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 .
This action is responsive to papers filed 01/22/2026.
Claims 1, 13, 19 and 20 have been amended. No claims have been newly added or newly canceled.
Claims 1-20 are currently pending and have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Drawings
A review of U.S. Patent and Trademark records indicates that all the criteria set forth in 37 CFR 1.84(a)(2) and MPEP § 608.02(VIII) have been satisfied. Accordingly, the petition under 37 CFR 1.84(a)(2) filed 01/22/2026 has been granted 02/05/2026.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5, 7-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gerecht et al (WO 2021/076684) in view of Mun et al (Artificial Organs 2013-newly cited).
Regarding claims 1-3, 5, 9-12, 13-18 and 20, Gerecht disclose an engineered three-dimensional vascular tissue graft (tubular scaffold with a hollow core surrounded by one or more layers of vascular cells, specifically vascular smooth muscle cells and pluripotent stem cell derived vascular cells, specifically human cells (page 3 para 10, page 4 para 16, page 12 para 52, page 14 para 62, page 15 para 66, page 38 para 134-135). The scaffold is described as natural (page 27 para 98) and contains a natural polymer material such as fibrin, alginate, gelatin, hyaluronic acid, collagen, chitosan, or a combination thereof (page 5 para 17). The material used is described as biodegradable (page 20 para 74-75). Since endothelial cells are listed as optional embodiments without endothelial cells are also included and thus an obvious option.
Regarding claim 7, Gerecht disclose the cellularized vascular graft with an elastic modulus in the ranges of 40 kPa to 200 kPa and 50 kPa to 150 kPa (page 15 para 62) which fall within the claimed range and thus anticipate the claimed range.
Regarding claim 8, Gerecht disclose wherein the scaffold has a tensile strength from 50 kPa to 500 kPa (pages 14 para 62). Gerecht also disclose wherein the diameter of the hollow core is in the range of 400 microns to 4.0 mm (page 17 para 67) which overlaps with the claimed range and thus renders it obvious.
The teachings of Gerecht disclose all the claim limitations as suitable and beneficial in their tubular vascular graft and thus would have provided the motivation to combine the claimed features with a reasonable expectation of success.
Gerecht disclose steps for perfusing the tubular scaffold when it is acellular (page 27 para 98), but are silent to applying a pulsatile force to a cellularized tubular scaffold lumen.
Mun disclose wherein electrospun nanofibrous scaffolds that are exposed to a pulsatile force via pulsatile bioreactor culture show the benefits of a higher proliferation rate of smooth muscle cells (SMCs), regulation of collagen and a significant increase in tensile strength of the engineered tissues (abstract, page E175-E176). The pulsatile flow of nutrient media is directed through the vascular lumen and this exposure of the developing vascular tissue to physical signals similar to those encountered in vivo accelerate tissue maturation and formation of mechanically stable vascular grafts (page E175-E176).
Therefore, one of ordinary skill in the art would have been motivated to apply pulsatile forces through a lumen of the cellular scaffold in the method of Gerecht because Mun teach and suggest that this provides the benefits of a higher proliferation rate of smooth muscle cells (SMCs), regulation of collagen and a significant increase in tensile strength of the engineered tissues (abstract, page E175-E176). One of ordinary skill in the art would have had a reasonable expectation of success because both Gerecht and Mun are drawn to culturing vascular cell seeded tubular scaffolds and because Gerecht is already applying pulsatile forces to their acellular vascular scaffolds.
Therefore, the combined teachings of Gerecht et al and Mun et al render obvious Applicant’s invention as claimed.
Claim(s) 1-6, 9-12, 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Harmon et al (US 2007/0292401) in view of Mun et al (Artificial Organs 2013-newly cited).
Regarding claims 1, 9-12, 13-17, Harmon disclose stem cell products for repair and regeneration of damaged tissue (page 1 para 1 and para 8). Scaffolds such as tubular structures like those of blood vessels are included for implantation purposes (page 11 para 160-162) and are seeded with cells such as vascular endothelial cells, fibroblasts, stem cells, smooth muscle cells and other soft tissue cells and cells derived from human pluripotent stem cells are also suggested (page 6 para 116-119, page 11 para 162, page 12 para 171-172, page 13 para 177-180). The cells may be configured outside the surface of the tube (page 12 para 169, page 13 para 180). Biodegradable materials are included in the scaffold material (page 5 para 41, page 11 para 162, para 166). Since endothelial cells are listed as optional embodiments without endothelial cells are also included and thus an obvious option.
Regarding claims 2-6 and 18-20, Harmon disclose wherein the scaffold includes natural and/or synthetic polymers such as PLA, PCL, PLGA, hyaluronic acid, collagen, elastic fibers, heparin sulfate, gelatin, alginates and other materials such as growth factors (page 12, para 164-171). The growth factors include FGF and VEGF, PDGF, IGF (page 7 page 124, page 8 para 137, page 10 para 149).
The specific combination of features claimed is disclosed within the broad genera of scaffold types, cell types and material types taught by Harmon, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any specific teaching to select this specific combination of variables, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have selected various combinations of scaffold types, cell types and material types from within the disclosure of Harmon to arrive at methods and compositions “yielding no more than one would expect from such an arrangement”.
The motivation and reasonable expectation of success in making these combinations comes from the fact that Harmon suggests that all these cited variables are suitable for inclusion in their method/composition.
Harmon are silent to applying a pulsatile force to a cellularized tubular scaffold lumen.
