrix; wherein both of the porous matrix and the non-woven fabric substrate are composed of biomaterial, e.g., hyaluronic acid (i.e., hyaluronate); wherein the composite dressings have a moisture content ranging from about 5% to about 25%. (abstract, para 101, 116-117, 124, 157) which would have suggested or otherwise rendered obvious to one of ordinary skill in the art at the time of invention a hyaluronate non-woven fabric comprising hyaluronate fibers, a moisture content of 5 to 25 wt%, and a hyaluronate content of 90 wt% (i.e., 100% hyaluronate content) or more with respect to a total fiber weight excluding a weight of moisture; wherein the hyaluronate non-woven fabric is for use as a biomaterial for tissue repairing.
Specifically regarding the limitation “a hyaluronate content of 90 wt%;” Mavely teaches the use of hyaluronic acid as the fabric (para 9-10); so it would have been obvious to one of ordinary skill in the art at the time of invention to use 100% hyaluronate content with respect to a total fiber weight excluding a weight of moisture; since it is prima facie obvious to select a known material based on its suitability for its intended use (MPEP § 2144.07).
Regarding the limitations “the fibers having a bending angle of 2° to 10°;” “as measured by a following described below: <Bending Angle Measurement Method> (a) Prepare HA fibers with a length of 20 cm and a diameter of 1 mm; (b) Fix a first end of each HA fiber by a length of 3 cm on an upper surface of a flat plate; and (c) Measure an angle (θ) between an extension line (T) from a second length (remaining end) of each HA fiber and an extension line (B) of the upper surface of the flat plate;” “wherein the hyaluronate fiber has a tensile strength of 3 to 15 kg/cm2;” and “wherein the hyaluronate non-woven fabric has an adhesion strength in a range of 0.9 to 2.7 kPa.” Mavely suggests the fibers and fabric meet the composition and structure of the instant claims; and further teaches the fibers may be heat activated (i.e., curled) (para 59); and the non-woven fabric is formed through needle punching (para 124); so the fibers and fabric are deemed to inherently possess these properties.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). (MPEP § 2112.01 I).
Furthermore, Mavely teaches the bonding strength or peel strength (i.e., adhesion strength) between fabric support and porous layer is controlled by the composition of fabric support, extent of interaction between the two layers, wettability of fabric support and the tensile strength of the fabric support; so it would have been obvious to one of ordinary skill in the art at the time of invention to adjust the composition of fabric support, extent of interaction between the two layers, wettability of fabric support and the tensile strength of the fabric support to optimize its adhesion strength.
Regarding claims 4 and 5, Mavely teaches the hyaluronate non-woven fabric has a thickness in a range from about 0.05 mm to about 5 mm (para 81); and the composite dressing has a tensile strength in a range of 0.1 MPa to about 5 MPa (i.e., ~1.02 to ~10.2 kg/cm2) in wet conditions (para 103). These ranges substantially overlap that of the instant claims. It has been held that overlapping ranges are sufficient to establish prima facie obviousness. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have selected from the overlapping portion of the range taught by Mavely, because overlapping ranges have been held to establish prima facie obviousness (MPEP § 2144.05).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Domard et al (US 2014/0242146 A1) describes non-woven materials comprising hyaluronic acid filament having a water content of 8-12% (para 14, 30, 41).
Kubíčková et al (12/23/21) “Nonwoven Textiles from Hyaluronan for Wound Healing Applications” describes preparation and testing of nonwoven textiles from hyaluronan (HA), a biocompatible, biodegradable and nontoxic polysaccharide naturally present in the human body (entire document).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN L VAN SELL whose telephone number is (571)270-5152. The examiner can normally be reached Mon-Thur, Generally 7am-6pm.
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NATHAN VAN SELL
Primary Examiner
Art Unit 1783
/NATHAN L VAN SELL/ Primary Examiner, Art Unit 1783
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