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 .
Claims 1-10,12-13,15,17-18,20-25,27-28,31-37 are under examination.
The examiner has considered applicants amendments and arguments. The examiner has withdrawn the claim objection because of applicants’ amendments.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8,10,15, 17-18,20-23,25,27, and 31-33,36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Jang “Droplet-based microtumor model to assess cell-ECM interactions and drug resistance of gastric cancer cells” Nature.com (2017) in view of Neal (US 20180119107) and Wang “Mixed hydrogel bead-based tumor spheroid formation and anticancer drug testing” Analyst 2014, 139, 2440-2458 (already of record)
Jang teaches forming an unpolymerized mixture comprising a tissue sample and a fluid matrix material, wherein the fluid matrix material comprises collagen I, wherein the tissue sample comprises tumor cells (Jang, Abstract, Pages 1-3, and Figure 1). In Figure 3, the Jang reference states that some of the tumor cells are positive for E-cadherin which would indicate that such cells are epithelial cells. Furthermore, Figure 3 of Jang states that some of the cells are positive for N-cadherin which indicates the presence of mesenchymal stem cells. This seems to suggest that the tumor tissue cell population is not completely homogenous and can contain epithelial and/or mesenchymal stem cells based on the evidence presented by Figure 3.
The Jang reference in Figure 1 shows that there are two streams that merge together to form the cell/tissue laden beads/droplets. There is an oil stream (immiscible fluid stream) and a continuous stream with collagen I and cells (unpolymerized mixture with dispersed cells). The cells are dissociated and isolated from one another (Figure 1 of Jang). The description of Figure 1 states that the continuous stream flow rates with the collagen and cells can be adjusted. Figure 1C shows 3 incidences in which the flow rate of the continuous flow was adjusted resulting in different sized spherical droplets. There is no mention of the oil phase being adjusted routinely. Since the oil phase is not adjusted like the continuous phase with the cells and collagen and there are at least 3 incidences of the continuous feed with the cells and collagen being adjusted, it would have been obvious for there to be an incidence in which the oil flow rate differed from the continuous feed containing collagen and cells (unpolymerized mixture) since the continuous feed is adjusted multiple times. Furthermore, Jang also acknowledges that, “the optimal flow rates for the formation of stable 300 and 700 µm microbeads were 5µL for a cell-laden ECM solution channel (unpolymerized mixture) and 13 and 20 µL/min for an oil channel (immiscible fluid) respectively (Page 8, Generation of cell-laden collagen beads (microtumors)). Therefore, this teaches the limitation “forming a plurality of spherical droplets of the unpolymerized mixture by moving a continuous stream of the unpolymerized mixture at a first flow rate across one or more streams of an immiscible fluid moving at a second flow rate that is different than the first flow rate.”
The Jang reference teaches polymerizing the droplets to form a plurality of spherical droplets each having a diameter of between 50 and 500 µm with between 1 and 500 dissociated cells distributed therein; (Figure 1 a-e). The Jang reference further teaches culturing the plurality of the spherical droplets for between 1-14 days (Pages 3-4)
Jang does not teach using biopsied/resected tissue containing a microstructure of the tumor with a mixed population of different cell types at the time of the biopsy. However, Neal teaches developing an in vitro cell culture model that utilizes the “cellular architecture and ultrastructure of the tumor sample from which they were derived, and includes immune cells such as tumor infiltrating lymphocytes, parenchymal and stromal cells (Paragraph 10 of Neal).” Paragraph 73 of Neal states that its solid tumor culture can include stromal and immune cells that are associated with the tumors in vivo. Paragraph 29 states that “immune cells” can include “cells that are of hematopoietic origin and play a role in the immune response, immune cells include lymphocytes such as B and T cells, natural killer cells, myeloid cells such as monocytes, macrophages, eosinophils, mast cells, basophils, and granulocytes.” Paragraph 74 of Neal further states that such cellular material can be harvested by a biopsy. It would have been obvious to an artisan of ordinary skill to have used the solid tumor material with the associated cells of Neal with the process of Jang. An artisan would have been motivated to have used such biopsy tissue in order to create a more realistic version of the tumor and its associated cells (Paragraph 10 of Neal). Since such dissociated biopsied tissue can be successfully cultured to maintain and preserve the structure of the tumor and the surrounding cells, there would have been a high expectation for success.
Jang fails to clearly teach that its collagen is considered a basement membrane substrate. Wang teaches that spherical droplets containing tumor cells can be formed by flowing a stream containing Matrigel/alginate into a immiscible fluid such as oil. (Page 2451, rt side, Figure 1). Wang teaches that the flow rates of the cell/Matrigel (a substrate basement membrane)/alginate flow and oil flow can be varied in order to control the size of the droplets (Page 2451, rt side, Figure 1). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the Matrigel/alginate taught in Wang in place of the collagen I taught in Jang because it is able to encapsulate cells when exposed to oils to form spherical droplets (Page 2451, rt side, Figure 1).
