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 .
Response to Amendment/Disposition of Claims
Applicant’s Amendment filed on 13 April 2026 has been received and entered. Claims 1, 4-5, 7, 9, 13, 15, 18-20, 36, 38, 41, 46-48, 50, 52-53, and 57 were pending. Claims 1, 4-5, 7, 9, 13, 18-20, 48, 50, 52-53, and 57 have been amended. Claims 2-3, 6, 8, 10-12, 14, 16-17, 21-35, 37, 39-40, 42-45, 49, 51, 54-56, and 58 have been cancelled. No new claims have been added.
Accordingly, Claims 1, 4-5, 7, 9, 13, 15, 18-20, 36, 38, 41, 46-48, 50, 52-53, and 57 are currently pending and will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US 2023/0341397 A1, Published 26 October 2023. Applicant’s amended Specifications as presented on 13 April 2026, 14 July 2023, and 10 March 2023 are acknowledged and entered.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
Drawings
Maintained Objections
(Objection Maintained and Extended) – The objection to the Drawings for containing references to colors either in the figures themselves or in the figure legends within the Specification is maintained as it relates to Figures 8, 10, and 14 and Paragraphs 0146, 0153, and 0157, and extended to include Paragraphs 0119 and 0154-0155.
Response to Arguments
Applicant's arguments filed with respect to the objection to the Drawings have been fully considered but they are not persuasive.
In their Response, Applicant argues that “Paragraphs [0120], [0150]-[0153], and [0155] are amended to remove references to red fluorescence, green fluorescence, red signal, and green signal, and also to clarify that fluorescence is emitted from a red or green protein and detected in a red or green channel” (see Page 1 of Remarks, Paragraph 5) and that the “text of FIGs. 10A, 10B, 11A, 11B, 12A, 12B, 12C, 13A, and 13B is amended to clarify that fluorescence is detected in a red or green channel” (see Page 1, Paragraph 6). Applicant also argues that “paragraph [0146] does not refer to colors in the drawings and that there is no paragraph [0157]” (see Page 1, Paragraph 4).
Examiner does not find these arguments persuasive. While Examiner appreciates Applicant’s attempts to clarify the language used in the specification, it does not address the fact that colors are referenced with regard to the specific assay readouts. Examiner strongly suggests filing a petition for color drawings to be used in the instant application, particularly since the readout for the claimed invention is a colorimetric one. If such a petition is granted by the Office, then it would overcome any objections to the drawings and specification. Regarding Applicant’s arguments with respect to Paragraphs 0146 and 0157, Examiner was using the paragraph numbering from the PGPub of the instant application, US 2023/0341397 A1, as is stated above and was stated in the previous Office Action. These paragraphs correspond to paragraphs 0144 and 0155, respectively, in both the specification filed on 10 March 2023 and the most recent specification filed on 13 April 2026. Examiner included this note so as to try to prevent any confusion over the paragraph numbers. As such, the objection to the Drawings for containing references to colors either in the figures themselves or in the figure legends within the Specification is maintained as it relates to Figures 8, 10, and 14 and Paragraphs 0146, 0153, and 0157, and extended to include Paragraphs 0119 and 0154-0155.
New Objections
(New Objection) – The drawings are objected to for containing minor informalities: In the figure legend for Figure 14, it accidentally recites “FIG. 13B”. It should be amended to instead recite “FIG. 14B”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Withdrawn Objections
(Objection Withdrawn) – The objection to the Abstract of the disclosure for not commencing on a separate sheet is withdrawn in light of the amendments to the Abstract.
New Objections
(New Objection) – The disclosure is objected to because of the following informalities: in Paragraph 0146, it should say “wells of fluorescence” instead of “wells of fluorescent”.
In Paragraph 0034, it should say “FIG. 14B” instead of “FIG. 13B”, as noted above.
Appropriate correction is required.
The use of the terms ATCC, mKate, mKate2, mNeonGreen, BacMam, BioTek Synergy, DMEM, which are trade names or a marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
(Objection Withdrawn) – The objection to Claims 4, 7, and 13 for containing minor informalities is withdrawn in light of the amendments to the claims.
Claim Rejections - 35 USC § 112(b); Second Paragraph
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.
(Rejection Withdrawn) – The rejection of Claims 4-5 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim Rejections - 35 USC § 112(a); First Paragraph
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.
Withdrawn Rejections
(Rejection Withdrawn) – The rejection of Claims 1, 4-5, 7, 9, 13, 15, 18-20, 36, 38, 41, 46-48, 50, 52-53, and 57 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for being enabling for an isolated vector or an isolated cell comprising said vector but not for a cell within a transgenic animal or a transgene therein is withdrawn in light of the amendments to the claims.
