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 .
Detailed Action
This action is in response to the papers filed March 11, 2026.
Amendments
Applicant's amendments, filed March 11, 2026, is acknowledged. Applicant has cancelled Claims 3-14, 16-37, 39-41, 43, 45-46, 48, 50-53, 56-90, 92-94, 96-99, 101-104, 108, and 110, amended Claims 1-2, 15, 38, 47, 54-55, 91, 95, 105-107, and 112, and added new claims, Claims 120-121.
Claims 1-2, 15, 38, 42, 44, 47, 49, 54-55, 91, 95, 100, 105-107, 109, and 111-121 are pending.
Election/Restrictions
Applicant has elected without traverse the invention of Group I, Claims 1-2, 10-11, 15, 38, 41-42, 44, 46-49, 54-55, 57, 89, 91, 95, and 100, drawn to a construct comprising a coding sequence operably linked to a promoter, wherein the coding sequence encodes a Kv7.4 protein, an AAV particle whose genome comprises said construct, and a cell comprising said construct.
Within Group I, Applicant has elected the following species, wherein:
i) the alternative promoter is a constitutive promoter, as recited in Claim 10.
Claims 1-2, 15, 38, 42, 44, 47, 49, 54-55, 91, 95, 100, 105-107, 109, and 111-121 are pending and under consideration.
Priority
This application is a 371 of PCT/US2021/31939 filed on May 12, 2021. Applicant’s claim for the benefit of a prior-filed application provisional application 63/024,488 filed on May 13, 2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
Applicant has filed an Information Disclosure Statement on March 11, 2026 that has been considered.
The signed and initialed PTO Forms 1449 are mailed with this action.
The Examiner cites below Applicant's own prior art, not cited in an IDS, to wit:
Simons et al (WO 18/039375).
Applicant is reminded of their duty to disclose information material to patentability. See MPEP §2001 and 37 C.F.R. 1.56.
The individuals covered by 37 CFR 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question. As set forth by the court in Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972):
[W]e think that it is unfair to the busy examiner, no matter how diligent and well informed he may be, to assume that he retains details of every pending file in his mind when he is reviewing a particular application . . . [T]he applicant has the burden of presenting the examiner with a complete and accurate record to support the allowance of letters patent.
See MPEP §2001.06(b).
Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), a copy of the Applicant's own publication(s) are not provided with the instant Office Action because it is presumed that Applicant has a copy of their own publications, as such is routine practice in the art, and that Applicant has provided their representative with a copy of said publications to establish a prosecution record. However, if Applicant’s representative insists upon receiving a copy of the entire references, then the Examiner will make attempts to provide it in the next Office Action.
Claim Objections
1. The prior objection to Claim 89 is withdrawn in light of Applicant’s cancellation of the claim.
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.
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.
2. The prior rejections of Claims 1-2, 10, 15, 38, 41, 44, 46-49, 54-55, 57, 89, 91, 95, 100, and 105-119 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn in light of Applicant’s amendments to the claim set as a whole.
3. The prior rejection of Claim 2 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn in light of Applicant’s amendments to independent Claim 1.
4. The prior rejections of Claims 38, 44, and 107-110 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn in light of Applicant’s amendments to Claim 38.
5. The prior rejection of Claims 41 and 46 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn in light of Applicant’s cancellation of the claims.
6. The prior rejections of Claim(s) 47-48 and 107-108 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, and under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn in light of Applicant’s amendments to Claim 47.
7. The prior rejection of Claim 112 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of Applicant’s amendments to the claim.
8. The prior rejection of Claims 57 and 110 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of Applicant’s cancellation of the claims.
9. The prior rejection of Claim 55 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of Applicant’s cancellation of the claims.
10. Claim 2 is 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.
As a first matter, the phrase “according to” in Claim 2 is a relative term which renders the claim indefinite. The phrase “according to” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Those of ordinary skill in the art immediately recognize that the phrase “according to” does not have the same meaning as, and is broader in scope than, the preposition “of”.
The claim denotes:
a first sub-genus of sequences encoding Kv7.4 protein that are not SEQ ID NO:2-10 or 90, nor are not “according to” SEQ ID NO:2-10 or 90, as opposed to
a second sub-genus of sequences encoding Kv7.4 protein that are not SEQ ID NO:2-10 or 90, yet are “according to” SEQ ID NO:2-10 or 90.
Thus, that which does/does not fulfill “according to” is considered an arbitrary and subjective determination, rendering the claim(s) indefinite.
As a second matter, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 2 recites the broad recitation “sequence according to” and the claim also recites SEQ ID NO:2-10 or 90 which is/are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
As a third matter, the phrase “a… nucleotide acid sequence according to SEQ ID NO…”, which renders the claim indefinite because the referenced SEQ ID NO’s is/are composed of a plurality of nucleic acid subsequences, respectively.
