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 .
Claim Status
Claims 1-98 and 100 are cancelled. Claims 99 and 101-116 are new and pending. Claims 111-116 are withdrawn. Claims 99 and 101-110 are under examination.
Priority
This application is a continuation-in-part of PCT/US2021/047774 filed on 8/26/2021 which claims priority from US provisional application 63/070,718 filed on 8/26/2020.
Information Disclosure Statements
The information disclosure statement filed 5/29/2026 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. For applicant’s information the size fee assertion form is available at https://www.uspto.gov/sites/default/files/documents/sb0008c.pdf and can be used for all IDS statements filed on or after January 19, 2025. Alternatively, applicant can make an acceptable statement regarding the size fee assertion (see https://www.uspto.gov/sites/default/files/documents/quick-reference-guide-to-the-information-disclosure-statement-ids.pdf).
Rejections Withdrawn
The rejection over USC 112(a) for “derivatives” is withdrawn per applicant’s cancellation of claim 100.
The rejection under USC 112(b) for derivatives is withdrawn per applicant’s cancellation of claim 100.
The rejection under USC 102(a)(2) over Underwood is withdrawn per applicant’s amendments to claim 98.
The rejection under USC 102(a)(1) over Cipolla is withdrawn per applicant’s amendments to claim 98.
The rejection under USC 103 over Underwood and Cipolla is withdrawn per applicant’s amendment to claim 98.
The rejection under USC 103 over Underwood and Longest is withdrawn per applicant’s amendment to claim 98.
The rejection under USC 103 over Cipolla, Eichel and Rosenblatt is withdrawn per applicant’s amendments and arguments.
The rejection under USC 103 over Cipolla, Eichel, Rosenblatt and Longest is withdrawn per applicant’s amendments and arguments.
The rejection under double patenting for copending 18/939,439 is withdrawn per applicant’s amendment to claim 98 which puts a DNase in the second population of particles while ‘439 desires a nucleic acid (which can be DNA). The DNase would be seen as damaging to the nucleic acid that is desired in ‘439’s particles.
As these rejections are withdrawn, applicant’s arguments toward these rejections are now moot. However, note that Underwood was combinable with another reference to teach the DSPC limitation as added by the applicant. This additional reference was necessitated due to the amendment to the claim.
Note the rejection under non-statutory double patenting over copending 17/433,220 (now an issued patent) is updated to include the reference necessary to teach the new limitation of 1,2-distearoyl-sn-glycero-3-phosphocholine.
New Rejections – As Necessitated by Amendments
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.
Claim 99, 101-105 and 110 are rejected under 35 U.S.C. 103 as being unpatentable over Underwood US 20220117893 (Has additional inventor, filed on 2-21-2020, effective filing date of 2-22-2019) and Ohgoda et al (Fundamental Toxicological Sciences, March 2020, volume 7, pages 55-76).
Underwood (above in rejection under USC 103) has shared inventors but also a different inventor than applicant’s application. This rejection might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the copending application was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the copending application and the claimed invention either were owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
“Target location of the airways of a subject” is read broadly as a portion of the airways where drug release from the particles mainly occurs. In the specification, this targeting is determined by particle size (e.g. MMAD) (i.e. size important for how far particles travel into the airways) and formulation agents/excipients such as the liposome lipids.
“Predominant absorption” at a target site will be read as the most absorption of the drug takes place at the target site, however, lesser amounts of absorption may occur elsewhere.
“Predetermined delay” is read as a delay in drug release based on formulation/structure of the particle(s) that provides for extended release over the time for immediate release. If the prior art provides for extended, sustained, delayed or controlled release for its formulations, it will be read to have a predetermined delay that offers extended release.
