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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claimed in claims 41-54 and 58-59 in the reply filed on 10/3/25 is acknowledged. Election was made without traverse of the insulin analog, insulin aspart.
Claims 41-59 are pending.
Claims 55-57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claims 41-54 and 58-59 read on the elected Group I and elected species and are under consideration.
Claim Objections
Claim 41 is objected to because of the following informalities: claim 41 recites two spellings of the same word: “insulin analog” and “insulin analogue”. The spelling should be consistent throughout the specification and claims.
Claim 43 is objected to because of the following informalities: “wherein the tonicity agent is one or a combination of glycerol, sodium chloride, and mannitol” should be amended to “wherein the tonicity agent is selected from the group consisting of glycerol, sodium chloride, mannitol and combination thereof”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 45 is 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 45 is indefinite because the linker formula is unclear. L1 and L2 are recited independently as a bond and wherein A is a bond, resulting in the linker that comprises solely bonds (bond-bond-bond). Therefore, the claim is unclear because the claimed linker is three bonds with no intervening atoms or chemical groups recited. For purposes of examination, the claimed linker is interpreted to be a single bond connecting CB7 and PEG.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 50 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 50 recites an embodiment wherein the preservative is phenoxyethanol. This embodiment fails to further limit claim 41 because claim 41 already claims the preservative is phenoxyethanol. Please note: this rejection is only to the embodiment of claim wherein the preservative is phenoxyethanol. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 (i.e., changing from AIA to pre-AIA ) 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 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 41, 43-48, 50-52, 54 and 58-59 are rejected under 35 U.S.C. 103 as being unpatentable over Webber et al. (WO2017/062622A1, cited on IDS and provided by Applicants).
Webber et al. teach formulating insulin (non-elected species) with CB[7] (claims 4-6, 10-12) that supramolecular PEGylation of insulin with PEG-T-CB[7] promotes dramatically increased stability under these conditions and that at the 50-day endpoint of the study, none of the PEG-T-CB[7] formulations had aggregated at pH 7.4 [0018]. Webber et al. teach that insulin is well known to form fibrillar aggregates in physiologic conditions, that insulin formulated with all molecular weights of PEG-T-CB[7] did not aggregate in 100 hours of kinetic study [00236]. With respect to claim 41, Webber et al. teach CB[7]-PEG conjugates ([0019], Fig. 4A, 5, 7), meeting the limitation of claim 41 (b). With respect to 41 (a), Fig. 1B discloses a schematic representation of supramolecular PEGylation of native insulin with PEG-T-CB[7] via strong non-covalent binding of the CB[7] moiety to the B l phenylalanine residue.
With respect to the limitation of “a tonicity agent” (41 (c)), Webber et al. teach the composition comprises diluents selected from mannitol and sodium chloride [00192]. As evidenced by instant claim 43, sodium chloride and mannitol are tonicity agents.
With respect to “a preservative” (41 (d)) and “wherein the preservative is phenoxyethanol” (claim 50), Webber et al. teach that the composition comprises preservatives and exemplary antimicrobial preservatives include phenoxyethanol [00198].
Webber et al. does not teach an example of a pharmaceutical composition comprising insulin, CB[7[-PEG, a tonicity agent and phenoxyethanol. However, the teachings of Webber et al. are suggestive of the limitations.
It would have been obvious to a person of ordinary skill before the effective filing date of the invention to include a tonicity agent, such as mannitol or sodium chloride and the preservative, phenoxyethanol in the composition comprising insulin and CB[7]-PEG. A person of ordinary skill in the art would be motivated to include the agents because Webber et al. teach that composition can include sodium chloride or mannitol which are well known diluents and tonicity agents. Webber et al. also teach an exemplary antimicrobial preservative includes phenoxyethanol. There is a reasonable expectation of success given that the tonicity agents and preservatives are well known agents used routinely in pharmaceutical compositions.
With respect to claim 43, Webber et al. teach the composition comprises diluents selected from mannitol and sodium chloride [00192]. As evidenced by instant claim 43, sodium chloride and mannitol are tonicity agents.
