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 .
Election/Restrictions
Applicant’s election without traverse of Group II drawn to a medical implant in the reply filed on 17 April 2026 is acknowledged.
Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 17 April 2026.
Claims 15-35 are examined on the merits herein.
Claim Rejections - 35 USC § 112(a)
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 29, 31, and 35 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention. The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Minerals Separation Ltd. v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? The factors to be considered when determining whether any necessary experimentation is undue have been set forth by the courts in the Wands factors (see MPEP 2164.01(a)) and In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
These factors are:
(1) the breadth of the claims; (2) the nature of the invention; (3) the state of the prior art; (4) the level of one of ordinary skill; (5) the level of predictability in the art; (6) the amount of direction provided by the inventor; (7) the existence of working examples; and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Regarding claim 29
(1) Breadth of the claims:
Claim 29 is drawn to medical implants comprising a stack of polymer fiber mats and a crosslinked hydrogel, wherein each of the polymer mats has the specific property of a compressive modulus in a range of 2 to 4 MPa.
(2) Nature of the invention; (3) State of the prior art: and (5) Level of predictability in the art:
It is evidenced by the instant specification that the polymer fiber mats of the instant invention have a compressive modulus of 0.13 MPa (Par. [0108]). It is further evidenced by Visser et al. (Nature Communications, 2015, Vol. 6, 6933 cited on Applicant’s IDS filed 17 August 2023) that electrospun PCL fiber scaffolds have a compressive modulus in the range of 1.1kPa to 15.2kPa (Pg. 3 left column last paragraph, Fig. 2a). Shim et al. (J Biomed Mat Res A, 2007, Vol. 84A, 247-255) teach an electrospun PLGA fibrous mats having a compressive modulus of about 150 kPa and PLGA/chitosan composite fibrous mats having a compressive modulus of about 390 kPa, as calculated by examiner based on the data presented in Fig. 6. Additionally, Varga et al. (Applied Physics Letters, 2013, Vol. 102, 153903) teach electrospun PLA mats having a compressive modulus of between 10 and 100 kPa (Abstract).
Based on the data disclosed in the instant specification and the prior art, there is a reasonable level of predictability in the art with values for the compressive modulus of electrospun polymer fiber mats in the range of 1.1 kPa to 390 kPa.
(4) Level of one of ordinary skill:
The level of skill to practice the art of the instantly claimed invention is high and requires a variety of skills usually found in institutions and companies that employ highly trained and skilled scientists to carry out these tasks.
(6) Amount of direction provided by the inventor; (7) Existence of working examples:
The inventor has indicated that the electrospinning solvent has an effect on the compressive modulus (Fig. 3G) but has not provided any direction as to how parameters such as the chemical composition of the polymer, fiber diameter, or crosslinking of the fibers would affect the compressive modulus. Further, there are no working examples of bare polymer fiber mats having a compressive modulus in a range of 2 to 4 MPa.
(8) Quantity of experimentation needed to make the invention:
Based on the level of predictability in the art indicating that values for the compressive modulus of electrospun polymer fiber mats fall in the range of 1.1 kPa to 390 kPa; the lack of working examples; and the 1-3 orders of magnitude difference between the values of the prior art and the instantly claimed values, a prohibitively large number of experiments would be required to determine how to make the invention of instant claim 29.
As such, claim 29 is rejected as being non-enabled.
Regarding claims 31 and 35
(1) Breadth of the claims:
Claims 31 and 35 are drawn to medical implants having the very specific properties of BSA permeability of the polymer fiber mats of 5 to 20 cm2/s and glucose diffusion of the entire implant in a range of 2 to 4 cm2/s.
(2) Nature of the invention; (3) State of the prior art: and (5) Level of predictability in the art:
It is evidenced by the instant specification that the polymer fiber mats of the instant invention have a BSA permeability in a range of 7.21x10-6 cm2/s to 1.74x10-5 cm2/s (Par. [0107]) and the PCL/hydrogel implant has a glucose diffusion of 2.82x10-6 cm2/s (Par. 0113]).
