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 .
Claim Status
Claims 1-82 and 95 have been cancelled.
Claims 83-94 and 96-103 are pending.
Specification
The Examiner acknowledges the new abstract.
Withdrawn rejections
Applicant's amendments and arguments filed 3/10/26 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 83-94 and 96-103 are rejected under 35 U.S.C. 103 as being unpatentable over Adamo et al. (WO2020212471) and Glassman (PRACTICAL GASTROENTEROLOGY • OCTOBER 2020; 26-33).
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.
Applicant claims, for example:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical metabolic acidosis research scientist, as is the case here, then one can assume comfortably that such an educated artisan requires knowledge of acid-base balance, the role of bicarbonate as a buffer, the potential risks and side effects of bicarbonate therapy, and how to properly administer and monitor the treatment.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 83 and 91, Adamo et al. teach a sterile medicinal product containing aqueous bicarbonate having a physiological pH value, hence within the range of 7.0 to 8.5, with a first wall and a second wall comprises a barrier material which is capable of preventing or retarding escape of carbon dioxide from the container and/or intake of carbon dioxide into the container such that the pH value of the aqueous liquid is maintained or substantially maintained during a shelf life at room temperature of the medicinal product for at least 12 months (Abstract; Figure 1; Example 1) where the pH value is from 6.8 to 7.6 (claims 1-3). Adamo et al. teach adding carbon dioxide to adjust the pH (Examples 1-9, 11-13). Intravenous use is taught (Page 18, lines 10-13). Thus, in the broadest reasonable interpretation of the claim, the bicarbonate/carbon dioxide composition in in a package for i.v. use and has a second wall overwrap where the initial pH of the composition increases by less than 0.5 after storage for at least 6 or at least 12 months at 25 °C because the pH is maintained for at least 12 months. Also note that Adamo et al. teach in Example 1 a plastic container comprising a sodium bicarbonate solution with a secondary container with a silicon oxide coating that is sterilized (Page 25). Adamo et al. teach employing a vacuum chamber and depositing the film layer on the container, which appears to read on evacuating the space between the container and the film layer “overwrap”. In an alternative interpretation, since nothing appears to be in the space between the container and the “overwrap” of Adamo et al., then it is evacuated.
Regarding claim 83, Adamo et al. teach that the aqueous solution in the product may contain 10 mmol/l to 40 mmol/l bicarbonate (Page 18, lines 14-16), which is 0.01 mmol/ml to 0.04 mmol/ml or 0.01 mEq/mL to 0.04 mEq/mL. Since claim 83 is “about 0.05 mEq/mL” that provides for lower values such 0.04 mEq/mL.
Regarding claims 83, 93 and 94, Adamo et al. teach a medicinal product with an outer container and an inner chamber container encased by the outer container (Claim 10) where the wall material of the inner container and outer container can have silicon dioxide (Claim 11) or multilayers with the lowest layer comprising silicon dioxide (Claims 12-13) and where that the container comprises SiOx (Claims 6-7; page 8, lines 20-21) because silicon oxide is an “especially useful barrier material for providing a stabilized ready-to-use or ready-to-infuse aqueous liquid, in particular stabilized ready-to-use or ready-to-infuse aqueous solution, containing bicarbonate” (Page 9, lines 1-3). Example 1 provides a multilayer polyolefin material sealed into a secondary container with polypropylene material with a silicon oxide coating (Page 25). Thus, the product of Adamo et al. is reasonably interpreted as having an inner layer and an outer layer with an inner layer comprising SiOx at the discretion of the ordinary artisan.
Regarding claim 92, Adamo et al. do not add preservative so the composition is preservative free.
Regarding claim 96, Adamo et al. teach that the product comprises a single container (Page 24, lines 3-8), and is thus a single dose product.
Regarding claims 97, 100 and 102-103, Adamo et al. teach sterile sodium bicarbonate solutions are well-known for acidosis or dialysis treatment (Abstract; page 1, lines 6-7; page 18, lines 4-6), thereby rendering obvious treatment of acidosis, replacing sodium bicarbonate in subjects that are suffering from sodium bicarbonate loss and treating kidney dysfunction in a subject with a sterile aseptic product upon administration to the subject.
Regarding claims 83-90, Parrish teaches treatment of metabolic acidosis with intravenous sodium bicarbonate solutions from 0.05 mEq/mL to 1 mEq/mL (Table 2 page 29). Parrish also teaches that “the level of bicarbonate has been determined, calculating the bicarbonate deficit can be helpful in estimating the amount of bicarbonate needed.” (Page 32, left column Treatment).
