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 .
Claim Rejections - 35 USC § 112
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 1-4, 6-9, 12, 18, 25, 26, 38, 45 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 rejected claims cover immunoconjugate comprising an immune checkpoint inhibitor linked to an oligonucleotide comprising an immunostimulatory sequence motif which contains at least one unmethylated CG dinucleotide and optionally, a detectable or purification label.
To satisfy the written-description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. Vas-Cath, 935 F.3d at 1563; see also Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention”); In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989) (“the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”).
With regard to the recited genus of conjugates, the following applies:
Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010) states that “...a generic claim may define the boundaries of a vast genus of chemical compounds...the question may still remain whether the specification, including the original claim language, demonstrates that the applicant invented species sufficient to support a claim to a genus”. See page 1171.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
See also Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a “laundry list” disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not “reasonably lead” those skilled in the art to any particular species.
Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) states that “it is well established in our law that conception of a chemical compound requires that the inventor be able to define it so as to distinguish it from other materials, and to describe how to obtain it”.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or structural features common to the members of the genus, which features constitute a substantial portion of the genus, so that one of skill in the art can “visualize or recognize” the members of the genus (Emphasis added). Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004)(“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).
In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(i), the court states, "An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention."
Courts have stated that “[i]n claims involving [non-genetic] chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus.” Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). (emphasis added).
There is no such specificity here, nor could one skilled in the art identify conjugates encompassed by the claims. Specifically, Applicant fails to disclose any other conjugates, besides those covered by the formulas in the specification, and in relation to the above, these disclosed species or subgenre do not represent the substantial variety covered by the genus of conjugates.
With regard to the functional definition of immune checkpoint inhibitor, immunostimulatory sequence or detectable or purification label, the specification does not clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed (see Vas-Cath at page 1116) because the specification contains almost no information by which a person of ordinary skill in the art would understand that the inventors possessed the all of the recited compounds. At best, it simply indicates that one should test an inordinate number of compounds, peptides and oligonucleotides to see if the different components can perform the required functions, separately, or as a conjugate, as claimed, see In re ’318 Patent Infringement Litigation, 583 F.3d 1317, 1327 (Fed. Cir. 2009) (“[A]t the end of the day, the specification, even read in light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient.”).
The Examiner acknowledges that a working example or exemplified embodiment is not necessarily a requirement for description. However, where a generic claim term is present in a claim, as in the present application, and defined only by functional characteristics, the specification must convey enough information, e.g., via sufficient representative examples, to indicate invention of species sufficient to constitute the genus. Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 967 2 (Fed. Cir. 2002). The written description requirement “requires a description of an invention, not an indication of a result that one might achieve if one made that invention.” Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997); see also Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1350 (Fed. Cir. 2013) (“A patent...‘is not a reward for the search, but compensation for its successful conclusion.’ ... For that reason, the written description requirement prohibits a patentee from ‘leaving it to the ... industry to complete an unfinished invention.’” (citations omitted)).
Accordingly, the specification lacks adequate written description for the recited conjugates.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4, 6-9, 12, 18, 25, 26, 38 and 45 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 1 recites an immunoconjugate, which is required to comprise an antibody, see paragraph 0029 of the published application. However, the claims do not require an antibody, or antigen-binding fragment thereof that binds to an immune checkpoint.
Claims 4 and 6 cover CDR’s of immune checkpoint inhibiting antibodies. The specification defines these as defined by one or more CDRs. In one embodiment, it includes one, or two or all three of the CDRs (e.g., CDR1, CDR2, CDR3) from the LC variable region with appropriate CDRs from other antibody CDRs, and equivalents of each thereof. Accordingly, and as an example, the CDR1 and CDR2 from the LC variable region can be combined with the CDR3 of another antibody's LC variable region, and in some aspects, can include an additional 50 amino acids, or alternatively about 40 amino acids, or alternatively about 30 amino acids, or alternatively about 20 amino acids, or alternatively about 10 amino acids, or alternatively about 5 amino acids, or alternatively about 4, or 3, or 2 or 1 amino acids at the carboxy-terminus. In one aspect all 6 CDRs from one antibody are utilized in the antibody or antigen binding fragment thereof, see paragraph 0084 of the published application, U.S. 20230331849.
However, this definition does not define the actual CDR’s. Therefore, it is unclear what sequences Applicant intends to cover by the recited CDR’s.
