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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/04/2025 has been entered.
Status of Claims
The amendments received on 08/04/2025 have been entered. Claims 17-18, 20-21, 23-25, and 30-31 are pending.
Claims 1-10, 14-15, 22, 26, and 32-37 have been cancelled.
Claims 20, 24, and 30-31 remain withdrawn.
Claim 17 has been amended.
Claims 17-18, 21, 23, and 25 are examined in this Office Action.
Information Disclosure Statement
Initialed and dated copy of Applicant’s information disclosure statement (IDS) filed on
08/04/2025 is attached to the instant Office Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Objections and Rejections that are Withdrawn
The rejection of claim 22 under 35 U.S.C. 112(a) New Matter is rendered moot in light of Applicant’s cancellation of the claim.
The rejection of claims 17 and 25 under 35 U.S.C. 102(a)(1) has been withdrawn in light of Applicant’s amendment to the claims.
The text of those sections of Title 35, U.S. Code, not included in this action, can be found in a prior Office action.
Claim Rejections - 35 USC § 103
Claims 17 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over DAVIS (Davis et al., Pub. No.: US 2019/0292217 A1, Pub. Date: Sep. 26, 2019; see List of references cited by examiner dated 05/12/2025) in view of JARDINAUD (Jardinaud et al., International Publication Number: WO 99/02687, International Publication Date: 21 January 1999). This is a new rejection necessitated by amendment.
Claim 17 recites “[a] method of producing a myoglobin protein in a transgenic plant, wherein the method comprises:
(a) growing the transgenic plant, wherein the transgenic plant is a Lactuca species and comprises at least one chloroplast with one or more recombinant nucleic acid sequences expressing a bovine myoglobin gene encoding the myoglobin protein, wherein the one or more recombinant nucleic acid sequences is integrated into the chloroplast DNA of the transgenic plant, and
(b) isolating the myoglobin protein from the transgenic plant.
DAVIS teaches and claims methods and materials for making transgenic plants, transgenic plant cells, and transgenic seeds in which heme biosynthesis is specifically upregulated (Davis, page 1, 0004); a transgenic plant comprising at least one recombinant nucleic acid, wherein the recombinant nucleic acid comprises a first promoter operably linked to a nucleic acid encoding a heme-containing polypeptide (Davis, claim 1) (i.e., method of producing a myoglobin protein in a transgenic plant).
DAVIS teaches the heme-containing polypeptide can be a bovine myoglobin (i.e., one or more recombinant nucleic acid sequences expressing a bovine myoglobin gene encoding the myoglobin protein) (Davis, page 3, 0033).
DAVIS teaches and claims growing a plant cell comprising at least one recombinant nucleic acid (i.e., growing the transgenic plant) (Davis, page 2, 0017; claim 52).
DAVIS teaches the nucleic acid construct further includes a targeting sequence that can be used to direct the heme polypeptide and/or heme biosynthesis polypeptide to one of several different intracellular compartments, including, for example, plastids (such as chloroplasts) (i.e., wherein the one or more recombinant nucleic acid sequences is integrated into the chloroplast DNA of the transgenic plant) (Davis, page 6, 0050).
DAVIS teaches the transgenic plants or plant cells can be grown in a manner suitable for the species under consideration, and then the heme-loaded polypeptide can be isolated (i.e., isolating the myoglobin protein from the transgenic plant) (Davis, page 7, 0060). To isolate the heme-loaded heme protein from the transgenic plants, cells, or seeds, the plant material can be processed using any appropriate measure (Davis, page 7, 0063).
DAVIS does not explicitly teach wherein the transgenic plant is a Lactuca species.
However, JARDINAUD teaches that iron deficiency is the most prevalent nutritional disorder worldwide. Individuals from socio-economically disadvantaged groups, ethnic groups (Aborigines, Asian migrants), vegetarians, and athletes are considered to be at particular risk from iron deficiency. Other groups at high risk are adolescents with increased requirements associated with growth and puberty, particularly females with the commencement of menstruation (Jardinaud, Background To The Invention, page 1, lines 25-26, and page 2, lines 4-8).
JARDINAUD teaches that nutritional iron problems associated with vegetarian diets are particularly prevalent in developing countries where major reliance is placed on staple cereals such as rice and wheat, and where intake of animal or fish sources of heme protein are either culturally unacceptable or impractical due to shortage or unreliability of supply, or poverty (Jardinaud, Background To The Invention, page 2, lines 10-13).
JARDINAUD sought to increase the bioavailability to humans and other animals, of iron in non-animal foodstuffs, such as plants, by introducing thereto an iron-binding protein molecule. In particular, JARDINAUD discovered that the bioavailability of iron may be increased by introducing a genetic sequence which encodes a heme protein into a plant cell and expressing said genetic sequence therein (Jardinaud, Background To The Invention, page 3, lines 15-20).
JARDINAUD teaches that the iron-binding protein is a heme protein, more preferably a hemoglobin, myoglobin or ferritin polypeptide or a homologue, analogue or derivative thereof (Jardinaud, page 13, lines 5-7).
JARDINAUD teaches plants which may be employed in practicing the present invention include all edible plants such as lettuce (e.g., Lactuca sativa) (i.e., wherein the transgenic plant is a Lactuca species) (Jardinaud, page 33, lines 6-19).
In regard to claim 25, DAVIS teaches and claims a transgenic plant comprising at least one recombinant nucleic acid, wherein the recombinant nucleic acid comprises a first promoter operably linked to a nucleic acid encoding a heme-containing polypeptide (i.e., wherein the myoglobin gene is operably linked to at least one promoter) (Davis, page 1, 0005; claim 1).
