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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-37, and Species A5, and B3 in the reply filed on 12/10/2025 is acknowledged. Applicant’s election of species was non-responsive (Applicant neglected to explicitly state what species A5 consisted of), however, in order to expedite prosecution and in the spirit of compact prosecution, the examiner withdraws the requirement for election of species among species groups A, and B and only restriction requirement remains.
Accordingly, the examiner will examine and search Group I, claims 1-37 (and all of the species).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 10, 16-22, 24-25, 29, 31-35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Nigam (U.S. Patent 6,881,197) in view of de Roulhac (U.S. Patent 5,752,928).
Regarding claim 1, Nigam discloses a drainage device for the eye comprising:
a collapsible, i.e., folded (“The diffusion chamber 20 may be doubled over or folded to facilitate insertion through a relatively small incisions and may subsequently be opened or unfolded while in the surgically-created pocket of tissue formed between the conjunctiva CON and sclera SC,” see col. 9:40-47 and figures 1-2, 7a-9, and 11-12, and other alternate/equivalent counterparts in other embodiments) body portion (the collapsible body portion is defined by and within the boundary given by “sealed perimeter flange 24,” col. 6:36-67 and figures 1-2, and other alternate/equivalent counterparts in other embodiments) defining a reservoir (“chamber 20,” see col. 6:27-35 figures 1-2, 7a-9, and 11-12, and other alternate/equivalent counterparts in other embodiments), wherein the collapsible body portion, when collapsed, includes a deformation of the body portion from a first planar state (see figures 1-2, 7a-9, and 11-12) to a second nonplanar state (“The diffusion chamber 20 may be doubled over or folded to facilitate insertion through a relatively small incisions and may subsequently be opened or unfolded while in the surgically-created pocket of tissue formed between the conjunctiva CON and sclera SC,” see col. 9:40-47); and
a conduit (“elongate tube 12,” see col. 6:27-35 and figure 1, and other alternate/equivalent counterparts in other embodiments) having a first end (“proximal end 18,” see col. 6:27-35 and figure 1, and other alternate/equivalent counterparts in other embodiments) fluidly coupled with the reservoir and a second end (“distal end 16,” see col. 6:27-35 and figure 1, and other alternate/equivalent counterparts in other embodiments) insertable into the eye to facilitate a drainage of the biological fluid into the conduit,
wherein in situ the second non planar state is at least one of a folded state (“The diffusion chamber 20 may be doubled over or folded to facilitate insertion through a relatively small incisions and may subsequently be opened or unfolded while in the surgically-created pocket of tissue formed between the conjunctiva CON and sclera SC,” see col. 9:40-47 and figures 1-2, 7a-9, and 11-12, and other alternate/equivalent counterparts in other embodiments), a deformed state, a bent state, or a crumpled state.
Nigam fails to recite wherein the collapsible body portion includes one or more of:
at least one temporary reinforcement element that maintains the collapsible body portion in the first planar state during implantation, or
a retaining portion defined by the collapsible body portion, the retaining portion being sized and positioned to convey a pulling force to the collapsible body portion to maintain the collapsible body portion in the first planar state during implantation.
Like Nigam, de Roulhac discloses a drainage device for the eye and teaches providing the device with retaining portion defined by the collapsible body portion, the retaining portion being sized and positioned to convey a pulling force to the collapsible body portion to maintain the collapsible body portion in the first planar state during implantation (“strengthening rib 24,” see col. 3:66 through col. 4:9 and figures 1-5 – wherein it is disclosed “a strengthening rib 24 within the top surface 26 of the base plate 12. The height of this rib 24 is to be approximately 0.12 millimeters. It is the function of the rib 24 to supply a certain amount of rigidity along the longitudinal center axis of the base plate 12. The rib 24 extends from the front end 28 to a recess defined as a mounting pocket 30 which is formed within the base plate 12 directly adjacent the rear end 32”) in order to provide a known and workable manner of introducing the device into the eye.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Nigam, as taught by de Roulhac, to provide the device with retaining portion defined by the collapsible body portion, the retaining portion being sized and positioned to convey a pulling force to the collapsible body portion to maintain the collapsible body portion in the first planar state during in order to provide a known and workable manner of introducing the device into the eye.
