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
The amendment filed October 9, 2025 in response to the Office Action of July 10, 2025 is acknowledged and has been entered.
Claims 9-11, 18, 20 and 23 have been amended.
Claim 38 has been added.
Claims 9-11 and 18-38 are pending.
Claims 24-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions or species, there being no allowable generic or linking claim.
Claims 9-11, 18-23 and 38 are currently under consideration as drawn to the elected invention.
Information Disclosure Statement
The Information Disclosure Statement filed on 12/23/2025 has been considered and entered by examiner.
MAINTAINED/MODIFIED REJECTIONS
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 9, 11, and 18-23 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.
Claim 9 recites “a variant human retinol dehydrogenase 12 (RDH 12) gene encoding a biologically active variant retinol dehydrogenase comprising SEQ ID NO: 30” which is ambiguous. This claim can be interpreted as the claimed RDH12 gene variants that encode the biologically active variant RDH wherein the biologically active variant comprising SEQ ID NO: 30, or RDH12 genes encoding variants of SEQ ID NO: 30. Based on claims 10, the variants can be encoded by SEQ ID NO: 17, or SEQ ID NO: 18 or SEQ ID NO: 20. As shown in the appendix (at the end of this Office Action), the encoded protein of SEQ ID NO: 17 (the elected sequence) or SEQ ID NO: 18 does not comprise full-length of SE ID NO: 30. And SEQ ID NO: 17 encodes a full-length RDH12 protein (see alignment below).
SEQ ID NO: 30 aligned with translated SEQ ID NO: 17
>17_TRANSLATED
Query Match 99.7%; Score 1500; DB 1; Length 316;
Best Local Similarity 100.0%;
Matches 290; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 2 AGGVCRTNVQLPGKVVVITGANTGIGKETARELASRGARVYIACRDVLKGESAASEIRVD 61
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 27 AGGVCRTNVQLPGKVVVITGANTGIGKETARELASRGARVYIACRDVLKGESAASEIRVD 86
Qy 62 TKNSQVLVRKLDLSDTKSIRAFAEGFLAEEKQLHILINNAGVMMCPYSKTADGFETHLGV 121
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 87 TKNSQVLVRKLDLSDTKSIRAFAEGFLAEEKQLHILINNAGVMMCPYSKTADGFETHLGV 146
Qy 122 NHLGHFLLTYLLLERLKVSAPARVVNVSSVAHHIGKIPFHDLQSEKRYSRGFAYCHSKLA 181
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 147 NHLGHFLLTYLLLERLKVSAPARVVNVSSVAHHIGKIPFHDLQSEKRYSRGFAYCHSKLA 206
Qy 182 NVLFTRELAKRLQGTGVTTYAVHPGVVRSELVRHSSLLCLLWRLFSPFVKTAREGAQTSL 241
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 207 NVLFTRELAKRLQGTGVTTYAVHPGVVRSELVRHSSLLCLLWRLFSPFVKTAREGAQTSL 266
Qy 242 HCALAEGLEPLSGKYFSDCKRTWVSPRARNNKTAERLWNVSCELLGIRWE 291
||||||||||||||||||||||||||||||||||||||||||||||||||
Db 267 HCALAEGLEPLSGKYFSDCKRTWVSPRARNNKTAERLWNVSCELLGIRWE 316
The translated amino acid sequence of SEQ ID NO: 17 is shown below (the sequence matched to SEQ ID NO: 30 is underlined).
MLVTLGLLTSFFSFLYMVAPSIRKFFAGGVCRTNVQLPGKVVVITGANTGIGKETARELASRGARVYIACRDVLKGESAASEIRVDTKNSQVLVRKLDLSDTKSIRAFAEGFLAEEKQLHILINNAGVMMCPYSKTADGFETHLGVNHLGHFLLTYLLLERLKVSAPARVVNVSSVAHHIGKIPFHDLQSEKRYSRGFAYCHSKLANVLFTRELAKRLQGTGVTTYAVHPGVVRSELVRHSSLLCLLWRLFSPFVKTAREGAQTSLHCALAEGLEPLSGKYFSDCKRTWVSPRARNNKTAERLWNVSCELLGIRWE
In addition, paragraph [0020] of the instant publication US 2022/0340949 A1 states that “the encoded human RDH12 protein can also encompass sequences comprising about 80, 85, 90, 95, 96, 97, 98, 99% sequence identity to SEQ ID NO: 30”. For the examination purpose, given Broadest Reasonable Interpretation (BRI), genes encoding variants of SEQ ID NO: 30 (without N-terminal transmembrane alpha helix) are encompassed by claim 9.
