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 .
This office action is in response to the application filed on August 25, 2023. The earliest effective filing date of the application is August 25, 2016.
Status of Application
The amendment filed March 2, 2026 with the Remarks has been entered. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 144 – 154
Withdrawn claims: 154
Previously cancelled claims: 1 – 144
Claims currently under consideration: 144 – 153
By not repeating the previously presented objection/rejection(s), it is sufficiently clear that said objection/rejection(s) are withdrawn.
Claim Objections
Claim 154 is objected to because the claim has disappeared from the claim set without acknowledgment of whether it has been cancelled, or continues to be withdrawn. The status identifier of the claim should read “Cancelled” or “Withdrawn”. The removed text in claim 154 must also be presented with markings to indicate the changes that have been made relative to the immediate prior version, such as “(Cancelled)”, if the claim has, in fact, been cancelled. See MPEP § 714(II)(C).
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 145 and 147 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.
Claims 145 and 147 recite “fragments thereof” which renders the claim indefinite. It is unclear what metes and bounds are encompassed by the recitation. For example, molecular hydrogen may be a fragment of α-lactalbumin. For the purpose of examination, “fragments thereof” of α-lactalbumin are interpreted to be any molecule generated from α-lactalbumin or a non-animal protein via biological, chemical, or thermodynamic processes.
Claims 145 and 147 recite the limitation "the […] fragment thereof". There is insufficient antecedent basis for this limitation in the claim. Changing the claim language to refer to “or a fragment thereof”, or removing “fragment thereof” would resolve this issue.
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.
Claims 144 and 146 – 150 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mayfield et al. (U.S. Patent No. 9,732,351 B2).
Regarding claim 144, Mayfield teaches a chloroplast comprising one or more polynucleotides encoding one mammalian alpha-lactalbumin (Abstract). Mayfield teaches the proteins produced can be delivered without purification, compared to conventional bioreactor systems, e.g., CHO, bacteria, or yeast, to yield bioactive compounds useful in an edible delivery system (col. 1, lines 59 – 62). Therefore, the proteins naturally present in the chloroplast are present in the final product (i.e., the composition comprises non-animal proteins). Mayfield teaches the invention is an edible delivery system comprising food (col. 1, lines 63 – 67).
With respect to the limitation “wherein the food product does not comprise any milk protein other than the recombinant a-lactalbumin”, given the chloroplast encodes one mammalian alpha-lactalbumin, the chloroplast does not comprise any milk protein other than the recombinant a-lactalbumin.
With respect to the limitation “wherein the α-lactalbumin imparts on the food product an attribute of a dairy product”, given α-lactalbumin is naturally present in dairy milk, any α-lactalbumin imparts on the food product of claim 144 an attribute of a dairy product. Therefore the edible delivery system (i.e., food product) of Mayfield anticipates claim 144.
Regarding claim 146, Mayfield teaches the food is an infant formula (col. 11, lines 13 – 18).
Regarding claim 147, Mayfield teaches the one mammalian polypeptide is a milk or colostrum polypeptide from a mammal selected from the group consisting of human, canine, feline, bovine, porcine, ovine and caprine (col. 3, lines 51 – 55). Absent evidence to the contrary, the polypeptide selected from the given mammal species is interpreted to have 100% identity to the protein naturally present in the given species.
Regarding claims 148 – 150, the claims recite the following limitations with respect to the source of the α-lactalbumin:
the recombinant α-lactalbumin is produced by a fungal cell or bacterial cell,
the recombinant α-lactalbumin is produced by a filamentous fungal cell, and
the recombinant α-lactalbumin is produced by an Aspergillus or Trichoderma filamentous fungal cell.
There is no material difference between, for example, α-lactalbumin generated in a fungal or bacterial cell, such as an Aspergillus filamentous fungal cell, as described by the instant disclosure and the same protein that may be naturally present in milk. While a protein may be prepared by a certain method, or obtained from a certain source, in product claims, the protein itself it considered, regardless of how it is made or where it is from. See MPEP § 2113.I. Therefore, “the recombinant α-lactalbumin is produced by a fungal cell or bacterial cell” is interpreted broadly to mean any α-lactalbumin, regardless of its original source.
Therefore, the edible delivery system of Mayfield anticipates claims 148 – 150.
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 144 – 153 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (U.S. Patent No. 6,991,824 B2 – Cited in Action filed on October 27, 2025).
