DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-10 and 12-18 are pending in the instant invention. According to the Amendments to the Claims, filed May 3, 2024, claims 3-5 and 7-10 were amended, claim 11 was cancelled and claims 12-18 were added.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/CN2022/129074, filed November 1, 2022, which claims priority under 35 U.S.C. § 119(a-d) to CN 202111308836.4, filed November 5, 2021.
Restrictions / Election of Species
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The inventor’s or joint inventor’s provisional election of the following, with traverse, in the reply filed on July 8, 2026, is acknowledged: a) Group I - claims 1-4, 8, 12 and 13; and b) solid dispersion comprising a pharma-ceutically acceptable matrix polymer including an enteric high molecular polymer and a non-enteric high molecular polymer and 1-{(6-[(1-methyl)-4-pyrazolyl]-imidazo[1,2-a]pyridine)-3-sulfonyl}-6-[(1-methyl)-4-pyrazolyl]-1-hydro-pyrazolo[4,3-b]pyridine (compound A) - Examples 1, 2, 8 and 10, referred to as a solid dispersion comprising a pharmaceutically acceptable matrix polymer including hydroxypropyl methylcellulose phthalate, copovidone and 1-{(6-[(1-methyl)-4-pyrazolyl]-imidazo[1,2-a]pyridine)-3-sulfonyl}-6-[(1-methyl)-4-pyrazolyl]-1-hydro-pyrazolo[4,3-b]pyridine (compound A). Claims 1-4, 8, 12 and 13 read on the elected species. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
Similarly, the inventor or joint inventor should further note that the traversal is on the grounds that Group I and Groups II-V possess unity and should be examined together without any undue burden being placed on the Examiner. This is not found persuasive because the multiple inventions in the instant invention are independent or distinct for the reasons disclosed in the Requirement for Restriction / Election of Species, mailed on May 6, 2026.
Likewise, the inventor or joint inventor should further note that there would be a serious burden on the examiner if restriction was not required because the inventions have acquired a separate status in the art due to their divergent subject matter and would require a different field of search.
Next, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Then, the inventor or joint inventor should further note that the elected species was found to be free of the prior art.
Moreover, the inventor or joint inventor should further note that claims 5-7, 9, 10 and 14-18 were withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected or cancelled invention, there being no allowable generic or linking claim.
Thus, a first Office action and prosecution on the merits of claims 1-4, 8, 12 and 13 is contained within.
Specification Objection - Disclosure
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the inventor’s or joint inventor’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility invention should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase Not Applicable should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR
DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A
COMPACT DISC.
(f) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art (including information disclosed under 37 CFR 1.97
and 1.98).
(g) BRIEF SUMMARY OF THE INVENTION.
(h) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(i) DETAILED DESCRIPTION OF THE INVENTION.
(j) CLAIM OR CLAIMS (commencing on a separate sheet).
(k) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(l) SEQUENCE LISTING (See MPEP § 2424 and 37 CFR 1.821-1.825).
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(b) above and 37 CFR 1.77(c). Revisions should particularly include and/or address: a) section headings (b-i), where applicable; and b) bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests identifying: a) the solid dispersion comprising 1-{(6-[(1-methyl)-4-pyrazolyl]-imidazo[1,2-a]pyridine)-3-sulfonyl}-6-[(1-methyl)-4-pyrazolyl]-1-hydro-pyrazolo[4,3-b]pyridine (compound A); and b) a particular utility for the solid dispersion comprising 1-{(6-[(1-methyl)-4-pyrazolyl]-imidazo[1,2-a]pyridine)-3-sulfonyl}-6-[(1-methyl)-4-pyrazolyl]-1-hydro-pyrazolo[4,3-b]pyridine (compound A).
The following title is suggested: SOLID DISPERSION COMPRISING 1-{(6-[(1-METHYL)-4-PYRAZOLYL]-IMIDAZO[1,2-a]PYRIDINE)-3-SULFONYL}-6-[(1-METHYL)-4-PYRAZOLYL]-1-HYDRO-PYRAZOLO[4,3-b]PYRIDINE (COMPOUND A) AS A C-MET INHIBITOR.