Similarly, the phrase "a variant retinol dehydrogenase 12 (RDH12) comprising SEQ ID NO: 30" of claim 11 renders the claim indefinite, as set forth above. Given Broadest Reasonable Interpretation (BRI), genes encoding variants of SEQ ID NO: 30 (without N-terminal transmembrane alpha helix) are encompassed by claim 11.
Claim 23 recites “a variant retinol dehydrogenase 12 (RDH12) comprising SEQ ID NO:30” which is ambiguous. It is unclear if the claim encompasses variants of SEQ ID NO: 30 or it is limited to an RDH12 comprising SEQ ID NO: 30. As set forth above, based on the second interpretation and paragraph [0020] of the instant publication US 2022/0340949, the variant RDH12 can also encompass variants comprising about 80, 85, 90, 95, 96, 97, 98, 99% sequence identity to SEQ ID NO: 30. For the examination purpose, given Broadest Reasonable Interpretation (BRI), variants of SEQ ID NO: 30 are encompassed by claim 23.
Claims 18-22 are also rejected because these claims depend on the rejected claims directly or indirectly.
Response to Arguments
For the 112(b) rejection, Applicant argues: the amended claims recite “a biologically active variant retinol dehydrogenase 12 comprising SEQ ID NO: 30, wherein the N-terminal transmembrane alpha helix is deleted from the variant retinol dehydrogenase and the solubility of the variant retinol dehydrogenase is increased over the wild-type retinol dehydrogenase” (claim 9); or the variant RDH12 gene (SEQ ID NO:17, SEQ ID NO: 18 or SEQ ID NO: 20), of claim 9, and “wherein the gene expresses a variant retinol dehydrogenase 12 (RDH12) comprising SEQ ID NO: 30, wherein the N-terminal transmembrane alpha helix is deleted from the variant retinol dehydrogenase and the solubility of the variant retinol dehydrogenase is increased over the wild-type retinol dehydrogenase” (claim 11); or “a variant retinol dehydrogenase 12 (RDH12) comprising SEQ ID NO:30, wherein the N-terminal transmembrane alpha helix is deleted from the variant retinol dehydrogenase… “ (claim 23), which make the claims definite.
Applicant’s arguments have been fully considered but they are not persuasive. As set forth above, the claims are still ambitious, because the claims can be interpreted as the claimed RDH12 gene variants that encode the biologically active variant RDH wherein the biologically active variant comprising SEQ ID NO: 30, or the claimed RDH12 genes encoding variants of SEQ ID NO: 30. Thus, the rejection is maintained for the reasons of record.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9-11, and 18-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a WRITTEN DESCRIPTION rejection.
Claim 9 is drawn a variant human retinol dehydrogenase 12 (RDH 12) gene encoding a biologically active variant retinol dehydrogenase 12 comprising SEQ ID NO: 30, wherein the N-terminal transmembrane alpha helix is deleted from the variant retinol dehydrogenase and the solubility of the variant retinol dehydrogenase is increased over the wild-type retinol dehydrogenase. Although claim 9 recites SEQ ID NO: 30, however, as set forth above it encompass genes encoding variants of SEQ ID NO: 30. As evidenced by paragraph [0020] of the instant publication US 2022/0340949 A1 : “the encoded human RDH12 protein can also encompass sequences comprising about 80, 85, 90, 95, 96, 97, 98, 99% sequence identity to SEQ ID NO: 30”. The genus of genes that encode protein at least 80% identical to SEQ ID NO: 30, which is 291 amino acid long, is over 10116 (1058 ways to pick 58 positions from 291 possible positions and 20 options for each picked position). Thus, the claim would encompass a broad genus of variants of human RDH12 gene. Similarly, claims 23 and 38 would encompass a broad genus of variants of RDH12 protein.
Vas-Gath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991), makes clear that: "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Gath at page 1116.)
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the
Applicants were in possession of the claimed genus.
The specification teaches SEQ ID NO: 30 which is a truncated human RDH12 protein without the N-terminal transmembrane alpha helix domain ([0066], [0099] and Example 1). Lee (Lee et al., Biotechnology and Bioengineering, 119(2): 399-410, Publication Date: 12/11/2024, in IDS of 10/24/2022) teaches expressing full length human RDH12 to make retinol.
The specification and prior art do not : provide any other variants which comprise about 80, 85, 90, 95, 96, 97, 98, or 99% sequence identity to SEQ ID NO: 30 and have required activity, e.g. converting retinal to retinol; produce or test any other variants in any practical application; provide any discussion on the structure-functional relationship between all possible variants; provide any evidence that the variants of RDH12 have increased solubility of any of the RDH proteins compared to wild type. Thus, one of ordinary skill in the art would not be able to readily recognize/visualize which variants would retain/gain the functions required for a practical application.