Maintained Rejections
(Rejection Maintained) – The rejection of Claims 9 and 18-19 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for being enabling for amino acid sequences which are 100% identical to instant SEQ ID NOs: 4, 6, and 13-14 and for amino acid sequences encoded by nucleotides sequences which are 100% identical to instant SEQ ID NOs: 7-9 and 23-24 but not for being enabling for variants of the claimed sequences with less than 100% sequence identity is maintained.
(Rejection Maintained) – The rejection of Claims 9 and 18-19 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 is maintained.
Response to Arguments
Applicant's arguments filed with respect to the enablement rejection of Claims 9 and 18-19 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, have been fully considered but they are not persuasive.
In their Response, Applicant argues that they disagree with the rejection “but to facilitate prosecution has amended the claims to encompass polypeptides at least 95% identical to the recited polypeptides” and “asserts that the claims 9 and 18-19 are enabling and have sufficient support in the specification and requests withdrawal of the rejection as it applies to those claims” (see Page 4 of Remarks, Paragraph 2).
Examiner does not find these arguments persuasive. Applicant failed to present any evidence or point out in the specification where the critical or essential amino acids or nucleotides of the claimed sequences are that cannot be changed, any variants of the claimed sequences, and failed to provide insight into what kinds of mutations or changes can be tolerated, even with the percent variability being claimed having been reduced from 25% to 5%. As noted in the previous Office Action, the claim language still does not limit how the claimed changes can be interpreted for either the degron or the cleavage site recited in Claim 18 and no percent identity threshold is again recited in said claim. While Claim 18 has been amended to limit the number of changes possible for the degron and the cleavage site, it still remains that no insight is provided into what kinds of mutations or changes can be tolerated. As such, the essential characteristics of the genera being claimed by Applicant have still not been identified or disclosed and, due to the unpredictability regarding whether or not peptide variants of known sequences will function as intended, one would still be burdened with undue experimentation to use the products of the instant claims as broadly as they are currently claimed. As such, the enablement rejection of Claims 9 and 18-19 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is maintained.
Applicant's arguments filed with respect to the rejection of Claims 9 and 18-19 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 have been fully considered but they are not persuasive.
Applicant presented the same, simultaneous arguments for both the 112a scope of enablement rejection and written description rejection of Claims 9 and 18-19. Examiner rebutted both simultaneously (see above). As such, a separate rebuttal for arguments against the outstanding written description rejection is not required. Thus, the written description rejection of Claims 9 and 18-19 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is maintained.
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.
(Rejection Withdrawn) – The rejection of Claim 48 under 35 U.S.C. 101 as being directed to or encompassing a human organism is withdrawn in light of the amendments to the claim.
Claim Rejections - 35 USC § 103
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.
(Rejection Maintained) – The rejection of Claims 1, 5, 9, 15, 19-20, 36, 38, 41, 47-48, 50, 53, and 57 under 35 U.S.C. 103 as being unpatentable over Tan et al. (US 2005/0214890 A1, Published 29 September 2005), Minshull and Theodorou (US 2015/0225468 A1, Published 13 August 2015), Ast et al. (US 2017/0247769 A1, Published 31 August 2017), Lakshmanan et al. (US 2021/0060185 A1, earliest Priority Date 28 August 2019), Brandon and Thomas (US 2008/0274988 A1, Published 06 November 2008), Bancel et al. (US 2014/0010861 A1, Published 09 January 2014), and Shaner et al. (U.S. Patent No. 10,221,221 B2, Issued 05 March 2019) is maintained as it relates to claims 1, 5, 15, 19-20, 36, 38, 41, 47-48, 50, 53, and 57 but is withdrawn as it relates to claim 9.
(Rejection Maintained) – The rejection of Claims 4, 7, 13, and 52 under 35 U.S.C. 103 as being unpatentable over Tan et al. (US 2005/0214890 A1, Published 29 September 2005), Minshull and Theodorou (US 2015/0225468 A1, Published 13 August 2015), Ast et al. (US 2017/0247769 A1, Published 31 August 2017), Lakshmanan et al. (US 2021/0060185 A1, earliest Priority Date 28 August 2019), Brandon and Thomas (US 2008/0274988 A1, Published 06 November 2008), Bancel et al. (US 2014/0010861 A1, Published 09 January 2014), and Shaner et al. (U.S. Patent No. 10,221,221 B2, Issued 05 March 2019), as applied to claims 1, 5, 9, 15, 19-20, 36, 38, 41, 47-48, 50, 53, and 57 above, and further in view of Meyer and Vignuzzi (US 2023/0257734 A1, earliest Priority Date 03 July 2020), Agrawal et al. (WO 2021/173865 A2, earliest Priority Date 25 February 2020), and Tanaka et al. (2012) (cited by Applicant on IDS filed on 10 March 2023) is maintained.
