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 .
Reissue Applications
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions. This application, filed September 19, 2023, is reissue continuation of Ser. No. 17/104,028, filed November 25, 2020, now U.S. Patent RE49,697, which is a reissue of U.S. Patent 10,137,117 (hereinafter the ‘117 patent), which issued from U.S. application Serial No. 15/683,127 (the ‘127 application) with claims 1-22 on November 27, 2018.
Statement Under 37 CFR 3.73(c)
The statement under 37 CFR 3.73 filed 02/19/2026 is acknowledged and accepted.
Objections and Rejection Overcome
The objection to the specification, the objection to claim 34 for informalities, and the rejection of claims 29 and 30 under 35 USC 112(b) have been overcome by Applicant’s amendment.
Reissue Declaration
The reissue declaration filed 03/18/2024 is defective (see 37 CFR 1.175 and MPEP § 1414) because of the following:
The reissue declaration is defective because it does not name all of the inventors by their legal names and provide their residence and mailing address. The reissue declaration only names Wilfried Schwab out of the seven co-inventors of the ‘117 patent. The reissue declaration checks the box for “Additional inventors are named on separately numbered sheets attached hereto” but the sheets are not in the reissue file. As noted in MPEP 1414.01, a reissue declaration must identify the joint inventors.
Also, said reissue declaration is made by the Assignee, “Acuris Anti-Infective Cures AG.” However, based on Applicant’s Remarks filed 02/19/2026, Acuris Anti-Infective Cures AG was not the assignee when the reissue declaration was filed on 03/18/2024 due to an ineffective name change.
A new reissue declaration identifying all of the joint inventors is required. If the new reissue declaration is made by the Assignee, then it must be made by the current Assignee of the ‘117 patent
Claims 23-36 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the reissue declaration is set forth in the discussion above in this Office action.
Consent of Assignee
This application is objected to under 37 CFR 1.172(a) as lacking the written consent of all assignees owning an undivided interest in the patent. The consent of the assignee must be in compliance with 37 CFR 1.172. See MPEP § 1410.01.
The Consent of Assignee filed 03/18/2024 is defective because, based on Applicant’s Remarks filed 02/19/2026, Acuris Anti-Infective Cures AG was not the assignee on 03/18/2024 due to an ineffective name change.
A proper assent of the assignee by the current assignee, and in compliance with 37 CFR 1.172 and 3.73, is required in reply to this Office action.
Claims Under Reissue
This reissue application contains claims 23-36. Claim 23, as presented in the amendment filed 02/19/2026, is representative:
23. (Previously Presented) A pharmaceutical composition comprising:
5 to 70% by weight of crystalline N-[5-(aminosulfonyl)-4-methyl-1,3-thiazol-2-yl]-N-methyl-2-[4-(2-pyridinyl)pheny]lacetamide mono methanesulfonic acid monohydrate particles of the following formula:
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wherein said particles have a purity of > 99%, and said particles have a particle size range from 2 µm to 500 µm, a particle size distribution which is defined by d(0.1) from 2 to 100 µm, d(0.5) from 30 to 210 µm and d(0.9) from 70 to 400 µm and a specific surface area of less than 1.0 m2/g; and
one or more pharmaceutically acceptable carriers.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 23-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. RE49,697 (the ‘697 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With respect to claims 23 and 24, claim 6 of the ‘697 patent sets forth a pharmaceutical composition comprising crystalline N-[5-(aminosulfonyl)-4-methyl-1,3-thiazol-2-yl]-N-methyl-2-[4-(2-pyridinyl)pheny]lacetamide mono methanesulfonic acid monohydrate particles (“the crystalline particles”) of the following formula:
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having a purity of >99%, and said particles in the composition have a particle size range from 2 µm to 500 µm, a particle size distribution which is defined by d(0.1) from 2 to 100 µm, d(0.5) from 30 to 210 µm and d(0.9) from 70 to 400 µm and a specific surface area of less than 1.0 m2/g; and a pharmaceutically acceptable carrier.
