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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/26/2026 has been entered.
Status of Claims
This office action is responsive to the amendment filed on 05/28/2026. As directed by the amendment: claims 13, 19, 22, 23, 27, 28, 33, 38 and 41 have been amended, no additional claims have been cancelled, new claims 42 and 43 have been added, and claims 1 and 7 remain withdrawn from consideration as being drawn to a non-elected invention. Thus, claims 13, 19, 22, 23, 27, 28, 33, 38 and 41-43 are presently examined in the current Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13, 19, 22, 23, 27, 28, 33, 38 and 41-43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 19, 28 and 41 (and all the claims that depend from them), which now, due to the amendments dated 05/28/2026, recite the invention as “An intrascopically removable” synthetic scaffold (claims 19 and 41)/gastrointestinal scaffold device (claim 28); however this invention(s) is consider to be new matter since the originally filed disclosure of the current application at hand never mentioned, suggested, or discussed an intrascopically removable synthetic/gastrointestinal scaffold device. Specifically, the entire disclosure, as originally filed, sets forth/teaches a synthetic/gastrointestinal scaffold, however there is not mention, suggestion or discussion of specific structure of a final device/inventive concept which is an intrascopically removable synthetic/gastrointestinal scaffold device. Moreover, the term intrascopically removable/removing is only mentioned one time in the entire originally filed disclosure, in paragraph [0119], which is discussing the method/process of using the synthetic scaffold (i.e. “an embodiment of the regeneration method”, as disclosed in paragraph [0025] of the originally filed specification), and it states “In certain embodiments, the removal process can include intrascopically removing the synthetic scaffold from the interior of the guided tissue growth” (emphasis added). However, there is never any recitation or mentioning, throughout the entire originally filed disclosure of the current application at hand, of an inventive device/apparatus that is an intrascopically removable synthetic/gastrointestinal scaffold, as set forth in independent claims 19, 28 and 41, and all the claims that depend from them.
Regarding claims 28, 41, 42 and 43, which set forth the parameters of “the cellular material including VEGF, GM-CSF, IL-6, IL-8 and IL-1RA” (claim 28), “the cellularized sheath layer having vascular endothelial growth factor, granulocyte-macrophage colony-stimulating factor, IL-6, IL-8, and IL-1RA” (claim 41), “the cellular material present in the cellular sheath layer includes VEGF, GM-CSF, IL-6, IL-8 and IL-1RA” (claim 42), and “the cellular material present in the cellular matrix includes VEGF, GM-CSF, IL-6, IL-8 and IL-1RA” (claim 43); however, these parameters were never mentioned in the originally filed disclosure. Specifically, the originally filed disclosure never mentions or suggests a final structure of the scaffold device, which comprises a cellular sheath layer, having/comprising VEGF (vascular endothelial growth factor), GM-CSF (granulocyte-macrophage colony-stimulating factor), IL-6, IL-8 and IL-1RA. Nor is it ever mentioned or suggested that the cellular material, which is seeded on the tubular polymeric portion of the scaffold device, “includes” VEGF, GM-CSF, IL-6, IL-8 and IL-1RA. In fact, it is well-known to one having ordinary skill in the art that VEGF, GM-CSF, IL-6, IL-8 and IL-1RA are not cellular materials, instead they are growth factors/proteins which are part of the stimulating/growth process of cellular material/stem cells; thus, the specification would clearly not mention that the cellular materials include VEGF, GM-CSF, IL-6, IL-8 and IL-1RA, as set forth in the above mentioned claims. It is noted that the only two paragraphs, of the originally filed specification of the current application at hand, which mention VEGF, GM-CSF, IL-6, IL-8 and IL-1RA are referring to the presence of these factors in samples of the fluid media, in which the cellular material is being cultured, to indicate secretion of these factors which assist in angiogenesis and immunomodulation. Applicant iterates this as well, in the response dated 05/28/2026, stating that the originally filed specification states the above mentioned factors are “detected in the conditioned medium”. However, no wherein in the originally filed specification, and/or disclosure, is it ever disclosed that the synthetic scaffold specifically comprises these factors, i.e. VEGF, GM-CSF, IL-6, IL-8 and IL-1RA, as part of the final device/product, as set forth in the claims (due to the claims being device/apparatus claims).
