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 .
Priority
The present Application, filed October 25, 2022, claims priority to U.S. Provisional Patent Application Ser. No. 63/271,857, filed October 26, 2021.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 9, 2026 has been entered.
Status of the Claims
In the amendment filed February 9, 2026, claims 1, 33, and 69 are amended. Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are currently pending.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on February 9, 2026 and May 19, 2026 are acknowledged.
Previous Rejections and/or Objections
Any objections and/or rejections raised in the previous Office Action but not reiterated below are considered to have been withdrawn.
Claim 1 was previously rejected for indefiniteness for reciting, “wherein the composition comprises less than about 0.5% oxidative impurities after 1 month at room temperature,” on two grounds: (i) the recitation failed to identify the “oxidative impurities” of which the compound was free, and (ii) the recitation failed to specify any conditions under which such stability would be observed. With respect to the latter, it was noted that the specification indicates that the composition has very different oxidative stability when in contact with glass containment vs when in contact with stainless steel containment. The first of these reasons is suitably addressed by the current amendment specifying that the composition comprises less than 0.3% desmethyl maralixibat after the storage period.
With respect to the second reason for finding indefiniteness referenced above, Applicant argues that compositions of maralixibat will necessarily be formed in stainless steel containment, and so the observation that such compositions are, in the absence of EDTA, considerably more oxidatively labile in the presence of steel than they are in the presence of glass, is “tangential.” This is understood as an assertion that the fact that unprotected maralixibat (e.g. in the absence of EDTA) will have the requisite stability if stored in glass is irrelevant to the question of definiteness, either because compositions of claim 1 will necessarily come into contact with steel or will necessarily be protected (e.g. by comprising EDTA). This argument has been fully considered, but is not found persuasive.
In order for the functional “wherein” clause of claim 1 to have patentable weight, it must distinguish between (i) compositions that meet the component limitations of claim 1 (maralixibat+preservative+antioxidant) but do not meet the functional limitation, from (ii) compositions that meet all limitations of claim 1. Furthermore, claim 1 is not limited to compositions containing EDTA; compositions of claim 1 can include any “antioxidant” in place of EDTA (as well as any “preservative” in place of propylene glycol). In order to determine whether a composition having a different antioxidant in place of EDTA satisfies the functional limitation of claim 1, one of skill in the art would need to know the storage conditions under which such stability is determined, including the demonstrably critical factor of containment material, as well as the starting amount of impurity. Applicant’s argument that maralixibat compositions will necessarily be prepared in stainless steel equipment may be construed as an argument that the recited storage implicitly includes composition formation and therefore implicitly includes some residence time, of unspecified duration, in stainless steel equipment. Such unrecited conditions would need to be made explicit and given specificity. Without such specificity, the functional limitation of claim 1 fails to further limit the claim, and the claim merely encompasses any composition containing maralixibat, an “antioxidant,” and a “preservative” at the recited concentrations.
In other words, the stability limitation is indefinite if it does not specify all relevant storage conditions that affect the stability. As such, the rejection of claim 1 and its dependent claims for indefiniteness is substantially maintained.
It will be noted that the previous rejections of claims 42-43, due to alleged dependency from claim 1, were in error as claim 42 is independent and claim 43 depends from claim 42. The previous rejections of claims 42-43 for indefiniteness are thus withdrawn.
Claim Rejections - 35 USC § 112 – Maintained in Substance
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 the applicant regards as his invention.
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-41, 45-49, and 52-55 are indefinite:
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-41, 45-49, and 52-55 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.
Claim 1 is indefinite for reciting “wherein the composition comprises less than about 0.3% desmethyl maralixibat impurity after 1 month at room temperature,” because a person having ordinary skill in the art could not reasonably determine the metes and bounds of this limitation. This functional limitation omits parameters that significantly affect the time-dependent appearance of desmethyl maralixibat impurity, making it impossible for one to determine which compositions fall within the scope of the element and of the claim. For example, the instant specification indicates that when maralixibat is stored in vessels made of different material (e.g. glass vs. stainless steel, see instant Table 23), this material has a marked effect on the rate of maralixibat oxidative degradation. Further, data presented in the instant specification suggests that 0.1% EDTA may be needed to stabilize the composition when it is stored in steel, (See Tables 24-25), but that otherwise equivalent compositions having no EDTA are sufficiently stable to meet this stability requirement when stored the composition is stored in a glass container (see, for example, Tables 14, 16, and 18). This result suggests that the recited stability limitation is present in all compositions of instant claim 1, if the composition is stored in glass, or potentially any non-metallic vessel.
Finally, the instant specification indicates it is fairly common for maralixibat to have some initial (prior to storage) impurity, including oxidative impurity (desmethyl maralixibat – see Tables 12-18, showing varying initial levels of Total % Impurities). The initial amount of impurity would obviously directly affect the amount of impurity after 1 month of storage, regardless of the stability, and the omission of this factor likewise increases the indefiniteness of the claim limitation.