At the time the instant application was filed, it would have been obvious and within the scope of one having ordinary skill in the art to use the method of producing a myoglobin protein in a transgenic plant as taught by Davis, in a plant of the Lactuca species as taught by Jardinaud, as required by the claims. One would have been motivated to use the method of producing a myoglobin protein in a transgenic plant as taught by Davis, in a plant of the Lactuca species as taught by Jardinaud, knowing that a Lactuca species is a suitable host for producing a myoglobin protein in a transgenic plant as taught by Jardinaud. Thus, one of ordinary skill in the art would have a high expectation of success by following the teachings of Davis and Jardinaud, since the method of producing a myoglobin protein in a transgenic plant is well-known in the art and has been employed to increase the accumulation of a target protein for decades.
Claims 18, 21, and 23 remain rejected under 35 U.S.C. 103 as being unpatentable over Davis and Jardinaud as applied to claims 17 and 25 above, in further view of TRAN (Tran et al., Pub. No.: US 2020/0332249 A1, Pub. Date: Oct. 22, 2020; see List of references cited by examiner dated 12/16/2024). This is a modified rejection necessitated by amendment.
Claim 18 recites “[t]he method of claim 17, wherein the one or more recombinant nucleic acid sequences is integrated into the chloroplast DNA of the transgenic plant, and wherein the transgenic plant comprises at least about 10 copies of the one or more recombinant nucleic acid sequences.”
DAVIS and JARDINAUD teach the method of claim 17, wherein one or more recombinant nucleic acid sequences is integrated into the chloroplast DNA of the transgenic plant (see 35 U.S.C. 103 rejection for claim 17 above).
DAVIS and JARDINAUD do not explicitly teach that the transgenic plant comprises at least about 10 copies of the one or more recombinant nucleic acid sequences.
TRAN teaches the chloroplast genome of two Chlamydomonas strains, THN1 and THN6, were transformed with a bovine myoglobin gene and placed under the transcriptional control of the 16S promoter; THN6+myoglobin grown in the dark is shown to accumulate myoglobin (page 15, paragraph 0106). Tran teaches microalgae that have genes encoding iron-complexed proteins (myoglobin) integrated into the chloroplast genome; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more polynucleotides encoding proteins are used to increase the accumulation of the iron-complexed protein (i.e., the transgenic plant comprises at least about 10 copies of the one or more recombinant nucleic acid sequences integrated into the chloroplast DNA of the transgenic plant) (page 4, paragraph 0037). It is well-known in the art that routine optimization of protein production would preferably require multiple copies of the gene of interest to be integrated into the chloroplast DNA of the plant; the number of copies being a mere design choice and routine optimization in the art.
At the time the instant application was filed, it would have been obvious and within the scope of one having ordinary skill in the art to use 10 or more polynucleotides encoding proteins as taught by Tran, integrated into the chloroplast genome of a plant in the method as taught by Davis, in a Lactuca species as taught by Jardinaud, as required by the claims. One would have been motivated to use the 10 or more polynucleotides encoding proteins as taught by Tran, integrated into the chloroplast genome of a plant in the method as taught by Davis, in a Lactuca species as taught by Jardinaud, knowing that using 10 or more copies of the recombinant nucleic acid sequence would increase the accumulation of the iron-complexed protein. Thus, one of ordinary skill in the art would have a high expectation of success by following the teachings of Davis, Jardinaud, and Tran, since the use of multiple copies of a recombinant nucleic acid sequence is well-known in the art and has been employed to increase the accumulation of a target protein for decades.
In regard to claim 21, TRAN teaches the expression of the iron-complexed protein (myoglobin) can be accomplished by inserting a nucleic acid molecule (gene) encoding the protein into the chloroplast and/or nuclear genome of a microalgae. The modified strain of microalgae can be made homoplasmic to ensure that the polynucleotide will be stably maintained in the chloroplast genome of all descendants (the transgenic plant is a stable homoplasmic transformant) (page 10, paragraph 0073).
In regard to claim 23, TRAN teaches SEQ ID NO: 13 (bovine myoglobin amino acid sequence) (i.e., bovine myoglobin) which shares 100% identity to instant sequence SEQ ID NO: 1 (myoglobin protein selected from SEQ ID NOs: 1-3 and 5-6) (see alignment below).
SEQUENCE ALIGNMENT BETWEEN TRAN SEQ ID NO:13 AND INSTANT SEQUENCE SEQ ID NO: 1
Qy 1 MGLSDGEWQLVLNAWGKVEADVAGHGQEVLIRLFTGHPETLEKFDKFKHLKTEAEMKASE 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MGLSDGEWQLVLNAWGKVEADVAGHGQEVLIRLFTGHPETLEKFDKFKHLKTEAEMKASE 60
Qy 61 DLKKHGNTVLTALGGILKKKGHHEAEVKHLAESHANKHKIPVKYLEFISDAIIHVLHAKH 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DLKKHGNTVLTALGGILKKKGHHEAEVKHLAESHANKHKIPVKYLEFISDAIIHVLHAKH 120
Qy 121 PSDFGADAQAAMSKALELFRNDMAAQYKVLGFHG 154
||||||||||||||||||||||||||||||||||
Db 121 PSDFGADAQAAMSKALELFRNDMAAQYKVLGFHG 154
Summary
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MEADOWS whose telephone number is (703)756-1430. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/CHRISTINA L MEADOWS/Examiner, Art Unit 1663
/BRATISLAV STANKOVIC/Primary Examiner, Art Unit 1663
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