DETAILED ACTION
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 Claims/Application
The preliminary amendment dated 11/13/2024 is acknowledged. Claims 3 – 9 and 11 – 15 are amended. Claim 10 has been canceled.
Claims 1 – 9 and 11 – 15 are currently pending and are examined on the merits herein.
Priority
Applicant's claim for the benefit of a prior-filed application under 35 U.S.C. 119(e)
or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The instant application is
a National Stage Application of PCT/ HU2022/000012, filed on 08/18/2022, and claims priority to Republic of Hungary Application No. HUP2100299, filed on 08/19/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted in the instant application on 05/08/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered 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 2 – 5 and 11 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.
Claims 2 and 3 recite the limitation "The pharmaceutical combination according to claim 1" in the claim preamble. There is insufficient antecedent basis for this limitation in the claims as claim 1 recites “A medicinal combination”. For examining purposes, “pharmaceutical combination” is being interpreted as the medicinal combination of claim 1.
Claims 4 and 5 recite the limitation "A therapeutic combination according to claim 1" in the claim preamble. There is insufficient antecedent basis for this limitation in the claims as claim 1 recites “A medicinal combination”. For examining purposes, “therapeutic combination” is being interpreted as the medicinal combination of claim 1.
Claim 11 recites the limitation "a therapeutic combination according to claim 1" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examining purposes, “therapeutic combination” is being interpreted as the medicinal combination of claim 1.
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.
Claim 2 is 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. Claim 2 recites “The pharmaceutical combination according to claim 1, characterised in that the combination comprises diosmin, folic acid and vitamin B6.” MPEP 2111.03 states “ The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004)”. Hence, claim 2 is not further limiting the medicinal combination of claim 1. 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 § 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, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tecosmina, 1-15 TecnoPharma Italia, (2019-06-25) (IDS 05/08/2025).
Tecosmina teaches a formulation with the following active ingredients, flavonoids (diosmin and hesperidin), folic acid, vitamin B12, and vitamin B6.
Regarding instant claims 1 and 11, the limitation “for the treatment of chronic venous insufficiency”, it is noted that the prior art does not teach the composition can be used in the manner instantly claimed. However, the cited recitations are considered as an “intended use” of the claimed combination or composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since the composition would be capable of performing the intended use. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 9 and 11 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/016408 (IDS 05/08/2025) in view of WO 2003/080062 (IDS 05/08/2025) and CH 704204 (Published on 06/15/2012) (PTO-892).
WO’408 teaches a pharmaceutical composition in the form of a chewable tablet containing a high dose of micronized diosmin. Said pharmaceutical composition comprises micronized diosmin amounting to 20% to 80% of the total weight of the pharmaceutical composition. The pharmaceutical composition is used in the treatment of venous insufficiency and hemorrhoidal crises (Abstract). WO’408 teaches that the amount of diosmin or flavone fraction in the pharmaceutical composition is between 1000 mg and 3000 mg, including 2000 mg, 1500 mg, 2500 mg. WO’408 teaches the use of the pharmaceutical compositions in the treatment of venous disease, more particularly venous insufficiency such as heavy legs, pain, impatiences of primo-decubitus, capillary fragility and the treatment of haemoroid attack. These pharmaceutical compositions are used as venotonics and vasculoprotective agents. WO’408 exemplifies a pharmaceutical composition containing 1000 mg of diosmin.
The teachings of WO’408 differ from the instantly claimed invention in that WO’408 does not teach a medicinal combination or a pharmaceutical composition containing folic acid and vitamin B6.
WO’062 teaches a compound for use in sclerotherapy treatment, venous insufficiency, circulation and microcirculation disorders (pg. 1, lines 4 – 5). WO’062 teaches that the compound consists of folic acid (vitamin B9), pyridoxine (vitamin B6), lipoic acid, and six different plant extracts: Ginkgo Biloba, Andrographis, Garlic (allium sativum), Centella Asiatica (Gotu Kola), Grape seeds and Horse Chestnut (pg. 3, lines 23 – 26). WO’062 teaches that folic acid (vitamin B9) and pyridoxine (vitamin B6) have anti-thrombotic properties (pg. 4, lines 3 – 4). WO’062 teaches that the compound is able to pharmacologically lower elevated homocysteine serum levels, through the action of folic acid (vitamin B9) and pyridoxine (vitamin B6) (pg. 5, lines 10 – 13).
CH’204 teaches vitamin B compositions for the therapeutic or prophylactic
reduction of homocysteine levels in blood, in particular for the treatment of vascular
diseases, and to a pharmaceutical composition comprising folic acid, pyridoxine and cobalamin [0001]. CH’204 teaches a composition comprising (i) 0.5 to 10 mg folic acid
(Vitamin B9), (ii) 0.01 to 10 mg cobalamin (Vitamin B12), and (iii) 3 to 50 mg, preferably pyridoxine (Vitamin B6) for the therapeutic or prophylactic reduction of the concentration of homocysteine in blood [0010]. CH’204 teaches that due to the pronounced reduction in the concentration of homocysteine levels in the blood,
the compositions are particularly suitable for the therapeutic or prophylactic treatment of vascular diseases, wherein the vascular diseases are particularly preferably selected from the group consisting of cardiovascular and cerebrovascular diseases, atherosclerosis, arterial and venous thromboses, arterial occlusions, endothelial
dysfunctions (damage to the vessel wall), myocardial infarction, stroke, peripheral arterial occlusive diseases, cardiovascular complications after cardiac surgery and aortic aneurysms [0022].
It would have been obvious to combine WO’408 with WO’062 and CH’204 before the effective filing date of the claimed invention by including the composition comprising of folic acid and vitamin B6 as taught by WO’062 and CH’204 to the pharmaceutical composition of WO’408 for the treatment of chronic venous insufficiency to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to include folic acid and vitamin B6 to the pharmaceutical composition of WO’408 and have a reasonable expectation of success as WO’062 teaches the compound comprising of folic acid and vitamin B6 which have anti-thrombotic properties for use in venous insufficiency , and CH’204 teaches that the compositions comprising of folic acid and vitamin B6 cause pronounced reduction in the concentration of homocysteine levels in the blood, and are particularly suitable for the therapeutic or prophylactic treatment of vascular diseases.
Regarding claims 6 – 7 and 11 – 13 it would have been obvious to administer the medical combination or the pharmaceutical composition of WO’408 including the composition comprising of folic acid and vitamin B6 as taught by WO’062 and CH’204 for treating a patient with venous insufficiency. One of ordinary skill in the art would be motivated to administer the modified combination or pharmaceutical composition and would have a reasonable expectation of success as WO’408 teaches pharmaceutical compositions comprising of diosmin are used as venotonics and vasculoprotective agents, and WO’062 and CH’204 teach compositions comprising of folic acid and vitamin B6 cause pronounced reduction in the concentration of homocysteine levels in the blood, and are particularly suitable for the therapeutic or prophylactic treatment of vascular diseases.
Regarding claims 8, 9, 14, and 15 one of ordinary skill in the art would be motivated to use the composition of WO’408 modified by the teachings of WO’062 and CH’204 and would have a reasonable expectation of success as both WO’408 and WO’062 teach that the compositions help in the treatment of venous insufficiency, implying that the treatment of venous insufficiency happens irrespective of the serum homocysteine levels.
Conclusion
Claims 1 – 9 and 11 – 15 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANAKI ANANTH MAHADEVAN whose telephone number is (571)272-0230. The examiner can normally be reached Monday-Friday 8-5PM.
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/J.A.M./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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