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
Claims 1-20 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Acknowledgment is made of applicant's claim for foreign priority based on an application filed in India on 12/25/2021. It is noted, however, that applicant has not filed a certified copy of the IN202141060758 application as required by 37 CFR 1.55.
As such, the instant Application is not afforded the effective filing date of 12/25/2021, the filing date of IN202141060758.
The instant application is a continuation of Application No. 18/146,393, now abandoned. The later-filed application, i.e., the instant application, must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 18/146,393, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
-In independent claims 1, 14, and 16, ‘393 does not provide support for “a dosage of 11.5 milligrams to at milligrams.”
-In independent claims 1, 14, and 16, ‘393 does not provide support for “an increase in (i) MPOD levels of 30% to >50%, and (ii) CFT of 3.8% to 4.2%.
-In independent claim 16, ‘393 does not provide support for “gum arabic as a carrier.”
As such, the instant application is afforded an effective filing date of the filing date of the instant application, 09/03/2024.
Abstract
The abstract of the disclosure is objected.
-In line 1, the phrase “Invention deals with” should be replaced with - -the invention is- -, or similar, clearer language.
-The second full sentence is confusing and should be replaced with clear language. It is not known how a formulation is related to prevention of age-related macular degeneration.
-The 2nd to last sentence is confusing. It is not known how the “present invention can be used for the development of functional food, dietary plan and as a nutritional supplement.” It appears that Applicant might mean that the macular carotenoid formulation is formulated as a functional food or nutritional supplement, that can be used in a diet plan.
-In the last sentence, the term - -an- -should be inserted prior to “exemplary.”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 9, 14, 16, and 20 are objected to because of the following informalities:
In independent claims 1, 14, and 16, the phrase - -to a subject in need thereof- - should be inserted following the phrase “comprising administering a macular carotenoid formulation”.
In independent claims 1, 14, and 16, the phrase “that comprises” in line 3, should be replaced with - -, comprising- -
In claim 9, the term “and” should be inserted following “Dunaliella salina,”.
In claim 20, for grammatic clarity, the claim should be amended to recite “wherein the lutein, the zeaxanthin isomers, the beta carotene, the alpha carotene, the lycopene, and the beta cryptoxanthin, are stabilized in the gum arabic, the modified food starch, and the antioxidant, and wherein the antioxidant is selected from vitamin E or rosemary extract.”
Appropriate correction is required.
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 1-20 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.
-In claims 1,14, and 16, the phrase “wherein administering to the subject, a dosage of 11.5 milligrams to 15 milligrams. . .of the formulation,” renders the claim indefinite. It is not clear how the dosage is calculated as a single milligram amount when it comprises at least five ingredients at different milligram amounts/percent weights, and one of the components, i.e., lutein, can be in an amount of 2-20mg, which is the greater than the milligram dosage amount of the formulation as a whole.
-In claims 1, 14, and 16, 3rd paragraph, the phrase “achieves an increase in (i) MPOD levels of 30% to >50%, and (ii) CFT of 3.8% to 4.2%,” renders the claims indefinite. It is not clear if the increase is based on a known baseline in the art of MPOD levels and CFT levels, or if the increase is based on the MPOD levels and CFT levels of individual subjects measured before administration of the “macular carotenoid formulation.”
-In claims 1, 14, and 16, last two lines, the phrase “wherein a positive correlation is established between the MPOD level and the CFT level” renders the claim indefinite. The phrase “is established” is confusing. It is not clear if “wherein a positive correlation is established” is merely the natural outcome of administering the instantly claimed “macular carotenoid formulation” to a subject, or if the phrase “is established” connotes an additional active step that is required in the claimed method to arrive at this “positive correlation.”
-Claim 7 is confusing, and thus indefinite. Lines 1-2 of the claim state that “the macular carotenoid formulation is derived from vegetarian sources comprising xanthophylls.” It is not clear if this means that the macular carotenoid formulations further comprise xanthophylls or if the vegetarian sources from which they are derived must further contain xanthophylls as a component. Moreover, it is not clear if lutein, zeaxanthin isomers, beta carotene, alpha carotene, lycopene, and beta cryptoxanthin, the components that comprise the macular carotenoid formulation, must all be derived from a single vegetarian source, or if they are derived from separate vegetarian sources, since lines 2-3 recite specific vegetarian sources from which lutein, zeaxanthin, meso zeaxanthin, beta carotene, and lycopene are extracted.
-Claim 7 recites the limitation "zeaxanthin and meso zeaxanthin" in line 2. There is insufficient antecedent basis for this limitation in the claim. While claim 1, from which claim 7 depends, recites “zeaxanthin isomers,” “zeaxanthin and meso zeaxanthin” are distinct from “zeaxanthin isomers.”
-In claim 7, the phrases within the parenthesis in lines 3 and 4 render the claim indefinite. It is not clear if these limitations are a further limitations of the claim, or if they are merely exemplary of “marigold flowers” or “carrot.”
-Claim 13 recites the limitation "zeaxanthin and meso zeaxanthin" in line 1. There is insufficient antecedent basis for this limitation in the claim. While claim 1, from which claim 13 depends, recites “zeaxanthin isomers,” “zeaxanthin and meso zeaxanthin” are distinct from “zeaxanthin isomers.”
-In claim 13, lines 2-3, the phrase “is extracted synthetically or extracted from Blakeslea trispora or Dunaliella salina or combination thereof” renders the claim indefinite. It is not clear if “combination thereof” is referencing just Blakeslea trispora and Dunaliella salina, or if it is referencing a synthetic extract, Blakeslea trispora, and Dunaliella salina.
