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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-2, 6, 8, 10-17, 19-20, and 22-23 is/are pending. Claim(s) 11-17 is/are withdrawn. Claim(s) 3-5, 7, 9, 18, and 21 is/are canceled.
Response to Arguments
Applicant's arguments filed 5/4/2026 have been fully considered but they are not persuasive.
Applicant argues Leong teaches dense scaffolds with a pore size <5 microns are those made by electrospinning and the scaffolds with a pore size > 5 microns are made using cryogenic crystals. Applicant argues claim 1 requires the exterior and luminal layers to have a larger pore size than the intermediate layer and thus, Leong teaches away from the claimed language. (Applicant's Response on 5/4/2026, herein "Response", pages 9-10)
The cited embodiment is the three layer embodiment of [0064] as each the exterior, intermediate, and luminal layers are cited from Leong. The use of [0099], which teaches a bilayer instead, was to reiterate that each layer is made of electrospun materials. Leong teaches "[w]ith the method of the present invention pore sizes of this size or within this range can be obtained. It should be understood that depending on the application, pore sizes other than the pore sizes or range of pore sizes mentioned above are possible" in [0094]. Thus, the pore sizes of the bilayer embodiment are not a teaching of the pore size of other embodiments, and thus not necessarily applicable to the three layer embodiment. Instead, the cited three layer embodiment has the dimensions as cited by the Examiner. [0064] requires a relative degradation rate (i.e. the intermediate layer degrades slower than the exterior and luminal layers). There is no requirement for relative pore sizes for this embodiment. Therefore, the combination made does not teach away from the non-cited embodiment.
With respect to the electrospun material, Leong's [0064] states "a three-layered design that consists of two electrospun dense scaffolds which need a shorter time for degradation compared to an electrospun scaffold which is sandwiched in between these two other scaffolds." Thus, all three layers are electrospun layers. [0099] also teaches that the layer are made of electrospun fibers. Therefore, all layers are of electrospun material.
Applicant argues Leong teaches the exterior and luminal layers are impenetrable to inflammatory cells before degradation and are not seeded with cells and the interior layer is only cell permeable after some degradation (Response, page 10).
The claim requirement is "an epithelium formation inducing environment" and "configured to induce formation of non-epithelial tissue" and "cell colonies in the luminal layer region". There is no requirement regarding what configuration/state these limitations are met in. Therefore, Leong's teachings that they occur after some degradation meets the claimed requirements.
With respect to pore size, claim 1 requires the luminal layer having an average pore size of 10.0 mm to 100.00 mm, the exterior layer having an average pore size of 10.0 mm to 100.0 mm, and the intermediate layer having an average pore size of 1 mm and 5 mm. Leong teaches the exterior layer has a pore size range of 60 mm to 150 mm for SMCs in [0094]. Also in [0094], the intermediate layer has pore sizes of 5 mm to 15 mm for fibroblast ingrowth (fibrosis in [0064]).
Applicant argues Leong's teaching of the polycarbonate based polyurethane is that from an almost infinite list of combinations and thus is not the particular claimed material claimed (Response, pages 10-11).
The claim language is "composed of a polycarbonate-based polyurethane polymeric material". The claim does not specify any particular polycarbonate-based polyurethane and does not require the product of any particular reaction (thereby constraining the claim to that particular material). Thus, any general polycarbonate-based polyurethane polymeric material of the prior art meets the claimed material.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., any particular polycarbonate-based polyurethane polymeric material) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With respect to the infinite number of items, the Examiner notes the rejection is based on a teaching from Leong as the primary reference and is not a combination made modifying Leong. Additionally, Applicant has not provided evidence that their particular compound (not claimed) provides some unexpected result. Therefore Applicant's argument is not persuasive.
Applicant argues Leong does not teach a polycarbonate based polyurethane that is not biodegradable (Response, page 11).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a polycarbonate based polyurethane that is not biodegradable) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues Leong does not teach the claimed cell seeding because if the delayed degradation discussed supra (Response, pages 11-12). As with the response supra, there is no requirement regarding what configuration/state these limitations are met in. Therefore, Leong's teachings that they occur after some degradation meets the claimed requirements.