Regarding RDH12, Sarkar (Sarkar et al., Experimental Eye Research, 188 (2019) 107793, Publication Date: 09/07/2019) teaches that due to the difficulty in expression and purification of RDHs, the structure of RDH12 or that of any other vertebrate RDH has not yet been solved (page 3, col. 1, para. 3). In addition, even a single amino acid change (Y226C) in RDH12 can lead to loss of enzyme activity (page 1, col. 2, para. 1).
In view of above, other than the truncated RDH12 (SEQ ID NO: 30), one of ordinary skilled in the art would not be able to readily recognize/visualize any other variants of truncated RDH12 protein, wherein the N-terminal transmembrane alpha helix is deleted, with required biochemical properties for a practical application.
Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993). And Amgen Inc. v. Chugai
Pharmaceutical Co. Ltd., 18 USPQ2d 1016. The Guidelines for Examination of Patent
Applications under the 35 USC §112 paragraph 1, "Revision 1" of Written Description
Requirement (66 FR 1099-1111, March 25, 2008) state, "[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the Applicant was in possession of the claimed invention (Id. At 1104). Moreover, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has the
Applicant described distinguishing identifying characteristics sufficient to show that
Applicant were in possession of the claimed invention at the time the application was filed.
Claims 10, 11, 18-23 and 38 also encompass a broad genus of variants of human RDH12 gene.
In addition, claim 10 recites SEQ ID NO: 17 which encodes a full length wild-type RDH12 protein. And SEQ ID NO: 17 does not encode SEQ ID NO: 30 as set forth above. The specification does not describe gene comprising SEQ ID NO: 17 which has the properties as claimed by claim 9.
Therefore for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that Applicant had possession of the claimed invention at the time the instant application was filed.
Response to Arguments
For the 112(a) rejection, Applicant argues:
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Applicant’s arguments have been fully considered but they are not persuasive. As set forth above, although the amended claims recite the variant retinol dehydrogenase has the N-terminal transmembrane alpha helix deleted, given BRI, the claims still encompass variants of SEQ ID NO: 30. The specification and prior art does not provide sufficient written description support for the broad genus of variants of SEQ ID NO: 30 which have the required properties as claimed, e.g. increased solubility, maintained enzyme activity. Thus, the rejection is maintained for the reasons of record.
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lee (Lee et al., Biotechnology and Bioengineering, 119(2): 399-410, Publication Date: 12/11/2024, in IDS of 10/24/2022, of record) in view of Rehbein (Rehbein et al., Protein Expr. Purif., 160: 84-93, Publication Date: 04/04/2019, in IDS of 05/09/2022, of record).
As set forth in 112(b) above and 112(d) below, SEQ ID NO: 17 encodes full-length wild-type RDH12 protein. Thus, claim 10 is not further limiting claim 9 (see 112(d) rejection below). Thus, the rejection is made to claim 10, not claim 9.
Lee teaches that retinol is a fat-soluble vitamin A that is widely used in the food and pharmaceutical industries. Microbial production of retinol has been alternatively explored but restricted to a mixture of retinoids including retinol, retinal, and retinoic acid. Thus, we introduced heterologous retinol dehydrogenase into retinoids mixture-producing Saccharomyces cerevisiae for the selective production of retinol. Expression of human RDH10 and Escherichia coli ybbO led to increase in retinol production, but retinal remained as a major product. In contrast, S. cerevisiae harboring human RDH12 produced retinol selectively with negligible production of retinal. The resulting strain (SR8A-RDH12) produced retinol only (Abstract). Lee teaches that RDH converts retinal to retinol (Fig. 1).
Lee also teaches that acetyl-CoA is a precursor for production of retinol (Fig. 1).
Lee teaches the variant human RDH12 as set forth above. However, Lee does not teach that the nucleic acid sequence is SEQ ID NO: 17 (the elected species). As indicated by paragraph [0053] of instant publication US 2022/0340949 A1, SEQ ID NO: 17 is a codon optimized version of full length human RDH12.
Rehbein teaches that for efficient and successful heterologous expression, the donor gene should be appropriately modified and made “compatible” for expression in the host species by accounting for the codon usage bias between donor and host (page 85, col. 1, para. 2).
Rehbein teaches methods and platform (e.g. CodonWizard) for codon optimization (§ 2. Material and methods).
Rehbein teaches codon optimization is not a mere theoretical concept anymore, but may be routinely implemented in practical everyday cloning effort (page 92, col. 1, para. 2).
It would have prima facie been obvious to one of ordinarily skilled in the art at the time the invention was filed to combine the teachings of Lee and Rehbein to optimizing codon of human RDH12 for heterologous expression in other host species, because codon optimization is important for efficient and successful heterologous expression as taught by Rehbein. Given that the instant application use the same codon optimization tool: CodonWizard (as evidenced by paragraph [0088] of the instant publication US 2022/0340949 A1) as taught by Rehbein, one of ordinary skilled in the art would have reasonable expectation of success to reach the claimed sequence.
