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 .
Claims Status
Amendment of claims 1-9, 11-15, 17, 22, 25, 27, 29, 31, 32, 34-39, 41 and 42 and cancellation of claims 10, 26 and 43 on 03 August 2022, are acknowledged. Claims 1-9, 11-25, and 27-42 are pending and under current examination in this application.
Claim Objections
Claims 1, 3-5 and 17-19 are objected to because of the following informalities:
Claim 1 recites “non-iconic” surfactants, which has been considered an typographical error for “non-ionic”, and should be corrected.
Claims 3-5 and 17-19 and the specification recite “poly(ethyleneglycol)”, which is missing a space and should be corrected to read “poly(ethylene glycol)”.
Claim Rejections - 35 USC § 112(b)
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 Applicant regards as his invention.
Claims 2-9, 11-14, 17, and 40-42 and therefore, additional dependent claims 18-21 (dependent on claim 17), 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, regards as the invention.
Dependent claims 2-9, 11-14, 17, and 40-42, are indefinite because of the improper use the indefinite article, “A”, implying any system/method/composition, instead the definite article, "The", referring back to the specific system/method/composition in the parent claim, thus creating ambiguity about whether the claim covers any system/method/composition or the specific system/method/composition in the parent claim (see MPEP § 706.03(d), In re Skvorecz (Fed. Cir. 2009), and Ex parte Porter (PTAB 2012)). Appropriate correction is required.
Claim 42 is indefinite because it is a “use” claim and as such, the scope cannot be determined.
Claim Rejections - 35 USC § 101
35 U.S.C. § 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 42 is rejected under 35 U.S.C. § 101 because the claimed invention is not directed to a statutory category of patent-eligible subject matter.
Claim 42, does not claim a process, machine, manufacture, or composition of matter, and thus is not a statutory patentable invention. The “use” claim merely recites a purpose without an actionable method or tangible steps (see Ex parte Mewherter (PTAB 2012)).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claims 1, 2, 8, 11-16, 22, 23, 27-31, and 39-41 are rejected under 35 U.S.C. § 103 as being unpatentable over Gedo (US20200121616A1; publication date 23 April 2020).
Claim 15 is rejected based on the rejection of claims 16 and 27-31, in which they depend, and claim 22 is rejected based on the rejection of claim 23, in which it depends.
Gedo teaches compositions and methods of making compositions comprising a combination of cannabidiol (CBD), hyaluronic acid, amphoteric surfactant (phospholipid), and optionally a carrier and methods for their preparation wherein, “In some embodiments the CBD is prepared from a cannabis extract.” (paragraph [0032]) which could include sativa, indica or hybrid strains, “In one embodiment, a composition as described herein further comprises at least two compounds selected from the group comprising: cannabichromene (CBC), cannabigerol (CBG), cannabinol (CBN), or any combination thereof.” (paragraph [0075]), and “In some embodiments, the concentration of CBD in the formulation is between 10 and 100 mg/ml.” (paragraph [0063]).
Additionally, “In some embodiments, the concentration of the hyaluronic acid in the formulation is between 1 mg/ml and 5 mg/ml.” (paragraph [0065]), wherein “The term “hyaluronic acid or salt thereof” is used interchangeably with “hyaluronan”, “hyaluronic acid”, “hyaluronate”, or “HA”.” (paragraph [0035]) wherein, “In some embodiments, the hyaluronic acid is sodium hyaluronate or potassium hyaluronate.” (paragraph [0069]), and “In some embodiments, the hyaluronic acid is crosslinked. Crosslinking may be carried out by any acceptable method, such as attaching thiol groups, methacrylates, hexadecylamides, or tyramine groups; or directly with formaldehyde (Hylan-A), or with divinylsulfone (trade name: Hylan-B). Hyaluronic acid can be cross-linked via various functional groups, e.g., via the acetyl group (NHCOCH3) after deacetylation, via the carboxylic acid group, or via one of the hydroxyl groups. Hyaluronic acid can be cross-linked with glutaraldehyde via hemiacetal formation.” (paragraph [0039]), and “Accordingly, in some embodiments, the molecular weight of the hyaluronic acid is above about 5×105 dalton, e.g. between about 5×105 dalton and about 107dalton, between about 5x105 dalton and about 8×105 dalton, between about 5x103 dalton and about 1×106 dalton, between about 8×105 dalton and about 2×106 dalton...” (paragraph [0037]), which includes instant claims 12 and 13 range of 0.5 x 106 Da to 2.2 x 106.
