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 .
Receipt is acknowledged of IDS filed on 07/02/2025.
Claims 1, 3, 6, 9, 10, 14, 17, 21, 25, and 27 have been amended.
Claims 1, 3, 6, 9-11, 14, 17, 19, 21, 24-25, 27 and 30-31 are pending.
Claims 2, 4, 5, 7, 8, 12, 13, 15, 16, 18, 20, 22, 23, 26, 28, and 29 are cancelled.
Claims 25, 27 and 30-31 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/02/2025 has been entered.
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.
Claims 1, 3, 6, 9-11, 14, 17, 19, 21 and 24 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.
A broad range or limitation together with a narrow range or limitation that falls within the
broad range or limitation (in the same claim) may be considered indefinite if the resulting claim
does not clearly set forth the metes and bounds of the patent protection desired. See MPEP §
2173.05(c). In the present instance, claim 1 recites the broad recitation “one or more surface amine groups” and the claim also recites “ranges from about 60 to 90 or about 246 to about 500” which is the narrower statement of the range/limitation. The phrase “one or more surface amine groups” is broad, the BRI is amine groups ranging from 1 to infinity, while the phrase “ranges from about 60 to 90 or about 246 to about 500” are narrower in scope.
The claim(s) are considered indefinite because there is a question or doubt as to whether the
feature introduced by such narrower language is (a) merely exemplary of the remainder of the
claim, and therefore not required, or (b) a required feature of the claims.
For compact prosecution purposes the claim is interpreted to only need one or more amine groups.
The dependent claims fall therewith.
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 1, 3, 6, 9-11, 14, 17, 19, 21 and 24 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 19/379,726 (reference application) in view of APRIKYAN (US 2018/0223260 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending application recites, a pharmaceutical composition comprising, a magnetic nanoparticle comprising an iron oxide core, a dextran coating functionalized with a number of surface amine groups from about 30 to 150 (claim 32). The amine groups are used to attach one or more oligonucleotides (claim 32).
The copending application does not teach crosslinking dextran with epichlorohydrin or the ratio of ferric and ferrous chloride used.
APRIKYAN teaches an iron oxide nanoparticle that are coated with dextran (page 20, paragraph 0191). and further modified with amine groups (page 17, paragraph 0155) coated with dextran (page 20, paragraph 0191). The nanoparticle is prepared by crosslinking the dextran with epichlorohydrin, which is used as a crosslinking agent and helps the amine groups to be attached to the dextran surface (page 20, paragraphs 0191 and 0200). The iron oxide core is made using ferric chloride and ferrous chloride (page 26, paragraph 0264), which is common in the art to synthesize iron oxide nanoparticles. The size of the nanoparticle core depends on the molar ratio of the metal complex (page 17, paragraph 0156), such as the ratio of ferric chloride and ferrous chloride.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate crosslinking dextran with epichlorohydrin. The person of ordinary skill in the art would have been motivated to make those modifications, because epichlorohydrin is used as a crosslinking agent and helps the amine groups to be attached to the dextran surface, and reasonably would have expected success because the references are in the same field of endeavor, such as iron oxide nanoparticles that are coated in dextran and functionalized with amines.
The reference does not specifically teach the ratio, weight percent or grams of ferric chloride and ferrous chloride as claimed by the Applicant. The amount of ferrous and ferric chloride is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal amount of ferrous and ferric chloride in order to best achieve desired results, such as the ideal size of nanoparticle. The size of the nanoparticle can affect the physical, optical, and electronic characteristics of nanoparticles and the size of the nanoparticle is controlled by the molar ratio of ferric and ferrous chloride. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the amount of ferrous and ferric chloride would have been obvious at the time of Applicant’s invention.
Note, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). This is in regards to the instant recitation of “ wherein the nanoparticle composition is prepared by a process comprising: crosslinking dextran with epichlorohydrin and controlling the number of the one or more surface amine groups by varying a concentration of ferric chloride and a concentration of ferrous chloride used during synthesis of the iron oxide core, wherein when the ferric chloride to ferrous chloride ratio is about 50% wt:50% wt, the number of the one or more surface amine groups ranges from about 60 to about 90, and wherein when the ferric chloride to ferrous chloride ratio is about 100% wt:0% wt, the number of the one or more surface amine groups ranges from about 246 to about 500.”.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 6, 9-11, 14, 17, 19, 21 and 24 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 12 and 14 of copending Application No. 18/035,174 (reference application) in view of APRIKYAN (US 2018/0223260 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because: The copending application recites, a therapeutic nanoparticle (claim 1), specifically an iron oxide nanoparticle (claim 12), comprising a dextran coating (claim 14), and amine group functionalization (claim 2). The amines are used to conjugate therapeutic and diagnostic molecules (claim 2). The nanoparticle further comprises a radiolabel and a chelator (claim 1).
