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 .
Priority
The present Application is a 371 of PCT/CN2021/134233, filed Nov. 30, 2021 and claims foreign priority to CN202011379310.0, filed Nov. 30, 2020 in the People’s Republic of China.
Formal Matters – Response to Restriction/ Election Requirement – Status of the Claims
Claims 29-44 are pending.
Applicant's election with traverse of Sulfate Crystal Form B in the reply filed on Dec. 1, 2025 is acknowledged. The traversal is on the ground(s) that all the crystal forms share the cation that is the compound of formula (I)/(Ia):
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.
This is not found persuasive because the cation of the compound of formula (I)/(Ia) is not a special technical feature because it does not make a contribution over the prior art in view of Liu et al. (WO2019076310A1, published April 25, 2019). As stated in the restriction requirement, Liu teaches the compound of formula (I)/(Ia) and pharmaceutical salts thereof: “provided herein is a compound having one of the following structures, or a stereoisomer, a tautomer, an N-oxide, a solvate, a metabolite, a pharmaceutically acceptable salt or a prodrug thereof…
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(Liu, Specification, p. 34-38, compound 34);
The requirement is still deemed proper and is therefore made FINAL.
Claims 29-35, 39, 41 and 43 read on the elected species and are currently active and subject to examination. Claims 36-38, 40, 42 and 44 are withdrawn.
Claim Rejections - 35 USC § 112(b)
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 30-35, and 43 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 30 is directed towards e.g. the sulfate salt which is sulfate crystal form B, characterized in that crystal form B comprises diffraction peaks with 2θ angles of 6.02±0.2°, 16.74±0.2°, 17.34±0.2°, 18.17 ±0.2, 19.52 ± 0.2° and 24.32 ±0.2°. It is unclear how the diffraction peaks further limit crystal form B because by reciting crystal form B, the Applicant has claimed the crystal form B with all of the diffraction peaks present in Fig. 1. The same is true for the other crystal forms in the claim. Therefore, one of ordinary skill in the art cannot determine the metes and bounds of the claim. Claims 31-32, 34 39 and 43 depend from claim 30 and do not resolve this ambiguity and are therefore also indefinite. To make the claims definite, the Applicant can amend the claims (1) to not recite, for example, “form B” and only claim an unnamed form, (2) remove the x-ray diffraction peaks and just claim, for example, sulfate crystal form B, (3) recite all of the characteristic peaks of form B.
Claims 33 and 35 are indefinite because they reference figures. “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).” (MPEP 2173.05(s)). Appropriate correction is required.
Claim Rejections - 35 USC § 103
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) 29, 39 and 41 and is/are rejected under 35 U.S.C. 103 as being obvious over Liu et al. (WO2019076310A1, published April 25, 2019) (of record).
Claim 29 is directed towards a salt of the compound having Formula (I) or (Ia):
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wherein the salt is sulfate, L-arginine, hydrochloride, phosphate, benzenesulfonate, hydrobromide, p-toluenesulfonate or oxalate.
Liu teaches the compound of formula (I)/(Ia) and pharmaceutical salts thereof: “provided herein is a compound having one of the following structures, or a stereoisomer, a tautomer, an N-oxide, a solvate, a metabolite, a pharmaceutically acceptable salt or a prodrug thereof…
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(Liu, Specification, p. 34-38, compound 34).
While Liu does not specifically make a salt of the compound, one of ordinary skill in the art would have a reasonable expectation of success to obtain the hydrochloride, sulfate, hydrobromide, phosphate, p-toluenesulfonate, and benzenesulfonate salt of the compound because Liu teaches that pharmaceutical salts of the compound include the salts prepared from reacting the compound with “hydrochloric acid, hydrobromic acid, sulfuric acid, nitric acid, phosphoric acid, and the like, or with an organic acid, such as acetic acid, maleic acid, succinic acid, mandelic acid, fumaric acid, malonic acid, pyruvic acid, malic acid, 2-hydroxypropionic acid, citric acid, oxalic acid, glycolic acid and salicylic acid; a pyranosidyl acid, such as glucuronic acid and galacturonic acid; an alpha-hydroxy acid, such as citric acid and tartaric acid; an amino acid, such as aspartic acid and glutamic acid; an aromatic acid, such as benzoic acid and cinnamic acid; a sulfonic acid, such as p-toluenesulfonic acid, benzenesulfonic acid, methanesulfonic acid, ethanesulfonic acid, trifluoromethanesulfonic acid, and the like; or the combination thereof.” (Liu, Specification, p. 68 (emphasis added)).