And, “In some embodiments, the concentration of phospholipid in the formulation is between 100 mg/ml and 200 mg/ml.” (paragraph [0066]) and “In some embodiments, the weight ratio of CBD/phospholipid is higher than 1/10…” (paragraph [0067]), wherein “According to certain embodiments, the lecithin is egg lecithin or soybean lecithin; the lecithin-like substance is lecithin egg yolk or soybean oil; or the phosphatidylcholine-based product is Phospholipon® 50, Phospholipon® 75, Phospholipon® 85G, Phospholipon® 90G, Phospholipon® 80H, Phospholipon® 90H, Phospholipon® E25, Phospholipon® E35, Phospholipon® E, Phospholipon® LPC2O, Phospholipon® LPC25, or Phospholipon® LPC65.” (paragraph [0047]) in which Phospholipon® 90G, Phospholipon® 80H and Phospholipon® 85G are water-soluble or aqueous-dispersible.
In addition, “In addition, the compositions further comprise binders… detergents (e.g., Tween 20, Tween 80, Pluronic F68, bile acid salts)…solubilizing agents (e.g., glycerol, polyethylene glycerol)… polymer coatings (e.g., poloxamers or poloxamines)…” (paragraph [0102]), that are nonionic surfactants and “In some embodiments, the composition further includes a co-solvent. In some embodiments, a co-solvent is a mixture of miscible solvents for solubilizing water-insoluble ingredients of the invention. In sonic embodiments, a co-solvent is composed of one organic solvent and water. In some embodiments, a co-solvent comprises: propylene glycol, PEG 400, ethanol, water, a surfactant, glycerin, propylene glycol, ethanol, polyethylene glycol 300, polyethylene glycol 400, dimethylacetamide (DMA), N-methyl-2-pyrrolidone (NMP; Pharmasolve), dimethylsulfoxide (DMSO), Solutol HS 15, Cremophor EL, Cremophor RH 60, and polysorbate 80. In some embodiments, a co-solvent comprises a compound described in: Robert G. Strickley: Solubilizing Excipients in Oral and Injectable Formulations. Pharmaceutical Research, Vol. 21, No. 2 pp. 201-230, February 2004, which is hereby incorporated by reference in its entirety. (paragraphs [0073]-[0074]).
Where, ““In some embodiments, injectables of the invention are formulated in aqueous solutions. In one embodiment, injectables of the invention are formulated in physiologically compatible buffers such as Hank's solution, Ringer's solution, or physiological salt buffer.” (paragraph [0083]).
Furthermore, “In some embodiments, the composition comprises a buffer keeping the pH of the solution at a physiological pH [7.3 to 7.45].” (paragraph [0072]).
Lastly, Gedo teaches “In one embodiment, administering is by an intra-articular injection into an inflamed joint. In some embodiments, injecting into an inflamed joint is joint injection. In some embodiments, the methods described herein include joint aspiration. In some embodiments, the methods described herein include joint aspiration prior to injecting a composition of the invention into an inflamed joint. In some embodiments, administering is injecting into an inflamed soft tissue next to a joint (such as bursa). In some embodiments, administering is injecting into a soft tissue next to an inflamed joint.” (paragraph [0123]) and “In some embodiments, the composition as described herein is used to inhibit inflammation. In some embodiments, the composition as described herein is used to alleviate joint pain. In some embodiments, the composition as described herein is further used to rebuild a connective tissue.” (paragraph [0148]), wherein keratins are structural proteins in cells of the synovial membrane.
Gedo only explicitly teaches specific weight ratios for phytocannabinoid/surfactant when the surfactant is an amphoteric surfactant (phospholipid) and not for other non-ionic surfactants comprised in the composition.
However, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to use concentrations disclosed for amphoteric surfactant in the invention when substituting a non-ionic surfactant as the primary surfactant, with a reasonable expectation of success.
Claims 1, 3-7, 15, 17-21, and 32-33 are rejected under 35 U.S.C. § 103 as being unpatentable over Gedo (US20200121616A1; publication date 23 April 2020) in view of Wilkhu (WO2019135076A1; publication date 11 July 2019).