The Directors Technology Center 1600 Memorandum, Nucleic Acid and Peptide Claim Interpretation: “A” and “The” (December 29, 2005) informs the TC1600 Examiners that the phrase “A nucleic acid comprising a nucleotide sequence of SEQ ID NO:1” encompasses nucleic acids that comprise any portion of SEQ ID NO:1; whereas, the phrase “A nucleic acid comprising the nucleotide sequence of SEQ ID NO:1” is directed only to nucleic acids that comprise the full length of SEQ ID NO:1.
English has two articles: ‘the’, and ‘a/an’.
‘the’ is a definite article, referring to a specific or particular noun; whereas, ‘a/an’ is an indefinite article, modifying non-specific or non-particular nouns.
The instant claim as a whole does not apprise one of ordinary skill in the art of its scope and, therefore, does not serve the notice function required by 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent.
The Examiner suggests amending the claim to recite “the nucleic acid sequence of SEQ ID NO…”.
11. Claim 55 is 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 55 recites the limitation “the coding sequence comprises at least one substitution, deletion, and addition” in reference to the cell of Claim 54 which comprises the construct of Claim 1. There is insufficient antecedent basis for this limitation in the claim because those of ordinary skill in the art immediately recognize that human cells, including human cochlear cells (Claim 54) inherently and naturally comprise coding sequences for a Kv7.4 protein, per natural law of biology. Thus, it is unclear if Applicant is requiring the host cell’s genome to comprise each of the three mutations, “at least one substitution, deletion, and addition”, or if Applicant is referring to the (v) coding sequence of the Claim 1 construct.
The instant claim as a whole does not apprise one of ordinary skill in the art of its scope and, therefore, does not serve the notice function required by 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent.
New matter
12. Claim 55 is 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.
Claim 55 has been amended to recite wherein the coding sequence comprises at least one substitution, deletion, and addition.
Clear support for the new limitation requiring the combination of at least one substitution, deletion, and addition cannot be found in the instant application or priority documents, and thus is considered to constitute new matter.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application”. MPEP 2163.06 further notes “When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure” (emphasis added).
While the specification does disclose “a substitution, addition, or deletion” (e.g. [0261]), the specification fails to disclose the coding sequence comprises the combination of at least one substitution, deletion, and addition.
Alternatively, if Applicant believes that support for the new limitation is present and clearly envisaged in the instant application or earlier filed priority documents, applicant must, in responding to this Office Action, point out with particularity, where such support may be found.
Declarations and new references cannot demonstrate possession of a concept after the fact.
Applicant does not indicate where these limitations are supported by the original specification, or how, as is Applicant's burden. See MPEP §714.02, last sentence of the third paragraph from the end and MPEP §2163.06 (I) last sentence.
The Examiner suggests amending the claim cancelling recitation of “and”, and instead recite the conjunction “or”.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
13. Claims 49, 54-55, 91, and 109 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claims 49, 91, and 109 recite a cell, or population of cells comprising said cell, said cell comprising a nucleic acid construct of Claim 1.
Claim 54 recites wherein said cell of Claim 49 is a human cell in the ear of a subject, including a human subject (e.g. [0475], “e.g. a human”).
The cell is present or intended to be present in a human being, said cell becoming integrated into the human being and therefore being an inseparable part of the human itself. The scope of the claim, therefore, encompasses a human being, which is non-statutory subject matter.
As such, the recitation of the limitation “isolated” would be remedial.
Response to Arguments
Applicant argues that the claimed cell comprises an engineered construct that is not found in nature.
Applicant’s argument(s) has been fully considered, but is not persuasive. Applicant’s argument is not on point. The cell is present or intended to be present in a human being, said cell becoming integrated into the human being and therefore being an inseparable part of the human itself. The scope of the claim, therefore, encompasses a human being, which is non-statutory subject matter.
As such, the recitation of the limitation “isolated” would be remedial. See, for example, Claim 120, “is an ex vivo cell”.
Claim Rejections - 35 USC § 102
14. The prior rejection of Claim(s) 1-2, 10, 42, 47-49, 57, 89, 95, 100, 111-113, and 116-117 under 35 U.S.C. 102(a)(1) as being anticipated by Kesser et al (An in vitro model system to study gene therapy in the human inner ear, Gene Therapy 14: 1121-1131, 2007; of record) is withdrawn in light of Applicant’s amendment to the independent Claim 1 to recite structural elements (i)-(vii), the combination of which Kesser et al do not teach.