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.
Claims 13, 19, 22, 23, 27, 28, 33, 38 and 41-43 are 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.
Regarding claims 19 and 41, which recite the limitation of “intrascopically removable” (specifically, “An intrascopically removable synthetic scaffold”, on line 1 of both claims); however this limitation is found to be confusing since it is not clear if it is meant to impart an actually structural limitation, or if it is a mere statement of purpose/functional language. Specifically, nowhere throughout the body of the claim, nor anywhere in the originally filed specification, is there any mentioning, detail, and/or explanation, of what exact structural limitations/features would be needed in order to structurally meet the limitation of an “intrascopically removable” synthetic scaffold. The originally filed disclosure merely mentions in passing, only once throughout the entire disclosure, that in “certain embodiments, the removal process can include intrascopically removing the synthetic scaffold”, however, there is never any mentioning, explanation, or details, of what actual structure is included/would be needed for the final synthetic scaffold device to be considered “intrascopically removable”. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claims indefinite.
Regarding claim 28, which recites the limitation of “intrascopically removable” (specifically, “An intrascopically removable gastrointestinal scaffold device”, on line 1); however this limitation is found to be confusing since it is not clear if it is meant to impart an actual structural limitation, or if it is a mere statement of purpose/functional language. Specifically, nowhere throughout the body of the claim, nor anywhere in the originally filed specification, is there any mentioning, detail, and/or explanation, of what exact structural limitations/features would be needed in order to structurally meet the limitation of an “intrascopically removable” gastrointestinal scaffold device. The originally filed disclosure merely mentions in passing, only once throughout the entire disclosure, that in “certain embodiments, the removal process can include intrascopically removing the synthetic scaffold”, however, there is never any mentioning, explanation, or details, of what actual structure is included/would be needed for the final gastrointestinal scaffold device to be considered “intrascopically removable”. Furthermore, lines 21-22 set forth the parameter of “the cellular material including VEGF, GM-CSF, IL-6, IL-8 and IL-1RA” (emphasis added); however, this parameter is found to be confusing since it is unclear how, exactly, cellular material can “include” VEGF, GM-CSF, IL-6, IL-8 and IL-1RA, which are growth factors/proteins, that are secreted by, and/or cultured with, cellular material to produce tissue growth. For at least these reasons, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 42, which sets forth the parameter of “the cellular material present in the cellular sheath layer includes VEGF, GM-CSF, IL-6, IL-8 and IL-1RA” (emphasis added); however, this parameter is found to be confusing since it is unclear how, exactly, cellular material can “include” VEGF, GM-CSF, IL-6, IL-8 and IL-1RA, which are growth factors/proteins, that are secreted by, and/or cultured with, cellular material to produce tissue growth. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 43, which recites the limitation “the cellular matrix”, on line 2; there is insufficient antecedent basis for this limitation in the claim. Additionally, it is not clear what exactly the “the cellular matrix” is, and/or how it relates to the final structure of the claimed synthetic scaffold. Moreover, it is unclear how, exactly, cellular material can include VEGF, GM-CSF, IL-6, IL-8 and IL-1RA, which are growth factors/proteins, that are secreted by, and/or cultured with, cellular material to produce tissue growth. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight; intended use/functional language and/or method of manufacturing is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2113 & 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 19, 22, 23 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Shastri et al. (US PG Pub. 2006/0085063), as previously disclosed, hereinafter Shastri, in view of Martin et al. (US Patent No. 4,043,331), as previously disclosed, hereinafter Martin, Jamiolkowski et al. (US Patent No. 4,889,119), as previously disclosed, hereinafter Jamiolkowski, Hall et al. (US PG Pub. 2014/0086971), as previously disclosed, hereinafter Hall, and Weitzner et al. (US PG Pub. 2013/0018452), as previously disclosed, hereinafter Weitzner .