Underwood teaches therapeutic agent as first and second inhalable particles with first and second mucolytic contained in biodegradable encapsulate (abstract and claim 1 of Underwood). Underwood teaches first and second mucolytic can be selected from a group that contains 2-mercaptoethane sulfonate and DNase (claim 2 of Underwood, also paragraph 49). Underwood teaches the first encapsulation being a liposomal formulation (claim 3 of Underwood). Underwood teaches “wherein said first particles are sized to be from about 5 microns to about 50 microns, said second particles are sized to be from about 0.01 microns to about 6 microns, whereby said first particles are configured for predominant absorption at a first target location of said airways and said second particle are configured for predominant absorption at a second target location of said airways” (claim 4 of Underwood). Underwood teaches particles stored in solution form or dry powder form (claim 9 of Underwood). Underwood teaches “said first biodegradable encapsulation is configured to release said first mucolytic immediately upon inhalation of said therapeutic agent by said subject, said second biodegradable encapsulation is configured to release said second mucolytic with a predetermined delay, whereby providing an extended time release mucolytic therapy to said subject” (claim 7 of Underwood). Underwood teaches antibiotic, antiviral and antifungal (paragraphs 50-51 of Underwood). Underwood teaches ciprofloxacin, aminoglycosides, tobramycin and other antibiotics (paragraph 51). Underwood teaches polyene antifungals, amphotericin B, Nystatin, ketoconazole, ciclopirox and other antifungals (paragraph 51). Underwood teaches “At least one of such inhalable particles may include a mucolytic within a biodegradable encapsulation, such as a liposomal formulation, microsphere, nanoparticles or engineered spray particles” (paragraph 22). Underwood teaches using the invention for various conditions that are lung and respiratory airway diseases (paragraphs 60-74).
Underwood does not teach the use of DSPC for the encapsulate of the particles.
Ohgoda teaches that 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) is shown to be safe for pulmonary administration and is used to form liposomes for increased drug retention time and to reduce the toxicity of the drugs to the subject (abstract and page 75). In materials and methods DSPC is shown to be formed into porous particles with calcium chloride (page 56).
One of ordinary skill in the art before the time of filing would have utilized DSPC for liposomal drug containing formulations of Underwood as Ohgoda provides that it is useful for a liposomal drug carrier to the lung and is regarded as being safe for use. Therefore, there was a reasonable expectation of success of using DSPC as a lipid for liposomal drug carriers and having them provide a safe profile while delivering drugs safely to the lungs.
Claims 106-108 are rejected under 35 U.S.C. 103 as being unpatentable over Underwood US 20220117893 (Has additional inventor, filed on 2-21-2020, effective filing date of 2-22-2019), Ohgoda et al (Fundamental Toxicological Sciences, March 2020, volume 7, pages 55-76) and Cipolla US 20120282328.
Underwood and Ohgoda teach the claims as discussed above.
Underwood and Ohgoda do not teach the limitations of claims 106-108 although it allows for a formulation to be used as a dry powder inhaler to target the airways.
Cipolla teaches “A formulation, comprising:a pharmaceutically acceptable excipient; and liposome-encapsulated ciprofloxacin wherein the liposomes are unilamellar, and comprise cholesterol and hydrogenated soy phosphatidyl-choline (HSPC) at a ratio such that the liposomes maintain integrity when aerosolized, and provide a ciprofloxacin release rate from the liposomes of 0.5% to 20% per hour” (claim 26 of Cipolla). Cipolla teaches “additional drug is an anti-inflammatory chosen from corticosteroids, leukotriene receptor antagonists, leukotriene synthesis inhibitors, and cyclooxygenase inhibitors” (claim 32 of Cipolla). Cipolla teaches DNase and other mucolytic agents (paragraphs 21, 80 and 95). Cipolla provides liposomes of the invention used with DNase, a mucolytic agent (paragraph 95). Cipolla teaches “20 nm to 1 micron as a size of liposome for pulmonary delivery (paragraph 53). Cipolla teaches 0.5 microns to 12 microns for droplets or particles (paragraphs 56 and 59). Cipolla teaches liposomes provided as dry powder that can be inhaled (paragraph 61). Cipolla teaches formulation of dry powder or suspended or dissolved in a liquid (paragraph 38). Cipolla provides for treating airways (paragraph 97). Cipolla teaches “anti-infective refers to agents that act against infections, such as bacterial, viral, fungal, mycobacterial, or protozoal infections” (paragraph 34). Cipolla teaches ciprofloxacin, tobramycin, penicillins and others (paragraph 35). Cipolla teaches polymixins, amphotericin B, ciclopirox, ketoconazole, and others (paragraph 35). Cipolla teaches “corticosteroids (such as beclometasone, budesonide, ciclesonide, fluticasone, etiprednol, mometasone, and the like)” (paragraph 37). Cipolla teaches “β2-adrenergic receptor agonists (such as albuterol, bambuterol, salbutamol, salmeterol, formoterol, arformoterol, levosalbutamol, procaterol, indacaterol, carmoterol, milveterol, procaterol, terbutaline, and the like), and antimuscarinics (such as trospium, ipratropium, glycopyrronium, aclidinium, and the like). Combinations of drugs may be used” (paragraph 36). Paragraphs 15-17 provide for liposomes.
