DETAILED CORRESPONDENCE
Application Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s amendment to the claims filed on 09/12/2025 in response to the Non-Final Rejection mailed on 06/13/2025 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
3. Claims 8-11 and 15 are cancelled.
4. New claims 16-18 are added.
5. Claims 1-2, 4-7, 12-14, and 16-18 are pending.
6. Applicant’s remarks filed on 09/12/2025 in response to the Non-Final Rejection mailed on 06/13/2025 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Specification
7. The objections to the specification for sequence disclosures and embedded hyperlinks are withdrawn in view of applicants’ amendment to the specification filed on 09/12/2025 to include sequence identifiers and delete the hyperlink.
Claim Rejections - 35 USC § 112(b)
8. The rejection of claims 2, 4, and 7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of applicants’ amendments to the claims.
Claim Rejections - 35 USC § 101
9. The rejection of claims 1-2, 5-7, and 12-14 under 35 U.S.C. 101 because the claimed invention is directed to a nature based product without significantly more is withdrawn in view of applicants’ amendment to the claims to recite “A recombinant vertebrate cell comprising a nucleic acid sequence encoding for a non-vertebrate and/or artificial phosphatidylethanolamine-binding protein…wherein the non-vertebrate and/or artificial PEBP is a nicotania subspecies or insect PEBP”. The claimed recombinant vertebrate cell is markedly different in structure from a naturally occurring vertebrate cell.
Claim Rejections - 35 USC § 102
10. The rejection of claims 1-7 and 12-14 under 35 U.S.C. 102(a)(1) as being anticipated by Nielson et al. (US Patent Application Publication 2011/0131682A1; cited on IDS filed on 04/21/2022) is withdrawn in view of applicants’ amendment to the claims to recite “wherein the non-vertebrate and/or artificial PEBP is a nicotania subspecies or insect PEBP” and amendment to cancel claim 3.
Claim Rejections - 35 USC § 103
11. 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.
12. Claim(s) 1-2, 4-7, 12-14, and 17-18 is/are newly rejected under 35 U.S.C. 103 as being unpatentable over Nielson et al. (US Patent Application Publication 2011/0131682A1; cited on IDS filed on 04/21/2022) in view of Brower-Toland et al. (US Patent Application Publication 2018/0105819 A1; cited on IDS filed on 04/21/2022). This new grounds of rejection is necessitated by applicants’ amendment to the claims to recite “wherein the non-vertebrate and/or artificial PEBP is a nicotania subspecies or insect PEBP”.
13. As amended, claims 1-2, 4-7, and 17-18, are drawn to a recombinant vertebrate cell, comprising (i) a nucleic acid sequence encoding for a non-vertebrate and/or artificial phosphatidylethanolamine-binding protein (PEBP) and/or (ii) a protein consisting of an amino acid sequence of the non-vertebrate and/or artificial phosphatidylethanolamine-binding protein (PEBP), wherein the non-vertebrate and/or artificial PEBP is a nicotania subspecies or insect PEBP.
As amended, claims 12-13 are drawn to an isolated nucleic acid construct suitable for recombinant expression in a vertebrate cell or cell line, comprising a coding element operatively linked with one or more expression elements which is suitable for regulating protein expression in the vertebrate cell, wherein the coding element comprises a nucleic acid sequence encoding a non-vertebrate and/or artificial phosphatidylethanolamine-binding protein (PEBP), wherein the non-vertebrate and/or artificial PEBP is a nicotania subspecies or insect PEBP.
Claim 14 is drawn to a recombinant vertebrate cell comprising the nucleic acid construct of claim 12.
14. With respect to claim 1, Nielson et al. teach a recombinant vertebrate cell (mammalian) comprising a nucleic acid encoding a plant PEBP protein [see Abstract; paragraphs 0011-0021, 0066]. Nielson et al. teach wherein the PEBP is a plant PEBP [see Abstract; paragraphs 0011-0021]. Nielson et al. teach the nucleic acid molecules encoding PEBP are useful in the controlling flowering in plants [see Abstract].
With respect to claim 2, Nielson et al. teach wherein the vertebrate cell is mammalian [see paragraph 0066].
