DETAILED CORRESPONDENCE
This office action is in response to applicant’s filing dated August 4, 2025.
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 .
Status of Claims
Claims 211-223, 226-237, 240-251, 254, 257, 259-269, and 271-291 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed August 4, 2025. Acknowledgement is made of Applicant's amendment of claims 257, 269, and 288; cancelation of claims 258 and 270; and addition of new claims 290 and 291. Claims 1-210, 224, 225, 238, 239, 252, 253, 255, and 256 were previously canceled.
Applicants elected without traverse Group I, drawn to a pharmaceutical composition comprising 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-benzyl)-4- methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenyl-ethylamino)-butyric acid (Compound A) or a pharmaceutically acceptable salt thereof:
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and an anti-gelling agent as the elected invention and a formulation comprising an anti-gelling agent, sodium carbonate and a water soluble filler, mannitol as the elected species in the reply filed on August 12, 2019. The requirement is still deemed proper. Claims 211-223, 226-237, 240-251, 254, and 281-283 remain withdrawn.
New claims 290 and 291 read on the elected species. Thus, claims 290 and 291 are presently under examination.
Claims 257, 259-269, 271-280, and 284-291 are presently under examination as they relate to the elected composition: a formulation comprising an anti-gelling agent, sodium carbonate and a water soluble filler, mannitol.
Priority
The present application is claims benefit of US Provisional Application Nos. 62/547,402 and 62/660,102 filed on August 18, 2017 and April 19, 2018, respectively and to PCT/US2018/043321 filed on July 23, 2018. The effective filing date of the instant application is August 18, 2017.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 28. 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Modified Objections and/or Rejections
Modifications Necessitated by Claim Amendment
Claim Rejections - 35 USC § 112(a)
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 257, 259-269, 271-280, and 284-291 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The Written Description Guidelines for examination of patent applications indicates, "the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical characteristics and/or other chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show applicant was in possession of the claimed genus." (Federal register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001, see especially page 1106 column 3) and (see MPEP 2164).
Regarding claims 257, 259-269, 271-280, and 284-291, independent claims 257 and 269 are directed to a stable pharmaceutical composition for a compressed immediate release tablet, comprising: a blend comprising: sodium 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6- trifluoromethyl-benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]- 1-phenyl-ethylamino)butanoate ("elagolix sodium"); a water soluble filler, wherein the water soluble filler is a polyol, a pregelatinized starch, or a combination thereof; and an anti-gelling agent, wherein the anti-gelling agent comprises a water soluble salt of a weak acid, a base, a basic amino acid, or a basic salt.
Thus, the claims encompass a genus of compositions comprising a genus of compounds which function as a water soluble filler and a genus of compounds that function as an anti-gelling agent with no other defined structural components. In a review of the instant specification, the specification does not appear to provide guidance as to what structural components are critical to the desired function (see below). The Examiner acknowledges that a water soluble filler has been limited to a polyol, a pregelatinized starch, or a combination thereof. The examiner notes that by broadest reasonable interpretation the term polyol is any compound containing multiple alcohol (-OH) substituents. Because there are an innumerably large number of compounds within the scope of the generic claims, it would require extensive manpower to make and test each compound to determine which compound would possess the recited properties (i.e., function as water soluble filler and/function as anti-gelling agent, respectively) and be useful in the instantly claimed compositions.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
In the instant case, the claims are drawn to a stable pharmaceutical composition for a compressed immediate release tablet, comprising: a blend comprising: about 155 mg sodium 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6- trifluoromethyl-benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]- 1-phenyl-ethylamino)butanoate ("elagolix sodium"); a water soluble filler; and an anti-gelling agent. The claims are generic, broadly reciting a genus of water soluble filler and an anti-gelling agent encompassed by the instant claims.
As stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claim(s) 257-280 is/are broad and generic, with respect to all possible compounds encompassed by the claims. The possible variation of any molecule that functions as water soluble filler, polyol, within the scope of claims 257, 259-269, 271-280, and 284-291 are limitless and would encompass compounds not yet discovered. The Examiner notes that by broadest reasonable interpretation a polyol encompasses any compound containing multiple hydroxyl groups. The possible variation of any molecule that functions as an anti-gelling agent within the scope of claims 257-280 are limitless and would encompass a water soluble salt of a weak acid, a base, a basic amino acid, or a basic salt, that functions as an anti-gelling agent in the disclosed compositions including compounds not yet discovered. The claims lack written description because there is no disclosure of a correlation between structural components of a water soluble filler, polyol, suitable for use in the instantly claimed composition. Furthermore, the claims lack written description because there is no disclosure of a correlation between structural components of an anti-gelling agent suitable for use in the instantly claimed composition. Moreover, the specification lacks sufficient variety of species to reflect this variance in the genus.
