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
Priority
The instant application is a national stage entry of PCT/IB2022/057208 filed on 8/3/2022 and claims benefit of foreign applications IN202141035170 filed on 8/4/2021 and IN202141053853 filed on 11/23/2021. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). However, it is noted that a certified copy of IN202141035170 has not been submitted.
Status of Claims
Claims 1-12 and 16-26 are pending.
Election/Restrictions
Applicants’ election of the following species: 1) Omega 3 ethyl ester for different forms of omega 3 fatty acid, 2) cannabidiol for different additional therapeutically active ingredients, and 3) lung disorders for different conditions, in the reply filed on 5/14/2026 is acknowledged. The election was made with traverse. The traversal is made on the ground that all the entities under species election 1 to 3 are a part of a single invention.
Upon reconsideration, the species election requirements for 1) different forms of omega 3 fatty acids and 3) different conditions are hereby withdrawn.
As to the species election for 2) different additional therapeutically active ingredients recited in claim 6, when a single claim defines alternatives of a Markush group, the requirement of a technical interrelationship and the same or corresponding special technical features as defined in Rule 13.2 is considered met when the alternatives are of a similar nature. However, the additional therapeutically active ingredients have different chemical structures (no common chemical structure shared by the species) and no common biological activities, thus the alternatives of additional therapeutically active ingredients are not regarded as being of similar nature as stated in the restriction requirement mailed on 1/15/2026. As such, the requirement of a technical interrelationship and the same or corresponding special technical features as defined in Rule 13.2, is not considered met. As such, the restriction requirement for different additional therapeutically active ingredients is still deemed proper, and is therefore made final.
Accordingly, claims 19-20 and 23-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 1-12, 16-18, 21-22, and 25-26 are under examination in the instant office action.
Duplicate Claims, Warning
Applicant is advised that should claim 5 be found allowable, claim 26 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
Claim Objections
Claims 6 and 17 are objected to because of the following informalities: typographical errors.
In claim 6, it is noted that --a combination--before “thereof” in line 4 appears to be missing.
In claim 17, the word, “and” should be inserted before “inflammatory conditions” in line 3.
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 6, 12, and 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 pre-AIA the applicant regards as the invention.
The claims recite “selected from the group comprising” in line 2.
Claims that set forth a list of closed alternatives from which a selection is to be made are typically referred to as Markush claims, after the appellant in Ex parte Markush, 1925 Dec. Comm’r Pat. 126, 127 (1924) for example see MPEP 2173.05(h) (most common language is “selected from the group consisting of”)
However, if a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claims are indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022)
This rejection might be overcome by amending “selected from the group comprising” to “selected from the group consisting of”, provided there is support in the disclosure for such an amendment.
Claim 12 is 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.
Claim 12 recites “interstitial lung disease (ILD) including sarcoidosis, idiopathic pulmonary fibrosis”. It is unclear whether the limitations following “including” is part of the claimed invention or not. For examination purpose, the feature introduced by "including” is considered as not being required.
Claims 16-17 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 pre-AIA the applicant regards as the invention.
The claims 16-17 recite “The formulation of claim 6 is administered to patients….”. The claims 16-17 are dependent from claim 6 which is drawn to a composition of matter statutory class. However, they also recite a step of administering the composition to patients. The claim thus, in addition to being directed to the composition of matter statutory class, also appears to be drawn to the process statutory class as it requires an active method step of administering.
Accordingly, the metes and bounds of the instant claims are unclear because it is not clear whether Applicants are claiming composition of matters or methods of using. See MPEP 2173.05 (p) II: “A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph”. Appropriate correction is required.
For the examination purpose, the claims are interpreted as if they recite “The formulation of claim 6 in use for patients…”.
Claims 18 and 21 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. All the dependent claims are included.
Claim 18 recites “A formulation comprising a therapeutically effective dose of phospholipid in which the phospholipid delivers docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), or eicosapentaenoic acid (EPA) or any combination of two or all three of DHA, DPA, and EPA”. It is unclear whether it is intended to recite: 1) “A formulation comprising a therapeutically effective dose of docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), or eicosapentaenoic acid (EPA) which is present as a form of phospholipid of DHA, DPA or EPA; or 2) the phospholipid is used as a separate carrier or excipient to deliver DHA, DHA or DPA as recited in the instant claim 4. Clarification is required.
For the examination purpose, the first interpretation will be used.
Claims 22 and 25 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. All the dependent claims are included.