Claim 1 is rejected based on rejecting claims 3-7, in which they depend, and claim 15 is rejected based on rejecting claims 17-21 and 32-33, in which they depend.
Regarding instant claims 3-7 and 17-21, Gedo teaches the limitations as disclosed above. Gedo does not teach the use of poly (ethylene glycol)-block-poly (propylene glycol)-block-poly(ethyleneglycol) derivative non-ionic surfactants.
Wilkhu teaches using blends of two poloxamers in a dual PEG-PPG-PEG system where two different block lengths are mixed intentionally for modified controlled release as, “A poloxamer is defined according to formula (II)
PNG
media_image1.png
236
514
media_image1.png
Greyscale
wherein a is an integer of from 10 to 110 and b is an integer of from 20 to 60. It is preferred that when a is 12, b is 20. When a is 12 and b is 20, this is known as poloxamer 124. It is also preferred that when a is 80, b is 27. When a is 80 and b is 27, this is known as poloxamer 188. The formulation may comprise two poloxamers. When the formulation comprises two poloxamers, it is preferred that they are poloxamer 124 and poloxamer 188. Other known poloxamers useful in the present invention are poloxamer 237 (a = 64; and b = 37), poloxamer 338 (a = 141 ; and b = 44) and poloxamer 407 (a = 101 ; and b = 56).” (page 12, lines 8-25). Thus, indicating that when more than one poloxamer is used, a may be = 10 to 141. As such, the instant claims 4 and 18 range encompasses the range disclosed by Wilkhu. Regarding instant claims 7 and 21, Wilkhu explicitly discloses the use of poloxamer 124 and poloxamer 237, however does not explicitly disclose the use of poloxamer 235 (a = 64 and b = 34), although it would be obvious to modify the block lengths by routine experimentation to achieve the desired result, given the invention is aimed at modifying block lengths to achieve desired controlled release profiles. Alternatively, one skilled in the art could blend poloxamer 237 (a=64, b=37) + poloxamer 181 (a=3, b=30) and adjust the ratios to approximate properties and meet the instant claim limitation through routine experimentation.
Wilkhu does not disclose the use of the poloxamers for modified-release with cross-linked hyaluronic acid but rather hydroxypropyl methyl cellulose (HPMC) and copolymer.
However, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to combine the use of mixed poloxamer nonionic surfactant of Wilkhu with the invention of Gedo using a crosslinked hyaluronic acid polymer to improve water solubility with a reasonable expectation of success, given both inventions are similarly directed at modified cannabidiol release compositions and methods for their preparation.
Regarding instant claims 32-33, Gedo teaches the limitations as disclosed above. Gedo does not teach the specific solvent limitations.
Wilkhu teaches “The pharmaceutical formulation comprises at least one cannabinoid; at least one poloxamer; and a solvent, wherein the solvent is defined according to formula (I)
PNG
media_image2.png
194
334
media_image2.png
Greyscale
wherein R1 and R2 are independently selected from hydrogen, C(0)CH3, OH, C(0)CH3, CH2OH and C(0)0CH2CH3; R3 is independently selected from CH3, CH2OH, OH, CH20C(0)CH3 and CH2C(0)CH2CH3; and R4 is independently selected from hydrogen and C(0)0CH2CH3.” (page 4, lines 26-31 and page 5, lines 1-2), wherein “The solvent may be selected from the group consisting of diacetin, propylene glycol, triacetin, monoacetin, propylene glycol diacetate, triethyl citrate and mixtures thereof.” (page 9, lines 10-12).
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to combine the use of mixed poloxamer nonionic surfactant and solvent of Wilkhu with the invention of Gedo using a crosslinked hyaluronic acid polymer to improve water solubility with a reasonable expectation of success, given both inventions are similarly directed at modified cannabidiol release compositions and methods for their preparation.
Claims 1, 8, 9, 22-24 are rejected under 35 U.S.C. § 103 as being unpatentable over Gedo (US20200121616A1; publication date 23 April 2020) in view of Wilkhu (WO2019135076A1; publication date 11 July 2019), Naheed (US9827322B2; publication date: 28 October 2017) and Friedman (US20190298683A1; publication date: 03 October 2019)
Claim 1 and 8 are rejected based on rejecting claim 9, in which it depends, and claims 1, 22 and 23 are rejected based on rejecting claim 24, in which it depends.