Regarding claims 19, 22, 23 and 27, Shastri discloses an intrascopically removable synthetic scaffold comprising a hollow body section/conduit having a first end and a second end opposed to the first end, the hollow body section/conduit further having at least one portion configured as a tubular member, the hollow body section/conduit comprising an outer layer and an inner layer connected to the outer layer and disposed radially inward relative to the outer layer, the hollow body section/conduit further comprising an outwardly oriented surface and an inwardly oriented surface, wherein the outwardly oriented surface has at least one region composed of randomly oriented spun polymeric fibers, wherein the spun polymeric fibers are formed by electrospinning, having an average diameter less than 20 microns, specifically between 3-10 microns, are interlinked to form pores of a small pore size, and are connected to form the outer layer of the hollow body section, wherein the spun polymeric fibers of the hollow body section, specifically the outer and inner layers, are composed of at least one of polyethylene terephthalate and/or polyurethane, and further comprising spun polymeric fibers interposed between the inner layer and the outer layer ([0014], Lines 1-7; [0016]; [0075], Lines 1-4; [0086]; [0089]; [0090]; [0108]; [0112], Lines 1-8 & [0169], Lines 14-19); a cellularized sheath layer composed of cellular material derived from seeded cells deposited in the spun polymeric fibers present in the outwardly oriented surface of the hollow body section/conduit and incubated in a liquid media that supports cell growth by rotating the hollow body section/conduit in a bath of the liquid media within a bioreactor chamber, the cellular material including mesenchymal cells or stem cells that secrete extracellular matrix components on the intrascopically removable synthetic scaffold, the at least one cellularized sheath layer/cellular material present in a defined layer overlying the spun polymeric fibers, and spanning the pores defined therein, of the outwardly oriented surface of the hollow body section/conduit of the tubular member ([0014], Lines 8-10; [0126]; [0128], Line 7; [0132], Lines 5-6; [0135] & [0227] – [0233]); wherein the hollow body section/conduit has a length, extending from the first to second end of 2 cm to 10 cm, and wherein the intrascopically removable synthetic scaffold is configured to promote ordered esophageal or tracheal tissue growth upon insertion of the intrascopically removable synthetic scaffold into a resected tubular organ ([0079], Lines 1-8; [0150], Last 6 Lines & [0151]); and though it is not specifically disclosed that the defined layer of the cellularized sheath layer is between 10 and 100 cells thick, this parameter is deemed to be a mere matter of normal design choice, not involving a novel inventive step, and it would have been obvious, and well within the capability of one having ordinary skill in the art before the effect filing date of the invention to determine an appropriate amount of cells in the defined layer, of the cellularized sheath, including between 10 and 100 cells thick, based on intended use of the scaffold and the type of cell growth/tissue growth wanted/needed at the implantation site, and it is to be noted that neither the claim, nor the originally filed specification gave any reason/benefit for, or criticality to, the parameter of the defined layer being between 10 and 100 cells thick, as opposed to any other thickness/number of cells; but Shastri does not specifically disclose the small pore size having an average diameter of 15-20 microns, one or more biodegradable attachments at the first and seconds ends to secure the intrascopically removable synthetic scaffold against the tubular organ, and an intermediate layer composed of a braided support material composed of at least one of polyethylene terephthalate, polyurethane, nitinol and mixtures thereof.
However, Martin teaches a tubular structure formed of electrospun polymeric fibers (Martin: Column 2, Lines 6-8, 17-18 & Column 3, Lines 1-5), wherein the interlinked fibers form pores having an average diameter of 15-20 microns, in order to allow for penetration of cells (Martin: Column 3, Lines 25-28); it is also noted that Shastri references the prior art of Martin as teaching a known way of producing spun fibers (Shastri: [0168], Lines 3-5). Furthermore, Jamiolkowski teaches that it is known in the art to have biodegradable attachments, such as clips or staples, in order to attach/fasten soft tissue, wherein the biodegradable attachments retain strength for a long enough period of time after implantation to perform the task of attaching/healing, and then soften to become impalpable as they are absorbed/degrade within the body; furthermore, the biodegradable attachments do not result in any traumatic problems that are known/been reported with metallic attachments (Jamiolkowski: Column 1, Lines 8-10; Column 2, Lines 65-68; Column 3, Lines 35-42 & Column 4, Lines 3-11). Moreover, Hall teaches a synthetic scaffold, illustrated in Figures 3A, 3B and 4E, comprising spun inner and outer layers (325/425 & 330/430), and an intermediate layer (320/420), between the inner and outer layers, comprising a stent scaffold acting as a support structure (Hall: [0090]; [0134] & [0143]). Additionally, Weitzner teaches that it is known in the art for stent scaffolds to be made by braiding, having a repeating diamond pattern, and composed of nitinol in order to deform to a reduced diameter and then restore its memorized shape after implantation, illustrated in Figures 5-9 (Weitzner: [0034], Lines 3-5; [0035], Lines 1-2 & [0061]).
