DETAILED ACTION
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 with traverse of EBV strain B95-8 and EBV positive tumor lysate C666-1 as the species of antigen, and a cytokine, TNF as the species of adjuvant, in the reply filed on 12/19/25 is acknowledged.
Applicant's traversal is on the grounds that the different lysates in claim 1 are a special technical feature that makes a contribution over the prior art and are linked to form a single general inventive concept. This is not found to be persuasive because the lysates lack a special technical feature that defines the contribution over the prior art cited below. Applicant further argues that there would not be a serious burden to examine all the species. This is not found persuasive because undue burden is irrelevant to the restriction practice for cases filed under 35 U.S.C 371 (see MPEP Chapter 1800).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-4 and 6-17 are being acted upon.
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 and 6-17 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.
The claims are indefinite in the recitation of a lysate of human immortalized B-LCLs derived from different EBV strains, wherein the tumor cell lysate of the human immortalized B-LCLs derived from different EBV strains is at least one selected from the group consisting of GD1, GD1, B95-8, M81, HKNPC1 to HKNPC9, SNU-719, and YCCEL1. B-LCLs can be obtained by infection of B cells with EBV leading to transformation and immortalization. However, the scope of “derived from different EBV strains” is unclear and indefinite. For example, do the claims require B-LCL derived by infection with different EBV strains? Are the claims meant to require more than one type of B-LCLs, wherein each B-LCL has been produced by infection with a different EBV strain? This is particularly the case since claim 3, which depends from claim 1, recites that the B-LCLs result from transformation with the same strains. In other words, is the “derived from” language in claim 1 meant to encompass something other than infection/transformation with the recited strains? Would the claims encompass B-LCLs produced by infection with a single strain of EBV, so long as it contained different EBV genomes, i.e. “derived from” different EBV strains (see Ryan, B cell lines can contain different EBV clones with different viral sequences, even when B cells have been immortalized by infection with the same strain of EBV). The claims are also unclear in that they require “different” EBV strains, but also recite at least “one” selected from a list of EBV strains, which is unclear. Furthermore, the claim does not recite that the EBV strains are selected from the list of strains, but rather recite that the tumor cell lysate of the B-LCLs is selected from the group consisting of a list of viral strains, which is also unclear and indefinite.
The claims are also indefinite in the recitation that the EBV-positive tumor cell lysate is at least one selected from the group consisting of C666-1, HNE1, and CCL85. C666-1, for example, is known in the art as a cell line derived from a nasopharyngeal carcinoma biopsy (see Wang, 2005, in particular). However, the claims do not recite a lysate from a C666-1 cell line, but rather recite that the lysate “is” C666-1, which renders the claims unclear. Do the claims intend a lysate of the C666-1 cell line? Regarding CCL85, the specification does not define what is meant by CCL85, and there is no well-known “CCL85” cell line. There is an EBV cell line called EB-3 that is an Burkitt’s lymphoma cell line that is available from ATCC with a “CCL-85” product designation. It is unclear, however, if this is the cell contemplated since the instant specification does not describe any characteristics or features of the claimed “CCL85” lysate.
Claim 2 and 10 are indefinite since the claims recite that the DC carries “the tumor complex antigen according to claim 1”, and also recites that the DC vaccine is loaded with “at least one EBV-associated tumor cel lysate” or “at least one lymphoblastoid cell line (LCL) tumor cell lysate”. The scope of the claim is unclear. The recitation that the DC “carries” the tumor complex would appear to require that it is loaded with the tumor complex antigen (i.e. carrying or loaded with an EBV associated tumor cell lysate or a B-LCL lysate). However, the further recitation that the DC vaccine is loaded with at least one EBV associated tumor cell lysate or at least one LCL tumor cell lysate is unclear. For example, would the first recitation that the DC vaccine carries the tumor complex antigen encompass something other than loading? Are the loaded LCL tumor cell lysates recited in the last line of claim 2 different than the B-LCL lysates of claim 1? The scope of the claim is unclear and indefinite.
