DETAILED ACTION
This Office action details a final action on the merits for the above referenced application No. Claims 1-30 are pending in this application.
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 .
Status of Claims
Claims 11-12, 26-27, and 29 are amended. Claim 30 is new.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 18 Jul. 2025 and 8 Oct. 2025 have been considered by the examiner.
Response to Amendment
The amendments filed on 7 Oct. 2025 have been considered.
The declaration under 37 CFR 1.132 filed 7 Oct. 2025 is insufficient to overcome the rejection of claims as set forth in the last Office action because of the reasons set forth below.
Jalomäki declares that there was nothing in the prior art that would have provided any indication that the currently claimed concentration of 177Lu-PSMA I&T could be produced with a radiochemical purity of >95% for at least 72 h. The technical field is highly unpredictable and the cited references also indicate unreliability and unpredictability as it relates to the instant invention. Pipes refers to a different radioisotope, a different ligand, a different chelator, and different dosage. Pipes would have needed to be modified in at least four different ways to teach a concentration of ≤ 6.0 µg/mL 177Lu-PSMA I&T and would still not provide any degree of predictability. The cited reference in Weineisen is mathematically incorrect and reflects a miscalculation. Because the alleged 4.5-fold molar ratio does not accurately correspond to either the stated radioactivity or the stated compound quantities, Weineisen cannot serve as a reliable teaching or disclosure of the molar ratio or concentrations claimed in the instant application. Rather than a PSMA I&T to 177Lu molar ratio of 4.5:1, however the true molar ratio calculation in Weineisen is approximately 12:1 for human studies and even higher for animal studies. The true molar ratio calculation in Weinesen for human patients is PSMA I&T to 177Lu molar ratio of 12:1. The mole ratio of 177Lu to PSMA I&T for in vitro and animals studies shows a mole ratio of 27:1. At best the cited passage of Weineisen refers to a PSMA I&T to 177Lu molar radio of much higher range of 12:1 to 27:1. Weineisen does not teach < 6.0 ug/mL of 177Lu-PSMA I&T. Someone following Weineisen would not have been able to make the currently claimed invention. The mole ratio is not a result effective variable, as incorrect molar ratios may lead to instability, degradation, and toxicity in radiopharmaceutical compositions. Routine optimization would logically lead to an increase, not a decrease in the molar ratio as higher molar ratios are routinely used to ensure sufficient chelation and radiochemical purity. A lower molar ratio is not recognized in the literature as a result effective variable for improved performance. Lower chelating agent levels are associated with reduced binding, lower purity and increased unbound radioisotope. The combination of McCann, Pipes, and Weineisen would require extensive modifications and offers not reasonable expectation of success. Barbato fails to teach either PSMAA I&T or DOTAGA, which are part of the currently claimed compositions. Barbato cannot teach the claimed molar ratio of 177Lu to PSMA I&T or the appropriate concentration of 177Lu PSMA I&T. If some ligands of Barbato and some conditions always below 95%, Barbato can provide no reasonable expectation of success for ligands and chelators that are not taught or tested. Barbato acknowledges that stabilizers are completely unpredictable and may even be counterproductive. Barbato provides no reliable teachings concerning 177Lu PSMA I&T. Hooijman does not actually show the claimed compositions. Hooikman’s lack of detection is relevant for an entirely different set of parameters. The dosimetry results of the claimed 177Lu-PSMA I&T compositions were completely unexpected and give rise to a better dosimetry result. The dosimetry performance of the claimed invention is extremely surprising, because it appears to selectively target cancer tissue over healthy tissues, which indicates superior safety and efficacy.
The Jalomäki declaration filed 7 Oct. 2025 has been fully considered but it has not been found persuasive. An expert testimony is entitled to some consideration and weight so long as the opinion is not on the ultimate legal conclusion at issue. See In re Chilowsky, 306 F.2d 908, 134 USPQ 515 (CCPA 1962). The Jalomäki declaration is not a declaration of unexpected results. A declaration of unexpected results requires a comparison with the closest prior art to be effective to rebut a prima facie case of obviousness. See In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. See In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). Claims 16 and 29 do not require a composition of 177Lu-PSMA I&T where the molar ratio of PSMA I&T to 177Lu is from 3.0:1.0 to 8.0:1.0. At pg. 52 and table 2, McCann provides a solution for injection to a patient in need thereof, wherein the solution comprises a radiopharmaceutical composition comprising 177Lu-PSMA I&T having radiochemical purities of 97.6% (condition 4) and 96.9% (condition 5) for 6 days at room temperature. McCann is silent about the µg/mL of 177Lu-PSMA I&T in the radiopharmaceutical compositions. McCann is silent about the molar ratio of PSMA I&T to 177Lu. McCann is silent about the specific activities of the 177Lu-PSMA I&T.
