DETAILED ACTION
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Claims 21, 23-26, 29, and 31 are withdrawn.
Claims 1-5 and 7-19 are pending and represent all claims currently under consideration.
Response to Amendment
The amendment filed 09/05/2025 has been entered.
Claims 6 and 20 were canceled. Claims 1-4 and 7-19 were amended. No new material was added.
Applicant’s amendments have overcome the previous objections to the claims; rejections under 35 U.S.C. 112(b); and the provisional rejection of claims 1-20 due to double patenting with respect to copending Application No. 18/568,219.
The rejections of claims 6 and 20 are moot, because the claims were canceled.
The objections to the specification have been modified to address the amendments and maintained.
The rejections of claims 1-5 and 7-19 have been modified to address the amendments and maintained.
Response to Arguments
Applicant's arguments filed 09/05/2025 have been fully considered but they are not persuasive.
The declaration under 37 CFR 1.132 filed 09/05/2025 is insufficient to overcome the rejection of claims 1-5 and 7-19 based upon 35 U.S.C. 103 as set forth in the last Office action because: the evidence did not show that a significant aspect of the claimed invention would have been unexpected.
Applicant argues that the method of Rooth results in abrasions, pinholes and/or cracks in the particle layers/coatings resulting in sub-optimal exposure of the core and an initial peak (burst) in plasma concentration of the active ingredient directly after administration (Remarks, page 11, 3rd paragraph). This argument is not persuasive, because no data is provided to support the assertion of abrasions, pinholes and/or cracks in the particle layers/coatings. Further, Rooth teaches a non-interrupted coating enclosing completely the solid core (i.e., no abrasions, pinholes, or cracks), and teaches an excellent profile of delayed release of the active substance (i.e., no initial burst in plasma concentration would be expected; Rooth, page 4, lines 12-17). The data regarding an initial burst in plasma concentration directly after administration suggests the 4.9% coating integrity of batch 1 is an improvement over the coating integrity of 9.0% for batch 2 (Declaration, page 5, item 16). However, it is not clear if this data is significant, because as shown in Figure 4 of the instant application, an initial burst of 10% was observed for the instant invention. The evidence relied upon should establish that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. See MPEP § 716.02(b).
Applicant argues that the mechanical sieving step allows coated particles to be easily deagglomerated using a non-aggressive technique (e.g., vortexing) in a manner that does not destroy the layers of coating material (Remarks, page 11, 4th paragraph). This argument is not persuasive, because Rooth teaches sonication treatment results in an agitation of the particles, which in turn leads to a disaggregation (i.e., deagglomeration) of the nanoparticles (Rooth, page 4, lines 3-4), and further teaches a non-interrupted coating enclosing completely the solid core (i.e., not destroyed; Rooth, page 4, lines 12-17).
Applicant argues that the mechanical sieving step provides particles with advantageous properties with particular reference to drug load, coating integrity and particle size distribution (Remarks, page 12, 2nd paragraph). This argument is not persuasive, because as stated by the Applicant in the Declaration, the drug load for batch 2, which was produced using the method of Rooth, was higher than (i.e., superior to) the drug load for batch 1 (Declaration, page 4, item 14). Further, Rooth teaches advantages of the invention include an extremely high drug load (Rooth, page 3, line 8), and teaches a non-interrupted coating enclosing completely the solid core (i.e., a good coating integrity; Rooth, page 4, lines 12-17). Rooth further teaches a person of ordinary skill in the art will be well acquainted with methods for preparing nanoparticles within the desired size range (Rooth, page 11, lines 7-8). Therefore, it would be obvious to utilize the sieving method of Shichibe as discussed below.
Applicant further argues that the process provides coated particles that can be formulated into injectable suspensions with a size distribution that is even and capable of forming a homogenous and more physically stable suspension within the injection liquid that can be injected through a needle (Remarks, page 11, 5th paragraph), and states particles are superior for formulating into suspensions for subcutaneous or intramuscular injection with a sustained release (Remarks, page 12, 3rd paragraph). This argument is not persuasive, because Rooth teaches the nanoparticles of the invention may be administered by subcutaneous or intramuscular injection (Rooth, page 23, lines 5-9) and can be in the form of a suspension (Rooth, page 23, line 12). Further, there is no data provided to suggest that the injectable suspension of the instant invention is more homogenous or physically stable than that of Rooth.