-In claim 16, the phrase “from about 10% to 30% by weight of gum arabic as a carrier, and i) from about 25% to 75% by weight of a stabilizing agent,” renders the claim indefinite. Since the instant specification defines gum arabic as a stabilizer/stabilizing agent (see paragraphs [011] and [017] of the instant specification), it is not clear if a composition comprising gum arabic meets the instant limitations of “gum arabic” and “a stabilizing agent” in claim 16, or if the macular carotenoid formulation further comprises “a stabilizing agent” other than gum arabic.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
Claim Interpretation
Claims 7-13 are interpreted as product-by-process claims. The final product of the macular carotenoid formulation, the lutein, the zeaxanthin, the alpha carotene, the beta carotene and the lycopene, appear to be identical to those set forth in the instant claims, regardless of how the macular carotenoid formulation ,the lutein, the zeaxanthin, the alpha carotene, the beta carotene or the lycopene was made. Therefore, absent evidence to the contrary, the manner in which the macular carotenoid formulation, the lutein, the zeaxanthin, the alpha carotene, the beta carotene or the lycopene were made would have been a simple matter of design choice for the person of ordinary skill in the art at the effective filing date of the instant invention.
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), see MPEP 2113.
Product-by-Process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially identical is found and a prior art rejection is made, the burden shifts to the applicant to show a nonobvious difference. See above paragraph and MPEP 2113.
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 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0210785 to Mehkri (published 07/06/2023, PTO-892).
Regarding instant claim 1, Mehkri teaches a macular carotenoid formulation for increasing the macular pigment optical density (MPOD) level in a subject, wherein the composition comprises 2-20mg lutein, 0.4-4mg zeaxanthin isomers, 1-10mg beta carotene, 40-1000 mcg alpha carotene, 1-10mg lycopene, and 1-1000mcg beta cryptoxanthin (pg. 7, claim 1).
Regarding instant claim 14, Mehkri teaches a macular carotenoid formulation for increasing the macular pigment optical density (MPOD) level in a subject, wherein the composition comprises 1.66-16.7% by weight lutein, 0.35-3.4% by weight zeaxanthin isomers, 0.74-8% by weight beta carotene, 0.01-0.4% by weight alpha carotene, 0.6-6.2% by weight lycopene, 0.001-0.2% by weight beta cryptoxanthin, 0.01-2% by weight antioxidant, about 10-30% by weight gum arabic, and from about 25-75% by weight of stabilizing agent (pg. 7, claim 5).
Regarding instant claim 16, Mehkri teaches a macular carotenoid formulation for increasing the macular pigment optical density (MPOD) level in a subject, wherein the composition comprises 1.66-16.6% by weight lutein, 0.35-3.4% by weight zeaxanthin isomers, 0.74-8% by weight beta carotene, 0.01-0.4% by weight alpha carotene, 0.6-6.2% by weight lycopene, j0.001-0.2% by weight beta cryptoxanthin, 0.01-2% by weight antioxidant, and from about 50-90% by weight of carrier oil (pg. 7, claim 7).
Further regarding claims 1, 14, and 16 Mehkri teaches its compositions as administered to subjects twice daily over 180 days, to assess a positive correlation between MPOD and central foveal thickness ([0089]-[0094], [102]-[0105]).
While Mehkri teaches a method of increasing MPOD and CFT levels in a subject by administering the instantly claimed macular carotenoid formulation, it differs from that of instant claims 1, 14, and 16, in that it does not teach a dosage of 11.5 milligrams to 15 milligrams.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the milligrams of the dosage of Mehkri, to arrive at instant claims 1, 14, and 16. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-the instantly claimed formulations and those of Mehkri are both directed toward a method for increasing the MPOD level in a subject to assess a positive correlation between MPOD and CFT level,
-Mehkri teaches the same milligram, microgram, or percent weights of the individual components as instantly claimed, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05(II)
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In the instant case, the wherein clauses in claims 1, 14, and 16 express the desired result of the positive step of administering the macular carotenoid formulation to a subject. Since Mehkri teaches the same step of administering the same macular carotenoid formulation to the same subject (note: the subject is not limited in any way and encompasses any subject that has MPOD and CFT levels), the limitations of “achieves an increase in (i) MPOD levels of 30% to >50%, and (ii) CFT of 3.8% to 4.2” and “a positive correlation is established between the MPOD level and the CFT level in the subject,” are met.
Moreover, Mehkri teaches its formulations has achieving a positive correlation between MPOD and central foveal thickness levels ([0101], [0103]).
Regarding instant claim 2, see claim 2 of Mehkri (pg. 7).
Regarding instant claim 3, see claim 3 of Mehkri (pg. 7).
Regarding instant claim 4, Mehkri teaches the formulation as a nutrient, nutraceutical or dietary supplement (pg. 7, claim 4).
Regarding instant claim 5, see instant claim 12 of Mehkri (pg. 7).
Regarding instant claim 6, see claim 14 of Mehkri (pg. 7).
Regarding instant claims 7-13, see claims 15-20 of Mehkri (pg. 7), and the claim interpretation selection above.
Regarding instant claim 15, see claim 6 of Mehkri (pg. 7).
Regarding instant claim 17, see claim 8 of Mehkri (pg. 7).
Regarding instant claim 18, see claim 9 of Mehkri (pg. 7).
Regarding instant claim 19, see claim 10 of Mehkri (pg. 7).
Regarding instant claim 20, see claim 11 of Mehkri (pg. 7).
As such, claims 1-20 are rendered obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Primary Examiner, Art Unit 1622
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