At pg. 1171, Weineisen plainly states, without referring to the supplemental data section, that for quantitative 177Lu complexation, 24.5 MBq of 177LuIII was reacted with a 4.5-fold molar excess of PSMA I&T, yielding 177Lu-PSMA I&T in specific activities of 27 GBq/µmol. In this case, Weineisen provides adequate teaching, suggestion, and motivation for one of ordinary skill in the art to supplement McCann to arrive at a molar ratio of PSMA I&T to 177Lu that is from 3.0:1.0 to 8.0:1.0. In other words, a molar ratio of PSMA I&T to 177LuIII near to or around 4.5:1 would have been obvious to try. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). After KSR, obvious to try is an adequate motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. MPEP 2144.05.II. Below is a calculation that show the 4.5:1 molar ratio of PSMA I&T to 177LuIII is supported in the supplementary data section of Weineisen at 177Lu-labeling for in vitro and animal studies.
Given:
n
(
P
S
M
A
I
&
T
)
=
0.91
n
m
o
l
S
A
177
L
u
C
l
3
=
120
G
B
q
µ
m
o
l
a
177
L
u
C
l
3
=
0.0245
G
B
q
Calculation for the mol amount of 177LuCl3
n
177
L
u
C
l
3
=
0.0245
G
B
q
×
1
µ
m
o
l
120
G
B
q
×
1,000
n
m
o
l
1
µ
m
o
l
=
0.2
n
m
o
l
Calculation of mol ratio (R) of PSMA I&T to 177Lu
R
=
1
0.9
n
m
o
l
0.2
n
m
o
l
=
1
4.5
The calculations provided in the Jalomäki declaration seem to be based on impractical theoretical quantities. For example, using Applicant’s own numbers, the Examiner has computed an unrealistic specific activity value.
As shown below, at pg. 1151, Weineisen reasonably provides for a composition having ≤ 6.0 µg/mL of 177Lu-PSMA I&T.
0.0245
G
B
q
×
1
µ
m
o
l
27
G
B
q
×
1672.3
µ
g
µ
m
o
l
≈
1.5
µ
g
Assuming a total volume from 10-20 mL, Weineisen provides 177Lu-PSMA I&T weight concentrations ranging 0.15-0.075 µg/mL.
A person of ordinary skill in the art interested in commercializing 177Lu-PSMA I&T for the treatment of prostate cancer would have been interested in economy and simplicity. Accordingly, a person of ordinary skill in the art would have had adequate reason and motivation to try a solution for injection of 177Lu-PSMA I&T to a patient in need thereof wherein the molar ratio of PSMA I&T to 177Lu is from 3.0:1.0 to 8.0:1.0.
At [0052], Pipes teaches that the radionuclide may be 177Lu and at [0080], Pipes provides for a range of molar ratios of ligand to radionuclide such as 5:1, 4:1, and 3:1. The DOTA chelator is a mere congener of the DOTAGA where the DOTAGA chelator has increased denticity. At example 3, Pipes provides an experiment using a molar ratio of ligand to radionuclide that is 4:1. Labeling is complete at 5 min even at reduced temperatures. A person of ordinary skill in the art reading Pipes in combination with Fleshner would not have interested in substituting various parameters of an established radioligand (177Lu-PSMA I&T) such as chelator etc; rather, person of ordinary skill in the art would have been interested in reaction conditions to that produce optimal yield and stability using economy and simplicity. Accordingly, a person of ordinary skill in the art would have had adequate reason and motivation from Pipes to arrive at molar ratio of PSMA I&T to 177Lu that is 4:1. At [0018], Pipes provide some teaching, suggestion and motivation for a radioligand concentrations that is about 0.6 µg/mL.
