DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-7, 10-20, 26, and 27 are pending in the application.
Applicant’s amendment to the claims, filed September 30, 2025, is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Applicant’s amendment to the specification, filed September 30, 2025, is acknowledged.
Applicant’s remarks filed September 30, 2025 in response to the non-final rejection mailed June 30, 2025 are acknowledged and have been fully considered.
Rejections previously applied to claims 8, 9, and 29 are withdrawn in view of applicant’s amendment to cancel these claims.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Restriction/Election
In response to a requirement for restriction/election mailed April 17, 2025, applicant elected without traverse Group I, pending claims 1-7, 10-20, and 26 in the reply filed June 16, 2025.
Claim 27 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 30, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
Specification/Informalities
The objection to the disclosure is withdrawn in view of applicant’s amendment to
delete “http://,” leaving only the top-level domain name.
Claim Rejections - 35 USC § 112(b)
The rejection of claims 16 and 17 under 35 U.S.C. 112(b) is withdrawn in view of applicant’s amendments to claims 16 and 17 to depend from claim 15.
Claims 11, 12, and 20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Rejection of claim 26 is necessitated by applicant’s amendment to cancel claim 21.
Claims 11, 12, and 20 are indefinite in the recitation of “about” with respect to a numerical value. The term “about” is a term of degree and while the specification provides a description of “about” (paragraph [0035]), it remains unclear from the specification and the claims as to variance intended by the recited term of degree. It is suggested that applicant clarify the meaning of the term “about.” See MPEP 2173.05(b).III.A.
RESPONSE TO REMARKS: Applicant argues that since the definition of “about” at specification paragraph [0035] is tied to the understanding and judgment of one of skill in the art and provides examples to illustrate this definition, the degree of variance encompassed by the term “about” is, by definition, clear to one of skill in the art.
Applicant’s argument is not found persuasive. What variance for “about” would be recognized by one of skill in the art depends on the individual situation as well as the person making the determination. As such, one of skill in the art would not recognize the variance intended by the specification paragraph [0035] disclosure of “a range of numbers that one of skill in the art would consider equivalent to the recited value.” Moreover, given the varying descriptions of “about” at specification paragraph [0035], one of skill in the art would not recognize the intended variance of “about.” For example, specification paragraph [0035] discloses exemplary variations that are within 20% or 10% or 5%, however, it is unclear from specification paragraph [0035] as to whether or not percentages that are not within 20%, e.g., 25% or 30%, are also intended to be encompassed by “about.” In the interest of compact prosecution, applicant may consider an amendment to expressly recite the variance intended by the term “about.”
Claim 26 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. This rejection is necessitated by applicant’s amendment to cancel claim 21.
Claim 26 is indefinite because the claim depends from a canceled claim. Appropriate correction is required.
Claim Rejections - 35 USC § 102
Claim 26 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Car et al. (Polish Journal of Neurology and Neurosurgery 55:13-140, 2021; cited on Form PTO-892 mailed June 30, 2025; hereafter “Car”). This rejection is necessitated by applicant’s amendment to cancel claim 21.
Claim 26 is drawn to a solid composition produced by the method of claim 21. As noted above, claim 21 has been canceled and consequently, it is entirely unclear as to the scope of the solid composition of claim 26.
Car teaches OnabotulinumtoxinA, which is a vacuum-dried powder (p. 134, Table 1). Given the indefiniteness of claim 26, OnabotulinumtoxinA as taught by Car is considered to be encompassed by claim 26.
Therefore, Car anticipates claim 26 as written.
Claim Rejections - 35 USC § 102/103
Claims 1-7, 10-20, and 26 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Car as evidenced by
Ferrari et al. (Functional Neurology 33:7-18, 2018; cited on Form PTO-892 mailed June 30, 2025; hereafter “Ferrari”),
Doctor Medica (obtained from https://www.doctormedica.co/blog/is-botox-vegan-juvederm-restylane on June 25, 2025, 2 pages; cited on Form PTO-892 mailed June 30, 2025), and
Prescribing Information (52 pages, November, 2023; cited on Form PTO-892 mailed June 30, 2025).
See MPEP 2112.III regarding a rejection under 35 U.S.C. 102 and 103 when the prior art product seems to be identical except that the prior art is silent as to an inherent characteristic.
