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
Responsive to communication entered 11/14/2025.
Priority
This application, filed 03/11/2022, Pub. No. US 2022/0283131 A1, published 09/08/2022, is a continuation of International Patent Application No. PCT/KR2021/005364, filed 04/28/2021, which claims priority to US provisional application 63/077,199, filed 09/11/2020, and claims foreign priority to KR 10-2020-0113398, filed 09/04/2020, KR 10-2020-0114142, filed 09/07/2020, and KR 10-2021-0052647, filed 04/23/2021.
Status of Claims
Claims 1-20 are currently pending. Claims 1-20 have been subject to restriction/election requirement mailed 09/25/2025. Claims 7-9 and 11-20 are withdrawn from consideration. Claims 1-6 and 10 are examined.
Election/Restriction
Applicant's election, without traverse, of Group I, Claims 1-10, drawn to a composition containing a complex compound represented by Formula 1 and kit for analyte detection comprising the composition of claim 1, and the species:
(1) CB3GA-Rhodamine-(SLVPR)5 (M=SLVPR, n=5, L1=Rhodamine, N1=CB3GA (albumin-binding peptide) as a complex compound represented by Formula 1;
(2) the trypsin-mediated cleavage condition, in which the (SLVPR)5 unit is cleaved into SLVPR monomers for subsequent mass-spectrometric detection as a reagent and/or conditions for cleaving [M]n in the complex compound represented by Formula 1 into units M,
in the reply filed on 11/14/2025 is acknowledged.
With regard to “N1=CB3GA (albumin-binding peptide)”, it is noted that one of skill in the art would have known that CB3GA (Cibacron® Blue F3GA) isn't a peptide, but a blue dye that has been used as a ligand for liquid chromatography and for depleting albumin for nearly 50 years.
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Emphasis added.
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Because Applicant did not distinctly and specifically point out the supposed errors in the species election requirement, the species election has been treated as an election without traverse (MPEP § 818.01(a)).
Although required, Applicant did not identify the claims encompassing the elected species. The Examiner believes that the elected species are encompassed by 1-6 and 10 of the elected Group I, because Claims 7-9 do not read on the elected species (1).
Claims 7-9 and 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/14/2025.
Information Disclosure Statement
The information disclosure statements, submitted on 03/11/2022 and 11/14/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the Examiner.
Specification
The use of the terms Triton and Tween, which are a trade name or a mark used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
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.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejection - 35 USC § 112
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 112 that form the basis for the rejections under this section made in this Office action.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
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 1-6 and 10 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-6, as recited in independent Claim 1, are drawn to:
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Claim 10 is drawn to:
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MPEP § 2163 states that to satisfy the written description requirement, 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, and that the invention, in that context, is whatever is now claimed:
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed.” In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an 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, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter.” Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In reKaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).” Emphasis added.
MPEP § 2163 further lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application for a claimed genus:
“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 (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., 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 inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").” Emphasis added.
It is the Examiner' position that the instant specification fails to provide adequate written description and clear guidance for the composition and kit as claimed and does not reasonable convey to one skilled in the relevant art that the inventor(s), at the time
the application was filed, had possession of the entire scope of the claimed invention.
The Examiner' position is based on the following facts and considerations.
First, it is not clear what analyte is implemented by recitation “the analyte” in Claim 1.
Second, the claims are not limited to any group of compounds that can be easily identifiable. The genus of complex compounds represented by Formula 1 is enormous because the substituents M, N1 and L1 can assume any chemical entities. M in any claim is chosen from any groups of amino acids, peptides, saccharides or polysaccharides. Just taking M alone, there are billions of compounds that fall within the definitions. The same applies to L1, which is a linker or a bond, and N1 which dependent on an analyte, with the analyte being unknown. It is further noted that it does not help to define M by its mass-to charge ratio (Claim 3) or by X1 ... Xm (Claim 4), as already m ranges from 1 to 100. The same considerations apply to Claim 5 with X1 and Xm being limited to a choice of 5 amino-acids, as m can be 100.
Third, the specification is limited to the use of the only example of a complex compound represented by Formula 1, which is the elected species (1) CB3GA-Rhodamine-(SLVPR)5 (M=SLVPR, n=5, L1=Rhodamine, N1=CB3GA (albumin-binding peptide), wherein the peptide polymer ((SLVPR)5) composed of 5 repeats of the SLVPR peptide fragment was used for albumin detection, the amplification effect could be produced as the peptide polymer was cleaved into 5 SLVPR peptide fragments due to trypsin treatment, and the sensitivity increased more than 6.5 times compared to that in the fluorescence measurement method. See [Experimental Example 6] (2) Evaluation of Diagnostic Ability of Detection Sensor.
Fourth, the present application concerns a composition for detection of analytes by mass spectrometry. Basically, the invention appears to rely on the use of [M]n with n at least being 2 to amplify the detection of a signal. The application reads that "In order to quantify the same biomarker in multiple samples using the peptide, a binding moiety that recognizes the analyte, such as a detection moiety composed of a different sequence for each sample, may be provided, so that multiple samples may be pooled into one and quantified simultaneously." (Paragraph [00222], page 122). From this statement it appears that the invention also relies on multiple probes and single peptides with n in [M]n
being 1 and not 2 as in the claims.
