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 .
Applicant’s election without traverse of group II and antisense oligonucleotide in the reply filed on 5/6/26 is acknowledged.
Applicant's election with traverse of plasmid vector and SEQ ID NO: 14 and parenteral in the reply filed on 5/6/26 is acknowledged. The traversal is on the ground(s) that the inventive step resides in novel synthetic acids which are effective to downregulate TUBB4A and that the vectors are conventional. This is not found persuasive because this is not a group restriction, but rather a species election. The species election requirement between different structures of vectors is appropriate and each requires different search considerations.
Applicant argues that there is no serious search burden for the antisense sequences. Search burden is not a consideration for applications filed as a 371. However, there certainly is a search burden because each of the sequences has a different sequence of nucleotides and activity.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/6/26. It is noted that SEQ ID NOs: 14 and 15 have been examined due to the minimal species recited in instant claim 19.
Drawings
The drawings are objected to for the following reasons:
37 C.F.R. 1.84 states “Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined.”
In the current case, the words in Figures 3C-D, 4, 5, 7A-C, 8, 10, 11A-C, 12, 13A-C, 14A-B, 15, 18A-B, 19A-B, and 20A-C are not fully legible.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 12 is objected to because of the following informalities: Claim 12 recites TUBB4A. The first recitation of an abbreviation is required to recite what the abbreviation is for. Appropriate correction is required.
Claim 14 is objected to because it includes tables with symbols that are not defined in the claims. Appropriate correction is required.
Improper Markush Rejection
Claims 12-18 and 20 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons: The claims recite the Markush group “an antisense oligonucleotide, an shRNA, an siRNA, and a guide strand suitable for CRISPR editing’. The siRNA and the gRNA are both RNAs that must be able to hybridize to a nucleic acid sequence found in a TUBB4A encoding nucleic acid. The term “gRNA’ refers to an RNA that will bind to a Cas protein for the purpose of localizing that protein with a DNA or RNA target. In contrast, siRNAs do not bind to Cas proteins, but instead bind to Argonaute proteins and function to guide those proteins to targets. Accordingly, siRNAs and gRNAs do not have sufficiently similar structures to provide the same function because each has a structure that dictates that it must bind to a different protein effector molecule.
Antisense oligonucleotides function by recruiting RNase H to cleave the RNA strand, preventing translation to protein. In contrast, siRNAs do not recruit RNase H, but instead bind to Argonaute proteins and function to guide those proteins to targets. Accordingly, siRNAs and antisense oligonucleotides and guide RNAs do not have sufficiently similar structures to provide the same function because each has a structure that dictates its pathway of action.
Therefore, the members of the Markush group lack any common substantial structural feature that provides a common use, and the group of alternatives is an improper Markush group. In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. 134 and 37 CFR 41.31(a)(1).
Additionally, each of the sequences of claim 14 have a different order of nucleotides and a different activity. One cannot be substituted for another with expectation of identical activity.
As set forth in MPEP2117, “Note that where a Markush group includes only materials from a recognized scientific class of equivalent materials or from an art-recognized class, "the mere existence of such a group in an application tend[s] to prove the equivalence of its members and when one of them [is] anticipated the group [is] therefore rendered unpatentable, in the absence of some convincing evidence of some degree of non-equivalency of one or more of the remaining members." In re Ruff, 256 F.2d 590, 598-99, 118 USPQ 340, 348 (CCPA 1958)("[A]ctual equivalence is not enough to justify refusal of a patent on one member of a group when another member is in the prior art. The equivalence must be disclosed in the prior art or be obvious within the terms of Section 103." Id. at 599, 118 USPQ at 348).”
In the instant case, art against any one type of inhibitor would not be evidence against any of the remaining members that have different structures and act via different mechanisms; and art against any one of the sequences would not be evidence against any of the remaining members that have different sequences and do not have identical activity.
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 12-20 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.
Claim 12 recites a guide strand “suitable” for CRISPR editing. The term “suitable” does not impart any meaningful structural limitation and therefore the metes and bounds of the claim are indefinite. It is unclear what structure is required for the guide strand to be suitable for CRISPR editing. Claims 13-20 are rejected because they depend from claim 12 and do not obviate the rejection.
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 12-20 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.
The claims are directed to a synthetic nucleic acid that specifically hybridizes to any TUBB4A encoding nucleic acid.
The specification does not adequately describe the genus of TUBB4A encoding nucleic acids.
The claims encompass any antisense oligonucleotide, shRNA, siRNA, or guide strand suitable for CRISPR editing that specifically hybridizes at any number of nucleotides to any TUBB4A encoding nucleic acid, which encompasses any TUBB4A homolog or allele from any species known or yet to be discovered of TUBB4A, as well as DNA genomic fragments, spliced variants or fragment that retains TUBB4A-like activity.
