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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/10/2026 has been entered.
Claims 4, 13, and 19 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Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment.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.
Claim Interpretation
The term “tissue model”, as recited in claim 13, has not been specifically defined in Applicant’s disclosure and has thus been given its broadest reasonable interpretation as any tissue structure that emulates, to some degree, the structure and function of natural tissue. This is deemed to include tissue models that are in vitro and/or in vivo. Any tissue structure that is capable of being used as a tissue model is deemed to meet this claim limitation and can include tissue cultures intended for other purposes such as therapeutic implants.
With regard to the phrase “allowing the scaffold to degrade, thereby producing the three-dimensional vascular tissue model” that has been added to the end of claim 13, this phrase is interpreted as requiring that the claimed method as a whole allows for the scaffold to degrade to some degree and at some point in time in the method of engineering the tissue model. This scaffold degradation can be during any time in the process (in vitro or in vivo) and can be to any degree (slight degradation to complete degradation). Therefore, the selection of biodegradable scaffold materials in a method is deemed to meet the requirements for allowing the scaffold to degrade.
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-previously cited) in view of Mun et al (Artificial Organs 2013-previously 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 scaffold material used is described as biodegradable and a step for allowing this material to degrade is included (page 20 para 74-75, page 21 para 78). Since endothelial cells are listed as optional embodiments without endothelial cells are also included and thus an obvious option.
While Gerecht does not specifically teach wherein the 3D tissue graft structure is used as a tissue model, since the reference tissue graft produced is capable of being used as a tissue model (as either an in vivo or in vitro tissue model) the limitation of tissue model is deemed to be met.
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-previously 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 and a step for allowing this material to degrade within the body after implantation and ultimately eliminated from the body is suggested (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.
While Harmon does not specifically teach wherein the 3D tissue graft structure is used as a tissue model, since the reference tissue graft produced is capable of being used as a tissue model (as either an in vivo or in vitro tissue model) the limitation of tissue model is deemed to be met.
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.
While the copending claims, Gerecht and Harmon do not specifically teach wherein a 3D tissue graft structure is used as a tissue model, since the reference tissue graft produced is capable of being used as a tissue model (as either an in vivo or in vitro tissue model) the limitation of tissue model is deemed to be met and rendered obvious. In addition, the selection of biodegradable scaffold material allows for the scaffold to degrade to some degree at some point in time.
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 07/10/2026 have been fully considered but they are not persuasive.
Applicant argues that the amendment to claim 13 requiring a fourth method step of allowing the scaffold to degrade, thereby producing the three-dimensional vascular tissue model is dispositive of both 103 rejections because it is absent from each cited reference, individually and in any combination.
This is not found persuasive. Both Gerecht and Harmon describe the use of biodegradable polymers and how these polymers degrade when exposed to tissue growth conditions as described above. Thus, a step for allowing the scaffold to degrade is deemed to be present both in Gerecht and Harmon as described above.
Applicant argues that Gerecht is directed to producing an engineered tubular vascular graft intended for in vivo implantation. Applicant argues that scaffold integrity is fundamental to Gerecht’s purpose and that the mechanical properties and structural stability of the graft are the measure of success. Applicant asserts that Gerecht fails to teach, suggest or contemplate deliberately degrading the cellularized scaffold as a step in producing the tissue construct.
This is not found persuasive. The selection of biodegradable scaffold materials allows for a scaffold that will be able and allowed to degrade as described above. In addition, Gerecht specifically states that they include steps for degrading their scaffold material to some degree both in vitro (before the graft is implanted) and in vivo (after the graft is implant) (see paragraph 20 Figure 1, paragraphs 74-75).
Applicant argues that Harmon is also directed to scaffolds for repair and regeneration of damaged tissue for repair and regeneration of damaged tissue for therapeutic implantation and similarly requires scaffold integrity throughout.
This is not found persuasive. The selection of biodegradable scaffold materials allows for a scaffold that will be able and allowed to degrade as described above.
Applicant argues that Mun evaluates burst strength pressure and tensile strength of the maintained scaffold construct as endpoints demonstrating fitness for implantation for implantation, which are properties that presuppose a structurally intact, non-degraded scaffold. Applicant asserts that the entire purpose of each cited reference is antithetical to scaffold degradation as each reference seeks to maintain the scaffold to produce a mechanically robust therapeutic graft. Applicant asserts that no combination of these references teaches or suggests deliberately allowing a cellularized scaffold to degrade in vitro as a step in producing a research tissue model. Applicant asserts that the combination therefore fails to render the amended claims obvious.
This is not found persuasive. The deliberate selection of biodegradable scaffold materials in the cited references allows for a scaffold that will be able and allowed to degrade as described above. The reference tissue structures are capable of being used as a tissue model and therefore meet the claim limitation of “tissue model”.
