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 08/12/2025.
Priority
According to the Filing Receipt mailed 12/03/2024, this application, filed 11/22/2024, Pub. No. US 2025/0085225 A1, published 03/13/2025, claims foreign priority to EP 20176696.1, filed 05/27/2020, and US application Ser. No 17/316,685, filed 05/10/2021, Pub. No. US 2021/0372999 A1, published 12/02/2021.
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Appropriate correction is required.
Status of Claims
Claims 1-7 are currently pending. Claims 1-7 have been subject to the species election requirement mailed 07/21/2025. Claim 6 is withdrawn from further consideration. Claims 1-5 and 7 are examined.
Election of Species
Applicant's election of the species:
(a) an extracellular antigen CD19 as a target moiety (See paragraph [0033] of the originally-filed specification);
(b) a conjugate of an antibody against CD19 with CP-FL represented at paragraph [0045] of the originally-filed specification as follows:
CP-FL
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wherein FL is fluorescein;
as a conjugate;
(c) H2O2 as an oxidative agent (See paragraph [0024] of the originally-filed specification); and
(d) fluorescence microscopy as use of the method (See Claim 7);
in the reply filed on 08/12/2025 is acknowledged.
Applicant identified Claims 1-7 as reading on the elected species (a)-(d). The Examiner respectfully disagrees with Applicant’s assessment because Claim 6 does not
read on the elected species (b), a conjugate of an antibody against CD19 with CP-FL.
Because Applicant did not distinctly and specifically point out the supposed errors in the species election requirement, the election of species (a)-(d) has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 6 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim.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 08/12/2025.
Information Disclosure Statement
The information disclosure statements, submitted on 11/22/2024, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the Examiner. Please note that the following references have been corrected by the Examiner:
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Specification
The use of the term(s) Alexa Fluor® and BODIPY®, which is a trade name or a mark used in commerce, has been noted in this application, for example, in paragraph [0030]. The term should be accompanied by the generic terminology; furthermore the term 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.
Claim Objections
Claims 1, 3 and 4 are objected to because of the following informalities: improper Markush format. Claim 1 recites “selected from the group consisting of H, … or a heteroaralkyl residue”. Claim 3 recites “FL is selected from the group consisting of Fluorescein, …, Naphthalimides und Porphyrines.” Claim 4 recites “from the group consisting of hydrogen, halogen or an antigen recognizing moiety at least one is biomolecule selected from the group onsisting of an antibody, …, receptors for cell adhesion or costimulatory molecules, …, receptors for costimulatory molecules or artificial engineered binding molecules.” Emphasis added. It is noted that claims are not indefinite because it is clear what Applicant intends to include in a Markush grouping. However, Applicant is reminded that, according to MPEP 2173.05(h) Alternative Limitations, when materials recited in a claim are so related as to constitute a proper Markush group, they may be recited in the conventional manner, or alternatively. For example, if "wherein R is a material selected from the group consisting of A, B, C and D" is a proper limitation, then "wherein R is A, B, C or D" shall also be considered proper.
Claim 1 is objected to because of the following informalities: reciting “Wherein” and containing a period after the following recitations: ”with the proviso that n+m=100 mol %” and “q is an integer from 1 to 10,000”. See MPEP 608.01(m) Form of Claims: “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v.Manbeck, 36 USPQ2d 1211 (D.D.C. 1995).”
Appropriate correction(s) is required.
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.
Claim 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter as being a “use” claim.
Claim 7 is drawn to:
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According to MPEP § 2173.05(q), a “use” claim should be rejected under alternative grounds based on 35 U.S.C 101 and 112:
“Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: “[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon” was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parteErlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
Other decisions suggest that a more appropriate basis for this type of rejection is 35 U.S.C. 101. In Ex parteDunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: “The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction.” In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: “The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid.”
Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In rePrater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim.
I.A “USE” CLAIM SHOULD BE REJECTED UNDER ALTERNATIVE GROUNDS BASED ON 35 U.S.C 101 AND 112
In view of the split of authority as discussed above, the most appropriate course of action would be to reject a “use” claim under alternative grounds based on 35 U.S.C. 101 and 112.” Emphasis added.
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 1-5 and 7 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.
The claims, as recited in independent Claim 1, are drawn to:
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The MPEP states that the purpose of written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These factors include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention." See MPEP § 2163. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “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. A disclosure in an application, to be complete, must contain such description and details as to enable any person skilled in the art or science to which the invention pertains to make and use the invention as of its filing date. In re Glass, 492 F.2d 1228, 181 USPQ 31 (CCPA 1974). Examples and description should be of sufficient scope as to justify the scope of the claims.
