DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendments to the claims and arguments filed on November 20, 2025 have been received and entered. Claims 1, 8, 13, and 17 have been amended. Claims 1, 4- 5, 8-9, 11-19 and 20 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of species (i) in the reply filed on June 7, 2019 was acknowledged. Upon further consideration election of species requirement between different species were withdrawn and all the withdrawn species were rejoined with the elected species. The requirement was deemed proper and was therefore made FINAL.
Priority
Instant application is a 371 of PCT/US16/43762 filed on 07/22/2016 that claims priority from provisional application no 62/196,634 filed on 07/24/2015.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/05/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claims 1, 4- 5, 8-9, 11-19 and 20 are under consideration.
Withdrawn-Claim Rejections - 35 USC § 112
Claims 13-16 were 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. Applicants’ amendments to the claim 13 obviates the basis of the rejection.
New-Claim Rejections - 35 USC § 112 -necessitated by amendments
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the instant case, the recitation of limitation “ a force of at least 100 gF in the thread direction” (claim 13) and “ micro-particles are formed as a plurality of ultrathin layers of aligned collagen encapsulating nucleic acid-based molecules through cross-linking followed by vector solution deposition” (claim 17) are considered new matter. Upon further review of the instant specification, examiner could only find support for a typical tensile strength is higher than 100 gF and therefore the maximum stress is more than 30 MPa. There is no explicit or implicit support for a force of at least 100 gF in the thread direction. The specification fails to disclose a force of 100gF as recited in the claims. IN the instant case, force and tensile strength are related but are different. For instance, force is defined as a push or pull on an object (collagen scaffold), while tensile strength is maximum stress a material could withstand while being stretched before breaking point. The tensile strength should be written in Pascal (Pa) or megapascal (MPa) or N/m2. Regarding limitation of claim 17, there is no evidence in the specification of a support for a fibrillar micro-particles are formed as a plurality of ultrathin layers of aligned collagen encapsulating nucleic acid-based molecules through cross-linking followed by vector solution deposition. The specification teaches suspension or solution of plasmids (HGF mRNA) will be uniformly sprayed on collagen layer. Vacuum attachment of multiple layers causes a spontaneous collagen-to-collagen crosslinking and thus encapsulating the plasmids. The specification fails to teach encapsulating nucleic acid-based molecules through cross-linking followed by vector solution deposition as required by the amended claim.
Thus, at the time the application was filed, an Artisan of skill would not recognize from the disclosure that Applicant was in possession of a force of at least 100 gF in the thread direction and encapsulating nucleic acid-based molecules through cross-linking followed by vector solution deposition, as claimed.
In case if applicants have evidence to support otherwise, applicants are invited to indicate page and line number for the written support specifically for “ a force of at least 100 gF in the thread direction” and encapsulating nucleic acid-based molecules through cross-linking followed by vector solution deposition recited in claims 13 and 17 respectively of the instant application.
MPEP 2163.06 further notes, “When an amendment is filed in reply to an objection or rejection based on U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendment made to the disclosure” Claims 14-16, 18-20 are included in the rejection because they directly or indirectly depend from the rejected base claim. This is a new matter rejection.
New-Claim Rejections - 35 USC § 112 -necessitated by amendments
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, 4- 5, 8-9, 11 and 12 are 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.
Claims 1 and 13 is vague and indefinite to the extent the metes and bounds of phrase “collagen material contains a specified ligand which targets a specific cell type” could not ascertained. The term “a specified” could be as selected in some unspecificized method. The specification fails to define the metes and bounds of a specified ligand and therefore scope of term could be not established. Likewise, the phrase “ targets a specific cell type” is functional language that is not defined in the instant specification and therefore, it is unclear whether targeting is to (i) expression marker, (ii) delivery or (iii) binding affinity to the unspecified or undefined cell type. The scope of an unspecified ligands that targets an unspecified cell type could not be ascertained. A direct recitation of ligand that specifically binds to a marker that is expressed on a target cell type. Appropriate correction and/or clarification on record is required.