Regarding claim 3, it is unclear if the claim is intending to require lysates from both the B-LCLs and the EBV positive tumor cell lysates of claim 1, or whether the claim recites limitations already present in claim 1 (and thus fails to further limit claim 1-2, from which it depends). Or is the limitation that the B-LCLs resulting from transformation by EBVs of GD1, B95-8, etc. intending to further limit the claim? It is not clear how it would do so, since claim 1 already requires B-LCLs derived from the same EBV strains (i.e. transformed with). The scope of what is intended in claim 3 is unclear and indefinite. Claim 14 is indefinite for the same reasons as claim 3.
Claims 6 and 16 are indefinite in “PloyI:C” since it is not clear what this encompasses. Amendment to recite “PolyI:C” would be remedial.
Claim 7, 12-13 , and 17 are indefinite in the recitation that each of the tumor cell lysates is “used” at an amount of 2.5 x 107 to 2.5 x 109. It is unclear how it is to be used, since no steps are recited. It is also unclear what amount is required. For example do the amounts refer to the number of cells used to create the lysate? Or is the amount meant to refer unit or weight amount of a lysate? For the purposes of applying prior art, the claims are being interpreted as indicating a number of cells for producing a lysate.
Claims 8 is indefinite in the recitation of a method “of use” of the tumor antigen complex in preparation of a drug for preventing or treating an EBV associated tumor. The claims do not set forth any active steps involved in the use; it is unclear what method applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Claims 9-10 and 14 -17 are rejected for the same reasons, as they depend from claim 8 and do not recite any active steps. For the purposes of applying prior art, the claims are being interpreted as encompassing a method of making a drug preparation, i.e. formulating the tumor complex antigen, or loading a dendritic cell with a tumor complex antigen would be within the scope of the “use” of the tumor complex antigen in preparation of a drug for preventing or treating an EBV associated tumor.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4, 6-7, 11-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (product of nature) without significantly more. The claim(s) recite(s) a tumor complex antigen comprising a tumor cell lysate. This judicial exception is not integrated into a practical application because said tumor cell lysates are products of nature. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
In the instant case, claims 1-4, 6-7, 11-13 are directed to compositions of matter as set forth in Step 1 of the subject matter eligibility test (see MPEP 2106). Regarding step2A, prong 1, the claims recite a tumor complex antigen comprising a tumor cell lysate of EBV B-LCLs and/or from EBV positive tumor cells. However, EBV positive tumor cells are products of nature. Additionally, B-LCL, when made in vitro, represent a transient differentiation stage of EBV infected B cells that are found in vivo during natural infection with EBV (see Mrozek-Gorska, 2019). Furthermore, EBV naturally induces cell lysis in vivo during physiological infection (see McKenzie, 2015). Additionally, EBV infected B cells or tumor cells would also be lysed naturally during physiological immune response by CTL in vivo (See Halle, 2017). It is noted that even if the limitation of a B-LCL would imply an vitro process for producing the cells, the present claims are directed to a product and during examination, a product-by-process claim is not limited to manipulations of the recited steps, but instead is only limited to the structure implied by the steps. A lysate of EBV infected cells would be structurally identical whether produced in vitro from B-LCLs, or produced in vivo from naturally occurring EBV infected B cells, or in tumor patients having EBV positive tumors. Regarding the limitations of different strains of EBV, it noted that subjects in vivo are naturally infected with multiple different EBV strains, and the strains in the instant claims represent naturally occurring EBV viral strains (see Rey, 2008 and Tsai, 2017). Thus, the present claims are not markedly different in structure or function from naturally occurring EBV cell lysates produced in vivo from infected B cells or tumor cells.
Regarding step 2A prong two and step 2B, the claims do not recite additional elements that integrate the judicial exception into a practical application, nor do the claims recite any additional elements that amount to significantly more than the judicial exception. Regarding the limitation of a dendritic cell, said dendritic cells are naturally present during physiological processes such as viral infection, or in the tumor microenvironment, wherein they take of tumor antigens or viral antigens (see Ma, 2012). Therefore, dendritic cells carrying said lysate would not be markedly different in structure or function from naturally occurring dendritic cells which take up lysates form cells infected with EBV during viral infection or tumor formation. In claims 4 and 6, the claims recite a cytokine, however cytokines are naturally occurring and are produced by dendritic cells and other immune cells and would be present in the immune environment.