Claim 1 is therefore indefinite, and its dependent claims 3, 8, 13-14, 16, 24-26, 32-33, 39-41, 45-49, and 52-55 are indefinite for depending from claim 1 without curing this indefiniteness. For the purpose of compact prosecution, this element of claim 1 will be construed according to a broadest reasonable interpretation in which any unspecified parameters of storage condition (e.g. storage vessel composition) or components of the claimed composition itself (e.g. maralixibat concentration) are open to all possibilities (e.g. the storage vessel is glass and the initial concentration of oxidative impurity is zero).
Claim Rejections - 35 USC § 103 – Maintained in Substance
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.
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, and 52-55 are obvious over Jaecklin, Lumena, and EMA:
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, and 52-55 are rejected under 35 U.S.C. § 103 as being unpatentable over International Patent Application No. WO2020167958 to Jaecklin et al. (hereinafter, “Jaecklin”), in view of the non-patent publication, The Evaluation Of The Intestinal Bile Acid Transport (Ibat) Inhibitor Lum001 In The Reduction Of Pruritus In Alagille Syndrome, A Cholestatic Liver Disease, clinical trial protocol number: LUM001-301, amendment 3 (2015), obtained at the url: repository.niddk.nih.gov/api/entity/v1/study/documents/download/file/2232 (hereinafter, “Lumena”), and the non-patent publication, Propylene glycol used as an excipient, European Medicines Agency (2017), obtained at the url: www.ema.europa.eu/en/documents/report/propylene-glycol-used-excipient-report-published-support-questions-and-answers-propylene-glycol-used-excipient-medicinal-products-human-use_en.pdf (hereinafter, “EMA”).
In its Remarks, Applicant argues that “the claimed compositions have unexpected oxidative stability due to the combination of the propylene glycol and EDTA at the claimed ranges, as demonstrated in Table 25 and paragraphs [000322]-[000323] of the specification (pg. 9 of Applicant’s Remarks, second full paragraph).”
As a first matter, there does not appear to be any evidence of record that the combination of propylene glycol and EDTA is important to conferring oxidative stability on the composition, or more specifically that propylene glycol plays any role in oxidative stability. The cited Table 25 compares two compositions, one having and one lacking EDTA, but otherwise identical, with both having 35% propylene glycol. The results in Table 25 show that EDTA inhibits oxidation of maralixibat – particularly when the drug has been exposed to metal – but does not appear to support the contention that propylene glycol or its combination with EDTA plays a role in inhibiting oxidation. In general, there does not appear to be any evidence of record that the presence or absence of propylene glycol, in combination with EDTA or otherwise, plays any role in conferring oxidative stability on the composition. Rather, on the present record, it appears that EDTA alone is responsible for increasing oxidative stability of the composition.
Similarly, the present record indicates minimal testing of different concentrations of EDTA or propylene glycol. Propylene glycol is tested at 25, 30, and 35%, in the absence of EDTA, for its antimicrobial ability (Table 21). EDTA is tested at 0.01% and 0.05% for its ability to inhibit maralixibat oxidation in the absence of propylene glycol (Figure 2; the degree of difference between these concentrations is difficult to determine due to lack of clarity of the Figure), and 0.1% EDTA is subsequently used in all formulations. The reason for selection of this concentration is not entirely clear.
Thus, the record does not appear to support the contention that “the claimed compositions have unexpected oxidative stability due to the combination of the propylene glycol and EDTA at the claimed ranges.” The record appears to support a view that maralixibat undergoes temperature-dependent oxidation to desmethyl maralixibat in aqueous solution, a process that is accelerated by contact with metal and inhibited by EDTA. The effect of 0.1% EDTA is substantial enough to largely eliminate desmethyl maralixibat production at 25 °C, even with exposure to stainless steel surfaces. Meanwhile, propylene glycol co-solvent at 25-35% is adequate to largely ameliorate microbial growth at 25 °C.
Second, if Applicant is making an assertion that unexpected results rebut the prima facie case of obviousness, Applicant must make the argument explicit and discuss how the evidence establishes “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Stated alternatively, Applicant should discuss specifically what the unexpected result is, and why it is unexpected. While there is currently no evidence of record indicating that the oxidation of maralixibat to desmethyl maralixibat was known in the art, it is noted that the use of EDTA to prevent drug oxidation, and particularly metal ion mediated oxidation, was generally known in the art. See, for example, International Patent Application No. WO/2007109523 to Mahadevan et al., which teaches that the ophthalmic API, ketotifen, is oxidatively unstable, particularly in the presence of metal ions, and the EDTA is used to stabilize the compound against oxidation (paragraph spanning the bottom of pg. 7 to the top of pg. 8).
Furthermore, “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” As noted above, the evidence currently of record pertains solely to aqueous solutions of maralixibat with propylene glycol preservative and EDTA antioxidant. It is unclear that, even if unexpected results were established, they would be commensurate with the scope of the present claims.