Withdrawn-Claim Rejections - 35 USC § 103
Claims 17 -20 are rejected under 35 U.S.C. 103 as being unpatentable over Paukshto et al (US Patent no 8227574, dated 07/24/2012, art of record), Pauksto et al (WO 2013/103423, dated 04/11/2013, art of record), Nakayama et al (ACS Nano. 17 Jun 2015, Vol. 9, No. 7; pages 6900-6908, IDS) as evidenced by Huang et al (Biomaterials, 2013, 34(16), 4038-4047, IDS) and further in view of Scherer (The Journal of Gene Medicine, 2002, 634-643)/or Samuel (Human Gene Therapy, 2002, 13, 791-802). In view of Applicants’ amendment of base claim 1, the previous rejections of claims are hereby withdrawn. Applicants’ arguments with respect to the withdrawn rejections are thereby rendered moot.
Maintained -Claim Rejections - 35 USC § 103 -in modified form
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.
Claims 1, 4-5, 8-9, 11-14, 15 and 16 remain rejected under 35 U.S.C. 103 as being unpatentable over Pauksto et al (WO 2013/103423, dated 04/11/2013, art of record), Nakayama et al (ACS Nano. 17 Jun 2015, Vol. 9, No. 7; pages 6900-6908, IDS) as evidenced by Huang et al (Biomaterials, 2013, 34(16), 4038-4047, IDS) and further in view of Samuel (Human Gene Therapy, 2002, 13, 791-802)/Scherer (The Journal of Gene Medicine, 2002, 634-643).
Claim interpretation: Recitation of that positively charged nanofibrillar collagen material compensate negatively charged nucleic acid molecule incorporated on the surface of the nanofibrillar collagen material is interpreted as mechanism or process of incorporation of nucleic acid on the surface of collagen nanofibrillar and facilitate transfection of the cells attached to the collagen nanofibrils by any mean including one facilitated by electrostatic interactions to bind the nucleic acid and to target cell membranes utilizing compounds selected from the group consisting of: calcium phosphate, polycations, liposomes, cationic lipids, polymers, dendrimers, nanoparticles, polyethylenimine, and polylysine (see claim 8). The term “solid state transfection” process is interpreted as nucleic acid that is immobilized on a solid surface and cells are cultured directly on that surface to facilitate uptake of the nucleic acid. Regarding recitation of tensile strength of at least 100 gF in the thread direction is indefinite for the reasons discussed above, therefore the limitation is interpreted as stress of at least 30Mpa in view the paragraph 50 of the instant specification. Recitation of where multiple vectors can be delivered in a sequence through the scaffold is interpreted as optional language and not required by the claims. To the extent prior art thread-like nanofibrillar collagen scaffold disclosed in Pauksto and Nakayama structurally similar to one recited in the instant application, it must be capable of delivering multiple vectors in a sequence through the scaffold. Further, claimed composition produced by any specific process is not given patentable weight. See MPEP 2113.
With respect to claim 1, Pauksto et al teach a composition comprising aligned nanofibrillar collagen material (see para. 103) with nanoweave structure (see para. 70-74) and enabling attachment and alignment of at least one type of cells (see para 98, 100, 106); and said nanofibrillar collagen material align endothelial cells according to some embodiments of the present invention depends in part on the diameter of the collagen fibrils. It is further disclosed that variations could include nucleic acid that can enhance endothelial proliferation, maintain endothelial differentiation, and/or attract circulating endothelial progenitor cells (see para. 28). Pauksto further teaches that aligned nanofibrillar collagen material further comprises a ligand (VEGF, or VEGF-C or VEGF-D) that targets a specific type of cell type (endothelial cells) (see para.28). Recitation of where multiple vectors can be delivered in a sequence through the scaffold is interpreted as optional language and not required by the claims. To the extent prior art thread-like nanofibrillar collagen scaffold disclosed in Pauksto and Nakayama structurally similar to one recited in the instant application, it must be capable of delivering multiple vector in a sequence through the scaffold as required by the claim.
Pauksto et al discloses the modulating properties of collagen scaffolds crosslinking to increase the mechanical property and decrease degradation rate of these scaffold (para. 11 and example 2 para. 91) (limitation of claim 4). Pauksto et al teaches the tensile strength of a crosslinked collagen scaffolds to be about 25.8 MPa (see page 25).
