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 .
Application Status
2. Applicant's amendment and response, filed on January 26, 2026 has been reviewed by the examiner and entered of record in the file.
3. Claims 22, 24-27, 31, 32, 35, 37 39, and 42 are amended.
4. Claims 22-42 are present in the application. Claims 35-41 remain withdrawn from consideration, with traverse, as directed to a non-elected invention.
5. Claims 22-34 and 42 are under examination and are the subject of this office action.
Previous Claim Rejections - 35 USC § 112(b)
6. Claims 22-34 and 42 were previously 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.
7. Claim 22 was previously rejected regarding the following aspects:
(a) The recitation, “having an anti-inflammatory property,” in line 4 was rejected as being indefinite. Applicant amended claim 22 to delete the recitation of “having an anti-inflammatory property from the claim.
(b) Component (ii) of claim 22 was previously rejected regarding the limitation: “an emulsion stabilizing polymer comprising a hydrophilic group,” and the following Markush group. Applicant amended the claim to limit the emulsion stable polymer to “acrylic acid copolymers that are crosslinked with a hydrophobic alkyl acrylate, carbomer copolymer.”
In view of Applicant’s amendatory changes to claim 22, the previous indefiniteness rejection is overcome and is withdrawn.
8. Claim 42 was previously rejected as being dependent upon claim 22 and limiting the emulsion stabilizing polymer to the following:
"a carbomers [sic], Pemulen® (acrylates/C10-30 alkylacrylate cross-polymers), sodium carboxymethylcellulose, hydroxypropylmethylcellulose, povidone, polyethylene glycol, or a combination thereof."
Applicant amended claim 42 to delete the above recitation.
(b) Claim 42 was previously rejected regarding the trademark/trade name Pemulen® in line 2. Applicant amended claim 42 to remove the term Pemulen® from the claim.
In view of Applicant’s amendatory changes to claim 42, the previous indefiniteness rejection is withdrawn.
9. The rejection of claims 29-34 and 42 as being dependent upon and including all of the limitations of the rejected base claim is also withdrawn.
News Claim Rejections - 35 USC § 112(b)
10. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
11. Claims 25, 26 and 32 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.
12. This rejection is necessitated by Applicant’s amendments to the claims.
13. Claim 25 depends from claim 22 and recites the limitation "said surfactant" in line 1. However, there is insufficient antecedent basis for this limitation in the claim, because there is no recitation of a surfactant in claim 22, as amended.
14. Claim 26 depends from claim 25, and limits the polysorbate to “polysorbate 80®, polysorbate 20®, polysorbate 188®, or a combination thereof.” However, it is unclear what is intended by this recitation because the terms polysorbate 80, polysorbate 20, and polysorbate 188 are not trademarks or trade names and thus do not require the use of the symbol “®” in each instance.
15. Claim 32 recites the trademark/trade name Pemulen® in line 2. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. Furthermore, Pemulen® is a brand name for a type of polymeric emulsifier, i.e., acrylic acid copolymers that are crosslinked with a hydrophobic alkyl acrylate (e.g., the C10-30 alkyl acrylate referred to in the parenthetical expression in the claim), and not synonymous with a specific polymer ingredient. And, while Pemulen® refers to a trademarked product(s) type, the trademarked product(s) can change. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe acrylic acid copolymers that are crosslinked with a hydrophobic alkyl acrylate and, accordingly, the identification/ description is indefinite.
Previous Claim Rejections - 35 USC § 112(a)
16. Claims 22-34 and 42 were previously rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement, regarding the entire scope of nanoemulsions embraced by the combination(s) of: (i) an oil comprising castor oil, corn oil, olive oil, oleic acid, sesame oil, soybean oil, cottonseed oil, peanut oil, safflower oil, sunflower oil, palm oil, palm kernel oil, canola oil or a combination thereof, (ii) an emulsion stabilizing polymer comprising a hydrophilic group selected from the group consisting of cellulose, sugar, ethylene oxide, hydroxide, carboxylic acid, a polyelectrolyte, or a combination thereof, (iii) a water soluble polymer comprising a polyacrylamide, a polyacrylic acid, copolymer of polyacrylic acid, polyethylene oxide, guars, hydroxyethyl cellulose, polyvinyl alcohol, or mixtures thereof, (iv) a surfactant comprising a polysorbate, poloxamer, alcohol ethoxylate, ethylene glycol-propylene glycol block copolymer, fatty acid amide, alkylphenol ethoxylate, phospholipid, or a mixture thereof, (v) a tonicity modifier or stabilizer comprising a polyol, a non-reducing disaccharide, or combination thereof, and optionally (vi) sodium citrate as a buffering salt, as presently claimed.