It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the solid tumor sections with their associated cells as taught by Neal in the process of Jang. An artisan would have been motivated to have used the solid tumor tissue and the associated cells taught by Neal because these tumor associated cells including immune cells and stromal cells present a more realistic model of a tumor in vivo, allowing for the interactions of the tumor cells with associated cells such as infiltrating lymphocytes (Paragraphs 7 and 8). There would have been a high expectation for success because Neal teaches that tumor biopsy material can be used to successfully harvest tumor cells and tumor associated cells to include stromal and immune cells (Paragraph 73 of Neal). Neal does teach that spherical droplets can cultured for 1-14 days (Paragraph 73) to form a three-dimensional cellular structure that replicate a three-dimensional microenvironment of the biopsy or resected sample from which the cells are derived (Paragraphs 10 and Paragraph 73-74) as in instant Claims 1,6 and 20,23, 25,36-37
Jang teaches that dissociated cells are modified by the addition of collagen solution (a substrate) initially and later by the addition of oil (Page 3, Figure 1a) as in instant Claim 2, Jang teaches wherein forming the plurality of droplets comprises forming a plurality of droplets of the unpolymerized mixture of uniform size with less than 25% variation in size (Figure 1c) as in instant Claim 3, wherein the dissociated tissue samples comprise dissociated cells that are not stem cells (Pages 1-2) as in instant Claim 4, the dissociated tissue sample are distributed within the fluid matrix material to a density of less than 5x106 cells/ml (Figure 1e) as in instant Claim 7, Jang teaches that the oil/immiscible fluid is removed (Page 2, Results Generation of Cell-Laden Collagen Beads) as in instant Claim 8, in order for the collagen to assemble into a droplet gel like structure, the temperature needs to be approximately 37C (as stated in Page 8, Generation of Cell-Laden collagen beads). Therefore, the oil that comes into contact with the cells and collagen would need to have a temperature of at least 37C or higher as in instant Claim 10, wherein the dissociated tissue sample further comprises epithelial cells (Page 5, Figure 3) as in instant Claim 15,(Page 8 Generation of cell laden collagen beads section mentions optimal flow rates of the solutions. In order to ensure that the correct flow rates occurred, the system would inherently have to have a monitoring component present to maintain a continuous stream of unpolymerized mixture and oil as in instant Claim 17, in order for the stream with the unpolymerized mixture to flow at a continuous rate (as mentioned on page 8, Generation of cell-laden collagen beads), there must be a force/pressure placed on it. This is shown in Figure 1a as in instant Claim 18, comprising culturing the plurality of spherical droplets for between 2-10 days of forming the droplets to form structured clusters of cells replicating structures of the tissue from which they were derived from (Pages 3-5) as in instant Claim 20, wherein the polymerizing comprises crosslinking the fluid matrix material chemically (Figure 1) as in instant Claim 21-22, wherein the unpolymerized mixture includes only the dissociated tissue sample and the fluid matrix material (Figure 1) as in instant Claim 27, a person of ordinary skill in the art would have used the teachings of Jang to have created as many spherical droplets as needed to properly carry out drug testing (Figure 1 shows multiple spherical droplets being product), Jang further teaches marking/labeling cells in the spherical droplets (Figure 1d, bottom paragraph of Page 3), and imaging the spherical droplets (Figure 1b-e) as in instant Claim 31. Jang teaches that different cell densities can be used resulting in spherical droplets with 10 cells/spherical droplet, 50 cells per spherical droplet, and 150 cells per spherical droplet. The amount of cells in each microsphere/spherical droplet is dependent upon the density of the tumor cells in the substrate solution taught in Figure 1 as in instant Claims 32-33.
Neal states that stromal and immune cells are present; these cells are not considered stem cells (Paragraph 73) as in instant Claim 4, wherein the dissociated tissue sample comprises a biopsy sample from a metastatic tumor (Paragraph 63 of Neal) as in instant Claim 5, wherein the dissociated tissue sample comprises a clinical tumor sample, further wherein the clinical tumor sample comprises both cancer cells and stroma cells (Paragraph 73) as in instant Claim 6, wherein the dissociated tissue sample further comprises epithelial cells (Paragraph 92) as in instant Claim 15, culturing the cells for 2-10 days to form a three-dimensional cellular structure that replicate a three-dimensional microenvironment of the biopsy or resected sample from which the cells are derived (Paragraph 73) as in instant Claim 20, wherein the dissociated tissue sample consists of freshly biopsied dissociated cells (Paragraph 74) as in instant Claim 23.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.'s and Ph.D.'s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in cell culture and microfluidics. Therefore, the level of ordinary skill in this art is high.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time the inventio was filed especially in the absence of evidence to the contrary.