One of ordinary skill in the art before the time of filing would have included the other active compounds as provided by Cipolla into a formulation for reaching the airways to treat diseases/infections as provided by Underwood and Ohgoda as they would be expected to provide their beneficial effects (anti-infective, bronchodilation, anti-inflammatory) to the subject in need. Both references are to treating conditions of the airways with a particulate/powder formulation that can be administered via the airways (MPEP 2144.06). Thus, there was a reasonable expectation of success in combining the teachings of the prior art and producing multifunctional formulations to treat the airways/lungs of a subject in need.
Claim 106, 107, 108 and 109 is rejected under 35 U.S.C. 103 as being unpatentable over Underwood US 20220117893 (Has additional inventor, filed on 2-21-2020, effective filing date of 2-22-2019), Ohgoda et al (Fundamental Toxicological Sciences, March 2020, volume 7, pages 55-76) and Longest US 20150107589.
Underwood and Ohgoda teach the claims as discussed above.
Underwood and Ohgoda do not provide for species of agents of claims 106-109.
Longest teaches dry powder inhalers (abstract). Longest teaches “Other examples include bronchodilators including albuterol, terbutaline, isoprenaline and levalbuterol, and racemic epinephrine and salts thereof; anti-cholinergics including atropine, ipratropium bromide, tiatropium and salts thereof; expectorants including dornase alpha (pulmozyme) (used in the management of cystic fibrosis; corticosteroids such as budesonide, triamcinolone, fluticasone” (paragraph 54). Longest teaches the antiviral agent ribavirin (paragraph 54) as well as the antivirals, including aciclovir, ganciclovir, birivudin, valaciclovir, zidovudine, didanosin, thiacytidin, stavudin, lamivudin, zalcitabin, ribavirin, nevirapirin, delaviridin, trifluridin, ritonavir, saquinavir, indinavir, foscarnet, amantadin, podophyllotoxin, vidarabine, tromantadine, and proteinase inhibitors (paragraph 57). Longest teaches the use of various medicaments (paragraph 53).
One of ordinary skill before the time of filing would have included antivirals, bronchodilators, anti-cholinergic agents and corticosteroids such as those listed in Longest in formulations motivated by the prior art as they are seen as effective agents to be used for dry powder inhalers for delivery to the lungs/airways to treat viral infections. One of ordinary skill in the art would have had a reasonable expectation of success in adding such antiviral agents and obtaining successful antiviral treatment in addition to mucolytic treatment through the combination of the prior art.
Non-Statutory 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 99, 101-110 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3-7, 9-12 of copending Application No. 17/433,220 (now US Patent 12691064, now claims 1-7 and 10) (reference application) in view of Cipolla US 20120282328, Ohgoda et al (Fundamental Toxicological Sciences, March 2020, volume 7, pages 55-76) and Longest US 20150107589. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for lipid encapsulates of first and second mucolytic agents and use of antifungal agents for inhalation delivery and controlled release.
‘220 does not teach the elected species of DNase as another mucolytic agent nor teach some of the additional agents besides antifungal agents for its formulations.
Ohgoda teaches that 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) is shown to be safe for pulmonary administration and is used to form liposomes for increased drug retention time and to reduce the toxicity of the drugs to the subject (abstract and page 75). In materials and methods DSPC is shown to be formed into porous particles with calcium chloride (page 56).