17. Applicant has amended claim 22 to limit the recited nanoemulsion to a sterile-filtered nanoemulsion consisting of the components (i) an oil comprising castor oil, olive oil, oleic acid, or a combination thereof, (ii) a crosslinked copolymer of acrylic acid and a hydrophobic C10-30 alkyl acrylate, carbomer copolymer, or a combination thereof, (iii) a polysorbate or a poloxamer or a mixture thereof, (iv) glycerin, and optionally a buffering agent that is sodium citrate, tris base, or a combination thereof.
18. Therefore, the previous rejection under 35 U.S.C. 112(a) for lack of written description is withdrawn.
Previous Claim Rejections - 35 USC § 112(a)
19. 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.
20. Claims 22-34 and 42 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating the ocular surface inflammatory disorder dry eye disease in a patient in need of treatment, comprising administering a therapeutically effective amount of a sterilized oil-in-water nanoemulsion that is free of cationic agents and consists of the components (i) an oil: castor oil, (ii), the copolymer: Pemulen® TR-2 (i.e., crosslinked copolymer of acrylic acid and a hydrophobic C10-30 alkyl acrylate), (iii) a polysorbate: Polysorbate 80, and (iv) glycerin, does not reasonably provide enablement for a method of treating any type of ocular surface inflammation with said nanoemulsion, or with any other nanoemulsion embraced by the claims.
This rejection has been modified as a result of Applicant’s amendment to the claims.
21. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The standard for determining whether the Specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? As recognized by the court in In re Wands, 858 F.2d 731 (Fed. Cir. 1988), that is still the standard to be applied, determined by consideration of the Wands factors (MPEP 2164.01(A)); namely, nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered, with the most relevant factors discussed below.
22. Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.”
In the instant case, the claimed invention pertains to a method of treating any type of ocular surface inflammation comprising administering a therapeutically effective amount of any sterile filtered oil-in-water nanoemulsion that is free of cationic agents and consisting of the components an oil comprising castor oil, olive oil, oleic acid, or a combination thereof, (ii) a crosslinked copolymer of acrylic acid and a hydrophobic C10-30 alkyl acrylate, carbomer copolymer, or a combination thereof, (iii) a polysorbate or a poloxamer or a mixture thereof, (iv) glycerin, and optionally a buffering agent that is sodium citrate, tris base, or a combination thereof.
23. The State of the Prior Art and the Relative Skill of those in the Art: As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed.”
24. As discussed above, the instantly claimed invention pertains to a method of treating any ocular surface disorder comprising administering the recited nanoemulsion(s) of the instant claims, which are alleged by the Specification to have anti-inflammatory activity on the ocular surface. At the time the instant application was filed, the state of the art regarding inflammation of the ocular surface (as recited) encompasses any disruption to the ocular surface of the eye resulting in inflammation, including inflammation in the cornea, limbus, conjunctiva, and the eyelids. Numerous ocular surface diseases are culprits in ocular surface inflammation, i.e., allergic conjunctivitis, episcleritis, scleritis, superficial punctate keratitis (from numerous causes), and toxicities from medications, wind, heat, or chemicals. Dry eye syndrome is the most common diagnosis of ocular surface inflammation. Effective treatment for ocular surface inflammation should target one or more of the pathophysiologic factors involved in order to break the cycle of pro-inflammatory effects (see Ophthalmology Times webpage printout, pages 2-3, October 16, 2019).