Although the specification discloses specific inhibitory agents that are fully complementary to a specific TUBB4A sequence, the specification does not describe an adequate species of inhibitory molecules to demonstrate that applicant was in possession of the claimed molecules within the instant method at the time the invention was made. The specification does not describe such agents directed to any other species of TUBB4A to describe the instantly claimed genus of any TUBB4A encoding nucleic acid. Each of the instantly disclosed agents is targeted to a single sequence, although the claims are drawn to any TUBB4A. One of ordinary skill in the art could not make such agents to any TUBB4A encoding nucleic acid without knowledge of the sequence. Given the breadth of sequences embraced in the instantly claimed genus, one could not envision the member agents that target such a broad genus.
With respect to antisense oligonucleotides, certainly not any antisense oligonucleotide that specifically hybridizes to any number of nucleotides in any TUBB4A encoding nucleic acid would have the recited function of reducing the expression of TUBB4A. It is widely known that not all antisense oligonucleotides are inhibitory of the target.
For example, Baker et al. (US 2004/0142346 A1) performed a gene walk of a specific target and demonstrates that some antisense oligonucleotides did not result in inhibition of the target (Tables 2 and 3).
The MPEP states that for a generic claim, the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. See MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad genus. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. Additionally, in Carnegie Mellon University v. Hoffman-La Roche Inc., Nos. 07-1266, -1267 (Fed. Cir. Sept. 8, 2008), the Federal Circuit affirmed that a claim to a genus described in functional terms was not supported by the specification’s disclosure of species that were not representative of the entire genus. Furthermore, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The Guidelines for Examination of Patent Applications under the 35 USC § 112, first paragraph, “Written Description” Requirement”, published at Federal Register, Vol. 66, No. 4, pp. 1099-1111 outline the method of analysis of claims to determine whether adequate written description is present. The first step is to determine what the claim as a whole covers, i.e., discussion of the full scope of the claim. Second, the application should be fully reviewed to understand how applicant provides support for the claimed invention including each element and/or step, i.e., compare the scope of the claim with the scope of the description. Third, determine whether the applicant was in possession of the claimed invention as a whole at the time of filing.
For example, Stein (The Journal of Clinical Investigation, 2001, 108, 5, 641-644) teaches that if the antisense oligonucleotide is either too long or too short, an element of specificity is lost. At the present time, the optimal length for an antisense oligonucleotide seems to be roughly 16–20 nucleotides (page 641).
Nedorezova et al. (Theranostics, 2022, Vol. 12, Issue 16, 7132-7157) teach that to ensure tight binding, a typical oligonucleotide gene therapy agent hybridizes to the stretch of 15-25 nucleotides of a unique targeted sequence. However, hybrids of such lengths tolerate one or more mismatches under physiological conditions, the problem known as the affinity/specificity dilemma (abstract). The instant claims read upon any antisense oligonucleotide that specifically hybridizes at any number of nucleotides to any TUBB4A encoding nucleic acid, which would not likely have the structure required for the function.
Thus, having analyzed the claims with regard to the Written Description guidelines, it is clear that the specification does not disclose a representative number of species for antisense oligonucleotides within the instant enormous genus that are inhibitory of the target as claimed. Thus, one skilled in the art would be led to conclude that Applicant was not in possession of the claimed invention at the time the application was filed.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 12, 13, 15-18, and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Almad et al. (US 2022/0265862 A1).
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Almad et al. teach antisense oligonucleotides targeting TUBB4A [0014] (page 26)(instant claim 12) and a kit and a composition comprising a pharmaceutical acceptable carrier [0098] (pages 25 and 37) (instant claims 12 and 18).
Almad et al. teach modification including LNA and teach that each of the sequences listed above may optionally include one or more modified backbone linkages and/or a modified sugar (page 67)(instant claim 13). The oligomers on page 67 have the same modification pattern as instant claim 14.
Almad et al. teaches: In another approach for treatment, a method for genome editing of a TUBB4A encoding nucleic acid is disclosed. An exemplary method comprises administering to a subject a vector, wherein the subject is a human (page 23)(instant claims 15 and 20); wherein the vector is a plasmid (instant claim 20); wherein the administration is parenteral (instant claim 16); via a single ICV bolus injection (instant claim 17).
Therefore, the claims are anticipated by Almad et al.
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.
Claim(s) 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over van der Knaap et al. (Lancet Neurol 2019, 18, 962-972), in view of Baker et al. (US 2004/0142346 A1) Collin et al. (US 2020/0407718 A1), Machuy et al. (WO 2011/076873 A1), and Vickers et al. (THE JOURNAL OF BIOLOGICAL CHEMISTRY, Vol. 278, No. 9, pp. 7108–7118, 2003).
van der Knaap et al. teach: Antisense nucleotides aim to target mutations with a dominant negative effect, silencing the mutant gene. A single intrathecal injection of this treatment in a mouse model of Alexander disease led to longlasting improvement (until the mice were sacrificed at 4 months). Other leukodystrophies with dominant inheritance, such as HABC caused by TUBB4 mutations are also candidates for this approach. Antisense nucleotides can also be used to correct aberrant splicing (page 968).
Therefore, it would have been obvious to formulate a composition comprising an antisense oligonucleotide targeting a TUBB4A encoding nucleic acid because van der Knaap et al. teach that HABC caused by TUBB4 mutations is a candidate for the antisense approach of targeting mutations. It would have been obvious to incorporate a carrier which is a routine means for antisense pharmaceutical formulations with the expectation of providing the antisense oligonucleotide (instant claim 12).