It is further evidenced by Zhao et al. (ACS Appl Polym Mater, 12 March 2021, Vol. 3, 1618-1627) that polyacrylonitrile nanofiber membranes (Abstract) formed by electrospinning (Sec. 2.2 on pg. 1619) have a PBS permeability of 5.9x10-7 cm2/s (Table 2 on pg. 1624). Additionally, as evidenced by Figueiredo et al. (J Tissue Eng Regen Med, 2018, Vol. 12, 1238-1246), molecules such as glucose have a diffusion in polymer hydrogels typically around 10-10 m2/s (Pg. 1244 left column last paragraph), corresponding to 10-6 cm2/s. Further, as evidenced by Sharifi et al., (Bioactive Materials, 17 April 2021, Vol. 6, 3947-3961 cited on Applicant’s IDS filed 17 August 2023) glucose diffusion in G-GMA hydrogels is in the range of 2.59x10-6 cm2/s to 5.32x10-6 cm2/s for differing degrees of crosslinking (SI Table 2).
Based on the values disclosed in the instant specification and the prior art, there is a relatively high level of predictability in the art, with values of BSA permeability falling in the range of 10-7 to 10-5 cm2/s and values of glucose diffusion of approximately 10-6 cm2/s.
(4) Level of one of ordinary skill:
The level of skill to practice the art of the instantly claimed invention is high and requires a variety of skills usually found in institutions and companies that employ highly trained and skilled scientists to carry out these tasks.
(6) Amount of direction provided by the inventor; (7) Existence of working examples:
The inventor has indicated that the electrospinning solvent and pore size distribution has an effect on the BSA permeability (Par. [0107]) and that the glucose diffusion depends on the concentration of the G-GMA in the hydrogel and the presence of the polymer fibers (Fig. 5C, Par. [0113]). There are no working examples of medical implants that display BSA permeability or glucose diffusion within the instantly claimed ranges.
(8) Quantity of experimentation needed to make the invention:
Based on the high level of predictability in the art, indicating that values of BSA permeability fall in the range of 10-7 to 10-5 cm2/s and values of glucose diffusion of are approximately 10-6 cm2/s, the lack of working examples, and the orders of magnitude difference between the values of the prior art and the instantly claimed values, a prohibitively large number of experiments would be required to determine how to make the invention of instant claims 31 and 35.
As such, claims 31 and 35 are rejected as being non-enabled.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 15 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kong et al. (Nature Communications, 2020, 11, 1435).
Claim 15 is drawn to a medical implant comprising:
a polymer fiber stack comprising electrospun polymeric fibers; and
a crosslinked hydrogel matrix,
wherein the polymer fiber stack is embedded within the crosslinked hydrogel matrix.
Claim 17 is drawn to the medical implant of claim 15, wherein the electrospun polymeric fibers comprise electrospun PCL polymer fibers.
Claim 19 is drawn to the medical implant of claim 15 wherein the hydrogel matrix includes a polypeptide biopolymer.
Claim 20 is drawn to the medical implant of claim 15, wherein the hydrogel matrix includes one of gelatin and its derivatives.
Kong et al. teach fiber reinforced GelMA (i.e., gelatin methacrylate) hydrogels for repair of the corneal stroma (Title). Kong et al. further teach an electrospun PCL fiber structure (Pg. 2-3 bridging paragraph) wherein the electrospun fibers are embedded within GelMA hydrogel matrix (Supplementary Figure 1). Kong et al. also teach the GelMA hydrogel being prepared by a method including the step of exposing the GelMA to 365 nm light in the presence of the photoinitiator LAP (“Preparation of GelMA hydrogel and fiber hydrogel construct” on pg. 9), indicating that the hydrogel is crosslinked. While Kong et al. do not explicitly teach a polymer fiber stack, Kong et al. do teach the fiber structure having a height of 100 µm (pg. 9 right column first paragraph) and the fibers having an average diameter of 5 µm (Pg. 3 right column first paragraph), indicating that the structure comprises fibers stacked on each other.
As such, claims 15, 17, and 19-20 are anticipated.
Claim 18 is drawn to the medical implant of claim 15, wherein the electrospun polymeric fibers include fibers of varying orientations.
Kong et al. further teach the fibers being arranged in an orthogonal grid having fibers in multiple directions (Pg. 9 left column first paragraph).
As such, claim 18 is anticipated.
