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 without traverse of Group I, claims 1-17 in the reply filed on 06/223/2026 is acknowledged.
Claim 18 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/23/2026.
Claims 1-17 are under current examination.
Specification
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
The specification is objected to for lacking the brief description of the drawings.
Claim Objections
Claims 1, 4, 12, 15, and 17 are objected to because of the following informalities:
In claim 1, the examiner recommends consistency of line indentation when introducing a new limitation on substances that must be present in the invention, specifically, in line 5 the claim recites “wherein the mixture comprises a weak basic salt” at the same indentation level of other limitations in the claim; however, all subsequent substances are afforded their own line in the claim. Moving the above phrase to a new line following line 5 would be remedial.
The examiner points out that the phrase “and phospholipids” at the end of the Markush group in claim 4, line 3 results in a Markush group that does not actually further limit the phospholipids of claim 1.
Claim 12 is missing a period at the end of the sentence (see MPEP 608.02(m)).
In claim 15, the examiner recommends consistency of line indentation when introducing a new limitation on substances that must be present in the invention, specifically, in line 4 the claim recites “wherein the mixture comprises a weak basic salt” following other limitations in the claim; however, all subsequent substances are afforded their own line in the claim. Moving the above phrase to a new line following line 5 would be remedial.
Claim 17 recites “of more natural phospholipids” in line 2. Did Applicant intend “one or more”?
Appropriate correction is required.
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 3, 4, 9, 12-14, 16, 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the enclosed mixture" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "said one or more natural phospholipids" in lines 2 and 4. There is insufficient antecedent basis for this limitation in the claim.
The phrase “said one or more natural phospholipids have a purity grade in terms of phosphatidylcholine content of below 50%” renders claim 4 indefinite because it is unclear what limitation the phrase places on the claim. The phrase appears to limit the content of phosphatidylcholine in the phospholipid component but the meaning is ambiguous.
Claim 9 recites the limitation "said one or more liquid nontoxic monohydric and/or polyhydric alcohols" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites “nature derived” but does not say what is nature derived, therefore the scope of the nature derived substances embraced by the claims is undefined.
Claim 13 recites the limitation "said one or more additional surfactants" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites limitations on amount of phospholipid component comprising phosphatidyl choline and negatively charged or deprotonable phospholipids etc., on amount of a mixture of glycerol and liquid or solid polyols etc., and on lipophilic components selected from natural triglyceride oils; however, the antecedent bases for each of these listed substances is not clear. As the claim depends from claim 1 but does not refer back to the categories each of the above substances falls in, it is unclear whether the claim further limits the identity and amounts of the phospholipid, oil/triglycerides/polyols etc delineated in claim 1 or whether the substances listed in claim 14 are required to be present in the claimed amounts in addition to the substances recited in claim 1. One way to overcome this rejection would be amending the claim to recite e.g. “The container according to claim 1, wherein the one or more phospholipids is present in an amount of 5-40% wt and comprises phosphatidylcholine and negatively charged phospholipids selected from the group consisting of phosphatidic acid, phosphatidyl ethanolamine, phosphatidyl glycerol, a glycophospholipid, and combinations thereof”, and so forth for the remaining substances recited in claim 1.
The antecedent basis of the phrase “one or more natural plant bioactive substances” in claim 14, line 12 is unclear because the claim does not identify whether the phrase further limits the lipophilic or poorly water-soluble biologically active ingredient recited in claim 1 or whether the phrase requires an additional bioactive substance that is not necessarily lipophilic or poorly water-soluble. Thus, the scope of the claim is unclear.
In a manner analogous to claim 14 as described above, Claim 17 recites limitations on amount of phospholipid etc., on amount of a mixture of liquid or solid polyols etc., and on natural triglyceride oils/butter; however, the antecedent bases for each of these listed substances is not clear. As the claim depends from claim 15 but does not refer back to the categories each of the above substances falls in, it is unclear whether the claim further limits the identity and amounts of the phospholipid, oil/triglycerides, polyols etc. delineated in claim 1 or whether the substances listed in claim 14 are required to be present in the claimed amounts in addition to the substances recited in claim 1.
Claim 17 recites the limitation "the emulsion" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 depends from rejected claim 14 and has also been rejected because it incorporates all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
Claim Rejections - 35 USC § 112
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.
