Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The response filed 06 January 2026 has been received, entered and considered. The following information has been made of record in the instant amendment:
1. Claims 6-7, and 15 have been canceled. The said claims were canceled in a previous filing.
2. No new Claims have been added.
3. No Claims have been amended.
4. Remarks drawn to rejections under 35 USC 103.
Claims 1-5 and 8-14 are pending in the case. Claims 8-14 have been withdrawn from consideration as being drawn to non-elected invention. Claims 1-5 are under prosecution.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 1-5 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Reusher et al (US 2004/0109920 A1; cited in the IDS filed 12/07/2022; of record) in view of Choi et al (J Agric Food Chem, 2000, 48, 4156-4161; of record) and further in view of Dabbah et al (Applied Microbiology, 1970, 19(1), 27-31), Bunea et al (Alternative Medicine Review, 2004, vol. 9, number 4, pages 420-428; of record), Jones et al (Advances in Therapy, 2000, 17(5), pages 213-221; of record), Murray (Encyclopedia of Nutritional Supplements, Prima Publishing, 1996, pages 27-36; cited in the IDS filed 12/07/2022; of record), Rosenthal (Baylor University Medical Center Proceedings, 2000, 13(4), 351-355; cited in the IDS filed 12/07/2022; of record) and Fuhrman (US 6,515,018; cited in the IDS filed 12/07/2022; of record).
Reusher et al teaches a composition comprising a cyclodextrin-carotenoid complex (paras 0007 and 0044; part of the limitations of claim 1). The composition also includes water (see Examples1-3). This should hydrate the cyclodextrin (as in claim 1). The carotenoid can be astaxanthin, carotene, lutein, lycopene, zeaxanthin among others (para 0019; limitation of claim 4). Claim 1 of Reusher teaches that its formulation can contain one or more carotenoids. This suggests that a plurality of carotenoids can be included in the composition as in claim 1. The cyclodextrin is preferably selected from alpha, beta and gamma cyclodextrins (para 0011; part of the limitation of claim 1 and the limitations of claims 2-3). Reuscher teaches that the complex can be prepared in a suitable medium or solution of the coating composition, and the complexes may be used directly in the form of reaction mixture (para 0020, 0017). This tells the artisan that the liquid carotenoid containing composition can be used without any liquid or filtrate removed prior to encapsulation as in claim 1. Reuscher also teaches that the complex can be isolated and processed by grinding (para 0017). This would reduce particle size as in claim 1. Even though the use of vacuum is not suggested one of ordinary skill in the art will recognize that milling under vacuum will produce particle size reduction.
Reusher et al does not teach fish oil being krill oil and its percentage, and D-limonene (as in claim 1), and the ingredients recited in claim 5 as components in its composition.
Choi et al teaches that limonene has radical scavenging activity (page 4159, Fig. 2).
According to Dabbah, D-limonene has antimicrobial effect (page 28, Table 1; component recited in claim 1). In view of the teachings of Choi and Dabbah one of ordinary skill in the art will include D-limonene as a component in the composition of Reusher.
Bunea et al teaches that Krill oil caused a significant reduction of LDL and HDL and also significant reduction in triglycerides (page 423, left col. last para through page 425). It also reduced blood glucose levels (page 425, left col., middle; Krill oil as in claim 1). In view of this one of ordinary skill in the art will include krill oil in the composition of Reusher.
Jones et al teaches that softgels often provide clinical benefits over other solid oral dosage forms and represents an attractive alternative (Abstract; softgels as in claim 1). According to Jones the 300 participants in its survey strongly preferred clear softgels to the other dosage forms, which was easy to swallow (page 220-Discussion: first para under this title). This teaching of Jones would motivate one of ordinary skill in the art to make the composition as soft gelatin capsules as in claim 1.
Murray teaches that carotenoids like lycopene and carotenes have several beneficial properties like antioxidant activity, cancer prevention, prevention of cardiovascular disease, immunity enhancement, and treating photosensitivity disorders (components recited in claim 4). This is also a suggestion to include a plurality of carotenoids as in claim 1.
Rosenthal teaches that consuming fish oil has lipid-lowering effects (page 353, under sub-heading Fish-Oil; part of the limitation of claim 1). It is suggested that consuming 200-300g per week, of fish oil produces preventive benefit on coronary disease. 2 to 3g per day of a 30% concentrate is recommended for those who do not eat fish. According to Rosenthal fish oil capsules contain anywhere from 30% to 85% omega-3 fatty acids EPA and DHA (percentage range of fish oil as in claim 1). This is a suggestion to the artisan to include fish oil as a component in the composition of Reusher. Rosenthal teaches that most people have elevated cholesterol levels because of increased hepatic lipoprotein synthesis rather than hyperabsorption. Omega-3 fatty acids EPA and DHA lower VLDL and triglyceride concentrations by depressing synthesis of triglycerides in the liver. For this reason, the artisan would use fish oil, the fish oil being Krill oil, as a component as in the instant invention instead of vegetable oils taught by Reusher at para 0012. In view of Bunea et al the artisan would use Krill oil as in claim 1.
