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 .
Response to Amendment
Applicant's submission filed on October 2, 2025 has been reviewed by the examiner and entered of record in the file.
No claim is amended, canceled or added.
Status of the Claims
3. Claims 10-20 (drawn to methods) remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), with traverse, as being drawn to a nonelected invention, there being no allowable generic or linking claim.
4. Claims 2 and 5-7, drawn to non-elected species, also remain withdrawn from consideration with traverse.
5. Claims 1, 4, 8 and 9 are under examination and are the subject of this office action.
Previous Claim Rejections - 35 USC § 103
6. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
7. Claim 1 remains rejected under 35 U.S.C. 103 as being unpatentable over Mohamed et al., Pain Physician (2016), and Lindenmuth et al., Anesth Prog (1989), and further in view of Tverskoy et al., Neuroscience Letters (1996).
The disclosure of prior-filed Provisional Application No. 61/856,979, Application No. 14/337,819, Application No. 14/997,046, and Application No. 16/129,026 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for the limitation of: the inclusion of an alpha agonist, i.e., dexmedetomidine.
Accordingly, this application is afforded the priority date of Application No. 16/834,863, filed March 30, 2020.
Claim 1, as amended, is drawn to a composition formulated for delivery to a therapeutic site of action for use in treating or preventing pain in a subject in need thereof, wherein the composition comprises:
(a) about 0.01%-0.5% of a local anesthetic comprising bupivacaine hydrochloride; and
(b) about 0.01-3.0 mg/cc of an NMDA receptor antagonist comprising ketamine hydrochloride; and
(c) about 0.01-1.5 mg/cc of a COX inhibitor comprising carprofen; and
(d) about 0.0001-0.05 mg/cc of an alpha agonist comprising dexmedetomidine,
wherein the therapeutic site of action comprises a source of peripheral nociceptive transduction or inflammation in the subject.
8. Mohamed et al. teach a multimodal approach to postsurgical pain relief comprising the administration of (a) the local anesthetic bupivacaine, (d) the alpha2-agonist dexmedetomidine, and (b) the NMDA antagonist ketamine, for the treatment of acute pain/ post-operative analgesia following major surgery (see E829, under “Objective”). Mohamed et al. demonstrate that the combination of 5 µg dexmedetomidine and 0.1 mg/kg of ketamine co-administered with 0.05% bupivacaine provided superior postoperative analgesia in patients (see page E833, right column, first paragraph under “Discussion”). A dose of 0.05% bupivacaine is within the range of 0.01-0.5% required by claim 1.
9. Mohamed et al. do not teach the administration of (c), carprofen.
10. However, Lindenmuth et al. evaluate the results of administering NSAIDS for postoperative surgical pain, in particular carprofen at doses of 75 mg, 100 mg, and 150 mg, wherein “the long duration of action of carprofen in comparison to the majority of analgesics within the same time frame reduces the need to remedicate frequently, possibly resulting in a smoother postoperative course,” (see page 206, right column under “Method,” page 207, Figures 1-3, and page 208, right column, under “Conclusion”).
11. As such, one skilled in the art would reasonably predict that combining bupivacaine, ketamine, carprofen and dexmedetomidine into a single pharmaceutical composition for postsurgical analgesia would have an additive effect against pain and would result in an improved composition for treating/ reducing postsurgical pain in a subject in need thereof.
12. And, the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law, please see In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings). Furthermore, MPEP 2144 teaches that the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.
13. In the instant case, the combination of Bupivacaine, Ketamine and Dexmedetomidine, with Carprofen, each having previously demonstrated post-surgical analgesic activity, could be combined in a single composition in order to achieve an additive effect for use in treating pain in a patient in need thereof.
14. See Sundance, Inc. v. DeMonte Fabricated, Ltd., 550 F.3d 1356 (Fed. Cir. 2008): a claimed invention is obvious is it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they had been combined. And, as stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976); see also: Merck v. Biocraft (874 F.2d 804, 807 (Fed. Cir. 1989), indicating that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands; Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945): indicating that “[r]eading a list and selecting a known component to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.”
15. Regarding the recited concentration(s) of Ketamine (0.01-3.0 mg/cc), Carprofen (0.01-1.5 mg/cc), and Dexmedetomidine (0.0001-0.05 mg/cc), it would have been obvious for one of ordinary skill in the art to use the starting point of Ketamine (i.e., 0.1 mg/kg), and Dexmedetomidine (i.e., 5 µg) disclosed by Abdel-Baky Mohamed et al. and Carprofen (i.e., 75 mg, 100 mg, and 150 mg) disclosed by Lindemuth et al., and optimize these amounts in a composition for intraperitoneal administration, with a reasonable expectation of success. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that "[W]here 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 optimization with a reasonable expectation of success.