Applicant next argues that the previous obviousness rejections utilizing inherency doctrine are flawed because inherency in obviousness requires a showing that the “missing” feature is necessarily present in the prior art combination. To that point, Applicant asserts that no evidence was presented in support of the proposition that the recited stability feature is necessarily present in a prior art composition having the maralixibat, EDTA, and propylene glycol of Jaecklin, Lumena, and EPA. This argument has been fully considered, but is not found persuasive.
Previously, the results of Table 23 were cited to demonstrate that maralixibat solution in a glass container, even in the absence of EDTA, meets the stability requirement of previous claim 1. Regarding the amended, more stringent (in terms of desmethyl maralixibat concentration), the primary reference, Jaecklin, teaches compositions of maralixibat having EDTA at 0.1% (w/v) or higher, in a variety of solvents, including water. The present record indicates that as low as 0.05% EDTA is sufficient to substantially eliminate desmethyl maralixibat formation for four weeks, at 25 °C (paragraph [000321]). As such, a composition of Jaecklin having maralixibat and 0.1% EDTA would necessarily satisfy the stability limitation of instant claim 1, especially with little to no metal ion present. For the aforementioned reasons, the rejections of claims 1 and its dependent claims are thus maintained.
With respect to claim 69, Applicant notes that the claim is amended to remove seladelpar from the list of recited PPAR agonists. As noted in the renewed rejection, however, the quaternary Dubrovsky reference teaches the use of PPAR agonists generally for the treatment of cholestatic liver disease, and presents elafibranor as an exemplary PPAR agonist for such use. The rejection of claim 69 is thus maintained.
Substantially maintained rejections:
Claim 1 recites a pharmaceutical composition comprising an ASBTI, a preservative, and an antioxidant, wherein the ASBTI is maralixibat, or a pharmaceutically acceptable salt thereof. As amended, claim 1 requires that the preservative is present at about 30-40% (w/w) of the composition, and the antioxidant is present at about 0.001 to 1% (w/w) of the composition. Claim 1 further recites wherein the composition comprises less than about 0.3% desmethyl maralixibat impurity after 1 month at room temperature.
Jaecklin teaches a pharmaceutical composition comprising an ASBT inhibitor (an ASBTI – paragraph [00640]. Jaecklin teaches that the ASBTI can be maralixibat. Jaecklin teaches the composition can include an antioxidant at a concentration in an exemplary range of from about 0.1% to 0.5% (w/v) (paragraphs [000682]-[000683], and/or can include a chelating agent such as ethylenediaminetetraacetic acid (EDTA) at a suitable concentration such as 0.1%-0.5% (w/v) – paragraphs [00679]-[00680]. Jaecklin teaches that the composition can include propylene glycol in any of several contexts, such as: as a liquid carrier vehicle co-solvent (paragraph [00672]), or as an alternative solvent to help increase solubility (understood to be substantially the same as a co-solvent – paragraph [00734]). Propylene glycol and EDTA are a preservative and an antioxidant, respectively, of instant claim 1 (see, for example, instant claims 16 and 26).
While the specific concentrations of EDTA taught by Jaecklin are in measurement of w/v, rather than w/w, they are plainly within the 0.001 to 1% w/w concentration of instant claim 1. Furthermore, while Jaecklin does not specify a concentration of propylene glycol, it would have been obvious to incorporate propylene glycol at a concentration within the range recited in claim 1, because propylene glycol concentrations near this were known in the art for maralixibat formulations, and concentrations within the recited range were known in the art as having preservative properties. See, for example, Lumena and EMA.
Lumena teaches a clinical study of the intestinal bile acid transport inhibitor, LUM001 (pg. 3, Protocol Title). LUM001 is maralixibat (see, for example, the non-patent publication, Maralixibat Drugbank sheet, obtained from the Drugbank website at the url go.drugbank.com/drugs/DB16226 (2020)) which states, “Maralixibat (also known as SHP625, LUM001, and lopixibat) is an ileal bile acid transporter inhibitor,” (Background, first paragraph).
Lumena teaches compositions of LUM001 (maralixibat) having 25% propylene glycol, see pg. 56, Tables 5 & 6 (these compositions of Lumena are essentially identical to the FDV-maralixibat compositions of the instant specification, e.g. Table 9 and paragraph [000302]), and teaches administration of these oral solutions to subjects as part of the study (pg. 58, 10.1 Study Drug Administration). It would have been obvious to utilize the 25% propylene glycol of the compositions of Lumena in the compositions of Jaecklin. In addition, while the propylene glycol of Lumena is at 25% w/v concentration, rather than 25% w/w, because water and propylene glycol both have density of approximately 1 g/mL, w/v and w/w concentrations are approximately the same in this instance.
