DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-15, 17, 19-23 and 25-27 are pending in this application.
Election/Restrictions
Applicant's election without traverse of Group I (Claims 1-13, 22 and 23 in the
reply filed on 09/30/2025 is acknowledged. Claims 14, 15, 17, 19-21 and 25-27 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withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a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 09/30/2025. Applicant’s election of the species (biological material/tissue: alimentary canal), (biological material source: mammal) and (bioadhesive: fibrin glue) in the reply filed on 04/28/2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claim 6 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1-5, 7-13, 22 and 23 were examined on their merits.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is too short to describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 9 is objected to because of the following informalities: The word “porous” should be inserted between “said” and “bioadhesive”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 4 recites, “wherein said collector of said elecrospinning apparatus is composed of said first and second layer”. It is unclear if Applicant intends that the collector of the apparatus comprises the first and second layers (such as layered upon) or if the collector of the apparatus itself is composed (made/constructed) of the first and second layers. For purposes of examination, the Examiner has interpreted the claim as the collector comprising the first and second layers.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 5, 7-13, 22 and 23 are rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Hinds et al. (WO 2006/099016 A2).
Hinds et al. teaches a composite graft, comprising: a collagen matrix layer comprising acellular small intestine submucosa (e.g. 100% free of cells, see Pg. 9, Lines 30-32) (Pg. 35, Claims 1-4);
an adhesive comprising fibrin adhering the collagen layer to an elastin (polymer) layer (Pg. 35, Claim 7);
wherein the elastin layer (Pg. 35, Claim 1) is a three-dimensional scaffold (Fig. 7A), and reading on Claim 1, 5 and 23;
wherein the small intestine submucosa can be obtained from a pig (Pg. 11, Lines 23-24), and reading on Claims 7 and 8;
and wherein the fibrin adhesive is a fibrin glue (Pg. 12, Lines 15-17), and reading on Claims 9-10.
The teachings of Hinds et al. were discussed above.
Hinds et al. did not specifically teach a method wherein the elastin layer is porous, as required by Claim 1;
or wherein the thickness of the bioadhesive layer is about 10-1000 µm before the elastin layer is connected to the bioadhesive layer, as required by Claim 13.
With regard to Claims 1 and 9, the Examiner notes that Hinds et al. teaches as fibrin adhesive which may be a fibrin glue which is the same as the claimed fibrin glue. Thus, the prior art composition would be expected to have the same properties and characteristics as the claimed fibrin glue, such as being porous.
With regard to Claim 11, Hinds et al. teaches that the elastin layer is isolated from an organism, be suitable for use in grafts and may be structurally substantially similar to the elastin matrix found in native vascular tissue (Pg. 12, Lines 4-11). Thus, the ordinary artisan would expect that the elastin would be biocompatible.
With regard to Claims 1 and 12, Hinds et al. teaches it is desirable to use graft materials that are sufficiently porous to allow in vivo remodeling or angiogenesis to occur yet are not so porous as to allow undesired fluid leakage and wherein pore sizes typically range from 2-100 microns and the porosity of each layer may be the same or different (Pg. 14, Lines 8-17).
With regard to Claim 13, Hinds et al. teaches the grafts (or layers thereof) can have thicknesses of about 200 µm-5mm, for example about 100 µm to about 1mm (Pg. 13, Lines 28-31).
With regard to Claim 22, Hinds et al. teaches the composite graft (e.g. a medicament) can be seeded with autologous endothelial cells (EC) prior to implantation (Pg. 22, Lines 1-11).
It would have been obvious to those of ordinary skill in the art before the instant invention to modify the layered composite graft of Hinds et al. which comprises a 3D elastin scaffold layer, to make the layers porous because the reference teaches the desirability of using sufficiently porous graft materials. Those of ordinary skill in the art before the instant invention would have been motivated to make this modification in order to have a composite graft which is sufficiently porous to allow in vivo remodeling or angiogenesis to occur yet are not so porous as to allow undesired fluid leakage.
There would have been a reasonable expectation of success in making this modification because Hinds et al. teaches a multilayer composite graft and that the graft components have a desired porosity.
It would have been further obvious to those of ordinary skill in the art before the instant invention to modify the layered composite graft comprising a bioadhesive layer attached to an elastin layer of Hinds et al. so that the bioadhesive layer has a thickness of about 10-1000 µm before connection to the elastin layer because the Hinds et al. reference teaches that the layers of the composite graft can be in the thickness range of 100-1000 µm (encompassed by the claimed range). Those of ordinary skill in the art would have recognized that the layers can only have two possible thicknesses, before and after attachment to another layer. Those of ordinary skill in the art would have been motivated to make this modification in order to construct a composite graft with the desired thickness. There would have been a reasonable expectation of success in making this modification because of the limited ways layers can be combined and because the reference teaches a thickness range that the layers can be.
