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
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-5, 7-10, 11-14, 16-19, 23 and 29, drawn to a method for stimulating regeneration of mammalian cartilage subject to an injury.
Group II, claim(s) 61-66, drawn to a pharmaceutical composition.
Group III, claim(s) 67, drawn to a method for stimulating regeneration of mammalian cartilage subject to an injury by contacting cartilage subject to an injury with composition of claim 61.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Invention groups I-III lack unity of invention because even though the inventions of these groups require the technical feature of a composition comprising GO-HA and XAV939, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Holsworth (US20190105398) teaching of a composition comprising GO-HA and XAV939 (abstract). Thus, the concept of a composition comprising GO-HA and XAV939 is known in the art and can not be used as special technical feature to link invention groups I-III together, Hence, the restriction requirement is proper.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
During a telephone conversation with Michael Adams on 11/17/2025 a provisional election was made without traverse to prosecute the invention of invention, claims 1-5, 7-10, 11-14, 16-19, 23 and 29. Affirmation of this election must be made by applicant in replying to this Office action. Claims 61-67 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-5, 7-10, 11-14, 16-19, 23, 29 and 61-67 are pending, claims 1-5, 7-10, 11-14, 16-19, 23 and 29 are under examination.
Priority
Acknowledge is made that this application is a national phase of International Application PCT/US2022/043391, filed on September 13, 2022, which claims priority from U.S. provisional patent application No. 63/243,638, filed September 13, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/05/2024 is being considered by the examiner.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 7-10, 11-14, 16-19, 23, 29 are rejected under 35 U.S.C. 103 as being unpatentable over Bastakoty et al. (“Inhibition of Wnt/β-catenin pathway promotes regenerative repair of cutaneous and cartilage injury”, FASEB J. 2015 Aug 12;29(12):4881–4892. doi: 10.1096/fj.15-275941; cited in IDS) in view of Holsworth (US20190105398).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Bastakoty et al. teaches Wound healing in mammals is a fibrotic process. The mechanisms driving fibrotic (as opposed to regenerative) repair are poorly understood. Herein we report that therapeutic Wnt inhibition with topical application of small-molecule Wnt inhibitors can reduce fibrosis and promote regenerative cutaneous wound repair. In the naturally stented model of ear punch injury, we found that Wnt/β-catenin pathway is activated most notably in the dermis of the wound bed early (d 2) after injury and subsides to baseline levels by d10. Topical application of either of 2 mechanistically distinct small-molecule Wnt pathway inhibitors (a tankyrase inhibitor, XAV-939, and the U.S. Food and Drug Administration–approved casein kinase activator, pyrvinium) in C57Bl/6J mice resulted in significantly increased rates of wound closure (72.3 ± 14.7% with XAV-939; and 52.1 ± 20.9% with pyrvinium) compared with contralateral controls (38.1 ± 23.0 and 40.4.±16.7%, respectively). Histologically, Wnt inhibition reduced fibrosis as measured by α-smooth muscle actin positive myofibroblasts and collagen type I α1 synthesis. Wnt inhibition also restored skin architecture including adnexal structures in ear wounds and dermal–epidermal junction with rete pegs in excisional wounds. Additionally, in ear punch injury Wnt inhibitor treatment enabled regeneration of auricular cartilage. Our study shows that pharmacologic Wnt inhibition holds therapeutic utility for regenerative repair of cutaneous wounds (abstract). To investigate the effect of Wnt pathway on wound healing, we treated ear punch wounds topically with small-molecule Wnt inhibitors (including XAV-939) every day after injury for 30 d. (page 4884, left column). A cutaneous wound healing response characterized by reduced fibrosis and regeneration of auricular cartilage and skin adnexa in response DMSO to inhibition of Wnt/b-catenin signaling has been demonstrated (page 4886, discussion section; page 4891, last paragraph).
