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 1-3,5-6,11,17-18,20,26,32,36-38,40,52, and 155-159 are under examination.
Claim Interpretation
The method claims disclose that there is a selection step for CD57- cells which involves removal of CD57+ cells, and another selection step for CD3+. The way that claims 1-3 are drafted encompass methods in which the CD57- selection step and CD3+ selection step can occur at the same time. There is nothing in the claims that requires that the first selection step take place before the second selection step.
Claim Rejections - 35 USC § 112
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 158-159 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 158 and 159 are inconsistent with independent claim 1 because independent claim 1 focuses on sorting cells based on expression of CD57- and CD3+ NOT CD27+ (mentioned in claim 158) or CD28+ (mentioned in claim 159). It is not clear how CD27+ or CD28+ cells are sorted in the process of claim 1.
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 1-3,5-6,11,17-18,20,26,36-38,40,155-157 are rejected under 35 U.S.C. 103 as being unpatentable over Dupuy d’Angeac “CD57+ T lymphocytes are derived from CD57- precursors by differentiation occurring in late immune responses” Eur J. Immunol. 1994; 24: 1503-1511 in view of Hinrichs et al. “Human effector CD8+ T cells derived from naïve rather than memory subjects possess superior traits for adoptive immunotherapy” Blood, 20 January, 2011, Volume 117, Number3, and Wiltzius (US 20170281766)
Dupuy d’Angeac discloses a method for enriching T cells. Dupuy d’Angeac’s method involves taking blood from donors and then layering the blood cells on Ficoll and spinning for 30 mins. The peripheral blood mononuclear cells (PBMCs) are then isolated from the blood cells, and the PBMCs are further sorted using a FACS Vantage system. CD3+CD57- and CD3+CD57+ isolated cell populations were obtained by cell sorting using FACS Vantage system after labeling with PE-labeled anti-CD3 mAb and FITC-labeled anti-CD57 mAbs. Each cell population was greater than 98% pure (Page 1504, 2.2 Cells) as in instant Claims 1-3.
The CD57- T cell population of Dupuy d’Angeac is composed of T cells that are CD57-. Dupuy d’Angeac fails to teach genetically engineering its population of CD57- cells produced by its separation process. Hinrichs teaches genetically engineering a population of T cells that contain CD57- cells (Abstract; Page 809, 1st Paragraph—left column; Figure 5, page 811). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have genetically engineered the CD57- T cells of Dupuy d' Angeac. An artisan would have been motivated to have genetically engineered CD57-T cells because Hinrichs teaches that such CD57- cells would be advantageous to use in therapies because these “cells were not only the most abundant subset but also the population most capable of in vitro expansion and T -cell receptor transgene expression. Despite increased expansion, naïve-derived cells displayed minimal effector differentiation, a quality associated with greater efficacy after cell infusion…retained longer telomeres, characteristics that suggest greater proliferation potential and that have been linked to greater efficacy in clinical trials” cv(Abstract of Hinrichs). Hinrichs further states, “taken together, these findings indicate that adoptive immunotherapy with T cells expressing TCR or CAR transgenes might be improved by transducing purified naïve T cells” which include T cells that are negative for CD57 (Page 809, 1st Paragraph and Figure 5 of Henricks).” Thus, Hinrichs teaches that CD57- T cells would be a preferred cell population to use for genetic engineering. Because these CD57-cells can be genetically engineered as shown in Figure 5 and they readily proliferate as discussed in the abstract of Hinrichs, there would have been a high expectation for success.
Although Henricks mentions genetic engineering with TCR/CAR transgenes, Hinrichs does not lay out a specific protocol for such genetic engineering. However, Wiltzius teaches introducing a heterologous polynucleotide encoding a recombinant receptor into a T cell population, thereby generating an engineered T cell population (Abstract and Paragraphs 4,6,73, 237 of Wiltzius); and cultivating cells of the engineered T cell population under conditions to promote proliferation or expansion of the engineered T cell population, thereby generating an expanded engineered T cell population (Paragraph 237 of Wiltzius).
It would have been obvious to an artisan of ordinary skill at the time of effective filing to have genetically engineered the T cell population of Dupuy d’Angeac with the genetic engineering method taught by Hinrichs and Wiltzius. An artisan would have been motivated to have genetically engineered the T cell population of Dupuy d’ Angeac into T cells that can express antigen receptors (CARs) or T cell receptors (TCRs) in order to specifically target and kill cancer cells using the genetically engineered T cells (Summary of the Invention, Paragraphs 6-7 taught n Wiltzius). Because it is well known that such genetically engineered cells can successfully kill cancer cells (Paragraphs 6-7 of Wiltzius), there would be a high expectation for success modifying the cells of Dupuy d’ Angeac using the method taught by Wiltzius as in instant Claims 1-3.