With respect to claim 5, Pauksto et al discloses the composition further comprises a medical device comprises (figure 13 A and B, abstract).
Regarding claim 9, Pauksto et al discloses that the composition comprises cells are selected from the group consisting of myocyte precursor cells, smooth muscle cells, cardiac myocytes, skeletal myocytes, satellite cells, fibroblasts, cardiac fibroblasts, chondrocytes, osteoblasts, osteocytes, endothelial cells, epithelial cells, epidermal cells, embryonic stem cells, hemopoietic cells, neuronal cells, Schwann cells, mesenchymal stem cells, glial cells, dorsal root ganglia, anchorage-dependent cell precursors, or combinations thereof (see para. 26, claim 23).
Regarding claim 11, Pauksto discloses that the crosslinking a collagen scaffold with poly (ethylene glycol) as an example (para. 91).
With respect to claim 12, Pauksto discloses that the transfection of cells is significantly higher as compared on cells grown on the tissue culture plastic (see figure 5). Absent evidence of any unexpected superior results, it would have been obvious to one of ordinary skill in the art to optimize and select an appropriate target cell membrane utilizing compound that would facilitate the electrostatically bind the nucleic acid and to the cell type that require transfection (see figures 4 and 6C).
With respect to claim 13, Pauksto discloses a composition comprising: a thread-lik
Pauksto differs from claimed invention by not explicitly disclosing (i) thread-like nanofibrillar collagen scaffold which has a porosity of more than 80% with interconnected pores to allow capillary flow along the scaffold and exhibits mechanical strength in the thread direction at least 20 MPa and (ii) incorporating nucleic acid suggested in Pauksto is immobilized on the collagen material that modulate gene expression of the cells attached to the-nanofibrillar collagen material, such that the positively charged nanofibrillar collagen material compensate negatively charged nucleic acid incorporated on the surface of the nanofibrillar collagen material.
Nakayama provide evidence of a composition forming a thread-like nanofibrillar scaffolds with the fibrils aligned in the direction of the thread (abstract) such that the fibrils enable an attachment and alignment of at least human ECs (abstract) as in Pauksto. Nakayama further provide motivation to alter the collagen concentration, ionic strength, and the shear rate, the nanofibril diameter and pattern that could be modulated. It is further disclosed that parallel-aligned nanofibrillar sheets can be further organized into thread-like porous scaffolds, wherein these thread-like nanofibrillar scaffolds provide mechanical strength, can be surgically sutured, and can be fabricated at clinically relevant length scales (see page 6901, col. 1, para. 1) as evidenced by Huang. It is relevant to noted that Huang teaches it was routine to optimize the collagen scaffold with controlled three-dimensional nano- and micro-structure, pre-determined thickness, fibril size, and high uniformity. These scaffolds 1) better mimic the complexity of native ECM at nano- and micro-scales, 2) show high mechanical strength, 3) have uniform properties over a large area of several cm2, and 4) have controlled biodegradation rate depending on the level of crosslinking. Furthermore, these scaffolds provide a high degree of cell adhesion and confer cell guidance signals (see page 4046, col. 1, para. 1). Huang discloses the physical properties of the nanofibrils of collagen scaffold with cross-section 1.2 μm × 25000 μm (∼180 μm effective diameter) showed that its maximum load was 2.1 N in dry state, 0.9 N in wet state that amount to at least 30 MPa (stress =F/A, page 4042, col. 1para. 3). Nakayama teaches that the thread-like scaffold has porosity at least 80% with interconnected pores to allow capillary flow along the scaffold (the cross-sectional view of the fibril shows porosity and scaffold having the diameter at least 50 microns (the cross-sectional view of the fibril shows scale of more than 100 μm; Figure 1 D).
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The combination of references differs from claimed invention by not disclosing nucleic acid that is immobilized on the collagen fibril material such that nucleic acid is incorporated on the surface of the nanofibrillar collagen material.