Response to Arguments
Applicant argues:
For "water soluble filler, polyol," the present Specification discloses the function of a filler, and specifically water soluble fillers. And, as the Office acknowledges, the structure of polyols is well-known in the art as "any compound containing multiple alcohol (-OH) substituents." The correlation between this disclosed function and the structure of polyols is well-established - it is precisely the alcohol (-OH) groups that allows such compounds to be water soluble. For "anti-gelling agent,” wherein the anti-gelling agent comprises a water soluble salt of a weak acid, a base, a basic amino acid or a basic salt," the present specification discloses the function of the anti-gelling agent. Lockwood, Gosteli, and Regents establish that the written description requirement is not satisfied where a specification lacks any disclosure of a claimed element. In contrast here, the present Specification clearly describes "a water soluble filler, polyol" and "anti-gelling agent."
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
The specification provides examples of what a water soluble filler could be, but does not specifically set forth the structural components required for said water soluble filler other than it comprise either pregelatinized starch or polyol (a compound comprising multiple alcohol (-OH) moieties). Thus, as set forth above, the possible variation of any molecule that functions as water soluble filler, polyol, within the scope of claims are limitless and would encompass water soluble filler compounds not yet discovered. The specification provides examples of anti-gelling agents, but does not specifically define an anti-gelling agent or set forth the structural components required for an anti-gelling agent. By broadest reasonable interpretation an anti-gelling agent is any agent that would prevent the formation of a gel. The Examiner acknowledges that the claims set forth that the anti- gelling agent comprises a water soluble salt of a weak acid, a base, a basic amino acid, or a basic salt and that the specification provides examples of compounds. As set forth above, the possible variation of any molecule that functions as an anti-gelling agent within the scope of claims are limitless and would encompass a water soluble salt of a weak acid, a base, a basic amino acid, or a basic salt, that functions as an anti-gelling agent in the disclosed compositions including compounds not yet discovered. The claims lack written description because there is no disclosure of a correlation between structural components of an anti-gelling agent suitable for use in the instantly claimed composition. Moreover, the specification lacks sufficient variety of species to reflect this variance in the genus.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 257, 259-269, 271-280, and 284-291 are rejected under 35 U.S.C. 103 as being unpatentable over Guo et al (US 7,419,983 B2, cited in a previous Office Action) in view of Li (US 2016/0354315 A1, cited in a previous Office Action) and Mohr (Standards of Practice for the Pharmacy Technician, Lippincott Williams & Wilkins, 2010, Chapter 8, cited in a previous Office Action).
Regarding claims 257, 259, 260, 263, 269, 271, 272, 275, 284, 288, 290 and 291, Guo teaches pharmaceutical compositions comprising GnRH antagonists (col 2, line 35-38, and claim 21) wherein the composition comprises a pharmaceutically acceptable carrier or diluent and a compound of formula (I) wherein the compound is 3-2(R)-hydroxycarbonylpropyl-amino-2-phenylethyl-5-(2-fluoro-3-methoxyphenyl)-1-2-fluoro-6-(trifluoromethyl)benzyl-6-methylpyrimidine-2,4(1H,3H)-dione or a pharmaceutically acceptable salt thereof, (claim 22, and col 17, Example 1), wherein the compound is the sodium salt of 3-2(R)-hydroxycarbonylpropyl-amino-2-phenylethyl-5-(2-fluoro-3-methoxyphenyl)-1-2-fluoro-6-(trifluoromethyl)benzyl-6-methylpyrimidine-2,4(1H.3H)-dione (claims 24 and 25):
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Guo teaches for oral administration, suitable pharmaceutical compositions of GnRH receptor antagonists include granules and tablets (col 16, lines 29-31). Guo teaches the compositions can be formulated as tablets which contain, in addition to a GnRH receptor antagonist, diluents, dispersing and surface active agents.
Guo does not teach the pharmaceutically acceptable carrier or diluent is an anti-gelling agent, sodium carbonate and a water soluble filler, a polyol, mannitol.
However, Li teaches a stable solid pharmaceutical dosage form for oral administration wherein the dosage form is so designed that the active pharmaceutical ingredient of the drug content is released in a controlled manner (abstract); wherein the API (active pharmaceutical ingredient) is elagolix [0091]; wherein the drug content further comprises an excipient, wherein the excipient is mannitol [0010]; wherein the dosage form comprises a gas-generating component loaded into the first compartment, the gas generating component is sodium carbonate [0111]. Moreover, Li teaches in certain embodiments the outer layers of the dosage form dissolve immediately and release the embedded drug content when the dosage form is administered. Thus, Li suggests a composition comprising elagolix wherein the excipients include mannitol and sodium carbonate. It would have been prima facie obvious to a person of ordinary skill in the art, formulate a solid composition comprising Compound A, mannitol, and sodium carbonate and wherein the composition is formulated for immediate release in view of the teachings of Li.
Regarding the limitation wherein the anti-gelling agent provides a microenvironment having a pH of about 3.5 to about 8.0 when the tablet contacts an acidic medium, the cited art teach the elected anti-gelling agent, sodium carbonate. “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01.II.