Dependent Claims taught by Dupuy d’Angeac
Dupuy d’ Angeac discloses that the depleted population includes: (i) less than 5% CD57+ T cells; (ii) a frequency of CD57+ T cells that is less than 35% of the frequency of CD57+T cells present in the biological sample; (iii) CD4+ T cells, wherein at least 95% of the CD4+ T cells are CD57-; and (iv) CD8+ T cells, wherein at least 95% of the CD8+ T cells are CD57- (Page 1504, Materials and Methods, 2.2 Cell Section. The purity rate for the CD3+CD57- T cell population which includes CD4/CD8 T cells is greater than 98% pure as in instant Claim 5.
Dupuy d’Angeac discloses an apheresis product that is formed by removing whole blood from a donor and then separating the whole blood into component parts (Page 1504, Materials and Methods, Cells Section) as in instant Claim 6.
Dupuy d’Angeac discloses that at least 95% of the CD3+ T cells of the depleted population comprises CD57-CD3+ T cells (Page 1504, Materials and Methods, 2.2 Cell Section) as in instant Claim 11.
Dupuy d’Angeac discloses that the isolated CD57-CD3+T cell population is greater than 98% pure so less than 2% of the cells would be positive for CD57+ (Page 1504, Materials and Methods, 2.2 Cell Section) as in instant Claim 17.
Dupuy d’Angeac discloses that the depleted population comprises less than 3% CD57+ T cells or essentially free of CD57+ T cells (Page 1504, Materials and Methods, 2.2. Cells) as in instant Claim 18.
Page 1504, Materials and Methods Section, 2.2. Cells Section of the Dupuy d’Angeac reference discloses that a nearly homogenous population of CD3+CD57- cells can be obtained with a purity level of greater than 98%. The population of CD3+CD57- cells represent a naïve-like T cell population compared to CD3+CD57+ T cells (Abstract). This population would have a greater concentration of naïve cells than the original sample taken directly from the blood since the majority of the cells after FACS are CD3+CD57-(higher purity of >98%) and are considered naïve cells when compared to the CD3+CD57+ population. These cells include CD4+ and CD8+ cells as in instant Claims 20 and 26,155-157.
Dupuy d’ Angeac discloses removal of the CD57+T cells immunoaffinity-based selection (FACS is a type of immunoaffinity selection) (Page 1504, Materials and Methods, 2.2. Cells). The affinity of the antibodies used in Dupuy d’ Angeac’s FACS sorting is “immunoaffinity” selection because immunoaffinity cell selection involves separating cells based on their ability to bind to specific antibodies as in instant Claim 36.
Dupuy d’Angeac discloses an immunoaffinity-based selection involving contacting cells with an antibody capable of specifically binding to CD57 and recovering cells not bound to the antibody, thereby effecting negative selection, wherein the recovered cells are depleted for CD57+ cells (Page 1504, Materials and Methods, 2.2. Cells) as in instant Claim 37.
Dupuy d’Angeac discloses enriching cells using immunoaffinity based selection (Page 1504, Materials and Methods, 2.2 Cells) as in instant Claim 38.
Dupuy d’Angeac discloses a selection that enriches for CD3 T cells by contacting the cells with an antibody capable of specifically binding to CD3. Dupuy d’Angeac discloses recovering the cells bound to the antibody, thereby effecting positive selection, wherein the recovered cells are enriched for the CD3+ cells (Page 1540, Materials and Methods, 2.2. Cells) as in instant Claim 40.
Dupuy d’Angeac teaches a method of generating a population of CD57-CD3+ cells with a high purity using FACS (a type of immunoaffinity-based selection). Dupuy d’ Angeac does not teach the benefits of modifying CD57- T cells; however, Henrichs teaches the genetic modification of population of T cells with CD57- T cells. An artisan of ordinary skill would have been further motivated to have modified Dupuy d’Angeac’s population of CD57-CD3+ T cells using genetic engineering in order to specifically target cancer/tumor cells as taught by Wiltzius. Given the teachings of the cited references and the level of skill of an ordinarily skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
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 molecular biology, cloning, cell culture, and cell selection. Therefore, the level of ordinary skill in this art is high.