Furthermore, while this 25% propylene glycol is outside the range of instant claim 1, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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 experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In addition, EMA provides a review of various uses of propylene glycol as an excipient. For example, EMA teaches that propylene glycol is a well-known pharmaceutical excipient that is used for several purposes in a wide range of pharmaceutical dosage forms e.g., as a preservative in solutions (15–30%) or as a co-solvent in parenterals (10–60%), oral solutions (10–25%) and topicals (5–80%). It therefore would have been particularly obvious to increase the propylene glycol concentration of Lumena to 30% to take advantage of its well-known preservative properties, for example, as taught by EMA. While Lumena does not specify the concentration format (e.g. (w/w) or (w/v)) but, as noted above, the different formats of percent concentration are nearly identical in the case of a percentage of propylene glycol in an aqueous solution.
Jaecklin, as modified by Lumena and EMA, thus teach a pharmaceutical composition having maralixibat with EDTA (an antioxidant) present at a concentration within a range of 0.001 to 1% (w/w) and propylene glycol (a preservative) present at a concentration within a range of 30-40% (w/w).
With respect to the element wherein the composition has less than 0.3% desmethyl maralixibat after 1 month at room temperature, the evidence of the instant specification indicates that as little as 0.05% EDTA desmethyl maralixibat formation, under at least some conditions (paragraph [000321]). As such, a composition of Jacklin having 0.1% EDTA (or a composition of Jaecklin/Lumena/EMA having 0.1% EDTA and 30% propylene glycol) would necessarily contain less than 0.3% desmethyl maralixibat when stored at RT for 1 month, under at least some conditions (e.g. with minimal or no metal ion present).
Inherency is limited in applicability in obviousness rejections, but is applicable when the property is an inevitable result of the prior art combination. In re Rijckaert 9 F.3d 1531 (Fed. Cir. 1993). See also MEP 2144.04(VI) and cases cited therein, summarizing that a limitation missing from the reference may be supplied by recourse to inherency when it is necessarily present in the prior art, i.e. is the natural result of the combination of elements explicitly disclosed. Because compositions of Jaecklin having at least 0.1% EDTA, whether or not having propylene glycol at 30% or more as modified by Lumena and EMA, inherently possess the stability limitation of claim 1 under at least some conditions, and in view of the teachings described above, claim 1 is obvious over Jaecklin, Lumena, and EMA. Stated alternatively, the inherent stability of claim 1 is present in compositions of the primary reference, and does not require the combination, although it would still of course be present in the combined composition, particularly given that the combined composition is a composition of instant Table 25.
With respect to claim 3, Jaecklin teaches the ASBTI can be maralixibat chloride (paragraph [00566]). Claim 8 recites the pharmaceutical composition of claim 1 wherein the ASBTI is present in an amount of about 0.1 mg/mL to about 500 mg/mL of the composition, while claim 13 recites a concentration range of about 9 mg/mL to about 10 mg/mL. While Jaecklin doesn’t explicitly teach these exact ranges, Jaecklin does teach that the liquid dosage forms (i.e. liquid forms of the pharmaceutical composition) can contain the active ingredient in an amount ranging from about 0.001 mg/mL to about 16 mg/mL, and can for example contain active ingredient at a concentration of 10 mg/mL (paragraph [00736]). The larger range recited in instant claim 8 is obvious over the narrower, encompassed range taught by Jaecklin, because where a claimed range overlaps ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP § 2144.05(I) and cases cited therein. Similarly, the range of 9-10 mg/mL of claim 13 is obvious over the overlapping range taught by Jaecklin as well as the example of 10 mg/mL taught by Jaecklin. With respect to claims 14 and 16, as noted, Jaecklin teaches the composition can include propylene glycol. With respect to claims 24-26, as noted, Jaecklin teaches the composition can include EDTA.
With respect to claim 32, Jaecklin explicitly teaches the chelating agent (e.g. EDTA) can be present at 0.1% (w/v). While it is not possible to precisely convert the (w/v) concentration of Jaecklin to a (w/w) concentration of instant claim 32, particularly as the claim does not specify a solvent, a 0.1% (w/v) concentration would be expected to be approximately equal to a 0.1% (w/w) concentration, depending somewhat on the concentration of ASBTI inhibitor, if the solvent were, for example a mix of water (1 g/mL density) and propylene glycol (1.04 g/mL density). With respect to claim 33, as discussed above with respect to claim 3, the fact that 0.05% EDTA effectively eliminates desmethyl maralixibat formation (as observed for four weeks, but there is no reason that it would not extend for 5 months or more), a composition of Jaecklin (or of Jaecklin/Lumena/EMA) having maralixibat and 0.1% EDTA necessarily possesses the stability limitation of claim 33, under at least some conditions (e.g. the conditions under which the experiment of Figure 2 of the instant specification was performed).
With respect to claim 39, Jaecklin teaches the composition can be a liquid composition for oral administration (e.g. paragraph [00594]). With respect to claim 40, Jaecklin teaches that the composition can be a solution (while the syntax is unclear, it appears to state the composition can be an aqueous or non-aqueous solution, paragraph [00696]), and that the pharmaceutical composition can have a liquid carrier vehicle that can be water (paragraph [00672]). With respect to claim 41, Jaecklin teaches that the composition can include at least one excipient that is a flavoring agent or sweetener (paragraph [00697]).
