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 1-30 are pending and have been examined on the merits.
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 1-11, 13-15, 17 and 20-30 are rejected under 35 U.S.C. 103 as being unpatentable over Wischik et al. (WO 2020/020751) in view of Roma et al. Transplantation Proceedings, vol. 42, no. 2, Mar. 2010, pp. 601–04.
Regarding claims 1 and 24-28, Wischik (abstract; page 1) teaches a therapeutic treatment of a neurodegenerative disorder with methylthioninium (MT)-containing compound. Wischik (page 14) teaches the following methylthioninium-containing compound:
PNG
media_image1.png
410
744
media_image1.png
Greyscale
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 explicitly teach a method of alleviating hypoxemia.
However, Roma (page 601-602) teaches the use of methylene blue to improve hypoxemia in patient with Hepatopulmonary syndrome, leading to oxygen saturation between (85%–92%). While Roma does not explicitly use the phrase “alleviating”, however, the measurable benefits by methylene blue corresponds to alleviating hypoxemia by the increased of oxygen saturation. Given that methylene blue is a methylthioninium analogue, thus, it would have been obvious to a person of ordinary skill in the art (POSITA) to modify the teachings of Wischik in view of Roma to arrive at the claimed invention, because Roma discloses the use of a methylthioninium analogue to treat or improve hypoxemia.
Regarding claims 2-9, Wischik (page 11), and as applied to claim 1 above, teaches oral administration of a total daily dose of methylthioninium analogues in the following range:
PNG
media_image2.png
208
714
media_image2.png
Greyscale
Regarding claims 10-15 and 17, Wischik does not explicitly teach blood oxygen saturation level (SpO2) or selecting the subject according to their SpO2 value.
However, Roma (abstract; page 603, Table 1), and as applied to claim 1 above, teaches treatment for patient with Hepatopulmonary syndrome (HPS), a disease characterizes by low oxygen levels and hypoxemia. Roma (abstract; page 603, Table 1) teaches, before treatment, a patient with a SatO2 (%) of 71, which correlates with a SpO2 value below 95%; thus, both
PNG
media_image3.png
256
752
media_image3.png
Greyscale
values are within the same hypoxemic range. Roma (page 603, Table 1) also teaches treatment with methylene blue improves SatO2 (%) by 86 after 40 min. Therefore, it would have been obvious to a POSITA that patients with HPS have an SpO2 value below 95%, and arrive at the claimed invention, because treatment with methylene significantly improves SatO2 (%) by 86 after 40 min.
Regarding claim 20, Wischik (page 72, claims 44 and 45), and as applied to claim 1 above, teaches the following:
PNG
media_image4.png
223
704
media_image4.png
Greyscale
Wischik (page 73, claim 50), teaches the following mono-protic acids for use with methylthioninium-containing compound:
PNG
media_image5.png
60
686
media_image5.png
Greyscale
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 21, 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.
PNG
media_image6.png
136
604
media_image6.png
Greyscale
Regarding claim 22, 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.
PNG
media_image7.png
172
302
media_image7.png
Greyscale
Regarding claim 23, 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.
PNG
media_image8.png
154
392
media_image8.png
Greyscale
Regarding claim 29, Wischik (page 14, claim 56), and as applied to claim 1 above, teaches the following compound, reading on the instant claim.
PNG
media_image9.png
138
370
media_image9.png
Greyscale
Regarding claim 30, Wischik (page 15), and as applied to claim 1 above, teaches the following compound, reading on the instant claim.
PNG
media_image10.png
140
372
media_image10.png
Greyscale
Claim Objections
It is noted that claims 12, 16 and 18-19 are free of the prior art. However, the claims are not allowed because they rely, directly or indirectly, on claim 1 that has 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, 21 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 Roma et al. Transplantation Proceedings, vol. 42, no. 2, Mar. 2010, pp. 601–04.
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 21.
PNG
media_image11.png
358
284
media_image11.png
Greyscale
Claims 5-6 and 9 of the US patent ‘796 also recites methylthioninium compound of the following formula, that is identical to that of the instant claim 22-24, 27 and 29.