Claims 6, 10, 11, and 16 are 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 6 fails to further limit claim 1, from which it depends, because claim 1 already requires the presence of a weak basic salt.
Claim 10 fails to further limit claim 1, from which it depends, because claim 1 already requires the presence of a lipophilic or poorly water soluble biologically active ingredient.
Claim 11 fails to include all the limitations of the claim upon which it depends because the biologically active agent of claim 11 falls outside the scope of the biologically active agent of claim 1. Specifically, claim 1 requires the biologically active agent to be lipophilic or poorly water soluble, whereas claim 11 requires it to be hydrophilic.
Claim 16 fails to include all the limitations of the claim upon which it depends because claim 16 is limited to the claimed mixture; however, claim 14 requires the invention to also include a container. Where possible, claims are to be complete in themselves. MPEP 2173.05(s).
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7, 10-12, and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Claim 15 recites “A mixture comprising: one or more phospholipids, wherein at least 2 wt% of the phospholipids: bears a net negative charge, and/or is deprotonable, whereby the mixture comprises a weak basic salt, one or more oils, butters and/or triglycerides, one or more lipophilic or poorly water-soluble biologically active ingredients, and one or more liquid or solid polyols, polyol sugars, natural sugars, monohydric and/or polyhydric alcohols.” The claim reads on milk, which is a naturally occurring mixture comprising phospholipids (Contarini, abstract), weak basic salts e.g. calcium phosphate (Lenton, abstract), triglycerides (Contarini, 2819), cholesterol (i.e. lipophilic biologically active ingredient; Contarini: 2809), and lactose (a natural sugar; Contarini, 2818). The phospholipids in milk are comprised of inter alia negatively charged phosphatidylinositol (1.4 – 14.1% of total phospholipids) and phosphatidylserine (2.0-16.1% of total phospholipids as well as the zwitterionic phospholipid phosphatidylcholine (8.0-45.5% of total phospholipids; limitation of instant claim 4; Contarini, page 2812), thus the total amount of phospholipids bearing a negative charge is greater than the requisite at least 2% recited in the instant claims.
Accordingly, the claims embrace milk and do not require any additional elements except the judicial exception. See MPEP 2106.04(II)(A): Because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017). In the instant case, the judicial exception is not integrated into a practical application because there are no additional limitations recited in the claims other than those noted above that read on milk. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements to consider.
Claims 1-7 and 10-12 require the mixture to be encapsulated in a sealed and air- or oxygen-impermeable and liquid-impermeable container, and thus recite additional elements. The examiner does not consider the additional elements to integrate the exception into a practical application because the phrase “sealed and air- or oxygen-impermeable and liquid-impermeable container” describes the additional limitation at a high degree of generality and it was well-understood, routine, and conventional to store foods such as milk in sealed and air- or oxygen-impermeable and liquid-impermeable containers as of the instant effective filing date.
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.
Claim 15 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Contarini et al. (Int J Mol Sci 14, 2808-2831; publication year: 2013) as evidenced by Lenton et al. (Dairy Sci. & Technol. 95:3-14; publication year: 2015).
Contarini discloses milk, which falls entirely within the scope of claim 15. Milk is a naturally occurring mixture comprising phospholipids (Contarini, abstract), weak basic salts e.g. calcium phosphate (Lenton, abstract), triglycerides (Contarini, 2819), cholesterol (i.e. lipophilic biologically active ingredient; Contarini: 2809), and lactose (a natural sugar; Contarini, 2818). The phospholipids in milk are comprised of inter alia negatively charged phosphatidylinositol (1.4 – 14.1% of total phospholipids) and phosphatidylserine (2.0-16.1% of total phospholipids; Contarini, page 2812), thus the total amount of phospholipids bearing a negative charge is greater than the requisite at least 2% recited in the instant claims.
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 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Nugent (US20200093151; publication date: 03/26/2020; cited in the IDS filed 07/15/2024) in view of Fitzpatrick (US 2444984; issue date: 07/13/1948) and Engelmann (US 1972764; issue date: 09/04/1934).