15. The prior rejection of Claim(s) 1-2, 10, 42, 49, 57, 89, 91, 95, 100, 112-113, and 116 under 35 U.S.C. 102(a)(1) as being anticipated by Zhong et al (Participation of KCNQ (Kv7) potassium channels in myogenic control of cerebral arterial diameter, J. Physiol. 588(17): 3277-3293, 2010; of record), as evidenced by Zhou et al (Effect of stable transfection with PHD3 on growth and proliferation of HepG2 cells in vitro and in vivo. Int. J. Clin. Exp. Med. 7(8): 2197-2203, 2014) is withdrawn in light of Applicant’s amendment to the independent Claim 1 to recite structural elements (i)-(vii), the combination of which Zhong et al do not teach.
16. The prior rejection of Claim(s) 1-2, 10, 15, 38, 41, 44, 46-49, 54, 57, 89, 95, 100, and 107-119 under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by Bance et al (U.S. 2013/0095071) is withdrawn in light of Applicant’s amendment to the independent Claim 1 to recite structural elements (i)-(vii), the combination of which Bance et al do not disclose.
17. The prior rejection of Claim(s) 1-2, 10, 15, 38, 41-42, 44, 46-49, 54, 57, 89, 91, 95, 100, and 105-119 under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by Stankovic et al (U.S. 2018/0369414) is withdrawn in light of Applicant’s amendment to the independent Claim 1 to recite structural elements (i)-(vii), the combination of which Stankovic et al do not disclose.
18. The prior rejection of Claim(s) 1-2, 10, 15, 38, 41-42, 44, 46-49, 54, 57, 89, 91, 95, 100, and 105-119 under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by Holt et al (WO 19/173367, filed March 5, 2019, published September 12, 2019; of record in IDS) is withdrawn in light of Applicant’s amendment to the independent Claim 1 to recite structural elements (i)-(vii), the combination of which Holt et al do not disclose.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
19. The prior rejection of Claims 1-2, 10, 15, 38, 41-42, 44, 46-49, 54, 57, 89, 91, 95, 100, and 105-119 under AIA 35 U.S.C. 103 as being unpatentable over Kesser et al (An in vitro model system to study gene therapy in the human inner ear, Gene Therapy 14: 1121-1131, 2007) in view of Bance et al (U.S. 2013/0095071), and Stankovic et al (U.S. 2018/0369414) is withdrawn for reasons discussed above.
20. The prior rejection of Claim 55 under AIA 35 U.S.C. 103 as being unpatentable over Kesser et al (An in vitro model system to study gene therapy in the human inner ear, Gene Therapy 14: 1121-1131, 2007) in view of Bance et al (U.S. 2013/0095071), and Stankovic et al (U.S. 2018/0369414), as applied to Claims 1-2, 10, 15, 38, 41-42, 44, 46-49, 54, 57, 89, 91, 95, 100, and 105-119 above is withdrawn for reasons discussed above.
21. Claims 1-2, 15, 38, 42, 44, 47, 49, 54-55, 91, 95, 100, 105-107, 109, and 111-121 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Bance et al (U.S. 2013/0095071; of record) in view of Stankovic et al (U.S. 2018/0369414; of record), Simons et al (WO 18/039275; Applicant’s own work not cited in an IDS), Gray et al (Optimizing Promoters for Recombinant Adeno-Associated Virus-Mediated Gene Expression in the Peripheral and Central Nervous System Using Self-Complementary Vectors, Human Gene Therapy 22: 1143-1153, 2011), and Ildefonso et al (U.S. 2016/0017012).
Determining the scope and contents of the prior art, and Ascertaining the differences between the prior art and the claims at issue.
With respect to Claim 1, Bance et al is considered relevant prior art for having disclosed a construct comprising a coding sequence operably linked to a promoter (e.g. [0112]), wherein the coding sequence encodes a Kv7.4 protein (e.g. claim 44, AAV expression vector; claim 57, KCNQ4) and a polyA tail (e.g. [0171], “a polyadenylation signal”).
Bance et al do not disclose ipsis verbis that the AAV expression vector comprises a 5’ ITR and a 3’ ITR. However, those of ordinary skill in the art have long-recognized and used cDNA coding sequences encoding the artisan’s protein of interest, said cDNA coding sequence further comprising a polyA tail. Similarly, those of ordinary skill in the art have long-recognized that AAV vectors inherently comprise 5’ and 3’ ITRs that flank the artisan’s promoter of interest that drives expression of the artisan’s transgene of interest, said transgene comprises a polyA tail.
Bance et al disclosed the vector may comprise a chicken beta-actin promoter (e.g. [0112]).