Regarding claim 2, Nigam discloses a drainage device for the eye comprising:
a collapsible, i.e., folded (“The diffusion chamber 20 may be doubled over or folded to facilitate insertion through a relatively small incisions and may subsequently be opened or unfolded while in the surgically-created pocket of tissue formed between the conjunctiva CON and sclera SC,” see col. 9:40-47 and figures 1-2, 7a-9, and 11-12, and other alternate/equivalent counterparts in other embodiments) body portion (the collapsible body portion is defined by and within the boundary given by “sealed perimeter flange 24,” col. 6:36-67 and figures 1-2, and other alternate/equivalent counterparts in other embodiments) defining a reservoir (“chamber 20,” see col. 6:27-35 figures 1-2, 7a-9, and 11-12, and other alternate/equivalent counterparts in other embodiments), wherein the collapsible body portion, when collapsed, includes a deformation of the body portion from a first planar state (see figures 1-2, 7a-9, and 11-12) to a second nonplanar state (“The diffusion chamber 20 may be doubled over or folded to facilitate insertion through a relatively small incisions and may subsequently be opened or unfolded while in the surgically-created pocket of tissue formed between the conjunctiva CON and sclera SC,” see col. 9:40-47); and
a conduit (“elongate tube 12,” see col. 6:27-35 and figure 1, and other alternate/equivalent counterparts in other embodiments) having a first end (“proximal end 18,” see col. 6:27-35 and figure 1, and other alternate/equivalent counterparts in other embodiments) fluidly coupled with the reservoir and a second end (“distal end 16,” see col. 6:27-35 and figure 1, and other alternate/equivalent counterparts in other embodiments) insertable into the eye to facilitate a drainage of the biological fluid into the conduit,
wherein in situ the second non planar state is at least one of a folded state (“The diffusion chamber 20 may be doubled over or folded to facilitate insertion through a relatively small incisions and may subsequently be opened or unfolded while in the surgically-created pocket of tissue formed between the conjunctiva CON and sclera SC,” see col. 9:40-47 and figures 1-2, 7a-9, and 11-12, and other alternate/equivalent counterparts in other embodiments), a deformed state, a bent state, or a crumpled state.
Nigam fails to recite during implantation the collapsible body portion includes at least one temporary reinforcement element that maintains the collapsible body portion in the first planar state.
Like Nigam, de Roulhac discloses a drainage device for the eye and teaches providing the device with reinforcement element that maintains the collapsible body portion in the first planar state (“strengthening rib 24,” see col. 3:66 through col. 4:9 and figures 1-5 – wherein it is disclosed “a strengthening rib 24 within the top surface 26 of the base plate 12. The height of this rib 24 is to be approximately 0.12 millimeters. It is the function of the rib 24 to supply a certain amount of rigidity along the longitudinal center axis of the base plate 12. The rib 24 extends from the front end 28 to a recess defined as a mounting pocket 30 which is formed within the base plate 12 directly adjacent the rear end 32”) in order to provide a known and workable manner of introducing the device into the eye.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Nigam, as taught by de Roulhac, to provide the device with reinforcement element that maintains the collapsible body portion in the first planar state in order to provide a known and workable manner of introducing the device into the eye.
With respect to the reinforcement element being a temporary reinforcement element, the combination meets this further limitation which the examiner interprets as a recitation of intended use or functional limitation since the combination device can be removed from the eye.
Applicant may wish to further limit the claimed invention in order to overcome this interpretation.
Regarding claim 10, Nigam fails to recite the collapsible body portion is made of a
microporous material.
Like Nigam, de Roulhac discloses a drainage device for the eye and teaches providing the body of the device with microporous material (“The porous block 22 can be constructed of plastic which includes a mass of tiny holes such as is defined within U.S. Pat. No. 5,073,163. Also, the block 22 can be constructed of a molded, open cell, high density, polymer with a nominal porosity of approximately eleven microns,” see col. 3:34-65 and figures 1-5) in order to maintain “a desired level of pressure within the anterior chamber with approximately fifteen millimeters of mercury or lower as preferred by the physician.”