For example, Baker et al. teach: [0168] The antisense compounds of the present invention include bioequivalent compounds, including pharmaceutically acceptable salts and prodrugs. This is intended to encompass any pharmaceutically acceptable salts, esters, or salts of such esters, or any other compound which, upon administration to an animal including a human, is capable of providing (directly or indirectly) the biologically active metabolite or residue thereof (instant claim 12).
Baker et al. teach: [0180] Regardless of the method by which the oligonucleotides of the invention are introduced into a patient, colloidal dispersion systems may be used as delivery vehicles to enhance the in vivo stability of the oligonucleotides and/or to target the oligonucleotides to a particular organ, tissue or cell type.
Baker et al. teach: [0152] As expected, the relative duplex stability can be enhanced by replacement of 2'-OH groups with 2'-F groups thereby increasing the C3'-endo population (instant claim 13).
Baker et al. teach incorporation of 2’-O-methoxyethyl modifications and phosphorothioates [0013] and teach that the modifications are for improving the pharmacodynamic properties of an oligonucleotide [0093].
Baker et al. teaches: One synthetic 2'-modification that imparts increased nuclease resistance and a very high binding affinity to nucleotides is the 2-methoxyethoxy [0153]. Baker et al. teach full modification with 2-methoxyethoxy modified nucleotides [0246].
Baker et al. teaches incorporation of phosphorothioates ([0050][0221], Table 2,[0223]). Baker et al. teach combination of 2-methoxyethoxy modified nucleotides and phosphorothioates (Table 4).
It would have been obvious to incorporate the modifications of Baker et al. into the antisense oligomer of van der Knaap et al. with an expectation and motivation of increased stability (modifications of instant SEQ ID NO: 15).
Baker et al. teach: [0181] The pharmaceutical compositions of the present invention may be administered in a number of ways depending upon whether local or systemic treatment is desired and upon the area to be treated. Administration may be topical (including ophthalmic, vaginal, rectal, intranasal, epidermal, and transdermal), oral or parenteral. Baker et al. teach intraventricular injection via a single bolus injection. Therefore, it would have been obvious to deliver the oligomer of van der Knaap et al. via parenteral administration or via a single ICV bolus injection as a matter of design choice (instant claims 16 and 17).
Baker et al. teach: [0037] The oligonucleotides of this invention can be used in diagnostics, therapeutics, prophylaxis, and as research reagents and in kits (instant claim 18). Formulation Ito a kit is routine and an obvious means of packaging the oligonucleotide.
It would have been obvious to deliver the antisense oligonucleotide from a plasmid because this was a known means of antisense oligonucleotide delivery, as evidenced by Collin et al.
Collin et al. teach: [0050] A cell can be provided with an AON for redirecting splicing according to the invention by plasmid-derived antisense oligonucleotide expression or viral expression provided by adenovirus- or adeno-associated virus-based vectors. One would have had a reasonable expectation of success of delivering the antisense oligonucleotide of van der Knaap et al. via a plasmid (instant claims 15 and 20).
With regards to instant SEQ ID NO: 15 (instant claims 14 and 19), Machuy et al. teach a TUBB4 siRNA target sequence comprising instant SEQ ID NO: 15 (see nucleotides 2-16 of the 4th TUBB4 target sequence in Table 4 on page 143).
It would have been obvious to target the antisense oligomer of van der Knaap et al. to the same target region as taught by Machuy et al. as a matter of design choice given that is was a known target region for nucleic acid inhibitors. Additionally, Vickers et al. teaches that in general, the activity of both siRNA and antisense oligomers correlates ta the same target position and that each are acceptable strategies (abstract).
Claim(s) 14 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable Almad et al. (US 2022/0265862 A1) as applied to claims 12, 13, and 15-18 and 20 above, and further in view of Machuy et al. (WO 2011/076873 A1), and Vickers et al. (THE JOURNAL OF BIOLOGICAL CHEMISTRY, Vol. 278, No. 9, pp. 7108–7118, 2003).
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Almad et al. does not teach instant SEQ ID NO: 15 (instant claims 14 and 19),. However, Machuy et al. teach a TUBB4 siRNA target sequence comprising instant SEQ ID NO: 15 (see nucleotides 2-16 of the 4th TUBB4 target sequence in Table 4 on page 143).
It would have been obvious to target the antisense oligomer of Almad et al. to the same target region as taught by Machuy et al. as a matter of design choice given that is was a known target region for nucleic acid inhibitors. Additionally, Vickers et al. teaches that in general, the activity of both siRNA and antisense oligomers correlates ta the same target position and that each are acceptable strategies (abstract). It would have been obvious to incorporate the same modification pattern for antisense oligomers taught by Almad et al. as a matter of design choice with a reasonable expectation of the benefits taught by Almad et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amy R Hudson whose telephone number is (571)272-0755. The examiner can normally be reached M-F 8:00am-6:00pm.
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/AMY ROSE HUDSON/Primary Examiner, Art Unit 1636
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