Holsworth teaches a composition for treating a wound includes graphene oxide (GO) and hyaluronic acid (HA) that are covalently linked, XAV939, and water. The composition can also include a surfactant, such as PEG. The composition can be topically administered to a subject to treat a wound of the subject. Methods of treating a wound using the composition are also provided (abstract). XAV939 is a small molecule that selectively inhibits Wnt/β-catenin-mediated transcription through TNK 1 and 2 inhibition with an IC50 of 11 nM/4 nM in cell-free assays, regulates axin levels, and does not affect CRE, NF-κB, or TGF-β. Recently, topical application of XAV939 in a mouse ear punch assay demonstrated that XAV939 significantly increased rate of wound closure with reduced fibrosis (scarring). However, XAV939 was dissolved in DMSO and used only as a “research tool” compound due to its very low aqueous solubility (<1 mg/mL). The problem with this approach is that humans cannot tolerate the use of DMSO. A soluble form of XAV939 suitable for humans is required for practical and medical use ([0010]). In some embodiments, the linker linking the GO and HA includes 2-25 carbons. In some embodiments, the linker can be straight-chained (or linear). In other embodiments, the linker can be branched. In some embodiments, the linker comprises a linear alkylene —CmH2m— unit where m can be from 1 to 20. In some other embodiments, the linker can comprise one or more heteroatoms. For example, the linker can include one or more —CH2CH2O— units. In certain embodiments, the linker comprises —Rx—RS—Ry—, wherein Rx and Ry are each independently selected from the group consisting of —CO—, —COO—, —NH—, —NH—NH—, —NH—NH—CO—, —CS—, —S—, —O—, and wherein RS is an unsubstituted or substituted linear alkylene group having 1-40, or 2-20 backbone carbons. In specific embodiments, Rx and Ry are each —NH—NH—CO— ([0014]). In some embodiments, the weight ratio of XAV939 to GO-HA can be from about 1:100 to about 100:1, for example, from about 1:2 to about 2:1. In some embodiments, XAV939 constitutes from about 0.001 wt % to about 5 wt % of the total composition. In certain embodiments, the GO-HA constitutes from 0.001 wt % to about 5 wt % of the total composition ([0015]). In one aspect of the invention, a composition for treating a wound is provided, which includes: a matrix component comprising a conjugate of graphene oxide (GO) and hyaluronic acid (HA) where GO and HA are covalently linked via a linker; XAV939; and water. The covalently-linked GO and HA is also referred to herein as GO-HA conjugate or simply GO-HA. XAV939 is a potent tankyrase inhibitor, with a chemical name 3,5,7,8-Tetrahydro-2-[4-(trifluoromethyl)phenyl]-4H-thiopyrano[4,3-d]pyrimidin-4-one ([0021-0022]). In the composition of present invention, the GO and HA are covalently linked to form a matrix component (or a carrier), which can serve to solubilize XAV939 as well as providing other simultaneous benefits to wound healing ([0025]). In general, the composition overall can appear as a slightly dark or black viscous liquid. XAV939 is evenly dispersed in the viscous suspension, which is stable at room temperature for months. In some embodiments, the composition further comprises a surfactant that enhances mixability or solubility of hydrophobic substances in water. In some examples, the surfactant can be a non-ionic hydrophilic material such as polyethylene glycol (PEG). In some embodiments, the PEG can be present in the composition in an amount of from about 0.1 to about 20 wt % of that of the total composition ([0029]). In some embodiments, the composition of the invention further comprises a thickener for desired viscosity of the composition for skin delivery. For example, the thickener can include hydroxypropyl cellulose (HPC) ([0033]). The composition(s) of the present invention described herein can be administered by applying the composition(s) topically on the wound site. In some embodiments, the method of treatment can include delivering a second wound medication or therapeutic agent to the subject ([0038-0039]). The present invention provides a wound treatment strategy that simultaneously addresses several facets of wound healing by synergistically combining a multi-functional scaffold (GO) conjugated to a highly hygroscopic material (HA) traditionally beneficial in wound healing, and aqueous solubilization of a potent Wnt pathway inhibitor (XAV939) for improved healing of cutaneous wounds with reduced scarring ([0043]). Additional benefits of the topical composition and topical administration of embodiments of the present invention is low toxicity and high bioavailability of the beneficial components to the site of injury/wound ([0044]). A specifical example of GO-HA is prepared ([0052, Scheme 3).
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While various inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the inventive teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, composition, device, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, compositions, devices, systems, articles, materials, kits, and/or methods, if such features, compositions, devices, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the inventive scope of the present disclosure ([0091]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Bastakoty et al. is that Bastakoty et al. do not expressly teach GO-HA conjugate, surfactant PEG and thickener hydroxypropyl cellulose. This deficiency in Bastakoty et al. is cured by the teachings of Holsworth.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
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 invention of Bastakoty et al., as suggested by Holsworth, and produce the instant invention.
One of ordinary skill in the art would have been motivated to include GO-HA conjugate in the topical composition comprising XAC939 for treating cartilage injury because GO-HA conjugate can serve to solubilize XAV939 as well as providing other simultaneous benefits to wound healing as suggested by Holsworth. Since it is advantage to do so, it is obvious for one of ordinary skill in the art to include GO-HA conjugate in the topical composition comprising XAC939 for treating cartilage injury and produce instant claimed invention with reasonable expectation of success.