At pg. 72, Barbato teaches and motivates identifying a minimum molar ratio of PSMA ligand to 177Lu for quantitative complexation of 177Lu. McCann provides a radiopharmaceutical composition of 177Lu-PSMA I&T having a radiochemical purity of > 95% for at least 6 days. Optimizing the molar ratio for near quantitative complexation of 177LuIII as taught and suggested by Barbato would have only been expected to predictably improve the economy and simplicity of 177Lu-PSMA I&T manufacture.
Hooijman teaches and motivates checking radiopharmaceutical comprising 177Lu for colloidal hydroxide and Hooijman teaches and motivates zero detectable colloidal hydroxides of radiopharmaceutical compositions comprising 177Lu.
Response to Arguments
In view of Applicants amendments, the rejection of claims 11-12, 26-27, and 29 under 35 USC 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn.
In view of the approved terminal disclaimer, the provisional rejection of claims 1-29 on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending application No. 19/209,267, in view of Pipes et al. (US 2022/0080059 A1; published 17 Mar. 2022) and Hooijman et al. (EJNMMI Radiopharm. Chem.; published 2022) is withdrawn.
In view of the approved terminal disclaimer, the provisional rejection of claims 1-29 on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending application No. 19/198,982, in view of Pipes et al. (US 2022/0080059 A1; published 17 Mar. 2022) and Hooijman et al. (EJNMMI Radiopharm. Chem.; published 2022) is withdrawn.
In view of the approved terminal disclaimer, the provisional rejection of claims 1-29 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-25, and 31-34 of copending application No. 18/791,288, in view of Pipes et al. (US 2022/0080059 A1; published 17 Mar. 2022) and Hooijman et al. (EJNMMI Radiopharm. Chem.; published 2022) is withdrawn.
In view of the approved terminal disclaimer, the provisional rejection of claims 1-29 on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending application No. 18/791,256, in view of Pipes et al. (US 2022/0080059 A1; published 17 Mar. 2022) and Hooijman et al. (EJNMMI Radiopharm. Chem.; published 2022) is withdrawn.
In view of the approved terminal disclaimer, the rejection of claims 1-29 on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of US patent No. 12,324,846, in view of Pipes et al. (US 2022/0080059 A1; published 17 Mar. 2022) and Hooijman et al. (EJNMMI Radiopharm. Chem.; published 2022) is withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCann et al. (WO 2022/013610 A2; published 20 Jan. 2022), in view of Pipes et al. (US 2022/0080059 A1; published 17 Mar. 2022) and Weineisen et al. (J. Nucl. Med.; published 2015) for the reasons cited in the Office action filed on 7 Jul. 2025.
Applicants Arguments
Applicants assert that regarding the claimed molar ratio range, the Weineisen reference contains a critical error. Applicants refer to the above Jalomaki declaration. Both the radioactivity dosages and the mass quantities used in experimental section of Weineisen indicate the 4.5 molar is a mathematical error. Once corrected Weineisen provides molar ratios of 12:1 to 27:1 for human and animal studies. Weineisen fails to teach < 6.0 ug/mL 177Lu-PSMA I&T and radiochemical purity of > 95% for at least 72 h. A person of ordinary skill in the art once aware of the key miscalculation errors in Weineisen would not utilize Weineisen for the purposes of that miscalculation error. Pipes is vastly different from a chemistry standpoint. Pipes requires at least four different simultaneous modifications., none of which are predictable. Routine optimization would result in the molar ratio being increased based on the teachings of the relevant art. The Office has cited no evidence of lower ligand/chelating agent being a result effective variable for improved performance. The dosimetry clinical trial results were completely unexpected and revealed considerably lower radioactive absorbed dose which is a strong secondary consideration.
Applicant's arguments filed 7 Oct. 2025 have been fully considered but they are not persuasive. The Jalomäki declaration is ineffective for the reasons discussed above. The Jalomäki declaration is not a declaration of unexpected results. The compositions of McCann differs from instant claim 1 only because McCann is silent about the weight concentrations of 177Lu-PSMA I&T and/or silent about the molar ratio of PSMA I&T to 177Lu. As discussed above, Weineisen provides adequate teaching, suggestion and motivation for a weight concentration of 177Lu-PSMA I&T that is ≤ 6.0 µg/mL and molar ratio of PSMA I&T to 177Lu that is about 4.5:1. At pg. 1171, Weineisen plainly states that for quantitative complexation, 24.5 MBq of 177LuIII was reacted with a 4.5-fold molar excess of PSMA I&T yielding 177Lu-PSMA I&T in specific activities of 27 GBq/µmol. A person of ordinary skill in the art interested in commercializing 177Lu-PSMA I&T would have been interested in economy and simplicity. A molar ratio of PSMA I&T to 177Lu that is 4.5:1 would have been obvious to try since that molar ratio would have been expected to allow for quantitative 177Lu complexation with economy and simplicity. Obviousness only requires a reasonable expectation of success; obviousness does not require absolute predictability.