Claim 6 of the ‘697 patent differs from claims 23 and 24 in not requiring that the crystalline particles are present in the composition at 5 to 70 wt% (claim 23) or 10 to 30 wt% (claim 24).
However, the crystalline particles of the ‘697 patent claims have the same utility as the instant crystalline particles, i.e., treatment and/or prophylaxis of herpes viruses and infections caused by herpes viruses and/or preventing from transmission of a herpes virus or herpes viruses (see col. 1, lines 32-47 of the ‘697 patent; and col. 1, lines 23-40 of the ‘117 patent).
It would have been obvious to one of ordinary skill in the art to have determined appropriate concentrations for the crystalline particles in the pharmaceutical composition in claim 6 of the ‘697 patent, such as the concentration ranges here claimed, so as to utilize the pharmaceutical composition for treatment and/or prophylaxis of herpes viruses and infections caused by herpes viruses and/or preventing from transmission of a herpes virus or herpes viruses. Therefore, claims 23 and 24 are rendered obvious.
Instant claims 25-32 require the following features which are not taught by the claims of the ‘697 patent: the pharmaceutical composition further comprises a filler (claim 25), e.g., 20-80% microcrystalline cellulose and 1 to 40% mannitol (claim 26); a disintegration auxiliary (claim 27), e.g., at 3-35% (claim 28); a lubricant (claim 29), e.g., magnesium stearate (claim 30); a flow agent (claim 31); or a preservative (claim 32).
However, claim 12 of the ‘697 patent depends from claim 6 and further requires the following for the pharmaceutical composition:
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The compositions taught in the ‘697 patent specification that are able to achieve the above mean maximum blood concentrations are prepared using the formulations according to Example 2, Table 2 (see col. 39, lines 4-10 and Table 9 of the ‘697 patent). Table 2 is reproduced below:
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The tablets in Table 2 contain microcrystalline cellulose and mannitol in the percentages here claimed, and also contain: croscarmellose sodium, i.e., a disintegration auxiliary, in a percentage here claimed; magnesium stearate; and colloidal anhydrous silica., i.e., a flow agent.
Accordingly, a person of ordinary skill in the art would be motivated to prepare tablets according to Table 2 of the ‘697 patent to achieve the mean maximum blood concentrations of the ‘697 patent’s claim 12. Though the tablets in Table 2 do not contain a preservative as per instant claim 32, the inclusion of a preservative, such as one in instant claim 32, is conventional in the art and thus, would have been obvious.
Accordingly, claims 25-32 are rendered obvious
With respect to claims 33-36, claim 10 of the ‘697 patent depends from claim 6 and further teaches a combination of the pharmaceutical composition and acetylsalicylic acid, acyclovir also known as “aciclovir”1, or penciclovir. Accordingly, 33-36 and rendered obvious.
Claims 23-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9,119,786 (the ‘786 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With respect to claims 23 and 24, claim 6 of the ‘786 patent sets forth a unit dosage of a composition comprising crystalline N-[5-(aminosulfonyl)-4-methyl-1,3-thiazol-2-yl]-N-methyl-2-[4-(2-pyridinyl)pheny]lacetamide mono methanesulfonic acid monohydrate particles (“the crystalline particles”) of the following formula:
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having a purity of >99%, and said particles in the composition have a particle size range from 2 µm to 500 µm, a particle size distribution which is defined by d(0.1) from 2 to 100 µm, d(0.5) from 30 to 210 µm and d(0.9) from 70 to 400 µm and a specific surface area of less than 1.0 m2/g; and a pharmaceutically acceptable carrier.
Claim 6 of the ‘786 reference patent differs from claims 23 and 24 in not requiring that the crystalline particles are present in the composition at 5 to 70 wt% (claim 23) or 10 to 30 wt% (claim 24).