Claim 42 recites a composition having about 5-50 mg of maralixibat, 300-400 mg of propylene glycol, 1 mg/mL EDTA (about 0.1% in water), a sweetener or flavorant, and water. Because the amount of water is unspecified, the concentration of the components, aside from EDTA is indeterminate. As noted, Jaecklin teaches maralixibat, propylene glycol, flavoring agent or sweetener, and EDTA at 0.1% or greater in a composition having water. The specific amounts recited are obvious variations, in part because they are not concentrations (i.e. depending on the amount of water, the concentration of the claimed element is not constrained), but particularly because there is no showing of criticality to any of these values. The recited amounts are thus within the concentration values of the prior art (e.g. Jaecklin teaches ASBTI concentration of 1 mM to 1 M, paragraph [00669]) and, in the absence of any showing of criticality of the recited amounts, claim 42 is obvious. Claim 43, which recites somewhat narrower ranges of amounts of maralixibat and propylene glycol, is obvious for the same reason.
With respect to claim 45, Jaecklin teaches that the active compound (i.e. maralixibat) can be employed with an additional therapeutic agent (paragraph [00642]), and teaches that this additional therapeutic agent can be administered simultaneously, and when so, the multiple therapeutic agents (i.e. maralixibat and the second therapeutic agent) can be provided in a single, unified form (i.e. the second therapeutic agent can be incorporated into the pharmaceutical composition along with the maralixibat). With respect to claim 46, Jaecklin teaches maralixibat can be used in combination with an FXR targeting drug (paragraph [00755]).
Claim 47 recites a pharmaceutical dosage form for oral administration comprising the pharmaceutical composition of claim 1. This is understood as meaning a pharmaceutical composition of claim 1 formulated for oral administration, i.e. claim 47 is understood to have substantially the same scope as that of claim 39, with the exception that claim 47 doesn’t require the composition be liquid. Claim 47 is therefore obvious for the same reason as is claim 39; Jaecklin teaches the composition can be a liquid (or solid) composition for oral administration (e.g. paragraph [00594]).
Claim 48 recites a method of treating or ameliorating a pediatric cholestatic liver disease comprising administering to a pediatric subject a therapeutically effective amount of the pharmaceutical composition of claim 1. Jaecklin teaches methods for treating cholestasis in a subject having a liver disease, comprising administering to a subject in need of treatment an ASBTI inhibitor (paragraph [00582]). Jaecklin teaches that the liver disease can be a cholestatic liver disease (paragraph [00583]), which further can be a pediatric form of liver disease (paragraph [00584]), so that the method is one of treating a pediatric cholestatic liver disease. Jacklin further teaches that the methods disclosed therein can comprise administering a composition that is taught therein (paragraph [00751]), such as a composition described above having EDTA and polypropylene glycol (i.e. a composition of claim 1).
With respect to claim 49, Jaecklin teaches that the cholestatic liver disease can be PFIC (paragraph [00583]). With respect to claims 52-54, Jaecklin teaches that the cholestatic liver disease can be characterized by a number of symptoms, including pruritis, hypercholemia, and xanthomas (paragraph [00585]). As such, the method of treating a cholestatic liver disease, discussed above, would intrinsically be a method of treating or ameliorating pruritis, hypercholemia, and/or xanthoma. With respect to claim 55, Jaecklin teaches a symptom of the cholestatic liver disease can be increased serum concentration of bile acids and, as such, the method of treating the cholestatic liver disease would intrinsically be a method of decreasing serum bile level in the subject.
Claim 69 is obvious over Jaecklin, Lumena, EMA, and Dubrovsky:
Claim 69 is rejected under 35 U.S.C. § 103 as being unpatentable over Jaecklin, Lumena, and EMA, further in view of the non-patent publication, Statins, Fibrates, and Other Peroxisome Proliferator-Activated Receptor Agonists for the Treatment of Cholestatic Liver Diseases, Gastroenterol. Hepatol (NY), 16, pgs. 31-38 (2020) by Dubrovsky et al. (hereinafter, “Dubrovsky”).
Claim 69 recites a method of treating or ameliorating a pediatric cholestatic liver disease comprising administering to a pediatric subject a therapeutically effective amount of maralixibat in combination with a therapeutically effective amount of a PPAR agonist, selected from the group consisting of five enumerated PPAR agonists (e.g. elafibranor). As noted above with respect to claim 48, Jaecklin teaches methods for treating cholestasis in a subject having a liver disease, comprising administering to a subject in need of treatment an ASBTI inhibitor (paragraph [00582]). Jaecklin teaches that the liver disease can be a cholestatic liver disease (paragraph [00583]), which further can be a pediatric form of liver disease (paragraph [00584]), so that the method is one of treating a pediatric cholestatic liver disease. Further as noted above with respect to claim 45, Jaecklin teaches that the active compound (i.e. maralixibat) can be employed with an additional therapeutic agent (paragraph [00642]). Jaecklin further teaches that methods taught therein can involve administering a combination of an ASBTI (e.g. maralixibat) with a PPAR agonist (paragraph [00754]). Jaecklin also provides multiple examples of suitable PPAR agonists for such combination therapy, including fenofibrate and GW501516 (paragraph [00754]).