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, reduction to drawings, 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 applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A description of a chemical genus will usually comprise a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. See University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). A chemical genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has substantial variance, the disclosure must describe a sufficient number of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not specifically define what constitutes a representative number of species, the courts have indicated what does not constitute the same. See, e.g., In re Gostelli, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989), holding that the disclosure of two chemical compounds within a subgenus did not adequately describe such subgenus. In the absence of structural characteristics that are shared by members of the genus; one of skill in the art would reasonably conclude that the disclosure fails to provide a
representative number of species to describe the genus.
It is the Examiner' position that the instant specification fails to provide adequate written description and clear guidance for the claimed method utilizing a genus of conjugates with the general formula (I) 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.
First, the specification as filed is limited to the investigation of an absorption behavior of the only species CP-FL, which is a fluorene polymer comprising 2 substituted fluorene monomers, wherein one monomer has two mPEG(methoxy poly(ethylene glycol)ylated groups attached at 9 position, and another monomer has methyl and a fluorescent moiety FL attached at 9 position, which fluorene polymer has Br and
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4-phenylbutanoic acid at its ends:
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,
whereas the recited general formula (I) covers an enormous genus of the conjugates of fluorene polymers comprising a monomer having two mPEG(methoxy poly(ethylene glycol)ylated groups attached at 9 position with different substituents at 1 through 8 positions of fluorene core and an aryl or a heteroaryl group located on the ends of the polymer.
Second, the specification does not provide any data regarding bleaching sensitivity of conjugates of any other fluorene polymers, and, as such, there is no known or disclosed correlation between structure and function.
Therefore, Claims 1-5 and 7 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 3 and 7 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.
Claim 3 contains the trademark/trade name BODIPY™ Fluorophores (Molecular Probes, Inc.), ALEXA™ Fluorophore (Molecular Probes, Inc.), DY™ Fluorophores (Dyomics GmbH). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe dyes and, accordingly, the identification/description is indefinite.
With regard to Claim 7, recitation “Use … in fluorescence microscopy, flow cytometer, spectrofluorometry, cell separation, pathology or histology” renders the claim indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Gaylord et al., US 2011/0256549 A1, published 10/20/2011, in view of Schubert et al., US 6,150,173, issued 11/21/2000, Dose et al., US 2016/0187326, published 06/30/2016, and Gerdes et al., US 2008/0118934 A1, published 05/22/2008.
Gaylord et al., throughout the publication, teach a method for detecting a target moiety in a sample using a conjugate of the elected species (b) in the context of multiplexing analysis (see especially paragraph [0196] reproduced below):
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Note: fluorescence microscopy is the elected species (d).
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Emphasis added.
Gaylord et al. do not teach degrading the fluorescent moiety FL of the labelled target moieties by irradiating the conjugate with light having a wavelength within the absorbance spectrum of fluorescent moiety FL for a time sufficient to deliver enough energy to reduce the fluorescence radiation emitted by the fluorescent moiety FL at least by 75% of the initial fluorescence radiation, as recited in Claim 1, and further degradation of the fluorescent moiety FL of the labelled target moieties by adding oxidative agents, as recited in Claim 5.
Schubert et al., throughout the patent and, for example, in Col. 1, 2 and 7, teach that elimination of the fluorescence signal is essential for immunofluorescence technologies based on sequentially staining specimen, and further teach degrading a fluorescent moiety by irradiating for a time sufficient to completely eliminate the initial fluorescence radiation:
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Emphasis added.
Dose et al., throughout the publication and, for example, in paragraph [0013], teach oxidative destruction of conjugated fluorescent moieties by photo- or chemical bleaching procedures:
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Emphasis added.
In paragraphs [0017]-[0020], [0038] and [0079], Dose et al. further teach:
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Emphasis added.
In paragraph [0039], Dose et al. teach fluorescein as a fluorescent moiety:
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Emphasis added.
In paragraph [0082], Dose et al. teach comprising the elimination of a fluorescence emission by a combination of enzymatic degradation and oxidative bleaching and that the necessary chemicals for bleaching are well-known in the art. Although, in paragraph [0013] reproduced above, Dose et al. teach that oxidative destruction of conjugated fluorescent moieties by chemical bleaching procedures is known in the art and recites, inter alia, U.S. Pat. No. 7,741,045 B2 (Prior Publication: Gerdes et al., US 2008/0118934 A1, published 05/22/2008), Dose et al. do not expressly teach the elected species (c) H2O2 as an oxidative agent.