Claims 15-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coburn et al. (Smart Struct Syst., 2011, Vol. 7, 213-222 cited on Applicant’s IDS filed 17 August 2023).
Claim 15 is drawn to a medical implant comprising:
a polymer fiber stack comprising electrospun polymeric fibers; and
a crosslinked hydrogel matrix,
wherein the polymer fiber stack is embedded within the crosslinked hydrogel matrix.
Claim 16 is drawn to the medical implant of claim 15, wherein the polymer fiber stack comprises a stack of a plurality of polymer mats, each polymer mat comprising the electrospun polymeric fibers.
Claim 17 is drawn to the medical implant of claim 15, wherein the electrospun polymeric fibers comprise electrospun PCL polymer fibers.
Claim 18 is drawn to the medical implant of claim 15, wherein the electrospun polymeric fibers include fibers of varying orientations.
Coburn et al. teach biomimetic scaffolds comprising a fiber-hydrogel composite material (Abstract), wherein the fibers comprise electrospun PCL (Pg. 2 second paragraph); further teaching the polymer fiber stack comprising a stack of a plurality of polymer mats, being embedded within the crosslinked hydrogel matrix, and including fibers of varying orientations (Fig. 1c on pg. 8). Coburn et al. further teach the hydrogel comprising UV crosslinked PEGDA (Pg. 2 fourth paragraph).
As such, claims 15-18 are anticipated.
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 15-21 and 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Sharifi et al. (Bioactive Materials, 17 April 2021, Vol. 6, 3947-3961 cited on Applicant’s IDS filed 17 August 2023) in view of Coburn et al. (Smart Struct Syst., 2011, Vol. 7, 213-222 cited on Applicant’s IDS filed 17 August 2023).
Claim 15 is drawn to a medical implant comprising:
a polymer fiber stack comprising electrospun polymeric fibers; and
a crosslinked hydrogel matrix,
wherein the polymer fiber stack is embedded within the crosslinked hydrogel matrix.
Claim 16 is drawn to the medical implant of claim 15, wherein the polymer fiber stack comprises a stack of a plurality of polymer mats, each polymer mat comprising the electrospun polymeric fibers.
Claim 17 is drawn to the medical implant of claim 15, wherein the electrospun polymeric fibers comprise electrospun PCL polymer fibers.
Claim 18 is drawn to the medical implant of claim 15, wherein the electrospun polymeric fibers include fibers of varying orientations.
Claim 19 is drawn to the medical implant of claim 15 wherein the hydrogel matrix includes a polypeptide biopolymer.
Claim 20 is drawn to the medical implant of claim 15, wherein the hydrogel matrix includes one of gelatin and its derivatives.
Claim 21 is drawn to the medical implant of claim 15, wherein the hydrogel matrix includes gelatin glycidyl methacrylate (G-GMA).
Sharifi et al. teach gelatin-based hydrogels for ocular tissue engineering (Title), wherein the hydrogel scaffolds comprise G-GMA (Section 2.2 on pg. 3949) that has been crosslinked (Section 2.4 on pg. 3949), further teaching the scaffold being implanted in the cornea (Fig. 7 on pg. 3959), reading on a medical implant.
Sharifi et al. do not teach a polymer fiber stack.
However, Coburn et al. teach many biomaterial scaffolds falling short of being biomimetic with respect to mimicking the architecture of the extracellular matrix (Introduction on pg. 1) which comprises a fibrous network and a hydrogel substance (Abstract). Coburn et al. further teach the inclusion of both fiber structures and hydrogels leads to scaffolds having significantly greater mechanical properties and inducing enhanced biological responses (Conclusions on pg. 5). Coburn et al. teach the use of electrospun PCL mats (Fiber synthesis on pg. 2) that are stacked and embedded within the hydrogel matrix and have fibers of varying orientation (Fig. 1c on pg. 8).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical implant of Sharifi et al. by including a stack of electrospun PCL mats as taught by Coburn et al. It would have been obvious to combine the known G-GMA hydrogel scaffold with the known use of PCL mats in a hydrogel scaffold to yield the predictable result of a scaffold with improved mechanical properties that induces enhanced biological response, with a reasonable expectation of success.