Claim 12 covers an isolated polynucleotide encoding an immune checkpoint inhibitor and an immunostimulatory sequence motif which contains at least one unmethylated CG dinucleotide. It is unclear how a polynucleotide can be translated into both a protein (checkpoint inhibitor) and a polynucleotide (immunostimulatory sequence).
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.
Claims 1-4, 6, 12, 18, 25, 26, 38 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2006/0135459 based on an application by Epstein et al. (hereinafter "EPSTEIN") in view Zhang et al., Oncotarget. 2017 Oct 6;8(52):90215–90224 ((hereinafter "ZHANG").
Claim 1, 18, 25, 26, 45: The combination of EPSTEIN and ZHANG teaches the recited immunoconjugate comprising an immune checkpoint inhibitor linked to an oligonucleotide comprising an immunostimulatory sequence motif which contains at least one unmethylated CG dinucleotide, e.g., CpG oligodeoxynucleotides. Specifically, EPSTEIN discloses an immunoconjugate (an immunoconjugate; paragraphs (0030]. (0032]) comprising a cancer targeting molecule linked to an oligonucleotide (a cancer targeting molecule linked to an oligonucleotide; paragraph (0030]) comprising an immunostimulatory sequence motif which contains at least one unmethylated CG dinucleotide (comprising an immunostimulatory sequence motif which contains at least one unmethylated CG dinucleotide; paragraph (0030)).
EPSTEIN may not explicitly an immune checkpoint inhibitor. ZHANG discloses as immune checkpoint inhibitor (anti-PD-L1 antibody atezolizumab blocks PD-1/PD-L1 pathway (PD-1/PD-L 1 is an immune checkpoint, therefore, atezolizumab is an immune checkpoint inhibitor); page 90216, column 1, paragraph 2; page 90222, column 1, paragraph 2). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the immunoconjugate disclosed by EPSTEIN, with an immune checkpoint inhibitor, as disclosed by ZHANG. to provide an immunoconjugate comprising an immune checkpoint inhibitor linked to an immunostimulatory sequence, for developing an improved cancer therapeutic, since immune checkpoint inhibitors are used for cancer treatment (anti-PD-L1 antibody atezolizumab for treatment of patients with metastatic urothelial carcinoma or non-small cell lung cancer; ZHANG, page 90216, column 1, paragraph 2).
Inducing an immune response would have been a necessary aspect of the immunoconjugate (claim 26), see MPEP 2112.01 (“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”).
A kit with instructions (claim 45) does not distinguish from the immunoconjugate described by EPSTEIN and ZHANG, see 2112.01 indicating that printed matter does not distinguish the claimed product from that disclosed or suggested by the prior art.
Claim 2: ZHANG discloses wherein the immune checkpoint inhibitor comprises an antibody and an antigen binding fragment thereof of an immune checkpoint inhibitor (anti-PD-L1 antibody atezolizumab blocks PD-1/PD-L 1 pathway (PD-1/PD-L1 is an immune checkpoint), Fab fragment of atezolizumab (Fab fragment is antigen-binding fragment); page 90216, column 1, paragraph 2; page 90222, column 1, paragraph 2). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the immunoconjugate disclosed by EPSTEIN with an immune checkpoint inhibitor wherein the immune checkpoint inhibitor comprises an antibody or an antigen binding fragment thereof, as disclosed by ZHANG, to provide an immunoconjugate comprising a checkpoint inhibitor that comprises an antibody or an antigen binding fragment thereof, linked to an immunostimulatory sequence, for developing a superior cancer therapeutic, since immune checkpoint inhibitors are used for cancer treatment (anti-PD-l1 antibody atezolizumab for treatment of patients with metastatic urothelial carcinoma or non-small cell lung cancer; ZHANG, page 90216, column 1, paragraph 2).
Claim 3: ZHANG discloses an anti-PD-L1 antibody (anti-PD-L1 antibody atezolizumab blocks PD-1/PD-L 1 pathway; page 90216, column 1, paragraph 2; page 90222, column 1, paragraph 2). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the immunoconjugate disclosed by EPSTEIN with an anti-PD-L1 antibody, as disclosed by ZHANG, to provide an immunoconjugate comprising an anti-PD-L1 antibody linked to an immunostimulatory sequence, for developing a superior cancer therapeutic, since anti-PD-L1 inhibitors are used for cancer treatment (anti-PD-L1 antibody atezolizumab for treatment of patients with metastatic urothelial carcinoma or non-small cell lung cancer; ZHANG, page 90216, column 1, paragraph 2).
