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
Claims 18-34 are pending in the instant application. Claims 1-17 are cancelled, claim 18 is amended and claims 19-34 are new via the amendment filed February 16th, 2026.
Priority
This is a divisional of Application No. 17/614,751, filed November 29th, 2021, which is a 35 U.S.C. 371 National Stage filing of International Application No. PCT/NO2020/050141 filed May 29th, 2020, which claims priority under 35 U.S.C. 119(a-d) to NO20190689, filed May 31st, 2019. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d).
Information Disclosure Statement (IDS)
The Information Disclosure Statement filed September 15th, 2025 was considered by the Examiner.
Response to Restriction/Election Requirement
Applicant’s election with traverse of group II, drawn to a method of treatment, the disease of skin and endothelia disease and the elongase system, ELOVL3 and ELOVL4, in the reply filed on February 16th, 2026 is acknowledged. The transversal is on the grounds that species A-B have unity under 37 CFR 1.475(b)(3) and share a common special technical feature that makes a contribution over the art. This is not found persuasive in view of the art below.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species is not allowable. Therefore, according to MPEP 803.02:
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability.
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.
If on examination the elected species is found to be anticipated or rendered obvious by prior art, the Markush claim and claims to the elected species will be rejected, and claims to the nonelected species will be held withdrawn from further consideration.
As the elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 18-34 have been examined to the extent that they are readable on the elected disease of skin and endothelia disease and the elected elongase system, ELOVL3 and ELOVL4. Since the elected species is not allowable, subject matter not embraced by the elected embodiment is therefore withdrawn from further consideration.
Claim Objections
Claims 21-34 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot dependent from any other multiple dependent claims. See MPEP § 608.01(n).
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 25, 27 and 34 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.
Regarding claim 25, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 27, the phrases "such as" and “including” render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 34, the term “substantially” is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claim recites that the VLFAs of the composition are substantially of the all-cis-form. It is unclear to what degree of the VLFAs are of the all-cis-form and to what degree the VLFAs are not on the all-cis-form.
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.
Claim(s) 18-29 and 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al (US 2012/0071558 A1, published March 22nd, 2012, as cited on the IDS) in view of Saadeh et al (WO 2017/100246 A1, published June 17th, 2017). Always reference the effective dates (filing date for WO)
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Anderson teaches a pharmaceutic composition comprising a lipid component having at least one very long chain polyunsaturated fatty acid (VLC-PUFA) having a chain length of at least 28 carbons. Anderson teaches that the long chain poly unsaturated fatty acids include omega-3 and omega-6 fatty acids (paragraph [0022]). Anderson further teaches that the very long chain polyunsaturated fatty acid content is most preferably at least 96% (paragraph [0048]). Also, Anderson teaches that the very long chain fatty acids are isolated from plants or animals (paragraph [0021]) and that lipids suitable for use in the composition are marine oils (paragraph [0085]).
Anderson teaches that the pharmaceutical composition is for the treatment of a skin disorder (abstract). Anderson further teaches that the ELOVL4 protein is involved in the elongation of VLCFAs that are normally incorporated into sphingolipids and ceramides that are necessary for skin barrier permeability (paragraph [0114]). This supports earlier findings in which ELOVL4 knockout results in neonatal lethality due to defects in skin barrier permeability in ELOVL4 knockout mice, while the heterozygote animals show reduction in levels of very long chain Saturated fatty acids, ceramides and sphingolipids. From these findings we concluded that in the skin, ELOVL4 is responsible for synthesis of very long chain saturated fatty acids that are incorporated into ceramides and sphingolipids to protect the skin from dehydration (paragraph [0114]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Anderson does not explicitly teach that the VLCFAs are taken up by specific body tissues of the subject. Anderson also does not explicitly teach that there are also very long chain monounsaturated fatty acids in the composition for treating skin disorders.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
In regards to the limitation that the VLCFAs are taken up by one or more specific body tissues where the VLCFAs play a role in the disease, Anderson teaches that routes of administration of the pharmaceutical or nutritional composition include, but are not limited to, subcutaneous, intradermal, intravenous, intramuscular and intraperitoneal routes (paragraph [0099]), while the preferred administration is orally (paragraph [0074]). Anderson also teaches that there is a carrier present in the composition that acts as a vehicle for delivering the composition to a suitable in vivo sit of action (paragraph [0099]). The instant specification describes that the administration route for the instantly claimed composition includes orally, intravenously, intramuscularly and subcutaneously (page 44). As the modes of administration are the same in the prior art as recited in the specification, the limitation is an inherent feature of the mode of administration taught by the prior art.
In regards to the limitation of the inclusion of very long chain monounsaturated fatty acids, Saadeh teaches that nervonic treats skin disorders in a composition with polyunsaturated fatty acids. Saadeh teaches a method of administering nervonic acid for the treatment of rosacea and psoriasis (claims 11, 16 and 20). Nervonic acid is of the formula CH3(CH2)7CH=CH(CH2)13COOH, making it a fatty acid with 24 carbons and one double bond, a very long chain monounsaturated fatty acid.