Applicant states that obviousness is based clearly on hindsight, specifically citing that there is not a reason why the skilled person might have been motivated to combine the teachings of atomic layer deposition and chemical coating by Rooth with the teaching of vibrational sieving by Shichibe (Remarks, page 10). This argument is not persuasive, because Rooth teaches the person of ordinary skill in the art will be well acquainted with methods for preparing the nanoparticles within the desired size range (Rooth, page 11, lines 6-7), providing motivation to utilize the teachings of Shichibe, which teaches products are ground and sieved to obtain products with a desired particle size (Shichibe, page 5, paragraph 0043), and exemplifies the type of sieving to be vibrational sieving (i.e., a mechanical sieving technique; Shichibe, page 10, paragraph 0101). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Rooth to include the vibrational sieving method taught by Shichibe, because Shichibe teaches the sieving method as preferred for obtaining intermediate products of sizes of 50 micrometers or less in high yield (Shichibe, page 3, paragraph 0028).
Information Disclosure Statement
The information disclosure statement filed 10/08/2025 has been considered.
Maintained Objections to the Specification
The use of the terms Advantech Manufacturing, Picosun, SUNALE, Espoo, Shimadzu, Sotax, Sigma-Aldrich, and Merck, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Maintained Double Patenting Rejection
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 1-5, 7-16 and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-20, and 22-25 of copending Application No. 18/567,466 (reference application).
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.
Regarding claim 1, the reference application teaches a process for the preparation of composition in the form of a plurality of particles having a weight-, number-, and/or volume-based mean diameter that is between amount 10 nm and about 700 micrometers (reference application, claim 1), which encompasses the claimed range of 1-50 micrometers. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). The reference application teaches the particles comprise: (a) solid cores; and (b) two or more sequentially applied, discrete layers, each of which comprises at least one separate coating material, and which two or more layers together surround, enclose and/or encapsulate said cores, which process comprises the sequential steps of: (1) applying an initial layer of at least one coating material to said solid cores by way of a gas phase deposition technique; (2) subjecting the coated particles to agitation to deagglomerate particle aggregates formed during step (1) by way of a sieving step; (3) applying a further layer of at least one coating material to the deagglomerated particles; and (4) optionally repeating steps (2) and (3) one or more times to increase the total thickness of the at least one coating material that enclose(s) said solid core, wherein at least one of the sieving steps comprises a vibrational sieving technique using a vibration motor coupled to a sieve (i.e., a mechanical sieving device that forces the coated particles through a sieve; reference application, claim 1). The reference application further teaches step (2) comprises discharging the coated particles from the gas phase deposition reactor prior to subjecting the coated particles to agitation, and step (3) comprises reintroducing the deagglomerated, coated particles from step (2) into the gas phase deposition reactor prior to applying a further layer of at least one coating material to the reintroduced particles (reference application, claim 8). The reference application further teaches the cores comprise a biologically active agent and/or a pharmaceutically-acceptable excipient (reference application, claim 9).
Regarding claim 2, the reference application teaches all the elements of the current invention as applied to claim 1. As above, the reference application further teaches the cores comprise a biologically active agent and/or a pharmaceutically-acceptable excipient (reference application, claim 9).
Regarding claim 3, the reference application teaches all the elements of the current invention as applied to claim 2. The reference application further teaches the carrier/excipient material is a sugar or a sugar alcohol and/or is a pH modifying agent (reference application, claim 10).
Regarding claim 4, the reference application teaches all the elements of the current invention as applied to claim 1. The reference application further teaches the cores consist essentially of biologically active agent (reference application, claim 11).
Regarding claim 5, the reference application teaches all the elements of the current invention as applied to claim 1. The reference application further teaches the biologically active agent is selected from the claimed list (reference application, claim 12).
