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 .
Election/Restrictions
Applicant’s election of the method of claims 20-44 in the reply filed on 04/23/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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.
Claim 22-23, 26 and 40 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 Claims 22-23 and 26, Claim limitations “device for supplying the eluent”, “device for discharging the extract”,” device for supplying the substance mixture” and “device for discharging the raffinate” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function of (supplying the eluent, discharging the extract, supplying the substance mixture and discharging the raffinate) in the claims 22-23 and 26 Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Regarding Claims 23, the term “large” in claim 23 is a relative term which renders the claim indefinite. The term “large” 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 variable “flow” in the claim has been rendered indefinite by the use of relative term “large”.
Regarding Claims 40, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 40 recites the broad recitation “at least one pre-resolving mediator”, and the claim also recites “preferably 18-HEPE, 17-HDHA and/or 14-HDHA” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 40 recites the broad recitation “at least one specialized pre-resolving mediator”, and the claim also recites “preferably lipoxins, resolvins, protectins and/or maresins” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 20-21, 29-31 and 35-39 are rejected under 35 USC § 102(a)(1) and/or 102(a)(2) as being anticipated by Kelliher et al. (US-20140107359-A1) herein known as Kelliher.
PNG
media_image1.png
406
507
media_image1.png
Greyscale
(Fig. 3, Kelliher)
Regarding Claim 20, Kelliher is directed to an improved chromatographic separation process for purifying polyunsaturated fatty acids (PUFAs) and derivatives thereof. In particular an improved chromatographic separation process which allows a reduced amount of eluent to be used ([0001]).
Kelliher discloses a method for separating a first substance from a substance mixture by chromatography, wherein the substance mixture comprises the first substance (substance C as shown in Fig. 3, EPA as shown in Table1), at least one second substance (substance B as shown in Fig. 3, DHA as shown in Table 1) and at least one third substance (substance A, as shown in Fig. 3, SDA as shown in Table1), the method comprising the steps of: subjecting the second substance to a longer retention (DHA retention time ( Table1) =8.3 minutes) than the first substance (EPA retention time ( Table1) =7.4 minutes) during chromatography; subjecting the least one third substance which is subject to a shorter retention (SDA retention time ( Table1) =6.7) minutes) than the first substance (EPA) during chromatography; feeding the substance mixture F(A+B+C) and an eluent to an apparatus for chromatography comprising a plurality of interconnected chromatography columns ( plurality of linked chromatography column); withdrawing the second substance (B) as an extract and the first substance (C) as a raffinate; and withdrawing the third substance (A) as an extract (Abstract; [0092],[0192] , [0292]- [0293]; Fig. 3; Table 1).
Regarding Claim 21, Kelliher discloses the method including withdrawing the third substance (A) and the second substance (B) jointly (A+B) as an extract (Fig.3 ; [0192]).
Regarding Claim 29, Kelliher discloses the method wherein the substance mixture is or comprises a fatty acid mixture (polyunsaturated fatty acid (PUFA)) and/or a carboxylic acid mixture and/or a mixture of pre-resolving mediators and/or of specialized pre-resolving mediators (Abstract; [0020]; [0035]- [0037], [0049]- [0056], [0062]).
Regarding Claim 30, Kelliher discloses the method wherein the fatty acid mixture is a mixture of unsaturated fatty acids (polyunsaturated fatty acid (PUFA) (Abstract; [0020], [0035]- [0037], [0049]- [0056], [0062]).
Regarding Claim 31, Kelliher discloses the method wherein the fatty acid mixture is a mixture of polyunsaturated fatty acids (Abstract; [0020], [0035]- [0037], [0049]- [0056], [0062]).
Regarding Claim 35, Kelliher discloses the method wherein the first substance is a polyunsaturated fatty acid or cannabidiol or tetrahydrocannabinol (Abstract, [0001], [0041]- [0045]).
Regarding Claim 36, Kelliher discloses the method wherein the first substance is eicosapentaenoic acid and/or docosahexaenoic acid ([0037], [0292]).
