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, 7, 34-35, 38, 40-41, 43-47, 51, 54, 58, 61-62, 68, 91, 93, 96, 119, 123-124, 126 and 128 are pending.
Claim 128 is added.
Claims 2-6, 8-33, 36, 37, 39, 42, 52, 53, 55-57, 59, 60, 63-67, 69-90, 92, 94, 95, 97-118, 120-122, 125, and 127 are cancelled.
Claims 38, 40-41, 43, 45-47, 51, 54, 61-62, 68, 119 and 123-124 are withdrawn.
Claims 1, 7, and 35 are amended.
Claims 1, 7, 34-35, 58, 91, 93, 96, 126 and 128 are currently being examined.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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, 7, 34-35, 58, 91, 93, 96, 126 and 128 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 77, 79, and 85 of copending Application No. 18/546,131 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending application recites an extracellular vesicle comprising a biologically active molecule covalently linked to the EV via an anchoring moiety (claim 1). The anchoring moiety comprises a linker and spacers (claim 1), including a cholesterol (claim 77), TEG (claim 77), phosphorothioate (claim 85) and phosphodiesterase/phosphodiester (claim 85). The spacer can be C6 (claim 79).
The difference between instant application and the patented claims is that the patent claims include additional limitations. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7, 34-35, 58, 91, 93, 96, 126 and 128 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 144 of copending Application No. 18/050,017 (reference application) in view of HARASZTI (Optimized Cholesterol-siRNA Chemistry Improves Productive Loading onto Extracellular Vesicles. Molecular Therapy. 2018.) and MANAHARAN (US 8,828,956 B2).
The copending application recites an extracellular vesicle comprising an antisense oligonucleotide (ASO), which reads on biologically active molecule (claim 144). The vesicle further comprises a cholesterol (claim 144) an anchoring moiety (claim 144). The anchoring moiety comprises a linker (claim 144), such as TEG (claim 90), a phosphorothioate (claim 144).
The application does not teach using C6 and phosphodiester.
MANAHARAN teaches a method of delivering siRNA by conjugating it to cholesterol (column 3, paragraph 1 and 3). Various spacers can be used and combined such as C3, C6, and TEG (column 73, paragraph 2). These spacers help to stabilize the composition (column 73, paragraph 2). MANAHARAN further teaches using a phosphodiester and phosphorothioate linkage (column 54, paragraph 8).
HARASZTI teaches extracellular vesicles that are conjugated to siRNA, which reads on a biologically active molecule, via a linkage (abstract), which reads on anchoring moiety. The linkage comprises a cholesterol (abstract), which reads on sterol, conjugated to triethylene glycol (TEG) (figure 1), that is further conjugated to a phosphorodiester/phosphodiester (PO) and phosphorothioate (PS) that is then connected to the siRNA (figure 4). The phosphodiester linkage, and the overall linkages in general, can be modified to modulate the rate of cholesterol cleavage (page 1977, paragraph 2)
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a C6 spacer. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because C6 and TEG, are functional equivalents of spacers commonly used in the pharmaceutical industry for delivering siRNA when it is conjugated to cholesterol. Furthermore these spacers helped to stabilize the composition.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate phosphodiester. The person of ordinary skill in the art would have been motivated to make those modifications, because a phosphodiester linkage, in general all forms of linkage combination, can be modified to modulate the rate of cholesterol cleavage, and reasonably would have expected success because the references are in the same field of endeavor, such as extracellular vesicles delivering biologically active molecules that utilize cholesterol and various linkers/spacers.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7, 34-35, 58, 91, 93, 96, 126 and 128 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 41, 50, and 52 of copending Application No. 18/546,130 (reference application) in view of HARASZTI (Optimized Cholesterol-siRNA Chemistry Improves Productive Loading onto Extracellular Vesicles. Molecular Therapy. 201.) and MANAHARAN (US 8,828,956 B2).
The copending application recites an extracellular vesicles comprising an siRNA (claims 1 and 3). The vesicle comprises an anchoring moiety (claim 50) and a phosphorothioate (claim 41), and a linker (claim 52).
The application does not teach using C6, phosphodiester and cholesterol.
MANAHARAN teaches a method of delivering siRNA by conjugating it to cholesterol (column 3, paragraph 1 and 3). Various spacers can be used and combined such as C3, C6, and TEG (column 73, paragraph 2). These spacers help to stabilize the composition (column 73, paragraph 2). MANAHARAN further teaches using a phosphodiester and phosphorothioate linkage (column 54, paragraph 8).
