DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-4, 8-14, 16, 17, 19, 20, 22, 23, 25, 26 and 28 to are still at issue and are present for examination.
Election/Restrictions
Applicant's election without traverse of the invention of Group 1, claims 1-4, 8-14, 16, 17, 19, 20, 22, 23, 25 and 26 to a composition comprising a helper enzyme comprising a helper enzyme having 90% sequence identity to SEQ ID NO:2 or a nucleotide encoding said helper enzyme , in the paper of 12/31/2025, is acknowledged. Applicant's election without traverse of the Species Group 1 species: mutation S8P, Species Group 2 species: MER75 end sequence, Species Group 3 species: SEQ ID NO:13, in the paper of 12/31/2025, is acknowledged.
Claims 16, 17, 20-26, 28 (Group 2) and the subject matter of Group 3 drawn to a composition comprising a gene transfer construct comprising end sequences having at least 90% sequence identity to SEQ ID NO:11 and SEQ ID NO:16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper."
Applicants filing of information disclosure statements on 5/19/2026 and 12/11/2023 are acknowledged and have been considered.
Specification
The disclosure is objected to because of the following informalities:
Applicants specification is objected to because applicants specification comprises Nucleotide and/or Amino Acids Disclosures Requiring a "Sequence Listing".
Applicants attention is directed to 37 CFR 1.821(a) which presents a definition for "nucleotide and/or amino acid sequences." This definition sets forth limits, in terms of numbers of amino acids and/or numbers of nucleotides, at or above which compliance with the sequence rules is required. Nucleotide and/or amino acid sequences as used in 37 CFR 1.821 through 37 CFR 1.825 are interpreted to mean an unbranched sequence of four or more amino acids or an unbranched sequence of ten or more nucleotides.
Specifically applicants specification at Figure 1, Figure 2, Figure 12A, Figure 12B, Figure 16A, Figure 17A, Figure 18A, Figure 19A, Figure 20A, Figure 21A, Figure 22A, Figure 23A and Figure 24A lists amino acid and nucleotide sequences which require a sequence identifier and are to be included in applicants sequence listing as per 37 CFR 1.821 through 37 CFR 1.825.
Further when amino acid or nucleotide sequence occur in a Figure as above applicants are required to list a sequence identifier either in the figure itself or in the description of the figure.
Appropriate correction is required.
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2 is objected to because claim 2 depends from rejected claim 1. It is noted that claim 2 which is dependent on rejected claim 1 also comprises additional non-elected subject matter (i.e, a gene transfer construct comprises a vector comprising a donor DNA comprising left and right end sequences recognized by the recombinant helper enzyme, the left and right end sequences having at least about 90% identity to the nucleotide sequences of SEQ ID NO: 11 and SEQ ID NO: 16).
Appropriate correction is required.
Claim Rejections - 35 USC § 101
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claims 1 is directed a composition comprising: a recombinant helper enzyme, or a nucleotide sequence encoding the same, having gene cleavage (Exc) and/or gene integration (Int) activity and at least about 90% identity to the amino acid sequence of SEQ ID NO: 2, that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 106 USPQ2d 1972 (June 13, 2013). Uniprot Accession No. F7FDY8, June 20, 2018 which discloses a naturally occurring protein from Callithrix jacchus that has greater than 90% sequence identity to instant SEQ ID NO:2, evidence that a recombinant helper enzyme, or a nucleotide sequence encoding the same, having gene cleavage (Exc) and/or gene integration (Int) activity and at least about 90% identity to the amino acid sequence of SEQ ID NO: 2, is a naturally occurring protein and/or encoding nucleotide sequence and is thus not patent eligible.
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 4, 10, 11 and 19 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 4 is indefinite in the reference to position G17R mutation relative to the amino acid sequence of SEQ ID NO:2 because position 17 of SEQ ID NO:2 is a valine not a glycine.
Claims 10 is indefinite in the reference to end sequences are selected from Pteropus vampyrus ends, MER75 which is indefinite in the reference to end sequences comprising a nucleotide sequence other than SEQ ID NOs:11 and 16 which is a limitation of the composition of claim 1 from which both claims 10 ultimately depends.
Claims 11 and 19 are indefinite in the reference to end sequences comprising a nucleotide sequence other than SEQ ID NOs:11 and 16 which is a limitation of the composition of claim 1 from which both claims 11 and 19 depend.