Nugent discloses a triglyceride (a triglyceride/oil) in glycerin (a liquid polyol) emulsion comprising lecithin as the emulsifier (0013). The instant specification and claims indicate that lecithin contains least 2 wt% of the phospholipids bearing a net negative charge and/or being deprotonable (see e.g. instant claim 4). The emulsion is formulated to contain hydrophobic active agents (0028, 0041). Nugent teaches that lecithin was traditionally considered less effective as an emulsifier but lecithin containing about 20% phosphatidylcholine is effective to stabilize oil in glycerin emulsions (0035):
Prior art teaches that lecithin alone is not effective in its emulsifying capacity to produce a triglyceride oil-in-glycerin emulsion; however, significant and natural variation is possible in lecithin commercial products in terms of phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol, phosphatidic acid, phosphatidylserine, sphingomyelin and glycolipids content. The principle characteristics that determine the variations in phospholipids ratios are commercial processing variables: (1) plant source; (2) starting phospholipids ratios; (3) phospholipids concentration; (4) process separation polarities; (5) process temperature; and (6) process extraction conditions. Experimental testing conducted by the inventor used commercial lecithin mixtures in various phospholipids ratios, and lecithin containing about 20% phosphatidylcholine has proven to be unexpectedly and particularly suitable in emulsification capacity of triglyceride oil-in-glycerin emulsions
Thus Nugent discloses a mixture comprising one or more phospholipids wherein at least 2 Wt % of the phospholipids bears a net negative charge and/or is deprotonable, one or more triglycerides, one or more poorly water soluble biologically active ingredients, and one or more liquid polyols. Nugent does not disclose including a weak basic salt in the mixture.
Fitzpatrick teaches lecithin can be used as an emulsifying agent and is edible and non-toxic (col 1); however, when lecithin mixtures are stored for long periods the pH of the product tends to decrease and lecithin tends to develop a sharp odor/rancidity (col 2). Fitzpatrick has found that mixing a small quantity of alkaline substance with lecithin to increase pH above 6 prevents rancidity from developing. Fitzpatrick adds an alkaline salt such as carbonate or phosphate salts of calcium (col 3; i.e. a weak basic salt). Fitzpatrick further teaches that if the lecithin is to be used in a food product care must be taken to use only alkaline substances which are non-toxic (col 4).
Engelmann teaches that in the presence of water, lecithin decomposes and this affects its solubility and its ability to emulsify (col 1); however, treating the lecithin with alkaline agent assists in the maintenance of lecithin emulsions (col 2).
It would have been prima facie obvious to add a quantity of basic salt to the lecithin-containing mixture used in Nugent’s invention. The artisan of ordinary skill would have been motivated to do so in order to improve the stability and emulsification capability of the lecithin, and had reasonable expectation of success because the combined teachings of Fitzpatrick and Engelmann establish this effect was known as of the instant effective filing date.
With regard to the amount of lecithin/phospholipid, triglyceride/oil, and polyol limited by instant claims 16 and 17, Nugent teaches 1-10% lecithin, 20-60% glycerin (i.e. polyol), and 40-70% triglyceride (abstract). The ranges in amounts of each of these substances overlaps with the ranges required by the instant claims (see MPEP 2144.05). It would have been a matter of routine for one of ordinary skill to optimize the quantities of each to form a stabilized emulsion for delivery of a particular active agent.
Claims 1-6, 8-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Nugent (US20200093151; publication date: 03/26/2020; cited in the IDS filed 07/15/2024) in view of Fitzpatrick (US 2444984; issue date: 07/13/1948) and Engelmann (US 1972764; issue date: 09/04/1934) as applied to claims 15-17 above, and further in view of Nimni (US 20030049326; publication date 05/20/2003) and Brysch et al. (US 20190084757; publication date: 03/21/2019).
The relevant disclosures of Nugent, Fitzpatrick, and Engelmann are set forth above, and render obvious a mixture comprising one or more phospholipids, wherein at least 2 wt% of the phospholipids: bears a net negative charge, and/or is deprotonable (i.e. lecithin), whereby the mixture comprises a weak basic salt (i.e. carbonate or phosphate salts), one or more oils and/or triglycerides, one or more lipophilic or poorly water-soluble biologically active ingredients, and one or more liquid or solid polyols (glycerin).
These references do not disclose a sealed and air- or oxygen- and liquid-impermeable container encapsulating the mixture.
Nimni teaches that lecithin is sensitive to oxidation (0058).