With respect to claims 44-45, Webber et al. teach and claim CB[7] is conjugated to a Tag, wherein the tag is PEG via a linker, wherein the linker if formula L-1 that is identical to the instantly claimed linker (claims 14-19 and [00146]).
With respect to claim 46, Webber et al. teach the PEG has a molecular weight <1 kDa. In certain embodiments, the PEG has a molecular weight between 1- 10 kDa, inclusive. In certain embodiments, the PEG has a molecular weight of approximately 5 kDa. In certain embodiments, the PEG has a molecular weight between 5- 10 kDa, inclusive. In certain embodiments, the PEG has a molecular weight of approximately 10 kDa. In certain embodiments, In certain embodiments, the PEG has a molecular weight between 10-30 kDa, inclusive. In certain embodiments, the PEG has a molecular weight of approximately 30 kDa. In certain embodiments, the PEG has a molecular weight >30 kDa. In certain embodiments, the PEG has a molecular weight under 100 kDa [00137,00161]. Webber et al. teach specific examples: CB[7]-N3 was synthesized to prepare supramolecular PEG conjugates by of copper-free "click" chemistry. Dibenzocyclooctyne (DBCO)-modified poly(ethylene glycol) (PEG-DBCO) polymers of varying molecular weights ( n = 5 kDa, 10 kDa, and 30 kDa) were reacted with CB[7]-N3 to yield PEG-T-CB[7], connected via a triazole linkage (Figure 1A).
With respect to claim 47, Webber et al. teach exemplary buffers include phosphate buffer [00202].
With respect to claim 48, Webber et al. does not teach formulations comprising zinc (see [00242 and 00243], meeting the limitation of “substantially free of zinc”.
With respect to claim 51, Webber et al. teach insulin in the concentration of 1mg/ml with 1 equivalent of unmodified CB[7] or PEG-CB[7] conjugates, which is a ratio of 1:1 [00245].
With respect to claim 52, reference would inherently have all of the activities and properties of the composition of claim 41. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same…[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzqerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430,433- 34 (CCPA 1977)).” In other words, Webber et al. make obvious the pharmaceutical composition of claim 41, therefore the same composition would necessarily have the same properties of claim 52. Moreover, MPEP 2112.01 states: “Products of identical chemical composition cannot 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.
With respect to claim 54, Webber et al. teach the composition is suitable for subcutaneous administration [00238]. Webber et al. teach examples of insulin, CB[7] conjugates injected subcutaneously [00247].
With respect to claims 58 and 59, as indicated above, Webber et al. makes obvious the pharmaceutical composition of claim 41. With respect to the instructions: The written instruction is not given patentable weight absent a new and unobvious functional relationship between the printed matter and the substrate. “[Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product form the prior art.” See MPEP 2112.01. Webber et al. teach and claim treatment of diabetes (claim 65, [00110-00111, 00224, 00231]). Furthermore, Webber et al. teach and claim a kit and instructions for administering the compound. Webber et al. teach the kits contain the pharmaceutical composition, a container (i.e. vial, bottle, syringe and/or dispenser package), instructions for using the claim (claim 66 [0013, 00220-00221]. Syringe meets the limitation of a delivery device configured to deliver the pharmaceutical composition to the subject.
Claims 41-54 and 58-59 are rejected under 35 U.S.C. 103 as being unpatentable over Prestrelski et al. (US2014/0349926) in view of Webber al.
Prestrelski et al. teach a formulation for parenteral administration comprising insulin (Abstract; claim 1) and further comprising amylin (claims 21-22; [0011]). Prestrelski et al. teach that insulin analogs have been developed to prevent fibrillation and degradation of insulin while also promoting subcutaneous absorption [0009]. Prestrelski et al. teach that teach that insulin lispro has an equilibrium in favor of the monomeric state have shown rapid absorption and a shorter duration of action, however they are less stable and prone to aggregation [0009]. Prestrelski et al. teach the insulin analog is include Lispro®, Aspart® (elected species) [0017, 0049, 0113].
Prestrelski et al. et al. does not teach a pharmaceutical composition comprising CB[7], a tonicity agent and phenoxyethanol. However, the teachings of Webber et al. cure this deficiency.