With respect to claims 4 and 17, Nielson et al. teach wherein the PEBP is a plant PEBP, which when aligned with human PEBP1 lacks the most C-terminal helix [see Abstract; paragraphs 0011-0021].
With respect to claim 5, Nielson et al. teach wherein the nucleic acid or protein is heterologous to the host cell [see paragraph 0066].
With respect to claim 6, Nielson et al. teach the cell wherein the cell expressing the PEBP has an increased growth phase [see paragraphs 0007, 0205].
With respect to claims 7 and 18, Nielson et al. teach a recombinant vertebrate cell (mammalian) comprising a nucleic acid encoding a plant PEBP protein [see Abstract; paragraphs 0011-0021, 0066]. Nielson et al. is interpreted as reading on the limitations of claim 7 because the recitation of “an amino acid sequence having at least 80% sequence identity to a sequence shown…” is sufficiently broad to encompass fragments of the claimed sequence such that the sequence need only share at least two contiguous amino acid residues with the claimed sequences.
With respect to claim 12, Nielson et al. teach an isolated nucleic acid construct suitable for recombinant expression in a vertebrate cell or cell line, comprising a coding element operatively linked with one or more expression elements which is suitable for regulating protein expression in the vertebrate cell, wherein the coding element comprises a nucleic acid sequence encoding a non-vertebrate and/or artificial phosphatidylethanolamine-binding protein (PEBP) [see Abstract; paragraphs 0011-0021; 0058; 0066].
With respect to claim 13, Nielson et al. teach the isolated nucleic acid construct is suitable for transient or stable transfection of the vertebrate cell [see paragraph 0177].
With respect to claim 14, Nielson et al. teach a recombinant vertebrate cell (mammalian) comprising a coding element operatively linked with one or more expression elements which is suitable for regulating protein expression in the vertebrate cell, wherein the coding element comprises a nucleic acid sequence encoding a non-vertebrate and/or artificial phosphatidylethanolamine-binding protein (PEBP) [see Abstract; paragraphs 0011-0021; 0058; 0066].
However, Nielson et al. does not teach wherein the non-vertebrate PEBP is a nicotiania subspecies.
Brower-Toland et al. is in the same field of invention of Nielson et al. of recombinant DNA constructs, vectors, and molecules encoding PEBP that share 100% sequence identity to SEQ ID NO: 1 (Nicotiana) and lacking residues 177 to 187 when aligned with SEQ ID NO: 623 useful in the increasing and improving crop yield by controlling flowering in the plant development [see Abstract; paragraphs 0004-0008; alignment attached as APPENDIX A].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Nielson et al. and Brower-Toland et al. to use a nucleic acid encoding a Nicotiana PEBP from Brower-Toland et al. in the recombinant vertebrate cells of Nielson et al. because Nielson et al. teach recombinant vertebrate cells encoding a plant PEBP protein. Brower-Toland et al. teach nucleic acids encoding PEBP proteins from Nicotiana that are useful in controlling plant growth and flower development. One of ordinary skill in the art would have had a reasonable expectation of success and a reasonable level of predictability to combine the teachings of Nielson et al. and Brower-Toland et al. because Brower-Toland et al. acknowledges that Nicotiana PEBP can be recombinantly expressed in host cells similar to Nielson et al. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
15. Claim 16 is newly rejected under 35 U.S.C. 103 as being unpatentable over Nielson et al. (US Patent Application Publication 2011/0131682A1; cited on IDS filed on 04/21/2022) in view of Brower-Toland et al. (US Patent Application Publication 2018/0105819 A1; cited on IDS filed on 04/21/2022) as applied to claims 1-2, 4-7, 12-14, and 17-18 above, and further in view of Kim et al. (Appl. Microbiol. Biotechnol., 2012; examiner cited). This new grounds of rejection is necessitated by applicant’s amendment to the claims to add new claim 16.
16. The relevant teachings of Nielson et al. and Brower-Toland et al. as applied to claims 1-2, 4-7, 12-14, and 17-18 are set forth above.