16. Regarding the preamble statement that the composition is “for use in treating or preventing pain… wherein the therapeutic site of action comprises a source of peripheral nociceptive transduction or inflammation in the subject,” a “mere statement of a new use for an otherwise old or obvious composition cannot render a claim to the composition patentable.” In re Zierden, 411 F.2d 1325, 1328 (CCPA 1969). Rather, a preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.” Catalina Marketing Int’l, Inc. v. Coolsavings.com, Inc. 298 F.3d 801,808 (Fed. Cir. 2002).
17. Likewise, claim 1 is drawn to a product (i.e., a composition comprising components a., b, c. and d.), and while the use of a descriptive clause pertaining to the process of formulating and/or using the composition is permitted, i.e., “formulated for delivery to a therapeutic site of action,” Applicant is reminded that a recitation of the intended administration/use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. As such, the claimed method by which the composition is formulated and intended for use does not carry patentable weight.
18. Assuming for the sake of argument that Applicant’s recitation that the composition “formulated for delivery to a therapeutic site of action for use in treating or preventing pain … wherein the therapeutic site of action comprises a source of peripheral nociceptive transduction or inflammation in the subject,” carries patentable weight, Tverskoy et al. teach the peripheral analgesic action of ketamine and that ketamine potentiates the analgesic effects of anesthetics when administered via local delivery:
“ketamine can enhance the analgesic and anesthetic effects of local anesthetics via peripheral mechanism,” [emphasis added], and specifically teach the local anesthetic bupivacaine HCl (see Tables 1 and 2, page 7).
Tverskoy et al. conclude that:
“ketamine acting via a peripheral mechanism can enhance the anesthetic and analgesic actions of a local anesthetic… [t]he degree of this enhancement is such that the use of the ketamine-bupivacaine combination may have important clinical applications,”
[emphasis added] (page 8, left column, last paragraph).
19. The optimization of result effective parameters (e.g., route of administration) is obvious as being within the skill of the artisan. Therefore, it would have been obvious to one of skill the art before the effective filing date of the claimed invention to combine bupivacaine, ketamine, carprofen and dexmedetomidine, each having demonstrated analgesic activity, into a single composition in order to achieve an additive anesthetic effect. One skill in the art would have been motivated to combine said ingredients because one would expect ketamine to enhance the analgesic and anesthetic effects of bupivacaine via a peripheral mechanism, with a reasonable expectation of success.
As such, claim 1 is prima facie obvious.
20. Claim 4 remains rejected under 35 U.S.C. 103 as being unpatentable over Mohamed et al., Pain Physician (2016), and Lindenmuth et al., Anesth Prog (1989), and further in view of Tverskoy et al., Neuroscience Letters (1996), as applied to claim 1 above, and further in view of Ng, et al., Anesthesia & Analgesia (2002).
Claim 1 is addressed in detail, above.
Claim 4 is drawn to the method of claim 3, and limits wherein the formulation further comprises epinephrine.
21. Mohamed et al. in view of Lindenmuth et al. and Tverskoy et al. suggest a multimodal composition for postsurgical pain relief, formulated for local delivery, comprising (a) the local anesthetic bupivacaine, (b) the NMDA antagonist ketamine, (c) the COX inhibitor carprofen, and (d) the alpha2-agonist dexmedetomidine, but do not teach the addition of epinephrine.
22. Yet, Ng et al. teach the beneficial effects of the combination of intraperitoneal bupivacaine with epinephrine during surgery, i.e., reduced pain on movement on awakening resulting in significant supplemental morphine-sparing postoperative analgesia.
23. As such, one skilled in the art would reasonably predict that combining bupivacaine, ketamine, carprofen, dexmedetomidine and epinephrine into a single pharmaceutical composition for local delivery of postsurgical analgesia would have an additive effect against pain and would result in an improved composition for treating/ reducing postsurgical pain in a subject in need thereof.
24. And, the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law, please see In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings). Furthermore, MPEP 2144 teaches that the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.
25. Thus it would have been obvious to one of skill in the art before the effective filing date of the claimed invention to combine Bupivacaine, Ketamine, Carprofen, Dexmedetomidine, and epinephrine, each having previously demonstrated post-surgical analgesic activity, into a single composition to achieve an additive effect for use in treating pain in a patient in need thereof. One skilled in the art before the effective filing date of the claimed invention would have been motivated to combine said ingredients into a single composition for the treatment of post operative pain in a subject in need thereof, and would have had a reasonable expectation of success in the additive effect of said composition.