Gedo and Wilkhu disclose the limitations as described above. Gedo and Wilkhu do not explicitly disclose wherein the non-ionic surfactant is a combination of glyceryl citrate/lactate/linoleate/oleate and polyglyceryl-2 oleate.
Naheed discloses cannabis derived substance and hyaluronic acid compositions and methods of preparing including “Examples of plasticizing agents include, but are not limited to, low molecular weight polymers such as single-block polymers, multi-block polymers, and copolymers; oligomers such as ethyl-terminated oligomers of lactic acid; small organic molecules; hydrogen bond forming organic compounds with and without hydroxyl groups; polyols such as low molecular weight polyols having aliphatic hydroxyls; alkanols such as butanols, pentanols and hexanols; sugar alcohols and anhydrides of sugar alcohols; polyethers such as poly(alkylene glycols); esters such as citrates, phthalates, sebacates and adipates; polyesters; aliphatic acids; proteins such as animal proteins and vegetable proteins; oils such as, for example, the vegetable oils and animal oils; silicones; acetylated monoglycerides; amides; acetamides; sulfoxides; sulfones; pyrrolidones; oxa acids; diglycolic acids; and any analogs, derivatives, copolymers and combinations thereof.” (page 31, column 53, lines 43-58).
Friedman discloses cannabinoid compositions and methods of making including, “The emulsifier component of the formulation can be used to improve cannabinoid solubilization and the self-emulsifying properties of the formulation. Emulsifier components are selected from the group consisting of poly-glycolized glycerides and polyoxyethylene glycerides of medium to long chain mono-, di-, and triglycerides, such as: … corn oil PEG-6 esters (Labrafil® M 2125 CS) [glyceryl linoleate],… glyceryl monooleate,…, glyceryl dioleate, glyceryl mono/dioleate,…, polyglyceryl oleate, polyglyceryl-2 dioleate, …, and mixtures thereof.” (paragraph [0090]-[0091]), where other PEG-glyceryl esters mentioned are functional analogs for glyceryl citrate and lactate.
Thus, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to add to use the surfactants listed when combining the inventions of Gedo and Wilkhu, given these surfactants and combinations thereof, were known to be used to solubilize cannabidiol compositions at the time of the invention and use would provide a reasonable expectation of success.
Claims 1, 15, 22, 25, and 34-36 are rejected under 35 U.S.C. § 103 as being unpatentable over Gedo (US20200121616A1; publication date 23 April 2020) in view of Wilkhu (WO2019135076A1; publication date 11 July 2019) and Babo (Babo PS, Reis RL, Gomes ME. Production and characterization of hyaluronic acid microparticles for the controlled delivery of growth factors using a spray/dehydration method. Journal of Biomaterials Applications. 2016;31(5):693-707.)
Claim 1 is rejected based on rejecting claims 15 and 22, in which they depend.
Gedo and Wilkhu disclose the limitations as described above. Gedo and Wilkhu do not explicitly disclose the instant claim cross-linking limitations.
Gedo discloses a method for preparing the composition of the invention wherein, “the method comprises the following steps: a) mixing the CBD, phospholipid and cholesterol to form a mixture; b) sonicating and homogenizing the mixture; and c) suspending the mixture in a solution of hyaluronic acid or a salt thereof, thereby forming liposomes suspended in hyaluronic acid.” (paragraph [0019]) and is further described in detail in Example 1 (paragraph [0153]).
Gedo discloses “In some embodiments, the hyaluronic acid is crosslinked. Crosslinking may be carried out by any acceptable method, such as attaching thiol groups, methacrylates, hexadecylamides, or tyramine groups; or directly with formaldehyde (Hylan-A), or with divinylsulfone (trade name: Hylan-B). Hyaluronic acid can be cross-linked via various functional groups, e.g., via the acetyl group (NHCOCH3) after deacetylation, via the carboxylic acid group, or via one of the hydroxyl groups. Hyaluronic acid can be cross-linked with glutaraldehyde via hemiacetal formation.” (paragraph [0039]), but carbodiimide and dihydrazide are not explicitly stated.