Mun disclose wherein nanofibrous scaffolds that are exposed to a pulsatile force via pulsatile bioreactor culture show the benefits of a higher proliferation rate of smooth muscle cells (SMCs), regulation of collagen and a significant increase in tensile strength of the engineered tissues (abstract, page E175-E176). The pulsatile flow of nutrient media is directed through the vascular lumen and this exposure of the developing vascular tissue to physical signals similar to those encountered in vivo accelerate tissue maturation and formation of mechanically stable vascular grafts (page E175-E176).
Therefore, one of ordinary skill in the art would have been motivated to apply pulsatile forces through a lumen of the cellular scaffold in the method of Harmon because Mun teach and suggest that this provides the benefits of a higher proliferation rate of smooth muscle cells (SMCs), regulation of collagen and a significant increase in tensile strength of the engineered tissues (abstract, page E175-E176). One of ordinary skill in the art would have had a reasonable expectation of success because both Harmon and Mun are drawn to culturing vascular cell seeded tubular scaffolds and both disclose using biodegradable polymer materials (i.e. poly(epsilon-caprolactone)).
Therefore, the combined teaching of Harmon et al and Mun et al renders obvious Applicant’s invention as claimed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 17/766569 in view of Gerecht et al (WO 2021/076684), Harmon et al (US 2007/0292401) and Mun et al (Artificial Organs 2013-newly cited).
The claims of application ‘569 are drawn to a tubular scaffold comprising a hollow core that can be cellularized as a vascular graft for treating vascular damage.
While the application claims do not recite all the limitations such as wherein the scaffold is biodegradable, the cell types and the scaffold materials and additional components, these limitations are well known in the art of tubular vascular grafts as described above by Gerecht, Harmon and Mun.
Therefore, the person of ordinary skill in the art would have been motivated with a reasonable expectation of success to include the same scaffold materials, cell types, additional components and the application of a pulsatile flow through a lumen of a tubular scaffold as taught and suggested by Gerecht, Harmon, and Mun as described above because they are all drawn to producing tubular vascular grafts for therapeutic use.
Therefore, the combined teachings of the copending application claims, Gerecht et al, Harmon et al and Mun et al render obvious Applicant’s invention as claimed.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 01/22/2026 have been fully considered but they are not persuasive. Applicant’s arguments have been addressed in so far as they relate to the new rejections above.
Applicant argues that Gerecht does not include a step for applying a pulsatile flow through the lumen of a cellularized scaffold. Applicant asserts that Gerecht only applies a pulsatile flow to acellular tubular scaffolds. Applicant asserts that Gerecht teaches away from the subject matter of the present claims.
This is not found persuasive. The new obviousness rejection above demonstrates that the application of a pulsatile flow to a lumen of a tubular cell seeded scaffold was known in the prior art to be beneficial and advantageous to the properties of a tubular vascular tissue scaffold. Gerecht does not teach away from using a pulsatile force to a cellular scaffold by disclosing applying this flow to an acellular scaffold. There is nothing in the disclosure of Gerecht that indicates that this flow cannot or should not be applied to a cellular scaffold. The fact that the Gerecht cellular tubular scaffold is intended to function as an in vivo implant suggests that an improvement that simulates the in vivo environment would be beneficial for inclusion.
Applicant argues that the prior art must be considered in its entirely including any portions that diverge from the claimed invention. Applicant argues that one cannot use hindsight reconstruction to pick and choose among isolated disclosures in the prior art to deprecate the claimed invention.
This is not found persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In the current case, the addition of the teaching of the Mun reference provides the necessary teaching and suggestion to provide a motivation and reasonable expectation of success to include applying a pulsatile flow to a lumen of a cell seeded vascular tubular scaffold as described above.
Applicant argues that Harmon fails to remedy the deficiencies of Gerecht because Harmon does not disclose the claimed method including a step for applying pulsatile flow through the lumen of a cellularized scaffold.
This is not found persuasive. The new obviousness rejection above demonstrates that the application of a pulsatile flow to a lumen of a tubular cell seeded scaffold was known in the prior art to be beneficial and advantageous to the properties of a tubular vascular tissue scaffold. The fact that the Harmon cellular tubular scaffold is intended to function as an in vivo implant suggests that an improvement that simulates the in vivo environment would be beneficial for inclusion.
Applicant argues that with regard to Harmon one cannot use hindsight reconstruction to pick and choose among isolated disclosures in the prior art to deprecate the claimed invention.
This is not found persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In the current case, the addition of the teaching of the Mun reference provides the necessary teaching and suggestion to provide a motivation and reasonable expectation of success to include applying a pulsatile flow to a lumen of a cell seeded vascular tubular scaffold as described above.
Applicant argues that the provisional double patenting rejection over claims 1-22 of US patent Application 17/766569 should be withdrawn because one of ordinary skill in the art would readily acknowledge that the pending claims of the present application and those of the ‘569 application are directed to patently distinct subject matter.
This is not found persuasive. The combination of the copending claims and the cited prior art renders obvious the pending claims of the present application and thus the provisional double patenting rejection is proper.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Engbers-Buijtenhuijs et al., “Biological characterisation of vascular grafts cultured in a bioreactor”, Biomaterials, 2006, Vol. 27, pp. 2390–2397.
(Discloses the step of applying a pulsatile flow of culture medium through the lumen of a cell-seeded tubular scaffold on page 2392, column 1)
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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