In view of the teachings of Martin, Jamiolkowski, Hall and Weitzner, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the small pore size, of the pores formed by the interlinked electro-spun polymeric fibers of the synthetic scaffold of Shastri, to have an average diameter of 15-20 microns, since this is a known structure of spun polymeric fiber tubes, as taught by Martin and Shastri, and such a size/diameter range allows for penetration of cells, as taught by Martin. Additionally, it would also have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the first and second ends of the intrascopically removable synthetic scaffold of Shastri to have/include one or more biodegradable attachments to secure the scaffold against a tubular/resected organ; the biodegradable attachments being able to retain strength during healing and then soften to become impalpable as they absorbed/degrade within the body, thereby not causing any traumatic issues/problems associated with metallic attachments, as taught by Jamiolkowski. Moreover, it would have further been obvious to one having ordinary skill in the art before the effective filing date of the invention for the intrascopically removable synthetic scaffold, of Shastri, to comprise an intermediate layer composed of a braided support material oriented in a repeating diamond pattern and composed of nitinol in order to act as a support structure, and have the ability to deform to a reduced diameter and then restore its memorized shape after implantation, as taught by Hall and Weitzner.
Claims 13, 28, 33, 38, 41 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Shastri in view of Martin and Murphy et al. (US PG Pub. 2013/0190210), as previously disclosed, hereinafter Murphy.
Regarding claims 13, 28 and 43, Shastri discloses an intrascopically removable gastrointestinal scaffold device for producing gastrointestinal tissue comprising a polymeric body/conduit, configured as a tubular gastrointestinal organ ([0151], Lines 1-3), having an outer polymeric surface and an inner surface and further having a first end and a second end opposed to the first end, the polymeric body/conduit further having at least one portion configured as a tubular member, the outer polymeric surface of the polymeric body/conduit having at least one region composed of randomly oriented electrospun polymeric fibers ([0014], Lines 1-7; [0075], Lines 1-4; [0086] & [0108]), the randomly oriented electrospun polymeric fibers having an average fiber diameter between 3 microns and 10 microns ([0112], Lines 1-8), at least a portion of the randomly oriented electrospun polymeric fibers interlinked to form pores of a small pore size ([0169], Lines 14-19), wherein the polymeric body is composed of polyethylene terephthalate and/or polyurethane ([0089], Lines 5-7, 21-22; [0090], Lines 1-2); and a cellularized sheath layer that is fabricated as a sheath composed of cellular material derived from seeded cells deposited on the outer polymeric surface on the polymeric body and incubated in a liquid media that supports cell growth by rotating the polymeric body in a bath of the liquid media within a bioreactor chamber, the cellular material, that secrets extracellular matrix components on the scaffold, including mesenchymal cells and stem cells present in a defined layer, wherein the cellularized sheath layer is in overlying relationship with the outer polymeric surface, such that the cells of the cellularized sheath layer span the pores defining the electro-spun fibers of the outer polymeric surface of the polymeric body/conduit, wherein the cells in the cellularized sheath layer provide an outer edge configured for proximal contact with at least one resected edge of a gastrointestinal organ of a patient ([0014], Lines 8-10; [0126]; [0128], Line 7; [0132], Lines 5-6; [0135] & [0227] – [0233]); wherein the polymeric body and the cellularized sheath layer are configured to promote guided tissue growth on a tubular gastrointestinal organ of a subject and are configured to be removed from the subject without damaging the tubular gastrointestinal organ ([0088], Lines 2-7 & [0151]); and though it is not specifically disclosed that the defined layer is between 10 and 100 cells thick, this parameter is deemed to be a mere matter of normal design choice, not involving a novel inventive step, and it would have been obvious, and well within the capability of one having ordinary skill in the art before the effect filing date of the invention to determine an appropriate amount of cells in the defined layer, of the cellularized sheath, including between 10 and 100 cells thick, based on intended use of the scaffold and the type of cell growth/tissue growth wanted/needed at the implantation site, and it is to be noted that neither the claim, nor the originally filed specification gave any reason/benefit for, or criticality to, the parameter of the defined layer being between 10 and 100 cells thick, as opposed to any other thickness/number of cells; but Shastri does not specifically disclose the small pore size having an average diameter of less than 50 microns, and the cellular material including VEGF, GM-CSF, IL-6, IL-8 and IL-1RA.