HARASZTI teaches extracellular vesicles that are conjugated to siRNA, which reads on a biologically active molecule, via a linkage (abstract), which reads on anchoring moiety. The linkage comprises a cholesterol (abstract), which reads on sterol, conjugated to triethylene glycol (TEG) (figure 1), that is further conjugated to a phosphorodiester/phosphodiester (PO) and phosphorothioate (PS) that is then connected to the siRNA (figure 4). The cholesterol enables efficient and reproductible loading of the vesicle with the siRNA (abstract). The phosphodiester linkage, and the overall linkages in general, can be modified to modulate the rate of cholesterol cleavage (page 1977, paragraph 2)
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a C6 spacer. The person of ordinary skill in the art would have been motivated to make those modifications because C6 helped to stabilize the composition and reasonably would have expected success the references are in the same field of endeavor such as compositions comprising linkers and spacers to deliver siRNA.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate cholesterol and phosphodiester. The person of ordinary skill in the art would have been motivated to make those modifications, because the cholesterol enables efficient and reproductible loading of the vesicle with the siRNA and phosphodiester linkage, in general all forms of linkage combination, can be modified to modulate the rate of cholesterol cleavage, and reasonably would have expected success because the references are in the same field of endeavor, such as extracellular vesicles delivering siRNA that utilize various linkers/spacers.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7, 34-35, 58, 91, 93, 96, 126 and 128 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 36, 88, and 90 of copending Application No. 17/635,298 (reference application) in view of HARASZTI (Optimized Cholesterol-siRNA Chemistry Improves Productive Loading onto Extracellular Vesicles. Molecular Therapy. 2018.) and MANAHARAN (US 8,828,956 B2).
The copending application recites an extracellular vesicle comprising an antisense oligonucleotide (claim 1), which reads on biologically active molecule. The vesicle further comprises an anchoring moiety and linker (claim 36 and 88), which includes cholesterol (claim 90). The linker can be TEG (claim 90).
The application does not teach using C6, phosphorothioate and phosphodiester.
HARASZTI teaches extracellular vesicles that are conjugated to siRNA, which reads on a biologically active molecule, via a linkage (abstract), which reads on anchoring moiety. The linkage comprises a cholesterol (abstract), which reads on sterol, conjugated to triethylene glycol (TEG) (figure 1), that is further conjugated to a phosphorodiester/phosphodiester (PO) and phosphorothioate (PS) that is then connected to the siRNA (figure 4). The phosphorothioate modification provided additional stabilization (page 1976, paragraph 1). The phosphodiester linkage, and the overall linkages in general, can be modified to modulate the rate of cholesterol cleavage (page 1977, paragraph 2)
MANAHARAN teaches a method of delivering siRNA by conjugating it to cholesterol (column 3, paragraph 1 and 3). Various spacers can be used and combined such as C3, C6, and TEG (column 73, paragraph 2). These spacers help to stabilize the composition (column 73, paragraph 2). MANAHARAN further teaches using a phosphodiester and phosphorothioate linkage (column 54, paragraph 8).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate phosphorothioate and phosphodiester. The person of ordinary skill in the art would have been motivated to make those modifications, because the phosphorothioate modification provided additional stabilization and phosphodiester linkage, in general all forms of linkage combination, can be modified to modulate the rate of cholesterol cleavage, and reasonably would have expected success because the references are in the same field of endeavor, such as extracellular vesicles delivering siRNA that utilize various linkers/spacers.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a C6 spacer. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because C6 and TEG are functional equivalents of spacers commonly used in the pharmaceutical industry for delivering siRNA when it is conjugated to cholesterol. Furthermore these spacers helped to stabilize the composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7, 34-35, 58, 91, 93, 96, 126 and 128 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 10, 15, and 20 of copending Application No. 19/103,894 (reference application) in view of HARASZTI (Optimized Cholesterol-siRNA Chemistry Improves Productive Loading onto Extracellular Vesicles. Molecular Therapy. 2018.).
The copending application recites An extracellular vesicle (EV) comprising a biologically active molecule (BAM) attached to the EV via an anchoring moiety (AM) according to Formula I: AM-SPi-Li-SP2-L2-SP3-L3-SP4-BAM (Formula I) wherein Li and L2 are the same or different and each is a cleavable linkage; L3 is an optional cleavable linkage and SP1, SP2, SP3, and SP4 are optional first, second, third, and fourth spacers, respectively (claim 1). The linker can be a phosphodiester (claim 15) and a C6 (claim 10). The AM comprises a sterol (claim 20).