Therefore, claim 29 was prima facie obvious at the time of filing.
Claim 39 is directed towards a pharmaceutical composition comprising the salt of claim 29 and a pharmaceutically acceptable carrier, excipient, diluent, adjuvant, vehicle or a combination thereof.
One of ordinary skill in the art would have a reasonable expectation of success to obtain a pharmaceutical composition comprising the salt of claim 29 because Liu contemplates pharmaceutical compositions comprising the salt of claim 29 and a pharmaceutically acceptable adjuvant:
It will also be appreciated that certain of the compounds disclosed herein can exist in free form for treatment, or where appropriate, as a pharmaceutically acceptable derivative thereof. According to the invention, the pharmaceutically acceptable derivatives include pharmaceutically acceptable prodrugs, salts, esters, salts of such esters, or any other adducts or derivatives which upon administration to a patient in need is capable of providing, directly or indirectly, a compound as otherwise described herein, or a metabolite or residue thereof.
As described above, the pharmaceutical compositions disclosed herein comprises any one of the compound of formula (I) or (Ia) , and further comprise a pharmaceutically acceptable an adjuvant, such adjuvant, which, as used herein, includes any and all solvents, solid excipients, diluents, binders, disintegrants, or other liquid excipients, dispersion, corrigents or suspension aids, surface active agents, isotonic agents, thickening or emulsifying agents, preservatives, solid binders, glidants, lubricants and the like, as suited to the particular dosage form desired.
Liu, Specification, p. 70.
Therefore, claim 39 was prima facie obvious at the time of filing.
Claim 41 is directed towards a method of preventing, managing, treating or lessening a viral disease in a patient, comprising administering to the patient a therapeutically effective amount of the salt of claim 29, wherein the viral disease is a hepatitis B virus infection or a disease caused by a hepatitis B virus infection, wherein the disease cause by hepatitis B virus infection is liver cirrhosis or hepatocellular carcinoma.
One of ordinary skill in the art would have a reasonable expectation of success to prevent, treat, manage or lessen HBV infection with the salt of claim 29 because Liu teaches a method of treating HBV disease comprising administering a therapeutically effective amount of the compound or composition thereof to a patient in need and the application of the compound and pharmaceutically acceptable salts thereof for effectively inhibiting HBV infection (Liu, specification, p. 68). Liu also teaches that the compound or pharmaceutical composition can be used in the treatment of hepatic cirrhosis or hepatocellular carcinogenesis cause by HBV infection (Liu, Specification, p. 67).
Therefore, claim 41 was prima facie obvious at the time of filing.
Nonstatutory 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 29, 39 and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,261,190 B2 (herein “the ‘190 patent”) in view of Liu et al. (WO2019076310A1, published April 25, 2019) (of record).
Claim 29 is directed towards a salt of the compound having Formula (I) or (Ia):
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wherein the salt is sulfate, L-arginine, hydrochloride, phosphate, benzenesulfonate, hydrobromide, p-toluenesulfonate or oxalate.
The ‘190 patent claims the compound of formula (I) and pharmaceutically acceptable salts thereof:
“A compound having the structure…
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… or a stereoisomer, a tautomer, an N-oxide, a solvate, a metabolite, a pharmaceutically acceptable salt or a prodrug thereof.” (Claim 12).
While the ‘190 patent does not specifically claim the salt forms as in instant claim 29, one of ordinary skill in the art would have a reasonable expectation of success to obtain the salt forms as in instant claim 1 because Liu contemplates the synthesis of these salt forms. Liu teaches the compound of formula (I)/(Ia) and pharmaceutical salts thereof: “provided herein is a compound having one of the following structures, or a stereoisomer, a tautomer, an N-oxide, a solvate, a metabolite, a pharmaceutically acceptable salt or a prodrug thereof…
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(Liu, Specification, p. 34-38, compound 34).