Jaecklin does not specify one of the PPAR agonists recited in amended claim 69, but it would have been obvious to utilize one of these PPAR agonists because these PPAR agonists were known in the art as potentially useful for the treatment of cholestatic liver disease. See, for example, Dubrovsky.
Dubrovsky teaches PPAR agonists are useful in the treatment of cholestatic liver disease (paragraph spanning the bottom of the left column to the top of the right column of pg. 32), with examples including the PPARα agonist, fenofibrate, and the PPARα/[Symbol font/0x64] agonist, elafibranor (pg. 32, left column, last full paragraph). Dubrovsky further teaches elafibranor is in clinical trials as a newer PPAR agonist for the treatment of primary biliary cholangitis, and that it helps achieve reduced levels of alkaline phosphatase (pg. 35, left column, first full paragraph) indicating improved liver health. It thus would have been obvious to use elafibranor as a PPAR agonist of Jaecklin in a combination therapy with maralixibat.
Double Patenting - Maintained
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 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are rejected for nonstatutory double patenting over the ’647 Patent in view of Jaecklin, Lumena, EMA, and Dubrovsky:
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,229,647 (hereinafter, “the ’647 Patent”), in view of Jaecklin, Lumena, EMA, and Dubrovsky. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ’647 Patent recites a method for treating Alagille Syndrome (a cholestatic liver disease) in a pediatric subject in need of such treatment comprising administering to the subject maralixibat chloride in an amount of from about 400 µg/kg/day to about 800 µg/kg/day. Claim 1 of the ’647 Patent thus recites all elements of instant claim 48 (which recites a method of treating a pediatric cholestatic liver disease comprising administering to a pediatric subject a pharmaceutical composition of instant claim 1) except that claim 1 of the ’647 Patent does not require that the maralixibat be administered as part of a composition that includes an antioxidant and a preservative of instant claim 1. However, inclusion of such an antioxidant and a preservative along with the maralixibat would have been obvious based on the teachings of Jaecklin, as described above in reference to the rejection of instant claim 1 for obviousness. In particular, and as demonstrated by Jaecklin, inclusion of an antioxidant (e.g. EDTA, at a concentration within the recited range) and a preservative (e.g. propylene glycol) along with maralixibat for administration in treating cholestatic liver diseases was well-known in the art. Lumena and EMA teach a concentration of propylene glycol within the recited range. Instant claim 48, which depends from claim 47 and specifies Alagille Syndrome as a disease to be treated, is subject to the nonstatutory double patenting rejection for the same reason.
The other instant method of treatment claims (52-55, and 69) are likewise obvious variants of the method of claim 1 of the ’647 Patent, in view of the teachings of Jaecklin. As noted above, Jaecklin teaches that a variety of cholestatic liver diseases and associated symptoms, such as pruritis (instant claim 52), hypercholemia (instant claim 53), xanthoma (instant claim 54), and elevated serum bile levels (instant claim 55) are similarly amenable to treatment via maralixibat administration (paragraph [00585]). Further, Jaecklin teaches the utility of combining maralixibat with a second therapeutic agent including a PPAR agonist (instant claim 69) such as fenofibrate (see Jaecklin paragraph [00754]), while Dubrovsky teaches the specific use of seladelpar in treating cholestatic liver disease.
With respect to the composition claims (1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, and 45-47), the composition itself is obvious over the method of using it. As such, the composition claims are rejected for nonstatutory double patenting over the method claims of the ’647 Patent, in view of Jaecklin, for the reasons described above relating to the rejections for obviousness.
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are rejected for nonstatutory double patenting over the ’745 Patent in view of Jaecklin, Lumena, EMA, and Dubrovsky:
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,497,745 (hereinafter, “the ’745 Patent”), in view of Jaecklin, Lumena, EMA, and Dubrovsky.
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are rejected for nonstatutory double patenting over the ’578 Patent in view of Jaecklin, Lumena, EMA, and Dubrovsky:
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,918,578 (hereinafter, “the ’578 Patent”), in view of Jaecklin, Lumena, EMA, and Dubrovsky.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ’745 Patent recites a method for treating Alagille Syndrome (a cholestatic liver disease) in a pediatric subject in need of such treatment comprising administering to the subject maralixibat chloride in an amount of from about 360 µg/kg/day to about 880 µg/kg/day. Similarly, claim 1 of the ’578 Patent recites a method for treating cholestatic pruritus in a subject having Alagille Syndrome comprising administering to the subject maralixibat in an amount of from about 400-800 µg/kg/day wherein the maralixibat is administered as a liquid pharmaceutical composition comprising about 0.001-16 mg/mL of maralixibat.