Regarding claims 97-103, Parrish teaches that: “Acidemia occurs when arterial pH falls below 7.35, which can result in a metabolic, respiratory, or mixed acid-base disorder.” (Page 26, left column 1st paragraph). Parrish teaches that metabolic acidosis can be caused by diabetes, lactic acidosis, shock (which would include septic shock as citation #7 Sodium Bicarbonate in the Treatment of Acidosis in Sepsis of Parrish evidences), renal failure (kidney dysfunction), diarrhea, renal tubular acidosis (kidney dysfunction) (Page 28, Tables 1A, 1B and right column Loss of Bicarbonate).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Adamo et al. is that Adamo et al. do not expressly teach sodium bicarbonate at a concentration of from about 0.05 mEq/mL to about 5 mEq/mL. This deficiency in Adamo et al. is cured by the teachings of Parrish.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to adjust the sodium bicarbonate concentration in the sterile ready-to-use liquid pharmaceutical composition of Adamo et al. to a concentration of from about 0.05 mEq/mL to about 5 mEq/mL, as suggested by Parrish, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Adamo et al. is directed to stable ready-to-use or ready-to-infuse liquid sodium bicarbonate products (Page 2, lines 17-21; page 5, lines 24-31; page 9, lines 1-5). Adamo et al. teach that the product may contain 10 mmol/l to 40 mmol/l bicarbonate (Page 18, lines 14-16), where the upper end of 40 mmol/l is equivalent to 0.04 mEq/ml and reads on “about 0.05 mEq/ml” as discussed above. Adamo et al. does not restrict their product to any particular concentration through the use of the permissive term “may”. Parrish teaches the artisan to employ 0.5, 0.9 and 1 mEq/mL sodium bicarbonate solutions for intravenous use (Table 2). The combined references reasonable suggest a range of from 0.04 to 1.0 mEq/ml of sodium bicarbonate, which encompasses the claimed ranges and single amounts of about 0.1, 0.25, 0.5, 0.75, 0.8 and 1 mEq/mL. See MPEP 2144.05(I): In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Plus, Parrish suggests that the artisan optimize the amount of bicarbonate to determine how much is needed. Thus, the claimed ranges even to about 5 mEq/mL and amounts are obvious over the combined references.
The difference between the instant application and Adamo et al. is that Adamo et al. do not expressly teach a method for alleviating metabolic acidosis in a subject comprising administering to the subject the composition of claim 83, wherein the subject has an arterial blood pH of less than 7.5; wherein the metabolic acidosis is due to diabetic ketoacidosis, lactic acidosis, septic shock, intraoperative metabolic acidosis, or cardiac arrest; wherein the sodium bicarbonate loss is due to hyperchloremic acidosis resulting from diarrhea or renal proximal tubular acidosis or a method of treating kidney dysfunction in a subject. This deficiency in Adamo et al. is cured by the teachings of Parrish.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use the sterile ready-to-use liquid pharmaceutical composition of Adamo et al., with the concentrations claimed for alleviating metabolic acidosis in a subject comprising administering to the subject the composition of claim 83, wherein the subject has an arterial blood pH of less than 7.5; wherein the metabolic acidosis is due to diabetic ketoacidosis, lactic acidosis, septic shock, intraoperative metabolic acidosis, or cardiac arrest; wherein the sodium bicarbonate loss is due to hyperchloremic acidosis resulting from diarrhea or renal proximal tubular acidosis or a method of treating kidney dysfunction in a subject , as suggested by Parrish, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because the ready-to-use sterile sodium bicarbonate liquid pharmaceutical composition of Adamo et al. is intended for treating acidosis or dialysis. Parrish teaches that such patients have a blood pH of less than 7.5 and that the acidosis can be caused by the claimed conditions such as diarrhea, renal proximal tubular acidosis, lactic acidosis, septic shock and kidney disease/dysfunction for example. It is well within the purview of the ordinary artisan in this art to ascertain when acidosis is occurring for any medical condition and administer the proper sodium bicarbonate solution to correct the blood pH with a reasonable expectation of success. Thus, methods of treating kidney dysfunction, replacing sodium bicarbonate in a subject and alleviating metabolic acidosis in a subject whose arterial blood pH is less than 7.5 with the product of Adamo et al. as modified by Parrish are obvious over the combined references.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicant’s arguments filed 3/10/26 have been carefully considered but are not persuasive.
On page 6 of remarks, Applicant respectfully disagrees and submits that this allegation is based on a misreading of Adamo. Indeed, to the extent that it discloses a vacuum chamber, it is in the context of a plasma assisted or plasma-enhanced chemical vapor deposition method for producing its barrier material, i.e., the material of its container. This is self-evidently different from evacuating a space between a container and an overwrap. Applicant also asserts that the Office's alternative interpretation of Adamo (i.e., that the absence of anything between its container and its secondary container should be considered "evacuated") is far beyond the broadest reasonable interpretation of "evacuated." Respectfully, the Examiner has a different perspective. Instant claim 83 requires a composition of sodium bicarbonate and carbon dioxide packaged in a container for intravenous use where the container is packaged in an overwrap. The Examiner cited Figure 1 of Adamo above and as seen in Figure 1 below Adamo schematically shows an inner container (17) containing aqueous liquid for intravenous use (12) packaged in an overwrap outer container (14).