Webber et al. teach formulating insulin with CB[7] (claims 4-6, 10-12) that supramolecular PEGylation of insulin with PEG-T-CB[7] of CB[7]-PEG promotes dramatically increased stability under these conditions and that at the 50-day endpoint of the study, none of the PEG-T-CB[7] formulations had aggregated at pH 7.4 [0018]. Webber et al. teach that insulin is well known to form fibrillar aggregates in physiologic conditions, that insulin formulated with all molecular weights of PEG-T-CB[7] did not aggregate in 100 hours of kinetic study [00236]. With respect to claim 41, Webber et al. teach CB[7]-PEG conjugates ([0019], Fig. 4A, 5, 7), meeting the limitation of claim 41 (b). With respect to the limitation of “a tonicity agent” (41 (c)), Webber et al. teach the composition comprises diluents selected from mannitol and sodium chloride [00192]. As evidenced by instant claim 43, sodium chloride and mannitol are tonicity agents. With respect to “a preservative” (41 (d)) and “wherein the preservative is phenoxyethanol” (claim 50), Webber et al. teach that the composition comprises preservatives and exemplary antimicrobial preservatives include phenoxyethanol [00198].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pharmaceutical composition of Prestrelski et al. comprising an insulin analog such as insulin lispro or insulin aspart and use CB[7] in the composition so as to inhibit the formation of amyloid fibrils as taught by Webber et al. because Webber et al. teach that formulating insulin with CB[7] promotes dramatically increased stability under these conditions and that at the 50-day endpoint of the study, none of the PEG-T-CB[7] formulations had aggregated ([0018]; claims 4-6, 10-12). One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in adding CB[7] in the composition of Prestrelski et al. because Webber et al. teach that supramolecular conjugates of therapeutic agents can help achieve improved stability and duration of action of the therapeutic agent [0005].
With respect to claim 42, Prestrelski et al. teach the insulin analog is include Lispro®, Aspart® (elected species) [0017, 0049, 0113].
With respect to claim 43, Webber et al. teach the composition comprises diluents selected from mannitol and sodium chloride [00192]. As evidenced by instant claim 43, sodium chloride and mannitol are tonicity agents.
With respect to claims 44-45, Webber et al. teach and claim CB[7] is conjugated to a Tag, wherein the tag is PEG via a linker, wherein the linker if formula L-1 that is identical to the instantly claimed linker (claims 14-19 and [00146]).
With respect to claim 46, Webber et al. teach the PEG has a molecular weight <1 kDa. In certain embodiments, the PEG has a molecular weight between 1- 10 kDa, inclusive. In certain embodiments, the PEG has a molecular weight of approximately 5 kDa. In certain embodiments, the PEG has a molecular weight between 5- 10 kDa, inclusive. In certain embodiments, the PEG has a molecular weight of approximately 10 kDa. In certain embodiments, In certain embodiments, the PEG has a molecular weight between 10-30 kDa, inclusive. In certain embodiments, the PEG has a molecular weight of approximately 30 kDa. In certain embodiments, the PEG has a molecular weight >30 kDa. In certain embodiments, the PEG has a molecular weight under 100 kDa [00137,00161]. Webber et al. teach specific examples: CB[7]-N3 was synthesized to prepare supramolecular PEG conjugates by of copper-free "click" chemistry. Dibenzocyclooctyne (DBCO)-modified poly(ethylene glycol) (PEG-DBCO) polymers of varying molecular weights ( n = 5 kDa, 10 kDa, and 30 kDa) were reacted with CB[7]-N3 to yield PEG-T-CB[7], connected via a triazole linkage (Figure 1A).
With respect to claim 47, Webber et al. teach exemplary buffers include phosphate buffer [00202].
With respect to claim 48, Webber et al. does not teach formulations comprising zinc (see [00242 and 00243], meeting the limitation of “substantially free of zinc”. In addition, Prestrelski et al. teach that the formulation does not include zinc or wherein zinc present in the formulation is bound to a chelating agent (claim 14; [0011]) and that it helps in reducing the likelihood of hexamer formation [0011, 0048].