The application does not teach using a phosphorothioate.
HARASZTI teaches extracellular vesicles that are conjugated to siRNA, which reads on a biologically active molecule, via a linkage (abstract), which reads on anchoring moiety. The linkage comprises a cholesterol (abstract), which reads on sterol, conjugated to triethylene glycol (TEG) (figure 1), that is further conjugated to a phosphorodiester/phosphodiester (PO) and phosphorothioate (PS) that is then connected to the siRNA (figure 4). The phosphorothioate modification provided additional stabilization (page 1976, paragraph 1). The phosphodiester linkage, and the overall linkages in general, can be modified to modulate the rate of cholesterol cleavage (page 1977, paragraph 2)
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate phosphorothioate. The person of ordinary skill in the art would have been motivated to make those modifications, because the phosphorothioate modification provided additional stabilization and reasonably would have expected success because the references are in the same field of endeavor, such as extracellular vesicles delivering siRNA that utilize various linkers/spacers.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7, 34-35, 58, 91, 93, 96, 126 and 128 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 12, 24, and 41 of copending Application No. 19/103,902 (reference application) in view of HARASZTI (Optimized Cholesterol-siRNA Chemistry Improves Productive Loading onto Extracellular Vesicles. Molecular Therapy. 2018.).
The copending application recites An extracellular vesicle (EV) comprising a biologically active molecule (BAM) attached to the EV via an anchoring moiety (AM) according to Formula I or II: AM-SP1-L1-SP2-L2-SP3-BAM-SP4-L3 (Formula I) AM-SP1-L1-SP2-L2-SP3-BAM (Formula II) wherein L1, L2, and L3 are the same or different and each is an optional cleavable linkage; and SP1, SP2, SP3, and SP4 are optional first, second, third, and fourth spacers, respectively, and wherein at least one of Li, L2, and L3 is present and comprises a cell penetrating peptide (claim 1), where the AM is a sterol (claim 24) and the linker comprises a phosphodiester (claim 12) and the spacer comprises a C6 (claim 41).
The application does not teach using a phosphorothioate.
HARASZTI teaches extracellular vesicles that are conjugated to siRNA, which reads on a biologically active molecule, via a linkage (abstract), which reads on anchoring moiety. The linkage comprises a cholesterol (abstract), which reads on sterol, conjugated to triethylene glycol (TEG) (figure 1), that is further conjugated to a phosphorodiester/phosphodiester (PO) and phosphorothioate (PS) that is then connected to the siRNA (figure 4). The phosphorothioate modification provided additional stabilization (page 1976, paragraph 1). The phosphodiester linkage, and the overall linkages in general, can be modified to modulate the rate of cholesterol cleavage (page 1977, paragraph 2)
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate phosphorothioate. The person of ordinary skill in the art would have been motivated to make those modifications, because the phosphorothioate modification provided additional stabilization and reasonably would have expected success because the references are in the same field of endeavor, such as extracellular vesicles delivering siRNA that utilize various linkers/spacers.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 7, 34-35, 58, 91, 93, 96, 126 and 128 are rejected under 35 U.S.C. 103 as being unpatentable over HARASZTI (Optimized Cholesterol-siRNA Chemistry Improves Productive Loading onto Extracellular Vesicles. Molecular Therapy. 2018.) in view of MANAHARAN (US 8,828,956 B2).
Regarding claim 1, HARASZTI teaches extracellular vesicles that are conjugated to siRNA, which reads on a biologically active molecule, via a linkage (abstract), which reads on anchoring moiety. The linkage comprises a cholesterol (abstract), which reads on sterol, conjugated to triethylene glycol (TEG) (figure 1), that is further conjugated to a phosphorodiester/phosphodiester (PO) and phosphorothioate (PS) that is then connected to the siRNA (figure 4).
Regarding claim 7, HARASZTI teaches a cholesterol is used (abstract).
Regarding claim 34, HARASZTI teaches using TEG (figure 4), which is a polyethylene glycol.
Regarding claim 35, HARASZTI teaches using TEG (figure 4), which has the formula of H-(O-CH2-CH2)3-O.
Regarding claim 58, HARASZTI teaches that TEG, PO and PS are used (figure 4)
Regarding claim 91, HARASZTI teaches that the siRNA is conjugated onto the extracellular vesicle (abstract), which reads on covalently linked on an exterior surface.