Claim 4: ZHANG discloses an antigen-binding region comprising the CDRs of an anti-PD-L1 antibody (prepared the Fab fragment of anti-PD-L1 antibody atezolizumab and solved its crystal structure in complex with PD-L1, structure revealed that both heavy chain and light chain of atezolizumab interact with PD-L1, Figure 1 shows wherein the heavy chain and light chain comprise HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3; page 90216, column 1, paragraphs 2-3; see Figure 1). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the immunoconjugate disclosed by EPSTEIN with the antigen binding fragment comprising the CDRs of an anti-PD-L1 inhibitor as disclosed by ZHANG, to provide an immunoconjugate comprising an antigen binding fragment comprising the CDRs of an anti-PD-L1 antibody, for developing a superior cancer therapeutic since anti-PD-L1 inhibitors are used for cancer treatment (anti-PD-L 1 antibody atezolizumab for treatment of patients with metastatic urothelial carcinoma or non-small cell lung cancer; ZHANG, page 90216, column 1, paragraph 2).
Claim 6: ZHANG discloses an immune checkpoint inhibitor comprising the 6 CDRs of an anti-PD-L1 antibody (anti-PD-L1 antibody atezolizumab blocks PD-1/PD-L1 pathway (PD-1/PD-L1 is an immune checkpoint, therefore, atezolizumab is an immune checkpoint inhibitor); Figure 1 shows HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 of atezolizumab; page 90216, column 1, paragraph 2; page 90222, column 1, paragraph 2; see Figure 1).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the immunoconjugate disclosed by EPSTEIN with an immune checkpoint inhibitor comprising the 6 CDRs of an anti-PD-L1 antibody, as disclosed by ZHANG, to provide an immunoconjugate comprising an immune checkpoint inhibitor comprising the 6 CDRs of an anti-PD-L1 antibody for developing an improved cancer therapeutic, since anti-PD-L1 antibodies are used for treating cancer (anti-PD-L1 antibody atezolizumab for treatment of patients with metastatic urothelial carcinoma or non-small cell lung cancer; ZHANG, page 90216, column 1, paragraph 2).
Also, EPSTEIN may not disclose wherein the immune checkpoint inhibitor comprises the CDRs of atezolizumab. ZHANG discloses an immune checkpoint inhibitor comprising the CDRs of atezolizumab (anti-PD-L1 antibody atezolizumab blocks PD-1/PD-l1 pathway (PD-1/PD-L 1 is an immune checkpoint, therefore, atezolizumab is an immune checkpoint inhibitor); Figure 1 shows HCDR1, HCDR2, HCDR3, LCDR1. LCDR2, and LCDR3 of atezolizumab; page 90216, column 1, paragraph 2; page 90222, column 1, paragraph 2; see Figure 1). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the immunoconjugate disclosed by EPSTEIN with the immune checkpoint inhibitor comprising the CDRs of atezolizumab, as disclosed by ZHANG, to provide an immunoconjugate comprising an immune checkpoint inhibitor or antigen-binding fragment thereof comprising the CDRs of atezolizumab, to develop an improved cancer therapeutic, since atezolizumab is used for treating cancer (anti-PD-L1 antibody atezolizumab for treatment of patients with metastatic urothelial carcinoma or non-small cell lung cancer; ZHANG, page 90216, column 1, paragraph 2).