25. Applicant’s instant Specification describes the scope of dry eye syndrome:
“Within dry eye syndrome, there are two major classes: (i) aqueous tear-deficient dry eye (ADDE) and (ii) evaporative dry eye (EDE). There are also cases of mixed mechanism dry eye (i.e., both ADDE and EDE). ADDE is primarily due to failure of lacrimal tear secretion. ADDE can be further subdivided into Sjogren syndrome dry eye (where the lacrimal and salivary glands are targeted by an autoimmune process, e.g., rheumatoid arthritis) and non-Sjogren's syndrome dry eye (lacrimal dysfunction, but the systemic autoimmune features of Sjogren's syndrome are excluded, e.g., age-related dry eye). In contrast, EDE is primarily due to excessive water loss from the exposed ocular surface in the presence of normal lacrimal secretory function. Its causes can be extrinsic (e.g., ocular surface disorder due to some extrinsic exposure, contact lens wear or vitamin A deficiency) or intrinsic (e.g., Meibomian gland dysfunction and disorders of eyelid aperture). Meibomian glands secrete a mixture of lipids and other components that form the outer layer of the preocular tear film. This lipid layer functions to decrease tear film evaporation. Meibomian gland dysfunction (MGD) leads to evaporative dry eye disease. One of the most well-recognized clinic finding in MGD is the presence of numerous telangiectatic blood vessels coursing across the eyelid margin. MGD can also accompany tear-deficient dry eye disease, as seen in ocular graft-versus-host-disease (oGVHD). Other specific dry eye syndromes that can be treated using compositions of the invention include keratoconjunctivitis, dry eye caused by conjunctivitis, dry eye caused by allergic conjunctivitis, dry eye caused by blepharitis, dry eye caused by keratitis, dry eye caused by dacryoadenitis, dry eye caused by ocular rosacea, dry eye caused by boehm syndrome, dry eye caused by conjunctivochalasis, dry eye caused by blepharoconjunctivitis, dry eye caused by blepharokeratoconjunctivitis, dry eye caused by superficial punctuate keratitis, dry eye caused by thygeson's superficial punctuate keratopathy, dry eye caused by GVHD, Sjogren's dry eye syndrome, dry eye caused by Stevens-Johnson syndrome, MGD, dry eye caused by meibomian gland disease, vitamin A deficiency induced dry eye, pharmacological induced dry eye (i.e. hormone replacement therapy, blood pressure medication, antihistamine, antidepressants, anticholinergic medications, glaucoma medication, antihypertensives, diuretics, sedatives, isotretinoin, nasal decongestants, oral contraceptives, beta-blockers, phenothiazines, atropine, pain relieving opiates), pregnancy induced dry eye, LASIK surgery or refractive surgery induced dry eye, dry eye induced by collagen vascular diseases (i.e. systemic lupus erythematosus, Wegener's granulomatosis, rheumatoid arthritis, relapsing polychondritis), dry eye caused by the infiltration of the lacrimal glands by tumors or sarcoidosis, dry eye caused by postradiation fibrosis of tear producing glands, dry eye caused by lacrimal gland, meibomian gland, or goblet cell ablation, dry eye caused by sensory denervation, dry eye caused by thermal or chemical burns, dry eye caused by underlying diabetic conditions, dry eye caused by viral, fungal, or bacterial infection, dry eye caused by prolonged contact lens use, dry eye caused by eyelid disorders or injury to the eyelid (i.e. bulging eyes, drooping eyelid), dry eye caused by corneal dystrophy, dry eye caused by autoimmune disorders, age- induced dry eye, and a combination thereof. Preferably, the present invention provides a method of treating ocular surface abnormalities, defects, deficiencies, disorders, symptoms or diseases caused by contact lens solution or contact lens use,” (Applicant’s Specification at paragraph [0047]).
In the instant case, the instant claimed invention is highly unpredictable since one skilled in the art would recognize that in regards to therapeutic effects of the above listed disorders whether or not the ocular surface inflammation is treated by the activity of the recited nanoemulsion(s) would make a difference. As such, the Specification fails to enable the skilled artisan to use the instant claimed nanoemulsion(s) to treat the full scope of ocular surface inflammation that is presently encompassed by the claims.