Based on all of the foregoing, claims 15-21 are rejected as prima facie obvious.
Claim 32 is drawn to the medical implant of claim 16, wherein an adhesion strength between each polymer fiber mat embedded in crosslinked hydrogel matrix is in a range of 0.2 to 0.7 MPa.
Sharifi et al. do not teach the adhesion strength between each polymer fiber mat.
However, Sharifi et al. teach increasing the crosslinking time of the G-GMA improving the adhesion strength of G-GMA, further teaching the adhesion strength as being related to the efficacy in laceration closure and facilitating sutureless grafting (Sec. 3.6 on pg. 3957).
As taught by Coburn et al., the adhesiveness of the hydrogel portion of the implant can be tailored for ease in clinical application (Pg. 4 first paragraph).
And, as discussed by MPEP 2144.05, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
In the instant case, the adhesive strength is clearly a result-effective variable, determining the efficacy of the implant as well as the ease of clinical use. Accordingly, it would have been customary for an artisan of ordinary skill in the art to determine the optimal adhesive strength in order to best achieve the desired results.
As such, claim 32 is rejected as prima facie obvious.
Claim 33 is drawn to the medical implant of claim 15, wherein the implant has a burst pressure in a range of 75 to 275 kPa.
Sharifi et al. further teach burst pressure as being dependent on the crosslinking time of the hydrogel and burst pressure values ranging up to about 700 mmHg (Fig. 6b), corresponding to 93.3 kPa as calculated by examiner, overlapping with the instantly claimed range.
As such, claim 33 is rejected as prima facie obvious.
Claim 34 is drawn to the medical implant of claim 15, wherein the implant has a suture rupture force in a range of 3 to 6 N.
Sharifi et al. further teach in Fig. 7c the adhesion strength of the hydrogel in a range of about 1.75 N/cm2 to 5 N/cm2 and the experimental setup utilizing portions of hydrogel having an area of 1cm2 (Sec. 2.13 on pgs. 3951-3952), corresponding to a suture rupture force of 1.75 N to 5 N as calculated by examiner, overlapping with the instantly claimed range.
As such, claim 34 is rejected as prima facie obvious.
Claims 22-26, 28, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Sharifi et al. and Coburn et al. as applied to claims 15-21 and 32-34 above, and further in view of Bakhshandeh et al. (Int J Nanomed, 2011, Vol. 6, 1509-1515 cited on Applicant’s IDS filed 17 August 2023).
The teachings of Sharifi et al. and Coburn et al. have been set forth above.
Claim 22 is drawn to the medical implant of claim 15, wherein the polymer fiber stack includes an opening and an additional crosslinked hydrogel matrix positioned in the opening.
Claim 25 is drawn to the medical implant of claim 22, wherein the additional crosslinked hydrogel matrix is transparent.
Sharifi et al. and Coburn et al. do not teach the polymer fiber stack including an opening.
Bakhshandeh et al. also teach cornea implants comprising a PCL fiber structure and a hydrogel (Abstract), wherein the hydrogel is cross-linked (Pg. 1510 right column fourth paragraph), further teaching that the central part of the implant should be transparent (Pg. 1510 left column second paragraph) in order to facilitate sufficient light transmittance to enable vision (Pg. 1513 right column second paragraph).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical implant of Sharifi et al. and Coburn et al. to include an opening in the polymer fiber stack and an additional crosslinked hydrogel matrix positioned in the opening. It would have been obvious to combine the known medical implant suitable for use in the eye with the known structure of an artificial cornea to yield the predictable result of a corneal implant that appropriately facilitates light transmittance, with a reasonable expectation of success.
As such, claims 22 and 25 are rejected as prima facie obvious.
Claim 23 is drawn to the medical implant of claim 22, wherein the additional crosslinked hydrogel matrix includes one of gelatin and its derivatives.
Claim 24 is drawn to the implant of claim 22, wherein the additional crosslinked hydrogel matrix included G-GMA.
Sharifi et al. further teach G-GMA having a similar transparency to the human cornea (Pg. 3955 right column first paragraph).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the additional crosslinked hydrogel matrix to comprise G-GMA. It would have been obvious to substitute one transparent crosslinked hydrogel suitable for use in corneal implants for another to obtain the predictable result of a corneal implant with suitable light transmittance, with a reasonable expectation of success.