Appropriate correction is required.
Specification Objection - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, e.g., The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics. Exemplification of a species could be illustrative of members of the class. For processes, the reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating the structure of 1-{(6-[(1-methyl)-4-pyrazolyl]-imidazo[1,2-a]pyridine)-3-sulfonyl}-6-[(1-methyl)-4-pyrazolyl]-1-hydro-pyrazolo[4,3-b]pyridine (compound A) into the abstract, to overcome this objection.
Claim Objections
Claim 1 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A solid dispersion comprising:
(a) a pharmaceutically acceptable polymer matrix, wherein the pharmaceutically acceptable polymer matrix comprises (i) at least one enteric high molecular weight polymer selected from the group consisting of cellulose acetate phthalate, cellulose acetate succinate, hydroxypropyl methylcellulose acetate succinate (HPMCAS), hydroxypropyl methylcellulose phthalate (HPMCP), polymethacrylate, and polyvinyl acetate phthalate (PVAP), or a combination thereof; and (ii) at least one non-enteric high molecular weight polymer selected from the group consisting of copovidone (N-vinylpyrrolidone/vinyl acetate copolymer, PVP/VA), 2-hydroxy-b-cyclodextrin (HPBCD), hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), polyvinyl alcohol, a polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, and povidone (polyvinylpyrrolidone, PVP), or a combination thereof; and
(b) 1-{(6-[(1-methyl)-4-pyrazolyl]-imidazo[1,2-a]pyridine)-3-sulfonyl}-6-[(1-methyl)-4-pyrazolyl]-1-hydro-pyrazolo[4,3-b]pyridine (compound A) of the following formula:
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compound A;
wherein the weight ratio of compound A to the pharmaceutically acceptable polymer matrix in the solid dispersion is in a range of from 1:3 to 1:35.
Appropriate correction is required. See MPEP § 2173.02.
Claim 2 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The solid dispersion of claim 1, wherein:
(i) at least one enteric high molecular weight polymer is selected from the group consisting of cellulose acetate phthalate, cellulose acetate succinate, hydroxypropyl methylcellulose acetate succinate (HPMCAS), hydroxypropyl methylcellulose phthalate (HPMCP), and polyvinyl acetate phthalate (PVAP), or a combination thereof; or
(ii) at least one non-enteric high molecular weight polymer is selected from the group consisting of copovidone, hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), polyvinyl alcohol, a polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, and povidone, or a combination thereof; or
(iii) the weight ratio of the enteric high molecular weight polymer to the non-enteric high molecular weight polymer is in a range of from 2:1 to 10:1.
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The solid dispersion of claim 1, wherein:
(i) at least one enteric high molecular weight polymer is selected from the group consisting of hydroxypropyl methylcellulose acetate succinate (HPMCAS) and hydroxypropyl methylcellulose phthalate (HPMCP), or a combination thereof; or
(ii) at least one non-enteric high molecular weight polymer is selected from the group consisting of copovidone, hydroxypropyl methylcellulose (HPMC), polyvinyl alcohol, and povidone, or a combination thereof; or
(iii) the weight ratio of the enteric high molecular weight polymer to the non-enteric high molecular weight polymer is in a range of from 2:1 to 6:1; or
(iv) the weight ratio of compound A to the pharmaceutically acceptable polymer matrix is in a range of from 1:4 to 1:25; or
(v) optionally, the solid dispersion further comprises at least one selected from the group consisting of a flow aid, a plasticizer, and a surfactant, or a combination thereof,
or a combination thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation(s):
4. The solid dispersion of claim 3, wherein:
(i) the weight ratio of compound A to the enteric high molecular weight polymer is in a range of from 1:2 to 1:15; or
(ii) the weight ratio of compound A to the non-enteric high molecular weight polymer is in a range of from 2:1 to 1:10; or
(iii) the solid dispersion further comprises at least one flow aid selected from the group consisting of animal fat, colloidal silica, plant fat, and wax, or a combination thereof; or
(iv) the weight ratio of at least one flow aid to compound A is in a range of from 1:1 to 1:100; or
(v) the solid dispersion further comprises at least one plasticizer selected from the group consisting of acetyl tributyl citrate, acetyl triethyl citrate, benzyl benzoate, trichlorobutyl alcohol, dextrin, dibutyl phthalate, diethyl phthalate, dimethyl phthalate, glycerol, glyceride monostearate, polyoxyl-40-stearate, mannitol, mineral oil, lanolin alcohol, palmitic acid, polyethylene glycol, polyethylene glycol monostearate, polyvinyl alcohol acetate phthalate, propylene glycol, 2-pyrrolidone, sorbitol, stearic acid, triacetin, tributyl citrate, triethanolamine, and triethyl citrate, or a combination thereof; or
(vi) the weight ratio of at least one plasticizer to compound A is in a range of from 1:1 to 1:20; or
(vii) the solid dispersion further comprises at least one surfactant selected from the group consisting an anionic surfactant, a cationic surfactant, and a non-ionic surfactant, or a combination thereof; or
(viii) the weight ratio of at least one surfactant to compound A is in a range of from 1:1 to 1:10.