28. The state of the art pertaining to treatment of ocular surface inflammation varies depending on the specific condition and its severity, but commonly involves topical steroids, which are highly beneficial for acute ocular surface inflammation; commercially available dry eye therapies including Restasis® (Allergan) and Cequa® (Sun Pharma), which are both cyclosporin formulations, and Xiidra® (lifitegrast ophthalmic solution, Novartis) that suppress T-cells and inflammation; and omega-3 fish oils possessing anti-inflammatory properties) (Ophthalmology Times, page 3). Thus treatment of ocular surface inflammation is specific to the individual cause of inflammation/severity, and there is no teaching or suggestion in the prior art that the anti-inflammatory activity of the instant nanoemulsion (which does not comprise an API) is effective against the full spectrum of types of ocular surface inflammation.
29. Therefore in view of the teachings of Shah, one of skill in the art would not expect a benefit from the treatment of any ocular surface inflammation, as claimed, other than what was established in the art, i.e., dry eye syndrome.
30. Those practitioners tasked with treating ocular disorders of any type (medical clinicians, pharmacists and/or pharmaceutical chemists) presumably would be highly skilled in the art.
31. The Level of Predictability in the Art: Even though the instant nanoemulsions may have been described by the art of record as having anti-inflammatory activity on the ocular surface for treating dry eye (see The State of the Art, above), as a practical matter their use as therapeutic agents for treating the broad range of all types and kinds of ocular surface disorders, as currently claimed, remains extremely unpredictable. It is noted that the pharmaceutical art generally is unpredictable, requiring each embodiment to be individually assessed for physiological activity. The court in In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) held that, “in cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.'' In other words, the more unpredictable an area the more specific enablement is needed in order to satisfy the statute. In the instant case, it has not yet been established in the art that the instant nanoemulsion’s activity would be effective, or even desirable, across the broad range of disorders.
32. Hence, in the absence of a showing of correlation between all types and forms of ocular surface inflammation as recited in claim 22 as capable of being treated by the recited sterile-filtered oil-in-water nanoemulsion of the same claim, one of skill in the art is unable to fully predict possible results from the administration of the claimed nanoemulsion for treating the broad scope of types of inflammation embraced by the claims. There is no question Applicant’s instant nanoemulsion of Table 2 may play a role in future methods of treating some of the aforementioned ocular surface inflammation, namely dry eye syndrome. What is disputed is the claim that the recited genus of nanoemulsions could be taken by one skilled in the art at the time of filing and used as treatment for any/ all of types of ocular surface inflammation embraced by claim 22, without undue experimentation.
33. The Amount of Direction Provided by the Inventor / Existence of Working Examples: The amount of direction provided by the Applicant is considered to be determined by the Specification and the working examples. In the instant case, the Specification demonstrates the efficacy of an exemplary nanoemulsion formulation in an art recognized mouse model of dry eye disease (Example 2 at pages 20-21). The Specification fails to demonstrate that the anti-inflammatory activity of said nanoemulsion of Table 2 is effective against any type or kind of ocular surface inflammation, or to demonstrate the efficacy of any other nanoemulsion formulation embraced by claim 22 against any/all types of ocular surface inflammation.
34. Scope or Breadth of the Claims: As stated in MPEP 2164.01(c), “[w]hen a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation.” Thus, as stated in MPEP 2164.08, “[t]he focus of the examination inquiry is whether everything within the scope of the claim is enabled” (emphasis added). Indeed, the Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright, 999 F.2d 1557 (Fed. Cir. 1993) (emphasis added).
35. At the same time, however, it is also recognized that not everything necessary to practice the invention need be disclosed. Nor is it necessary that an Applicant test all the embodiments of his invention. In re Angstadt, 537 F.2d 498 (CCPA 1976) (emphasis added). In fact, as stated by the court in In re Buchner, 929 F.2d 660 (Fed. Cir. 1991), a patent need not teach, and preferably omits, what is well known in the art.
