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 .
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.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/28/2024, 03/24/2024, 07/12/2024, 10/20/2024, 01/08/25, and 06/24/2025 were filed. Accordingly, the information disclosure statements have been considered by the examiner.
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 1-20 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 1 recites that the polymeric dye comprises a reactive group Q but the chemical structure representing the polymeric dye of claim 2 does not depict the limitation Q. Although claim 2 recites R2 and R3 may contain Q in the alternative but does not require R2 or R3 to contain Q. Therefore, it is unclear if whether the limitation Q is required in the claims. Additionally, the recitation of a reactive group Q capable of forming a covalent bond is not a positive recitation to the process of staining because it is unclear to what is being measured. In particular, it is unclear to what is being detected at the appropriate wavelength, as claimed. Claims 2-20 are rejected as being dependent from claim 1.
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.
Claims 2 and 6-20 are 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 1 recites that the polymeric dye comprises a reactive group Q but the chemical structure representing the polymeric dye of claim 2 does not depict the limitation Q. Although claim 2 recites R2 and R3 may contain Q in the alternative but does not require R2 or R3 to contain Q. Because claim 2 does not require Q and recites it in the alternative form, claim 2 and its dependent claims fail to include all the limitations of claim 1.
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.
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.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Matray et al. (WO2016/183185A1, published 11/17/2016, IDS submitted 07/12/2024, cite no 16).
With respect to claims 1-4, Matray teaches cells are tested for viability by positively staining necrotic cells to compare damaged cells to intact cells and assays are used to target non-intact (fixed and non-fixed) cells with positively charged moieties, cell debris, apoptotic bodies, depolarized cell membrane, and permeabilized membranes (see pg. 67, lines 5-10). Matray teaches the compounds useful as fluorescent or colored dyes (see abstract and pg. 22), which would read on the claimed polymeric dye comprising two or more fluorescent or colored moieties, negatively charged phosphate group; and a reactive group Q. Matray teaches structure (IB) (see pg. 22), which would read on the polymeric dye of claim 2. Matray teaches compounds include salts (see abstract). Matray teaches Q comprises a moiety capable of bonding with an analyte molecule (see pg. 24, lines 1-5). Matray teaches a method for staining a sample (see pg. 3, lines 5-10). Matray teaches the analyte molecule is an antibody (see pg. 29, line 5). Matray also teaches M has a desired color and/or fluorescence emission wavelength (see pg. 29, lines 15-20). Matray teaches the compound is in an amount sufficient to produce an optical response when said sample is illuminated at an appropriate wavelength (see pg. 3, lines 5-10). Maytray teaches all compounds which exist in free base or acid form can be converted to their salts by treatment with the appropriate inorganic or organic base or acid by methods known to one skilled in the art and salts of the compounds of the invention can be converted to their free base or acid form by standard techniques (see pg. 45, lines 5-10). Maytray teaches examples of inorganic bases for salt may include magnesium salts (see pg. 17, lines 5-8).
Matray does not explicitly exemplify the polymeric dye is stored in the presence of a magnesium salt. However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have used the polymeric dye with magnesium salt prior to detection of a sample because Matray recognizes that magnesium charges with the compound produce compound’s stability while in solution prior to detection and teaches that the compounds are in salt forms through defined inorganic bases of particular charges such as magnesium salt to preserve the compound.
With respect to claim 5, Matray teaches biological includes cells (see pg. 15, lines 10-15).
With respect to claims 6-9, Maytray shows Table 2 (page 33) wherein F is fluorophore (i.e., M), which would read on the claimed compounds.
With respect to claim 10, Matray teaches exemplary Table 1 which would read on the claimed Q.
With respect to claim 11, Matray teaches M is fluorescent such as BODIPY (see pg. 31, lines 1-10).
With respect to claims 12-15, Matray shows Table 2 (page 33) wherein F is fluorophore (i.e., M) and with the claimed R2 and R3 groups.
With respect to claim 16, Matray teaches L1, L2 or L3 is heteroalkylene linker (see pg. 21, lines 3-5).
With respect to claim 17, Matray teaches polyethylene glycol (see pg. 6, line 30).
With respect to claims 18-20, Maytray shows Table 2 (page 33) wherein F is fluorophore (i.e., M), which would read on the claimed compounds.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-20 and 22 of U.S. Patent No. 10865310B2 (‘310) in view of Matray et al. (WO2016/183185A1, published 11/17/2016).