Regarding claim 7, the reference application teaches all the elements of the current invention as applied to claim 1. The reference application further teaches between 3 and 10 discrete layers of coating material are applied to the core sequentially (reference application, claim 14).
Regarding claim 8, the reference application teaches all the elements of the current invention as applied to claim 1. The reference application further teaches the total thickness of the discrete layers of coating material is between about 0.5 nm and about 2 micrometers (reference application, claim 15).
Regarding claim 9, the reference application teaches all the elements of the current invention as applied to claim 1. The reference application further teaches the maximum thickness of an individual discrete layer of coating material is about 1 hundredth of the weight-, number-, or volume-based mean diameter of the core, including any other previously-applied discrete layers of coating material that are located between said individual discrete layer and the outer surface of the core (reference application, claim 16).
Regarding claim 10, the reference application teaches all the elements of the current invention as applied to claim 1. The reference application further teaches the coating materials of the one or more discrete layers comprise one or more inorganic coating materials (reference application, claim 17).
Regarding claim 11, the reference application teaches all the elements of the current invention as applied to claim 10. The reference application further teaches the coating materials comprise one or more metal-containing, or metalloid-containing, compounds (reference application, claim 18).
Regarding claim 12, the reference application teaches all the elements of the current invention as applied to claim 11. The reference application further teaches the compounds comprise a hydroxide and/or an oxide (reference application, claim 19).
Regarding claim 13, the reference application teaches all the elements of the current invention as applied to claim 10. The reference application further teaches the one or more coating materials comprise silicon oxide, aluminum oxide, titanium dioxide, zinc sulphide and/or zinc oxide (reference application, claim 20).
Regarding claim 14, the reference application teaches all the elements of the current invention as applied to claim 10. The reference application further teaches the one or more coating materials selected from a group comprising zinc oxide (reference application, claim 20).
Regarding claim 15, the reference application teaches all the elements of the current invention as applied to claim 1. The reference application further teaches applying the separate layers of coating materials to cores, and/or previously- coated cores, by atomic layer deposition (reference application, claim 22).
Regarding claim 16, the reference application teaches all the elements of the current invention as applied to claim 15. The reference application further teaches a vibrational sieving technique, in which the vibrational sieving technique comprises supplying electrical power to a vibration motor coupled to a sieve (reference application, claim 1).
Regarding claim 18, the reference application teaches all the elements of the current invention as applied to claim 1. The reference application further teaches a further step of resuspending separated particles in a solvent, with or without the presence of one or more pharmaceutically acceptable excipients (reference application, claim 23).
Regarding claim 19, the reference application teaches all the elements of the current invention as applied to claim 2. The reference application further teaches the biologically-active agent is an anti-cancer agent (reference application, claim 24).
Maintained/Modified Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 7-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Rooth (WO 2014187995 A1; IDS reference, 06/06/2022), further in view of Shichibe (US 20070275853 A1; IDS reference, 12/30/2022). The references were cited previously by the Examiner.
Regarding claim 1, Rooth teaches a method of preparing a plurality of coated nanoparticles comprising a solid core comprising a biologically active substance (i.e., agent) and one or more layers of inorganic coating (Rooth, claim 1) wherein in a step i, the inorganic material (i.e., initial layer of coating material) is applied to the solid cores (i.e., step 1), then in a step ii, the solid cores are submitted to agitation (i.e., step 2), then in a step iii, the coating step is repeated (i.e., a further layer of coating material is applied), and in a step iv, the agitation step is also repeated, with both steps repeated n number of times (Rooth, claim 3) and wherein n is 1-50 times (Rooth, claim 4). Rooth further teaches coating via atomic layer deposition (i.e., a gas phase deposition technique; Rooth, claim 8) and exemplifies discharging of the particle powder from an atomic layer deposition reactor for deagglomeration (i.e., step 2; Rooth, page 27, lines 26-34) and reloading of the particles for additional coating (i.e., step 3; Rooth, page 28, lines 1-2). Rooth teaches the nanoparticles have a diameter in a range of from about 20-50 micrometers (Rooth, page 24, line 2), which lies within the claimed range of 1-50 micrometers, and teaches the particle size is expressed as the diameter of the particle (Rooth, page 8, line 24) which is determined using methodology well-known to a person of ordinary skill in the art (Rooth, page 8, lines 33-35). Rooth further teaches particles of the same weight or volume can be utilized for determining the size of non-spherical particles, suggesting a weight- or volume-based diameter is an acceptable method of measurement (Rooth, page 9, lines 5-6).