Regarding Claim 37, Kelliher discloses the method wherein a) the third substance is stearidonic acid and/or the second substance is arachidonic acid and/or docosahexaenoic acid, b) the third substance is stearidonic acid and/or eicosapentaenoic acid and/or the second substance is arachidonic acid, or c) the third substance is tetrahydrocannabinol, CBGA and/or CBG and/or the second substance is CBDVA, THCV and/or CBDV ([0037], [0292]).
Regarding Claim 38, Kelliher discloses the method wherein the first substance is a metabolite of a polyunsaturated fatty acid (e.g. omega-3 or omega-6 PUFA) or has the same composition as the metabolite ([0037], [0053]- [0056]).
Regarding Claim 39, Kelliher discloses the method wherein the first substance is a metabolite of eicosapentaenoic acid and/or docosahexaenoic acid (DHA) and/or docosapentaenoic acid ([0037], [0292]).
Claims 20, 22-26, 29 and 32 are rejected under 35 USC § 102(a)(1) and/or 102(a)(2) as being anticipated by Erfurt et al. (US-20190144414-A1) herein known as Erfurt.
PNG
media_image2.png
720
454
media_image2.png
Greyscale
(Fig 2. Erfurt)
Regarding Claim 20, Erfurt is related to methods for purifying one or two cannabinoid compounds using simulated moving bed chromatography, wherein the cannabinoid compound(s) is/are obtained in the extract and/or the raffinate with the total amount of isomeric impurities being below detection level [0001] . Erfurt also discloses the method provides one or two desired cannabinoid products with an unexpectedly high degree of purity while still allowing the process to be implemented on an economically relevant scale [0041].
Erfurt discloses a method for separating a first substance from a substance mixture by chromatography (simulated moving bed chromatography), wherein the substance mixture comprises the first substance (dronabinol), at least one second substance (Δ9(11)-tetrahydrocannabinol) and at least one third substance (olivetol) ((Abstract), [0001], [0128], [0139], [0039], [0044), the method comprising the steps of: subjecting the second substance (Δ9(11)-tetrahydrocannabinol to a longer retention 15.6 min) than the first substance (dronabinol 14.8 min) during chromatography; subjecting the least one third substance (olivetol 2.8 min)) which is subject to a shorter retention than the first substance (dronabinol 14.8 min) ) during chromatography ([0128], [0133]); feeding the substance mixture and an eluent to an apparatus for chromatography comprising a plurality of interconnected chromatography columns; withdrawing the second substance (Δ9(11)-tetrahydrocannabinol) as an extract and the first substance (dronabinol) as a raffinate([0001], [0039], [0053]- [0054], [0058], [0139]; Fig. 2) and withdrawing the third substance (olivetol) as an extract ( [0139], [0141], the obtained reduced raffinate is extracted twice with cyclohexane).
Regarding Claim 22, Erfurt discloses the method including forming zones in the chromatography columns, the zones including a) a first zone formed between a device for supplying the eluent and a device for discharging the extract, b) a second zone formed between the device for discharging the extract and a device for supplying the substance mixture, c) a third zone formed between the device for supplying the substance mixture and a device for discharging the raffinate, and d) a fourth zone formed between the device for discharging the raffinate and the device for supplying the eluent ( [0039]- [0040], [0133]; Fig. 2]).
Regarding Claim 23, Erfurt discloses the method including adjusting substance flows via the supply and/or discharge devices so that in the fourth zone between the device for discharging the raffinate and the device for supplying the eluent, there is such a large flow that the third substance is removed as an extract ([0039] -[0040], [0053]-[0054] , [0058], [0104] ,[0133]; Fig. 2]).
Regarding Claim 24, Erfurt discloses the method wherein a content of the first substance in the raffinate is greater than a content of the first substance in the substance mixture ([0039] , [0053]- [0054] ,[0058], [0104]).
Regarding Claim 25, Erfurt discloses the method wherein a content of the second and/or the third substance in the extract is greater than a content of the second or the third substance in the substance mixture ([0053]- [0054], [0058] , [0104]).
Regarding Claim 26, Erfurt discloses the method wherein the device for supplying the eluent, the device for discharging the extract, the device for supplying the substance mixture and the device for discharging the raffinate comprise a plurality of supply and discharge connections between different chromatography columns, the method including adjusting respective substance flows through the supply and discharge connections so that the zones are formed alternately in different chromatography columns ([0039]-[0040], [0046], [0133], Fig. 2]).
