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 .
Status of Claims
This office action is responsive to the amendment filed on 11/07/2025. As directed by the amendment: claims 19, 27, 28 and 41 have been amended, claim 30 has been cancelled, no new claims have been added, and claims 1 and 7 remain withdrawn from consideration as being drawn to a non-elected invention.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 are presently examined in the current Office Action.
Terminal Disclaimer
The terminal disclaimer filed on 11/07/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 12,048,619 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claim 28 is objected to because of the following informalities: lines 17-18 state “including VEGF, GM-CSF, IL-1RA, IL-6, IL-8 and IL-1RA” (emphasis added), the term “IL-1RA” is included twice; it is suggested one, of the two, recitations of “IL-1RA” be deleted. Appropriate correction is required.
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 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 and 41, which set forth the parameter of the cellular material include (claim 19)/the cellularized sheath layer having (claim 41) “elevated levels of” 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, this parameter was never mentioned in the originally filed disclosure. Specifically, the originally filed disclosure never mentioned or suggested that either the cellular material and/or the cellularized sheath layer, of the synthetic scaffold, has/includes 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). It is to be noted that paragraph [0150], of the originally filed specification of the current application at hand, states that “vascular endothelial growth factor (VEGF), granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin (IL)-6, IL-8, and IL-1RA was detected in conditioned medium at levels significantly above medium alone” (emphasis added). However, nowhere in the entire originally filed specification of the current application at hand does it state that either the cellular material and/or the cellularized sheath layer, of the synthetic scaffold, has/includes, at elevated or any levels, any of VEGF, GM-CSF, IL-6, IL-8, and IL-1RA.
Regarding claim 28, which sets forth the parameter of the cellular material, which is in a defined layer, “including VEGF, GM-CSF, IL-1RA, IL-6, IL-8, and IL-1RA”; however, this parameter was never mentioned in the originally filed disclosure. Specifically, the originally filed disclosure never mentioned or suggested that the cellular material, of the synthetic scaffold, includes VEGF, GM-CSF, IL-6, IL-8, and IL-1RA. It is to be noted that paragraph [0150], of the originally filed specification of the current application at hand, states that “vascular endothelial growth factor (VEGF), granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin (IL)-6, IL-8, and IL-1RA was detected in conditioned medium at levels significantly above medium alone” (emphasis added). However, nowhere in the entire originally filed specification of the current application at hand does it state that the cellular material, of the synthetic scaffold, has/includes any of VEGF, GM-CSF, IL-6, IL-8, and IL-1RA.
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 19, 22, 23, 27 and 41 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 set forth the parameter of the cellular material/the cellularized sheath layer including/having “elevated levels of” 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, this parameter is found to be confusing since it is not clear that the chemicals are “elevated” compared to, i.e. what is the standard/baseline. Thus, one having ordinary skill in the are would not reasonable be apprised of the scope of the invention, thereby rendering the claims 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 presented, hereinafter Shastri, in view of Martin et al. (US Patent No. 4,043,331), as previously presented, hereinafter Martin, Jamiolkowski et al. (US Patent No. 4,889,119), as previously presented, hereinafter Jamiolkowski, Hall et al. (US PG Pub. 2014/0086971), as previously presented, hereinafter Hall, Weitzner et al. (US PG Pub. 2013/0018452), as previously presented, hereinafter Weitzner, and Murphy et al. (US PG Pub. 2013/0190210), hereinafter Murphy.
Regarding claims 19, 22, 23 and 27, Shastri discloses a 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 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 centimeters to 10 centimeters, and wherein the synthetic scaffold is configured to guide esophageal or tracheal growth ([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 synthetic scaffold against a tubular organ, an intermediate layer composed of a braided support material composed of at least one of polyethylene terephthalate, polyurethane, nitinol and mixtures thereof, and elevated levels of VEGF, GM-CSF, IL-1RA, IL-6 and IL-8.
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]). Moreover, 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, Jamiolkowski, Hall, Weitzner 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 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. 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 first and second ends of the synthetic scaffold of Shastri to have/include one or more biodegradable attachments to secure the synthetic 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. Additionally, it would have further been obvious to one having ordinary skill in the art before the effective filing date of the invention for the 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. Moreover, it would also have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the cells, of the synthetic scaffold of Shastri, to be cultured with, and produce, growth factors such that there are elevated levels of VEGF, GM-CSF, IL-1RA, IL-6 and IL-8, as taught by Murphy.
Claims 13, 28, 33, 38 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Shastri in view of Martin and Murphy.
Regarding claims 13 and 28, Shastri discloses a 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 3-10 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] – to clarify, it is stated the polymeric body/conduit can biodegradable and can degrade while remodeling/guided tissue growth on the gastrointestinal organ of a subject occurs; thus the polymeric body is removable without damaging the tubular gastrointestinal organ), wherein the removable gastrointestinal scaffold has an inner diameter between 0.5 and 5cm ([0083], Last 5 Lines); 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 50mm, and the cellular material including VEGF, GM-CSF, IL-1RA, IL-6 and IL-8.
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 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 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 centimeters to 10 centimeters, 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 a 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 -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 elevated levels of vascular endothelial growth factor, granulocyte-macrophage colony-stimulating factor, interleukin-6, interleukin-8, and interleukin-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 there are elevated levels of 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.
Response to Arguments
Applicant’s arguments with respect to independent claims 19, 28 and 41 have been considered but are moot because the arguments do not apply to the current rejections presently used in the Office Action. Specifically, in response to Applicant’s amendment, Examiner now cites the prior art of Murphy, in addition to the prior art of Shastri, Martin, Jamiolkowski, Hall, and Weitzner; rejecting independent claim 19, and those claims that depend from it, as being unpatentable over Shastri in view of Martin, Jamiolkowski Hall, Weitzner, and Murphy, and rejecting independent claims 28 and 41, and those claims that depend from them, as being unpatentable over Shastri in view of Martin and Murphy.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774