Furhman teaches a synergistic mixture containing lycopene and vitamin E and their ability to block the oxidation of LDL and/or atherosclerosis, and reduce cholesterol levels in plasma (col. 3, lines 49-52; col. 4, lines 15-19; components recited in claims 4 and 5). The composition can further contain other dietary components, additives, excipients, binding agents and coatings. The composition can be in the form of gelatin capsules (col. 7, claim 7 of Fuhrman). In view of this and the teaching of Jones the artisan would make softgel capsules as in claim 1.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to make the claimed composition based on the combined teachings of the prior art. The artisan would find it obvious to use all the other related ingredients recited in claims 4 and 5 in view of the combined teachings of the prior art.
One of ordinary skill in the art would be motivated to make the instant composition since carotenes have several beneficial properties (Murray) and cyclodextrin stabilizes carotenoids (Reusher). Fish oils including Krill oil have lipid-lowering effects and Fuhrman teaches that lycopene and vitamin E have synergistic effect on LDL oxidation. The combination of a carotenoid, cyclodextrin and additional nutritional agents like vitamin E would provide exceptional protective effects. D-limonene as a component would provide radical scavenging activity (aka-antioxidant activity) and antimicrobial activity.
One of ordinary skill in the art would be motivated to adjust the percentage of Krill oil in the composition (as in claim 1) in order to obtain a composition that provides optimal protective benefits for coronary diseases based on the teachings of Rosenthal and Bunea. The artisan would also find it obvious to use a combination of beta- and gamma cyclodextrins or combinations thereof since the use of both these cyclodextrins is taught by Reuscher as being useful for complexing carotenoids. The artisan would select one or both of the cyclodextrins depending on the size of the active ingredient being complexed and the degree of complexation desired. In view of the teachings of Fuhrman regarding Vitamin E, the artisan would also include other nutritional components as in claim 5 in the composition. Therefore, the claimed invention as a whole is prima facie obvious over the combined teachings of the prior art.
Response to Applicant’s Remarks
Applicant has traversed the rejection of claims 1-5 under 35 USC 103 of record arguing that there is no motivation to combine D-limonene to the present composition. Choi discusses limonene as a natural component of citrus oils and reports in vitro antioxidant properties, such as radical scavenging, while Dabbah discloses that limonene has antimicrobial effect. Neither reference teaches or suggests adding D-limonene to a hydrated carotenoid-cyclodextrin complex that is dispersed in 75-85% krill oil and encapsulated in a soft gelatin capsule where the complex is further vacuum milled and the composition is further processed without filtration. The Examiner’s rationale seems to be that because limonene is known to be an antioxidant, it would be obvious to add it to the composition. This is incorrect. Neither Choi nor Daballah provide any motivation, compatibility teaching, or expectation that limonene would function as intended in the claimed composition and dosage form. Limonene’s volatility and solvent-like properties can adversely affect soft gelatin capsules, which underscores the unpredictability of the Examiner’s proposed modification.
The Examiner cannot use a shopping list reconstruction that is based on Applicant’s own disclosure. It appears that the Examiner is using impermissible hindsight reconstruction in order to reach the claimed invention. Just because limonene is known to have antioxidant and antimicrobial properties is not sufficient motivation for the artisan to add it to the present composition. For the above reasons withdrawal of the rejection is requested (Remarks-pages 1-2).
Applicant’s arguments are not persuasive.
Regarding hindsight, indeed, "[a]ny judgement on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time of the effective filing date of the claimed invention and does not include knowledge gleaned only from applicant's disclosure, such a reconstruction is proper." In re McLaughlin 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). In the instant case, the Examiner pointed to specific disclosures in the prior art that give a reason or motivation to combine the ingredients as claimed, thereby overcoming any concern regarding hindsight bias. See Otsuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1292 (Fed. Cir. 2012).
Choi and Dabbah teach important properties of D-limonene, which provide motivation to include D-limonene as a component. Murray teaches that carotenoids have antioxidant properties. Choi et al teaches that limonene has radical scavenging activity (antioxidant) and Dabbah teaches that limonene has antimicrobial properties. Therefore, inclusion of D-limonene as a component in the composition would be beneficial in that it would enhance the antioxidant property of the composition in addition to providing antimicrobial effect. There need not necessarily be a teaching in Choi and Dabbah to include D-limonene in the to a hydrated carotenoid-cyclodextrin complex that is dispersed in 75-85% krill oil and encapsulated in a soft gelatin capsule. The beneficial properties of limonene taught by Choi and Dabbah provide the motivation to add it to the composition. There is a reasonable expectation of success that limonene would be compatible, and that limonene would function as intended in the claimed composition and dosage form. Applicant has advanced this argument but has not provided any supporting evidence for the same. If compatibility and functioning of limonene as intended is in doubt then it should not have been included in the claimed composition by the applicant. Applicant has not shown any unexpected result due to the presence of limonene in the composition either. Applicant has not advanced any arguments regarding the teachings of the other references cited in the rejection. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Therefore, the combined teachings of the prior art do render claims 1-5 prima facie obvious. The rejection is maintained.
Conclusion
1. Elected claims 1-5 are rejected.
2. Claims 8-14 have been withdrawn as being drawn to non-elected invention.
3. Claims 6-7 and 15 have been canceled.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693