Claims 1, 2, 3, 4, 5, 7-13, 22 and 23 are rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Hinds et al. (WO 2006/099016 A2), as applied to Claims 1, 5, 7-13, 22 and 23 above, and further in view of Boland et al. (2004), Simonet et al. (10/23/2006-10/25/2006), cited in the IDS, and Atala et al. (US 2006/0204539 A1).
The teachings of Hinds et al. were discussed above.
Hinds et al. does not teach a method wherein the elastin layer is
electrospun, as required by Claim 2;
wherein said electrospun scaffold is obtained by providing an electrospinning apparatus;
forming crystals from a molecule or group of molecules, which are in vapor phase
comprised in the surrounding atmosphere, at the surface of a [[the]] collector of said
electrospinning apparatus, wherein the reaction chamber of said electrospinning apparatus has a temperature which allows formation of crystals at said surface of said collector;
electrospinning a solution comprising at least one polymer dissolved therein around the crystals;
continuing the formation of crystals and the electrospinning simultaneously; and
removing the crystals by sublimation, as required by Claim 3;
or wherein said collector of said electrospinning apparatus is comprised of said first and second layer and thus said electrospun scaffold is electrospun directly onto the surface of said second layer, as required by Claim 4.
Boland et al. teaches an electrospinning apparatus comprising a collector (Pg. 1423, Fig. 1) and a method of electrospinning elastin into a porous 3D scaffold (Pgs. 1427-1428, Paragraph 4.2 and Fig. 8) and that the electrospinning of natural polymers provides a simple method to achieve the necessary properties of successful tissue engineered vascular prosthesis (Pg. 1424, Column 2, Lines 2-5).
Simonet et al. teaches a method of making a 3D polymer (PLG or poly-glycolic acid) scaffold (with potential applicability in tissue engineering) with an electrospinning apparatus comprising forming ice crystals from water molecules in vapor phase comprised in the surrounding atmosphere at the surface of a collector (drum), wherein the collector has a temperature which allows formation of crystals at the surface of the collector; electrospinning a solution comprising at least one polymer dissolved therein around the crystals; continuing the formation of crystals and the electrospinning simultaneously; and removing the ice crystals leaving pores (Poster, Fig. 1-3 and Results).
Simonet et al. teaches the method provides an easily applicable method to increase the porosity of electrospun polymer meshes and can increase the void space between fibers by a factor of 4 (Conclusion).
Atala et al. teaches electrospun matrices suitable for cell attachment comprising naturally occurring materials, including elastin and biocompatible synthetic polymers, such as poly-glycolic acids (PGA) (Pg. 4, Paragraphs [0051]-[0052] and Pg. 24, Claim 1)
It would have been further obvious to those of ordinary skill in the art before the instant invention to modify the multilayered composite graft comprising a 3D porous elastin scaffold layered on a bioadhesive layer of Hinds et al. to use the elecrospinning technique of Boland et al. to layer the elastin layer onto the bioadhesive layer already on the collector because this is a suitable technique for providing a 3D porous elastin layer to an adhesive layer. It would have been further obvious to those of ordinary skill in the art to modify the method of Hinds et al. and Boland et al. to perform the elastin electrospinning under the low-temperature conditions of Simonet et al. because this will provide the desired porous layer. While Simonet et al. does not indicate how the ice crystals are removed from the electrospun polymer, the ordinary artisan would have recognized that ice can only be removed via melting or sublimation and the selection of either method would have been a matter of artisan preference. See the MPEP citing KSR at 2143, I., E. Those of ordinary skill in the art would recognized in view of the teachings of Atala et al. that elastin and PLG are recognized equivalent polymers suitable for electrospinning into cell scaffolds and which could be substituted. See the MPEP at 2144.06, II. Those of ordinary skill in the art would have been motivated to make this modification because Simonet et al. teaches the method provides an easily applicable method to increase the porosity of electrospun polymer meshes and can increase the void space between fibers by a factor of 4. There would have been a reasonable expectation of success in making this modification because all of the methods are drawn to the same field of endeavor, that is, the construction of polymeric scaffolds for tissue engineering.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/Examiner, Art Unit 1653 05/06/2026
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