Regarding Claim 29, Erfurt discloses the method according wherein the substance mixture is or comprises a fatty acid mixture and/or a carboxylic acid mixture and/or a mixture of pre-resolving mediators and/or of specialized pre-resolving mediators (Abstract, (purification of cannabidiol, trans-(−)-delta-9-tetrahydrocannabinol, cannabidivarin, trans-(−)-delta-9-tetrahydrocannabivarin and cannabigerol)).
Regarding Claim 32, Erfurt discloses the method wherein the carboxylic acid mixture is a mixture of cannabinoids (Abstract, [0030], [0001], [0030], [0044]).
Claims 20, 29, 33-34 and 40-44 are rejected under 35 USC § 102(a)(1) and/or 102(a)(2) as being anticipated by Bannenberg et al. (US 20150126602 A1) herein known as Bannenberg.
PNG
media_image3.png
471
332
media_image3.png
Greyscale
(Fig. 3B, Bannenberg)
Regarding Claims 20, Bannenberg is directed to the invention relates generally to the fields of natural products, inflammation, pathology, and medicine. More particularly, the invention relates to Specialized Proresolving Mediators (SPMs) and SPM precursora obtained from natural sources and their use in nutritional supplements and pharmaceutical and cosmetic formulations for ameliorating inflammation and diseases having an inflammatory component [0002].
Bannenberg discloses a method for separating a first substance from a substance mixture by chromatography, wherein the substance mixture comprises the first substance (17S-HDHA), at least one second substance (4S-HDHA) and at least one third substance (4R-HDHA), the method comprising the steps of: subjecting the second substance to a longer retention (4S-HDHA) than the first substance (17S-HDHA), during chromatography; subjecting the least one third substance (4R-HDHA), which is subject to a shorter retention than the first substance (17S-HDHA), during chromatography; feeding the substance mixture and an eluent to an apparatus for chromatography comprising a plurality of interconnected chromatography columns; withdrawing the second substance as an extract and the first substance as a raffinate; and withdrawing the third substance as an extract (Abstract; [0021], [0027], [0114], [0127], [0159], [0164]; Fig 3B).
Regarding Claims 29, Bannenberg discloses the method wherein the substance mixture is or comprises a fatty acid mixture and/or a carboxylic acid mixture and/or a mixture of pre-resolving mediators and/or of specialized pre-resolving mediators (Abstract; [0002], [0005], [0007], [0020], [0027]).
Bannenberg discloses the method wherein the mixture of pre-resolving mediators includes 18-HEPE, 17-HDHA and/or 14-HDHA ((Abstract, [0007], [0162], [0164]).
Regarding Claims 34, Bannenberg discloses the method wherein the mixture of specialized pre-resolving mediators includes lipoxins, resolvins, protectins and/or maresins ( (Abstract, [0001]- [0002] , [0005]- [0008]).
Regarding Claims 40, Bannenberg discloses the method including withdrawing at least one pre-resolving mediator, preferably 18-HEPE, 17-HDHA and/or 14-HDHA, and/or at least one specialized pre-resolving mediator, preferably lipoxins, resolvins, protectins and/or maresins, is withdrawn from the substance mixture (Abstract, [0001]- [0002] , [0005]- [0008], [0162], [0164]).
Regarding Claims 41, Bannenberg discloses the method including withdrawing 18-HDPE, 17-HDHA and/or 14-HDHA from the substance mixture ((Abstract, [0007], [0162], [0164]).
Regarding Claims 42, Bannenberg discloses the method including withdrawing lipoxins, resolvins, protectins and/or maresins from the substance mixture (Abstract, [0001]- [0002], [0005]- [0008]).
Regarding Claims 43, Bannenberg discloses the method wherein the first substance is a pre-resolving mediator and/or a specialized pre-resolving mediator (Abstract, [0001]- [0002] , [0005]- [0008], [0162], [0164]),
Regarding Claims 44, Bannenberg discloses the method wherein a) the third substance is a pre-resolving mediator and/or a specialized pre-resolving mediator and/or the second substance is arachidonic acid and/or docosahexaenoic acid, b) the third substance is a pre-resolving mediator and/or a specialized pre-resolving mediator and/or the second substance is eicosapentaenoic acid and/or arachidonic acid or c) the third substance is a pre-resolving mediator and/or a specialized pre-resolving mediator and/or the second substance is docosapentaenoic acid (Abstract, [0001]- [0002] , [0005]- [0008], [0037], [0292], [0162], [0164]).
