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 .
DETAILED ACTION
Filing Receipt
The filing receipt mailed 01/23/2025 states that the instant application is a 371 of PCT/EP2023/000001, filed 01/05/2023. The filing receipt also states that the instant application claims foreign benefit of EPO 220000007.9, filed 01/07/2022.
Information Disclosure Statement
The information disclosure statement filed 07/05/2024 has been considered.
Claim Objections
Claim 14 states “The pharmaceutical composition according to claim 13 for oral application…”.
Claim 13 states “The pharmaceutical composition according to claim 11, wherein said pharmaceutical composition is suitable for intravenous, oral, sublingual…or dermal administration.” This is inconsistent with claim 14.
Additionally, several claims’ preambles are not consistent. For example, claims 4-6 state “The pharmaceutical combination as defined in claim 1 for use…”. Claims 7-9 then state “The pharmaceutical combination for use according to claim 6…”. Claim 10 then reverts back to “The pharmaceutical combination for use according to claim 6…”. There are no formal issues with this claim language. However, for consistency, examiner requests amendment.
Rejections
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 3, 11, and 15 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 3 recites the limitation "for use" in l. 1 of said claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite any “use” or even uses the word “use”.
Claim 11 states “The pharmaceutical composition containing…”. The claim is independent of any prior claim but uses dependent claim language. It is not clear which “pharmaceutical combination” claim 11 is referring to.
Claim 15 states “The pharmaceutical composition according to claim 11, wherein said at least one pharmaceutically acceptable excipient is selected from a group comprising carriers,…and flavoring substances.”
The claim invokes closed-group Markush language (“Is selected from…”) but uses open-ended Markush language (“Comprises”). It is not clear if applicant intends to uses closed-group claim language or open-ended group language. Therefore, the claim is indefinite.
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.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over MetrioPharm AG (EP 3248602, published 2017).
Claim 1 is drawn to a pharmaceutical combination consisting of budesonide and 5-amino-2,3-dihydro-1,4-phthalazinedione (luminol) or a pharmaceutically acceptable salt (of luminol).
Claim 2 specifies the sodium salt of luminol.
Claim 3 specifies crystalline anhydrate polymorph forms I-III of luminol.
Claims 4-10 are drawn to the same pharmaceutical combination of claim 1 and specify an intended use.
Claim 11 is drawn to a composition comprising budesonide, luminol, and at least one pharmaceutically acceptable excipient.
Claims 12-15 are drawn to the same composition of claim 11 and specify intended uses or forms of the composition of claim 11. Claim 12 specifies that the use is treatment of chronic inflammatory diseases. Claim 13 specifies that the composition is suitable for specific forms of administration. Claim 14 specifies that the composition is for oral administration and claims a listing of various oral administration forms. Claim 15 claims various possible excipients genera.
Claims 16-19, dependent upon claim 2 which specified the sodium salt of luminol, are drawn to intended uses (claims 16-18) and forms for administration (claim 19).
Regarding claim 1, MetrioPharm AG in para. [0092] contemplates the combination of luminol and steroidal anti-inflammatory drugs. MetrioPharm AG in para. [0093] contemplates possible steroidal anti-inflammatory drugs including “budesonide”.
Regarding claim 2, MetrioPharm AG in para. [0007] states “Sodium, potassium, and lithium salts have been described for therapeutic applications (cf. WO 2010/082858).
Regarding claim 3, MetrioPharm Ag in para. [0010]-[0012] describes Luminol sodium salt forms I-III, shown below.
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Regarding claim 11, MetrioPharm AG in para. [0058] teaches excipients which can be added to a composition.
Claims 4 and 16 only specify an intended use (glucocorticoid-sparing), which is not considered an inventive modification of the composition as the claim does not clearly indicate how the use leads to a structural modification. Essentially, claims 4 and 16 are drawn to a pharmaceutical combination that can be used for the purpose glucocorticoid-sparing.
Claims 6-9, 12, and 18 are drawn to the intended use of treatment of chronic inflammatory diseases. Claims 7-9 specify chronic inflammatory diseases.
Claims 5 and 17 are drawn to the intended use of “reducing or avoiding unwanted budesonide side effects.”
Similar to claims 4 and 16, claims 5-9, 12, and 17-18 are all drawn to intended uses which do not have patentable weight as they do not specify how the composition is further modified.
Regarding claims 13 and 19, MetrioPharm AG in para. [0111] contemplates oral, parenteral, intravenous, intramuscular, topical, transdermal, subcutaneous, intradermal, sublingual, rectal, and nasal administration.
Regarding claim 14, MetrioPharm AG in para. [0059] contemplates solid, liquid, and topical dosage forms. Tablets, pills, and capsules are contemplate and discussed in para. [0069]-[0070].
Regarding claim 15, MetrioPharm AG in para. [0058] contemplates excipients.
Regarding claim 10, combined administration is contemplated in MetrioPharm AG, para. [0112].
MetrioPharm AG does not explicitly disclose the combination of 5-amino-2,3-dihydro-1,4-phthalazinedione (luminol) or a sodium salt of 5-amino-2,3-dihydro-1,4-phthalazinedione with budesonide. However, one of ordinary skill in the art would find the instant claims obvious over the teachings of MetrioPharm AG which does at least contemplate the combination of luminol with budesonide. The additional teachings of MetrioPharm AG also make obvious the addition of an excipient for various dosage forms and administration and for chronic inflammatory conditions.
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to have arrived at the instant claims via the teachings of MetrioPham AG. One of ordinary skill in the art be motivated to make the combination of luminol, or the sodium salt of luminol, with budesonide as MetrioPharm AG contemplates the combination for treatment of inflammatory conditions.
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€ 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€ 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.
Co-pending application 18/004,806
Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21 and 29 of copending Application No. 18/004,806 (reference application) in view of Martin (US 10,258,620, published 2019) and Breu (US 9,079,863, published 2015). Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims contemplate the administration of the combination of 5-amino-2,3-dihydro-1,4-phtalazinedione, or a pharmaceutically acceptable salt, and a glucocorticoid sparing agent. Reference claim 29 includes budesonide as a glucocorticoid sparing agent. Breu ‘620 and Breu ‘863 teach the forms I-III.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner’s Comments
Luminol Sodium Salt forms I-III are disclosed in Martin (US 10,258,620, published 2019) and Breu (US 9,079,863, published 2015).
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
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