Claims 1-3,5-6,11,17-18,20,26,32,36-38,40, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Dupuy d’Angeac “CD57+ T lymphocytes are derived from CD57- precursors by differentiation occurring in late immune responses” Eur J. Immunol. 1994; 24: 1503-1511 in view of Hinrichs et al. “Human effector CD8+ T cells derived from naïve rather than memory subjects possess superior traits for adoptive immunotherapy” Blood, 20 January, 2011, Volume 117, Number3, Wiltzius (US 20170281766) and Ramsborg (WO 2015164675).
Dupuy d’ Angeac, Hinrichs, and Wiltzius apply as above to teach claims 1-3,5-6,11,17-18,20, and 26, 36-38,40. Dupuy d’ Angeac teaches separation of cells using a FACS Vantage system (a form of immunoaffinity) (Page 1504, Materials and Methods Section, 2.2. Cells Section). Dupuy d’Angeac does not disclose a specific ratio of CD4/CD8 T cells that can be harvested using immunoaffinity. Dupuy d’ Angeac does not disclose harvesting the T cells from a subject with a disease and/or condition. Dupuy d’ Angeac also fails to disclose wherein the T cell sample is formulated with a cryoprotectant.
Ramsborg teaches wherein the primary T cells are from a subject with a disease or condition (Paragraph 39). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have harvested the T cells from an individual with a disease or condition in order to better understand how the disease/condition impacts the T cell populations (Paragraph 39 of Ramsborg). Because Ramsborg teaches that T cells can be harvested from an individual with a disease or condition, there would be a high expectation for success (Paragraph 39 of Ramsborg) as in instant Claim 32.
Ramsborg teaches wherein the biological sample comprising T cells is a sample formulated with a cryoprotectant (Paragraph 266). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have treated the biological sample with a cryopreservation agent. An artisan would have been motivated to have treated the original sample containing T cells with a cryopreservation agent at the time of cryopreservation to preserve the population of T cells while removing unwanted granulocytes and monocytes in the cell population. Because Ramsborg teaches that addition of cryopreservation agents followed by cryopreservation can better preserve the desired cell populations, there would have been a high expectation for success (Ramsborg Paragraph 266) as in instant Claim 52.
Dupuy d’Angeac teaches a method of generating a population of CD57-CD3+ cells with a high purity using FACS (a type of immunoaffinity-based selection). Dupuy d’ Angeac does not teach the benefits of modifying CD57- T cells; however, Henrichs teaches the genetic modification of population of T cells with CD57- T cells An artisan of ordinary skill would have been further motivated to have modified Dupuy d’Angeac’s population of CD57-CD3+ T cells using genetic engineering in order to specifically target cancer/tumor cells as taught by Wiltzius. Ramsborg teaches the use of immunoaffinity to successfully sort cells. The ordinarily skilled artisan would have been motivated to have used immunoaffinity taught by Ramsborg to obtain the desired population of CD4/CD8 T cells. An artisan would have been motivated to have used T cells from an individual with a disease and/or condition as taught by Ramsborg to better understand the impact of the disease/condition on T cells. Furthermore, an artisan would have been motivated to have cryopreserved the biological sample containing the T cells in order to protect T cells and remove contaminating granulocytes and monocytes. Given the teachings of the cited references and the level of skill of an ordinarily skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
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 molecular biology, cloning, cell culture, and cell selection. Therefore, the level of ordinary skill in this art is high.
Response to Applicants Arguments/Amendments
Applicants argue, “Claims 1-3 are directed to methods of enriching CD57- T cells, introducing a heterologous polynucleotide encoding a recombinant receptor into the enriched cells, and expanding the engineered cells, wherein the expanded cells exhibit an increase in consistency of recombinant receptor expression as compared to a similar method that does not enrich for CD57-T cells. Thus, the claims recited an improved method for engineering T cells, where the improvement (i.e.increased consistency of recombinant receptor expression) is attributable to the enrichment of CD57- T cells.”
The limitations recited in the claims are taught in the prior art cited in the past rejections. Dupuy d’ Angeac teaches the limitations for selecting for a population of CD57- T cells. Although Dupuy d’ Angeac does not teach genetically manipulating one or more of its cell populations, an artisan would have been motivated to have taken the nearly homogenous population of CD57- T cells produced by Dupuy d' Angeac and to have further genetically engineered those cells. Hinrichs teaches genetically engineering a population of T cell that contain CD57- T cells/naïve T cells (Abstract of Hinrichs). Hinrichs teaches in particular it is advantageous to genetically engineer CD57- T/naïve T cells because these “cells were not only the most abundant subset but also the population most capable of in vitro expansion, and T-cell receptor transgene expression (making this population attractive for genetic engineering (Abstract of Hinrichs).” Hinrichs further states, “taken together, these findings indicate that adoptive immunotherapy with T cells expressing TCR and CAR transgenes might be improved by transducing purified naïve T cells (CD57- T cells) (Page 809, Introduction, last paragraph). Thus, Hinrichs, a secondary reference, provides the proper motivation for taking a population of naïve CD57- T cells such as the ones generated by Dupuy d’ Angeac and genetically engineering them. Although Hinrichs teaches that CD57- T cells/naïve T cells can be genetically engineered, an additional reference (Wilzius) is used to teach the actual process of further culturing/expanding the cells that have been genetically engineered. The teachings of Wilzius can be applied to any cell type that has been genetically engineered.
