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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 5/01/2026 has been entered.
Non-Final Rejection
The Status of Claims:
Claims 21-37 are pending.
Claims 21-37 are rejected.
DETAILED ACTION
1. Claims 21-37 are under consideration in this Office Action.
Priority
2. It is noted that this application is a 371 of PCT/EP2021/000078 07/08/2021 which has a foreign priority document, EPO EP20000248.3 07/09/2020.
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Drawings
3. The drawings filed on 1/09/2023 are accepted by the examiner.
IDS
The IDS filed on 5/01/2026 were reviewed by the examiner.
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 21-29, 31, 33, and 35-37 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 pre-AIA the applicant regards as the invention.
In claim 21, the phrase “a method of treatment comprising the administration of an effective dose of 5-amino-2,3-dihydro-1,4-phthalazinedione or one of its pharmaceutically acceptable salts as a glucocorticoid sparing agent in pharmaceutical combination with a glucocorticoid in conditions or diseases treated with glucocorticoids to a patient in needa glucocorticoid-sparing agent” is recited.
This expression can be vague and indefinite because the claims do not elaborate what kinds of conditions or diseases can be treated by using an effective dose of 5-amino-2,3-dihydro-1,4-phthalazinedione or one of its pharmaceutically acceptable salts. The examiner recommends to put the specific conditions or diseasesin the claim 21.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
5. Claims 21-37 are rejected under 35 U.S.C. 103 as being unpatentable over Abidov (RU 2132188).
Determination of the scope and content of the prior art
Abidov discloses the method for treating hypothyroidism in patients
with thyroiditis, which includes the administration of drugs, "Galavit" is used as the drug, which is administered intramuscularly 1-3 times a day in a course of 10-35 injections in two stages, and in the first stage, for 3-7 days, injections are carried out daily, and in the second stage, for 10-45 days, injections are carried out with breaks of 1-3 days after each daily administration of the drug, while the drug is administered in a single dose of 25-1000 mg in 1-10 ml of water for injection; furthermore, it is t is additionally administered napmsin or rheopyrin in combination with prednisolone (see page 1, claims).
It teaches the treatment of endocrine diseases, particularly those accompanied by impaired immune status (page 3, left column, paragraph 1 ). It describes that conventional treatments for hypothyroidism in thyroiditis, an autoimmune lesion of the thyroid gland, include the administration of drugs such as Napsilon or Reopirin, and glucocorticoids such as prednisolone, and that this method requires long-term treatment lasting up to 4 to 6 months (page 3, left column, paragraphs 2 to 4). On the other hand, it describes that in the treatment of hypothyroidism, when the immunomodulator Galavit (i.e., 5-amino-2,3-clihydro-1,4-phthalazinedione sodium salt) is used in combination with conventional medicines, the treatment period until complete recovery is shortened by 1 to 2.5 months compared to other known methods (page 3, left column, paragraphs 5 to 7, right column). Column 2, specifically, the examples describe the use of Naprosyn or Reopirin, and prednisolone in combination with Galavit to treat patients with thyroiditis (Examples 1 and 2).
In addition, it describes the administration of glucocorticoids such as prednisolone as a conventional treatment for hypothyroidism in thyroiditis. Therefore, the hypothyroidism corresponds to the "condition usually treated with glucocorticoids" in claim 1 of the present application, and this condition corresponds to the "autoimmune disorder". Furthermore, in view of the statements in paragraphs [0013] and [0025] of the specification, etc., the "glucocorticoid-sparing agent" in claim 1 can be interpreted as an agent for reducing the required dose of glucocorticoid. As mentioned above, since it describes that when Galavit is used in combination with conventional pharmaceuticals, the treatment period until full recovery is shortened by 1 to 2.5 months compared to other known methods, it is recognized that the total dose of glucocorticoid required throughout the entire treatment period is also reduced. Therefore, the prior art is equivalent to describing the "glucocorticoid-sparing agent" of claim 1. Furthermore, in view of the statements in paragraphs [0112] and others of the specification of the present application, it is highly likely that the prior art reduces or avoids the undesirable glucocorticoid effects". The combined use of Galavit and prednisolone corresponds to the "pharmaceutical combination" and "administration as an add-on".
The current invention, however, differs from the prior art in that the reduction of the glucocorticoid dose to 80% or 20 % of an original glucocorticoid dose are unspecified in the prior art.
Ascertainment of the difference between the prior art and the claims
The difference between the instant application and the applied Abidov art is that the Abidov does not expressly teach the reduction of the glucocorticoid dose to 80% or 20 % of an original glucocorticoid dose.
Resolving the level of ordinary skill in the pertinent art.
Regarding the Claimd 35-37, with respect to the lack of disclosing the claimed the reduction of the glucocorticoid dose to 80% or 20 % of an original glucocorticoid, the Abidov is silent about it. However, the limitation with respect to the reduction of the glucocorticoid dose in the range of a percentage is not a patentable weight over the prior art. A simple experimentation by a skilled artisan in the art can be carried out in order to verify the benefit of using 5-amino-2,3-dihydro-1,4-phthalazinedione compound as a glucocorticoid sparing agent.
So, it would have been obvious to the skilled artisan in the art to be motivated to perform an experiment to estimate how much the reduction of the glucocorticoid dose takes place by a routine experimentation. This is within the purview of the skilled artisan in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Abidov expressly teaches that conventional treatments for hypothyroidism in thyroiditis, an autoimmune lesion of the thyroid gland, include the administration of drugs such as Napsilon or Reopirin, and glucocorticoids such as prednisolone, and that this method requires long-term treatment lasting up to 4 to 6 months. However, it describes that in the treatment of hypothyroidism, when the immunomodulator Galavit (i.e., 5-amino-2,3-clihydro-1,4-phthalazinedione sodium salt) is used in combination with conventional medicines, the treatment period until complete recovery is shortened by 1 to 2.5 months compared to other known methods.
Although the prior art does not describe the reduction of the glucocorticoid dose to 80% or 20 % of an original glucocorticoid dose, a simple experimentation by a skilled artisan in the art can be carried out in order to verify the benefit of using 5-amino-2,3-dihydro-1,4-phthalazinedione compound as a glucocorticoid sparing agent.
So, if the skilled artisan in the art had desired to find out how much the reduction of the glucocorticoid dose could take place, it would have been obvious to the skilled artisan in the art to be motivated to perform such an experiment in a routine way. This is within the purview of the skilled artisan in the art to do that.
Conclusion
Claims 21-37 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 5/16/2026
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