Regarding the limitation “compressed immediate release tablet,” as set forth above the cited art suggest a tablet composition comprising Compound A, mannitol, and sodium carbonate wherein the composition is formulated for immediate release. The cited art do not explicitly teach the tablet is compressed. However, Mohr teaches one of the oldest and most common dosage forms is the oral tablet; the tablet is a solid dosage form that contains an active ingredient (the drug) and may or may not have additional diluents, colorings, flavorings, and/or disintegrates; and most commercial tablets on the market today are compressed tablets formed by using pressure and some type of punch machine to create the desired size and shape. It would have been prima facie obvious to one of ordinary skill in the art to formulate the tablet composition comprising Compound A, mannitol, and sodium carbonate wherein the composition is formulated for immediate release suggested by the prior art in a compressed tablet since compressed tablets are the most common commercially available tablets on the market.
Regarding the amount of elagolix of instant claim 257, 269 and 289, Guo teaches the GnRH antagonist is in an amount from 0.1 mg to 250 mg, more typically from 1 mg to 60 mg (col 16, lines 1-5). Regarding the claimed ratio of elagolix to anti-gelling agent of instant claims 257, 264, 268, 269, 276, and 280, it would have been prima facie obvious to one of ordinary skill in the art to optimize ratio of elagolix and sodium carbonate to formulate a composition comprising elagolix and sodium carbonate because ratio of components is a result-effective variable, i.e., a variable that achieves a recognized result. Similarly, regarding claims 265, 277, and 285-288, it would have been obvious to one of ordinary skill in the art to optimize amounts of elagolix, mannitol, and sodium carbonate to formulate a composition comprising elagolix, mannitol and sodium carbonate amounts of active agents and excipients is a result-effective variable, i.e., a variable that achieves a recognized result. Therefore, the determination of the optimum or workable amounts and ratios would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosage given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Regarding claims 261, 262, 266, 267, 273, 274, 278, and 279, the prior art does not explicitly teach the anti-gelling agent, sodium carbonate, acts as a stabilizer to reduce formation of Compound B (claims 261, 262, 273, and 274); wherein the composition comprises less than 0.7% Compound B after storage for at least one month at 25°C and 60% relative humidity (claims 266 and 278); or wherein the composition comprises less than 0.7% Compound B after storage from about one month to about three months at 25°C and 60% relative humidity (claim 267 and 279). However, the above functional and pharmacokinetic properties depend, among other things, from the specific components, relative amounts, type of formulation, and pH of the formulation etc., all of which seem to be the same or very similar to the composition made obvious by the prior art (see above rejection).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the formulations comprising elagolix, sodium carbonate, and mannitol that will result from the teachings of the prior art does not possess the same material, structural and functional characteristics of the formulation claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the formulation used in the instantly claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Taken together, all this would result in the composition of claims 257, 259-269, 271-280, and 284-291 with a reasonable expectation of success.
Response to Arguments
Applicant argues:
None of the cited references teach or suggest "wherein the weight ratio of elagolix sodium to the anti-gelling agent is between 0.5:1 and 20:1.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
As set forth above, Guo teaches the GnRH antagonist is in an amount from 0.1 mg to 250 mg, more typically from 1 mg to 60 mg (col 16, lines 1-5). Regarding the claimed ratios of elagolix to anti-gelling agent of instant claims, it would have been prima facie obvious to one of ordinary skill in the art to optimize ratio of elagolix and sodium carbonate to formulate a composition comprising elagolix and sodium carbonate because ratio of components is a result-effective variable, i.e., a variable that achieves a recognized result. Therefore, the determination of the optimum or workable amounts and ratios would have been well within the practice of routine experimentation by the skilled artisan.
Applicant argues:
Guo does not disclose an anti-gelling agent, much less a weight ratio of elagolix to anti-gelling agent in a tablet. Li does not disclose an amount of elagolix or sodium carbonate, much less a weight ratio between the two.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
Applicants are reminded that it must be remembered that the references are relied upon in combination and are not meant to be considered separately as in a vacuum. It is the combination of all of the cited and relied upon references, which make up the state of the art with regard to the claimed invention. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference and it is not that the claimed invention must be expressly suggested in any one or all of the references; but rather the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, as set forth above, Guo teaches an oral tablet pharmaceutical composition comprising elagolix, diluents, dispersing agents, and surface active agents. As set forth above, Li teaches a stable solid pharmaceutical dosage form for oral administration comprising elagolix; wherein the drug content further comprises an excipient, wherein the excipient is mannitol; wherein the dosage form comprises a gas-generating component loaded into the first compartment, the gas generating component is sodium carbonate. Moreover, Li teaches in certain embodiments the outer layers of the dosage form dissolve immediately and release the embedded drug content when the dosage form is administered. Thus, Li suggests a composition comprising elagolix wherein the excipients include mannitol and sodium carbonate. It would have been prima facie obvious to a person of ordinary skill in the art, formulate a solid composition comprising Compound A, mannitol, and sodium carbonate and wherein the composition is formulated for immediate release in view of the teachings of Li.
Applicant argues:
The cited references do not teach or suggest "wherein the anti-gelling agent provides a microenvironment having a pH of about 3.5 to about 8.0 when the tablet contacts an acidic medium."
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
As set forth above, the cited art teach the elected anti-gelling agent, sodium carbonate. “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01.II.
Conclusion
Claims 257-280 and 284-289 are rejected.
No claim is 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 RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628