However, the crystalline particles of the ‘786 patent claims have the same utility as the instant crystalline particles, i.e., treatment and/or prophylaxis of herpes viruses and infections caused by herpes viruses and/or preventing from transmission of a herpes virus or herpes viruses (see col. 1, lines 23-41 of the ‘786 patent; and col. 1, lines 23-40 of the ‘117 patent).
It would have been obvious to one of ordinary skill in the art to have determined appropriate concentrations for the crystalline particles in the unit dosage composition in claim 6 of the ‘786 patent, such as the concentration ranges here claimed, so as to utilize the unit dosage for treatment and/or prophylaxis of herpes viruses and infections caused by herpes viruses and/or preventing from transmission of a herpes virus or herpes viruses. Therefore, claims 23 and 24 are rendered obvious.
Instant claims 25-32 require the following features which are not taught by the claims of the ‘786 patent: the pharmaceutical composition further comprises a filler (claim 25), e.g., 20-80% microcrystalline cellulose and 1 to 40% mannitol (claim 26); a disintegration auxiliary (claim 27), e.g., at 3-35% (claim 28); a lubricant (claim 29), e.g., magnesium stearate (claim 30); a flow agent (claim 31); or a preservative (claim 32).
However, claim 12 of the ‘786 patent depends from claim 6 and further requires the following for the unit dosage:
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The unit dosages taught in the ‘786 patent specification that are able to achieve the above mean maximum blood concentrations are prepared using the formulations according to Example 2, Table 2 (see col. 38, lines 1-7 and Table 9 of the ‘786 patent). Table 2 is reproduced below:
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The tablets in Table 2 contain microcrystalline cellulose and mannitol in the percentages here claimed, and also contain: croscarmellose sodium, i.e., a disintegration auxiliary, in a percentage here claimed; magnesium stearate; and colloidal anhydrous silica., i.e., a flow agent.
Accordingly, a person of ordinary skill in the art would be motivated to prepare tablets according to Table 2 of the ‘786 patent to achieve the mean maximum blood concentrations of the ‘786 patent’s claim 12. Though the tablets in Table 2 do not contain a preservative as per instant claim 32, the inclusion of a preservative, such as one in instant claim 32, is conventional in the art and thus, would have been obvious.
Accordingly, claims 25-32 are rendered obvious
With respect to claims 33-36, claim 10 of the ‘786 patent depends from claim 6 and further teaches a combination of the unit dosage and acetylsalicylic acid, acyclovir also known as “aciclovir”2, or penciclovir. Accordingly, 33-36 and rendered obvious.
Claims 23-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 9,340,535 (the ‘535 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With respect to claims 23 and 24, claim 15 of the ‘535 patent sets forth a pharmaceutical composition containing crystalline N-[5-(aminosulfonyl)-4-methyl-1,3-thiazol-2-yl]-N-methyl-2-[4-(2-pyridinyl)phenyl]acetamide methane-sulfonic acid monohydrate according to claim 9 of the ‘535 patent together with at least one pharmaceutically acceptable carrier. While the claims of the ‘535 patent do not recite the instantly claimed particle size range, particle size distribution, specific surface and purity >99%, such are inherent in the crystalline N-[5-(aminosulfonyl)-4-methyl-1,3- thiazol-2-yl]-N-methyl-2-[4-(2-pyridinyl)-phenyl]acetamide mono methanesulfonic acid monohydrate (hereinafter “crystalline compound”) of said claims 9 and 15.
In particular, based on the X-ray diffraction pattern and crystal parameters in the ‘535 patent’s claim 9, and especially based on the fact that the synthesis process in Example 1 of the ‘535 patent is identical to the synthesis process in Example 1 of the ‘117 patent, the crystalline compound in claims 9 and 15 of the ‘535 patent has the instantly claimed particle size range, particle size distribution, specific surface and purity.