19. The solid dispersion of claim 4, wherein at least one anionic surfactant is selected from the group consisting of sodium dodecyl sulfate and docusate sodium, or a combination thereof.
20. The solid dispersion of claim 4, wherein at least one cationic surfactant is selected from the group consisting of cetrimide, benzethonium chloride, cetylpyridinium chloride, and lauric acid, or a combination thereof.
21. The solid dispersion of claim 4, wherein at least one non-ionic surfactant is selected from the group consisting of polyoxyethylene alkyl ether, polyoxyethylene sorbitan fatty acid ester, a polyoxyethylene castor oil derivative, polyoxyethylene polyoxypropylene ether block copolymer, and polyoxyethylene stearate, or a combination thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The solid dispersion of claim 1, wherein the solid dispersion further comprises less than or equal to 4.8 wt% or less than or equal to 6.0 wt% of phthalic acid.
Appropriate correction is required. See MPEP § 2173.02.
Claim 12 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The solid dispersion of claim 3, wherein the weight ratio of compound A to the pharmaceutically acceptable polymer matrix is in a range of from 1:5 to 1:15.
Appropriate correction is required. See MPEP § 2173.02.
Claim 13 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The solid dispersion of claim 4, wherein:
(i) the weight ratio of compound A to the enteric high molecular weight polymer is in a range of from 1:3 to 1:10; or
(ii) the weight ratio of compound A to the non-enteric high molecular weight polymer is in a range of from 2:1 to 1:5.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claims 1 and 8 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the phrase, enteric high molecular polymer, in claim 1, is a relative phrase which renders the claim indefinite. The phrase, enteric high molecular polymer, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification, on page 3, defines the phrase, enteric high molecular polymer as hydroxypropyl methylcellulose phthalate (HPMCP), hydroxypropyl methylcellulose acetate succinate (HPMCAS), polymethacrylate, polyvinyl acetate phthalate (PVAP), cellulose acetate phthalate, and cellulose acetate succinate; however, the claim fails to explicitly limit the invention to any specifically disclosed or recited embodiments. Consequently, the solid dispersion comprising 1-{(6-[(1-methyl)-4-pyrazolyl]-imidazo[1,2-a]pyridine)-3-sulfonyl}-6-[(1-methyl)-4-pyrazolyl]-1-hydro-pyrazolo[4,3-b]pyridine (compound A) has been rendered indefinite by the use of the phrase, enteric high molecular polymer.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claims 1 and 8 are further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the phrase, non-enteric high molecular polymer, in claim 1, is a relative phrase which renders the claim indefinite. The phrase, non-enteric high molecular polymer, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification, on page 3, defines the phrase, non-enteric high molecular polymer as polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (Soluplus), copovidone (i.e. N-vinylpyrrolidone/vinyl acetate copolymer, PVP/VA), povidone (i.e. polyvinylpyrrolidone, PVP), polyvinyl alcohol, 2-hydroxy-ß-cyclodextrin (HPBCD), hydroxypropyl methylcellulose (HPMC), and hydroxypropyl cellulose (HPC); however, the claim fails to explicitly limit the invention to any specifically disclosed or recited embodiments. Consequently, the solid dispersion comprising 1-{(6-[(1-methyl)-4-pyrazolyl]-imidazo[1,2-a]pyridine)-3-sulfonyl}-6-[(1-methyl)-4-pyrazolyl]-1-hydro-pyrazolo[4,3-b]pyridine (compound A) has been rendered indefinite by the use of the phrase, non-enteric high molecular polymer.