Applicant argues Leong only teaches cell seeding with fibroblasts (Response, page 12). Applicant does not address the additional citations and comments in the rejection of record regarding the differing cell types, e.g. [0097], [0099].
Applicant argues the citation to Sexton [0057] and argues the prior art does not teach more than one cell type (Response, page 12). Sexton was only used for evidence of the size of SMCs for claim 20 and was not used as a teaching of seeding cells into the scaffold. Instead Leong's [0094] teaches example uses of the scaffold of Leong and therefore does teach that each type of listed cell can be seeded onto the cited Leong device. Therefore, Applicant's arguments are not found persuasive.
Applicant argues Ehrenreich is not in the field of a scaffold to initiate and direct generation of new tissue to repair an organ (Response, page 12). The Examiner notes this is not the cited common field of endeavor, which is tubular implants made of electrospun layers. Therefore, as reasoning that is not the Examiner's reasoning is argued, the argument is not found persuasive.
Applicant argues Ehrenreich does not teach intrascopic removal of the device (Response, page 12). The Examiner notes the claim language is "configured to be intrascopically removable" and the claim is a product claim and not a method claim. Thus, the cited teaching that the device is usable with a catheter means the device is capable of being retracted into the catheter and removed as claimed. Therefore, Applicant's argument is not persuasive.
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.
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.
Claims 1-2, 6, 8, 10, 19, and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leong, et al (Leong) (US 2010/0093093 A1) in view of Zhu, et al (Zhu) (Circumferentially aligned fibers guided functional neoartery regeneration in vivo, Biomaterials, v61, pp 85-94 (2015)) and further in view of Ehrenreich, et al (Ehrenreich) (US 2011/0230948 A1).
Regarding Claim 1, Leong teaches a multilayer scaffold device (e.g. [0064]) comprising:
a luminal electrospun layer (radially innermost layer), the luminal electrospun layer configured to provide an epithelium formation inducing environment on the luminal electrospun layer of the multilayer scaffold device (e.g. [0064], [0099]), the luminal electrospun layer having an inwardly oriented surface (luminal layer) and a luminal layer region proximate to and inward of the inwardly oriented surface (abluminal surface of the luminal layer, inward into the thickness of the device), the inwardly oriented surface defining a hollow interior (e.g. [0019], the device is formed on a mandrel and thus has a hollow interior where the mandrel is located during manufacturing, creating a hollow, tubular structure) the luminal electrospun layer has a luminal electrospun layer thickness (the layer inherently has a (radial) thickness), wherein the luminal electrospun layer comprises a continuous elongated polymeric electrospun fiber (e.g. [0064], [0099], electrospun layers inherently have fibers; [0077], polymeric material; [0043]; continuous fiber seen in Figure 1, oriented with the label at the top, the top row, right had side), the continuous elongated polymeric electrospun fiber of the luminal electrospun layer having a first end, a second end opposed to the first end and an intermediate region located between the first end and the second end (the fiber inherently has these sections), wherein the continuous elongated polymeric electrospun fiber present in the luminal electrospun layer is oriented such that segments of the continuous elongated polymeric electrospun fiber of the intermediate region of the luminal electrospun layer are in overlaying relationship to one another (e.g. Figure 1, oriented with the label at the top, the top row, right had side; [0112] indicates the prior descriptions are on a non-rotating mandrel (i.e. a stationary mandrel); the section of Figure 1 shows a single fiber being deposited back and forth longitudinally, thus on a stationary mandrel different segments of the fiber overlay each other as deposited) and contact each other forming luminal electrospun layer points of contact such that between 1,000 and 100,000,000 points of contact per cubic millimeter are defined in the luminal electrospun layer (e.g. annotated Figure 3c below, there are a plurality of contact points between the electrospun fibers; since the scale bar represents 100 mm or 0.1 millimeter, the area of a square scale bar is 0.01 mm squared; therefore, a square millimeter would contain at least 1,000 contact points);
an exterior electrospun layer (radially outermost layer), the exterior electrospun layer located radially exterior to the luminal electrospun layer (e.g. [0064]), the exterior electrospun layer having an outwardly oriented surface (abluminal/radially outermost surface), the exterior electrospun layer configured to induce formation of non-epithelial tissue (e.g. [0064], [0094], configured for muscle cells), wherein the exterior electrospun layer comprises a continuous exterior electrospun layer elongated polymeric electrospun fiber (e.g. [0043]), the continuous exterior electrospun layer elongated polymeric electrospun fiber having an average pore size between 10.0 mm and 100.0 mm (e.g. [0094], 60 mm -150 mm for SMCs, which are on the exterior electrospun layer (see cell populations below)); and