36. Accordingly, for purposes of enablement, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate in scope with the protection sought by the claims. Thus, while “a patent application is entitled to claim his invention generically” it is necessary that “he provide a disclosure sufficient to enable one skilled in the art to carry out the invention commensurate with the scope of his claims." Amgen, Inc, v. Chugai Pharmaceutical Co., Ltd. (Fed. Cir. 1991). As noted by the court in In re Fisher, 427 F.2d 833 (CCPA 1970), the scope of enablement must bear a “reasonable correlation” to the scope of the claims. See also Ak Steel Corp. v. Sollac, 344 F.3d 1234 (Fed. Cir. 2003) and In re Moore, 439 F.2d 1232 (CCPA 1971). As stated in MPEP 2164.08, resolution of this concern requires two stages of inquiry: “[t]he first is to determine how broad the claim is with respect to the disclosure. The entire claim must be considered. The second inquiry is to determine if one skilled in the art is enabled to make and use the entire scope of the claim without undue experimentation.”
37. As to the first inquiry, as discussed above, the claims are drawn to a method of treating any type or kind of ocular surface inflammation comprising administering the sterile filtered oil-in-water nanoemulsion recited by claim 22, which is alleged by the Specification to have anti-inflammatory activity for the treatment of any/all ocular surface disorders. Considering that the claims embrace thousands of possible disorders that result in inflammation, including inflammation in the cornea, limbus, conjunctiva, and the eyelids, it is evident that the claims are broad (See above under “State of the Art”). Yet, as discussed above, the instant Specification fails to disclose the efficacy of any nanoemulsion formulation(s) (other than NanoE of Table 2 for the treatment of dry eye) against any/all types of ocular surface inflammation(s).
As such, the claim is extremely broad with respect to the disclosure. The second inquiry is discussed in detail below.
38. Amount of Experimentation Necessary: In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the invention as claimed. As discussed above, the claims currently embrace a method of treating any/ all ocular surface inflammation comprising administering any nanoemulsion recited by claim 22, alleged by the Specification to have anti-inflammatory activity. Since identifying any composition which is capable of effectively treating an ocular surface disorder can be extremely complex, the nature of the instant invention considered to be one of extreme complexity. In the instant case, this complexity is exacerbated by the broadness of the full scope of ocular surface inflammation types, with respect to the disclosure since “ocular surface inflammation” potentially encompasses thousands of possible disorders affecting the cornea, limbus, conjunctiva, and the eyelids, whereas the instant Specification fails to demonstrate that the anti-inflammatory activity of the recited nanoemulsions is effective against any type of ocular surface inflammation. Although the relative skill of those in the art to which the invention pertains is high, the state of the art and unpredictability within the art is such that even the most talented artisan could not reasonably predict which of the broad spectrum of types of ocular surface inflammation embraced by the claims could be treated by the recited nanoemulsion, the skilled artisan (at minimum) would have to carry out assays using the nanoemulsion of claim 22 against the entire scope of disorders to be treated. Thus, it is highly unpredictable whether any of the recited nanoemulsion(s) would, in fact, be usable across the full scope of ocular surface inflammation embraced by claim 22. As such, the only way one skilled in the art could ascertain which of the many ocular surface inflammation types encompassed by the claims are treatable based on the limited disclosure would require undue experimentation.
Response to Arguments
39. Applicant amended claim 22 to recite that the method is directed to treating ocular surface inflammation, as stated in paragraph [0017] of the Specification. Applicant alleges that the amendment to claim 22 obviates the new rejection of claims 22-34 and 42 under 35 U.S.C. 112(a), first paragraph.
40. Applicant's arguments have been fully considered but they are not persuasive. Applicant’s amendment changed the scope of the claims to treat a different patient population, i.e., a subject suffering from ocular surface inflammation. However, the scope of ocular surface inflammation embraced by the amended claims is not commensurate in scope with the unexpectedly beneficial results or criticality demonstrated in the Specification. In Example 2, Applicant demonstrates the effects of the exemplary nanoemulsion “NanoE” (Table 2) relative to a composition comprising the known ophthalmic drug lifitegrast for the treatment of dry eye disease.
Applicant’s Specification does not support the claim of treating the broad scope of ocular surface inflammation(s) comprising the nanoemulsion of claim 22. Accordingly, the previously enablement rejection of claims 22-34 and 42 is maintained.
Conclusion
41. In conclusion, claims 22-42 are present in the application. Claims 35-41 are withdrawn from consideration. Claims 22-34 and 42 are rejected. No claim is presently allowable.
42. 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.
43. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
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