The copending application does not teach crosslinking dextran with epichlorohydrin or the ratio of ferric and ferrous chloride used.
APRIKYAN teaches an iron oxide nanoparticle that are coated with dextran (page 20, paragraph 0191). and further modified with amine groups (page 17, paragraph 0155) coated with dextran (page 20, paragraph 0191). The nanoparticle is prepared by crosslinking the dextran with epichlorohydrin, which is used as a crosslinking agent and helps the amine groups to be attached to the dextran surface (page 20, paragraphs 0191 and 0200). The iron oxide core is made using ferric chloride and ferrous chloride (page 26, paragraph 0264), which is common in the art to synthesize iron oxide nanoparticles. The size of the nanoparticle core depends on the molar ratio of the metal complex (page 17, paragraph 0156), such as the ratio of ferric chloride and ferrous chloride.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate crosslinking dextran with epichlorohydrin. The person of ordinary skill in the art would have been motivated to make those modifications, because epichlorohydrin is used as a crosslinking agent and helps the amine groups to be attached to the dextran surface, and reasonably would have expected success because the references are in the same field of endeavor, such as iron oxide nanoparticles that are coated in dextran and functionalized with amines.
The reference does not specifically teach the ratio, weight percent or grams of ferric chloride and ferrous chloride as claimed by the Applicant. The amount of ferrous and ferric chloride is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal amount of ferrous and ferric chloride in order to best achieve desired results, such as the ideal size of nanoparticle. The size of the nanoparticle can affect the physical, optical, and electronic characteristics of nanoparticles and the size of the nanoparticle is controlled by the molar ratio of ferric and ferrous chloride. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the amount of ferrous and ferric chloride would have been obvious at the time of Applicant’s invention.
Note, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). This is in regards to the instant recitation of “ wherein the nanoparticle composition is prepared by a process comprising: crosslinking dextran with epichlorohydrin and controlling the number of the one or more surface amine groups by varying a concentration of ferric chloride and a concentration of ferrous chloride used during synthesis of the iron oxide core, wherein when the ferric chloride to ferrous chloride ratio is about 50% wt:50% wt, the number of the one or more surface amine groups ranges from about 60 to about 90, and wherein when the ferric chloride to ferrous chloride ratio is about 100% wt:0% wt, the number of the one or more surface amine groups ranges from about 246 to about 500.”.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
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 1, 3, 6, 11, 14, 17, 19, 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over APRIKYAN (US 2018/0223260 A1).
Regarding claim 1, APRIKYAN teaches an iron oxide nanoparticle that are coated with dextran (page 20, paragraph 0191). and further modified with amine groups (page 17, paragraph 0155) coated with dextran (page 20, paragraph 0191). The nanoparticle is prepared by crosslinking the dextran with epichlorohydrin, which is used as a crosslinking agent and helps the amine groups to be attached to the dextran surface (page 20, paragraphs 0191 and 0200).The iron oxide core is made using ferric chloride and ferrous chloride (page 26, paragraph 0264). The size of the nanoparticle core depends on the molar ratio of the metal complex (page 17, paragraph 0156), such as the ratio of ferric chloride and ferrous chloride.
Regarding claim 17, APRIKYAN teaches the nanoparticle has core crystal diameter of 5 nm (page 14, paragraph 0128) and hydrodynamic diameter of 15 nm (paragraph 0132).
Regarding claim 21, APRIKYAN teaches that a nucleic acid is also attached to the nanoparticle (page 20, claim 0192).
Regarding claim 24, APRIKYAN teaches the composition is designed to be administered in a solution (page 51, paragraph 0496 and page 23, paragraph 0234), which reads on pharmaceutically acceptable carrier or dilutant.
Additional disclosures: APRIKYAN teaches that the size of the nanoparticle can affect the physical, optical, and electronic characteristics of nanoparticles (page 15, paragraph 0135). The amines are used to conjugate bioactive molecules for therapeutic purposes (page 20, paragraph 0192 and 0197)
The reference does not specifically teach the amount of amine groups as claimed by the Applicant. The amount of amine groups is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal amount of amine groups in order to best achieve desired results, such as having the appropriate amount of amine groups to achieve the therapeutic function desired. Since the bioactive molecule attaches to the amine groups, the amount of therapeutic agents added is dependent upon the amount of amine groups present on the nanoparticle. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the amount of amine groups would have been obvious at the time of Applicant’s invention.
Regarding claims 1, 3, 6, 11, 14, the reference does not specifically teach the ratio, weight percent or grams of ferric chloride and ferrous chloride as claimed by the Applicant. The amount of ferrous and ferric chloride is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal amount of ferrous and ferric chloride in order to best achieve desired results, such as the ideal size of nanoparticle. The size of the nanoparticle can affect the physical, optical, and electronic characteristics of nanoparticles and the size of the nanoparticle is controlled by the molar ratio of ferric and ferrous chloride. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the amount of ferrous and ferric chloride would have been obvious at the time of Applicant’s invention.