Appropriate correction and/or comment is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10, 11, 12 and 19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 is drawn to the composition of claim 9, wherein one or more of the end sequences are optionally flanked by a TTAA sequence. By virtue of the recitation “optionally” in claim 12, claim 12 does not further limit claim 9 from which it depends.
Claim 11 (claims 13-14 and 19 dependent on) is drawn to the composition of claim 10 and ultimately claim 1, wherein the end sequences are selected from nucleotide sequences of SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 18, SEQ ID NO: 19, and SEQ ID NO: 20, or a nucleotide sequence having at least about 90% identity thereto. The end sequences of claim 11, such as elected SEQ ID NO:13 are not 90% identical to the required end sequences of claim 1, SEQ ID NO:11 and SEQ ID NO:16 and thus claim 11 cannot further limit and improperly depends from claim 1.
Claim 19 is drawn to the composition of claim 11 and ultimately claim 1, wherein the end sequences are selected from nucleotide sequences have 90% identity to SEQ ID NO: 13. The end sequences of claim 19, drawn to SEQ ID NO:13 are not 90% identical to the required end sequences of claim 1, SEQ ID NO:11 and SEQ ID NO:16 and thus claim 19 cannot further limit and improperly depends from claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1, 3, 4, 8-14 and 19 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim(s) 1, 3, 4, 8-14 and 19 are directed to all possible compositions comprising a recombinant helper enzyme, or a nucleotide sequence encoding the same, having gene cleavage (Exc) and/or gene integration (Int) activity and at least about 90% identity to the amino acid sequence of SEQ ID NO: 2, including those helper enzymes having mutations which confer hyperactivity. The specification, however, only provides the representative species of that helper enzyme comprising the amino acid sequence of SEQ ID NO: 2, encompassed by these claims. There is no disclosure of any particular structure to function/activity relationship in the disclosed species. The specification also fails to describe additional representative species of these helper enzymes and mutations which confer hyperactivity by any identifying structural characteristics or properties, for which no predictability of structure is apparent.
Regarding the level of skill and knowledge in the art of amino acid mutation, the reference of Singh et al. (Curr. Protein Pept. Sci. 18:1-11, 2017; cited on the attached Form PTO-892) reviews various protein engineering methods and discloses that despite the availability of an ever-growing database of protein structures and highly sophisticated computational algorithms, protein engineering is still limited by the incomplete understanding of protein functions, folding, flexibility, and conformational changes (see p. 7, column 1, top). Also, the unpredictability associated with amino acid mutations is exemplified by the reference of Zhang et al. (Structure 26:1474-1485, 2018; cited on the attached Form PTO-892), which discloses that even a mutation of a surface residue that was predicted to be benign caused significant structural changes and unexpected effects on the function of a polypeptide (p. 1475, column 1).
Given this lack of additional representative species as encompassed by the claims, Applicants have failed to sufficiently describe the claimed invention, in such full, clear, concise, and exact terms that a skilled artisan would recognize Applicants were in possession of the claimed invention.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Claim(s) 1, 3, 4, 8-14 and 19 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for that composition comprising a recombinant helper enzyme, or a nucleotide sequence encoding the same, having gene cleavage (Exc) and/or gene integration (Int) activity and comprising the amino acid sequence of SEQ ID NO: 2, including a S8P mutation which confers hyperactivity, does not reasonably provide enablement for all possible compositions comprising a recombinant helper enzyme, or a nucleotide sequence encoding the same, having gene cleavage (Exc) and/or gene integration (Int) activity and at least about 90% identity to the amino acid sequence of SEQ ID NO: 2, including those helper enzymes having mutations which confer hyperactivity. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required, are summarized in In re Wands (858 F.2d 731, 8 USPQ 2nd 1400 (Fed. Cir. 1988)) as follows: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claim(s).