Claims 8-10 and 14-17 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
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 8-10 and 14-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for: using a tumor complex antigen for treating an EBV associated tumor, does not reasonably provide enablement for: using a tumor complex antigen for preventing an EBV associated tumor
The specification disclosure is insufficient to enable one skilled in the art to practice the invention as claimed without an undue amount of experimentation. Undue experimentation must be considered in light of factors including: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill in the art, the level of predictability of the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention, in re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988). “The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling (MPEP 2164.03)” The MPEP further states that physiological activity can be considered inherently unpredictable.
The present claim encompasses using a tumor complex antigen for preventing an EBV associated tumor. Given its broadest reasonable interpretation, this would encompass a complete prevention, such that cells do not even become infected with EBV. Such prevention would be highly unpredictable. Furthermore, Sharma teaches that despite the development of preventative vaccines against other malignant viruses, and notwithstanding substantial efforts undertaken by a number of groups, a preventative vaccine against EBV has yet to be developed (see page 1836). Sharma teaches that numerous unique challenges face the development of a preventative vaccine including the scarcity of available animal models, difference in EBV life cycle stages which correlate with unique antigen expression and a varied immune response against the virus, and the length time period of EBV infection. Furthermore, the specification does not provide any guidance or examples regarding “prevention”, and only discloses using the dendritic cells in vitro to stimulate T cells. Thus, given the unpredictability of the art and the lack of guidance provided by the instant specification, it would require undue experimentation to use the claimed dendritic cells as broadly claimed.
Claim 1-4 and 6-17 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that C666-1, HNE1, and CCL85 cell lines are required to practice the claimed invention. As required elements, they must be known and readily available to the public or obtainable by a repeatable method set forth in the specification.
In the instant case, at least the C666-1 and HNE1 cell lines appear to be known in the art. However, to avoid the need for a deposit on this basis, the biological material must be both known and readily available - neither concept alone is sufficient. A material may be known in the sense that its existence has been published, but is not readily available to those who wish to obtain that particular known biological material. Likewise, a biological material may be available in the sense that those having possession of it would make it available upon request, but no one has been informed of its existence. To satisfy the enablement requirement, Applicant can adequately established that the biological material is known and readily available. In particular, there are many factors that may be used as indicia that a biological material is known and readily available to the public. Relevant factors include commercial availability, references to the biological material in printed publications, declarations of accessibility by those working in the field, evidence of predictable isolation techniques, or an existing deposit made in accordance with these rules. Each factor alone may or may not be sufficient to demonstrate that the biological material is known and readily available. See MPEP 2404.01.
It is noted that an inventor declaration was filed in related application 18/574,764 (with the same Applicants as the instant application) regarding this issue. Making that declaration of record in the instant application (along with similar claim amendments to address the indefiniteness issue regarding CCL85) would be remedial.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang, 2005.
Wang teaches a composition comprising a lysate of human EBV-positive tumor cell line C666.1, i.e. a tumor complex antigen (See page 1524-1525, Table 1, in particular).
Claim(s) 1, 8-9, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li, 2010.
Li teaches a composition comprising a lysate of human EBV-positive tumor cell line C666.1, i.e. a tumor complex antigen (See page 205, in particular). Li teaches collecting the lysate and diluting the lysate in PBS, i.e. formulating the lysate or “preparing a drug”. The limitation that the drug be used for preventing or treating an EBV associated tumor refers to an intended use, but does not distinguish for the lysate prepared in the prior art, since it is structurally identical to the lysate of the instant claims.
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.
Claim 1-4 and 6-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herr, 2000 (of record), in view of Tsai, 2017, Zyl, Feb. 2019, Tyagi, 2017, and WO 02/053176.
