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 .
Status of the Claims
Claims 1-27 are pending.
Claims 4-6 and 15-19 are withdrawn.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/EP2021/000071, filed 6/09/2021; and further claims priority to FOR application numbers EP20000366.3 and EP20000212.9, filed 10/08/2020 and 06/10/2020, respectively.
Information Disclosure Statement
All references from IDS(s) received on 07/07/2023 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 08/18/2025 is acknowledged.
Claims 5-6 and 15-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) for being a non-elected composition, combination, and method of use.
Applicant’s election without traverse of SARS-CoV-2 in the reply filed on 08/18/2025 is acknowledged.
Applicant withdrew claim 4.
Claims 1-3, 7-14, and 20-27 will be examined upon their merits. See 102 analysis below.
Claim Interpretation
Claims 1, 7-14, and 20-27 contain intended use language. The claims recite a “use” but fails to recite further steps involved in the process. This would be considered intended use language. When a product claim has intended use language, the use is given no weight. See MPEP 2173.05(q).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claims 7-14, and 20-27 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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 claims recite a “use” but fails to recite further steps involved in the process. This would be considered intended use language. See MPEP 2173.05(q). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the invention:
The invention is drawn to a sodium salt form of 5-amino-2,3-dihydro-1,4-phthalazinedione and its 3 crystalline anhydrate polymorph forms.
Breadth of the claims:
The claim is broadly directed to various polymorph forms of 5-amino-2,3-dihydro-1,4-phthalazinedione where the form used an be any or more than one of the three. The varying forms are listed below.
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Level of ordinary skill in the art/ State of the prior art and predictability in the art:
The artisans using applicant’s method would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience.
The range of values varies from those taught in the art (see WO2017140430A1, US20170368063A1 and US20230053455A1 as examples). The polymorph forms taught in the art include a synthetic explanation, along with data evidence, to support its polymorph form. The instant application does not provide details of how the polymorph is formed (how its crystallized, purified, etc.) or any data to support the theta and d-values claimed.
The amount of direction provided and working examples:
The only direction or guidance present in the instant specification is the disclosure of where the salt of the compound was obtained from. There are no working examples of how to achieve the polymorph forms claimed in the instant application.
See MPEP 2164.02 (“Compliance with the enablement requirement of 35 USC 112, first paragraph, does not turn on whether an example is disclosed ... Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.”).
Quantity of experimentation needed to use the invention based on the content of the disclosure:
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine through undue experimentation how to prepare the polymorph in a way that is different from the prior art that would lead to these different d-values.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.
Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 7-14, and 20-27 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Martin, T. et al. (WO2017140430A1; cited in the IDS filed 7/7/2023; “Martin”).
Martin teaches a crystalline polymorph form of 5-amino-2,3-dihydrophthalazine-1,4-dione (Claim 1), as well as its sodium salt (Page 2, Lines 25-26) for use in use in the prophylaxis or treatment of an inflammatory or respiratory disease (Claim 13), as required by instant claims 1-2. Martin teaches the pharmaceutical formulations for oral administration can be capsules or tablets, sugar-coated tablets or pills; powders or granulates; juices, syrups, drops, teas, solutions or suspensions in aqueous or non-aqueous liquids; edible foams or mousses; or in oil-in-water or water-in-oil in lotions (Page 9, Lines 24-27), as required by instant claims 7 and 20.
Martin also teaches pharmaceutical formulations of the compounds for use according to the invention can be administered by any suitable way, e.g. orally (incl. buccally and sublingually), rectally, vaginally, nasally, inhalatory, respiratory, alveolary, topically (incl. buccally, sublingually, conjunctivally or transdermally), or parenterally (incl. intraperitoneally, subcutaneously, intramuscularly, intravenously, intraarterially or intradermally) (Page 7, Last para.), as required by instant claims 7-8, 11-12, 20-21, and 24-25.
Finally, Martin teaches the aerosols can be delivered to the patient through a nebulizer that uses oxygen, compressed air or ultrasonic power to produce aerosol droplets from a medical solution or suspension and direct them to a mouthpiece used by the patient for inhalation (Page 22, First para.), as required by instant claims 9 and 22.
With respect to claims 10, 13-14, 23, and 26-27, the claims recite a “use” but fails to recite further steps involved in the process. This would be considered intended use language. Claiming an intended use does not further limit the claim. Therefore, these claims are rejected as being anticipated by Martin because they do not further limit the previous claims.
Therefore, claims 1-2, 7-14, and 20-27 are anticipated by Martin.
Conclusion
Claims 1-3, 7-14, and 20-27 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clint Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621