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Nigam, as taught by de Roulhac, to provide the body of the device with microporous material in order to maintain “a desired level of pressure within the anterior chamber with approximately fifteen millimeters of mercury or lower as preferred by the physician.”
Regarding claim 16, Nigam discloses the claimed invention including the collapsible body portion includes a material that is sufficiently flexible to deform in response to a directional force being applied to the body portion during implantation of the drainage device (“The diffusion chamber 20 may be doubled over or folded to facilitate insertion through a relatively small incisions and may subsequently be opened or unfolded while in the surgically-created pocket of tissue formed between the conjunctiva CON and sclera SC,” see col. 9:40-47). Here the force is simply the force used to unfold the device.
Regarding claim 17, Nigam discloses the claimed invention including the collapsible body portion deforms in response to an external frictional force caused by the tissue of the eye when applying the directional force to the body portion during implantation of the drainage device (again see, (“The diffusion chamber 20 may be doubled over or folded to facilitate insertion through a relatively small incisions and may subsequently be opened or unfolded while in the surgically-created pocket of tissue formed between the conjunctiva CON and sclera SC,” see col. 9:40-47). Claims 17 recites a recitation of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed. A recitation of intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. However, if a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. It is well established that a recitation with respect to the manner in which an apparatus is intended to be employed, i.e., a functional limitation, does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963). Where the prior art reference is inherently capable of performing the function described in a functional limitation, such functional limitation does not define the claimed apparatus over such prior art reference, regardless of whether the prior art reference explicitly discusses such capacity for performing the recited function. In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971). In addition, where there is reason to believe that such functional limitation may be an inherent characteristic of the prior art reference, Applicant is required to prove that the subject matter shown in the prior art reference does not possess the characteristic relied upon. In re Spada, 911 F.2d 705, 15 USPQ2d 1655 (Fed. Cir. 1990); In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 138 (Fed. Cir. 1986); In re Ludtke, 441 F.2d at 664, 169 USPQ at 566 (CCPA 1971). A recitation with respect to the manner in which an apparatus is intended to be employed does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Yanush, 477 F.2d 958, 177 USPQ 705 (CCPA 1973); In re Finsterwalder, 436 F.2d 1028, 168 USPQ 530 (CCPA 1971); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963); Ex parte Masham, 2 USPQ2d 1647 (BdPatApp & Inter 1987).
Regarding claims 18 and 19, Nigam discloses the claimed invention including the collapsible body portion has a first length in an uncollapsed state in absence of an external force (length of W1 in figure 11), a second length less than the first length in a collapsed state when the external force is applied (length of half of W2 in figure 11), and a third length greater (length of half of W3 in figure 11) than the second length and less than the first length in a resting state after the external force is removed, wherein the third length is no greater than approximately 90% of the first length (see figure 11).
Regarding claim 20, Nigam discloses the claimed invention including the collapsible body portion is formed by at least partially adhering (“The upper and lower membrane walls 22a, 22b are sealed to one another at their edges to form a sealed perimeter flange 24,” see col. 6:59-67 and figure 2) a periphery of a first body layer (“upper membrane wall 22a,” see col. 6:59-67 and figure 2) to a periphery of a second body layer (“lower membrane wall 22b,” see col. 6:59-67 and figure 2).
Regarding claim 21, Nigam discloses the claimed invention including the collapsible body portion comprising at least one suture hole – more specifically at least one hole (any one of the holes 34 and 36 in figure 1) configured to receive a suture to facilitate attaching the drainage device to the tissue of the eye.
Regarding claim 22, Nigam discloses the claimed invention including the collapsible body portion further comprising at least one marker to mark a position of the conduit along the body portion (any one of the holes 34 and 36 in figure 1 serve as markers).
Regarding claim 24, Nigam discloses the claimed invention including the collapsible body portion has a thickness of no greater than about 0.5 mm around the reservoir when the reservoir is empty (see col. 9:21-29, figure 2 and the distal tip of the deformable body portion in figure 2).