Gerdes et al., throughout the publication and, for example, in the claims, teach a method for probing multiple targets in a biological sample comprising the use of an oxidizing agent, such as hydrogen peroxide, which is the elected species (c), that selectively inactivates a fluorescent probe:
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Emphasis added.
In paragraphs [0058] and [0119], Gerdes et al. teach fluorescein as a fluorescent moiety and the elected species (a) an extracellular antigen CD19 as a target moiety:
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Emphasis added.
It would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have made and used the step of degrading a fluorescent moiety by irradiating for a time sufficient to completely eliminate the initial fluorescence radiation, taught by Schubert et al., in the detecting method, taught by Gaylord et al.
One of ordinary skill in the art would have been motivated to have made and used the step of degrading a fluorescent moiety by irradiating for a time sufficient to completely eliminate the initial fluorescence radiation, taught by Schubert et al., in the detecting method, taught by Gaylord et al., because it is essential for immunofluorescence technologies based on sequentially staining specimen in multiplexing analysis to eliminate the fluorescence signal, as taught by Schubert et al. and Dose et al.
One of ordinary skill in the art would have had a reasonable expectation of success in making and using the step of degrading a fluorescent moiety by irradiating for a time sufficient to completely eliminate the initial fluorescence radiation, taught by Schubert et al., in the detecting method, taught by Gaylord et al., because photobleaching of the dye conjugates was known in the art, as taught by Schubert et al. and Dose et al.
Moreover, it would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have made and used further degradation of the fluorescent moiety FL of the labelled target moieties by adding oxidative agents, because oxidative bleaching is well-known in the art, as taught by Dose et al. and Gerdes et al.
Claims 1-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Gaylord et al., US 2011/0256549 A1, published 10/20/2011, in view of Fauerbach et al., US 2019/0162721 A1, published 05/30/2019 (IDS submitted 11/22/2024).
The teachings of Gaylord et al. are discussed above and incorporated herein in its entirety.
Gaylord et al. do not teach degrading the fluorescent moiety FL of the labelled target moieties by irradiating the conjugate with light having a wavelength within the absorbance spectrum of fluorescent moiety FL for a time sufficient to deliver enough energy to reduce the fluorescence radiation emitted by the fluorescent moiety FL at least by 75% of the initial fluorescence radiation, as recited in Claim 1, and further degradation of the fluorescent moiety FL of the labelled target moieties by adding oxidative agents, as recited in Claim 9.
Fauerbach et al., throughout the publication and, for example, in the claims, teach:
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In paragraph [0008], Fauerbach et al. teach that:
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It would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have made and used the step of degrading a fluorescent moiety by irradiating for a time sufficient to eliminate the initial fluorescence radiation, as taught by Fauerbach et al., in the detecting method, taught by Gaylord et al.
One of ordinary skill in the art would have been motivated to have made and used the step of degrading a fluorescent moiety by irradiating for a time sufficient to eliminate the initial fluorescence radiation, as taught by Fauerbach et al., in the detecting method, taught by Gaylord et al., because it is essential for immunofluorescence technologies based on sequentially staining specimen in multiplexing analysis to eliminate the
fluorescence signal, as taught by Fauerbach et al.
One of ordinary skill in the art would have had a reasonable expectation of success in making and using the step of degrading a fluorescent moiety by irradiating for a time sufficient to eliminate the initial fluorescence radiation, as taught by Fauerbach et al., in the detecting method, taught by Gaylord et al., because photobleaching of the dye conjugates was known in the art, as taught by Fauerbach et al.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5 and 7 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over Claims 1-6 of U.S. Patent No. 11,073,515 B2, issued on 07/27/2021, in view of Gaylord et al., US 2011/0256549 A1, published 10/20/2011; Schubert et al., US 6,150,173, issued 11/21/2000, Dose et al., US 2016/0187326, published 06/30/2016, and Gerdes et al., US 2008/0118934 A1, published 05/22/2008.
U.S. Patent No. 11,073,515 claims:
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The teachings of Gaylord et al. are discussed above and incorporated herein in its entirety.
It would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have made and used the fluorescent conjugate, taught by Gaylord et al., as substituting equivalent in the method claimed by U.S. Patent No. 11,073,515, because Gaylord et al. teach a method for detecting a target moiety in a sample using a conjugate of the elected species (b) in the context of multiplexing analysis, which requires sequentially staining specimen, as taught by Schubert et al.
Moreover, it would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have made and used further degradation of the fluorescent moiety FL of the labelled target moieties by adding oxidative agents, because oxidative bleaching is well-known in the art, as taught by Dose et al. and Gerdes et al.
Conclusion
No claims are allowed.
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/GALINA M. YAKOVLEVA/Primary Examiner, Art Unit 1678