Herr teaches mature dendritic cells that have been loaded with lysates from EBV infected B-LCL cells for use as a vaccine to treat patients suffering from EBV associated tumor such as a lymphoma or carcinoma (i.e. a method of use of a tumor lysate in preparation of a drug, see pages 1857 and 1863, in particular). Herr teaches that the B-LCL cells are immortalized by infection with B95.8 EBV strain (see page 1858, in particular). Herr teach combining the dendritic cells with TNF-alpha to mature the dendritic cells (See page 1858, in particular). Herr teach producing a cell lysate from 109 B-LCL cells (See page 1858, in particular). Herr teaches that the use of tumor lysates as a source of antigen for pulsing dendritic cells is attractive, since it can activate a broad repertoire of antigen specific T cells to multiple tumor antigens present in the lysate (see page 1863, in particular). Herr teaches that the strategy can be extrapolated to using tumor cell lines for generating lysates (see page 1863, in particular).
The reference differs from the claimed invention in that it does not explicitly teach different EBV strains, or EBV positive tumor cell lysates.
Tsai teach that different EBV strains can cause the development of tumors and B lymphocytes can be infected to produce a panel B-LCLS transformed with different EBV strains.
Zyl teaches that a cocktail of EBV antigens from different EBV strains might be able to achieve a higher level of protection against EBV and the malignant consequences of EBV infection (see page 8, in particular).
Tyagi teaches EBV infected nasopharyngeal carcinoma tumor cell line C666-1, and that antigens derived from said C666-1 tumor cells can be used as source of tumor antigens for loading into dendritic cells as a therapeutic vaccine for cancer.
WO 02/053176 teaches using a mixture of lysates from different tumor cells lines as an antigen for loading dendritic cells for producing a vaccine (see pages 3-4). WO teaches that doing so is advantageous since it provides for a large number of different antigens from different cell lines which will enhance the T cell response. WO 02/053176 teaches that the dendritic cells are matured by treatment with TNF-alpha (See page 8-9, in particular). WO 02/053176 teaches the use of said loaded dendritic cells as a vaccine for cancer, including lymphoma and carcinoma (see pages 6-8, in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use antigen lysate from more than one strain of EBV and/or from EBV tumor cell lines, as taught by Tsai, Zyl, Tyagi, and WO 02/053176, for loading the dendritic cells of Herr. The ordinary artisan at the time the invention was made would have been motivated to do so, because Zyl teaches that a cocktail of EBV antigens from different EBV strains might be able to achieve high level of protection against infection and its malignant consequences. Likewise, WO 02/053176 teaches that using a mixture of lysates from different tumor cells lines as an antigen source for loading dendritic cells is advantageous since it provides for a large number of different antigens from different cell lines. Furthermore, the ordinary artisan would have a reasonable expectation of success, since Tsai teaches that B lymphocytes can be infected with various EBV strains to produce EBV infected B cell lines (B-LCLs) and Tyagi teaches that antigens from EBV infected tumor cell lines like C666-1 can be used for loading dendritic cells for inducing therapeutic immune responses. Therefore, one could readily envision using a lysate obtained from BLCLs infected with different EBV strains and/or lysates from different EBV tumor cell lines to create a lysate having a cocktail of EBV antigens and tumor antigens, as suggested by the cited references.
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 1-4 and 6-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,419,912.
The ‘912 patent claims a method of treating an EBV associated infectious disease comprising administering a dendritic cell based vaccine loaded with EBV antigen composites, wherein the antigen composite comprises lysates of human immortalized B lymphoblastoid cell lines (B-LCLs) B95-8-LCL, GD1-LCL, M81-LCL, HKNPC1-LCL to HKNPC9-LCL, SNU-719-LCL, YCCEL1-LCL, and lysates of EBV positive infected cells C666-1, HNE1, and EB-3. The ‘912 patent claims that the dendritic cell vaccine is made by a process comprising co-cultivating dendritic cells with said EBV antigen composite and TNF-alpha, which would be within the scope of a adjuvant, and a method of using an EBV antigen/lysate composition in preparation of a vaccine (i.e. a drug). The further limitation of “for preventing or treating an EBV associate tumor” refers to an intended use in claim 8, which does not distinguish the claims from the preparation method claimed in the ‘912 patent. Alternatively, the method of administering for treating an EBV infectious disease, would be within the scope of “preventing” an EBV associated tumor, as recited in the present claims. The ‘912 patent claims that the amount of the lysate is from 2 x 107 cells.
No claim is allowed.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644