Claim 12: EPSTEIN discloses an isolated polynucleotide (a nucleic acid; paragraph (0082)) encoding a cancer targeting molecule (encoding the cancer targeting agent; paragraphs [0030), [00821) and an immunostimulatory sequence motif which contains at least one unmethylated CG dinucleotide (and the immunostimulatory sequence motif which contains at least one unmethylated CG dinucleotide; paragraphs [0030), (0082)). EPSTEIN does not disclose an immune checkpoint inhibitor. ZHANG discloses as immune checkpoint inhibitor (atezolizumab is an anti-PD-L1 antibody, atezolizumab blocks PD-1/PD-L1 pathway (PD-1/PD-L1 is an immune checkpoint, therefore, atezolizumab is an immune checkpoint inhibitor); page 90216, column 1, paragraph 2; page 90222, column 1, paragraph 2). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the isolated polynucleotide disclosed by EPSTEIN, with an immune checkpoint inhibitor, as disclosed by ZHANG, to provide an isolated polynucleotide encoding an immune checkpoint inhibitor and an immunostimulatory sequence, for developing a superior cancer therapeutic by combining the immune adjuvant effect of oligonucleotides comprising unmethylated CG dinucleotides (unmethylated CpG ODNs (oligonucleotides comprising unmethylated CG dinucleotides) behave as immune adjuvants; EPSTEIN, paragraph [0008)) with an immune checkpoint inhibitor used for cancer treatment (anti-PD-L1 antibody atezolizumab approved for the treatment of patients with metastatic urothelial carcinoma or non-small cell lung cancer; ZHANG, page 90216, column 1, paragraph 2).
Claim 38: EPSTEIN discloses a method for preparing an immunoconjugate (a method for preparing an immunoconjugate; paragraphs (0030), [0032)) comprising chemically crosslinking a cancer targeting molecule linked to an oligonucleotide (chemically crosslinking a cancer targeting agent and an oligonucleotide; paragraphs [0030), [0033)) comprising an immunostimulatory sequence motif which contains at least one unmethylated CG dinucleotide (comprising an immunostimulatory sequence motif which contains at least one unmethylated CG dinucleotide; paragraph (0030)). EPSTEIN does not disclose an immune checkpoint inhibitor. ZHANG discloses as immune checkpoint inhibitor (anti-PD-L1 antibody atezolizumab blocks PD-1/PD-L1 pathway (PD-1/PD-L 1 is an immune checkpoint, therefore, atezolizumab is an immune checkpoint inhibitor); page 90216, column 1, paragraph 2; page 90222, column 1, paragraph 2). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the method for preparing an immunoconjugate, as disclosed by EPSTEIN, with an immune checkpoint inhibitor, as disclosed by ZHANG, to provide a method for preparing an immunoconjugate comprising chemically crosslinking an immune checkpoint inhibitor to an oligonucleotide comprising an immunostimulatory sequence motif with unmethylated CG dinucleotide, for making an improved cancer therapeutic, since immune checkpoint inhibitors are used for cancer treatment (anti-PD-L1 antibody atezolizumab for treatment of patients with metastatic urothelial carcinoma or non-small cell lung cancer; ZHANG, page 90216, column 1, paragraph 2).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2006/0135459 based on an application by Epstein et al. (hereinafter "EPSTEIN") in view Zhang et al., Oncotarget. 2017 Oct 6;8(52):90215–90224 (hereinafter "ZHANG") in further view of Jie et al., Int J Mol Sci. 2018 Mar 20;19(3):920 (hereinafter "JIE")
The primary references may not teach that the immunostimulatory sequence motif is CpG oligodeoxynucleotide (ODN), and comprises CpG oligodeoxynucleotide, such as CpG1826. However, JIE teaches that CPG1826 refers to CpG oligodeoxynucleotide 1826, a synthetic molecule that also stimulates the immune system by activating the Toll-like receptor 9 (TLR9):
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In this way, those of ordinary skill could have applied CpG1826 of JIE in the manner required and in a predictable fashion for the purposes of providing the recited immunoconjugates. As outlined above, EPSTEIN and ZHANG teach the recited immunoconjugate comprising an immune checkpoint inhibitor linked to an oligonucleotide comprising an immunostimulatory sequence motif, i.e., CpG oligodeoxynucleotides. JIE is added for the proposition that CpG1826 is applicable to these conjugates. Specifically, JIE teaches that using CPG 1826 as an immunostimulatory CpG oligodeoxynucleotide was recognized as part of the ordinary capabilities of one skilled in the art. In this manner, those of ordinary skill would have recognized that applying the known technique to those conjugates that use CpG oligodeoxynucleotides, such as those taught by EPSTEIN and ZHANG, would have yielded predictable results. Accordingly, using CpG1826 for the purposes of providing the recited immunoconjugates comprising and oligonucleotide comprising an immunostimulatory sequence would have been prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's acting supervisor, Janet Epps-Smith, can be reached at telephone number (571)272-0757. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646