Claim 15 of the ‘535 reference patent differs from claims 23 and 24 in not requiring that the crystalline particles are present in the pharmaceutical composition at 5 to 70 wt% (claim 23) or 10 to 30 wt% (claim 24).
However, the crystalline particle of N-[5-(aminosulfonyl)-4-methyl-1,3-thiazol-2-yl]-N-methyl-2-[4-(2-pyridinyl)phenyl]acetamide methane-sulfonic acid monohydrate in claim 15 of the ‘535 patent have the same utility as the instant crystalline particles, i.e., treatment and/or prophylaxis of herpes viruses and infections caused by herpes viruses and/or preventing from transmission of a herpes virus or herpes viruses (see col. 13, lines 16-22 of the ‘535 patent; and col. 1, lines 23-40 of the ‘117 patent).
It would have been obvious to one of ordinary skill in the art to have determined appropriate concentrations for the crystalline particles in the pharmaceutical composition in claim 15 of the ‘535 patent, such as the concentration ranges here claimed, so as to utilize the composition for treatment and/or prophylaxis of herpes viruses and infections caused by herpes viruses and/or preventing from transmission of a herpes virus or herpes viruses. Therefore, claims 23 and 24 are rendered obvious.
Instant claims 25-32 require the following features which are not taught by the claims of the ‘535 patent: the pharmaceutical composition further comprises a filler (claim 25), e.g., 20-80% microcrystalline cellulose and 1 to 40% mannitol (claim 26); a disintegration auxiliary (claim 27), e.g., at 3-35% (claim 28); a lubricant (claim 29), e.g., magnesium stearate (claim 30); a flow agent (claim 31); or a preservative (claim 32).
However, these are all conventional ingredients for preparing a pharmaceutical composition containing a drug, and thus, would have been obvious to one of ordinary skill in the art.
With respect to claims 33-36, claim 19 of the ‘535 patent depends from claim 15 and further teaches the inclusion of acetylsalicylic acid, acyclovir also known as “aciclovir”3, or penciclovir. Accordingly, 33-36 and rendered obvious.
Response to Arguments
Applicant's arguments filed 02/19/2026 have been fully considered but they are not persuasive.
With respect to the rejection under 35 USC 251 on grounds that the reissue declaration is defective, Applicant notes they will file a new reissue declaration naming all the inventors and executed by the current assignee, AIC316 GmbH (Remarks, p. 9). Applicant also states they will file a new Consent of Assignee executed by AIC316 GmbH (Remarks, p. 9). However, these documents have not yet been received and thus, the rejection under 35 USC 251 is maintained.
Applicant requests that the non-statutory double patenting rejections be held in abeyance until the claims are otherwise indicated as allowable (Remarks, p. 10).
This argument is unpersuasive because only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. See 37 CFR 1.111(b). Accordingly, the non-statutory double patenting rejections are maintained.
It is noted that the instant claims would be allowable if Applicant files a proper Consent of Assignee executed by the current assignee, a proper Reissue Declaration (executed by the current Assignee or the inventors), and terminal disclaimer over U.S. Patents RE 49,697, 9,119,786 and 9,340,535.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceed-ing in which Patent No. 10,137,117 is or was involved. These proceedings would include interferences, reissues, reexaminations, and litigation. Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is mate-rial to patentability of the claims under consideration in this reissue appli-cation. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN D DIAMOND whose telephone number is (571)272-1338. The examiner can normally be reached Monday through Thursday 5:30 am to 3:00 pm, and Fridays from 5:30 am to 9:30 am.
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, Patricia Engle can be reached on 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Signed:
/ALAN D DIAMOND/Patent Reexamination Specialist
Central Reexamination Unit 3991
Conferees:
/JOSEPH R KOSACK/Patent Reexamination Specialist
Central Reexamination Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
1 See col. 11, lines 23-24 of the ‘117 patent.
2 See footnote 1.
3 See footnote 1.