Claims 1-20 are drawn to a solid composition comprising a 900 kDa Clostridium botulinum neurotoxin serotype A (BoNT/A) complex, human serum albumin (HSA), and sodium chloride (NaCl), wherein the HSA comprises HSA monomer and HSA aggregates, wherein at least a portion of the HSA is in the form of soluble HSA when the solid composition is reconstituted in an aqueous medium, and wherein less than 34% of soluble HSA contained in the solid composition are HSA aggregates.
Claim 26 is drawn to a solid composition produced by the method of claim 21. As noted above, claim 21 has been canceled and consequently, it is entirely unclear as to the scope of the solid composition of claim 26.
Regarding claims 1-6 and 13, Car teaches OnabotulinumtoxinA (p. 134, Table 1), which is a BoNT/A product derived from Clostridium botulinum Hall strain (p. 133, column 1, bottom) having a molecular weight of 900 kDa (p. 134, Table 1), comprising human serum albumin and sodium chloride (p. 134, Table 1) that is a vacuum-dried powder (p. 134, Table 1).
Car does not teach the claim 1 limitation “wherein the HSA comprises HSA monomer and HSA aggregates, wherein at least a portion of the HSA is in the form of soluble HSA when the solid composition is reconstituted in an aqueous medium, and wherein less than 34% of soluble HSA contained in the solid composition are HSA aggregates” and the limitations of claims 2-6. However, according to the instant specification, the properties of “wherein at least a portion of the HSA is in the form of soluble HSA when the solid composition is reconstituted in an aqueous medium, and wherein less than 34% of soluble HSA contained in the solid composition are HSA aggregates” in claim 1 and the properties of claims 2-6 are a result of vacuum drying without a freezing step (see, e.g., specification at paragraphs [00158] to [00168] and [00180] to [00185]). Given that OnabotulinumtoxinA is vacuum dried without a freezing step (see evidentiary reference Ferrari at p. 9, column 2, bottom), and otherwise satisfies all other structural features of the solid composition of claims 1-6, OnabotulinumtoxinA inherently has the property of “wherein at least a portion of the HSA is in the form of soluble HSA when the solid composition is reconstituted in an aqueous medium, and wherein less than 34% of soluble HSA contained in the solid composition are HSA aggregates” in claim 1 and the properties recited in claims 2-6. Since the Office does not have the facilities for examining and comparing applicants’ solid composition with OnabotulinumtoxinA, the burden is on the applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., that OnabotulinumtoxinA does not possess the same material structural and functional characteristics of the claimed solid composition). See MPEP 2112.IV.
Regarding claim 7, Car teaches OnabotulinumtoxinA is a vacuum-dried powder (p. 134, Table 1) that is widely used in clinical practice (p. 133, Abstract).
Regarding claim 9, Car does not teach OnabotulinumtoxinA is animal product free. However, evidentiary reference Doctor Medica is cited to show that OnabotulinumtoxinA (i.e., Botox) does not contain ingredients derived from animals (p. 1, top).
Regarding claim 10, the recitation of “recombinant” in the phrase “recombinant HSA” does not structurally and/or functionally distinguish over the human serum albumin of OnabotulinumtoxinA.
Regarding claims 11 and 12, Car teaches OnabotulinumtoxinA comprises 0.5 mg human serum albumin and 0.9 mg sodium chloride per 100 units (p. 134, Table 1).
Regarding claims 14-17, the recitation of “the BoNT/A is produced by…” in claims 14 and 15 are product-by-process limitations (see MPEP 2113.I) and do not structurally and/or functionally distinguish over the BoNT/A of OnabotulinumtoxinA.
Regarding claims 18 and 19, the components of OnabotulinumtoxinA are BoNT/A, human serum albumin, and sodium chloride (see Car at p. 134, Table 1). A protease inhibitor and benzamidine hydrochloride are not components of OnabotulinumtoxinA.
Regarding claim 20, evidentiary reference Prescribing Information is cited to show that the potency of BOTOX® (i.e., OnabotulinumtoxinA) is approximately 20 Units/nanogram, which is equivalent to 2.0 x 107 units/mg.
Regarding claim 26, Car teaches OnabotulinumtoxinA, which is a vacuum-dried powder (p. 134, Table 1). Given the indefiniteness of claim 26, OnabotulinumtoxinA as taught by Car is considered to be encompassed by claim 26.