A person of ordinary skill in the art reading Pipes in combination with McCann interested in commercial application of 177Lu-PSMA I&T would not have been interested modifying 177Lu PSMA I&T by e.g. chelator or radionuclide substitution. Instead, a person of ordinary skill in the art would reading Pipes would have been interested in supplementing information omitted by McCann such as a molar ratio of PSMA I&T to 177Lu and acceptable endotoxin concentrations. As discussed above Pipes adequately establishes the molar ratio of ligand to radionuclide as a result effective variable and provides some teaching and suggestion for quantitative complexation in 5 min using a molar ratio of 4:1.
Claim(s) 1-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCann et al. (WO 2022/013610 A2; published 20 Jan. 2022), in view of Pipes et al. (US 2022/0080059 A1; published 17 Mar. 2022) and Weineisen et al. (J. Nucl. Med.; published 2015), in further view of Hooijman et al. (EJNMMI Radiopharm. Chem.; published 2022) for the reasons cited in the Office action filed on 7 Jul. 2025.
Applicants Arguments
Applicants assert that as explained by the expert declaration, adding Barbato and/or Hooijman to the alleged prior art combination of references adds even mor ligands and chelator combinations and increases uncertainty and unpredictability of the results. Barbato highlights that there is no reasonable expectation of success by identifying a number of 177Lu ligand complexes that are incapable of maintaining a radiochemical purity above 95% for at least 72 h in direct contrast to the claims.
Applicant's arguments filed 7 Oct. 2025 have been fully considered but they are not persuasive. McCann, Pipes, and Weineisen are not deficient for the reasons discussed above. Barbato additionally teaches and motivates identifying a minimum molar ratio of PSMA ligand to 177Lu for quantitative complexation of 177Lu. Hooijman teaches and motivates checking radiopharmaceutical comprising 177Lu for colloidal hydroxide and Hooijman teaches and motivates zero detectable colloidal hydroxides of radiopharmaceutical compositions comprising 177Lu.
New Grounds of Rejection
Claim Rejections - 35 USC § 103
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCann et al. (WO 2022/013610 A2; published 20 Jan. 2022), in view of Pipes et al. (US 2022/0080059 A1; published 17 Mar. 2022) and Weineisen et al. (J. Nucl. Med.; published 2015), in further view of Okamoto et al. (J. Nucl. Med.; published 2017; see attached 892).
McCann et al. teach as discussed above. McCann et al. teach radiopharmaceutical and methods (see title). McCann et al. teach an aqueous composition including 1) a complex of lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA and 2) one or more ascorbate compounds. The radiochemical purity of the composition is at least 99% where the composition is maintained at 30oC or less for 3 or more days following preparation (pg. 35). The 177Lu-PSMA I&T is provided as a sterile solution for intravenous use. A single dose vial will contain 6.8 ± 10% GBq 177Lu-PSMA I&T in 10-14 mL formulated with one or more radioprotectants and may include a buffer. The pH is from 5.0 to 7.0 (pg. 39). McCann et al. teach example 2 where radiolabeling was performed using no-carrier added 177LuCl3. The racemic 177Lu-PSMA-I&T or 177Lu-PSMA-I&T having optical excess of structure 2A was diluted using a reaction buffer and was added to a reaction vial (pgs 48-49). The preparation of 177Lu-PSMA-I&T following conditions described in condition 4 and condition 5, demonstrates for the first time a product that is >99% pure post incorporation reaction and maintains >95% radiochemical purity over 6 d at room temperature in the formulation composition. Condition 5 places 65 mg in the reaction composition and an admixture of 26 mg ascorbic acid and 66 mg gentisic acid in the formulation composition with 177Lu-PSMA-I&T (table 2). (Composition comprising a solution for injection into a human patient in need thereof in a single use vial wherein the solution comprises a radio-pharmaceutical composition comprising 177Lu-PSMA I&T and 177Lu-PSMA-I&T at a radiochemical purity of >95% for at least 72 h post production.) McCann et al. teaches a preferred preparation process (example 3). 177Lu-PSMA I&T having an optical excess of structure 2A in sterile aqueous solution is administered by intravenous injection. The dosing regimen may include four infusions of 6.8 ± 10% each, administered 8 wk apart (see pg. 55). A dose of 0.1 GBq to about 30 GBq may be administered (pg. 39). The one or more stabilizer compounds may include ethanol (pg. 37). McCann et al. teach ascorbate amounts ranging from 5 mg/mL to 90 mg/mL (pg. 15).