Rooth teaches sonication of the particles for deagglomeration of the particles (Rooth, page 28, lines 18-20), but does not specify a mechanical sieving device that forces the coated particles through a sieve. Shichibe teaches a method for producing a product comprising a solid core and coating layers (Shichibe, claim 1), wherein products are ground and sieved to obtain products with a desired particle size (Shichibe, page 5, paragraph 0043). Shichibe exemplifies the type of sieving to be vibrational sieving (i.e., a preferred mechanical forcing means as defined by the instant specification, page 16, lines 16-29; Shichibe, page 10, paragraph 0101).
Rooth and Shichibe are considered to be analogous to the claimed invention, because all are in the same field of processes for preparing particle-containing compositions with a solid core and coatings. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Rooth to include the vibrational sieving method taught by Shichibe, because Rooth teaches the person of ordinary skill in the art will be well acquainted with methods for preparing the nanoparticles within the desired size range (Rooth, page 11, lines 6-7), and Shichibe teaches the sieving method as preferred for obtaining intermediate products of sizes of 50 micrometers or less in high yield (Shichibe, page 3, paragraph 0028).
Regarding claim 2, Rooth and Shichibe together teach all the elements of the current invention according to claim 1. Rooth teaches the solid core comprises a biologically active substance (Rooth, abstract) and a pharmaceutically acceptable excipient (Rooth, claim 23).
Regarding claim 3, Rooth and Shichibe together teach all the elements of the current invention according to claim 2. Rooth teaches a pharmaceutically acceptable carrier, which can be a sugar (Rooth, page 22, line 28).
Regarding claim 4, Rooth and Shichibe together teach all the elements of the current invention according to claim 1. Rooth teaches the solid core is essentially comprised of only one or more biologically active substance and is free from excipients and any other non-biologically active substances (i.e., consists essentially of biologically active agent; Rooth, page 9, lines 24-27).
Regarding claim 5, Rooth and Shichibe together teach all the elements of the current invention according to claim 1. Rooth teaches the biologically active substance can be selected from a group comprising several of the biologically active agents from the claimed list (e.g., analgesics; Rooth, page 10, lines 6-24).
Regarding claim 7, Rooth and Shichibe together teach all the elements of the current invention according to claim 1. Rooth teaches the coating step is repeated 3-10 times (Rooth, claim 6), which would result in 3-10 discrete layers as claimed.
Regarding claim 8, Rooth and Shichibe together teach all the elements of the current invention according to claim 1. Rooth teaches the inorganic coating in a thickness range of 0.1 nm to 5 micrometers (Rooth, page 11, line 17), which encompasses the claimed range of about 0.5 nm to about 2 micrometers. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Regarding claim 9, Rooth teaches all the elements of the current invention according to claim 1. Rooth teaches a composition with a particle size of 150 nm in the core (Rooth, page 28, line 33) and a coating of about 0.5-2 nm in thickness (Rooth, page 29, line 2), which would be approximately .003 to 0.013 of the particle size diameter, overlapping the claimed range of less than 1 hundredth (i.e., 0.01 or less). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Regarding claim 10, Rooth and Shichibe together teach all the elements of the current invention according to claim 1. Rooth teaches the coating comprises one or more layers composed of mixtures of two or more metal oxides or metalloid oxides (i.e., inorganic coating materials; Rooth, page 12, lines 10-12).