Response to Arguments
Applicant's arguments filed with respect to the rejection of Claims 1, 5, 9, 15, 19-20, 36, 38, 41, 47-48, 50, 53, and 57 under 35 U.S.C. 103 as being unpatentable over Tan et al. (US 2005/0214890 A1, Published 29 September 2005), Minshull and Theodorou (US 2015/0225468 A1, Published 13 August 2015), Ast et al. (US 2017/0247769 A1, Published 31 August 2017), Lakshmanan et al. (US 2021/0060185 A1, earliest Priority Date 28 August 2019), Brandon and Thomas (US 2008/0274988 A1, Published 06 November 2008), Bancel et al. (US 2014/0010861 A1, Published 09 January 2014), and Shaner et al. (U.S. Patent No. 10,221,221 B2, Issued 05 March 2019) have been fully considered but they are not persuasive.
In their Response, Applicant argues that “Examiner has mischaracterized the teachings of Lakshmanan” (see Page 5 of Remarks, Paragraph 2), and that “Lakshmanan is directed to engineered protease-sensitive gas vesicles (acoustic reporter particles for ultrasound contrast-enhanced imaging to detect protease activity, not a fluorescent protein-based biosensor of any kind” (see Page 5, Last Paragraph). Applicant also argues that the “reference to a ‘5’ UTR’ in Lakshmanan appears only in the context of explaining that a mammalian expression cassette ‘typically’ contains a 5’ UTR region and describing what a 5’ UTR is”, that there “is no teaching or suggestion in Lakshmanan , or any of the other cited art of a specific functional 5’ UTR as an operative element of a protease biosensor” (see Page 5, Last Paragraph), and that there is no “motivation to combine Minshull and Lakshmanan” (see Page 5, Last Paragraph and Page 6, First Paragraph). Applicant then argues that the protease activity assay system of Tan et al. is for in vitro use only and that there “is no teaching in Tan to use the system in cells, which is where a degron would actually be functional” (see Page 6, Paragraph 2). Additionally, Applicant argues that the “Ast fluorescent proteins are nested” and “would not be functional in the biosensor” of the instant claims (see Page 6, Paragraph 3). Furthermore, Applicant argues that the teachings of Brandon and Bancel are non-analogous art to the subject matter of the instant claims (see Page 6, Last Paragraph and Page 7, Paragraph 2). Finally, Applicant argues that “Shaner teaches isolated nucleic acid sequences encoding a monomeric green/yellow fluorescent proteins, and fragments and derivatives thereof” (see Page 7, Paragraph 3).
Examiner does not find these arguments persuasive.
In response to Applicant’s arguments regarding Lakshmanan, while the biosensor in question is not directed to a fluorescent protein-based biosensor, it is still directed to a biosensor for detecting protease activity and protease-associated activity. The biosensor in question is expressed using an expression cassette, which would presumably have all of the necessary regulatory elements to properly and sufficiently express the gene or genes comprised within, including a 5’ UTR. It would be obvious to a person of ordinary skill in the art to include such an element, as it can contain sequences such as a Kozak sequence, as taught by Lakshmanan, which ensures the proper and efficient expression of any downstream gene or genes.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Minshull and Theodorou teach an expression vector encoding a biosensor which can be used as an indicator for protease activity, which Lakshmanan et al. also teach. Both references also teach an expression cassette encoding said biosensor. As noted above, said expression cassettes, and the vectors which comprise them, would presumably have all of the necessary regulatory elements to properly and sufficiently express the gene or genes comprised within, including a 5’ UTR. It would be obvious to a person of ordinary skill in the art to include such an element, as it can contain sequences such as a Kozak sequence, as taught by Lakshmanan, which improves expression efficiency of any downstream gene or genes. Thus, both references teach the same or similar elements for the same or a similar purpose. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
Regarding Applicant’s arguments regarding Tan et al., the fluorescent fusion substrate expression construct is expressed from an expression vector, which can be a viral vector and which Tan et al. explicitly states can be used for the purpose of transferring DNA, RNA, or other nucleic acids into cells either in vitro or in vivo (see Paragraph 0032). It is possible that an in vitro assay system is the preferred embodiment, but that does not mean the reference does not teach an in vivo assay system. Applicant is reminded that preferred embodiments are not the only teaching of a reference.
“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also > Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005)(reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); < Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. “The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.”).
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). MPEP 2123.
Regarding Applicant’s arguments with respect to Ast et al., while the fluorescent sensor construct might not be the same as the instantly claimed construct, the constituent parts are applicable. Specifically, the baculovirus-derived vector comprising said construct as well as the first and second fluorescent proteins used, all of which are well-known in the art and therefore do not confer patentability.
Similarly to Ast et al., the teachings of Shaner et al. might not be identical to the instantly claimed construct, the constituent parts are still applicable. Specifically, Shaner et al. teach a specific sequence for the mNeonGreen fluorescent protein, which is well-known in the art and therefore does not confer patentability.