Thus, claim 4 is prima facie obvious.
26. Claim 8 remains rejected under 35 U.S.C. 103 as being unpatentable over Mohamed et al., Pain Physician (2016), in view of Lindenmuth et al., Anesth Prog (1989), and Tverskoy et al., Neuroscience Letters (1996), as applied to claim 1, above, and further in view of Benito et al., Front Vet Sci (2019), and Shawky et al., Egyptian Journal of Hospital Medicine (2018).
Claim 1 is addressed in detail, above.
Claim 8 is drawn to claim 1, and limits wherein the composition is formulated for intraperitoneal delivery.
27. Mohamed et al. in view of Lindenmuth et al. and Tverskoy et al. suggest a multimodal composition for postsurgical pain relief, formulated for local delivery, comprising (a) the local anesthetic bupivacaine, (b) the NMDA antagonist ketamine, (c) the COX inhibitor carprofen, and (d) the alpha2-agonist dexmedetomidine, but do not teach intraperitoneal delivery.
28. Yet, Benito et al. demonstrate the post-surgical analgesic efficacy of the intraperitoneal administration of bupivacaine and dexmedetomidine (see abstract), wherein:
“the intraperitoneal technique has been recommended for pain management as part of a multimodal analgesic approach,”
(page 6, left column, first paragraph).
29. Shawky et al. teach that the intraperitoneal administration of ketamine at a dose of 0.5 mg/kg is successful for post-surgical pain relief (see abstract).
30. And, the optimization of result effective parameters (e.g., route of administration) is obvious as being within the skill of the artisan. Therefore, it would have been obvious to one of skill the art before the effective filing date of the claimed invention to combine bupivacaine, ketamine, carprofen and dexmedetomidine, each having demonstrated analgesic activity, into a single composition with the intent of achieving a peripheral additive anesthetic effect for treating pain. Thus one skilled in the art would have been motivated before the effective filing date of the claimed invention to combine said ingredients into a single composition to achieve a peripheral additive anesthetic effect in postsurgical pain relief, and would have had a reasonable expectation of success.
As such, claim 8 is prima facie obvious.
31. Claim 9 remains rejected under 35 U.S.C. 103 as being unpatentable over Mohamed et al., Pain Physician (2016), Lindenmuth et al., Anesth Prog (1989), and Tverskoy et al., Neuroscience Letters (1996), as applied to claim 1, above, and further in view of Grubb et al., JAAHA (2020) and Mitchell, Mark, Seminars in Avian and Exotic Pet Medicine (2005).
Claim 1 is addressed in detail, above.
Claim 9 is drawn to claim 1, and limits wherein the formulation is formulated for veterinary use.
32. Mohamed et al. in view of Goldstein et al., Lindenmuth et al. and Tverskoy et al. suggest a multimodal composition for postsurgical pain relief, comprising (a) the local anesthetic bupivacaine, (b) the NMDA antagonist ketamine, (c) the COX inhibitor carprofen, and (d) the alpha2-agonist dexmedetomidine, but do not suggest wherein the composition is formulated for veterinary use.
33. Yet, Grubb et al. teach a multimodal analgesic protocol in cats and dogs, suggesting the use of a local anesthetic bupivacaine (page 10, Figure 3, and page 11, Figure 4), and the adjunct drugs dexmedetomidine, which provides sedation and analgesia (page 10, left column, last paragraph- right paragraph, first sentence), and ketamine, which prevents/ decreases the development of central sensitization (page 10, right column, first paragraph). Grubb et al. teach the benefits of peripheral/ intraperitoneal delivery (page 11, Figure 4). Grubb et al. suggest the administration of NSAIDS in said multimodal anesthesia protocol, and Mitchell discloses the benefits of administering the commonly employed NSAID carprofen for analgesia in dogs and cats, (pages 61 and 62).
34. Thus, it would have been obvious to one of skill in the art before the effective filing date of the claimed invention to employ the multimodal composition comprising the local anesthetic bupivacaine, the adjunct drugs dexmedetomidine and ketamine, and the NSAID carprofen for postsurgical pain relief in veterinary applications. One skill in the art would have been motivated before the effective filing date of the claimed invention to formulate the multimodal composition for veterinary use, and would have had a reasonable expectation of success.
As such, claim 9 is prima facie obvious.
