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 .
The instant application is a CON of 17/341,220, now US Pat. No. 12,031,152.
Claim 1 is examined in the instant application.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,031,152. Although the claims at issue are not identical, they are not patentably distinct from each other because the methods of ‘152 produce the instantly claimed nutrient medium.
The instant application was filed as a CON and the court has found that safe harbor does not apply when the continuing application is filed as CON. The court found that safe harbor from an ODP rejection only applies when a continuing application is filed as a DIV. See AMGEN INC., v. F. HOFFMANN-LA ROCHE LTD. 580 F.3d l340; 2009 U.S. App, LEXIS 20409; 92 U.S.P.Q.2D (BNA) 1289.
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims do not recite something significantly different than a judicial exception. The rationale for this determination is explained below.
The Claims
The claim is directed to:
An edible nutrient medium comprising an ingredient approved for use in food.
Teachings in the Art
Regarding claim 1, the art teaches that vitamin B12 is an ingredient that is approve for use in food and is naturally made in bacteria (Rakusa et al. (2023, Molecules, Vol. 28, pgs. 1-30).
The nutrient medium further encompasses water as an ingredient, which is also naturally occurring.
Teachings in the Specification
The specification teaches in Example 1 (pg. 69) the formulation of a nutrient medium comprising a plurality of GRAS ingredients. However, while the formulated edible nutrient media was made from a plurality of GRAS ingredients, the claimed nutrient media recites no structural or functional feature that would distinguish it from a nutrient media, such as vitamin B12 in water, that occurs in nature.
Accordingly, the claim is directed to a composition using only nature-based products, i.e., vitamin B12 and water, these nature-based products are then analyzed to determine whether they have markedly different characteristics from any naturally occurring counterpart(s) in their natural state. The claims thus encompass vitamin B12 in water which are identical (no difference in characteristics) to a naturally occurring vitamin B12 and water.
Because there is no difference between the vitamin B12 and water used in the claimed composition, the claimed nutrient media does not have markedly different characteristics, and thus is a “product of nature” exception. In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1338-39 (Fed. Cir. 2014). Accordingly, the claimed nutrient media is directed to an exception. Because the claimed nutrient media does not include any additional features that could add significantly more to the exception, the claimed nutrient media does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
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An examination of Step 2A in the revised 101 guidance, with respect to the claimed invention, the answer is yes since the claimed nutrient media comprises only naturally occurring products (judicial exceptions), in the instant case these naturally occurring products are vitamin B12 and water.
It is only the recited limitations in the claims that are examined under 101 and not aspects such as what the nutrient media is being capable of being used for (i.e. production of slaughter-free meat). In this case only the nutrient media is examined with respect its status as a judicial exception. It is emphasized that the claimed invention is a composition and not a method.
An examination of Step 2B, the answer is no with respect to the claimed invention. There are no other additional elements recited in the claim that would amount to significantly more than the judicial exceptions. This is because while the claimed invention is drawn to nutrient medium, there are no additional components which impart any additional element or structural limitations to the recited nutrient medium. The water and vitamin B12 in the claimed nutrient medium are indistinguishable from water and vitamin B12 that exists in nature.
The only factors which can be examined under 101 in the claimed composition are those that are recited in the claim i.e. a nutrient medium comprising ingredients approved for use in food.
How the nutrient medium is obtained and the knowledge of using said medium is not considered with respect to a composition, it is only the judicial exceptions themselves that are analyzed under 101 and in this case all of the components in the claimed nutrient medium are naturally-occurring product and thus qualify as a judicial exception.