Response to Arguments
For the 103 rejection to claim 10, Applicant argues:
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Applicant’s arguments have been fully considered but they are not persuasive. As set forth above in 112(b), claim 10 recites SEQ ID NO: 17 which encodes full-length wild-type RDH12 protein. Thus, claim 10 encompass genes which do not have the N-terminal transmembrane alpha helix deleted. It would have prima facie been obvious to one of ordinarily skilled in the art at the time the invention was filed to combine the teachings of Lee and Rehbein to optimizing codon of human RDH12 for heterologous expression in other host species, because codon optimization is important for efficient and successful heterologous expression as taught by Rehbein. Given that the instant application use the same codon optimization tool: CodonWizard (as evidenced by paragraph [0088] of the instant publication US 2022/0340949 A1) as taught by Rehbein, one of ordinary skilled in the art would have reasonable expectation of success to reach the claimed sequence. Thus, the rejection is maintained for the reasons of record.
NEW REJECTIONS
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10, which depend on claim 9, recites “wherein the gene comprises a nucleic sequence selected from the group consisting of: SEQ ID NO: 17, SEQ ID NO: 18; or SEQ ID NO: 20. The coded protein of SEQ ID NO: 17 (the elected species) is identical to the full length human RDH12:
|Q96NR8|RDH12_HUMAN Retinol dehydrogenase 12 OS=Homo sapiens
Alignment for protein encoded by SEQ ID NO: 17 and human RDH12
Score
Expect
Identities
Positives
649 bits(1675)
0.0
316/316(100%)
316/316(100%)
Query 1 MLVTLGLLTSFFSFLYMVAPSIRKFFAGGVCRTNVQLPGKVVVITGANTGIGKETARELA 60
MLVTLGLLTSFFSFLYMVAPSIRKFFAGGVCRTNVQLPGKVVVITGANTGIGKETARELA
Sbjct 1 MLVTLGLLTSFFSFLYMVAPSIRKFFAGGVCRTNVQLPGKVVVITGANTGIGKETARELA 60
Query 61 SRGARVYIACRDVLKGESAASEIRVDTKNSQVLVRKLDLSDTKSIRAFAEGFLAEEKQLH 120
SRGARVYIACRDVLKGESAASEIRVDTKNSQVLVRKLDLSDTKSIRAFAEGFLAEEKQLH
Sbjct 61 SRGARVYIACRDVLKGESAASEIRVDTKNSQVLVRKLDLSDTKSIRAFAEGFLAEEKQLH 120
Query 121 ILINNAGVMMCPYSKTADGFETHLGVNHLGHFLLTYLLLERLKVSAPARVVNVSSVAHHI 180
ILINNAGVMMCPYSKTADGFETHLGVNHLGHFLLTYLLLERLKVSAPARVVNVSSVAHHI
Sbjct 121 ILINNAGVMMCPYSKTADGFETHLGVNHLGHFLLTYLLLERLKVSAPARVVNVSSVAHHI 180
Query 181 GKIPFHDLQSEKRYSRGFAYCHSKLANVLFTRELAKRLQGTGVTTYAVHPGVVRSELVRH 240
GKIPFHDLQSEKRYSRGFAYCHSKLANVLFTRELAKRLQGTGVTTYAVHPGVVRSELVRH
Sbjct 181 GKIPFHDLQSEKRYSRGFAYCHSKLANVLFTRELAKRLQGTGVTTYAVHPGVVRSELVRH 240
Query 241 SSLLCLLWRLFSPFVKTAREGAQTSLHCALAEGLEPLSGKYFSDCKRTWVSPRARNNKTA 300
SSLLCLLWRLFSPFVKTAREGAQTSLHCALAEGLEPLSGKYFSDCKRTWVSPRARNNKTA
Sbjct 241 SSLLCLLWRLFSPFVKTAREGAQTSLHCALAEGLEPLSGKYFSDCKRTWVSPRARNNKTA 300
Query 301 ERLWNVSCELLGIRWE 316
ERLWNVSCELLGIRWE
Sbjct 301 ERLWNVSCELLGIRWE 316
However, claim 9 recites the variant has the N-terminal transmembrane alpha helix deleted. Thus, claim 10 fails to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
Claim 38 is drawn to allowable subject matter.
Claims 9-11, and 18-23 are rejected.
All other objections and rejections set forth in the previous Office Action of July 10, 2025 are hereby withdrawn in view of the claim amendments and Applicant’s arguments.
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 CHENG LU whose telephone number is (571)272-0334. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571)270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHENG LU/ Examiner, Art Unit 1642
/PETER J REDDIG/Primary Examiner, Art Unit 1646
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