Response to Arguments
35. Applicant traverses the obviousness rejection, arguing the following points:
(i) Applicant argues that Mohamed teaches away from the present invention:
“Mohamed teaches three combinations: Group I (hyperbaric bupivacaine plus intrathecal dexmedetomidine); Group II (hyperbaric bupivacaine plus intrathecal ketamine); and Group III (hyperbaric bupivacaine plus intrathecal dexmedetomidine and ketamine). Mohamed teaches away from the present invention by indicating that Group II (bupivacaine plus ketamine) experienced 16.7% nausea and 13.3% vomiting, and Group III (bupivacaine plus dexmedetomidine and ketamine) experienced 13.3% nausea and 13.3% vomiting. Mohamed therefore teaches that combinations involving bupivacaine and ketamine (and dexmedetomidine), as required by Claim 1, induce nausea and vomiting.”
36. Applicant's arguments have been fully considered but they are not persuasive. Regarding Applicant’s argument that Mohamed teaches away from the claimed invention, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (The invention was directed to an epoxy impregnated fiber-reinforced printed circuit material. The applied prior art reference taught a printed circuit material similar to that of the claims but impregnated with polyester-imide resin instead of epoxy. The reference, however, disclosed that epoxy was known for this use, but that epoxy impregnated circuit boards have "relatively acceptable dimensional stability" and "some degree of flexibility," but are inferior to circuit boards impregnated with polyester-imide resins. The court upheld the rejection concluding that applicant’s argument that the reference teaches away from using epoxy was insufficient to overcome the rejection since "Gurley asserted no discovery beyond what was known in the art." 27 F.3d at 554, 31 USPQ2d at 1132.). Thus, "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed...." In re Fulton, 391 F.3d 1195,1201,73 USPQ2dii4i, 1146 (Fed. Cir. 2004).
37. And, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005)(reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.").
PNG
media_image1.png
18
19
media_image1.png
Greyscale
38. In this case, Mohamed teaches in Table 3 that out of 30 patients in Group III (bupivacaine plus dexmedetomidine and ketamine), 4 experienced nausea, and 4 experienced vomiting. However, this data in Group III is an improvement over Group I (bupivacaine plus dexmedetomidine) wherein out of 30 patients, 6 patients experienced nausea and 4 patients experienced vomiting; and improvement over Group II (bupivacaine plus ketamine), wherein out of 30 patients, 5 patients experienced nausea, and 4 patients experienced vomiting. That is, the number of patients with postoperative nausea actually decreased in Group III relative to Group I or Group II.
(ii) Applicant argues that: “[by contrast, the present invention produced the following surprising result: related US Patent No. 11,559,521 [Exhibit A] teaches that over 92% of patients receiving bupivacaine, ketorolac (here, carprofen would likely produce a similar result), and ketamine had no nausea and vomiting whatsoever, with less than 8% having some nausea and vomiting, and only 0.18% having severe nausea and vomiting. This represents a dramatic improvement in nausea and vomiting rates in patients treated with bupivacaine, ketamine, and an NSAID.”
(Applicant’s Remarks, pages 6-7).
37. Applicant's arguments have been fully considered but they are not persuasive. According to MPEP 716.02(d), the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." Applicant relies on the alleged unexpected results demonstrated in US Patent No. 11,559,521 [Exhibit A], which are for the administration of BKK: bupivacaine, ketorolac and ketamine. However, the instant claims recite the combination of bupivacaine, ketamine, carprofen, and dexmedetomidine, which combination is not commensurate in scope with the “surprising result” produced in U.S. Patent No. 11,559,521. Applicant alleges that “carprofen would likely produce a similar result” as ketorolac but have not submitted evidence to support this. Furthermore, the effective minimal concentration for each of the components in the formulation: (a) 0.048 to 0.5% of the local anesthetic, (b) 0.12 mg/kg to 3 mg/kg of the N-methyl-D-aspartate (NMDA) receptor, (c) 0.4 mg/kg to 1.5 mg/kg of the cyclooxygenase (COX) inhibitor, and (d) the alpha agonist concentration is from 0.001 to 0.5 mg/ccm, 1 to 10 mg/kg, are not recited in the claims, which presently recite a broader range for each ingredient (see instant Specification at paragraph [00141]). It is recommended to incorporate the critical amount for each component into the claims (i.e., not a broader range).
Conclusion
38. In conclusion, claims 1, 2 and 4-20 are present in the application. Claims 2, 5-7 and 10-20 are presently withdrawn from consideration. Claims 1, 4, 8 and 9 are rejected. No claim is currently allowable.
39. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM 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, Amy Clark can be reached on 571-272-1310. 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.
/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628