Thus, it is reasonably concluded that Bance et al disclosed an AAV expression vector comprising, in 5’ to 3’ order:
i) an AAV 5’ ITR;
ii) a CBA promoter;
iii) a cDNA encoding KCNQ4;
iv) a polyA tail; and
v) an AAV 3’ ITR.
Similarly, Stankovic et al is considered relevant prior art for having disclosed a construct comprising a coding sequence operably linked to a promoter (e.g. [0012]), wherein the coding sequence encodes a Kv7.4 protein (e.g. [0015], AAV vector encoding KCNQ4), the expression vector comprises a constitutive promoter (e.g. [0012], CMV promoter, CBA promoter).
Stankovic et al do not disclose ipsis verbis that the AAV expression vector comprises a 5’ ITR, a polyA tail, and a 3’ ITR. However, those of ordinary skill in the art have long-recognized and routinely used coding sequences encoding the artisan’s protein of interest, said coding sequence further comprising a polyA tail for transgene expression in eukaryotic cells. Thus, the ordinary artisan would have reasonably understood that the transgene of Stankovic et al comprises a polyA tail.
Similarly, those of ordinary skill in the art have long-recognized that AAV vectors inherently comprise 5’ and 3’ ITRs that flank the artisan’s promoter of interest that drives expression of the artisan’s transgene of interest, said transgene comprises a polyA tail.
Thus, it is reasonably concluded that Stankovic et al disclosed an AAV expression vector comprising, in 5’ to 3’ order:
i) an AAV 5’ ITR;
ii) a CBA promoter;
iii) a cDNA encoding KCNQ4;
iv) a polyA tail; and
v) an AAV 3’ ITR.
Neither Bance et al nor Stankovic et al disclose wherein the AAV vector comprises a CMV enhancer and/or a chimeric intron.
However, prior to the effective filing date of the instantly claimed invention, Applicant (Simons et al) previously disclosed an AAV expression vector comprising, in 5’ to 3’ order:
i) an AAV 5’ ITR;
ii) a CBA promoter;
iii) a chimeric intron;
iv) a cDNA encoding the artisan’s transgene of interest; and
v) a polyA tail; and
vi) an AAV 3’ ITR (e.g. pg 196-197, joining para),
wherein the transgene of interest is to be expressed in cochlear cells (e.g. Figure 6; pg 15, lines 27-28; pg 16, lines 4-5).
Applicant disclosed rAAV vectors combining a CMV enhancer with a human beta-actin promoter (e.g. pg 206, lines 23-24; pg 210, lines 18-19; Figure 1).
While Applicant disclosed the transgene encodes otoferlin (OTOF), Applicant also disclosed that OTOF and KCNQ4 are in a small (29), defined genus of genes associated with deafness (e.g. pg 4, line 23; pg 7, lines 6-9), and that there is a long-felt need for agents, including gene therapy agents (e.g. claim 33), and methods for preventing or reversing deafness (e.g. pg 10, lines 29-30).
Gray et al is considered relevant prior art for having taught an AAV expression vector comprising, in 5’ to 3’ order:
i) an AAV 5’ ITR;
ii) a CMV enhancer;
iii) a CBA promoter;
iv) a chimeric intron;
v) a cDNA encoding the artisan’s transgene of interest; and
vi) a polyA tail; and
vii) an AAV 3’ ITR (e.g. Table 1, CBA-GFP, CBh-GFP; pg 1149, col. 1, “AAV2 ITRs”),
whereby said rAAV vectors express the artisan’s transgene of interest in neural cells, e.g. CNS expression (e.g. pg 1146, col. 1).
Ildefonso et al is considered relevant prior art for having disclosed an AAV expression vector comprising, in 5’ to 3’ order:
i) an AAV 5’ ITR;
ii) a CMV enhancer;
iii) a CBA promoter;
iv) a chimeric intron;
v) a cDNA encoding the artisan’s transgene of interest;
vi) a polyA tail; and
vii) an AAV 3’ ITR (e.g. Figure 6).
Resolving the level of ordinary skill in the pertinent art.
People of the ordinary skill in the art will be highly educated individuals such as medical doctors, scientists, or engineers possessing advanced degrees, including M.D.'s and Ph.D.'s. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology and viral expression vectors. Therefore, the level of ordinary skill in this art is high.
"A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at ___, 82 USPQ2d at 1396.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The focus when making a determination of obviousness should be on what a person of ordinary skill in the pertinent art would have known at the time of the invention, and on what such a person would have reasonably expected to have been able to do in view of that knowledge. This is so regardless of whether the source of that knowledge and ability was documentary prior art, general knowledge in the art, or common sense. M.P.E.P. §2141.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning). See MPEP §2144.