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This interpretation is reasonably and sound because Adamo states: “In a further and especially preferred embodiment of the invention, the container is an outer container, i.e. is in the form of an outer container, and the medicinal product further comprises an inner container, in particular a flexible, i.e. pliable or soft, inner container, which is encased or surrounded, in particular completely and/or directly, i.e. immediately, encased or surrounded, by the outer container.” (Page 13, lines 13-17). Consequently, Adamo meets the structural limitations of claim 83. On the one hand, “completely encased” would leave no room for any space and on the other hand the Examiner cited the vacuum chamber chemical vapor deposition of materials which includes silicon oxide (Page 9, lines 4-6) and the outer container first side wall and/or second side wall comprises silicon oxide (Page 15, lines 29-31). Thus, it makes reasonable sense that a vacuum chamber evacuates the space between the outer container and inner container when undergoing the process. Where patentability rests upon a property of the claimed material not disclosed within the art, the USPTO has no reasonable method of determining whether there is, in fact, a patentable difference between the prior art materials and the claimed material. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Therefore, where the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the USPTO can require an applicant to prove that the prior art products do not necessarily possess the characteristics of his claimed product. Id. It remains the Examiner’s position that there is no space between the container and the “overwrap” of Adamo. Also note that a process claim is not under examination. So how the space between the layers is “evacuated” is immaterial in the Examination of a composition of matter claim.
Applicant argues: “FIG. 3 shows the results of the study discussed in Example 9, that is, the effect of vacuum on the pH of compositions according to claim 83. Notably, FIG. 3 provides evidence of the inventors' surprising discovery that the pH of solutions in IV bags with overpouches that were evacuated increased less compared to the pH of solutions in IV bags with overpouches that were not evacuated.” The Examiner has carefully reviewed FIG. 3 and is not persuaded. FIG. 3 shows an Examiner estimated drop in pH for the week 1 aluminum overpouch without vacuum pH 8.4 to week 2 pH ~8.1 and the week 1 clear overopouch without vacuum pH ~8.4 to week 2 pH ~ 8.1. The week 1 aluminum overpouch with vacuum pH ~8.1 to week 2 pH -7.95. The week 1 clear overpouch pH with vacuum ~8.2 to week 2 pH to ~7.9. The figure only shows a 2 week period. However, the claims require that “wherein the initial pH of the composition increases by less than 0.5 after storage for at least 6 months at 25°C.” A decrease of about 0.3 pH units between weeks 1 and 2 does not support the claimed limitation. Furthermore, Adamo expressly teach that: “the pH-value of the aqueous liquid (12) is maintained or substantially maintained during a shelf life at room temperature of the medicinal product (10) for at least 12 months (Claim 1); the pH-value of the aqueous liquid (12) is maintained or substantially maintained during a shelf life at room temperature of the medicinal product (10) for at least 12 months (Claim 2); and the pH-value of the aqueous liquid (12) does not exceed 7.8, in particular is from 6.5 to 7.8, preferably 6.8 to 7.6, more preferably 7.0 to 7.5, during the shelf life at room temperature of the medicinal product (10) (Claim 3). Thus, Adamo meets the claimed limitation while Applicant’s data does not. Respectfully, Applicant’s arguments are not persuasive.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 83-94 and 96 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 19196581. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending is also directed to:
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No preservatives are added and the copending composition appears to be a single-dose container.
The copending does not expressly teach the concentration ranges or amounts of sodium bicarbonate in the aseptic ready-to-use liquid pharmaceutical composition. However, sodium bicarbonate dosage amounts are readily ascertained by the ordinary artisan to alleviate the particular condition of the patient with a reasonable expectation of success. Pharmaceutical dose has been recognized as a result-effective parameter susceptible to routine optimization. See, e.g., Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 809 (Fed. Cir. 1989). Since the components are the same as claimed, then the initial pH of the composition increases by less than 0.5 after storage for at
least 6 or 12 months at 25°C as well.
The copending does not expressly teach that the container comprises an inner
layer and an outer layer, and wherein the inner layer comprises SiOx or that the space between the container and the overwrap is evacuated. However, placement of the SiOx layer on the inner or outer layer is at the discretion of the ordinary artisan for the desired purpose of the SiOx. There does not appear to be anything in the space between the overwrap and the container and thus it is evacuated. Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 83-94 and 96 are directed to an invention not patentably distinct from claims 1-10 of commonly assigned copending Application No. 19196581. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned copending Application No. 19196581, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Arguments:
Applicant submits that the '581 application has not issued or been allowed, thereby rendering filing a Terminal Disclaimer to obviate a provisional double patenting rejection premature. At this time, the claims remain rejected.
Conclusion
No claims are allowed.
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 ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
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