The instant claims are subject to nonstatutory double patenting rejections over the claims of the ’745 Patent and the ’578 Patent for the same reasons as described above with respect to the ’647 Patent.
Provisional Rejections for Nonstatutory Double Patenting
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected for nonstatutory double patenting over the ’132 Application in view of Jaecklin, Lumena, EMA, and Dubrovsky:
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8-10, 12, 18, 46, 48-50, 52-55, 58, 63, 66, 71, 100-101, and 103-106 of copending Application No. 17/119,132 (hereinafter, “the ’132 Application”), in view of Jaecklin, Lumena, EMA, and Dubrovsky. This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected for nonstatutory double patenting over the ’168 Application in view of Jaecklin, Lumena, EMA, and Dubrovsky:
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 8-14, and 16-25 of copending Application No. 17/430,168 (hereinafter, “the ’168 Application”), in view of Jaecklin, Lumena, EMA, and Dubrovsky. This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected for nonstatutory double patenting over the ’210 Application in view of Jaecklin, Lumena, EMA, and Dubrovsky:
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-102 of copending Application No. 17/430,210 (hereinafter, “the ’210 Application”), in view of Jaecklin, Lumena, EMA, and Dubrovsky. This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected for nonstatutory double patenting over the ’125 Application in view of Jaecklin, Lumena, EMA, and Dubrovsky:
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-53 and 69-112 of copending Application No. 17/430,125 (hereinafter, “the ’125 Application”), in view of Jaecklin, Lumena, EMA, and Dubrovsky. This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected for nonstatutory double patenting over the ’725 Application in view of Jaecklin, Lumena, EMA, and Dubrovsky:
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 103-123 of copending Application No. 18/417,725 (hereinafter, “the ’725 Application”), in view of Jaecklin, Lumena, EMA, and Dubrovsky. This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected for nonstatutory double patenting over the ’029 Application in view of Jaecklin, Lumena, EMA, and Dubrovsky:
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 103-123 of copending Application No. 18/423,029 (hereinafter, “the ’029 Application”), in view of Jaecklin, Lumena, EMA, and Dubrovsky. This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected for nonstatutory double patenting over the ’909 Application in view of Jaecklin, Lumena, EMA, and Dubrovsky:
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 and 30-36 of copending Application No. 17/972,909 (hereinafter, “the ’909 Application”), in view of Jaecklin, Lumena, EMA, and Dubrovsky. This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected for nonstatutory double patenting over the ’033 Application in view of Jaecklin, Lumena, EMA, and Dubrovsky:
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 9-10, 13, 20-24, 27-33, 37-38, 42-44, 48, 50, 52, 58-63, and 65-68 of copending Application No. 17/981,033 (hereinafter, “the ’033 Application”), in view of Jaecklin, Lumena, EMA, and Dubrovsky. This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected for nonstatutory double patenting over the ’636 Application in view of Jaecklin, Lumena, EMA, and Dubrovsky:
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7, 9, 18-19, 21, 24-25, 27, 29-30, 37, 47, 54, 67-69, 7581, and 85 of copending Application No. 18/382,636 (hereinafter, “the ’636 Application”), in view of Jaecklin, Lumena, EMA, and Dubrovsky. This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected for nonstatutory double patenting over the ’216 Application in view of Jaecklin, Lumena, EMA, and Dubrovsky:
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 171-200 of copending Application No. 18/377,216 (hereinafter, “the ’216 Application”), in view of Jaecklin, Lumena, EMA, and Dubrovsky. This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected for nonstatutory double patenting over the ’443 Application in view of Jaecklin, Lumena, EMA, and Dubrovsky:
Claims 1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-49, 52-55, and 69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 171-200 of copending Application No. 19/200,443 (hereinafter, “the ’443 Application”), in view of Jaecklin, Lumena, EMA, and Dubrovsky. This is a provisional nonstatutory double patenting rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ’132 Application recites a method for treating a cholestatic liver disease in a subject in need of such treatment comprising administering an ASBTI, while claim 3 specifies that the ASBTI is maralixibat. Similarly, claim 1 of the ’168 Application recites a method for increasing growth in a pediatric subject having cholestatic liver disease comprising administering to the subject an ASBTI that can be maralixibat (claim 3 specifying the ASBTI is maralixibat). To this point, it is noted that Jaecklin teaches maralixibat is useful to improve growth in a subject having cholestatic liver disease (paragraph [00618]).