Fifth, there is no known or disclosed correlation between function and structure because, when considering the “laundry” lists of the over 600 peptides in Tables 2 to 19 of the description, each of these peptides appear to have their own function, namely, characterized by their own retention time. The same applies for the peptides in Tables 20-22.
Therefore, the compositions and kits of Claims 1-6 and 10 do not meet the written description provision of 35 U.S.C. §112(a) or 35 U.S.C. §112 (pre-AIA ), first paragraph.
Claims 1-6 and 10 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 pre-AIA the applicant regards as the invention.
Regarding Claim 1, it is not clear what analyte is implemented by recitation “the analyte”. Claims 2-6 and 10 are rejected as being dependent upon the rejected Claim 1 and fail to cure the indefiniteness of Claim 1.
Claim Rejections - 35 USC § 102
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 1-6 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Duncan et al., “Cleavage site for sterol-regulated protease localized to a leu-ser bond in the lumenal loop of sterol regulatory element-binding protein-2,” J. Biol. Chem., 1997, vol. 272, pp. 12778–12785.
With respect to Claims 1-6, Duncan et al., throughout the publication and, for example, at page 12779, teach a complex compound represented by Formula 1, wherein M=MASMTGGQQMG, n=3, L1=BP2 peptide, N1=the HSV epitope (QPELAPEDPED) (HSV antibody-binding peptide):
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Emphasis in the original.
With respect to Claim 10, Duncan et al. as above teach a complex compound
represented by Formula 1. Although Duncan et al. do not specifically invoke the use of a “kit” comprising the aforementioned complex compound, it is noted that the terminology “kit” is not found to further limit the scope of the claim beyond requiring the use of this named reagent, as this is the sole constituent reagents of the kit of Claim 10. This terminology of a “kit” does not clearly invoke any additional ingredients or provide antecedent basis for terms appearing in the body of the claim (such as specific packaging or container elements, for example). Consequently, when the claims are given their broadest reasonable interpretation, the teachings of Duncan et al. are anticipatory even though the reference does not employ the word "kit" in describing their invention, as the reference teaches all necessary reagents of the claimed “kit.” See also MPEP 2111.02:
II. PREAMBLE STATEMENTS RECITING PURPOSE OR INTENDED USE
The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use “can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim” as drafted without importing “‘extraneous’ limitations from the specification.” Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). Emphasis added.
Therefore, Duncan et al. teach all limitations of the instant Claims 1-6 and 10.
Claims 1-4, 6 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sahar et al., "Sequence and Conformational Analysis of Peptide-Polymer Bioconjugates by Multidimensional Mass Spectrometry," Biomacromolecules, 2018, vol. 19, no. 5, pp. 1498–1507.
With respect to Claims 1-4 and 6, Sahar et al., throughout the publication and, for example, in Abstract, teach a complex compound represented by Formula 1, wherein
M=AAQA, n=2, L1=bond, N1=PEG (binds an analyte, such as an anti-PEG antibody):
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With respect to Claim 10, Sahar et al. as above teach a complex compound represented by Formula 1. Although Sahar et al. do not specifically invoke the use of a “kit” comprising the aforementioned complex compound, it is noted that the terminology “kit” is not found to further limit the scope of the claim beyond requiring the use of this named reagent, as this is the sole constituent reagents of the kit of Claim 10. This terminology of a “kit” does not clearly invoke any additional ingredients or provide antecedent basis for terms appearing in the body of the claim (such as specific packaging or container elements, for example). Consequently, when the claims are given their broadest reasonable interpretation, the teachings of Sahar et al. are anticipatory even though the reference does not employ the word "kit" in describing their invention, as the
reference teaches all necessary reagents of the claimed “kit.” See also MPEP 2111.02:
II. PREAMBLE STATEMENTS RECITING PURPOSE OR INTENDED USE
The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use “can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim” as drafted without importing “‘extraneous’ limitations from the specification.” Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). Emphasis added.
Therefore, Sahar et al. teach all limitations of the instant Claims 1-4, 6 and 10.
With regard to the elected species (1), no prior art teaching CB3GA-Rhodamine-(SLVPR)5 (M=SLVPR, n=5, L1=Rhodamine, N1=CB3GA (albumin-binding peptide) as a complex compound represented by Formula 1, was found.
With regard to the elected species (2), as evidenced by a print-out retrieved from https://web.expasy.org› peptidecutter_special_enzymes on 12-25-2025, one of skill in nthe art would have known that trypsin hydrolyzes peptide bonds specifically at the C-terminus of lysine (K) and arginine (R) residues, unless followed by proline:
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Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6 and 10 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over Claims 1-7, 9, 10, 19, 23-36, 39 and 45 of copending Application No. 18/251,919, Pub. No. US 2024/0011979 A1, published 01/11/2024. Although the claims at issue are not identical, they are not patentably distinct from each other because Application No. 18/251,919 claims:
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GALINA M YAKOVLEVA whose telephone number is (571)270-3282. The examiner can normally be reached on M-F 8:30 AM-5:00 PM.
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, GREGORY S EMCH can be reached on (571)272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GALINA M. YAKOVLEVA/Primary Examiner, Art Unit 1678