One of ordinary skill in the art would have been motivated to include surfactant PEG and thickener hydroxypropyl cellulose because surfactant PEG can enhance mixability or solubility of hydrophobic substances in water and thickener can provide desired viscosity of the topical composition. Since it is advantage to do so, it is obvious for one of ordinary skill in the art to include surfactant PEG and thickener hydroxypropyl cellulose and produce instant claimed invention with reasonable expectation of success.
Regarding claims 1, prior art teaches a method of treating ear punch injury to enable regeneration of auricular cartilage by topically administration to cartilage of a composition comprising GO-HA and XAV939.
Regarding claims 2-3 and 17-18, since this is ear punch injury, it is considered as acute and elastic.
Regarding claim 7, prior art teaches 0.1 to about 20 wt % of PEG.
Regarding claims 11-13, Holsworth teaches the linker can include one or more —CH2CH2O— units. In certain embodiments, the linker comprises —Rx—RS—Ry—, wherein Rx and Ry are each independently selected from the group consisting of —CO—, —COO—, —NH—, —NH—NH—, —NH—NH—CO—, —CS—, —S—, —O—, and wherein RS is an unsubstituted or substituted linear alkylene group having 1-40, or 2-20 backbone carbons. In specific embodiments, Rx and Ry are each —NH—NH—CO—.
Regarding claims 14 and 29, Holsworth teaches the weight ratio of XAV939 to GO-HA can be from about 1:100 to about 100:1, for example, from about 1:2 to about 2:1.
Regarding claim 16, prior art teaches administration daily instead of every 48h (2d), it is within skill of one artisan in the art to adjust and optimize the frequency of administration through routing experimentation and have administration every 48h, especially in the absence of showing criticality of claimed range. MPEP 2144.05.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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 1-5, 7-10, 11-14, 16-19, 23 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11291730 in view of Bastakoty et al. (“Inhibition of Wnt/β-catenin pathway promotes regenerative repair of cutaneous and cartilage injury”, FASEB J. 2015 Aug 12;29(12):4881–4892. doi: 10.1096/fj.15-275941; cited in IDS). The reference patent teaches a topical composition comprising GO-HA and XAV939 for treating wound, in view of Bastakoty et al. teaching a topical composition comprising XAV939 treating cartilage injury for regeneration of cartilage, it is obvious for one of ordinary skill in the art to administer a topical composition comprising GO-HA and XAV939 for treating cartilage injury for regeneration of cartilage and produce applicant’s claimed invention with reasonable expectation of success.
Claims 1-5, 7-10, 11-14, 16-19, 23 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11369685 in view of Bastakoty et al. (“Inhibition of Wnt/β-catenin pathway promotes regenerative repair of cutaneous and cartilage injury”, FASEB J. 2015 Aug 12;29(12):4881–4892. doi: 10.1096/fj.15-275941; cited in IDS). The reference patent teaches a topical composition comprising GO-HA and XAV939 for treating wound, in view of Bastakoty et al. teaching a topical composition comprising XAV939 treating cartilage injury for regeneration of cartilage, it is obvious for one of ordinary skill in the art to administer a topical composition comprising GO-HA and XAV939 for treating cartilage injury for regeneration of cartilage and produce applicant’s claimed invention with reasonable expectation of success.
Claims 1-5, 7-10, 11-14, 16-19, 23 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12059469 in view of Bastakoty et al. (“Inhibition of Wnt/β-catenin pathway promotes regenerative repair of cutaneous and cartilage injury”, FASEB J. 2015 Aug 12;29(12):4881–4892. doi: 10.1096/fj.15-275941; cited in IDS). The reference patent teaches a topical composition comprising GO-HA and XAV939 for treating wound, in view of Bastakoty et al. teaching a topical composition comprising XAV939 treating cartilage injury for regeneration of cartilage, it is obvious for one of ordinary skill in the art to administer a topical composition comprising GO-HA and XAV939 for treating cartilage injury for regeneration of cartilage and produce applicant’s claimed invention with reasonable expectation of success.
Claims 1-5, 7-10, 11-14, 16-19, 23 and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 15-20, 22-24 and 27-28 of copending Application No. 18776025 in view in view of Bastakoty et al. (“Inhibition of Wnt/β-catenin pathway promotes regenerative repair of cutaneous and cartilage injury”, FASEB J. 2015 Aug 12;29(12):4881–4892. doi: 10.1096/fj.15-275941; cited in IDS). The reference application teaches a topical composition comprising GO-HA and XAV939 for treating wound, in view of Bastakoty et al. teaching a topical composition comprising XAV939 treating cartilage injury for regeneration of cartilage, it is obvious for one of ordinary skill in the art to administer a topical composition comprising GO-HA and XAV939 for treating cartilage injury for regeneration of cartilage and produce applicant’s claimed invention with reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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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.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613