Regarding claims 93 and 96, HARASZTI teaches that the biologically active molecule is an siRNA, which reads on a polynucleotide.
HARASZTI does not teach adding a C6.
Regarding claims 1, 126, and 128, MANAHARAN teaches a method of delivering siRNA by conjugating it to cholesterol (column 3, paragraph 1 and 3). Various spacers can be used and combined such as C3, C6, and TEG (column 73, paragraph 2). These spacers help to stabilize the composition (column 73, paragraph 2). MANAHARAN further teaches using a phosphodiester and phosphorothioate linkage (column 54, paragraph 8). The C6 spacer can be – (CH2)6 – which is an alkylene (column 81, paragraph 4).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a C6 spacer. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because C6 and TEG, which is used in HARASZTI, are functional equivalents of spacers commonly used in the pharmaceutical industry for delivering siRNA when it is conjugated to cholesterol. Furthermore these spacers helped to stabilize the composition.
Response to Arguments
Applicant argues, Haraszti discloses fully modified cholesterol-hsiRNAs targeting Huntingtin mRNA using either TEG or C7 linkers and that cholesterol-TEG-hsiRNAs loaded more efficiently onto extracellular vesicles than cholesterol C7-hsiRNAs at all ratios tested. Haraszti, p. 1974, col. 2, para. 1, and Figure. IA Haraszti explains that more efficient loading led to more potent Huntingtin mRNA silencing and as a result cholesterol-TEG-hsiRNA was used for subsequent experiments. Id. Haraszti further discloses that TEG proved to be favorable compared to C7 for productive exosomal loading of cholesterol-siRNA, and that the length and hydrophilic character of the TEG linker might favor the lipid bilayer geometry and promote more efficient hsiRNA loading. Haraszti, p. 1978, col. 1, para. 2. Thus, at best Haraszti discloses and encourages using a TEG linker and teaches away from using C7 or a shorter linker with a similar hydrophobicity profile such as C6.
The examiner does not find the argument persuasive because in the 103 discussed above, C6 is added to the composition of HARASZTI not replacing it. Therefore, the length and hydrophilic character would still be present. Additionally, since length is what assists in the exosomal loading of cholesterol-siRNA, it would be assumed that adding further length, via the C6 discussed in MANAHARAN, that the exosomal loading would increase. Applicant’s data even shows that when TEG is used with a carbon spacer the loading efficiency is 79.67% (Applicant’s specification, Fig. 26, No. T2), which is above some of the cholesteral-C6 lipid anchors and almost equal to others within that same category. Additionally, as discussed above the C6 spacer can add stability to the composition and it is well known in the art that spacers and their positions can be added or changed to optimize for the compositions use. Furthermore, obviousness does not require complete predictability and less preferred embodiments do not constitute a teaching away.
Applicant argues, as shown in FIG. 25 and 26 of the instant application, constructs with a cholesterol-C6 lipid anchor showed significantly higher loading efficacy than constructs with a cholesterol-TEG lipid anchor. Haraszti is completely silent on this improvement with the C6 spacer, and in contrast achieved greater hsiRNA loading with the TEG linker at or greater than double than the C7 linker. Haraszti, Figure IA.
The examiner does not find the argument persuasive because in order to overcome a prima facie case of obviousness, it is incumbent upon the Applicant to provide comparative test evidence that demonstrates unexpected superiority of the claimed compositions versus the closest prior art compositions, and not simply an advantage predictable from the prior art. See In re Chapman, 148 USPQ 711, 715 (CCPA, 1966). Moreover, such proffered comparisons must be commensurate in scope with the breadth of the claims. See In re Clemens, 206 USPQ 289, 296 (CCPA, 1980) and In re Coleman, 205 USPQ 1172, 1175 (CCPA 1980). In the instant case, the results are not commensurate in scope with claim 1. Applicant claims every biological active molecule, wherein Applicant active molecule is only an firefly luciferase (FFLuc). Additionally, instant claim 1 can have a multitude of linkers, between 1-10 linkers with only 1 defined linker PS, the other 9 possible linkers are undefined and no evidence is provided that the supposed unexpected results would still hold true for the many, and undefined, combinations that claim 1 covers. Additionally, some linker combinations that utilized TEG, Tocopherol, and Palmitate-C6 achieved loading efficiency higher than some of the cholesteral-C6 anchors (Applicant’s specification, Fig 26.).
For a complete discussion of unexpected results, Applicants are referred to MPEP 716.02 et seq.
Conclusion
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 SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./ Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
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