Cipolla teaches “A formulation, comprising:a pharmaceutically acceptable excipient; and liposome-encapsulated ciprofloxacin wherein the liposomes are unilamellar, and comprise cholesterol and hydrogenated soy phosphatidyl-choline (HSPC) at a ratio such that the liposomes maintain integrity when aerosolized, and provide a ciprofloxacin release rate from the liposomes of 0.5% to 20% per hour” (claim 26 of Cipolla). Cipolla teaches “additional drug is an anti-inflammatory chosen from corticosteroids, leukotriene receptor antagonists, leukotriene synthesis inhibitors, and cyclooxygenase inhibitors” (claim 32 of Cipolla). Cipolla teaches DNase and other mucolytic agents (paragraphs 21, 80 and 95). Cipolla provides liposomes of the invention used with DNase, a mucolytic agent (paragraph 95). Cipolla teaches “20 nm to 1 micron as a size of liposome for pulmonary delivery (paragraph 53). Cipolla teaches 0.5 microns to 12 microns for droplets or particles (paragraphs 56 and 59). Cipolla teaches liposomes provided as dry powder that can be inhaled (paragraph 61). Cipolla teaches formulation of dry powder or suspended or dissolved in a liquid (paragraph 38). Cipolla provides for treating airways (paragraph 97). Cipolla teaches “anti-infective refers to agents that act against infections, such as bacterial, viral, fungal, mycobacterial, or protozoal infections” (paragraph 34). Cipolla teaches ciprofloxacin, tobramycin, penicillins and others (paragraph 35). Cipolla teaches polymixins, amphotericin B, ciclopirox, ketoconazole, and others (paragraph 35). Cipolla teaches “corticosteroids (such as beclometasone, budesonide, ciclesonide, fluticasone, etiprednol, mometasone, and the like)” (paragraph 37). Cipolla teaches “β2-adrenergic receptor agonists (such as albuterol, bambuterol, salbutamol, salmeterol, formoterol, arformoterol, levosalbutamol, procaterol, indacaterol, carmoterol, milveterol, procaterol, terbutaline, and the like), and antimuscarinics (such as trospium, ipratropium, glycopyrronium, aclidinium, and the like). Combinations of drugs may be used” (paragraph 36). Paragraphs 15-17 provide for liposomes. Cipolla provides for sustained release a site of infection and that liposomal encapsulation allows for sustained drug release (extended) (paragraphs 16-17). Cipolla teaches different treatments and means of administration can be used to treat a single patient (paragraph 62). Cipolla teaches combination therapies with the liposome formulations (paragraph 95). Cipolla teaches “At least one therapeutic agent in addition to the free and liposome-encapsulated anti-infective may also be included in the composition. That therapeutic agent may be free drug or encapsulated drug present with a pharmaceutically acceptable carrier useful for direct inhalation into human lungs. The other drugs may include enzymes to reduce the viscoelasticity of the mucus such as DNase or other mucolytic agents” (paragraph 21). Cipolla provides for both immediate and sustained release profiles for its formulations (abstract).
Longest provides for dry powder inhalers (abstract). Longest teaches the antiviral agent ribavirin (paragraph 54) as well as the antivirals, including aciclovir, ganciclovir, birivudin, valaciclovir, zidovudine, didanosin, thiacytidin, stavudin, lamivudin, zalcitabin, ribavirin, nevirapirin, delaviridin, trifluridin, ritonavir, saquinavir, indinavir, foscarnet, amantadin, podophyllotoxin, vidarabine, tromantadine, and proteinase inhibitors (paragraph 57).
One of ordinary skill in the art would have selected DNase as an additional mucolytic agent and other active agents of the prior art in making new formulations for inhalation treatment of infections and other diseases of the pulmonary system based on claims of ‘220 combined with the teachings of Cipolla, Ohgoda and Longest and had a reasonable expectation of success in producing DSPC liposomal drug particle powder formulations that could better treat pulmonary diseases/conditions. Cipolla connects the use of other therapeutic agents with mucolytic agent.
Response to Applicant’s Arguments as Pertain to Art Still Used in the Office Action
Applicant makes arguments toward Cipolla, Eichel, Rosenblatt and Longest (pages 11-15), but as these are included in rejections under USC 103 that rely on the combination of the references, the references cannot be argued individually. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Furthermore, only Cipolla and Longest are still used after withdrawals of particular rejections due to applicant’s amendments and arguments. These references were used in combination with Underwood to teach other useful pharmaceutical agents that were known to be used in pulmonary delivery powder formulations. It should be noted that Underwood taught both of the drugs (DNase and 2-mercaptoethane sulfonate) now imported into claim 99 within a relatively short list of options.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Rejections under USC 103 using Cipolla as the primary reference have been withdrawn. However, it remains relevant to pharmaceutical agents useful for pulmonary inhalation formulations, and thus, is still able to be combined with Underwood for one of ordinary skill in the art to add such prior art recognized pulmonary delivered drugs for their benefits in making such formulations.
Applicant argues the rejection under double patenting over copending 17/433220 (now issued patent) since they can no longer bridge the gap between the amended claims and the copending claims. Ohgoda is now included to show the known safe use of DSPC in pulmonary formulations.
In response to applicant's argument that the examiner has combined an excessive number of references to reach non-statutory double patenting, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991). The claims of ‘220 are a genus that would allow the incorporation of other known mucolytic drugs into a materially similar multi-particle formulation for pulmonary administration. A claim of ‘220 provides for a 2-mercaptoethane sulfonate as one mucolytic out of a first and/or a second mucolytic. The encapsulation of ‘220’s formulation is provided to be lipid encapsulated with prior art recognizing DSPC for liposomes.
Conclusion
No claims are allowed.
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 MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613