Response to Applicants’ Arguments
Neal’s approach is incompatible with Jang’s microfluidic system.
Applicants argue that “the dimensions of the samples produced by Neal’s process are incompatible with the dimensions of Jang’s microfluidic device: Neal’s samples are simply too large to fit through the microfluidic channels of Jang’s device. The combination of Neal with Jang is thus improper.”
Examiner did not find this argument to be persuasive because Jang is relied upon to teach the microfluidic method and a population of dissociated cells. Neal is not being used to teach the actual microfluidic process including the size dimensions of the spherical droplets. Neal is being applied because it teaches that tissue/cells can be derived from biopsied tissue. The dissociated cells of Jang are descended from cells that were originally isolated and dissociated from tissue. Similarly, cells could be dissociated from a tumor biopsy and used; each cell in Neal’s tumor biopsy can be isolated and dissociated out so that it can be used in Jang’s process. There is a strong motivation for using cells from a tumor biopsy because tumors contain cancer cells and other cells associated with the cancer environment. The instant claims are not reciting active steps on how the dissociation process occurs.
There is no motivation to use Neal’s tumor sample with Jang’s microfluidic device
Applicants are arguing that an artisan would not have been motivated to have used Neal’s minced samples with the process of Jang because the minced biopsy samples of Neal have dimensions of around 500 µm which are close to the size of Jang’s microbeads. Applicants also argue that Neal cannot be combined with Jang because Neal’s cells are not dissociated individually like Jang’s cells. Neal’s tumor samples are minced which can be considered a type of dissociation. Furthermore, Jang’s reference is being relied upon to teach a population of dissociated cells which are also individually isolated. Jang’s individually isolated cells can easily be used with Jang’s process in the microfluidic device. An artisan would have been motivated to have fully dissociated and individually isolated cells from Neal’s tumor biopsy sample since the tumor/cancer cells can then be treated and placed into a spherical droplet using Jang’s system. The cells of Jang are descended from cells that were originally completely dissociated and isolated from tissue. The instant set of claims are not reciting a dissociation method step that produces minced pieces of tumor of a specific size. Applicants also argue that the densities of the spherical droplets of Jang and Neal are different. A cell density of the spherical droplets is not recited in the instant set of claims. The examiner would like to respectfully point out that the claim limitations do not establish a structure of the cells within the spherical droplets. There are no limitations that indicate how large the tumor/cancer pieces should be within the spherical droplets.
Applicants argue that one would not be motivated to combine Jang with Neal because the technique of Neal would produce tumor samples that were significantly more dense than the cells present in the spherical samples of Jang. Cell density is not addressed in the instant set of claims. The examiner does feel that including such limitations would help distinguish the claimed invention from the prior art references cited in the most recent rejections. The specification also mentions the number of cells that can be present in the spherical droplet. Applicants’ specification also mentions cell density ranges. The examiner feels that it would be helpful to introduce additional limitations that mention these topics.
Neal’s tumor cell samples are not dissociated tissue samples
Applicants further argue that a person of ordinary skill in the art would not be motivated to combine the teachings of Jang with those of Neal because Jang teaches a method using dissociated cells while the samples of Neal are not dissociated. The tumor biopsies of Neal are minced which is a form of dissociation. Jang is the reference relied upon to teach the dissociated cells. It is well known that dissociated cells can be generated from both primary cell lines and solid tissue. There are no active method steps in the instant claims that require a specific step of dissociation in which specific sized pieces of tissue are produced.
The argument against Wang is that it does not cure the deficiencies of Jang or Neil. Since these references are not defective, Wang is not deficient.
Claims 1 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over
Jang “Droplet-based microtumor model to assess cell-ECM interactions and drug resistance of gastric cancer cells” Nature.com (2017) in view of Neal (US 20180119107), Wang “Mixed hydrogel bead-based tumor spheroid formation and anticancer drug testing” Analyst 2014, 139, 2440-2458 (already of record), and Miyoshi (WO 2019111998)
Jang, Neal, and Wang apply as above to teach claim 1. Jang fails to teach the addition of a cryopreservation/freezing medium. However, the inclusion of such a cryopreservation/freezing medium is taught by Miyoshi (Section 2, Methods of Producing Cancer Spheroids found in Description of Embodiments). It would have been obvious to an artisan of ordinary skill at the time of effectively filing to have added a cryopreservation/freezing medium taught by Miyoshi into the unpolymerized mixture taught by Jang. An artisan would have been motivated to have added a cryopreservation/freezing medium in order to allow for the spherical droplets of Jang to be subsequently frozen and further preserved as taught in Miyoshi (Section 2, Methods of Producing Cancer Spheroids found in Description of Embodiments). Because Miyoshi teaches that a cryopreservation/freezing medium can freeze and successfully preserve such organoids/spherical droplets, there would have been a high expectation for success (Miyoshi—Section 2, Methods of Producing Cancer Spheroids found in Description of Embodiments) as in instant Claim 28
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.'s and Ph.D.'s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in cell culture and microfluidics. Therefore, the level of ordinary skill in this art is high.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time the inventio was filed especially in the absence of evidence to the contrary.