Regarding claim 19, APRIKYAN teaches that dextran molecular weight can be optimized through ultrafiltration (Page 23, paragraph 0228), the dextran molecular weight affects the size of the nanoparticle (Page 23, paragraph 0231-0232). The reference does not specifically teach the dextran molecular weight as claimed by the Applicant. The dextran molecular weight is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal dextran molecular weight in order to best achieve desired results, such as having the proper sized nanoparticle for drug delivery. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the dextran molecular weight would have been obvious at the time of Applicant’s invention.
Note, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). This is in regards to the instant recitation of “ wherein the nanoparticle composition is prepared by a process comprising: crosslinking dextran with epichlorohydrin and controlling the number of the one or more surface amine groups by varying a concentration of ferric chloride and a concentration of ferrous chloride used during synthesis of the iron oxide core, wherein when the ferric chloride to ferrous chloride ratio is about 50% wt:50% wt, the number of the one or more surface amine groups ranges from about 60 to about 90, and wherein when the ferric chloride to ferrous chloride ratio is about 100% wt:0% wt, the number of the one or more surface amine groups ranges from about 246 to about 500.”.
Claims 1, 3, 6, 9-11, 14, 17, 19, 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over APRIKYAN (US 2018/0223260 A1) in view of NIKITIN (Ultrasensitive detection enabled by nonlinear magnetization of nanomagnetic labels. Royal Society of Chemistry. 2018).
APRIKYAN teaches Applicant’s invention as discussed above. APRIKYAN further teaches the nanoparticle can be used for imaging (page 35, paragraph 0368).
APRIKYAN does not teach the nonlinearity index as claimed by Applicant.
Regarding claims 9-11, NIKITIN teaches that nanomaterials with a high nonlinearity of magnetization, which reads on nonlinearity index, improves the detectability limits of magnetic tags which allows for detection in deep organs of the human body (Page 11643, paragraph 1).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a nonlinearity index. The person of ordinary skill in the art would have been motivated to make those modifications, because the nonlinearity of nanomaterials improves the detectability in deep organs of the human body, and reasonably would have expected success because both references are in the same field of endeavor such as magnetic iron nanoparticles used for imaging.
The reference does not specifically teach a non-linearity index as claimed by the Applicant. The non-linearity index is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal non-linearity index in order to best achieve desired results, such improving the detectability in deep organs of the human body. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of a non-linearity index would have been obvious at the time of Applicant’s invention.
Response to Arguments
Applicant argues, Nickels does not teach a composition having "the number of the one or
more surface amine groups range[s] from about 60 to about 90 or about 246 to about 500,"
Examiner does not find the argument persuasive because as discussed, claim 1 is indefinite and it is unclear whether the narrow ranges of about 60 to about 90 or about 246 to about 500 is actually required. For compact prosecution it is interpreted that only one or more amine groups are required.
Furthermore, although the reference does not specifically teach the amount of amine groups as claimed by the Applicant. The amount of amine groups is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal amount of amine groups in order to best achieve desired results, such as having the appropriate amount of amine groups to achieve the therapeutic function desired. Since the bioactive molecule attaches to the amine groups, the amount of therapeutic agents added is dependent upon the amount of amine groups present on the nanoparticle. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the amount of amine groups would have been obvious at the time of Applicant’s invention.
Applicant argues, Nickels does not disclose a nanoparticle composition prepared by the process recited in claim 1.
Examiner does not find the argument persuasive because as discussed above even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). This is in regards to the instant recitation of “ wherein the nanoparticle composition is prepared by a process comprising: crosslinking dextran with epichlorohydrin and controlling the number of the one or more surface amine groups by varying a concentration of ferric chloride and a concentration of ferrous chloride used during synthesis of the iron oxide core, wherein when the ferric chloride to ferrous chloride ratio is about 50% wt:50% wt, the number of the one or more surface amine groups ranges from about 60 to about 90, and wherein when the ferric chloride to ferrous chloride ratio is about 100% wt:0% wt, the number of the one or more surface amine groups ranges from about 246 to about 500.”.
Furthermore, APRIKYAN teaches an iron oxide nanoparticle that are coated with dextran (page 20, paragraph 0191). and further modified with amine groups (page 17, paragraph 0155) coated with dextran (page 20, paragraph 0191). The nanoparticle is prepared by crosslinking the dextran with epichlorohydrin, which is used as a crosslinking agent and helps the amine groups to be attached to the dextran surface (page 20, paragraphs 0191 and 0200).The iron oxide core is made using ferric chloride and ferrous chloride (page 26, paragraph 0264). The size of the nanoparticle core depends on the molar ratio of the metal complex (page 17, paragraph 0156), such as the ratio of ferric chloride and ferrous chloride.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618