Patent No. ‘310 of claim 18 recites a method of staining a sample, comprising adding to said sample the compound of claim 1 in an amount sufficient to produce an optical response when said sample is illuminated at an appropriate wavelength. Patent claim 19 recites a method for visually detecting an analyte molecule, the method comprising: (a) providing the compound of claim 1, wherein R.sup.2 or R.sup.3 is a linker comprising a covalent bond to the analyte molecule; and (b) detecting the compound by its visible properties. Patent claim 20 recites a method for visually detecting an analyte molecule, the method comprising: (a) admixing the compound of claim 1, wherein R.sup.2 or R.sup.3 is Q or a linker comprising a covalent bond to Q, with the analyte molecule; (b) forming a conjugate of the compound and the analyte molecule; and (c) detecting the conjugate by its visible properties. Patent claim 22 recites a method for determining the presence of dead cells in a sample, the method comprising contacting the sample with a compound of claim 1, thereby binding or associating the compound with the dead cells, and observing a fluorescent signal from the compound bound or associated with the dead cells.
However, the Patent does not recite the polymeric dye is stored in the presence of a magnesium salt and the sample comprises a targeting moiety comprising an antibody. Matray has been discussed in the above rejection.
It would have been obvious to the person at the time of filing to have used the polymeric dye as recited in the Patent with magnesium salt for antibody detection because the Patent has recited that the compound is in a salt form prior to detecting an analyte molecule and Matray recognizes that magnesium charges with the compound would produce a stable compound salt in solution and teaches that the compounds can be in salt forms with defined inorganic bases of particular charges such as magnesium salt to maintain the compound.
With respect to claims 2-17, Patent claim 18 recites the claimed structures.
With respect to claims 18-20, the Patent does not explicitly recite the claimed structures. As stated above, Matray teaches the claimed structures. Therefore, it would have been obvious to have used the compounds of Matray for staining detection in the presence of magnesium salt because Matray recognizes that magnesium charges with the compound would produce a stable compound salt in solution.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11874280B2 (‘280) in view of Matray et al. (WO2016/183185A1, published 11/17/2016).
Patent No. ‘280 of claim 1 recites a method for forming a covalent conjugate of a polymeric dye and a targeting moiety, the method comprising preparing a mixture comprising the polymeric dye, the targeting moiety, and a magnesium salt, and allowing the mixture to age for a time and at a temperature sufficient to form the covalent conjugate, wherein: a) the polymeric dye comprises: i) two or more fluorescent or colored moieties; ii) at least one negatively charged phosphate group; and iii) a reactive group Q capable of forming a covalent bond with a complementary reactive group Q′ on the targeting moiety, wherein each of the two or more fluorescent or colored moieties are joined to an adjacent fluorescent or colored moiety via a linker comprising the at least one negatively charged phosphate group; and b) the targeting moiety has affinity for a target analyte and comprises the complementary reactive group Q′. Patent claim 2 recites a method for detecting a target analyte, the method comprising: a) associating a covalent conjugate with the target analyte to form an analyte-targeting moiety complex in the presence of a magnesium salt, the covalent conjugate comprising: i) a targeting moiety that has affinity for the target analyte and comprises a covalent bond to a polymeric dye; ii) the polymeric dye comprising: A) two or more fluorescent or colored moieties; B) at least one negatively charged phosphate group; and C) a covalent bond to the targeting moiety, wherein each of the two or more fluorescent or colored moieties are joined to an adjacent fluorescent or colored moiety via a linker comprising the at least one negatively charged phosphate group; and b) detecting a fluorescent or colored signal from the analyte-targeting moiety complex. Patent claim 3 recites magnesium salt. Patent claim 4 recites a method for detecting a target analyte, the method comprising: a) associating a covalent conjugate with the target analyte to form an analyte-targeting moiety complex, the covalent conjugate comprising: i) a targeting moiety that has affinity for the target analyte and comprises a covalent bond to a polymeric dye; and ii) the polymeric dye comprising: A) two or more fluorescent or colored moieties; B) at least one negatively charged phosphate group; and C) a covalent bond to the targeting moiety, wherein each of the two or more fluorescent or colored moieties are joined to an adjacent fluorescent or colored moiety via a linker comprising the at least one negatively charged phosphate group; b) treating: i) the covalent conjugate and the target analyte with a magnesium salt during the associating the covalent conjugate and the target analyte; and/or ii) the analyte-targeting moiety complex with a wash solution comprising a magnesium salt after the associating the covalent conjugate and the target analyte; and c) detecting a fluorescent or colored signal from the analyte-targeting moiety complex. Patent claim 5 recites further comprising substantially removing all of the magnesium salt from the analyte-targeting moiety complex before detecting the fluorescent or colored signal. Patent claim 16 recites the targeting moiety is an antibody. However, the Patent does not recite staining a sample.