at least one intermediate layer interposed between the luminal electrospun layer and the exterior electrospun layer (e.g. [0064]), the intermediate layer defining a region acting on the luminal electrospun layer and the exterior electrospun layer wherein formation of epithelial tissue and non-epithelial tissue on the luminal electrospun layer and exterior electrospun layer are organized (as broadly claimed, the intermediate layer acts on and organizes the tissue formation by being a physical partition between the luminal and exterior layers) and subcellular material is maintained and transit(s) therethrough (e.g. [0099], the pore structure allows for proliferation of cells through the layer; [0088]-[0089] discusses adding components of the extracellular matrix to the pores of the scaffold, thus these materials are moved into the intermediate layer at that time; further [0089] also discloses the extracellular matrix material recruiting other cells; thus, because cellular sized particles can pass through the region, so can subcellular material because subcellular is smaller than cellular), the intermediate layer having a plurality of pores defined therein (e.g. [0064], the openings through which cells infiltrate the layers), the plurality of pores having an average pore size between 1 mm and 5 mm (e.g. [0094]), the at least one intermediate layer that is interposed between the luminal electrospun layer and the exterior electrospun layer comprises at least one elongated polymeric electrospun fiber (e.g. [0064], [0099], electrospun layers inherently have fibers; [0077], polymeric material; [0043]), the at least one elongated polymeric fiber in the intermediate layer has a first end, a second end opposed to the first end and an intermediate region located between the first end and the second end (the fiber inherently has these sections), wherein the intermediate region of the elongated polymeric fiber of the intermediate layer is oriented such that segments of the intermediate region of the intermediate layer contact each other forming between 2,000 and 200,000,000 points of contact per cubic millimeter between different locations of the electrospun fiber in the intermediate electrospun layer (e.g. annotated Figure 3c below, there are a plurality of contact points between the electrospun fibers; since the scale bar represents 100 mm or 0.1 millimeter, the area of a square scale bar is 0.01 mm squared; therefore, a square millimeter would contain at least 2,000 contact points) and defines the plurality of pores in the intermediate electrospun layer (e.g. [0064], the openings through which cells infiltrate the layers), the pores have an average pore size that is at least 25% less than the average pore size of pores defined in the exterior electrospun layer (e.g. [0094], when the average pore size exterior electrospun layer is 150 mm and the intermediate layer average port size is 60 mm, the intermediate layer average pore size is 50% less than those of the exterior electrospun layer), at least a portion of the pores present in the luminal electrospun layer are through the plurality of pores within the luminal layer (e.g. Leong, Figures 3b-c, the through holes have a black background) communicating with pores defined in the intermediate electrospun layer (since the pores are through pores, they inherently go through to the immediately adjacent layer, which is the intermediate electrospun layer);
a first population of cells comprising a first cell type adhering to the inwardly oriented surface defined on the luminal electrospun layer (e.g. [0097], bone marrow stem cells are MSCs, which can be differentiated into the epithelial cells noted supra) the first population of cells comprising the first cell type further present as cell colonies (e.g. [0097], [0099], the cells that grow at this layer inherently grow in groups as they divide and thereby for colonies adhered to the inwardly oriented surface) in the luminal layer region that is located proximate to and inward of the inwardly oriented luminal surface (e.g. [0099], the cells are throughout each layer and therefore at the luminal layer region); and
a second population of cells, wherein the second populations of cells comprises a second cell type and adheres to the outwardly oriented surface of the exterior electrospun layer (e.g. [0099], [0094], SMCs) forming a cellular sheath (the layer is a tubular layer and the cells are placed on the layer and are thereby a sheath), wherein the second cell type is different from the first cell type (discussed supra, MSCs and SMCs);
wherein the intermediate layer and at least one of the luminal electrospun layer or the exterior electrospun layer are composed of a polycarbonate-based polyurethane polymeric material (e.g. [0077], combination of polycarbonate and polyurethane), and
wherein the at least one exterior electrospun layer elongated polymeric electrospun fiber present in the exterior electrospun layer is randomly oriented (e.g. [0021], the electrospinning process randomly lays down the fiber).