Regarding claim 25, Nigam discloses a drainage device for the eye comprising:
a collapsible, i.e., folded (“The diffusion chamber 20 may be doubled over or folded to facilitate insertion through a relatively small incisions and may subsequently be opened or unfolded while in the surgically-created pocket of tissue formed between the conjunctiva CON and sclera SC,” see col. 9:40-47 and figures 1-2, 7a-9, and 11-12, and other alternate/equivalent counterparts in other embodiments) body portion (the collapsible body portion is defined by and within the boundary given by “sealed perimeter flange 24,” col. 6:36-67 and figures 1-2, and other alternate/equivalent counterparts in other embodiments) defining a reservoir (“chamber 20,” see col. 6:27-35 figures 1-2, 7a-9, and 11-12, and other alternate/equivalent counterparts in other embodiments), wherein the collapsible body portion, when collapsed, includes a deformation of the body portion from a first planar state (see figures 1-2, 7a-9, and 11-12) to a second nonplanar state (“The diffusion chamber 20 may be doubled over or folded to facilitate insertion through a relatively small incisions and may subsequently be opened or unfolded while in the surgically-created pocket of tissue formed between the conjunctiva CON and sclera SC,” see col. 9:40-47); and
a conduit (“elongate tube 12,” see col. 6:27-35 and figure 1, and other alternate/equivalent counterparts in other embodiments) having a first end (“proximal end 18,” see col. 6:27-35 and figure 1, and other alternate/equivalent counterparts in other embodiments) fluidly coupled with the reservoir and a second end (“distal end 16,” see col. 6:27-35 and figure 1, and other alternate/equivalent counterparts in other embodiments) insertable into the eye to facilitate a drainage of the biological fluid into the conduit,
wherein in situ the second non planar state is at least one of a folded state (“The diffusion chamber 20 may be doubled over or folded to facilitate insertion through a relatively small incisions and may subsequently be opened or unfolded while in the surgically-created pocket of tissue formed between the conjunctiva CON and sclera SC,” see col. 9:40-47 and figures 1-2, 7a-9, and 11-12, and other alternate/equivalent counterparts in other embodiments), a deformed state, a bent state, or a crumpled state.
Nigam fails to recite wherein the collapsible body portion includes a retaining portion is sized and positioned to convey a pulling force to the collapsible body portion to maintain the collapsible body portion in the first planar state during implantation.
Like Nigam, de Roulhac discloses a drainage device for the eye and teaches providing the device with retaining portion defined by the collapsible body portion, the retaining portion being sized and positioned to convey a pulling force to the collapsible body portion to maintain the collapsible body portion in the first planar state during implantation (“strengthening rib 24,” see col. 3:66 through col. 4:9 and figures 1-5 – wherein it is disclosed “a strengthening rib 24 within the top surface 26 of the base plate 12. The height of this rib 24 is to be approximately 0.12 millimeters. It is the function of the rib 24 to supply a certain amount of rigidity along the longitudinal center axis of the base plate 12. The rib 24 extends from the front end 28 to a recess defined as a mounting pocket 30 which is formed within the base plate 12 directly adjacent the rear end 32”) in order to provide a known and workable manner of introducing the device into the eye.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Nigam, as taught by de Roulhac, to provide the device with retaining portion defined by the collapsible body portion, the retaining portion being sized and positioned to convey a pulling force to the collapsible body portion to maintain the collapsible body portion in the first planar state during in order to provide a known and workable manner of introducing the device into the eye.
Regarding claims 29, Nigam discloses the claimed invention including the collapsible body portion includes a material that is sufficiently flexible to deform in response to a directional force being applied to the body portion during implantation of the drainage device (“The diffusion chamber 20 may be doubled over or folded to facilitate insertion through a relatively small incisions and may subsequently be opened or unfolded while in the surgically-created pocket of tissue formed between the conjunctiva CON and sclera SC,” see col. 9:40-47). Here the force is simply the force used to unfold the device.