Response to Argument
The argument against Miyoshi is that it does not cure the deficiencies of Jang, Neil, or Wang. Since these references are not defective, Miyoshi is not deficient.
Claims 1,9,12-13,23-24,34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Jang “Droplet-based microtumor model to assess cell-ECM interactions and drug resistance of gastric cancer cells” Nature.com (2017) in view of Neal (US 20180119107), Wang “Mixed hydrogel bead-based tumor spheroid formation and anticancer drug testing” Analyst 2014, 139, 2440-2458 (already of record), and Kretzschmar WO 2019122388
Jang, Neal, Wang apply as above to teach claims 1 and 23. Jang teaches screening the plurality of spherical droplets with a plurality of drug compositions (Pages 3-7 of Jang). A person would be expected to test as many drugs as needed in order to determine the appropriate drugs/treatments needed to be applied to treat cancer/tumor cells using as many spherical droplets as needed as in instant Claims 12-13
Jang does not expressly teach the need to process biopsy/resected tumor tissue immediately after collection. However, such a sense of urgency for processing after collection is expressed in Kretzschmar (Example 1, Collection of Normal Colon and Colorectal Cancer Biopsies from the Hospital). Kretzschmar teaches that biopsies are to be collected on ice and immediately processed (Example 1, Collection of Normal Colon and Colorectal Cancer Biopsies from the Hospital). Example 1 of Kretzschmar further states that, “biopsies can be kept on ice and immediately processed or can be stored for up to 24 hours at 4C until the start of isolation.”
It would have been obvious to an artisan of ordinary skill at the time of effective filing to have immediately processed the tissue samples of Jang as taught by Kretzschmar. An artisan would have been motivated to have quickly processed such as samples because such samples can only be stored for a short period of time (up to 24 hours as taught by Kretzschmar. Therefore, It would have been obvious to an artisan of ordinary skill at the time of effective filing to have processed the tumor sample expeditiously as discussed in Kretzschmar (Example 1). The time period immediately or within 24 hours is a subrange of within 14 days. Kretzschmar teaches that the sample can be immediately processed (Example 1). Because Example 1 teaches that such samples can be processed within 24 hours, there would be a high expectation for success. (Summary of the invention Section)as taught in claims 9, 12-13,The quick processing time taught in Kretzschmar would allow the spherical droplets of Jang to be immediately used in a drug testing assay of Jang requiring 5 days after 1 day of culture (Jang--Page 3, Analysis of drug resistance). This quick turnaround time would allow hundreds of drug compositions to be screened within 4 to 10 days as in instant Claims 34-35.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.'s and Ph.D.'s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in cell culture and microfluidics. Therefore, the level of ordinary skill in this art is high.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time the inventio was filed especially in the absence of evidence to the contrary.
Response to Argument
The argument against Kretzschmar is that it does not cure the deficiencies of Jang, Neil, or Wang. Since these references are not defective, Kretzschmar is not deficient.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 25,31 of copending Application No. 17/178,210 (reference application)in view of Jang “Droplet-based microtumor model to assess cell-ECM interactions and drug resistance of gastric cancer cells” Nature.com (2017) and Neal (US 20180119107).
Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of Claims 1 and 31 of ‘210 are species of instant claim 1. Unlike instant claim 1, Claim 1 of ‘210 also requires the formation of a library of spherical droplets from the dissociated tissue, expressly requires the automation/control of parameters such as pressure and flow rate, and requires a flow rate of about 0.01 ml to about 100 ml/min. Claim 1 of ‘210 does not mention that the unpolymerized mixture and the immiscible fluid have different flow rates. However, Jang teaches that when forming such droplets, different flow rates can exist on Page 8, “Generation of cell-laden collagen beads (microtumors) Section.” Instant Claim 20 corresponds to claim 25 of ‘210. Neal teaches that the tumor microstructure can be preserved by solid tumor tissue with immune cells and stromal cells by biopsy (Paragraphs 10 and 73-74). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Arguments concerning the Double Patenting Rejection
The rejection for Double Patenting is maintained since the appropriate terminal disclaimer has not been filed.
Conclusion
All claims stand rejected.
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 LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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, Tracy Vivlemore can be reached at 571-272-2914. 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.
LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638