PNG
media_image12.png
614
298
media_image12.png
Greyscale
The US patent ‘796 does teach hypoxemia. However, Roma (page 601-602) teaches the use of methylene blue to improve hypoxemia in patient with Hepatopulmonary syndrome, leading to oxygen saturation between (85%–92%). While Roma does not explicitly use the phrase “alleviating”, however, the measurable benefits by methylene blue corresponds to alleviating hypoxemia by the increased of oxygen saturation. Given that methylene blue is a methylthioninium analogue, thus, it would have been obvious to a person of ordinary skill in the art (POSITA) to modify the teachings of US patent ‘796 in view of Roma to arrive at the claimed invention, because Roma discloses the use of a methylthioninium analogue to treat or improve hypoxemia.
Given that the claimed compounds of the instant claim are identical to that of the US patent ‘796 in view of Roma, 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, 4-8, 20, 23-24 and 27-30 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 Roma et al. Transplantation Proceedings, vol. 42, no. 2, Mar. 2010, pp. 601–04.
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.
PNG
media_image13.png
176
278
media_image13.png
Greyscale
Claim 3 of the US patent ‘256 teaches the following compound, as an example, that is identical to that of the instant claim 20.
PNG
media_image14.png
112
250
media_image14.png
Greyscale
Claims 4-7 of the US patent ‘256 teaches the following compound, as an example, that is identical to that of the instant claims 23-24 and 27-28.
PNG
media_image15.png
292
296
media_image15.png
Greyscale
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 4-7 and 29.
PNG
media_image16.png
206
296
media_image16.png
Greyscale
Claims 11 of the US patent ‘256 teaches the following compound, as an example, that is identical to that of the instant claim 30.
PNG
media_image17.png
300
288
media_image17.png
Greyscale
The US patent ‘256 does teach hypoxemia. However, Roma (page 601-602) teaches the use of methylene blue to improve hypoxemia in patient with Hepatopulmonary syndrome, leading to oxygen saturation between (85%–92%). While Roma does not explicitly use the phrase “alleviating”, however, the measurable benefits by methylene blue corresponds to alleviating hypoxemia by the increased of oxygen saturation. Given that methylene blue is a methylthioninium analogue, thus, it would have been obvious to a person of ordinary skill in the art (POSITA) to modify the teachings of US patent ‘256 in view of Roma to arrive at the claimed invention, because Roma discloses the use of a methylthioninium analogue to treat or improve hypoxemia.
Given that the claimed compounds of the instant claim are identical to that of the US patent ‘256 in view of Roma, 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 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. US 11759469 in view of Roma et al. Transplantation Proceedings, vol. 42, no. 2, Mar. 2010, pp. 601–04.
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 29.
PNG
media_image18.png
112
272
media_image18.png
Greyscale
The US patent ‘469 does teach hypoxemia. However, Roma (page 601-602) teaches the use of methylene blue to improve hypoxemia in patient with Hepatopulmonary syndrome, leading to oxygen saturation between (85%–92%). While Roma does not explicitly use the phrase “alleviating”, however, the measurable benefits by methylene blue corresponds to alleviating hypoxemia by the increased of oxygen saturation. Given that methylene blue is a methylthioninium analogue, thus, it would have been obvious to a person of ordinary skill in the art (POSITA) to modify the teachings of US patent ‘469 in view of Roma to arrive at the claimed invention, because Roma discloses the use of a methylthioninium analogue to treat or improve hypoxemia.
Given that the claimed compounds of the instant claim are identical to that of the US patent ‘469 in view of Roma, 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, 4-8, 20, 23-24 and 27-30 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 Roma et al. Transplantation Proceedings, vol. 42, no. 2, Mar. 2010, pp. 601–04.
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.
PNG
media_image19.png
166
284
media_image19.png
Greyscale
Claim 3 of the US patent ‘051 teaches the following compound, as an example, that is identical to that of the instant claims 20.
PNG
media_image20.png
122
254
media_image20.png
Greyscale
Claims 4-7 of the US patent ‘051 teaches the following compound, as an example, that is identical to that of the instant claims 23-24 and 27-28.
PNG
media_image21.png
328
292
media_image21.png
Greyscale
Claims 8-9 of the US patent ‘051 teaches the LMTM compound, as an example, that is identical to that of the instant claims 4-8 and 29.