Prior to the effective filing date of the instantly claimed invention, it would have been obvious to one of ordinary skill in the art to substitute a first rAAV expression vector encoding a KCNQ4 transgene, as disclosed by Bance et al and Stankovic et al, with a second rAAV expression vector comprising a CMV enhancer, a CBA promoter, and a chimeric intron, as taught/disclosed by Applicant (Simons et al), Gray et al, and Ildefonso et al, operably linked to the KCNQ4 transgene with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06. An artisan would be motivated to substitute a first rAAV expression vector encoding a KCNQ4 transgene with a second rAAV expression vector comprising a CMV enhancer, a CBA promoter, and a chimeric intron operably linked to the KCNQ4 transgene because those of ordinary skill in the art had long-recognized and successfully reduced to practice the ability to clone their transgene of interest into an rAAV expression vector comprising a CMV enhancer, a CBA promoter, and a chimeric intron operably linked to the transgene, whereby the transgene of interest is to be expressed in cochlear cells (Applicant-Simons et al) and/or in neural cells (Gray et al).
Instant claims are directed to an AAV expression vector comprising, in 5’ to 3’ order:
i) an AAV 5’ ITR;
ii) a CMV enhancer;
iii) a CBA promoter;
iv) a chimeric intron;
v) a cDNA encoding a KCNQ4 protein;
vi) a polyA tail; and
vii) an AAV 3’ ITR.
Prior to the effective filing date of the instantly claimed invention, it would have been obvious to one of ordinary skill in the art to combine elements (i)-(vii) in an rAAV expression vector with a reasonable expectation of success because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
The motivation to combine can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. MPEP §2144.
Making rAAV particles comprising the artisan’s transgene of interest is an old, routinely practiced, art.
Thus, no undue experimentation is required.
It is proper to "take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741,82 USPQ2d 1385, 1396 (2007). See also Id. At 1742, 82 USPQ2d 1397 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton.").
It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness. See the recent Board decision Ex parte Smith, —USPQ2d—, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925 .pdf).
With respect to Claim 2, Bance et al disclosed wherein the Kv7.4 protein coding sequence is a KCNQ4 gene (e.g. claim 44, AAV expression vector; claim 57, KCNQ4), and thus is considered to fulfill “a nucleotide sequence according to SEQ ID NO’s…”.
Stankovic et al disclosed wherein the Kv7.4 protein coding sequence is a KCNQ4 gene (e.g. [0015], AAV vector encoding KCNQ4), and thus is considered to fulfill “a nucleotide sequence according to SEQ ID NO’s…”.
To the extent Applicant argues otherwise, see 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, rejection above.
With respect to Claim 15, Bance et al disclosed wherein the construct is in an AAV expression vector (e.g. claim 44, AAV expression vector; claim 57, KCNQ4), whereby those of ordinary skill in the art have long-recognized that the artisan’s transgene of interest operably linked to the promoter naturally comprises a polyA sequence and said expression cassette is flanked at the 5’ and 3’ ends with AAV ITRs.
Stankovic et al disclosed wherein the construct is in an AAV expression vector (e.g. [0015], AAV vector encoding KCNQ4), whereby those of ordinary skill in the art have long-recognized that the artisan’s transgene of interest operably linked to the promoter naturally comprises a polyA sequence and said expression cassette is flanked at the 5’ and 3’ ends with AAV ITRs (e.g. [0066, 88]).
Applicant (Simons et al) previously disclosed an AAV expression vector comprising 5’ and 3’ ITRs that flank the CMVenhancer and polyA tail (e.g. Figure 1).
Gray et al taught wherein the AAV expression vector comprises 5’ and 3’ ITRs that flank the CMVenhancer and polyA tail (e.g. pg 1149, col. 1, “AAV2 ITRs”).
Ildefonso et al disclosed wherein the AAV expression vector comprises 5’ and 3’ ITRs that flank the CMVenhancer and polyA tail (e.g. Figure 6).
With respect to Claims 38, 42, 44, and 121, Bance et al disclosed wherein the rAAV particles comprise an AAV capsid (e.g. [0026, 69]).
Bance et al do not disclosed a reduction to practice making a composition of rAAV particles whose genomes encode a KNCQ4 expression cassette. However, the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970).
A reference contains an "enabling disclosure" if the public was in possession of the claimed invention before the date of invention. "Such possession is effected if one of ordinary skill in the art could have combined the publication's description of the invention with his [or her] own knowledge to make the claimed invention." In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985).
Bance et al disclosed rAAV particles comprising the artisan’s transgene of interest (e.g. [0173; 0194]).