Applicants further argue that Hinrichs selects cells based on a CD62L high/CD45RO low naïve phenotype, not CD57. Hinrichs is not relied upon for teaching a sorting/selection process; the sorting/selection process is taught by Dupuy d’ Angeac. Hinrichs teaches the advantages of using naïve T cells for genetic engineering therapies. Hinrichs shows that naïve T cells do not express CD57 which means they are CD57- cells (Figure 5). There would have been motivation for further genetically engineering and expanding/culturing the population of isolated CD57- T cells because they contain naïve T cells. Naïve T cells are cells, “most capable of in vitro expansion and T-cell receptor transgene expression (Abstract of Hinrichs).” Because the CD57- T cell population of Dupuy d’ Angeac contains naïve T cells, there would have been motivation to have further expanded and genetically engineered these cells since Hinrichs teaches that CD57- T cells include naïve T cells which can be easily expanded and genetically engineered. Hinrichs is used to connect CD57- expression status to recombinant receptor expression, not Wiltzius and/or Ramsborg.
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Applicants are arguing that an absence of CD57 expression can be present in many types of T cells including effector, naïve, and memory cells. Therefore, it would not be a desired marker to use when identifying naïve T cells. Applicants further argue that it is not the predominant marker taught by Hinrichs. Although CD57- expression can exist in T (central memory) and T (EM) cells, the naïve T cell population in Figure 5 is always CD57- and never CD57+. Therefore, if the goal is to choose a population that can be easily genetically manipulated such as the naïve T cells, it would be obvious to choose a T cell population with CD57- expression because the naïve T cells that can be easily genetically manipulated would be present in such a population. The examiner would have found applicants arguments more persuasive if there was variability in CD57 expression in the naïve T cell population. However, Figure 5 shows that the naïve cells are always CD57- (Figure 5). Furthermore, the selection process is not just relying on expression of one maker (CD57), other marker expression is included in the process (CD3+).
The examiner feels that it would help to better define the cell population that the sorting process is generating. In the independent claims, applicants mention sorting by markers CD57 and CD3. That is rather broad since sorting is based on two markers. The examiner feels that applicant is after a more specific cell population that might be positive for CD27 and CD28. The examiner feels that it would help to include these markers into the sorting process mentioned in the independent claims to better define what specific cell population is being produced.
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 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1,7-8,11,14-16 of Patent 12/703,733 in view of Dupuy d’Angeac “CD57+ lymphocytes are derived from CD57- precursors by differentiation occurring in late immune responses” Eur J. Immunol. 1994; 24: 1503-1511 and Hinrichs et al. “Human effector CD8+ T cells derived from naïve rather than memory subsets possess superior traits for adoptive immunotherapy” Blood, 20 January 2011, volume 117, Number 3. Instant claims 1-3 encompass selection method steps that result in a population of CD57-CD3+ T cells which are used for genetic engineering purposes. Claims 1,7-8,11,14-16 of Patent 12/703,733 teach selecting T cells that are negative for CD57 and CD3+ which can be used for genetic engineering purposes. Dupuy d’Angeac teaches the detailed CD57- T cell lymphocyte selection process that the claims of Patent 12/703,733 fail to completely teach. Hinrichs et al. teaches the motivation for using CD57- T cells in genetic engineering.
Response to Applicants’ Arguments
Application 17/924,635 is now Patent 12/703,733. Because the claims are not in condition for allowance, the double patenting rejection remains in place. Dupuy d’Ageac is still appropriate because it teaches the sorting of CD57- CD3+ cells. Hinrichs applies as above because it still teaches that CD57- T cells can contain useful T cell populations (naïve T cells) that can be used in genetic engineering therapies. The appropriateness of Dupuy d’Ageac and Hinrichs have been argued above in the art rejection section. Patent 12/703,733 can be viewed as a type of species of the instant application since some claims of 12/703,733 state that the T cells can be pooled T cells from multiple individuals.
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.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
Prosecution Insights