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 .
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
Claims 1-3 and 5-10 are pending, claim 4 is canceled in this application. This application claims foreign priority to CN 2023106529677, filed on 06/02/2023 in China.
Election/Restrictions
Applicant's election with traverse of group II, claims 5-7, in the reply filed on 04/24/2026, is acknowledge. No specific traversal is provided.
Claims 1-3 and 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 5-7 will presently be examined to the extent they read on the elected subject matter of record.
Priority
The examiner noted that the instant application claims CN 2023106529677 as foreign priority; however, the examiner couldn’t find the certified copy of the claimed CN 2023106529677 of record. The examiner would appreciate the assistance form the applicants in procuring the documents for addition to the file; otherwise the claim to foreign priority will not be met and the right of priority may be lost. Please refer to MPEP 215.I and MPEP 215.II:
35 U.S.C. 119(b)(3) authorizes the Office to require the applicant to furnish a certified copy of the foreign priority application, and the Office requires such a copy pursuant to 37 CFR 1.55.
The certified copy which must be filed is a copy of the original foreign application with a certification by the patent office of the foreign country in which it was filed.
In the application data sheet: applicant bears the ultimate responsibility for ensuring that a copy of the foreign priority application is received by the office from the participating foreign intellectual property office or a certified copy of the foreign priority application is filed, within the time period specified in 37 CFR 1.55(g)(1).
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 5 and 6 are rejected under 35 U.S.C. 103(a) as being unpatentable over Park et al. (KR 2018-0026138 A) in view of Wang et al. (CN 114854049 A).
Park et al. teach a 3D print artificial penile biotissue comprising a biodegradable artificial penis backbone comprising an inner support provided annularly or spirally around the porous polymer, and an outer support provided on the outer side of the inner support and covering the inner support (abstract);
wherein the biodegradable artificial penis backbone
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has a cylindric cavity 10 (figure 1 and 2) and comprises an inner support provided annularly or spirally around the porous polymer
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(21 in figure 2) (figure 4), and an outer support provided, in form of strain, on the outer side of the inner support and covering the inner support
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(22 in figure 1 and 2, the claimed external bionic white membrane structure in the instant claim 5) (figure 6 and paragraph 25);
wherein the biodegradable artificial penis backbone is made with bioabsorbable polymer material such as PDO (polydioxanone) (paragraph 14); and wherein it is possible to more precisely and easily regenerate intricate vascular structures such as the corpus cavernosum (paragraph 16).
Corpus cavernosum is known to have irregular shaped sinusoids (vascular spaces also known as cavernous sinuses) and with known corpus cavernosum size ranges (length and diameter and subsequent length and diameter of the strain) and size range of sinusoids for any particular mammal species. Thus, the shape of sinusoids in corpus cavernosum generated by 3D printing taught by Park et al. would not be not limited to any specific shape which would include spherical and 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 determine the appropriate corpus cavernosum size ranges (length and diameter and diameter and subsequent length and diameter of the strain) and size range of sinusoids for any particular mammal species. Please refer to MPEP 2144.04.IV.B:
The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.
Park et al. do not specify the material of artificial penis backbone being hydrogel and the components of the 3D printing composition (bio-ink) for printing the artificial penile backbone.
This deficiency is cured by Wang et al. who teach in example 2 a 3D printing composition hydrogel precursor solution (bio-ink) comprising 25.6 g of acrylamide and 8.3 g of 2-acrylamide-2-methylpropanesulfonic acid (33.9 g of polymer-based material), 0.17 g of lithium phenyl (2,4, 6-trimethylbenzoyl) phosphate (photoinitiator), 0.09 g of methylene bisacrylamide (crosslinker), and 0.01 g of lemon yellow (light absorber) in 100mL of deionized water → total 134.17 g → 25.27% by weight of polymer-based material (33.9/134.17=0.2527), 0.127% by weight of photoinitiator (0.17/134.17=0.001267), 0.067% by weight of crosslinker (0.09/134.17=0.0006707), and 0.0075% by weight of light absorber (0.01/134.17=0.0000745) very close to the claimed 0.01% light absorber.
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 Park et al. and Wang et al. to specify the 3D printing material taught by Park et al. comprising 25.27% by weight of polymer-based material, 0.127% by weight of photoinitiator, 0.067% by weight of crosslinker, and 0.0075% by weight of light absorber. A 3D printing material comprising 25.27% by weight of polymer-based material, 0.127% by weight of photoinitiator, 0.067% by weight of crosslinker, and 0.0075% by weight of light absorber 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 both having been used in the prior art, and from both being recognized in the prior art as useful for the same purpose.
Claims 5-7 are rejected under 35 U.S.C. 103(a) as being unpatentable over Park et al. (KR 20180026138 A) in view of Wang et al. (CN 114854049 A) and Park et al. (US 2019/0183667 A1).
The teachings of Park et al. (KR) and Wang et al. are discussed above and applied in the same manner.
Park et al. (KR) do not specify the same material for the outer support stain in the instant claim 7.
This deficiency is cured by Park et al. (US) who teach3D printed stent with wire (120W) with a biodegradable polymer M1 (paragraph 43) such as polyethylene (paragraph 45) or PDO (polydioxanone) (paragraph 47) and polyethylene including high density polyethylene (paragraph 80).
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 Park et al. (KR) and Park et al. (US) to replace polydioxanone in the composition taught by Park et al. (KR) with polyethylene and specify polyethylene including high density polyethylene as a component. Both polyethylene and polydioxanone being suitable 3D printing material for outer supporting strain and polyethylene including high density polyethylene were well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for replacing polydioxanone in the composition taught by Park et al. (KR) with polyethylene and specify polyethylene including high density polyethylene flows from both having been used in the prior art, and from both being recognized in the prior art as useful for the same purpose.
Correspondence
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.
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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
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