However, before the effective filing date of instant application, it was generally known in prior art that controlled delivery of nucleic acid from collagen matrices could be achieved by regulating matrix degradation rates through implementing different crosslinking strategies and/or altering the degree of plasmid/ matrix integration. Both gene loading efficiency and retention/ release profiles have been expanded using physical crosslinking techniques such as dehydrothermal (DHT) and ultraviolet (UV) treatments, and/or chemical methods including 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide (EDC) treatments. For instance, Samuel teaches a method to fabricate a porous gene-supplemented collagen–glycosaminoglycan (GSCG) matrix for sustained delivery (over a period of several weeks) of plasmid DNA to articular chondrocytes when implanted into cartilage lesions (see abstract). It is disclosed that Collagen–glycosaminoglycan matrices are synthesized without cross-linking, and by cross-linking treatments with 1-ethyl-3-(3-dimethyl aminopropyl) carbodiimide (EDC) to incorporate collagen–glycosaminoglycan matrices in solutions at different pH (see abstract) that is lyophilized. Samuel further teaches plasmid DNA continually transfected canine articular chondrocytes seeded into GSCG matrices in vitro for a 4-week period as evidenced by luciferase reporter gene expression at a higher rate as compared to cells seeded on non-crosslinked matrix (abstract, and fig. 4 and 5). It is disclosed that EDC cross linked collagen-glycosaminoglycan (GSCG) matrices supplemented with nucleic acid (luciferase-encoding genes) shows higher transgene expression in chondrocytes over a four-week period relative to non-crosslinked and DHT or UV treated matrices (see fig. 4 and 5). Samuel further contemplates the mechanism of transfection may relate to the endocytosis of solubilized plasmid DNA passively released from the collagen matrix (see page 800, col. 2, para. 3 and page 801, col. 1).
Likewise, prior art summarized by the teaching of Scherer teaches immobilizing the nucleic acid directly to the upper faces of collagen and incubated for 4 h that is subsequently lyophilized (freeze-dried). It is disclosed that collage sponges coated with naked DNA, luciferase expression was observed until day 7 for cells growing on/in the sponges and in the culture dishes (Figure 3a). Cells on PEI-DNA sponges showed gene expression throughout the experimental period of 45 days while cells in the corresponding wells expressed just for 7 days, and at a low level on day 45 (Figure 3c).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to modify the composition of Pauksto/ Nakayama by immobilizing the nucleic acid on the surface of the aligned nanofibrils collagen, in order to provide a collagen fibril composition for gene delivery using methods disclosed in Scherer, as instantly claimed, with a reasonable expectation of success, before the effective filing date of the instant application. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so because prior art explicitly provided motivation to use controlled three-dimensional nano- and micro-structure, pre-determined thickness, fibril size, and high uniformity, high mechanical strength and controlled biodegradation. It would have been further obvious to modify the composition of aligned nanofibrils collagen scaffold comprising nucleic acid-based molecules as taught in prior art to optimize the porosity of said scaffold that has at least 80% with interconnected pores as reported in Nakayama, in order to provide capillary flow and incorporation of nucleic acid along the scaffold, as instantly claimed, with a reasonable expectation of success. One of skill in the art would have had a reasonable expectation of success because prior art successfully reported incorporation of negatively charged nucleic acids on the surface of positively charged collagen leading to enhanced cellular uptake as exemplified by Samuel/ Scherer who reported successful ways to (i) incorporate the DNA into the cross linked collagen-glycosaminoglycan (GSCG) matrices that shows higher transgene expression in cells over a four-week period relative to non-crosslinked, or (ii) immobilize DNA on the surface of collagen fibril by simple lyophilization as in Scherer and (iii) optimize the porosity with interconnected pores to allow capillary flow along the scaffold having the diameter at least 50 microns and mechanical strength in the thread direction that is at least 30 MPa. It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) ( www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Response to arguments
Applicant’s representative disagrees with the rejection arguing claimed feature of solid-state transfection, specific method of vector encapsulation, cell type selection cultivated by ligand selection and multiple vector delivery in specified sequence. Applicant further argues that claimed feature that the nanofibrils can withstand at least 100 gF in the thread direction in combination with the other claimed features. Applicant continue to argue that none of the prior art discuss, reasonably suggest or even recognize features of solid-state transfection and multilayer construct to be used for sequenced delivery of multiple RNA/DNA vector solutions as required by the amended claims. Applicants’ arguments have been fully considered, but are not found persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., specific method of vector encapsulation, and multiple vector delivery in specified sequence or multilayer construct to be used for sequenced delivery of multiple RNA/DNA vector solutions ) are not recited in the rejected independent claims 1 and 13. Further, claim 1 also does not require nanofibrils that could withstand force of at least 100gF in the thread direction. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is further noted that claims recite multiple vectors can be delivered in a sequence through the scaffold is an intended use limitation and multiple vectors as such are not required by the composition as claimed.