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 1 is 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 1 is unclear. Claim 1 recites the term “ADI value”, however it is not clear what the metes and bounds are of the ADI value since the ADI for an ingredient can be temporary or change over time. Specifically, the International Programme on Chemical Safety (2009, IPCS, Environmental Health Criteria 240, Chapter 5) teaches that the ADI value is a value that is not fixed for any ingredient. For example, IPCS teaches:
(1) “For substances intentionally added to food, such as food additives, and for residues of pesticides and veterinary drugs in food, the health based guidance value is termed the ADI. JECFA and JMPR determine ADIs based on all the known facts at the time of the evaluation.” (pg. 5-20 parag. 1),
(2) the ADI value can be calculated by two different methods, NOAEL-derived and BMD-derived (Table 5.4),
(3) can have no value at all at taught on parag. 1 lines 1-5 on pg. 5-34:
“There are occasions when JECFA considers the setting of an ADI in numerical terms not to be appropriate. This situation arises when the estimated consumption of the additive is expected to be well below any numerical value that would ordinarily be assigned to it. Under
such circumstances, JECFA uses the term ADI “not specified”.
(4) that the ADI can be temporary or be revised as taught in parag. 2 on pg. 5-34 bridging lines 1-2 on pg. 5-35:
“JECFA has encountered several situations in which either the body of available data on a new additive had some limitations or the safety of a food additive for which the Committee had previously assigned an ADI was brought into question by new data. When the Committee feels confident that the use of the substance is safe over the relatively short period of time required to generate and evaluate further safety data, but is not confident that its use is safe over a lifetime,
it often establishes a “temporary” ADI, pending the submission of appropriate data to resolve the safety issue on a timetable established by JECFA. When establishing a temporary (numerical) ADI, the Committee always uses a higher than usual safety factor, usually increasing it by a factor of 2. The additional biochemical or toxicological data required for the establishment of an ADI are clearly stated, and a review of these new data is conducted before expiry of the provisional period.” and on pg. 5-47 parag. 1:
“If, during the derivation of an ARfD, it becomes apparent that a previously derived ADI is higher than the ARfD, the ADI should be reconsidered. Such a situation can occur for a number of reasons (e.g. the availability of additional studies, or compounds producing more severe effects when given by gavage than when administered in the diet) (FAO/WHO, 2001b). Even when there is no obvious basis to revise the ADI, it is recommended that the lower of the ARfD and the ADI be used as the ADI.”
Thus, as taught in by the IPCS the ADI value is not a fixed value that is permanent, but rather a value that is open to revision and change over time as well as being just a temporary value. Accordingly, the metes and bounds of the ADI value for the recited ingredients are unclear with respect to a nutrient medium.
Claim 1 is unclear. Claim 1 recites the term “approved” in relation to an ingredient. However, the term “approved” is both a conditional term and a relative term depending on who approves an ingredient or where the ingredient is approved. The specification teaches on pg. 13 parag. 77 lines 6-10):
“In some embodiments the cell culture medium comprises a plurality of ingredients wherein one or more ingredient is approved for use in food. In some embodiments the cell culture medium comprises a plurality of ingredients wherein each ingredient is approved for use in food. As used in the present disclosure, an ingredient “approved for use in food” refers to an ingredient that is approved for use in food by a widely accepted standard, e.g. a nationally or internationally accepted standard.”
The metes and bounds of an approved ingredient is not clear since an ingredient such as brominated vegetable oil, olestra, potassium bromate, BHA/BHT, and color dyes Yellow No. 5,6 and Red No. 40 are approved in the USA, but are not approved in Europe or Japan. Thus, the metes and bounds of an approved ingredients is not known since this encompasses foods that are approved by one national standard but are not approved by another national standard. (see Five American Food Ingredients That Are Banned in Other Countries, published 3/23/2022, attached).
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(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rouiller et al. (2013, mAbs, Vol. 5:3, pgs. 501-511) and evidenced by the teachings of Rakusa et al. (2023, Molecules, Vol. 28, pgs. 1-30).
Regarding claim 1, Rouiller et al. teach a nutrient medium comprising cyanocobalamin (vitamin B12) (pg. 505 col. 2 and Table 2) and mixing the vitamin B12 (pg. 506 col. 2 parags. 2-4). While Rouiller does not explicitly “water” it was routine and well established in the art that cell culture media requires water as an aqueous base, particularly for the CHO-S cells used by Rouiller.
The teachings of Rakusa are relied upon in teaching that Vitamin B12 is an ingredient approved for use in food.
Thus the teachings of Rouiller clearly anticipate the invention of claim 1.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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