Similarly, claim 1 of the ’210 Application recites a method for treating a cholestatic liver disease in a subject in need of such treatment comprising administering an ASBTI, while claim 3 specifies that the ASBTI is maralixibat. Claim 1 of the ’125 Application recites a method for treating or ameliorating a cholestatic liver disease in a subject in need thereof, wherein the subject has a BSEP deficiency, the method comprising administering an ASBTI, while claim 3 specifies that the ASBTI is maralixibat. Claim 103 of the ’725 Application recites a method for treating PFIC in a subject in need of such treatment comprising administering maralixibat in an amount of from about 560-1400 µg/kg/day. Claim a of the ’443 Application recites a method for treating a rare cholestatic liver disease in a subject in need thereof, the method comprising administering an to the subject about 300-1200 µg/kg/day of maralixibat.
Claim 103 of the ’029 Application recites a method for treating Alagille Syndrome in a subject in need of such treatment comprising administering a liquid pharmaceutical composition comprising maralixibat in an amount of from about 400-800 µg/kg/day, a chelating agent, a sweetener, a flavoring agent, and a liquid carrier. Claim 10 of the ’909 Application recites a method for treating cholestatic liver disease in a subject in need thereof, the method comprising administering a therapeutically effective amount of an ASBTI (where the ASBTI is one of two enumerated, including maralixibat) to the subject before ingestion of food, wherein the subject experiences a reduction in frequency and/or severity of one or more side effects associated with the administration of the ASBTI.
Claim 65 of the ’033 Application recites a method of treating Alagille syndrome in a pediatric subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of maralixibat or a pharmaceutically acceptable salt thereof, wherein the administration results in several enumerated functional outcomes. Claim 1 of the ’636 Application recites a method for treating a progressive familial intrahepatic cholestasis (PFIC) in a subject in need thereof comprising administering to the subject maralixibat, or a pharmaceutically acceptable salt thereof, wherein the maralixibat or pharmaceutically acceptable salt thereof is administered in an amount from about 600 µg/kg/day to about 1200 µg/kg/day.
Claim 171 of the ’216 Application recites a pharmaceutical composition comprising maralixibat along with a diluent, a glidant, a lubricant, and a disintegrant. Thus, while the ’216 Application claims a solid formulation, i.e. a tablet, this is within the scope of many of the instant composition claims, while Jaecklin teaches that solid and liquid maralixibat formulations are viable alternative forms (e.g. paragraph [00703]). Claim 188 of the ’216 Application recites a method of treating cholestatic liver disease in a subject in need thereof comprising administering to the subject a therapeutically effective amount of the pharmaceutical composition of claim 171.
The U.S. Patent Application Publication for each of the above-referenced Patent Applications is referenced in the Notice of References Cited, filed along with this Office Action.
The above-referenced method claims of the cited copending Patent Applications recite all elements of instant claim 48 (which recites a method of treating a pediatric cholestatic liver disease comprising administering to a pediatric subject a pharmaceutical composition of instant claim 1) except that the reference claims generally not require that the maralixibat be administered as part of a composition that includes an antioxidant and a preservative of instant claim 1 (although claim 103 of the ’029 Application does require a chelating agent that can be EDTA and a liquid carrier that can be propylene glycol). However, inclusion of such an antioxidant and a preservative along with the maralixibat would have been obvious based on the teachings of Jaecklin, as described above in reference to the rejection of instant claim 1 for obviousness. In particular, and as demonstrated by Jaecklin, inclusion of an antioxidant (e.g. EDTA, including at a concentration within the recited range) and a preservative (e.g. propylene glycol) along with maralixibat for administration in treating cholestatic liver diseases was well-known in the art. A propylene glycol concentration within the recited range is taught by Lumena and ELA. Instant claim 48, which depends from claim 47 and specifies Alagille Syndrome as a disease to be treated, is subject to the nonstatutory double patenting rejection for the same reason.
The other instant method of treatment claims (52-55, and 69) are likewise obvious variants of the methods of the reference claims, in view of the teachings of Jaecklin. As noted above, Jaecklin teaches that a variety of cholestatic liver diseases and associated symptoms, such as pruritis (instant claim 52), hypercholemia (instant claim 53), xanthoma (instant claim 54), and elevated serum bile levels (instant claim 55) are similarly amenable to treatment via maralixibat administration (paragraph [00585]). Further, Jaecklin teaches the utility of combining maralixibat with a second therapeutic agent including a PPAR agonist (instant claim 69) such as fenofibrate (see Jaecklin paragraph [00754]), with the specific use of seladelpar taught by Dubrovsky.
With respect to the composition claims (1, 3, 8, 13-14, 16, 24-26, 32-33, 39-43, 45-47), the composition itself is obvious over the method of using it. As such, the composition claims are rejected for nonstatutory double patenting over the method claims of the reference Applications, in view of Jaecklin, for the reasons described above relating to the rejections for obviousness. And as noted, claim 171 of the ’216 Application recites solid compositions that, while not requiring the obvious antioxidant and preservative of the instant claims, are otherwise a subset of the general instant composition claims and an obvious variant of the instant liquid composition claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER K SHOWALTER whose telephone number is (571)270-0610. The examiner can normally be reached M-F 9:00 am to 5:00 pm, eastern time.
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/ALEXANDER K. SHOWALTER/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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