However, Martin teaches a tubular structure formed of electro-spun polymeric fibers (Martin: Column 2, Lines 6-8, 17-18 & Column 3, Lines 1-5), wherein the interlinked fibers form pores having an average diameter of less than 50 microns in order to allow for penetration of cells (Martin: Column 3, Lines 25-28); furthermore, it is to be noted that Shastri references the prior art of Martin as teaching a known way of producing electro-spun fibers (Shastri: [0168], Lines 3-5). Additionally, Murphy teaches that it is well-known in the art for cells to be cultured with, and produce, growth factors such as VEGF, GM-CSF, IL-1RA, IL-6 and IL-8 (Murphy: [0093]).
In view of the teachings of Martin and Murphy, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the small pore size, of the pores formed by the interlinked electro-spun polymeric fibers of the removable gastrointestinal scaffold device of Shastri, to have an average diameter of less than 50 microns, since this is a known structure of electro-spun polymeric fiber tubes, as taught by Martin and Shastri, and such a size/diameter range allows for penetration of cells, as taught by Martin. Furthermore, it would also have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the cellular material, of the synthetic scaffold of Shastri, to be cultured with, and produce/include, growth factors such as VEGF, GM-CSF, IL-1RA, IL-6 and IL-8, as taught by Murphy.
Regarding claim 33, Shastri in view of Martin disclose the intrascopically removable gastrointestinal scaffold device of claim 28, wherein Shastri further teaches the polymeric body has at least one layer and wherein the at least one layer has a thickness between 100 nm and 1000 microns (Shastri: [0080], Lines 1-2).
Regarding claim 38, Shastri in view of Martin disclose the intrascopically removable gastrointestinal scaffold of claim 28, wherein Shastri further teaches the polymeric body has a length that extends longitudinally from the first end to the second end, the length being 2 cm to 10 cm, and wherein the polymeric body is configured to guide esophageal growth (Shastri: [0079], Lines 1-8; [0150], Last 6 Lines & [0151]).
Regarding claim 41, Shastri discloses an intrascopically removable synthetic scaffold comprising a tubular body section/conduit having a first end and a second end opposed to the first end, the tubular body section/conduit defining a hollow interior and comprising and outwardly oriented surface composed of electrospun polymeric fibers, the electrospun polymeric fibers having an average diameter between 3 microns and 10 microns, and at least a portion of the electrospun polymeric fibers interlinked to form pores of a small pore size, wherein the electrospun polymeric fibers of the hollow body section/conduit are composed of at least one of polyethylene terephthalate and/or polyurethane ([0014], Lines 1-7; [0016]; [0075], Lines 1-4; [0086]; [0089], Lines 5-7, 21-22; [0090], Lines 1-2; [0112], Lines 1-8; & [0169], Lines 14-19); a cellularized sheath layer composed of cellular material derived from seeded mesenchymal cells deposited in a defined layer overlying the outwardly oriented surface of the tubular body section, wherein the cellularized sheath layer spans at least a portion of outwardly positioned spun polymeric fibers present in the hollow body section of the tubular body section ([0014], Lines 8-10; [0126]; [0128], Line 7; [0132], Lines 5-6; [0135] & [0227] – [0233]); and though it is not specifically disclosed that the defined layer of the cellularized sheath layer has a thickness between 10 and 100 cells, this parameter is deemed to be a mere matter of normal design choice, not involving a novel inventive step, and it would have been obvious, and well within the capability of one having ordinary skill in the art before the effect filing date of the invention to determine an appropriate amount of cells in the defined layer, of the cellularized sheath, including between 10 and 100 cells thick, based on intended use of the scaffold and the type of cell growth/tissue growth wanted/needed at the implantation site, and it is to be noted that neither the claim, nor the originally filed specification gave any reason/benefit for, or criticality to, the parameter of the thickness of the defined layer of the cellularized sheath layer being between 10 and 100 cells, as opposed to any other thickness/number of cells; but Shastri does not specifically disclose the small pore size having an average diameter of 15-20 microns, and the cellularized sheath layer having vascular endothelial growth factor (VEGF), granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-6 (IL-6), interleukin-8 (IL-8), and interleukin-1RA (IL-1RA).