Leong discloses the invention substantially as claimed but fails to teach the continuous elongated polymeric electrospun fiber present in the luminal electrospun layer having a fiber diameter between 1.0 mm and 25.0 mm and the continuous exterior electrospun layer elongated polymeric electrospun fiber having a fiber diameter between 1.0 mm and 25.0 mm and the at least one elongated polymeric electrospun fiber of the intermediate layer having a fiber diameter between 1.0 mm and 25.0 mm.
Zhu teaches a fiber diameter between 1.0 mm and 25 mm (e.g. page 88, Results section 3.1, first paragraph, 18.26 ± 6.13 mm).
Zhu and Leong are concerned with the same field of endeavor as the claimed invention, namely electrospun, multi-layer grafts.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Leong such that the fiber diameter of each of the luminal electrospun layer, the exterior electrospun layer, and the intermediate layer is between 1.0 mm and 25.0 mm as taught by Zhu in order to enhance cellular adhesion due to modulating the pore size (e.g. Leong, [0061] and Zhu, page 88, Results section 3.1, first paragraph).
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Annotated Figure 3C, Leong
The combination of Leong and Zhu discloses the invention substantially as claimed but fails to teach the luminal electrospun layer has an average pore size between 10.0 mm and 100.0 mm.
Leong teaches the following pore size: [0064], [0094], epithelial cells are skin cells and layers supporting them have pore diameters of 20 mm to 125 mm.
Leong is concerned with the same field of endeavor as the claimed invention, namely electrospun, multi-layer scaffolds seeded with cells.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Leong and Zhu such that the luminal electrospun layer has an average pore size between 10.0 mm and 100.0 mm for these cell types since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
If not inherent that Leong in the combination of Leong and Zhu teaches between 1,000 and 100,000,000 points of contact per cubic millimeter are defined in the luminal electrospun layer and between 2,000 and 200,000,000 points of contact per cubic millimeter between different locations of the electrospun fiber in the intermediate electrospun layer, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Leong and Zhu such that there are between 1,000 to 100,000,000 points of contact between different locations defined in the luminal electrospun layer and between 2,000 to 200,000,000 points of contact between different locations defined in the intermediate electrospun layer since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
The combination of Leong and Zhu discloses the invention substantially as claimed but fails to teach the scaffold device is configured to be intrascopically removable.
Ehrenreich teaches a tubular implant made of electrospun layers (e.g. [0019], abstract), that is configured to be intrascopically removable (e.g. [0016]).
Ehrenreich and the combination of Leong and Zhu are concerned with the same field of endeavor as the claimed invention, namely tubular implants made of electrospun layers.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Leong and Zhu such that the scaffold is configured to be intrascopically removable as taught by Ehrenreich as it is combining prior art elements according to known methods to yield predictable results (MPEP 2143(I)). Here, the results are predictable because each claimed element performs in the same manner in the combination as it does separately. Specifically, the scaffold functions as a replacement vessel having a lumen and the delivery expansion/collapsible configurations allow for minimally invasive delivery.
Regarding Claim 2, each of the luminal electrospun layer, the exterior electrospun layer, or the intermediate layer are composed of a polycarbonate-based polyurethane polymeric material (e.g. Leong, [0077], as discussed supra for claim 1).
Regarding Claim 6, the at least one exterior electrospun layer elongated polymeric electrospun fiber having a first end, a second end opposed to the first end and an intermediate region located between the first end and the second end (the fiber inherently has these sections), wherein the at least one elongated polymeric electrospun fiber present in the exterior electrospun layer is oriented such that segments of the intermediate region of the at least one elongated polymeric electrospun fiber contact each other forming between 1,000 and 1,000,000 points of contact between different locations defined in the exterior electrospun layer (e.g. Leong, annotated Figure 3c above, there are a plurality of contact points between the electrospun fibers; since the scale bar represents 100 mm or 0.1 millimeter, the area of a square scale bar is 0.01 mm squared; therefore, a square millimeter would contain at least 1,000 contact points).