As such it would have been prima facie obvious to someone of ordinary skill in the art to modify the composition for treating a skin disorder as taught by Anderson to include a very long chain monounsaturated fatty acid in the nutritional or pharmaceutical composition as Saaadeh teaches that nervonic acid is treats skin disorders, including psoriasis. As both the composition taught by Anderson and nervonic acid, as taught by Saadeh are known to treat skin disorder, there would be a reasonable expectation that their combined use would also effectively treat macular degeneration. MPEP 2144.06 recites:
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine)”.
Regarding the limitation of “providing a positive health effect” as recited in instant claim 18, the prior art teaches utility in treating and preventing the condition corresponding to a positive health effect.
Regarding claims 19-20, Anderson teaches that ELOVL4 is necessary for fatty acid elongations (paragraph [0109]) and that absence of very long chain polyunsaturated fatty acids causes skin disorders.
Regarding claim 21, Anderson teaches that the nutritional or pharmaceutical composition includes carriers. Anderson further teaches that carrier refers to any substance suitable as a vehicle for delivering a molecule or composition to a suitable in Vivo site of action (paragraph [0099]).
Regarding claim 22, as seen above, Anderson teaches that macular degeneration is associated with a deficiency in the ELVOL4 elongase system.
Regarding claim 23, as seen above, Anderson teaches the method of treatment for skin disorders, which is relevant to the skin.
Regarding claim 24, Anderson also teaches that the composition is for treating age related maculopathy (abstract).
Regarding claim 25-26, as seen above, the method that Anderson teaches is for the treatment of skin disorders, which includes an increase in VLCFAs (paragraph [0113]) and prevention of a skin disorder (paragraph [0074]).
Regarding claim 27, Anderson teaches that the composition is for the treatment of skin disorders and Saadeh teaches that the composition for the treatment of skin disorders, including psoriasis.
Regarding claim 28, that the very long chain polyunsaturated fatty acids are with 6 or more double bonds (paragraph [0016]).
Regarding claim 29, teaches that the very long chain polyunsaturated fatty acids used in the nutritional or pharmaceutical composition include C28: 7n3 and C28: 8n3 (paragraph [0024]).
Regarding claim 31, Anderson teaches that the nutritional or pharmaceutical composition can be used in combination with DHA (paragraph [0070]).
Regarding claim 32, Anderson teaches that the very long chain polyunsaturated fatty acid composition comprises at least 10% (paragraph [0048]).
Regarding claim 33, Anderson teaches that the very long chain polyunsaturated fatty acid containing oil is produced from an algae (paragraph [067]).
Regarding claim 34, Anderson teaches that the double bounds of the very long chain polyunsaturated fatty acids are of the cis configuration (paragraph [0016]).
Claims 18-34 rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al (US 2012/0071558 A1, published March 22nd, 2012,as cited on the IDS) in view of Saadeh et al (WO 2017/100246 A1, published June 17th, 2017), as applied to claims 18-29 and 31-34 above and in further view of Anderson et al (US 2017/0014365 A1, published January 19th, 2017, as cited on the IDS). Effective dates missing.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Neither Anderson (US 2012/0071558 A1) nor Saadeh teach that the composition for the treatment of skin disorders further comprises very long chain saturated fatty acids. However, as seen in the 103 rejection above, Anderson (US 2012/0071558 A1) teaches a fatty acid mixture with omega-3 and omega-6 VLCPUFA isolated from a marine animal or plant for the treatment of skin disorder and Saadeh teaches a VLCMUFA for the treatment of skin disorders.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02
The prior art does not teach that a composition for the treatment of skin disorders that comprises very long chain saturated fatty acids.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Anderson (US 2017/0014365 A1) teaches a method of treating a condition caused by a mutation in the Elongation of Very Long chain fatty acids-4 (ELOVL4) elongase in a subject in need of such therapy, the method comprising administering to the subject an effective amount of a fatty acid composition comprising at least one purified very long chain Saturated fatty acid (VLC-SFA) monoglyceride comprising a VLC-SFA conjugated to a glycerol molecule, wherein the VLC-SFA has a chain length in a range of from 28 carbons to 40 carbons (claim 4). Anderson (US 2017/0014365 A1) further teaches that mutations in the ELOVL4 lead to issues in the skin (paragraph [0046]). Further, Anderson (US 2017/0014365 A1) teaches that the VLC-SFA formulations can be used in the treatment of a skin disorder.
As such it would have been prima facie obvious to someone of ordinary skill in the art to modify the method made obvious over the teachings of Anderson (US 2012/0071558 A1) and Saadeh to have the composition further comprise very long chain saturated fatty acids and would have a reasonably expectation of success as all components are known in the art to treat skin disorders. MPEP 2144.06 states:
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine)”.
Conclusion
No claims allowed
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699