DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim status
Claims 1, 2, 6-12 and 14-29 are pending and have been examined on the merits.
Claim Rejections - 35 USC § 112 (Enablement)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 6-12, and 14-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is drawn to a method of therapeutic or prophylactic treatment of COVID-19 in a subject. However, the specification does not provide any experimental data or disclosure demonstrating the capability of a methylthioninium (MT)-containing compound to achieve the therapeutic or prophylactic effects as claimed. The specification fails to provide data of any subject who have been administered with any of the claimed compounds to demonstrate therapeutic effectiveness as treatment against COVID-19 infection. The specification does not provide any experimental data demonstrating how each compound of the claimed genus function in treating or preventing COVID-19 infection. Thus, without appropriate data regarding therapeutic or prophylactic treatment, a person of ordinary skill in the art (POSITA) would not know whether the compound actually achieves the claim functions. For these reasons, a POSITA would also recognize that the absence of any in vivo data or experimental results suggest that the claimed compound may not be prophylactic or used for treatment as claimed, which then significantly weakens the enablement of the claimed invention. Therefore, the absence of such data supports the conclusion that the specification does not provide adequate disclosure to conclude that the compounds can act as prophylactic or therapeutic treatment of COVID-19 in a subject.
Furthermore, specification (page 11) discloses:
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Therefore, a mere statement or prophetic example is not sufficient, if not supported by experimental evidence or detailed disclosure. Consequently, the lack of enablement of the claimed subject matter at the time of filing, suggest that Applicant did not possess supporting data to claim a method of therapeutic or prophylactic treatment of COVID-19 in a subject.
112 (Written description)
Claims 1, 2, 6-12 and 14-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites a method of therapeutic or prophylactic treatment of COVID-19 in a subject.
The specification fails to describe any subject who have been administered any of the claimed compounds to demonstrate therapeutic or prophylactic treatment against COVID-19 infection. The specification provides no guidance how to differentiate the prophylactic from therapeutic treatment for patient populations at highest risk of getting very sick from COVID-19 compared to patient suffering from an acute COVID-19 infection. The specification does not provide sufficient detail demonstrating how each compound with the claimed genus function in treating or preventing COVID-19 infection. The specification’s failures to disclose details on any specific regarding the compound efficacy as preventive or treatment, but instead relying on published data for efficacy, further supports the conclusion that the specification lacks adequate written description of the claimed subject matter.
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 1 and 6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 and 6 recite phrases in parenthesis therefore it is not clear if they are a limitation of the claim or not. It is suggested to remove the parenthesis. The dependent claims do not cure this deficiency.
Claim Objections
Claims 12 and 29 recite list of substituents with the phrase “and” instead of “or” to indicate alternative options. However, using the phrase “and” in such a list implies that all substituents must be present together, which may not reflect the intended purpose. Therefore, for clarity and proper interpretation, Applicant is required to correct the claims by replacing “and” with the phrase “or”.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office
action.
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.
Claims 1-2, 6-9, 11, 17-26 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Wischik et al. (WO 2020/020751) in view of Alamdari et al. Arch Bone Jt Surg. 2020 Apr;8(Suppl1):291-294.
Regarding claims 1-2 and 21-25, Wischik (page 67, claim 1) teaches a therapeutic treatment of a neurodegenerative disorder with methylthioninium (MT)-containing compound. Wischik (page 14) teaches the following methylthioninium-containing compound:
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Wischik (page 67, claim 1) teaches “administration provides a total daily dose of between 20.5 and 40, 20.5 and 60, 20.5 and 80 or 20.5 and 99 or 100 mg of MT to the subject per day, optionally split into 2 or more doses.” Wischik, however, does not teach a method of therapeutic or prophylactic treatment of COVID-19 in a subject.
However, Alamdari (page 291-292) discloses the use of leucomethylene blue, the reduced form of methylene blue, a methylthioninium-containing compound, as a novel treatment against COVID-19 infection. Wischik (page 2) also references on the use of methylene blue, as treatment and prophylaxis for various diseases. Given that leucomethylene blue is a methylthioninium-containing compound; thus, it would have been obvious to a POSITA to modify the teachings of Wischik in view of Alamdari’s disclosure to arrive at the claimed invention, because Alamdari discloses the use of a methylthioninium-containing compound to treat COVID-19 infection. Therefore, it would have been obvious to a POSITA to also conclude that treatment for patients with COVID-19, also means that such patients were diagnosed with COVID-19.