Therefore, claims 1-7, 10-20, and 26 are anticipated by or, in the alternative, obvious over Car.
RESPONSE TO REMARKS: Applicant argues that a vacuum drying process for a solution without a freezing step is a different concept from a vacuum drying process for a solution without undergoing freezing. According to applicant, while Ferrari discloses that OnabotulinumtoxinA is prepared by vacuum drying without a freezing step, Ferrari fails to provide a basis for showing that the preparation of OnabotulinumtoxinA avoids entering the frozen state during the vacuum drying process and in fact, one of ordinary skill in the art would know that the opposite is true.
Applicant’s arguments are not found persuasive. According to MPEP 706.I, “[t]he standard to be applied in all cases is the ‘preponderance of the evidence’ test. In other words, an examiner should reject a claim if, in view of the prior art and evidence of record, it is more likely than not that the claim is unpatentable.”
As stated above, the instant specification discloses the properties of “wherein at least a portion of the HSA is in the form of soluble HSA when the solid composition is reconstituted in an aqueous medium, and wherein less than 34% of soluble HSA contained in the solid composition are HSA aggregates” in claim 1 and the properties recited in claims 2-6 are a result of vacuum drying without a freezing step (see, e.g., specification at paragraphs [00158] to [00168] and [00180] to [00185]). Since OnabotulinumtoxinA is prepared by vacuum drying without freezing (as evidenced by Ferrari), it is the examiner’s position that in view of the preponderance of the evidence, OnabotulinumtoxinA inherently has the property of “wherein at least a portion of the HSA is in the form of soluble HSA when the solid composition is reconstituted in an aqueous medium, and wherein less than 34% of soluble HSA contained in the solid composition are HSA aggregates” and the properties recited in claims 2-6. Dependent claim 13 even limits the composition to being OnabotulinumtoxinA.
The examiner has provided a rationale and evidence to show inherency and according to MPEP 2112.V, once a reference teaching a product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant. Although applicant argues that “one of ordinary skill in the art would know that the opposite is true” (i.e., that in the process for preparing OnabotulinumtoxinA, one of ordinary skill in the art would know that a solution of BoNT/A is frozen during vacuum drying), there is no evidence of record to support applicant’s allegation and arguments presented by applicant cannot take the place of evidence in the record (MPEP 716.01(c)).
For these reasons, it is the examiner’s position that claims 1-7, 10-20, and 26 are anticipated by or, in the alternative, obvious over Car.
Claim Rejections - 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-7, 10-20, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 9, 11, 13, 16, 19, 20, and 22-24 of co-pending application no. 18/418,028 (reference application) as evidenced by Car and Ferrari.
Regarding instant claims 1-7 and 11-13, claim 1 of the reference application recites a composition comprising a plurality of 900 kDa Clostridium botulinum neurotoxin serotype A (BoNT/A) complex species, wherein the composition comprises:
(a) a 900 kDa BoNT/A complex species comprising a 150 kDa BoNT/A sequence variant species with a C-terminal truncated light chain, wherein the C-terminal truncated light chain has an amino acid sequence set forth in SEQ ID NO: 4, and
(b) a 900 kDa BoNT/A complex species comprising a 150 kDa BoNT/A sequence variant species with a full-length light chain, wherein the full-length light chain has an amino acid sequence set forth in SEQ ID NO: 2,
wherein the abundance ratio of the 150 kDa BoNT/A sequence variant species with the C-terminal truncated light chain to the 150 kDa BoNT/A sequence variant species with the full-length light chain is less than 3.9;
claim 8 of the reference application recites the composition of claim 1, wherein the 900 kDa BoNT/A complex is onabotulinumtoxin A;
claim 9 of the reference application recites the composition of claim 1, which further comprises about 0.5 mg of human serum albumin per 100 units of the 900 kDa BoNT/A complex and about 0.9 mg of sodium chloride per 100 units of the 900 kDa BoNT/A complex; and
claim 20 of the reference application recites the composition of claim 1, which is a powdered pharmaceutical composition.