Liu teaches that pharmaceutical salts of the compound include the salts prepared from reacting the compound with “hydrochloric acid, hydrobromic acid, sulfuric acid, nitric acid, phosphoric acid, and the like, or with an organic acid, such as acetic acid, maleic acid, succinic acid, mandelic acid, fumaric acid, malonic acid, pyruvic acid, malic acid, 2-hydroxypropionic acid, citric acid, oxalic acid, glycolic acid and salicylic acid; a pyranosidyl acid, such as glucuronic acid and galacturonic acid; an alpha-hydroxy acid, such as citric acid and tartaric acid; an amino acid, such as aspartic acid and glutamic acid; an aromatic acid, such as benzoic acid and cinnamic acid; a sulfonic acid, such as p-toluenesulfonic acid, benzenesulfonic acid, methanesulfonic acid, ethanesulfonic acid, trifluoromethanesulfonic acid, and the like; or the combination thereof.” (Liu, Specification, p. 68 (emphasis added)).
Therefore, claim 29 is rejected on the grounds of obviousness type double patenting.
Claim 39 is directed towards a pharmaceutical composition comprising the salt of claim 29 and a pharmaceutically acceptable carrier, excipient, diluent, adjuvant, vehicle or a combination thereof.
Claim 1 of the ‘190 patent is directed towards a generic form of the compound or a pharmaceutically acceptable salt thereof. Claim 13 of the ‘190 patent claims a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable adjuvant.
While the ‘190 patent does not specifically claim the salt of claim 29 in a pharmaceutical composition, one of ordinary skill in the art would have a reasonable expectation of success to obtain a pharmaceutical composition comprising the salt of claim 29 because Liu contemplates pharmaceutical compositions comprising the salt of claim 29 and a pharmaceutically acceptable adjuvant:
It will also be appreciated that certain of the compounds disclosed herein can exist in free form for treatment, or where appropriate, as a pharmaceutically acceptable derivative thereof. According to the invention, the pharmaceutically acceptable derivatives include pharmaceutically acceptable prodrugs, salts, esters, salts of such esters, or any other adducts or derivatives which upon administration to a patient in need is capable of providing, directly or indirectly, a compound as otherwise described herein, or a metabolite or residue thereof.
As described above, the pharmaceutical compositions disclosed herein comprises any one of the compound of formula (I) or (Ia) , and further comprise a pharmaceutically acceptable an adjuvant, such adjuvant, which, as used herein, includes any and all solvents, solid excipients, diluents, binders, disintegrants, or other liquid excipients, dispersion, corrigents or suspension aids, surface active agents, isotonic agents, thickening or emulsifying agents, preservatives, solid binders, glidants, lubricants and the like, as suited to the particular dosage form desired.
Liu, Specification, p. 70.
Therefore, claim 39 is rejected on the grounds of obviousness type double patenting.
Claim 41 is directed towards a method of preventing, managing, treating or lessening a viral disease in a patient, comprising administering to the patient a therapeutically effective amount of the salt of claim 29, wherein the viral disease is a hepatitis B virus infection or a disease caused by a hepatitis B virus infection, wherein the disease cause by hepatitis B virus infection is liver cirrhosis or hepatocellular carcinoma.
Claim 1 of the ‘190 patent is directed towards a generic form of the compound or a pharmaceutically acceptable salt thereof. Claim 16 of the ‘190 patent is directed towards A method of treating or lessening a virus disease comprising administering the compound of claim 1 to a patient in need thereof, wherein the virus disease is hepatitis B infection or a disease caused by hepatitis B infection. Claim 17 limits the disease caused by HBV infection to hepatic cirrhosis or hepatocellular carcinogenesis.
While the ‘190 patent does not specifically claim the salt of claim 29 for treating HBV infection, one of ordinary skill in the art would have a reasonable expectation of success to apply the salt of claim 29 to such a method of treating HBV infection because Liu teaches a the application of the compound and pharmaceutically acceptable salts thereof for effectively inhibiting HBV infection (Liu, specification, p. 68).
Therefore, claim 41 is rejected on the grounds of obviousness type double patenting.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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/HEATHER DAHLIN/Examiner, Art Unit 1629