Regarding 6, 9 and 11, Wischik (page 67, claim 1), and as applied to claim 1 above, teaches oral administration of a total daily dose of between 20.5 and 40 mg of methylthioninium to a subject per day, optionally split into 2 or more doses.
Regarding claim 17, Wischik (page 72, claims 44 and 45), and as applied to claim 1 above, teaches the following:
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Wischik (page 73, claim 50), teaches the following mono-protic acids for use with methylthioninium-containing compound:
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Given this disclosure, it would have been obvious to a POSITA to select the appropriate protic acid from the provided selection, because Wishick provides motivation and expectation of success of using methylthioninium-containing compound with different mono-protic acids to arrive at the claimed invention.
Regarding claim 18, Wischik (page 5), and as applied to claim 1 above, teaches the following compound, wherein p is 2 and HnX is HCl, reading on the instant claim.
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Regarding claim 19, Wischik (page 74, claim 56), and as applied to claim 1 above, teaches the following compound, wherein H2A is 1,2-ethanedisulfonic acid, reading on the instant claim.
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Regarding claim 20, Wischik (page 74, claim 56), and as applied to claim 1 above, teaches the following compound, wherein 2(HA) is p-toluenesulfonic acid, reading on the instant claim.
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Regarding claim 26, Wischik (page 14, claim 56), and as applied to claim 1 above, teaches the following compound, reading on the instant claim.
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Regarding claim 29, Wischik (page 15), and as applied to claim 1 above, teaches the following compound, reading on the instant claim.
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Claim Objections
It is noted that claims 7-8, 10, 12, 14-16 and 27-28 are free of the prior art. However, the claims are not allowed because they rely, directly or indirectly, on claims 1 and 26 that have been rejected. As a result, until this issue is remedied or resolved; the claims cannot be subject of allowance.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine
grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or
improper timewise extension of the “right to exclude” granted by a patent and to prevent possible
harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where
the conflicting claims are not identical, but at least one examined application claim is not
patentably distinct from the reference claim(s) because the examined application claim is either
anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may
be used to overcome an actual or provisional rejection based on nonstatutory double patenting
provided the reference application or patent either is shown to be commonly owned with the
examined application, or claims an invention made as a result of activities undertaken within the
scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination
under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §
2146 et seq. for applications not subject to examination under the first inventor to file provisions
of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be
accompanied by a reply requesting reconsideration of the prior Office action. Even where the
NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used.
Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or
PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely
online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 18-21, 24 and 26.are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-6 and 9 of U.S. Patent No. US 10842796 in view of Alamdari et al. Arch Bone Jt Surg. 2020 Apr;8(Suppl1):291-294.
Although the claims at issue are not identical, they are not patentably distinct from each
other because compounds claimed in US patent '796 are comparable to those of the instant
claims. For example, claim 4 of the US patent ‘796 recites the LMTX compound of the following formula, that is identical to that of the instant claim 1 and 18.
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Claims 5-9 of the US patent ‘796 also recites methylthioninium compound of the following formula, that is identical to that of the instant claim 19-21, 24 and 26.
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The US patent ‘796 does teach COVID-19. However, Alamdari (page 291-292) discloses the use of leucomethylene blue, the reduced form of methylene blue, as a novel treatment against COVID-19 infection. Given that leucomethylene blue is a methylthioninium compound and the US patent ‘796 also teaches methylthioninium analogues; thus, it would have been obvious to a POSITA to combine the teachings of US patent ‘796 and Alamdari to arrive at the claimed invention, because both Alamdari and US patent ‘796 disclose methylthioninium analogues, while Alamdari emphasizes methylthioninium used to treat COVID-19 infection.
Given that the claimed compounds of the instant claim are identical to that of the US patent ‘796 in view of Alamdari, without meaningful inventive distinction, thus the instant application is not in proper condition to warrant a Notice of Allowance. This is because, allowing both claims to issue as separate patents would unjustly extend the patent rights beyond the statutory term.
Claims 1, 17-21, 24-26 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-8, 11 and 18 of U.S. Patent No. US 11065256 in view of Alamdari et al. Arch Bone Jt Surg. 2020 Apr;8(Suppl1):291-294.