The claims of the reference application do not recite the instant claim 1 limitation “wherein the HSA comprises HSA monomer and HSA aggregates, wherein at least a portion of the HSA is in the form of soluble HSA when the solid composition is reconstituted in an aqueous medium, and wherein less than 34% of soluble HSA contained in the solid composition are HSA aggregates” and the limitations of instant claims 2-6. However, according to the instant specification, the properties of “wherein at least a portion of the HSA is in the form of soluble HSA when the solid composition is reconstituted in an aqueous medium, and wherein less than 34% of soluble HSA contained in the solid composition are HSA aggregates” in claim 1 and the properties recited in claims 2-6 are a result of vacuum drying without a freezing step (see, e.g., specification at paragraphs [00158] to [00168] and [00180] to [00185]). Given that OnabotulinumtoxinA is vacuum dried without a freezing step (see evidentiary reference Car at p. 134, Table 1 and evidentiary reference Ferrari at p. 9, column 2, bottom), and otherwise satisfies all other structural features of the solid composition of claims 1-6, it follows that OnabotulinumtoxinA inherently has the property of “wherein at least a portion of the HSA is in the form of soluble HSA when the solid composition is reconstituted in an aqueous medium, and wherein less than 34% of soluble HSA contained in the solid composition are HSA aggregates” in claim 1 and the properties recited in instant claims 2-6. Since the Office does not have the facilities for examining and comparing applicants’ solid composition with OnabotulinumtoxinA, the burden is on the applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., that OnabotulinumtoxinA does not possess the same material structural and functional characteristics of the claimed solid composition). See MPEP 2112.IV.
Regarding instant claim 10, claim 11 of the reference application recites the human serum albumin is recombinant human serum albumin.
Regarding instant claims 14-17, claim 22 of the reference application recites wherein the 900 kDa BoNT/A complex is purified by one or more steps of column chromatography;
claim 23 of the reference application recites wherein the one or more steps of column chromatography comprise hydrophobic interaction chromatography; and
claim 24 of the reference application recites wherein the one or more steps of column chromatography further comprise anion exchange chromatography or cation exchange chromatography.
Regarding instant claim 18, claim 16 of the reference application recites the composition does not contain a protease inhibitor.
Regarding instant claim 19, the components of OnabotulinumtoxinA are BoNT/A, human serum albumin, and sodium chloride (see Car at p. 134, Table 1). Benzamidine hydrochloride is not a component of OnabotulinumtoxinA.
Regarding instant claim 20, claim 19 of the reference application recites the composition of claim 1, wherein the composition has a potency of about 1.5×107 units/mg to about 6.0×107 units/mg.
Regarding instant claim 26, given the indefiniteness of claim 26, OnabotulinumtoxinA of claim 8 of the reference application and/or the powdered pharmaceutical composition of claim 20 of the reference application is/are considered to be encompassed by claim 26.
Therefore, claims 1-7, 10-20, and 26 of this application are unpatentable over the claims of the reference application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7, 10-20, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 13, 17, 18, 21-24, and 26-28 of co-pending application no. 18/890,636 (reference application) as evidenced by Car and Ferrari.
Regarding instant claims 1-7 and 13, claim 1 of the reference application recites a composition comprising a plurality of 900 kDa Clostridium botulinum serotype A (BoNT/A) neurotoxin complex species, wherein the oxidation level of 150 kDa neurotoxin species present in the composition is less than 6% at each of the following positions: 411 (M411) as shown in SEQ ID NO:2, 550 (M550) as shown in SEQ ID NO:3, 1004 (M1004) as shown in SEQ ID NO:3, and 1144 (M1144) as shown in SEQ ID NO:3;
claim 2 of the reference application recites the composition of claim 1, wherein the 900 kDa BoNT/A complex is onabotulinumtoxinA;
claim 17 of the reference application recites the composition of claim 16, wherein the pharmaceutically acceptable carrier comprises human serum albumin and sodium chloride; and
claim 18 of the reference application recites the composition of claim 1, wherein the composition is vacuum-dried.
The claims of the reference application do not recite the composition is a powdered solid as recited in instant claims 1 and 7. However, evidentiary reference Car is cited to show that onabotulinumtoxinA is a vacuum-dried powder (p. 134, Table 1).