In addition, 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. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In the current case, the obviousness rejection does not require the bodily incorporation of the entire Mun system and method to be incorporated into Gerecht and Harmon, just the suggestion of the benefit of applying a pulsatile force through the lumen of a cellular scaffold as suggested by Mun (abstract, page E175-E176).
Applicant argues that the Examiner’s stated rationale for combining Mun with either Gerecht or Harmon is result-based and does not provide the required non-hindsight reason for making the specific claimed combination. Applicant asserts that the rejection does not identify any teaching, recognized problem, design incentive, or other articulated reason that would have led a person of ordinary skill in the art to select those scaffold systems for use with Mun’s pulsatile bioreactor in the manner claimed without knowledge of Applicant’s disclosure. Applicant asserts that there is no reason to combine the reference teachings.
This is not found persuasive. The rejections specifically describe a motivation to apply the teaching and suggestion of Mun to the reference methods of Gerecht and Harmon.
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).
With regard to Gerecht, 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.
With regard to Harmon, 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)).
Applicant argues that Mun’s pulsatile bioreactor was developed to address a limitation specific to electrospun synthetic nanofibrous scaffolds that is not present in the scaffolds of Gerecht or Harmon. Applicant asserts that Mun is limited to overcome the limitations of nanosize pores in a PLCL scaffold and cannot be applied to any other scaffold such as those described in Gerecht or Harmon. Applicant asserts that there is no motivation independent of hindsight for a person of ordinary skill in the art to apply Mun’s solution limited to nanosize pores that does not exist in Gerecht’s or Harmon’s systems.
This is not found persuasive. 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. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In the current case, Mun disclose that the application of pulsatile forces through a lumen of the cellular scaffold 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). These are benefits that would be relevant for any method drawn to the production of a cellular tubular tissue construct.
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).
With regard to Gerecht, 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.
With regard to Harmon, 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)).
Applicant argues that the rejections fail to establish a reasonable expectation of success for the proposed combinations as applied to the amended claims. Applicant asserts that no reference describes a methodology for the combined process as claimed. Applicant asserts that the rejection rests on the possibility that the references could be combined not on the required showing that a skilled artisan would have a reasonable expectation of success in doing so.
This is not found persuasive. One of ordinary skill in the art would have had a reasonable expectation of success to apply the teachings of Mun to Gerecht 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.
One of ordinary skill in the art would have had a reasonable expectation of success to apply the teachings of Mun to Harmon 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)).
Applicant argues that the claims of the ‘569 application are directed to a tubular scaffold comprising hydrogel nanofibers having internally aligned polymer chains which is a structural limitation that has no counterpart in the present method claims. Applicant asserts that the claims are not drawn to the same invention and the ‘569 application claims do not render the amended claims obvious. Applicant asserts that no combination of the ‘569 claims with Gerecht, Harmon or Mun teaches or suggests the step of deliberately allowing the cellularized scaffold to degrade in vitro as the step that produces the final research tissue model. Applicant asserts that the same reasons described above for why the cited references do not render the claims obvious are also applicable to the double patenting rejection.
This is not found persuasive. The double patenting rejection is based on the fact that the claims of the copending application would render obvious the claims of the current application based on the teachings of Gerecht, Harmon and Mun. The selection of biodegradable scaffold materials as required by the copending claims and the cited references allows for a scaffold that will be able and allowed to degrade as described above.
While the copending claims require additional limitations not required by the current claims this does not render the claims nonobvious as the current claims do not exclude these additional limitations.
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.
Mao et al., “Method for Preparing Electro-mechanically Stretched Hydrogel Micro Fibers”, US 10,119,202
(Discloses natural and synthetic polymers for use in making tubular scaffolds, specifically column 6 lines 9-20, lines 33-35, column 7 lines 24-29).
Zhang S, Liu X, Barreto-Ortiz SF, et al. 2014, Creating polymer hydrogel microfibres with internal alignment via electrical and mechanical stretching, Biomaterials, 35 (10): 3243-3251. (Discloses natural polymers for tissue engineering).
Gui et al., “Development of Novel Biodegradable Polymer Scaffolds for Vascular Tissue Engineering”, TISSUE ENGINEERING: Part A Volume 17, Numbers 9 and 10, 2011, pp. 1191-1200.
(Disclose optimization of synthetic polymers for degradation during tissue culture).
Johnson et al., “Matrix Metalloproteinase-2 and-9 Differentially Regulate Smooth Muscle Cell Migration and Cell-Mediated Collagen Organization”, Arteriosclerosis, Thrombosis, and Vascular Biology, 2004, Volume 24, Issue 1, Pages 54-60.
(Discloses that the enzymes secreted by smooth muscles cells during culture on natural scaffold materials, such as matrix proteins of collagen, will degrade these scaffold materials-see page 59, column 2).
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.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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