Although the claims at issue are not identical, they are not patentably distinct from each other because compounds claimed in US patent ‘256 are comparable to those of the instant claims. For example, claim 1 of the US patent ‘256 recites the LMTX compound of the following formula, that is identical to that of the instant claim 1.
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Claim 3 of the US patent ‘256 teaches the following compound, as an example, that is identical to that of the instant claim 17-19.
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Claims 4-7 of the US patent ‘256 teaches the following compound, as an example, that is identical to that of the instant claims 20-21 and 24-25.
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Claims 8-9 and 18of the US patent ‘256 teaches the following compound, as an example, that is identical to that of the instant claims 26.
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Claims 11 of the US patent ‘256 teaches the following compound, as an example, that is identical to that of the instant claim 29.
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The US patent ‘256 does teach COVID-19. However, Alamdari (page 291-292) discloses the use of leucomethylene blue, the reduced form of methylene blue, as a novel treatment against COVID-19 infection. Given that leucomethylene blue is a methylthioninium compound and the US patent ‘256 also teaches methylthioninium analogues; thus, it would have been obvious to a POSITA to combine the teachings of US patent ‘256 and Alamdari to arrive at the claimed invention, because both Alamdari and US patent ‘256 disclose methylthioninium analogues, while Alamdari emphasizes methylthioninium used to treat COVID-19 infection.
Given that the claimed compounds of the instant claim are identical to that of the US patent ‘256 in view of Alamdari, without meaningful inventive distinction, thus the instant application is not in proper condition to warrant a Notice of Allowance. This is because, allowing both claims to issue as separate patents would unjustly extend the patent rights beyond the statutory term.
Claims 26-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 5 of U.S. Patent No. US 11759469 in view of Alamdari et al. Arch Bone Jt Surg. 2020 Apr;8(Suppl1):291-294.
Although the claims at issue are not identical, they are not patentably distinct from each other because compounds claimed in US patent ‘469 are comparable to those of the instant claims. For example, claims 1 and 5 of the US patent ‘469 recite a LMTM compound that is identical to that of the instant claim 26. Claims 3 of the US patent ‘469 teaches the total daily
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dose is between 0.8 to 33 mg which falls within the range of the instant claim 27-28.
The US patent ‘469 does teach COVID-19. However, Alamdari (page 291-292) discloses the use of leucomethylene blue, the reduced form of methylene blue, as a novel treatment against COVID-19 infection. Given that leucomethylene blue is a methylthioninium compound and the US patent ‘469 also teaches methylthioninium analogues; thus, it would have been obvious to a POSITA to combine the teachings of US patent ‘469 and Alamdari to arrive at the claimed invention, because both Alamdari and US patent ‘469 disclose methylthioninium analogues, while Alamdari emphasizes methylthioninium used to treat COVID-19 infection.
Given that the claimed compounds of the instant claim are identical to that of the US patent ‘469 in view of Alamdari, without meaningful inventive distinction, thus the instant application is not in proper condition to warrant a Notice of Allowance. This is because, allowing both claims to issue as separate patents would unjustly extend the patent rights beyond the statutory term.
Claims 1, 17-21, and 24-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-9 and 11 of U.S. Patent No. US 12128051 in view of Alamdari et al. Arch Bone Jt Surg. 2020 Apr;8(Suppl1):291-294.
Although the claims at issue are not identical, they are not patentably distinct from each other because compounds claimed in US patent ‘051 are comparable to those of the instant claims. For example, claim 1 of the US patent ‘051 recites the methylthioninium compound of the following formula, that is identical to that of the instant claim 1.
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Claim 3 of the US patent ‘256 teaches the following compound, as an example, that is identical to that of the instant claims 17-19.
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Claims 4-7 of the US patent ‘256 teaches the following compound, as an example, that is identical to that of the instant claims 20-21 and 24-25.
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Claims 8-9 of the US patent ‘256 teaches the LMTM compound, as an example, that is identical to that of the instant claims 26-29.
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Claims 11 of the US patent ‘256 teaches the following compound, as an example, that is identical to that of the instant claim 29.
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The US patent ‘051 does teach COVID-19. However, Alamdari (page 291-292) discloses the use of leucomethylene blue, the reduced form of methylene blue, as a novel treatment against COVID-19 infection. Given that leucomethylene blue is a methylthioninium compound and the US patent ‘051 also teaches methylthioninium analogues; thus, it would have been obvious to a POSITA to combine the teachings of US patent ‘051 and Alamdari to arrive at the claimed invention, because both Alamdari and US patent ‘051 disclose methylthioninium analogues, while Alamdari emphasizes methylthioninium used to treat COVID-19 infection.