Matray has been discussed in the above rejection. It would have been obvious to the person at the time of filing to have used the polymeric dye as recited in the Patent for staining as taught by Matray because Matray teaches the compound of the Patent is for staining a sample.
With respect to claims 2-17, Patent claims 18-19 recite the claimed structures.
With respect to claims 18-20, Patent claim 19 recite the claimed structures.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-18 of U.S. Patent No. 11142647B2 (‘647) in view of Matray et al. (WO2016/183185A1, published 11/17/2016).
Patent No. ‘647 of claim 16 recites a method of staining a sample, comprising adding to said sample the compound of claim 1 in an amount sufficient to produce an optical response when said sample is illuminated at an appropriate wavelength. Patent claim 17 recites a method for visually detecting an analyte molecule, the method comprising: (a) providing the compound of claim 1, wherein R.sup.2 or R.sup.3 is a linker comprising a covalent bond to the analyte molecule; and (b) detecting the compound by its visible properties. Patent claim 18 recites a method for visually detecting an analyte molecule, the method comprising: (a) admixing the compound of claim 1, wherein R.sup.2 or R.sup.3 is Q or a linker comprising a covalent bond to Q, with the analyte molecule; (b) forming a conjugate of the compound and the analyte molecule; and (c) detecting the conjugate by its visible properties. However, the Patent does not recite the polymeric dye is stored in the presence of a magnesium salt and the sample comprises a targeting moiety comprising an antibody. Matray has been discussed in the above rejection.
It would have been obvious to the person at the time of filing to have used the polymeric dye as recited in the Patent with magnesium salt for antibody detection because the Patent has recited that the compound is in a salt form prior to detecting an analyte molecule and Matray recognizes that magnesium charges with the compound would produce a stable compound salt in solution and teaches that the compounds can be in salt forms with defined inorganic bases of particular charges such as magnesium salt to maintain the compound.
With respect to claims 2-17, Patent claim 16 recites the claimed structures.
With respect to claims 18-20, the Patent does not explicitly recite the claimed structures. As stated above, Matray teaches the claimed structures. Therefore, it would have been obvious to have used the compounds of Matray for staining detection in the presence of magnesium salt because Matray recognizes that magnesium charges with the compound would produce a stable compound salt in solution.
Claims 1-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-11, 15 and 17-20 of copending Application No. 18632909 (‘909) in view of Matray et al. (WO2016/183185A1, published 11/17/2016).
Copending Application ‘909 recites:
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However, the copending Application does not recite two or more fluorescent or colored moieties and the polymeric dye is stored in the presence of a magnesium salt and the sample comprises a targeting moiety comprising an antibody for staining. Matray has been discussed in the above rejection.
It would have been obvious to the person at the time of filing to have used the polymeric dye as recited in the copending Application with magnesium salt for antibody detection because the copending Application has recited that the compound is in a salt form prior to detecting an analyte molecule and Matray recognizes that magnesium charges with the compound would produce a stable compound salt in solution and teaches that the compounds can be in salt forms with defined inorganic bases of particular charges such as magnesium salt to maintain the compound. Additionally, it would have been obvious to have added a fluorescent or colored moieties at the G position of the copending Application because the G moiety are recognized structures for covalent attaches and the copending Application recites a method for labeling.
With respect to claims 2-17, Patent claim 9-11 recite the claimed structures.
With respect to claims 18-20, the copending Application does not explicitly recite the claimed structures. As stated above, Matray teaches the claimed structures. Therefore, it would have been obvious to have used the compounds of Matray for staining detection in the presence of magnesium salt because Matray recognizes that magnesium charges with the compound would produce a stable compound salt in solution.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678