If not inherent that Leong in the combination of Leong, Zhu, and Ehrenreich teaches the number of contact points being 1,000 to 1,000,000, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Leong, Zhu, and Ehrenreich such that there are between 1,000 to 1,000,000 points of contact between different locations defined in the exterior electrospun layer since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
Regarding Claim 8, the pores present in the exterior electrospun layer have an average pore size between 10.0 mm and 50.0 mm (e.g. Leong, [0094]).
Regarding Claim 10, the plurality of pores in the intermediate electrospun layer (discussed supra for claim 1) communicates between the luminal electrospun layer and the exterior electrospun layer (discussed supra for claim 4), the plurality of pores present in the intermediate electrospun layer have an average pore size less than 10 mm (discussed supra for claim 1).
Regarding Claim 19, the first population of cells is located in the thickness of the luminal electrospun layer (claim 1 requires the first population be at the surface, which is also the surface of the thickness) and is present in between 50% and 100% of the thickness of the luminal electrospun layer (e.g. [0064], [0094], during infiltration there is a configuration where the cells are located as claimed) and wherein the first population of cells comprises mesenchymal stem cells (MSCs) (e.g. Leong, [0097], bone marrow stem cells are MSCs) present in a percentage greater than 40% of total cells in the first cell population (100% of the population is MSCs), wherein the MSCs organize to produce esophageal tissue in a subject (e.g. Leong, [0099]; the organization would happen when the device is placed in a subject as the cells will continue to grow).
Regarding Claim 22, the points of contact between different locations in the intermediate layer is between 750,000 and 1,000,000 per cubic millimeter (discussed supra for claim 1).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the thickness of the intermediate layer (and thereby increase the number of contact points) such that there are between 750,000 and 1,000,000 contact points per millimeter as such a modification would have been an obvious matter of design choice involving a change in the size/proportions (here, thickness) of a component. A change in size is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04 IV).
Regarding Claim 23, the limitations of claim 23 are discussed supra for claims 1-2 and 6, except that as follows.
If not inherent that Leong in the combination of Leong, Zhu, and Ehrenreich teaches between 1,000 and 1,000,000 points of contact per cubic millimeter between different locations of the electrospun fiber in the intermediate electrospun layer, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Leong, Zhu, and Ehrenreich such that there are between 1,000 to 1,000,000 points of contact between different locations defined in the intermediate electrospun layer since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
Claim 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leong, et al (Leong) (US 2010/0093093 A1) in view of Zhu, et al (Zhu) (Circumferentially aligned fibers guided functional neoartery regeneration in vivo, Biomaterials, v61, pp 85-94 (2015)) in view of and further in view of Ehrenreich, et al (Ehrenreich) (US 2011/0230948 A1) and as evidenced by Sexton (US 2017/0049627).
Regarding Claim 20, the second population of cells is present in between 50% and 100% of the exterior electrospun layer and wherein the second population of cells comprises smooth muscle cells (SMCs) (e.g. Leong, [0099], [0094]) present in a percentage greater than 40% of the total cells in the second cell population (100% of the cells in this population are SMCs) and are derived from cells seeded on the multilayer scaffold device during an incubation process (since the cells are present, they were inherently incubated in order to be present) and is configured as a cellular sheath connected to the outwardly oriented surface of the exterior electrospun layer (the layer is a tubular layer and the cells are placed on the layer and are thereby a sheath), wherein the cellular sheath has a cell thickness between 10 and 100 cells (Sexton teaches the size of vascular smooth muscle cells ranges from 0.1 mm to 100 mm (e.g. [0057]). Leong teaches the thickness of the exterior layer is 50 mm (e.g. [0140]) and this layer degrades (e.g. [0064]). When the layer degrades the cells seeded therein remain. Therefore the SMC layer is at least 50 mm thick and is 50-1 mm cells thick.)
Conclusion
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 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 LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 5/21/2026