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 .
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 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.
DETAILED ACTION
Status of claims
The amendment filed on 12/08/2025 is acknowledged. Claims 2, 3, and 9 have been canceled and claims 13-19 have been withdrawn. Claims 1, 4-8, 10-12, 20, and 21 are under examination in the instant office action.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Rejections withdrawn
Applicant’s amendments and arguments filed on 1208/2025 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. Applicant’s amendments have overcome the 35 U.S.C. 112(b) rejection of claims 1, 4-8, 10-12, 20, and 21 from the previous Office Action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Rejections maintained
The following rejections of the claims are remained for reasons of record and the following. The rejections are modified based on the amendments (the deletion of the 7th “wherein” and thus the numbering the wherein clauses).
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4-6, 10-12, 20, and 21 are rejected under 35 U.S.C. 103(a) as being unpatentable over Bas et al. (An Integrated Design, Material, and Fabrication Platform for Engineering Biomechanically and Biologically Functional Soft Tissues, ACS Applied Materials & Interfaces, Vol 9/Issue 35, page 29430-29437).
Bas et al. teach stretchable soft network composites for engineering tissues including heart valve leaflet (the instant claims 11 and 21 and the claimed “configured to mimic the anisotropic mechanical properties of cardiovascular tissue” and the 8th wherein clause in the instant claims 1 and 20) (abstract, the first paragraph after abstract and the paragraph on page 29434) prepared by melt electrospinning writing (MEW) (figure 1 g, corrected from “a”)
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two groups of serpentine fibers perpendicular to each other (horizontal vs vertical) and fibers of each group are parallel to each other in a layer (the 1st and 2nd wherein clauses in the instant claim 1, the instant claims 1, 6, and 20 and also planar in the instant claim 12) and
one or more horizontal fibers connect adjacent vertical fibers and vice versa (the 3rd wherein clause in the instant claim 1) (figure 1 g) with E (Yong’s modulus) being 3.19 MPa (the instant claim 4) (abstract).
The pathlength of the horizontal fiber group is measured as about 1.1 cm and the pathlength of the vertical fiber group is measured as about 1.2 cm in figure 1 g, i.e., unequal (the 5th - 7th wherein clauses in the instant claim 1).
Bas et al. teach directional variation of fibers being proportional to degree of anisotropy (figure 1 f), i.e., parameters of fibers of different directions (horizontal and vertical) can be adjusted to fulfill design requirements of a specific tissue. Thus, it would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to vary the parameters of fibers of horizontal and vertical which would result in one of the embodiments with fibers of horizontal and vertical having different path lengths (the 5th - 7th wherein clauses in the instant claim 1).
Bas et al. do not teach the E being the same for both groups of fibers. However, Bas et al. teach directional variation of fibers being proportional to degree of anisotropy Given the variations in pathlength (curvature) between the horizontal fiber group and the vertical fiber group in figure 1 g and f discussed above, there will be difference in E values of the two groups (the 4th and 8th wherein clauses in the instant claim 1).
Bas et al. teach the fibers have a diameter of 23 ± 0.9 µm (the instant claim 10) (the paragraph bridges page 29432 and 29433).
Bas et al. do not specify stiffness difference between the two groups of fibers (the instant claim 5).
This deficiency is cured by Bas et al.’s teachings of stiffness being adjusted by adjusting fiber diameter and pore size and the rationale that it would have been customary for an artisan of ordinary skill to determine the optimal parameters of fibers of horizontal and vertical in order to best achieve the desired results.
The difference in stiffness between two groups of fibers in a MEW stretchable soft network tissues is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize or, alternatively obvious to try to reach another workable product or process. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal parameters of fibers of horizontal and vertical in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of parameters of fibers of horizontal and vertical would have been obvious at the time of Applicants' invention.
Response to Applicants’ arguments:
Applicants argue that Bas et al. are silent about the measurement of the relative pathlength of the horizontal and vertical.
However, this argument is not deemed persuasive. The figures, especially figure 1 g, in Bas et al. are also teachings of Bas et al. The pathlength of the horizontal fiber group is measured by the examiner as about 1.1 cm and the pathlength of the vertical fiber group is measured by the examiner as about 1.2 cm in figure 1 g. Furthermore, the pathlength of the 1st set of fibers MAY be unequal to the pathlength of the 2nd set of fibers according to the instant specification (paragraph 8 and 10), i.e., the pathlength of the 1st set of fibers MAY be EQUAL to the pathlength of the 2nd set of fibers. Thus, the criticality of the pathlength of the 1st set of fibers being UNEQUAL to the pathlength of the 2nd set of fibers is not established.
Applicants argue that Bas et al. do not teach the scaffold in figure g being for generating heart valve tissue.
However, this argument is not deemed persuasive. Bas et al. teach that figure 1 g is a demonstration of soft network composites for various soft tissues including skin, anterior longitudinal ligament, masseter muscle and anterior cruciate ligament, i.e., not limited to skin, anterior longitudinal ligament, masseter muscle and anterior cruciate ligament while, as stated in the rejection above and in the previous office action, Bas et al. teach the stretchable soft network composites for engineering tissues including heart valve leaflet (abstract, the first paragraph after abstract and the paragraph on page 29434). Thus, a person of ordinary skill in the art can readily envisage various soft tissues in figure 1 g would also include heart valve leaflet.
Applicants argue that the rejection used “obvious to try” rationale while Bas et al. do not teach the effect of pathlength.
However, this argument is not deemed persuasive. As stated above, the examiner measured pathlength of the horizontal fiber group and the pathlength of the vertical fiber group in figure 1 g in Bas et al. to be about 1.1 cm and about 1.2 cm, respectively.
The “obvious to try” rationale is used for establish prima facia obviousness of the limitation of stiffness difference between the two groups of fibers in the instant claim 5 in the rejection above and in the previous office action and as an alternative rationale to routine optimization based on Bas et al.’s teachings of stiffness being adjusted by adjusting fiber diameter and pore size, not for the limitation of the pathlength of the horizontal fiber group being different from the pathlength of the vertical fiber group.
Claims 7 and 8 are rejected under 35 U.S.C. 103(a) as being unpatentable over Bas et al. (An Integrated Design, Material, and Fabrication Platform for Engineering Biomechanically and Biologically Functional Soft Tissues, ACS Applied Materials & Interfaces, Vol 9/Issue 35, page 29430-29437), as applied to 1, 4-6, 10-12, 20, and 21, in view of Chun et al. (US 2013/0006349 A1).
The teachings of Bas et al. are discussed above and applied in the same manner.
Bas et al. do not specify the stretchable soft network composites being attached to two more layers or having three layers.
This deficiency is cured by Chun et al. who teach tissue engineered blood vessels having multiple (≥3) layers (abstract and figure 7).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Bas et al. and Chun et al. to specify the stretchable soft network composites taught by Bas et al. having ≥3 layers. Engineered tissue having ≥3 layers was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Response to Applicants’ arguments:
No additional argument is presented by Applicants.
Conclusion
No claims are allowed.
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 HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614