PNG
media_image22.png
224
292
media_image22.png
Greyscale
Claims 11 of the US patent ‘051 teaches the following compound, as an example, that is identical to that of the instant claim 30.
PNG
media_image23.png
274
288
media_image23.png
Greyscale
The US patent ‘051 does teach hypoxemia. However, Roma (page 601-602) teaches the use of methylene blue to improve hypoxemia in patient with Hepatopulmonary syndrome, leading to oxygen saturation between (85%–92%). While Roma does not explicitly use the phrase “alleviating”, however, the measurable benefits by methylene blue corresponds to alleviating hypoxemia by the increased of oxygen saturation. Given that methylene blue is a methylthioninium analogue, thus, it would have been obvious to a person of ordinary skill in the art (POSITA) to modify the teachings of US patent ‘051 in view of Roma to arrive at the claimed invention, because Roma discloses the use of a methylthioninium analogue to treat or improve hypoxemia.
Given that the claimed compounds of the instant claim are identical to that of the US patent ‘051 in view of Roma, 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 Roma et al. Transplantation Proceedings, vol. 42, no. 2, Mar. 2010, pp. 601–04.
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
PNG
media_image18.png
112
272
media_image18.png
Greyscale
between 20.5 and 40 mg that falls within the range of the instant claim 27-28.
The US patent ‘175 does teach hypoxemia. However, Roma (page 601-602) teaches the use of methylene blue to improve hypoxemia in patient with Hepatopulmonary syndrome, leading to oxygen saturation between (85%–92%). While Roma does not explicitly use the phrase “alleviating”, however, the measurable benefits by methylene blue corresponds to alleviating hypoxemia by the increased of oxygen saturation. Given that methylene blue is a methylthioninium analogue, thus, it would have been obvious to a person of ordinary skill in the art (POSITA) to modify the teachings of US patent ‘175 in view of Roma to arrive at the claimed invention, because Roma discloses the use of a methylthioninium analogue to treat or improve hypoxemia.
Given that the claimed compounds of the instant claim are identical to that of the US patent ‘175 in view of Roma, 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 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. US 12280061 in view of Roma et al. Transplantation Proceedings, vol. 42, no. 2, Mar. 2010, pp. 601–04.
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 29.
PNG
media_image18.png
112
272
media_image18.png
Greyscale
The US patent ‘061 does teach hypoxemia. However, Roma (page 601-602) teaches the use of methylene blue to improve hypoxemia in patient with Hepatopulmonary syndrome, leading to oxygen saturation between (85%–92%). While Roma does not explicitly use the phrase “alleviating”, however, the measurable benefits by methylene blue corresponds to alleviating hypoxemia by the increased of oxygen saturation. Given that methylene blue is a methylthioninium analogue, thus, it would have been obvious to a person of ordinary skill in the art (POSITA) to modify the teachings of US patent ‘061 in view of Roma to arrive at the claimed invention, because Roma discloses the use of a methylthioninium analogue to treat or improve hypoxemia.
Given that the claimed compounds of the instant claim are identical to that of the US patent ‘061 in view of Roma, 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. 17/922,837. 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.
PNG
media_image24.png
246
664
media_image24.png
Greyscale
Claim 17 of co-pending application is drawn to the following formula, that is identical to that of the instant claim 20.
PNG
media_image25.png
154
292
media_image25.png
Greyscale
Claim 18 of co-pending application is drawn to the following formula, that is identical to that of the instant claim 21.
PNG
media_image26.png
138
300
media_image26.png
Greyscale
Claim 19 of co-pending application is drawn to the following formula, that is identical to that of the instant claim 22.
PNG
media_image27.png
152
294
media_image27.png
Greyscale
Claim 20 of co-pending application is drawn to the following formula, that is identical to that of the instant claim 23.
PNG
media_image28.png
132
300
media_image28.png
Greyscale
Claim 26 of co-pending application is drawn to the following compound, that is identical to that of the instant claim 29.
PNG
media_image29.png
148
328
media_image29.png
Greyscale
Claim 29 of co-pending application is drawn to the following compound, that is identical to that of the instant claim 30.
PNG
media_image30.png
354
368
media_image30.png
Greyscale
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622