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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/21/2026 has been entered.
Claim 19 has been amended. Claims 1-8, 10, 12-14, 19-20, 22-24 and 26-32 are currently pending.
Claims 1-8, 10, 12-14 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/04/2024.
Claims 19, 22-24 and 26-32 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Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment.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
With regard to the phrase “a luminal surface” as recited in lines 1 and 2 of claim 19, this is interpreted broadly as referring to one or a combination of all the lumens available in a composition material.
With regard to the term “pharmaceutical material” as recited in claims 29 and 31, Applicant has provided examples for such and included active substances such as proteins, nuclei, cells, tissues, cell products, tissue products, proteins, antibodies, vaccines, vaccines components, antigens, epitopes, drugs, salts, nutrients, buffers, acids, bases and/or the like (see page 29 paragraph 78 of Applicant’s Specification as filed).
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) 19, 22-24,26-32 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al (US 2018/0002658-previously cited) as evidenced by Guillermo et al (Biomacromolecules, 2016-previously cited) and in view of Magin et al (WO 2019/136453-newly cited).
Regarding claims 19 and 24, Miller disclose a luminal surface comprising a layer of polymerized material disposed on the luminal surface (this layer is interpreted as an interfacial layer) and a cell embedded in this layer of polymerized material using 3D printing (page 5 para 63-64, pages 8-9 para 90). Miller disclose patterned fluidic networks (pages 1-2 para 8, para 10-11, page 4 para 61). The luminal surface is formed from a hydrogel matrix (abstract, pages 1-2 para 8, para 10-11, pages 8-9 para 90) and wherein the hydrogel includes from 10 to 2,000 layers of hydrogel matrix (page 6 para 74) and wherein the hydrogel layers are stacked on top of one another (inner and outer layers) (page 9 para 94).
Regarding claims 22-23, Miller does not use a sacrificial template to form their luminal surface, however, the shape of their luminal surface is formed by a 3D bioprinter creating a tubular shape and this tubular shape can correspond to any sacrificial template shape that is also intended for the same purpose of implantable constructs as evidenced by Guillermo (abstract, page 906 scheme 1). The limitations of claims 22-23 are in reference to the shape of the luminal surface and do not necessarily require that the claimed product is made by the use of a sacrificial template.
Regarding claim 26-27 and 30, Miller disclose wherein the thickness of the hydrogel layers is about 50 microns (page 6 para 74) which falls within the ranges claimed by Applicant. These hydrogel layers include the interfacial layer that is embedded with cells (pages 8-9, para 90).
Regarding claim 28-32, Miller disclose confluent cells layers (monolayer of cells that is uniform) are developed along the channel lumens (page 5 para 64). These cells are interpreted as a pharmaceutical material according to Applicant’s Specification page 29 paragraph 78. Miller disclose wherein the thickness of the hydrogel layers is about 50 microns (page 6 para 74) which falls within the ranges claimed by Applicant. These hydrogel layers include the interfacial layer that is embedded with cells (pages 8-9, para 90).
The specific combination of features claimed is disclosed within the broad genera of polymerizable material, number of hydrogel layers, hydrogel thickness, and pharmaceutical materials, such as cells, taught by Miller, 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 polymerizable material, number of hydrogel layers, hydrogel thickness, and pharmaceutical materials, such as cells from within the disclosure of Miller to arrive at luminal surface 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 Miller suggests that all these cited variables are suitable for inclusion in their method/composition.
Miller does not specifically describe wherein the polymerized material comprises a reaction product from a list of (i)-(vi). However, Miller do suggest that their photosensitive polymer can include vinyl groups such as acrylate, acrylamide and methacrylate and the polymers include, by example, poly(ethylene glycol, MMP-sensitive poly(ethylene glycol), gelatin methacrylate,, methacrylate functionalized hyaluronic acid and PEGylated fibrinogen (pages 5-6, para 69).
Magin disclose methods of culturing cells in an in vitro tissue model or administering a polymer composition to treat a disease or disorder (page 1 line 30- page 2 line 6). Cells may be embedded in the polymers (page 7 lines 28-30). Magin disclose wherein their polymers include functionalized poly (ethylene glycol), poly (meth acrylic acid), methacrylate-functionalized gelatin, methacrylate-functionalized hyaluronic acid and wherein the functional moiety is selected from a group consisting of methacrylate and thiol (page 2 line 22- page 3 line 2, page 5, page 7). Magin specifically include options such as PEG-dithiol (click chemistry pair) (page 10 line 28- page 11 line 3, Figure 2).
One of ordinary skill in the art would have been motivated to substitute a click chemistry pair comprising PEG-dithiol for one of the polymers used in Miller because Magin teach and suggest that a click chemistry pair comprising PEG-dithiol is a suitable alternative to other polymer options such as poly (ethylene glycol), poly (meth acrylic acid), methacrylate-functionalized gelatin, methacrylate-functionalized hyaluronic acid and wherein the functional moiety is selected from a group consisting of methacrylate which are indicated as suitable for the Miller polymer. The substitution of equivalents known for the same purpose is deemed to be prima facie obvious (MPEP 2144.06). One of ordinary skill in the art would have had a reasonable expectation of success because both Miller and Magin are directed to cell-containing polymer constructs intended to mimic in vivo tissue structures.
Therefore, the combined teachings of Miller et al and Magin et al renders obvious Applicant’s invention as claimed.
Claim(s) 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al (US 2018/0002658-previously cited) in view of Magin et al (WO 2019/136453-newly cited) as applied to claims 19, 22-24, 26-32 above, and further in view of Guillermo et al (Biomacromolecules, 2016-previously cited).
Regarding claims 22- 23, Miller and Magin render obvious the luminal surface as described above, but do not specifically use a sacrificial template of carbohydrate-based material formed through extrusion or selective laser sintering.
Guillermo disclose the use of sacrificial templates made from a carbohydrate -based material (cellulose) formed through extrusion for the preparation to prepare freestanding cell constructs, such as luminal surfaces (abstract, page 906, scheme 1, pages 911-912).
One of ordinary skill in the art would have been motivated to select the shape of the luminal surface for Miller that corresponds to the sacrificial template disclosed by Guillermo for the luminal surface of Miller because Guillermo teach that this is a beneficial shape for forming tubular tissue constructs and Miller is also forming a tubular tissue construct intended for implant purposes. One of ordinary skill in the art would have had a reasonable expectation of success because both Miller and Guillermo are directed to the construction of tissue constructs with coated luminal surfaces for implantation.
Therefore, the combined teachings of Miller et al, Magin et al, and Guillermo et al render obvious Applicant’s invention as claimed.
Response to Arguments
Applicant’s arguments, see page 8, second paragraph, filed 04/14/2026, with respect to the rejection(s) of claim(s) 19, 22-24, 26-32 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Magin et al (WO 2019/136453). The combined teachings of Miller and Magin render obvious the newly amended claims as described above.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Studer et al., “Redox and photoinitiated crosslinking polymerization II. Neat acrylate resin”, Progress in Organic Coatings, (2005), Vol. 53, pp. 134–146.
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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