Regarding claim 11, Rooth and Shichibe together teach all the elements of the current invention according to claim 10. As above, Rooth teaches the coating comprises metals or metalloids (Rooth, page 12, lines 27-28).
Regarding claim 12, Rooth and Shichibe together teach all the elements of the current invention according to claim 11. As above, Rooth teaches the coating comprises metals or metalloids in the form of oxides or hydroxides (Rooth, page 12, lines 27-29).
Regarding claim 13, Rooth and Shichibe together teach all the elements of the current invention according to claim 10. Rooth teaches the metals can be aluminum, titanium, and zinc, in the form of oxides (Rooth, page 12, lines 28-31).
Regarding claim 14, Rooth and Shichibe together teach all the elements of the current invention according to claim 10. Rooth teaches the metal can zinc in the form of an oxide (i.e., zinc oxide; Rooth, page 12, lines 28-29).
Regarding claim 15, Rooth and Shichibe together teach all the elements of the current invention according to claim 1. Rooth teaches the coating is applied by atomic layer deposition (Rooth, claim 8).
Regarding claim 16, Rooth and Shichibe together teach all the elements of the current invention according to claim 15. As above, Rooth teaches sonication of the particles for deagglomeration of the particles (Rooth, page 28, lines 18-20), but does not teach a mechanical sieving technique. Shichibe teaches a method for producing a product comprising a solid core and coating layers (Shichibe, claim 1), wherein products are ground and sieved to obtain products with a desired particle size (Shichibe, page 5, paragraph 0043). Shichibe exemplifies the type of sieving to be vibrational sieving (i.e., a mechanical sieving technique; Shichibe, page 10, paragraph 0101). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Rooth to include the vibrational sieving method taught by Shichibe, because Shichibe teaches the sieving method as preferred for obtaining intermediate products of the claimed size in high yield (Shichibe, page 3, paragraph 0028).
Regarding claim 18, Rooth and Shichibe together teach all the elements of the current invention according to claim 1. Rooth teaches the nanoparticles may be suspended in a carrier, such as water (i.e., a solvent; Rooth, page 24, lines 18-19).
Regarding claim 19, Rooth and Shichibe together teach all the elements of the current invention according to claim 2. Rooth teaches the biologically active substance can be selected from a group comprising anticancer agents (Rooth, page 10, line 8).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Rooth (WO 2014187995 A1; IDS reference, 06/06/2022) and Shichibe (US 20070275853 A1; IDS reference, 12/30/2022) as applied to claims 1-5, 7-16, and 18-19, further in view of Pittenger (ASM Handbook, 2015). The references were cited previously by the Examiner.
Regarding claim 17, Rooth and Shichibe together teach all the elements of the current invention according to claim 15. As above, Rooth teaches particle size can be determined using methodology and instrumentation well-known to the person of ordinary skill in the field (Rooth, page 8, lines 33-35), but does not specify a step of sonic sifting. Shichibe teaches products are ground and sieved to obtain products with a desired particle size (Shichibe, page 5, paragraph 0043), and exemplifies the type of sieving to be vibrational sieving (i.e., a mechanical sieving technique; Shichibe, page 10, paragraph 0101), but also does not specify the vibrational sieving is performed using a sonic sifter. Pittenger, however, teaches methods of sieving to obtain particular powder sizes (Pittenger, page 95, column 1, 2nd paragraph), and teaches sonic sifting as a method of machine sieving (Pittenger, page 106, column 3, 4th paragraph).
Rooth, Shichibe, and Pittenger are considered to be analogous to the claimed invention, because all are in the same field of processes for preparing powders. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Rooth and Shichibe to include the specific method of machine sieving taught by Pittenger, because Rooth teaches any method well-known in the field can be used (Rooth, page 8, lines 33-35) and Pittenger teaches sonic sifting is known to speed up the deagglomeration process (Pittenger, column 2, 5th paragraph).
Conclusion
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 CHASITY P JANOSKO whose telephone number is (703)756-5307. The examiner can normally be reached 7:30-3:30 ET.
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, Brian-Yong Kwon can be reached at (571)272-0581. 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.
/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613