Making rAAV particles comprising the artisan’s transgene of interest is an old, routinely practiced, art.
Thus, no undue experimentation is required.
Stankovic et al disclosed an AAV comprising Anc80 capsid whose genome comprises a KCNQ4 expression vector (e.g. [0050], Figure 28; Example 1; [0096]), which the Examiner interprets to reasonably fulfill a “kit”, recited at a high level of generality.
Applicant (Simons et al) previously disclosed an AAV particle comprising a capsid protein (e.g. pg 135, lines 8-12).
Gray et al taught wherein the rAAV particles comprise an AAV capsid (e.g. pg 1144, col. 1, Methods, recombinant AAV production).
Ildefonso et al disclosed an AAV particle comprising a capsid protein (e.g. [0055]).
With respect to Claims 47 and 107, Bance et al disclosed pharmaceutical compositions comprising the rAAV expression vectors and a pharmaceutically acceptable carrier (e.g. [0141-142]).
Stankovic et al disclosed pharmaceutical compositions comprising the rAAV expression vectors (e.g [0015]) and a pharmaceutically acceptable carrier (e.g. [0074]).
Applicant (Simons et al) previously disclosed pharmaceutical compositions comprising the rAAV expression vectors and a pharmaceutically acceptable carrier (e.g. pg 174, lines 12-19).
Gray et al taught pharmaceutical compositions comprising the rAAV expression vectors and a pharmaceutically acceptable carrier (e.g. pg 1144, col. 1, Methods, recombinant AAV production).
Ildefonso et al disclosed pharmaceutical compositions comprising the rAAV expression vectors and a pharmaceutically acceptable carrier (e.g. [0068], claims 4 and 10).
With respect to Claims 49, 91, 109, and 120, Bance et al do not disclosed a reduction to practice of a cell comprising the construct or rAAV particles whose genomes encode a KNCQ4 expression cassette. However, the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970).
A reference contains an "enabling disclosure" if the public was in possession of the claimed invention before the date of invention. "Such possession is effected if one of ordinary skill in the art could have combined the publication's description of the invention with his [or her] own knowledge to make the claimed invention." In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985).
Bance et al disclosed a cell comprising a rAAV expression construct comprising the artisan’s transgene of interest (e.g. [0052-53]; Figures 15-16).
Making genetically modified cells comprising a construct or rAAV particles comprising the artisan’s transgene of interest is an old, routinely practiced, art.
Thus, no undue experimentation is required.
Stankovic et al disclosed a population of KNCQ4 knockout cochlear cells, including ex vivo cochlear explants (e.g. Example 1, [0089]) comprising an AAV-KCNQ4 expression vector (e.g. [0050], Figure 28; [164-165]).
Stankovic et al disclosed a cell comprising a rAAV expression construct comprising the artisan’s transgene of interest (e.g. [0030], Figure 8; [0067], “transiently or stably”).
Applicant (Simons et al) previously disclosed a population of explant cochlear cells comprising an AAV expression vector (e.g. pg 213, Example 17).
Gray et al taught a cell, including ex vivo explants, comprising a rAAV expression construct (e.g. pg 1144, col. 2, Methods, cultured rat hippocampal slices).
Ildefonso et al disclosed a cell, e.g. a cell line, comprising a rAAV expression construct comprising the artisan’s transgene of interest (e.g. [0055]).
With respect to Claim 54, Bance et al disclosed wherein the mammalian cell is in the cochlea of a subject (e.g. [0188]), whereby the subject is human (e.g. [0187]).
Stankovic et al disclosed wherein the mammalian cell is in the cochlea of a subject (e.g. [0030]), whereby the subject is human (e.g. Example 1C, In vivo, [0100], “gene delivery into human vestibular organs”).
Applicant (Simons et al) previously disclosed wherein the mammalian cell is human (claim 31).
Ildefonso et al disclosed wherein the mammalian cell is human (e.g. [0007]).
With respect to Claim 55, Stankovic et al disclosed a population of KNCQ4 knockout cochlear cells comprising an AAV-KCNQ4 expression vector (e.g. [0050], Figure 28), which the Examiner interprets to fulfill instant recitation of a KCNQ4 coding sequence comprising at least one deletion.
Applicant (Simons et al) previously disclosed that dominant mutations in the KCNQ4 gene lead to hearing loss (e.g. pg 7, lines 6-9), which the Examiner interprets to fulfill instant recitation of a KCNQ4 coding sequence comprising at least one deletion, substitution, or addition.
To the extent Applicant argues otherwise, see 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections above.