Claim 22 recites “A formulation comprising a therapeutically effective dose of glycerolipid in which the glycerolipid delivers docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), or eicosapentaenoic acid (EPA) or any combination of two or all three of DHA, DPA, and EPA”. It is unclear whether it is intended to recite: 1) “A formulation comprising a therapeutically effective dose of docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), or eicosapentaenoic acid (EPA) which is present as a form of glycerolipid of DHA, DPA or EPA; or 2) the glycerolipid is used as a separate carrier or excipient to deliver DHA, DHA or DPA. Clarification is required.
For the examination purpose, the first interpretation will be used.
Claim Rejections - 35 USC § 102
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 1-5, 7-12, 22, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 90/08543 (hereafter, GEORGIEFF).
GEORGIEFF teaches an emulsion for endotracheal application comprising omega 3-fatty acids, in particular EPA, or their physiologically acceptable esters in their pure form, or as components of fish oils and/or fish oil fractions; and at least one physiologically acceptable emulsifier such as phospholipids (abstract and claims 1 and 5).
GEORGIEFF further teaches that lower alkyl esters or glycerol esters of ω-3 fatty acids, in particular EPA, are physiologically and pharmacologically harmless and the ethyl esters and triacylglycerols (glycerolipid of EPA) are preferred (p5, para 2-3).
GEORGIEFF also teaches that for patients who are already ventilated, it is possible to apply ω-3 fatty acid esters directly or using a nebulizer into the tube and in non-ventilated patients, the active ingredient can be administered as an aerosol (inhalation spray) (p6, para 3). GEORGIEFF further teaches that metered-dose aerosols of this type are filled in accordance with generally known technology with the emulsions and the propellant gases / propellant gas mixtures which are usually used (p6, para 3).
GEORGIEFF specifically discloses emulsions comprising ethyl eicosapentaenate (EPA) and purified egg phospholipids (Examples 1-2) and an emulsion comprising highly purified fish oil and purified soy phospholipids (Example 3).
In addition, GEORGIEFF teaches the emulsion for endotracheal use in chronic obstructive pulmonary diseases, asthma and chronic bronchitis (claim 12).
As to claims 7-11, the instant claims are directed to a composition, thus intended uses recited in the claims 7-11 do not have a patentable weight. An intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963).
In this case, GEORGIEFF teach the same formulation comprising the same active ingredient (i.e., omega 3-fatty acid such as EPA) in a therapeutically effective dose for administering by inhalation in the treatment of lung disease as the instant invention, thus it would be capable of performing the intended use as claimed. In accordance with the patent statutes, an article or composition of matter, in order to patentable, must not only be useful and involve invention, but must also be new. If there is no novelty in an article or composition itself, then a patent cannot be properly granted on the article or composition, regardless of the use for which it is.
As such, the instant claims are anticipated by GEORGIEFF.
Claims 1-5, 7-12, 18, 22, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5731346 (hereafter, EGBERG) as evidenced by US 2018/0000732.
EGBERG teaches an omega-3-fatty acid containing preparations in the form of emulsions, or aerosols for inhalation, wherein said omega3-fatty acid is selected from the group consisting EPA, DHA, salt thereof, derivative thereof and mixtures thereof (abstract and claims 3 and 5).
EGBERG further teaches that the preparation contains the omega 3-fatty acids as salts of glycerol ester (glycerolipid), ethyl esters, or phospholipids (col 5, lines 18-26) and the omega 3-fatty acids may come from marine oils, vegetable oils rich in omega 3-fatty acids or from phospholipids containing omega 3-fatty acids (col 4, lines 61-63).
EGBERG further teaches aerosols can be effective, both in a conventional form and in a form where the omega 3-fatty acids are comprised in eventually bilayer forming phospholipids (liposomes) and different nasal preparations and the aerosols are intended to be administered by inhalation to the lungs (col 5, lines 27-34).
EGBERG specifically disclose an emulsion comprising fish oil and egg yolk phospholipid wherein the fish oil comprises docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and eicosapentaenoic acid (EPA) (col 8, Example 1). The emulsion comprises 200 g fish oils (20%), wherein the fish oil has the following fatty acid content in %: 13.5% DHA, 2.9% DPA and 17.8% EPA (col 8, Example 1). The fish oil extract comprises EPA and DHA in esterified form, e.g. in form of triglycerides or ethyl esters as evidenced by US 2018/0000732 ([0034] and [0036]).
As to claims 7-12, the instant claims are directed to a composition, thus intended uses recited in the claims 7-12 do not have a patentable weight. An intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). In this case, EGBERG teach the same formulation comprising the same active ingredient (i.e., DHA, DPA, or EPA or a combination thereof) in a therapeutically effective dose for administering by inhalation to the lungs as the instant invention, thus it would be capable of performing the intended use as claimed. In accordance with the patent statutes, an article or composition of matter, in order to patentable, must not only be useful and involve invention, but must also be new. If there is no novelty in an article or composition itself, then a patent cannot be properly granted on the article or composition, regardless of the use for which it is.
