Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Current Status of 18/921,113
This Office Action is responsive to the original claims of 10/21/2024.
Claims 1-24 are examined on the merits.
Priority
This application is a continuation application of United States Serial No. 18/130,530, which is a continuation application of United States Serial No. 17/470,131, filed 09/09/2021, which is a continuation application of 16/839,178, filed 04/03/2020, which is a continuation application of United States Serial No. 16/266,305, filed 02/04/2019, which is a continuation application of United States Serial No. 15/821,242, filed 11/22/2017, which is a continuation of United States Serial No. 15/019,244, filed 2/9/2016, which is a continuation of United States Serial No. 13/733,031, filed 01/02/2013, which claims priory to British Patent Application No. 1200192.1, filed 1/6/2012.
There is also an abandoned application, 18/921,107.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/470,131, filed on 09/09/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/21/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 4 is objected to because of the following informalities: claim 4 is grammatically awkward. Between the last two options in Claim 4’s list, there is no “and” or “or” separating them. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In Claim 9, Claim limitation “means for” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no structure which completely dissolves the methotrexate (as required by the claim). Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 9 and its dependent claims (10-17) are rejected.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 1-5, 7-8, 18-22 and 24 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by AHMED (US 2005/0101605 A1).
AHMED teaches compositions of methotrexate for oral administration (Abstract “[t]he present invention relates to novel formulations of methotrexate [and salts thereof] in liquid form that are suitable for oral use”).
AHMED discloses the formulations are solutions (paragraph [0017] (“[e]xamples of liquid dosage forms include, but are not limited to, solutions, suspensions, emulsions, elixirs and/or aerosols”]).
AHMED teaches the pH of the oral liquid pharmaceutical composition can have a pH between 6.0 to about 8.0, adjusted with one more buffer agents (citric acid/sodium citrate of claim 4) ([0023]; FIG. 1; Tables 1-3).
AHMED teaches the composition of the invention can contain preservatives ([0024]; FIG. 1; Tables 1-3).
AHMED teaches the oral liquid pharmaceutical composition can be combined with various sweeteners or flavoring agents ([0030]; FIG. 1; Tables 1 and 3).
AHMED teaches the diluent is water, e.g., purified water ([0031]; FIG. 1; Tables 1-3).
This anticipates claims 1 and 18, since it does not comprise a polyol. This also discloses all the physical limitations of claim 9.
More specifically, AHMED teaches solutions comprising methotrexate disodium (paragraph [0027]), one or more buffers (citric acid/sodium citrate) to adjust the pH of the composition to pH 7.0, one or more preserving agents (methylparaben/propylparaben), one or more flavoring compounds and sweetening agents (saccharin, banana flavor), and purified water. This anticipates claims 2, 4, 7, 19, and 21. This also discloses methotrexate disodium of claim 10, citric acid of claim 12, the pH of claim 15, and water of claim 16.
AHMED (paragraph [0027]) shows methotrexate disodium is present in the composition at 1mg/mL. This anticipates claims 3 and 20 (5mg/5mL). This discloses 5mg/5mL of claim 11.
AHMED discloses .4mg/mL of anhydrous Citric Acid (table 3), which Examiner calculates to be 2 millimolar (0.4mg/mL[Wingdings font/0xE0] 400 mg/L of anhydrous Citric Acid. Divide by the molar mass of anhydrous Citric Acid which is 192.12 g/mol. 400/192.12 = 2 millimolar). This anticipates claims 5 and 22. This discloses the same for claim 13.
Claims 8, 17, and 24 are product-by-process claims. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I). Because claim 1 is anticipated, claim 8 is also anticipated.
Similarly, because claim 18 is anticipated, claim 24 is also anticipated.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claim 1-8 and 18-24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over AHMED (US 2005/0101605 A1) in view of ROWE (Rowe et al., “Handbook of Pharmaceutical Excipients”, Nalox-1 Pharmaceuticals, 2009)
AHMED teaches claims 1-5, 7-8, 18-22 and 24 above and teaches using preservatives such as Methylparaben (also known as methyl hydroxybenzoate from paragraph [0024]).
AHMED does not teach the sodium salt of methyl hydroxybenzoate (i.e. sodium methyl hydroxybenzoate of claims 6, 14, and 23).
ROWE teaches sodium methyl hydroxybenzoate can be used instead of methylparaben as a preservative and sodium methyl hydroxybenzoate has a greater aqueous solubility compared to methyl hydroxybenzoate (page 444).
An artisan would have been motivated to replace methyl hydroxybenzoate with sodium methyl hydroxybenzoate because of its greater aqueous solubility (ROWE page 444). The artisan would have expected sodium methyl hydroxybenzoate to behave the same as the replaced preservative, because both are known preservatives. This teaches claims 6, and 23. This also discloses the salt in claim 14.
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, 7, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12396947. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claim anticipates the instant claims.
Ref 1 claim is a methotrexate composition for oral administration consisting of methotrexate or a salt thereof (like the instant claims);
One or more buffer agents to adjust the pH of the composition, where the pH is 6 to 7 (like the instant claims);
One or more preserving agents (like the instant claims);
One or more agents selected from flavoring compounds and sweetening agents (like the instant claims); and purified water (like the instant claims),
Wherein the composition is a solution.
The ref claim does not include polyol. Therefore, instant claims 1, 7, and 18 are anticipated.
Claims 1-8 and 18-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11969503B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claim anticipates the instant claims.
Ref claim 1 discloses: A methotrexate composition for oral administration, said composition consisting of:
methotrexate or a salt thereof;
one or more buffer agents to adjust the pH of the composition, wherein the pH of the composition is 6 to 7;
one or more preserving agents;
one or more agents selected from flavoring compounds and sweetening agents; and purified water.
Ref claim 1 anticipates instant claims 1, 7, and 18.
Ref claims 2-3 anticipates instant claim 2 and 19.
Ref claim 4 anticipates instant claims 3 and 20.
Ref claim 14 anticipates instant claims 6 and 23.
Ref claim 9 anticipates instant claims 4 and 21.
Ref claim 13 anticipates instant claims 5 and 22.
Instant Claims 8, and 24 are product-by-process claims. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I). Because instant claim 1 is anticipated, instant claim 8 is also anticipated.
Similarly, because instant claim 18 is anticipated, instant claim 24 is also anticipated.
Conclusion
No claims are allowed currently.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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, Andrew Kosar can be reached at 571-272-0913. 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.
/G.A.H./Examiner, Art Unit 1625
/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
Prosecution Insights