McCann et al. do not further teach that the composition comprises 7.4±5 GBq of 177Lu PSMA I&T.
Pipes et al. teach as discussed above. Pipes et al. teach radiolabeling and formulation for scale up of 64Cu-dotatate (see title). Pipes et al. teach supplying commercial quantities of radioactive diagnostic agent indicated for use with PET (see abstract). Pipes et al. teach 177Lu-dotatate ([0008]) and in certain embodiments the radionuclide is lutetium-177 ([0052]). The molar ratio of ligand to radionuclide is 5:1, 4:1, 3:1 ([0080]). Pipes et al. teach 5% ethanol (95% water) ([0093]). Pipes et al. teach the formation of Cu-DOTATATE at lower temperatures (example 3). Reaction conditions included a DOTATATE:Cu molar ratio of 4:1. The data confirm that labeling of dotatate is largely complete after 5 min (table 7). Pipes et al. teach the preparation of 64Cu-DOTATATE prepared at reduced DOTATATE concentration (example 6) and the effects of gentisic acid and ethanol on 64Cu-DOTATATE stability (example 7). Pipes et al. teach sodium ascorbate and 2.8% or 3.5% EtOH (table 9). Pipes et al. teach an improved purification yield of Cu-DOTATATE (example 11). Pipes et al. teach radiolabeling DOTATATE with copper-64 at a concentration of about 0.6 µg/mL (µg of DOTATATE per mCi of Copper-64) and the radionuclidic purity of Copper-64 in the drug product is about 99% ([0018]). Pipes et al. teach bacterial endotoxins are present in the drug product in an amount of < 1 EU/mL ([0102]). Pipes et al. teach specific activities of drug product > 90 mCi/mg ([0120]-[0121]).
Weineisen et al. teach as discussed above. Weineisen et al. teach 68Ga- and 177Lu-labeled PSMA I&T (see title). Weineisen et al. teach for quantitative 177Lu complexation, 24.5 MBq of 177LuIII was reacted with 4.5-fold excess of PSMA I&T yielding 177Lu-PSMA I&T in specific activities of 27 GBq/µmol or more (pg. 1171). 177Lu-PSMA I&T for clinical use was prepared after incubation of 150-200 ug PSMA I&T with 6-8 GBq of 177LuCl3 at 90oC for 30 min in NaOAc (0.4 M, 800 µl, pH 5.5) (see pg. S2).
Okamoto et al. teach radiation dosimetry for 177Lu PSMA-I&T in metastatic castration resistant prostate cancer (see title). Okamoto et al. teach estimating the absorbed doses for 177Lu PSMA I&T in normal organs and in tumor lesions in a considerable number of patients with mCRPC undergoing up to 4 cycles with a reference activity of 7.4 GBq. The mean activity for all cycles was 7.3±0.3 GBq, 7.3±0.23 for the first cycle, 7.3±0.34 for the second cycle, 7.5±0.22 GBq for the third cycle, and 7.3±0.24 GBq for the fourth cycle. Whole body scintigraphy was performed (pg. 446). Okamoto et al. teach 5 cycles using 7.4 GBq of 177Lu-PSMA I&T achieving relevant absorbed doses on tumor lesions and offering the possibility of several cycles for midterm tumor control. SPECT should be the method of choice to avoid overlap with physiologic uptake and tumor uptake (pg. 449).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify McCann et al. so that the obvious composition further comprises 7.4±5% GBq of 177Lu-PSMA I&T as taught by Okamoto et al. because that dose of 177Lu-PSMA would have been expected to provide effective 77Lu-PSMA I&T therapy and advantageously enable multiple cycles of 177Lu-PSMA I&T therapy for patients with mCRPC.
Conclusion
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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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618