With respect to Claim 95, Bance et al disclosed pharmaceutical compositions comprising the rAAV expression vectors and a pharmaceutically acceptable carrier (e.g. [0141-142]), which the Examiner interprets to reasonably fulfill a “kit”, recited at a high level of generality.
Stankovic et al disclosed pharmaceutical compositions comprising the rAAV expression vectors (e.g [0015]) and a pharmaceutically acceptable carrier (e.g. [0074]), which the Examiner interprets to reasonably fulfill a “kit”, recited at a high level of generality.
Applicant (Simons et al) previously disclosed pharmaceutical compositions comprising the rAAV expression vectors and a pharmaceutically acceptable carrier (e.g. pg 174, lines 12-19), which the Examiner interprets to reasonably fulfill a “kit”, recited at a high level of generality.
Gray et al taught pharmaceutical compositions comprising the rAAV expression vectors and a pharmaceutically acceptable carrier (e.g. pg 1144, col. 1, Methods, recombinant AAV production), which the Examiner interprets to reasonably fulfill a “kit”, recited at a high level of generality.
Ildefonso et al disclosed pharmaceutical compositions comprising the rAAV expression vectors and a pharmaceutically acceptable carrier (e.g. [0068], claims 4 and 10), which the Examiner interprets to reasonably fulfill a “kit”, recited at a high level of generality.
With respect to Claim 100, Bance et al disclosed wherein said kit comprises a device, as those of ordinary skill in the art immediately recognize that a tool/device of some kind must necessarily be used to transfect/transduce the cells with the nucleic acid composition (e.g. [0193], “AAV Injection”).
Stankovic et al disclosed wherein said kit comprises a device, as those of ordinary skill in the art immediately recognize that a tool/device of some kind must necessarily be used to transfect/transduce the cells with the nucleic acid composition (e.g. Example 1C, In Vivo Injections, [0096], “injection needles”).
Applicant (Simons et al) previously disclosed kits comprising a syringe (e.g. claim 48).
Gray et al taught wherein said kit comprises a device, e.g. injection needle (e.g. pgs 1144-1145, joining para, “injected”, “needle penetration”).
Ildefonso et al disclosed wherein said kit comprises a device (e.g. [0017], “injected”).
With respect to Claim 111, Bance et al disclosed wherein said kit comprises a pre-loaded syringe comprising the aqueous nucleic acid composition (e.g. [0182], “vector injections are carried out using a microsyringe”).
Stankovic et al disclosed wherein said kit comprises a vial comprising the aqueous nucleic acid composition (e.g. [0155], “virus aliquots were stored”), as those of ordinary skill in the art have long-recognized the aqueous nucleic acid composition “aliquots were stored” necessarily requires a vial of some kind, recited at a high level of generality.
Applicant (Simons et al) previously disclosed kits comprising a syringe (e.g. claim 48).
Gray et al taught wherein said kit comprises a device, e.g. injection needle (e.g. pgs 1144-1145, joining para, “injected”, “needle penetration”), as those of ordinary skill in the art have long-recognized the aqueous nucleic acid composition necessarily requires a vial of some kind, recited at a high level of generality.
Ildefonso et al disclosed wherein said kit comprises a device (e.g. [0017], “injected”), as those of ordinary skill in the art have long-recognized the aqueous nucleic acid composition necessarily requires a vial of some kind, recited at a high level of generality.
With respect to Claim 112, Bance et al disclosed pharmaceutical compositions comprising the rAAV expression vectors and a pharmaceutically acceptable carrier, wherein the pharmaceutical composition is in solid or liquid form (e.g. [0141-142]).
Stankovic et al disclosed pharmaceutical compositions comprising the rAAV expression vectors and a pharmaceutically acceptable carrier, wherein the pharmaceutical composition is in liquid form (e.g. [0155]).
Applicant (Simons et al) previously disclosed pharmaceutical compositions comprising the rAAV expression vectors and a pharmaceutically acceptable carrier, wherein the pharmaceutical composition is in liquid form (e.g. pg 174, lines 12-19).
Gray et al taught pharmaceutical compositions comprising the rAAV expression vectors and a pharmaceutically acceptable carrier, wherein the pharmaceutical is in liquid form (e.g. pg 1144, col. 1, Methods, recombinant AAV production).
Ildefonso et al disclosed wherein said kit comprises a pharmaceutical composition comprising the expression vectors and a pharmaceutically acceptable carrier, wherein the pharmaceutical is in liquid form (e.g. [0017], “injected”; [0068]),
With respect to Claim 113, Bance et al disclosed wherein said kit comprises instructions for performing a method (e.g. [0193], “AAV Injection”; [0182], “vector injections are carried out using a microsyringe”).