The claims of the reference application do not recite the instant claim 1 limitation “wherein the HSA comprises HSA monomer and HSA aggregates, wherein at least a portion of the HSA is in the form of soluble HSA when the solid composition is reconstituted in an aqueous medium, and wherein less than 34% of soluble HSA contained in the solid composition are HSA aggregates” and the limitations of instant claims 2-6. However, according to the instant specification, the properties of “wherein at least a portion of the HSA is in the form of soluble HSA when the solid composition is reconstituted in an aqueous medium, and wherein less than 34% of soluble HSA contained in the solid composition are HSA aggregates” in claim 1 and the properties recited in claims 2-6 are a result of vacuum drying without a freezing step (see, e.g., specification at paragraphs [00158] to [00168] and [00180] to [00185]). Given that OnabotulinumtoxinA is vacuum dried without a freezing step (see evidentiary reference Ferrari at p. 9, column 2, bottom), and otherwise satisfies all other structural features of the solid composition of claims 1-6, it follows that OnabotulinumtoxinA inherently has the property of “wherein at least a portion of the HSA is in the form of soluble HSA when the solid composition is reconstituted in an aqueous medium, and wherein less than 34% of soluble HSA contained in the solid composition are HSA aggregates” in claim 1 and the properties recited in instant claims 2-6. Since the Office does not have the facilities for examining and comparing applicants’ solid composition with OnabotulinumtoxinA, the burden is on the applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., that OnabotulinumtoxinA does not possess the same material structural and functional characteristics of the claimed solid composition). See MPEP 2112.IV.
Regarding instant claim 10, the recitation of “recombinant” in the phrase “recombinant HSA” does not structurally and/or functionally distinguish over the human serum albumin of OnabotulinumtoxinA.
Regarding instant claims 11 and 12, evidentiary reference Car teaches OnabotulinumtoxinA comprises 0.5 mg human serum albumin and 0.9 mg sodium chloride per 100 units (p. 134, Table 1).
Regarding instant claims 14-17, claim 21 of the reference application recites wherein the 900 kDa BoNT/A complex is purified by one or more steps of column chromatography;
claim 22 of the reference application recites wherein the one or more steps of column chromatography comprise hydrophobic interaction chromatography.
claim 23 of the reference application recites wherein the one or more steps of column chromatography further comprise anion exchange chromatography; and
claim 24 of the reference application recites wherein the one or more steps of column chromatography further comprise cation exchange chromatography.
Regarding instant claims 18 and 19, claims 27 and 28 of the reference application respectively recite the composition does not contain a protease inhibitor and does not contain benzamidine hydrochloride.
Regarding instant claim 20, claim 13 of the reference application recites the composition of claim 1, wherein the composition has a potency of about 1.5×107 units/mg to about 6.0×107 units/mg.
Regarding instant claim 26, given the indefiniteness of claim 26, OnabotulinumtoxinA of claim 2 of the reference application is considered to be encompassed by claim 26.
Therefore, claims 1-7, 10-20, and 26 of this application are unpatentable over the claims of the reference application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
RESPONSE TO REMARKS: In responding to the provisional obviousness-type double patenting rejections, applicant reiterates their arguments addressing the rejection under 35 U.S.C. 102/103, which are not found persuasive for the reasons set forth above.
For these reasons, it is the examiner’s position that claims 1-7, 10-20, and 26 of this application are unpatentable over the claims of the reference application.
Citation of Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Brin et al. (Biologics 8:227-241, 2014) disclose OnabotulinumtoxinA is vacuum dried, in which the liquid is removed under reduced air pressure without the freezing step (p. 229, column 1, bottom).
“The Fact Behind Empty Toxin Vial” (April 2022, 2 pages; obtained from https://fillerhouse.com/blog/all-posts/the-fact-behind-empty-toxin-vial on October 8, 2025) describes differences in drying methods for botulinum toxins, noting that in the vacuum-drying process, water sublimes without freezing (p. 2).
Conclusion
Status of the claims:
Claims 1-7, 10-20, 26, and 27 are pending.
Claim 27 is withdrawn from consideration.
Claims 1-7, 10-20, and 26 are rejected.
No claim is in condition for allowance.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID J STEADMAN whose telephone number is (571)272-0942. The examiner can normally be reached Monday to Friday, 7:30 AM to 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MANJUNATH N RAO can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/David Steadman/Primary Examiner, Art Unit 1656