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 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Kelliher et al. (US-20140107359-A1) herein known as Kelliher, as applied to the claims above, in view of Murakado et al. (WO9720608A1, Machine Translation) herein known as Murakado.
Regarding Claims 27-28, Kelliher teaches all the limitations in the claims as set forth above.
However, Kelliher is silent to the method including determining a substance property of the raffinate and/or of the extract using at least one sensor, and adjusting flows of the substance mixture, of the eluent, of the raffinate and/or of the extract in the apparatus as a function of a result of the determination of the substance property (Claim 27), the method wherein the substance property is a content of an ingredient (Claim 28).
Murakado is directed to a pseudo-moving bed separation apparatus, and more specifically,
to a pseudo-moving bed separation apparatus that can detect the entire concentration distribution formed in a pseudo-moving bed in real time, or a pseudo-moving bed separation apparatus that can grasp the operating status of the pseudo-moving bed separation apparatus in real time, and moreover produces no defective products, has low sample loss and high recovery efficiency, and can separate each component from a mixture containing multiple components with high productivity, or more precisely, to a pseudo-moving bed separation apparatus that can grasp the operating conditions in real time, or more precisely, every cycle or every step, in particular the pattern change of concentration (or purity, in some cases) per cycle or the pattern change of concentration (or purity, in some cases) per step, and based on the data on these pattern changes, can change the temperature, the flow rate of
each pump, the step dim, etc., to continuously separate and manufacture products with stable concentrations. [0002].
Murakado discloses the pseudo-mobile bed type separation device can accurately monitor the concentration in each zone of a pseudo-mobile bed, can be operated with operations as simple as those of a liquid chromatography apparatus, can reduce the number of defective products, minimize sample loss, and perform component separation with high recovery rates and good productivity, and can be operated easily and accurately without requiring skill and intuition to operate the device. pseudo-moving bed type separation apparatus with an integrated automatic control system that can monitor the concentration pattern (purity pattern) of each zone in real time, even under high-pressure operating conditions, allowing for easy understanding of the operating status and enabling stable quality operation over long periods of time ([0016]- [0017]).
Murakado discloses the method including determining a substance property (concentration or purity) of the raffinate and/or of the extract using at least one sensor (concentration detectors), and adjusting flows of the substance mixture, of the eluent, of the raffinate and/or of the extract in the apparatus as a function of a result of the determination of the substance property (Claim 27), the method wherein the substance property is a content of an ingredient (concentration or purity) (Claim 28) ([0002], [0022], [0025] -[0027], [0065]- [0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Kelliher ‘s method for separating a first substance from a substance mixture by chromatography wherein the method including determining a substance property (concentration or purity) of the raffinate and/or of the extract using at least one sensor (concentration detectors), and adjusting flows of the substance mixture, of the eluent, of the raffinate and/or of the extract in the apparatus as a function of a result of the determination of the substance property (Claim 27), the method wherein the substance property is a content of an ingredient (concentration or purity) (Claim 28), as taught by Murakado , in order to accurately monitor the concentration in each zone and reduce the number of defective products, minimize sample loss, and perform component separation with high recovery rates and good productivity, and the chromatography can be operated easily and accurately without requiring skill and intuition to operate the device, also the integrated automatic control system that can monitor the concentration pattern (purity pattern) of each zone in real time, even under high-pressure operating conditions, allowing for easy understanding of the operating status and enabling stable quality operation over long periods of time ([0016]- [0017]) (See Murakado , [0016]- [0017]), yielding nothing more than predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHMOUD MOTAZ ABDEL LATIF whose telephone number is (571)272-6535. The examiner can normally be reached Monday-Friday 8:30-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin L Lebron can be reached at 571-272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MAHMOUD MOTAZ ABDEL LATIF/Examiner, Art Unit 1773
/BENJAMIN L LEBRON/Supervisory Patent Examiner, Art Unit 1773
Prosecution Insights