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 08/09/2026 is acknowledged. Claims 4, 6, and 7 have been canceled and claims 1-3 and 8-10 have been withdrawn. Claim 5 is under examination in the instant office action.
Priority
The examiner noted that applicant filed Request to retrieve priority application(s) filed with nonparticipating office(s) that is available in a participating office for foreign priority CN 2023106529677 on 06/18/2026; however, the examiner couldn’t find the retrieved copy of the claimed CN 2023106529677 of record. 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).
Rejections withdrawn
Applicant’s amendments and arguments filed on 08/09/2026 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 Any rejection and/or objection not specifically addressed below is herein withdrawn.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. 103(a) rejection of claims 5 and 6 over Park et al. (KR 2018-0026138 A) and Wang et al. (CN 114854049 A) 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 rejection of the claim is remained for reasons of record and the following. The rejection is modified based on the amendments and for clarity (newly underlined).
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.
Claim 5 is 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).
Park et al. (KR) 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) (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 (the 2nd wherein clause) and being erectile tissue which configured to receive water injection to expand the penile corpus cavernosum prosthesis to an erection state (the 1st part of the 4th wherein clause). 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 being configured to receive water injection to expand the penile corpus cavernosum prosthesis to an erection state 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.
Though Park et al. (KR) do not expressly teach the properties of the 2nd part of the 4th wherein clause, as a result of the 3D print artificial penile biotissue being the same artificial penile biotissue as claimed, the artificial penile biotissue would necessarily have the claimed properties, whether expressly recognized by Park et al. (KR) or not. Please refer to MPEP 2112.III and MPEP 2112.V
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102 and 103 rejection is appropriate for these types of claims as well as for composition claims.
“[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255).
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 (the 1st wherein clause).
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.
Park et al. (KR) do not specify the same material for the outer support stain (the 3rd wherein clause).
This deficiency is cured by Park et al. (US) who teach 3D 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.
Response to Applicants’ arguments:
Applicant’s arguments based on the amendments are addressed in the modified rejection above (newly underlined).
Applicants argue that Park et al. (KR) teach a porous polymer scaffold that is eventually replaced by host tissue while the claimed invention requires a permanent, non-degradable prothesis using high density polyethylene fibers and thus Park et al. (KR) teach away from the claimed invention.
However, this argument is not deemed persuasive. The penile prothesis being permanent and non-degradable is not claimed while, as stated in the rejection above and in the previous office action, both high density polyethylene and polydioxanone being biodegradable polymer according to Park et al. (US).
Applicants argue that Wang et al. do not teach implantable prothesis with anti-thrombogenicity biocompatibility for long-term implantation.
However, this argument is not deemed persuasive. First, anti-thrombogenicity biocompatibility for long-term implantation is not claimed.
Second, this is a 35 USC 103(a) rejection and not a 35 USC 102 rejection and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case Wang et al. provide teaching of 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. Please refer to MPEP 2145.III:
the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.
Applicants argue that Park et al. (US) only list HDPE as one of many possible materials for a separate film, not a structural fiber.
However, this argument is not deemed persuasive. First, Park et al. (US) teach biodegradable stent (abstract); thus, the stent, including the film, is biodegradable.
Second, this is a 35 USC 103(a) rejection and not a 35 USC 102 rejection and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case Park et al. (US) provide teaching of polyethylene including high density polyethylene in paragraph 80 and both polyethylene and polydioxanone being suitable polymer for 3D printed stent in paragraph 45 and 47. Please refer to MPEP 2145.III discussed above. Whether a film is structural or not is semantic.
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