Given that the claimed compounds of the instant claim are identical to that of the US patent ‘051 in view of Alamdari, without meaningful inventive distinction, thus the instant application is not in proper condition to warrant a Notice of Allowance. This is because, allowing both claims to issue as separate patents would unjustly extend the patent rights beyond the statutory term.
Claims 26-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. US 12263175 in view of Alamdari et al. Arch Bone Jt Surg. 2020 Apr;8(Suppl1):291-294.
Although the claims at issue are not identical, they are not patentably distinct from each other because compounds claimed in US patent ‘175 are comparable to those of the instant claims. For example, claims 1-5 of the US patent ‘175 recite a LMTM compound that is identical to that of the instant claim 26. Claims 2-5 of the US patent ‘175 teaches the total daily dose is
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between 20.5 and 40 mg that falls within the range of the instant claim 27-28.
The US patent ‘175 does teach COVID-19. However, Alamdari (page 291-292) discloses the use of leucomethylene blue, the reduced form of methylene blue, as a novel treatment against COVID-19 infection. Given that leucomethylene blue is a methylthioninium compound and the US patent ‘175 also teaches methylthioninium analogues; thus, it would have been obvious to a POSITA to combine the teachings of US patent ‘175 and Alamdari to arrive at the claimed invention, because both Alamdari and US patent ‘175 disclose methylthioninium analogues, while Alamdari emphasizes methylthioninium used to treat COVID-19 infection.
Given that the claimed compounds of the instant claim are identical to that of the US patent ‘175 in view of Alamdari, without meaningful inventive distinction, thus the instant application is not in proper condition to warrant a Notice of Allowance. This is because, allowing both claims to issue as separate patents would unjustly extend the patent rights beyond the statutory term.
Claims 26-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. US 12280061 in view of Alamdari et al. Arch Bone Jt Surg. 2020 Apr;8(Suppl1):291-294.
Although the claims at issue are not identical, they are not patentably distinct from each other because compounds claimed in US patent ‘175 are comparable to those of the instant claims. For example, claims 1 of the US patent ‘175 recites a LMTM compound that is identical to that of the instant claim 26. Claims 2-5 of the US patent ‘175 teaches the total daily
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dose is between 20.5 and 40 mg that falls within the range of the instant claim 27-28.
The instant claim does teach COVID-19. However, Alamdari (page 291-292) discloses the use of leucomethylene blue, the reduced form of methylene blue, a methylthioninium-containing compound, as a novel treatment against COVID-19 infection. Given that leucomethylene blue is a methylthioninium compound and the US patent ‘175 also teaches methylthioninium compound; thus, it would have been obvious to a POSITA to combine the teachings of Alamdari and US patent ‘175 to arrive at the claimed invention, because both Alamdari and US patent ‘175 discloses the use of a methylthioninium, while Alamdari emphasizes the used to treat COVID-19 infection.
Given that the claimed compound of the instant claim reads on the US patent ‘175 in view of Alamdari, without meaningful inventive distinction, thus the instant application is not in proper condition to warrant a Notice of Allowance. This is because, allowing both claims to issue as separate patents would unjustly extend the patent rights beyond the statutory term.
Provisional nonstatutory double patenting
Claim 1, 17-20, 26 and 29 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 20-23 and 29-30 of copending Application No. 17/922,886. Although the claims at issue are not identical, they are not patentably distinct from each other because
Claim 1 of co-pending application is drawn to a methylthioninium compound of the following formula, that is identical to that of the instant claim 1.
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Claim 20 of co-pending application is drawn to the following formula, that is identical to that of the instant claim 17.
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Claim 21 of co-pending application is drawn to the following formula, that is identical to that of the instant claim 18.
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Claim 22 of co-pending application is drawn to the following formula, that is identical to that of the instant claim 19.
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Claim 23 of co-pending application is drawn to the following formula, that is identical to that of the instant claim 20.
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Claim 29 of co-pending application is drawn to the following compound, that is identical to that of the instant claim 26.
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Claim 30 of co-pending application is drawn to the following compound, that is identical to that of the instant claim 29.
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This suggests the overlap conflicting claims are not patentably distinct between the instant and co-pending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Therefore, no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES H ALSTRUM-ACEVEDO can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622