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 2 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 2 recites the broad limitation, or, and the claim also recites and, which is the narrower statement of the limitation.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claims 4 and 13 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 4 recites the broad limitations, (1) anionic surfactant; (2) cationic surfactant; and (3) non-ionic surfactant, respectively, and the claim also recites (1) sodium dodecyl sulfate and docusate sodium; (2) cetrimide, benzethonium chloride, cetylpyridinium chloride, and lauric acid; and (3) polyoxyethylene alkyl ether, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene castor oil derivative, polyoxyethylene polyoxypropylene ether block copolymer, and polyoxyethylene stearate, respectively, which are the narrower statements of the limitations.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Next, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 12 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 12 recites the limitation, The solid dispersion of claim 3, characterized in that the weight ratio of the compound A to the medicinal polymer matrix is 1:5-1:15, in lines 1-2 of the claim. There is insufficient antecedent basis, in claim 3, for this limitation, with respect to the solid dispersion comprising 1-{(6-[(1-methyl)-4-pyrazolyl]-imidazo[1,2-a]pyridine)-3-sulfonyl}-6-[(1-methyl)-4-pyrazolyl]-1-hydro-pyrazolo[4,3-b]pyridine (compound A). According to claim 3, a medicinal matrix polymer is not recited, with respect to the solid dispersion comprising 1-{(6-[(1-methyl)-4-pyrazolyl]-imidazo[1,2-a]-pyridine)-3-sulfonyl}-6-[(1-methyl)-4-pyrazolyl]-1-hydro-pyrazolo[4,3-b]pyridine (compound A).
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim Rejections - 35 U.S.C. § 112(d)
The following is a quotation of the fourth paragraph of 35 U.S.C. § 112:
(d) REFERENCE IN DEPENDENT FORMS. Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The inventor or joint inventor should note that claim 8 recites the limitation, The solid dispersion of claim 1, wherein… the content of phthalic acid is ≤ 6.0 wt% or ≤ 4.8 wt%, in lines 1-3 of the claim. According to claim 1, phthalic acid is not recited, with respect to the solid dispersion comprising 1-{(6-[(1-methyl)-4-pyrazolyl]-imidazo[1,2-a]pyridine)-3-sulfonyl}-6-[(1-methyl)-4-pyrazolyl]-1-hydro-pyrazolo[4,3-b]pyridine (compound A). Consequently, since The solid dispersion of claim 1, wherein… the content of phthalic acid is ≤ 6.0 wt% or ≤ 4.8 wt%, fails to specify a further limitation to the solid dispersion comprising 1-{(6-[(1-methyl)-4-pyrazolyl]-imidazo[1,2-a]pyridine)-3-sulfonyl}-6-[(1-methyl)-4-pyrazolyl]-1-hydro-pyrazolo[4,3-b]pyridine (compound A), as recited in claim 1, and/or fails to include all the limitations of the solid dispersion comprising 1-{(6-[(1-methyl)-4-pyrazolyl]-imidazo[1,2-a]pyridine)-3-sulfonyl}-6-[(1-methyl)-4-pyrazolyl]-1-hydro-pyrazolo[4,3-b]pyridine (compound A), as recited in claim 1, the instant dependent claim is rendered improperly dependent under 35 U.S.C. § 112(d).
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, particularly as stated in the section above entitled Claim Objections, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
Prosecution Insights