In response to applicant's argument that Brandon and Bancel are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Brandon and Thomas teach a specific amino acid sequence for ubiquitin, which is not novel. Both Minshull and Theodorou Lakshmanan teach biosensors with degrons or degradation signals, which encompasses a molecule such as ubiquitin. Simply claiming a specific sequence for said ubiquitin, which is well-known in the art, does not confer patentability. This same line of applies to the sequence disclosed by Shaner et al., as noted above. The rejection of Claim 9 has been withdrawn and this was the only claim Bancel was used to reject, so the arguments presented are moot in light of the amendments to the claim.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the feature upon which applicant relies (i.e., “a specific functional 5’ UTR”) is not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Specifically, neither Claim 1 nor Claim 20 recite a specific 5’ UTR. This element is only recited in Claim 4, which is a dependent claim of Claim 1, not Claim 20, and which is not included in this rejection.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
As such, rejection of Claims 1, 5, 9, 15, 19-20, 36, 38, 41, 47-48, 50, 53, and 57 under 35 U.S.C. 103 as being unpatentable over the prior art is maintained as it relates to claims 1, 5, 15, 19-20, 36, 38, 41, 47-48, 50, 53, and 57 but is withdrawn as it relates to claim 9.
Applicant's arguments filed with respect to the rejection of Claims 4, 7, 13, and 52 under 35 U.S.C. 103 as being unpatentable over Tan et al. (US 2005/0214890 A1, Published 29 September 2005), Minshull and Theodorou (US 2015/0225468 A1, Published 13 August 2015), Ast et al. (US 2017/0247769 A1, Published 31 August 2017), Lakshmanan et al. (US 2021/0060185 A1, earliest Priority Date 28 August 2019), Brandon and Thomas (US 2008/0274988 A1, Published 06 November 2008), Bancel et al. (US 2014/0010861 A1, Published 09 January 2014), and Shaner et al. (U.S. Patent No. 10,221,221 B2, Issued 05 March 2019), as applied to claims 1, 5, 9, 15, 19-20, 36, 38, 41, 47-48, 50, 53, and 57 above, and further in view of Meyer and Vignuzzi (US 2023/0257734 A1, earliest Priority Date 03 July 2020), Agrawal et al. (WO 2021/173865 A2, earliest Priority Date 25 February 2020), and Tanaka et al. (2012) (cited by Applicant on IDS filed on 10 March 2023) have been fully considered but they are not persuasive.
In their Response, Applicant argues that “the rejection of claims 4, 7, 13, and 52 fails for the same reasons provided in the rejection of claims 1, 5, 9, 15, 19-20, 36, 38, 41, 47-48, 50, 53, and 57 above” and that the “teachings of Meyer, Agrawal, and Tanaka do not cure the deficiencies and were not cited for that purpose” (see Page 8 of Remarks, First Paragraph). Applicant also argues that “Meyer and Agrawal do not teach UTRs”, that “Tanaka was cited for teaching that the 5’ UTR of SARS-CoV-1 RNA protects viral mRNA from the host translational shutoff caused by the viral NSP1 protein”, but that since “Tanaka was published in 2012”, it “cannot teach or suggest the 5’ UTR of SARS-CoV-1 RNA” (see Page 8, First Paragraph).
Examiner does not find these arguments persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s arguments, Examiner acknowledges that neither Meyer and Vignuzzi and Agrawal et al. teach UTRs and that Tanaka was published long before the COVID-19 pandemic, but Examiner did not claim that Tanaka et al. taught the 5’ UTR of SARS-CoV-2. Examiner stated that Tanaka et al. taught that the 5’ UTR of SARS-CoV-1 RNA protects viral mRNA from the host translational shutoff caused by the viral NSP 1 protein and that it would have been for a skilled artisan to try the SARS-CoV-2 5’ UTR as a means for avoiding translational shutoff of the prior art vector in the cells being tested for the presence of SARS-CoV-2, given how closely related the two viruses are. It would not be an unreasonable stretch of the imagination that the 5’ UTR in SARS-CoV-2 would function in the same or a similar manner as the one found in SARS-CoV-1. As such, the rejection of Claims 4, 7, 13, and 52 under 35 U.S.C. 103 as being unpatentable over the prior art is maintained.
Conclusion
No claims are allowed.
The prior art made of record, but not relied upon, and considered pertinent to applicant's disclosure is listed below:
Stein and Alexandrov (US 2016/0223529 A1, Published 04 August 2016)
Stein and Alexandrov teach a bimolecular protease-based biosensor for the detection of one or more target molecules. This reference has not been utilized, as rejection would have been redundant to those set forth above.
THIS ACTION IS MADE FINAL. 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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAREY ALEXANDER STUART/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
Prosecution Insights