However, Martin teaches a tubular structure formed of electrospun polymeric fibers (Martin: Column 2, Lines 6-8, 17-18 & Column 3, Lines 1-5), wherein the interlinked fibers form pores having an average diameter of 15-20 microns, in order to allow for penetration of cells (Martin: Column 3, Lines 25-28); it is also noted that Shastri references the prior art of Martin as teaching a known way of producing spun fibers (Shastri: [0168], Lines 3-5). Additionally, Murphy teaches that it is well-known in the art for cells to be cultured with, and produce, growth factors such as vascular endothelial growth factor (VEGF), granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-6 (IL-6), interleukin-8 (IL-8), and interleukin-1RA (IL-1RA) - (Murphy: [0093]).
In view of the teachings of Martin and Murphy, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the small pore size, of the pores formed by the interlinked electro-spun polymeric fibers of the synthetic scaffold of Shastri, to have an average diameter of between 15 and 20 microns, since this is a known structure of spun polymeric fiber tubes, as taught by Martin and Shastri, and such a size/diameter range allows for penetration of cells, as taught by Martin. Furthermore, it would also have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the cellularized sheath layer, of the synthetic scaffold of Shastri, to be cultured with, and produce, growth factors such that it has vascular endothelial growth factor (VEGF), granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-6 (IL-6), interleukin-8 (IL-8), and interleukin-1RA (IL-1RA), as taught by Murphy.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Shastri in view of Martin, Jamiolkowski Hall and Weitzner as applied to claim 19 above, and further in view of Murphy.
Regarding claim 42, Shastri in view of Martin, Jamiolkowski Hall and Weitzner disclose the intrascopically removable synthetic scaffold of claim 19, but does not specifically teach the cellular material present in the cellular sheath layer incudes VEGF, GM-CSF, IL-6, IL-8 and IL-1RA.
However, Murphy teaches that it is well-known in the art of cellular culturing, for cells to be cultured with, and produce, growth factors such as VEGF, GM-CSF, IL-6, IL-8 and IL-1RA (Murphy: [0093]).
In view of the teachings of Murphy, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the cellular material in the cellular sheath layer, of the scaffold of Shastri in view of Martin, Jamiolkowski Hall and Weitzner, to be cultured with, and produce/include, growth factors such as VEGF, GM-CSF, IL-6, IL-8 and IL-1RA, as taught by Murphy.