Stankovic et al disclosed wherein said kit comprises instructions for performing a method (e.g. Example 1C, In Vivo Injections, [0096], “injection needles”).
Applicant (Simons et al) previously disclosed the kit comes with instructions for use (e.g. pg 177, lines 15-16).
Gray et al taught wherein said kit comprises instructions for performing a method (e.g. pgs 1144-1145, joining para, “injected”, “needle penetration”).
Ildefonso et al disclosed wherein said kit comprises instructions for performing a method (e.g. [0017], “injected”; [0068]).
With respect to Claims 114-115, Bance et al disclosed wherein said kit is comprises instructions for introducing the composition into the cochlea of a subject (e.g. [0188], “cochlear gene transfection with AAV”).
Stankovic et al disclosed wherein said kit is comprises instructions for introducing the composition into the cochlea of a subject (e.g. Example 1C, In Vivo Injections, [0096]; [0098], “Anc80 transduction…throughout the cochlea”).
Applicant (Simons et al) previously disclosed the kit comes with instructions for use (e.g. pg 177, lines 15-16).
With respect to Claim 116, Bance et al disclosed wherein said kit is comprises instructions for performing a method for introducing the nucleic acid composition into a mammalian of a subject (e.g. [0187], “Vector Delivery…in Humans”).
Stankovic et al disclosed wherein said kit is comprises instructions for performing a method for introducing the nucleic acid composition into a mammalian of a subject (e.g. Example 1C, In Vivo Injections, [0096]).
Applicant (Simons et al) previously disclosed the kit comes with instructions for use (e.g. pg 177, lines 15-16).
Gray et al taught wherein said kit comprises instructions for performing a method in a mammalian subject (e.g. pgs 1144-1145, joining para, rodent injections, “injected”, “needle penetration”).
Ildefonso et al disclosed wherein said kit comprises instructions for performing a method in a mammalian subject (e.g. [0017], “injected”, “mice”; [0068]).
With respect to Claim 117, Bance et al disclosed wherein said mammalian cell is a cochlear hair cell (e.g. [0188], “cochlear gene transfection with AAV”; [0190]).
Stankovic et al disclosed wherein said mammalian cell is a cochlear hair cell (e.g. Example 1C, In Vivo Injections, [0096]; [0098], “Anc80 transduction…throughout the cochlea”).
Applicant (Simons et al) previously disclosed the kit comes with instructions for use (e.g. pg 177, lines 15-16), e.g. methods of treating deafness or hearing loss (e.g. pg 207, Example 16).
With respect to Claims 118-119, Bance et al disclosed wherein said kit is comprises instructions for performing a method of treating hearing loss (e.g. [0193]).
Stankovic et al disclosed wherein said kit is comprises instructions for performing a method of treating hearing loss (e.g. [0164], “demonstrates Anc80 delivery of KCNQ4 to cells in KCNQ4 mutant mice. Thus, Anc80 is an effective vector for treating a number of different genetic defects…that result in hearing loss.).
Applicant (Simons et al) previously disclosed the kit comes with instructions for use (e.g. pg 177, lines 15-16), e.g. methods of treating deafness or hearing loss (e.g. pg 207, Example 16).
Gray et al taught wherein said kit comprises instructions for performing a method in a mammalian subject (e.g. pgs 1144-1145, joining para, rodent injections, “injected”, “needle penetration”).
Ildefonso et al disclosed wherein said kit comprises instructions for use e.g. methods of treating (e.g. [0017], “injected”, “mice”; [0068]).
Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed, explaining "[i]f we were to adopt [applicant’s] position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product."). See also In re Gulack, 703 F.2d 1381, 1385-86, 217 USPQ 401, 404 (Fed. Cir. 1983) ( "Where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability….[T]he critical question is whether there exists any new and unobvious functional relationship between the printed matter and the substrate." ); In re Miller, 418 F.2d 1392, 1396 (CCPA 1969) (finding a new and nonobvious relationship between a measuring cup and writing showing how to "half" a recipe). See MPEP 2112.01(III)
With respect to Claims 105-106, Stankovic et al disclosed wherein the AAV capsid is Anc80 (e.g. Example 1, [0088, 96]).
Applicant (Simons et al) previously disclosed wherein the AAV capsid is Anc80 (e.g. pg 214, lines 15-16; pg 182, Example 1; pg 197, line 6).
The cited prior art meets the criteria set forth in both Graham and KSR, and the teachings of the cited prior art provide the requisite teachings and motivations with a clear, reasonable expectation of success. Thus, the invention as a whole is prima facie obvious.
Conclusion
22. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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KEVIN K. HILL
Examiner
Art Unit 1638
/KEVIN K HILL/Primary Examiner, Art Unit 1638
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