Claim(s) 1, 3, 4, 8-14 and 19 are so broad as to encompass all possible compositions comprising a recombinant helper enzyme, or a nucleotide sequence encoding the same, having gene cleavage (Exc) and/or gene integration (Int) activity and at least about 90% identity to the amino acid sequence of SEQ ID NO: 2, including those helper enzymes having mutations which confer hyperactivity. The scope of the claims is not commensurate with the enablement provided by the disclosure with regard to the extremely large number of helper enzymes and mutations conferring hyperactivity thereof broadly encompassed by the claims. The claims rejected under this section of U.S.C. 112, first paragraph, place minimal structural limits on the helper enzymes and encoding nucleotides encompassed by the claims. Since the amino acid sequence of a protein determines its structural and functional properties, predictability of which changes can be tolerated in a protein's amino acid sequence and obtain the desired activity requires a knowledge of and guidance with regard to which amino acids in the protein's sequence, if any, are tolerant of modification and which are conserved (i.e. expectedly intolerant to modification), and detailed knowledge of the ways in which the proteins' structure relates to its function. However, in this case the disclosure is limited to that composition comprising a recombinant helper enzyme, or a nucleotide sequence encoding the same, having gene cleavage (Exc) and/or gene integration (Int) activity and comprising the amino acid sequence of SEQ ID NO: 2, including a S8P mutation which confers hyperactivity.
While recombinant and mutagenesis techniques are known, it is not routine in the art to screen for multiple substitutions or multiple modifications, as encompassed by the instant claims, and the positions within a protein's sequence where amino acid modifications can be made with a reasonable expectation of success in obtaining the desired activity/utility are limited in any protein and the result of such modifications is unpredictable. In addition, one skilled in the art would expect any tolerance to modification for a given protein to diminish with each further and additional modification, e.g. multiple substitutions.
The specification does not support the broad scope of the claims which encompass any possible compositions comprising a recombinant helper enzyme, or a nucleotide sequence encoding the same, having gene cleavage (Exc) and/or gene integration (Int) activity and at least about 90% identity to the amino acid sequence of SEQ ID NO: 2, including those helper enzymes having mutations which confer hyperactivity, because the specification does not establish: (A) regions of the helper enzymes which may be modified effecting the gene cleavage (Exc) activity, integration (Int) activity and hyperactivity; (B) the general tolerance of the helper enzymes to modification and extent of such tolerance; (C) a rational and predictable scheme for modifying any amino acid residue of a helper enzyme, or a nucleotide sequence encoding the same, having gene cleavage (Exc) and/or gene integration (Int) activity, including those helper enzymes having mutations which confer hyperactivity with an expectation of obtaining the desired biological function; and (D) the specification provides insufficient guidance as to which of the essentially infinite possible choices is likely to be successful. Because of this lack of guidance, the extended experimentation that would be required to determine which substitutions would be acceptable to retain the required helper enzyme activities and the fact that the relationship between the sequence of a peptide and its tertiary structure (i.e. its activity) are not well understood and are not predictable (e.g., Ngo et al. in The Protein Folding Problem and Tertiary Structure Prediction, 1994, Merz et al. (ed.), Birkhauser, Boston, MA, pp. 433 and 492-495; Franceus et al., J. Ind. Microbiol. Biotechnol. Vol 44, pp 687-695, 2017), it would require undue experimentation for one skilled in the art to arrive at the majority of those compositions comprising a recombinant helper enzyme, or a nucleotide sequence encoding the same, having gene cleavage (Exc) and/or gene integration (Int) activity and at least about 90% identity to the amino acid sequence of SEQ ID NO: 2, including those helper enzymes having mutations which confer hyperactivity of the claimed genus.
Thus, applicants have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims broadly including any composition comprising a recombinant helper enzyme, or a nucleotide sequence encoding the same, having gene cleavage (Exc) and/or gene integration (Int) activity and at least about 90% identity to the amino acid sequence of SEQ ID NO: 2, including those helper enzymes having mutations which confer hyperactivity. The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of those helper enzymes having the desired biological characteristics is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
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) 1 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hood et al. (US 8,586,006).
Hood et al. (US 8,586,006) teach methods for identifying and using organ-specific proteins and transcripts. Hood et al. further teach compositions comprising the identified organ specific proteins and transcripts (nucleotides) encoding said proteins. Hood et al. further teach detection reagents for detecting such proteins and transcripts and measuring the organ specific proteins/transcripts in blood, biological tissue or other biological fluid. Hood et al. teach a composition comprising the organ specific protein number 63346 and its encoding transcript (see column 65, line 41 and supporting text) which has at least about 90% identity to the amino acid sequence of SEQ ID NO:2 (see alignment below). Claim 8 is included in the reaction on the basis that the taught composition comprising a nucleotide encoding the organ specific protein number 63346 is considered a gene transfer construct, based upon applicants specification that does not define a gene transfer construct otherwise and states “the helper enzyme is included in the gene transfer construct” (page 3, lines24-25 of applicant’s specification).