Regarding claim 144, Huang teaches a seed composition (i.e., a food product) containing a flour, extract, or malt obtained from mature monocot seeds (i.e., one or more native non-animal proteins) and one or more seed-produced human milk proteins (i.e., a recombinant milk protein) in substantially unpurified form (col. 6, lines 1 – 7). Huang teaches milk proteins such as alpha-lactalbumin are known to have a number of nutritional and other beneficial effects, particularly for infants (col 5, lines 10 – 15). Huang teaches the food is an infant formula (Claim 4).
While Huang does not explicitly teach the recombinant milk protein is alpha-lactalbumin, Huang’s acknowledgment that alpha-lactalbumin is beneficial for infants, in combination with Huang’s teaching that the composition is an infant formula, suggests to one of ordinary skill in the art that the one or more seed-produced human milk proteins may be alpha-lactalbumin. It would have been obvious to one of skill in the art to have selected alpha-lactalbumin as the human milk protein in the seed composition of Huang on the basis of its suitability for a similar intended use. See MPEP § 2144.07.
With respect to the limitation “wherein the food product does not comprise any milk protein other than the recombinant a-lactalbumin”, given the seed composition (i.e., a food product) may comprise only one seed-produced human milk protein (i.e., alpha-lactalbumin), the modified the seed composition (i.e., a food product) of Huang does not comprise any milk protein other than the recombinant a-lactalbumin.
With respect to the limitation “wherein the α-lactalbumin imparts on the food product an attribute of a dairy product”, given α-lactalbumin is naturally present in dairy milk, any α-lactalbumin imparts on the food product of claim 144 an attribute of a dairy product.
Regarding claim 145, Huang teaches the milk protein preferably includes at least 0.25 weight percent of the total protein in the harvested mature seeds (col. 6, lines 55 – 57). Therefore, the weight ratio of alpha-lactalbumin to plant protein is at least 1:400, which may increase to, for example, 1:100 or higher.
The range of weight ratios of alpha-lactalbumin to native non-animal protein, at least 1:400, as disclosed by Huang, overlaps with the claimed range of 100 to 1 to 1 to 100. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 146, Huang teaches the food is an infant formula (Claim 4).
Regarding claim 147, given the purpose of the invention of Huang is to provide a human infant formula, it would have been obvious to provide a composition comprising alpha-lactalbumin that is at least 80% identical to human alpha-lactalbumin due to its suitability for its intended purpose. See MPEP § 2144.07.
Regarding claims 148 – 150, the claims recite the following limitations with respect to the source of the α-lactalbumin:
the recombinant α-lactalbumin is produced by a fungal cell or bacterial cell,
the recombinant α-lactalbumin is produced by a filamentous fungal cell, and
the recombinant α-lactalbumin is produced by an Aspergillus or Trichoderma filamentous fungal cell.
There is no material difference between, for example, α-lactalbumin generated in a fungal or bacterial cell, such as an Aspergillus filamentous fungal cell, as described by the instant disclosure and the same protein that may be naturally present in milk. While a protein may be prepared by a certain method, or obtained from a certain source, in product claims, the protein itself it considered, regardless of how it is made or where it is from. See MPEP § 2113.I. Therefore, “the recombinant α-lactalbumin is produced by a fungal cell or bacterial cell” is interpreted broadly to mean any α-lactalbumin, regardless of its original source.
Therefore, the modified seed composition (i.e., a food product) of Huang is encompassed by claims 148 – 150.
Regarding claim 151, Huang teaches the malt obtained from mature monocot seeds (i.e., one or more native non-animal proteins) is hydrolyzed by the naturally present enzymes in the germinating seed (col. 37, lines 14 – 22). More specifically, Huang teaches proteolytic enzymes (i.e., enzymes that hydrolyze proteins) work on the proteins in the seed and render them soluble (col. 37, lines 19 – 22). Therefore, the seed composition of Huang comprises hydrolyzed non-animal proteins.
Regarding claim 152, Huang teaches the seed composition comprises a flour, extract, or malt obtained from mature monocot seeds (i.e., plant proteins).
Regarding claim 153, Huang teaches preferred plants for hosting recombinant milk proteins are also dicots exemplified by soybean (Glycine spp.) (col. 33, lines 18 – 31).
Response to Arguments
Applicant's arguments filed March 2, 2026 have been fully considered.
Applicant argues the present amendments overcome the previous rejections of claims 144 – 153 over Cho.
Applicant’s argument has been fully considered and is persuasive. Therefore, the rejections under 35 U.S.C. §§ 102 and 103 over Cho have been withdrawn. However, upon further consideration, new grounds of rejection are made in view of Mayfield and Huang.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 LARK JULIA MORENO whose telephone number is (571)272-2337. The examiner can normally be reached 6:30 - 4:30 M - F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at (571) 272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.J.M./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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