With respect to claim 49, The concentration of an active agent in a pharmaceutical composition is a result-effective variable and the determination of the optimum or workable ranges of said variable maybe characterized by routine experimentation (Please see MPEP 2144 II-Optimization of Ranges). In the instant case, Webber et al. teach insulin in the concentration of 1mg/ml [00245]. Prestrelski et al. teach and claim the formulation comprises 3 mg/ml to 50 mg/ml of insulin and in others can include 0.5-100 mg/ml of insulin or more as needed (claim 6, [0011]). It would have been obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize the concentration, to arrive at the ranges of claim 49.
With respect to claim 51, Webber et al. teach insulin in the concentration of 1mg/ml with 1 equivalent of unmodified CB[7] or PEG-CB[7] conjugates, which is a ratio of 1:1 [00245].
With respect to claim 53, Prestrelski et al. teach that the formulation further includes amylin ([0011, 0018 ] and claim 21-22).
With respect to claim 54, Webber et al. teach the composition is suitable for subcutaneous administration [00238]. Webber et al. teach examples of insulin, CB[7] conjugates are injected subcutaneously [00247].
With respect to claims 58 and 59, as indicated above, Webber et al. makes obvious the pharmaceutical composition of claim 41. With respect to the instructions: The written instruction is not given patentable weight absent a new and unobvious functional relationship between the printed matter and the substrate. “[Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product form the prior art.” See MPEP 2112.01. Webber et al. teach and claim treatment of diabetes (claim 65, [00110-00111, 00224, 00231]). Furthermore, Webber et al. teach and claim a kit and instructions for administering the compound. Webber et al. teach the kits contain the pharmaceutical composition, a container (i.e. vial, bottle, syringe and/or dispenser package), instructions for using the claim (claim 66 [0013, 00220-00221]. Syringe meets the limitation of a delivery device configured to deliver the pharmaceutical composition to the subject.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 41-54 and 58-59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-28 and 31-34 of copending Application No. 17/340,664 (reference application) in view of Webber et al. Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. The copending application claims a pharmaceutical application comprising amylin analogue, insulin analogue and CB[7]-PEG conjugate, wherein the insulin analogue is aspart or lispro, wherein the CB[7]-PEG to insulin analog is from 1:1 to 10:1, wherein the analogue is zinc free, wherein the PEG has a MW less than 1 Kda, 1-5, 5-10, 10-30 or 30-100 kDa. The copending Application does not teach the tonicity agent or preservative. However, the teachings of Webber et al. cure this deficiency.
Webber et al. teach formulating insulin with CB[7] (claims 4-6, 10-12) that supramolecular PEGylation of insulin with PEG-T-CB[7] of CB[7]-PEG promotes dramatically increased stability under these conditions and that at the 50-day endpoint of the study, none of the PEG-T-CB[7] formulations had aggregated at pH 7.4 [0018]. Webber et al. teach that insulin is well known to form fibrillar aggregates in physiologic conditions, that insulin formulated with all molecular weights of PEG-T-CB[7] did not aggregate in 100 hours of kinetic study [00236]. With respect to (41 (c)), Webber et al. teach the composition comprises diluents selected from mannitol and sodium chloride [00192]. As evidenced by instant claim 43, sodium chloride and mannitol are tonicity agents. With respect to “a preservative” (41 (d)) and “wherein the preservative is phenoxyethanol” (claim 50), Webber et al. teach that the composition comprises preservatives and exemplary antimicrobial preservatives include phenoxyethanol [00198].
It would have been obvious to a person of ordinary skill before the effective filing date of the invention to include a tonicity agent, such as mannitol or sodium chloride and the preservative, phenoxyethanol in the composition comprising insulin and CB[7]-PEG. A person of ordinary skill in the art would be motivated to include the agents because Webber et al. teach that composition can include sodium chloride or mannitol which are well known diluents and tonicity agents. Webber et al. also teach an exemplary antimicrobial preservative includes phenoxyethanol. There is a reasonable expectation of success given that the tonicity agents and preservatives are well known agents used routinely in pharmaceutical compositions.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TARA L MARTINEZ whose telephone number is (571)270-1470. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to TARA L MARTINEZ whose telephone number is (571)270-1470. The examiner can normally be reached Mon-Fri 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TARA L MARTINEZ/Examiner, Art Unit 1654