As such, claims 23-24 are rejected as prima facie obvious.
Claim 26 is drawn to the medical implant of claim 22, wherein the crosslinked hydrogel matrix, the opening, and the additional crosslinked hydrogel matrix are each dimensioned such that the implant is a corneal implant.
Sharifi et al., Coburn et al. and Bakhshandeh et al. do not explicitly teach the size of the hydrogel matrix, opening, and additional hydrogel matrix. However, as Sharifi et al. and Bakhshandeh et al. both teach corneal implants (Sharifi et al. Fig. 7; Bakhshandeh et al. Title, Abstract), it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have made the hydrogel matrix, opening, and additional hydrogel matrix to be appropriately sized such that the implant could be used as a corneal implant.
As such, claim 26 is rejected as prima facie obvious.
Claim 28 is drawn to the medical implant of claim 16, wherein each polymer mat has a tensile modulus in a range of 2.5 to 5.5 MPa.
Bakhshandeh et al. further teach that the tensile modulus is Young’s modulus (Pg. 1513 right column first paragraph and Table 1 on pg. 1512), further teaching the native cornea having a Young’s modulus between 0.3 to 7 MPa (Pg. 1513 right column first paragraph), overlapping with the instantly claimed range.
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical implant of Sharifi et al., Coburn et al. and Bakhshandeh et al. to have a tensile modulus between 0.3 and 7 MPa as taught by Bakhshandeh et al. It would have been obvious to combine the known corneal implant with the known tensile modulus of the cornea to yield the predictable result of a corneal implant with compatible properties to the cornea, with a reasonable expectation of success.
As such, claim 28 is rejected as prima facie obvious.
Claim 30 is drawn to the medical implant of claim 16, wherein each polymer mat has a contact angle in a range of 130° to 135°.
Bakhshandeh et al. teach the water contact angle as being an indicator of the hydrophilicity of the PCL scaffold, further teaching a water contact angle of 131.5° for the PCL fiber scaffold (“Contact angle measurement” on pg. 1512).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical implant of Sharifi et al., Coburn et al. and Bakhshandeh et al. to comprise PCL having a water contact angle of 131.5°. It would have been obvious to combine the known medical implant with the known hydrophilicity of PCL suitable for use in a medical implant to yield the predictable result of a medical implant with suitable hydrophilicity, with a reasonable expectation of success.
As such, claim 30 is rejected as prima facie obvious.
Claims 27 is rejected under 35 U.S.C. 103 as being unpatentable over Sharifi et al. and Coburn et al. as applied to claims 15-21 and 32-34 above, and further in view of Formisano et al. (Adv Health Mat, 2021, Vol. 10, 2100972).
The teachings of Sharifi et al. and Coburn et al. have been set forth above.
Claim 27 is drawn to the medical implant of claim 16, wherein each polymer mat has an ultimate tensile strength in a range of 2.5 to 5.5 MPa.
Sharifi et al. and Coburn et al. do not teach the ultimate tensile strength of the polymer mats.
Sharifi et al. teach the ultimate tensile strength of the hydrogel as being dependent on the degree of functionalization of the G-GMA, the crosslinking time, and the concentration of G-GMA in the hydrogel (Fig. 2c, g, and k).
However, Formisano et al. teach mechanical properties of bioengineered corneal implants (Title, abstract) and the importance of providing adequate mechanical properties in implants to improve the success rate of the implants (Pg. 1 right column last paragraph). Formisano et al. further teach the ultimate tensile strength of the cornea being about 3.8 MPa (Pg. 4 right column second paragraph).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical implant of Sharifi et al. and Coburn et al. to have an ultimate tensile strength of about 3.8 MPa as taught by Formisano et al. It would have been obvious to combine the known corneal implant with the known ultimate tensile strength of the cornea to yield the predictable result of a corneal implant with compatible properties to the cornea, with a reasonable expectation of success.
As such, claim 27 is rejected as prima facie obvious.
Conclusion
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/PAUL HOERNER/Examiner, Art Unit 1611
/CRAIG D RICCI/Primary Examiner, Art Unit 1611