With respect to claim 16, Nielson et al. teach a recombinant vertebrate cell (mammalian) comprising a nucleic acid encoding a plant PEBP protein [see Abstract; paragraphs 0011-0021, 0066]. Nielson et al. teach wherein the PEBP is a plant PEBP [see Abstract; paragraphs 0011-0021]. Nielson et al. teach the nucleic acid molecules encoding PEBP are useful in the controlling flowering in plants [see Abstract].
However, the combination of Nielson et al. and Brower-Toland et al. does not teach the recombinant vertebrate cell of claim 16, wherein the mammalian cell is a human cell, a mouse cell, or a hamster cell.
Kim et al. teach that recombinant Chinese hamster ovary cells (CHO) have been the most commonly used mammalian host for large-scale commercial production of therapeutic proteins [see Abstract].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Nielson et al., Brower-Toland et al., and Kim et al. according to the teachings of Kim et al. to use CHO cells in the recombinant vertebrate cells of Nielson et al. and Brower-Toland et al. because Nielson et al. and Brower-Toland et al. teach a recombinant mammalian cell for expression of a PEBP protein. Kim et al. teach that CHO cells are the most commonly used mammalian host for large-scale commercial production. One of ordinary skill in the art would have had a reasonable expectation of success and a reasonable level of predictability to combine the teachings of Nielson et al., Brower-Toland et al., and Kim et al. because Kim et al. acknowledges that CHO cells are the most commonly used mammalian host for large-scale commercial production. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Response to Remarks Regarding Prior Art Rejections
17. Applicants’ remarks filed on 09/12/2025 have been fully considered by the examiner; however, they are rendered moot in view of the new rejections set forth above, which are necessitated by applicants’ amendment to the claims.
Conclusion
18. Status of the claims:
Claims 1-2, 4-7, 12-14, and 16-18 are pending.
Claims 1-2, 4-7, 12-14 and 16-18 are rejected.
No claims are in condition for an allowance.
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 PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL J HOLLAND/Primary Examiner, Art Unit 1656
APPENDIX A
Brower-Toland et al. with SEQ ID NO: 1
Query Match 100.0%; Score 935; Length 174;
Best Local Similarity 100.0%;
Matches 174; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MPRIDPLIVGRVVGDVLDPFTRSVDLRVVYNNREVNNACGLKPSQIVTQPRVQIGGDDLR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MPRIDPLIVGRVVGDVLDPFTRSVDLRVVYNNREVNNACGLKPSQIVTQPRVQIGGDDLR 60
Qy 61 NFYTLVMVDPDAPSPSNPNLREYLHWLVTDIPATTDTSFGNEVICYENPQPSLGIHRFVF 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NFYTLVMVDPDAPSPSNPNLREYLHWLVTDIPATTDTSFGNEVICYENPQPSLGIHRFVF 120
Qy 121 VLFRQLGRETVYAPGWRQNFSTRDFAEVYNLGLPVSAVYFNCHRESGTGGRRAY 174
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VLFRQLGRETVYAPGWRQNFSTRDFAEVYNLGLPVSAVYFNCHRESGTGGRRAY 174
Brower-Toland et al. with SEQ ID NO: 623
Query Match 14.4%; Score 146.5; DB 1; Length 174;
Best Local Similarity 30.1%;
Matches 40; Conservative 21; Mismatches 55; Indels 17; Gaps 5;
Qy 41 LTPTQVKNRPTSISWDGLDSGKLYTLVLTDPDAPSRKDPKYREWHHFLVVNMKG-NDISS 99
| |:|: :| : | | ||||: |||||| :| ||: |:|| :: | |
Db 41 LKPSQIVTQP-RVQIGGDDLRNFYTLVMVDPDAPSPSNPNLREYLHWLVTDIPATTDTSF 99
Qy 100 GTVLSDYVGSGPPKGTGLHRYVWLVYEQDRPLKCDEPILSNR---SGDHRGKFKVASFRK 156
| : | | |:||:|:::: | | : | | | :
Db 100 GNEVICY--ENPQPSLGIHRFVFVLFRQ----------LGRETVYAPGWRQNFSTRDFAE 147
Qy 157 KYELRAPVAGTCY 169
| | ||: :
Db 148 VYNLGLPVSAVYF 160