Applicant’s argument that prior art fails to teach the fibrillar micro-particles are formed as a plurality of ultrathin layers of aligned collagen encapsulating nucleic acid-based molecules by vector solution deposition and wherein the multilayer construct is used for sequenced delivery of multiple RNA/DNA vector is found persuasive, therefore, previous rejection of claim 17 is hereby withdrawn. Please note claims 1 and 13 recite multiple vectors can be delivered in a sequence through the scaffold is interpreted as intended use recitation and therefore to the extent prior art references teach the composition that is structurally similar to one claimed in the instant application, it is applicable to the rejection.
In response, it should be noted that the concept of sold-state transfection involving nucleic acid immobilized on a sold surface (for example a nano or micro structured substrate) and cell cultured directly on that solid surface to facilitate nucleic acid uptake was known in prior art as evident from Scherer (The Journal of Gene Medicine, 2002, 634-643) who reported immobilizing the nucleic acid directly to the upper faces of collagen and incubated for 4 h that is subsequently lyophilized (freeze-dried). This is further supported by Salvay et al (Gene Therapy, 2010, 1134-1141, cited as evidence without relying on rejection) who reported vectors are immobilized to the material after the scaffold has been fabricated. Scaffolds are modified to interact with the vector to limit release and maintain elevated concentrations locally, with complexed DNA being primarily used to mediate interactions between the vector and biomaterial (see page 1134, col. 2, para. 2). Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to modify the composition of Pauksto/ Nakayama by immobilizing the nucleic acid in the aligned nanofibrils collagen, in order to provide a collagen fibril composition for gene delivery using methods disclosed in Scherer, with a reasonable expectation of success, In view of foregoing, the nucleic acid incorporated in at least one aligned nanofibrillar collagen disclosed in Paukshto et al (US Patent no 8227574)/ Pauksto et al (WO 2013/103423,) using the methods disclosed in Scherer would structurally be indistinguishable from the instantly recited at least one aligned nanofibrillar collagen material containing nucleic acid.
Therefore, in view of the fact patterns of the instant case, and the ground of rejection outlined by the examiner, applicants’ arguments on record are not compelling and do not overcome the rejection of record.
Conclusion
No claims allowed.
Claim 17 is free of prior art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Fang J et al 1996. Stimulation of new bone formation by direct transfer of osteogenic plasmid genes. Proceedings of the National Academy of Sciences. 93(12):5753-5758
Scherer F, Schillinger U, Putz U, Stemberger A, Plank C. 2002. Nonviral vector loaded collagen sponges for sustained gene delivery in vitro and in vivo. J. Gene Med.. 4(6):634-643
Sun et al (Biomaterials 301222–1231 (Year: 2009)) teach preparation of collagen scaffolds incorporating plasmid complexes that facilitates transfection of MSC seeded on the collagen scaffold.
Akhtar et al (Advanced Drug Delivery Reviews 59 (2007) 164–182)
Balmayor et al (USPGPUB20180214572) teach a pharmaceutical composition comprising a mRNA encoding a bone morphogenetic protein (BMP) further comprising a collagen scaffold to which said RNA has been added or into which said RNA has been loaded along with seeding increasing number of cells on collagen sponges (see para. 418, example 11, figure 17).
Shepherd et al APL Mater. 3, 014902 online 11/05/2014, 1-8.
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.
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/ANOOP K SINGH/ Primary Examiner, Art Unit 1632
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