Response to Arguments
Applicant's arguments filed 05/28/2026 have been fully considered but they are not persuasive. Applicant argues the rejections of independent claims 19, 28 and 41, as currently amended, stating that the rejections, specifically the prior art of Shastri, does not teach ordered tracheal/esophageal/gastrointestinal tissue growth once inserted into a resected tubular organ and intrascopic removal of the synthetic/ gastrointestinal scaffold. Examiner respectfully disagrees with Applicant’s assertions. Firstly, it is to be noted that these claims are device/apparatus claims, wherein only the claimed structure of the final device bears patentable weight; intended use/functional language and/or method of manufacturing are only considered to the extent that they further define the claimed structure of the final device (see MPEP 2113 & 2114). Secondly, it is noted that the current amendments to the claims are made in the preamble of the claims, and according to section 2111.02 of the MPEP “determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing ‘extraneous’ limitations from the specification”. Looking at the parameter of ordered gastrointestinal/tracheal or esophageal tissue growth “once inserted into a resected tubular organ”, this limitation is clearly an intended use/function of the claimed invention/device; i.e. the claimed structure of the scaffold device results in tissue growth once/after the device is implanted/used. Nevertheless, in addition to Shastri (in view of Martin, Jamiolkowski Hall, Weitzner and/or Murphy, depending on the claims) teaching all the structural limitations set forth in the claims, Shastri also clearly teaches the above mentioned intended use/functional language, i.e. the device/scaffold achieving ordered gastrointestinal/tracheal or esophageal tissue growth once inserted into a resected tubular organ, at least in paragraphs [0088], [0151] and [0237]. Specifically, paragraph [0088] states the device/conduit can undergo remodeling by the cells of a host subject and that “the conduit or scaffold thus functions as a substitute body part, and, while still functioning as a substitute body part, it functions as a remodeling template for the in-growth of host cells”, paragraph [0151] state “the prosthesis or scaffold can be used, for example, to replace a length of tubular organs such as vasculature, ureters, urethra, esophagus, trachea, intestine,…” (emphasis added), and paragraph [0237] states “the invention is directed to a biocompatible tubular conduit, prosthesis, or scaffold, which, when implanted into a subject, can serve as a functioning repair, augmentation, or replacement body part or tissue structure” (emphasis added).
Regarding the limitation of intrascopic removal/the scaffold being intrascopically removable, which was newly added to the preamble of the claims by the amendment dated 05/28/2026, the question rises of if this limitation is considered a structural limitation, or a mere statement of purpose. Looking again at the MPEP section 2111.02, it states “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction” (emphasis added), and that “a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention”. In the instant case, the limitation of the scaffold being removable is deemed to be a statement of purpose, and not one of structural limitation, for the following reasons. Firstly, there is no actual structure set forth, or mentioned, not only in the claim(s), but anywhere in the originally filed disclosure for the scaffold being removable. Specifically, nowhere in the entire originally filed disclosure was there any explanation, or details as to what exact structure would be needed in order to meet the use/function of the scaffold being intrascopically removable. In fact, the term intrascopically removable/removing is only mentioned one time in the entire originally filed disclosure, in paragraph [0119], which is discussing the method/process of using the synthetic scaffold (i.e. “an embodiment of the regeneration method”, as disclosed in paragraph [0025] of the originally filed specification), and it states “In certain embodiments, the removal process can include intrascopically removing the synthetic scaffold from the interior of the guided tissue growth”. However, there is never any recitation or mentioning, throughout the entire originally filed disclosure of the current application at hand, of an actual structure which would result in/cause the inventive device/apparatus to be considered intrascopically removable. Secondly, as mentioned above from the MPEP, the body of the claims “describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention”. According to the originally filed disclosure of the current application at hand, the inventive concept, as a whole, “relates to engineered tissues that are useful for replacement or repair of damage tissues” (paragraph [0002] of the originally filed specification). The claims set forth multiple structural limitations required for the complete/final inventive device/scaffold, and deletion of the preamble phrase “intrascopically removable” would not change/affect “the structure or steps of the claimed invention”. Moreover, if Applicant feels that the limitation of “intrascopically removable” in the preamble (or even if it was set forth anywhere else in the claim language/body), is more than a mere statement of purpose/intended use/functional language, then Applicant is asked to disclose/clarify, either in the claims or at the very least in a subsequent response, what exact physical, structural and/or chemical limitations would be required for the scaffold to be considered/meet the limitation of being “intrascopically removable”; since no such limitations could be found throughout the entire originally filed disclosure to distinguish the device/scaffold ,of the current application at hand, from that of prior art. Thus, the rejection of independent claim 19, as being unpatentable over Shastri in view of Martin, Jamiolkowski Hall and Weitzner, and the rejections of independent claims 28 and 41, as being unpatentable over Shastri in view of Martin and Murphy, are deemed to be proper since all the structural limitations set forth in the claims are taught by the prior art; hence, the rejections stand.
Conclusion
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/DINAH BARIA/Primary Examiner, Art Unit 3774 07/11/2026
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