Query Match 89.8%; Score 2787.5; Length 585;
Best Local Similarity 90.8%;
Matches 531; Conservative 17; Mismatches 36; Indels 1; Gaps 1;
SEQ 2: 1 MSNPRKRSIPTCDVNFVLEQLLAEDSFDESDFSEIDDSDDFSDSASEDYTVRPPSDSESD 60
|||||||||| | | ||||||||||||||||||||||:||||| | :|| | |||
Hood et al. 1 MSNPRKRSIPMRDSNTGLEQLLAEDSFDESDFSEIDDSDNFSDSALEADKIRPLSHLESD 60
Qy 61 GNSPTSADSGRALKWSTRVMIPRQRYDFTGTPGRKVDVSDTTDPLQYFELFFTEELVSKI 120
| | ||:||||::||| | ||||||||||||||||||||| |||||||||||||||||||
Db 61 GKSSTSSDSGRSMKWSARAMIPRQRYDFTGTPGRKVDVSDITDPLQYFELFFTEELVSKI 120
Qy 121 TSEMNAQAALLASKPPGPKGFSRMDKWKDTDNDELKVFFAVMLLQGIVQKPELEMFWSTR 180
| | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TRETNAQAALLASKPPGPKGFSRMDKWKDTDNDELKVFFAVMLLQGIVQKPELEMFWSTR 180
Qy 181 PLLDIPYLRQIMTGERFLLLLRCLHFVNNSSISAGQSKAQISLQKIKPVFDFLVNKFSTV 240
|||| ||||||||||||||| |||||||||||||||||||||||||||||||||||||||
Db 181 PLLDTPYLRQIMTGERFLLLFRCLHFVNNSSISAGQSKAQISLQKIKPVFDFLVNKFSTV 240
Qy 241 YTPNRNIAVDESLMLFKGRLAMKQYIPTKCARFGLKLYVLCESQSGYVWNALVHTGPSMN 300
|||||||||||||||||| ||||||:||| |||||||||||||||||||||||||| ||
Db 241 YTPNRNIAVDESLMLFKGPLAMKQYLPTKRVRFGLKLYVLCESQSGYVWNALVHTGPGMN 300
Qy 301 LKDSADGLKSSCIVLTLVNDLLGQGYCVFLNNFYTSPMLFRELHQNRTDAVGTARLNRKQ 360
||||||||||| ||||||||||||||||||:|| |||||||||||||||||||||||||
Db 301 LKDSADGLKSSRIVLTLVNDLLGQGYCVFLDNFNISPMLFRELHQNRTDAVGTARLNRKQ 360
Qy 361 MPNDLKKRIAKGTTVARFCGELMALKWCDKKEVTMLSTFHNDTVIEVDNRNGKKTKKPCV 420
:|||||||||||||||||||||||||||| |||||||||||||||||:||||||||:| |
Db 361 IPNDLKKRIAKGTTVARFCGELMALKWCDGKEVTMLSTFHNDTVIEVNNRNGKKTKRPRV 420
Qy 421 IVDYNENMGAVDSADQMLTSYPTERKRHKFWYKKFFRHLLNITVLNSYILFKKDNPEHTI 480
||||||||||||||||||||||:|||||| |||||| |||:||||||||||||||||||:
Db 421 IVDYNENMGAVDSADQMLTSYPSERKRHKVWYKKFFHHLLHITVLNSYILFKKDNPEHTM 480
Qy 481 SHVNFRLTLIERMLEKHHKPGQQRLRGRPCSDDVTPLRLSGRHFPKSIPPTSGKQNPTGR 540
||:|||| ||||||||||||||| ||||||||||||||||||||||||| ||||||||||
Db 481 SHINFRLALIERMLEKHHKPGQQHLRGRPCSDDVTPLRLSGRHFPKSIPATSGKQNPTGR 540
Qy 541 CKVCCS-HDKDGKKIRRETLYFCAECDVPLCVVPCFEIYHTKKNY 584
||:||| :||||||||:|| |||||||||||||||||||||||||
Db 541 CKICCSQYDKDGKKIRKETRYFCAECDVPLCVVPCFEIYHTKKNY 585
Thus, claim(s) 1 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hood et al. (US 8,586,006).
Remarks
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached 6-3 EST Mon-Fri.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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rgh
2/19/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652