Regarding claims 31 and 32, Nigam discloses the claimed invention including the collapsible body portion has a first length in an uncollapsed state in absence of an external force (length of W1 in figure 11), a second length less than the first length in a collapsed state when the external force is applied (length of half of W2 in figure 11), and a third length greater (length of half of W3 in figure 11) than the second length and less than the first length in a resting state after the external force is removed, wherein the third length is no greater than approximately 90% of the first length (see figure 11).
Regarding claim 33, Nigam discloses the claimed invention including the collapsible body portion is formed by at least partially adhering (“The upper and lower membrane walls 22a, 22b are sealed to one another at their edges to form a sealed perimeter flange 24,” see col. 6:59-67 and figure 2) a periphery of a first body layer (“upper membrane wall 22a,” see col. 6:59-67 and figure 2) to a periphery of a second body layer (“lower membrane wall 22b,” see col. 6:59-67 and figure 2).
Regarding claim 34, Nigam discloses the claimed invention including the collapsible body portion further comprising at least one marker to mark a position of the conduit along the body portion (any one of the holes 34 and 36 in figure 1 serve as markers).
Regarding claim 35, Nigam discloses the claimed invention including the collapsible body portion has a thickness of no greater than about 0.5 mm around the reservoir when the reservoir is empty (see col. 9:21-29, figure 2 and the distal tip of the deformable body portion in figure 2).
Regarding claim 37, Nigam discloses the claimed invention including the collapsible body portion has a thickness of no greater than about 0.5 mm around the reservoir when the reservoir is empty (see col. 9:21-29, figure 2 and the distal tip of the deformable body portion in figure 2).
Claims 15, 28, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Nigam (U.S. Patent 6,881,197) in view of de Roulhac (U.S. Patent 5,752,928) as applied to claims 2 and 25 above, and further in view of Baerveldt (U.S. Patent Application Publication 2017/0020731).
Regarding claims 15 and 28, Nigam fails to disclose the first planar state is defined by a
curved plane corresponding to a curvature of the eye.
Like both Nigam and de Roulhac, Baerveldt discloses a drainage device for the eye and teaches providing the first planar state defined by a curved plane corresponding to a curvature of the eye (see figures 1, 3A-3B) in order to provide a known and workable shape so that the body may be placed comfortably against the eye.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Nigam and de Roulhac, as taught by Baerveldt, to provide the first planar state defined by a curved plane corresponding to a curvature of the eye in order to provide a known and workable shape so that the body may be placed comfortably against the eye.
Regarding claim 30, Nigam discloses the claimed invention including the collapsible body portion deforms in response to an external frictional force caused by the tissue of the eye when applying the directional force to the body portion during implantation of the drainage device (again see, (“The diffusion chamber 20 may be doubled over or folded to facilitate insertion through a relatively small incisions and may subsequently be opened or unfolded while in the surgically-created pocket of tissue formed between the conjunctiva CON and sclera SC,” see col. 9:40-47). Claims 17 recites a recitation of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed. A recitation of intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. However, if a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. It is well established that a recitation with respect to the manner in which an apparatus is intended to be employed, i.e., a functional limitation, does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963). Where the prior art reference is inherently capable of performing the function described in a functional limitation, such functional limitation does not define the claimed apparatus over such prior art reference, regardless of whether the prior art reference explicitly discusses such capacity for performing the recited function. In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971). In addition, where there is reason to believe that such functional limitation may be an inherent characteristic of the prior art reference, Applicant is required to prove that the subject matter shown in the prior art reference does not possess the characteristic relied upon. In re Spada, 911 F.2d 705, 15 USPQ2d 1655 (Fed. Cir. 1990); In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 138 (Fed. Cir. 1986); In re Ludtke, 441 F.2d at 664, 169 USPQ at 566 (CCPA 1971). A recitation with respect to the manner in which an apparatus is intended to be employed does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Yanush, 477 F.2d 958, 177 USPQ 705 (CCPA 1973); In re Finsterwalder, 436 F.2d 1028, 168 USPQ 530 (CCPA 1971); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963); Ex parte Masham, 2 USPQ2d 1647 (BdPatApp & Inter 1987).
Allowable Subject Matter
Claims 3-9, 11-14, 23, 26-27, and 36 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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/AARON F ROANE/Primary Examiner, Art Unit 3792