Brysch teaches a beverage preparation capsule for the delivery of a solubilisate. Poorly water-soluble dietary supplements or pharmaceutical active agents can be delivered in this new dosage form in order to increase the bioavailability of these substances (abstract). The cup and cover materials are impermeable for oxygen and moisture (0039).
It would have been prima facie obvious to contain the mixture of Nugent/Fitzpatrick/Engelmann in the vessel described by Brysch. The artisan of ordinary skill would have been motivated to do so in order to further minimize risk that the lecithin would degrade during storage and had reasonable expectation of success because removing moisture (water taught by Engelmann to degrade lecithin) and oxygen (lecithin sensitive to oxidation) would decrease the potential for decomposition reactions.
With regard to claim 2, the examiner considers the vessel taught by Brysch to fall within the scope of cartridge.
With regard to claim 3, Nugent teaches using naturally derived substances exclusively (0019).
With regard to claim 4, Nugent teaches lecithin is derived from plant sources including sunflower, soy, corn, cottonseed, marine, rapeseed and canola (0022).
With regard to claim 5, Nugent teaches lecithin is selected from the group consisting of phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol, phosphatidic acid, phosphatidylserine, sphingomyelin and glycolipids (0022).
With regard to claim 6, as noted above it would have been obvious to add a weak base salt to the composition
With regard to claims 8 and 9, as noted above, the composition contains glycerol.
With regard to claims 10 and 11, the composition can efficiently accommodate both lipophilic and hydrophilic bioactives (0020).
With regard to claim 12, as discussed above, Nugent teaches lecithin is selected from the group consisting of phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol, phosphatidic acid, phosphatidylserine, sphingomyelin and glycolipids therefore it would have been prima facie obvious to add any of these substances to the composition (see MPEP 2144.06).
With regard to claim 14, Nugent teaches 1-10% lecithin, 20-60% glycerin (i.e. polyol), and 40-70% triglyceride (abstract). The ranges in amounts of each of these substances overlaps with the ranges required by the instant claims (see MPEP 2144.05). It would have been a matter of routine for one of ordinary skill to optimize the quantities of each to form a stabilized emulsion for delivery of a particular active agent.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Nugent (US20200093151; publication date: 03/26/2020; cited in the IDS filed 07/15/2024), Fitzpatrick (US 2444984; issue date: 07/13/1948), Engelmann (US 1972764; issue date: 09/04/1934), Nimni (US20030049326; publication date 05/20/2003), and Brysch et al. (US 20190084757; publication date: 03/21/2019). as applied to claims 1-6, 8-12, and 14-17 above, and further in view of Mason et al. (US 20150196708; publication date: 07/16/2015).
The relevant disclosures of Nugent, Fitzpatrick, Engelmann, Nimni, and Brysch are set forth above. None disclose the salts required by instant claim 7.
Mason teaches that in addition carbonate, bicarbonate salts were known salts of weak bases as of the instant effective filing date.
It would have been prima facie obvious to use a bicarbonate salt as the salt in the composition rendered obvious by Nugent/Fitzpatrick/Engelmann because one having ordinary skill would have recognized it as falling into the category of alkaline salt taught by Fitzpatrick (weak base salt) and therefore suitable (see MPEP 2144.07).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Nugent (US20200093151; publication date: 03/26/2020; cited in the IDS filed 07/15/2024), Fitzpatrick (US 2444984; issue date: 07/13/1948), Engelmann (US 1972764; issue date: 09/04/1934), Nimni (US20030049326; publication date 05/20/2003), and Brysch et al. (US 20190084757; publication date: 03/21/2019). as applied to claims 1-6, 8-12, and 14-17 above, and further in view of Yoo et al. (US 20030175315; publication date: 09/18/2003).
The relevant disclosures of Nugent, Fitzpatrick, Engelmann, Nimni, and Brysch are set forth above. None disclose the surfactants required by claim 13.
Yoo teaches that in addition to phosphatidylcholine, lysophosphatidylcholine was known to function as an emulsifier as of the instant effective filing date (0044).
It would have been prima facie obvious to add lysophosphatidylcholine to Nugent’s composition because it was known for the same purpose as the phosphatidylcholine taught therein (see MPEP 2144.06).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617
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