As such, the instant claims are anticipated by EGBERG.
Claims 1-3, 6-12, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2017/0136076 (hereafter, SOMAN).
SOMAN teaches compositions for smoking and vaporization (inhalation) comprising herbal extracts and essential oils useful in the treatment of various symptoms and diseases (abstract and [0005] and claim 1).
SOMAN specifically disclose a formulation for smoking and vaporization (inhalation) for use in the treatment for neuron regeneration and increasing hippocampus by antioxidants and anti-inflammatory activity (CNS disorder), wherein the formulation comprises CBD and one or more fixed oils with minimum omega 3 fatty acids (EPA) 10 to 65% of total formulation ([0078] and claim 13). The fixed oil includes flax seed oil, soyabean oil, seasame oil, or castor oil ([0028]).
As to claims 7-12 and 16-17, the instant claims are directed to a composition, thus intended uses recited in the claims 7-12 and 16-17 do not have a patentable weight. An intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). In this case, SOMAN teach the same formulation comprising the same active ingredients (CBD and EPA) in a therapeutically effective dose for administering by inhalation as the instant invention, thus it would be capable of performing the intended use as claimed. In accordance with the patent statutes, an article or composition of matter, in order to patentable, must not only be useful and involve invention, but must also be new. If there is no novelty in an article or composition itself, then a patent cannot be properly granted on the article or composition, regardless of the use for which it is.
As such, the instant claims are anticipated by SOMAN.
Claims 1-4, 6-12, 16-18, 21-22, and 25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20210362074 (hereafter, FAROKHI).
FAROKHI teaches a composition comprising a cannabis extract comprising at least one cannabinoid and a lipid solvent, the lipid solvent comprising one or more of omega-3 fatty acids, monacylglycerides (MAG), diaglycerides (DAG) and phospholipids (claim 1), wherein the omega-3 fatty acids comprise alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or a combination thereof (abstract, [0128], [0133], and claims 1- 3, 11, and 12-13).
FAROKHI teaches the omega-3 fatty acids are present as omega-3 monacylglycerides, omega-3 diaglycerides (glycerolipid), omega-3 phospholipids or a combination thereof ([0119] and claim 2).
FAROKHI further teaches the cannabinoid comprises THC, THCA, CBD, CBDA or a combination thereof (claim 13) and the at least one cannabinoid comprises a combination of THC and CBD ([0110]).
FAROKHI also teaches that the compositions may be formulated for inhalation and can be formulated as vapors or aerosols that can be inhaled into the lungs ([0149]).
As to claims 7-12 and 16-17, the instant claims are directed to a composition, thus intended uses recited in the claims 7-12 and 16-17 do not have a patentable weight. An intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). In this case, FAROKHI teach the same formulation comprising the same active ingredient for administering by inhalation to the lungs as the instant invention, thus it would be capable of performing the intended use as claimed. In accordance with the patent statutes, an article or composition of matter, in order to patentable, must not only be useful and involve invention, but must also be new. If there is no novelty in an article or composition itself, then a patent cannot be properly granted on the article or composition, regardless of the use for which it is.
Double Patenting Rejections
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3, 5-12, 16-17, 22, and 25-26 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, 6-8, 10, 13-15, and 20-24 of co-pending application 19/107655.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘655 application are drawn to a parenteral emulsion formulation, comprising an oil phase comprising cannabidiol (CBD) and an omega 3 component selected from omega 3 fatty acids, omega 3 fatty acid ethyl esters and omega 3 triglycerides, an aqueous phase, and excipients. The omega 3 components refer to DHA, DPA, and EPA as evidenced by the specification of ‘655 application (p5, lines15-30). While the claims of ‘655 application are silent about the formulation being suitable for inhalation or nebulization and intended uses recited in claims 7-12 and 16-17, the formulation of ‘655 application comprises the same components in the same dosage form (emulsion) as claimed, thus the composition of ‘655 application is necessarily suitable for inhalation as claimed and would be capable of performing the intended use as claimed in the absence of evidence to the contrary. Also, the instant claims are directed to a composition, thus such intended uses do not have a patentable weight. An intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). In accordance with the patent statutes, an article or composition of matter, in order to patentable, must not only be useful and involve invention, but must also be new. If there is no novelty in an article or composition itself, then a patent cannot be properly granted on the article or composition, regardless of the use for which it is.
As such, the instant claims are anticipated by the claims of ‘655 application.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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