Babo discloses “Hyaluronic acid microparticles were produced using a spray/dehydration method, as depicted in Figure 1, followed by crosslinking with ADH [adipic dihydrazine], using a previously [e]stablished ca[r]bodiimide-based chemistry.” (page 2, left column, paragraph 2), wherein carbodiimide (EDC/NHS) activates hyaluronic acid -COOH groups for crosslinking, carbonyl imidazole/benzotriazole forms active esters with hyaluronic acid and adipic dihydrazide (ADH) reacts with hyaluronic acid -COOH groups to form hydrazide bond crosslinking.
Babo also discloses pH adjustment after crosslinking as, “The pH of the HA/ADH solution was set to 4.75 with 3M HCl and filtered.” (page 2, right column, paragraph 1), wherein it is routine in the art to also adjust pH to desired level using the addition of a 0.25 M solution of sodium hydroxide (NaOH) or 0.25 M solution of hydrochloric acid (HCl), as needed.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to add the hyaluronic acid crosslinking of Babo for crosslinking methods mentioned by Gedo following phytocannabinoid and hyaluronic acid solution mixing, given that all of the methods are used to crosslink hyaluronic acid and the method described by Babo was known at the time of the invention to reduce toxic reactant by-products for FDA-approved clinical hydrogels (i.e., hyaluronic acid dermal fillers), thus one would be motivated to make this change for products with intended use as human therapeutic with a reasonable expectation of success.
Claims 1, 15, 37 and 38 are rejected under 35 U.S.C. § 103 as being unpatentable over Gedo (US20200121616A1; publication date 23 April 2020) in view of Wilkhu (WO2019135076A1; publication date 11 July 2019) and Shimojo (Shimojo, Andrea Arruda Martins. “Sterilization of Auto-Crosslinked Hyaluronic Acid Scaffolds Structured in Microparticles and Sponges.” Bio-medical materials and engineering. 26.3–4 (2015): 183–191).
Claims 1 and 15 is rejected based on rejecting claim 37, in which it depends.
Gedo and Wilkhu disclose the limitations as described above. Gedo and Wilkhu do not explicitly disclose the instant claim steam sterilization limitations.
Shimojo teaches “The steam treatment was applied to the microparticles only. The treatment was achieved by wet heating at 126°C under a vapor pressure of 1.5 kgf/cm2 for 1, 2.5, 5, 10 and 15 min in an autoclave.” (page 3, paragraph 4).
Thus, would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to add the missing steam sterilization limitation to the inventions of Gedo and Wilkhu, given that clinical-grade crosslinked hyaluronic acid scaffolds structured were known in the art at the time of the invention to commonly be sterilized by autoclave steam treatment.
Claims 1, 39 and 42 are rejected under 35 U.S.C. § 103 as being unpatentable over Gedo (US20200121616A1; publication date 23 April 2020) in view of Wilkhu (WO2019135076A1; publication date 11 July 2019) and Kleidon (WO2016094810A2; publication date 11 December 2015).
Claims 1 and 39 are rejected based on rejecting claim 42, in which it depends.
Gedo and Wilkhu disclose the limitations as described above. Gedo and Wilkhu do not explicitly disclose cosmetic or nutraceutical limitation for skin.
Kleidon teaches cannabinoid compositions wherein cannabidiol extract compounds from plant sources relax, calm and moisturize skin as, “Phytol can be used to relax a subject, such as by inhibiting degradation of GABA, as an anxiolytic, to resist menadione-induced oxidative stress, and as an antimicrobial” (paragraph [0079]), “Sabinene can be used…relieve skin conditions.” (paragraph [0081]), “Camphor can be used to improve skin healing (e.g., reconstructed human epidermis), as a local anesthetic, a muscle relaxant, an antipathogenic, and an antimicrobial agent.” (paragraph [0082]) and wherein, The compositions of the present disclosure can be provided as cosmetics or personal care products, such as…lotions, massage oils masks, makeup, moisturizers…” (paragraph [00110]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to use the invention of Gedo and Wilkhu for skin relaxation, calming and moisturization, given it was known at the time of the invention that cannabinoid extract compositions function to serve these purposes.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L. SCOTLAND whose telephone number is (571) 272-2979. The examiner can normally be reached M-F 9:00 am to 5:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at: http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at (866) 217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call (800) 786-9199 (IN USA OR CANADA) or (571) 272-1000.
/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615