Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the claims
Claims 1-22 are pending and claims 1-7, 14-18 and 20-22 are examined on merits in this office action.
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 1-7, 14-18 and 20-22 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.
Claims 1 recites “narrow-band monomer”. The term “narrow-band” has not been clearly defined or described in the specification. “Narrow” is a relative term and thus it is unclear what bands of emission will be considered as a narrow-band for a “narrow-band monomer”. It is unclear how much narrow a band is intended to encompass for the “narrow-band monomer” and what types of monomers are intended to encompass for a “narrow-band monomer”. Without a clear definition, the meets and bounds of the band and types of monomers for the narrow-band monomers is vague and indefinite.
Claims 1 recites the term “condensed chromophoric polymer”, which has not been clearly defined in the specification and thus it is unclear what is intended to encompass by condensed chromophoric polymer. Is it intended to include a polymer obtained by condensation reaction or is intended to encompass a polymer crosslinked forming a particle structure. Without a clear definition, it is unclear what is intended to encompass by the term “condensed chromophoric polymer”.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7, 14-18 and 20-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is directed to a polymeric dot comprising a condensed chromophoric polymer wherein the “condensed chromophoric polymer” comprising a “narrow-band monomer” and one or more general monomers, wherein the narrow-band monomer is integrated into the condensed chromophoric polymer wherein the one or more general monomer comprise energy donors and the narrow-band monomer is an enrgy acceptor configured to receive energy from the general monomer of the one or more general monomer. The term “condensed” for the “condensed chromophoric polymer” has not been clearly defined or describe in the specification and also the term “narrow-band polymer” has not been clearly defined or described in the specification. In the absence of a clear definition of “condensed chromophoric polymer”, definition of condensation polymer from wikipedia has been taken, which describes as follows: in polymer chemistry, condensation polymers are any kind of polymers whose process of polymerization involves a condensation reaction (i.e. a small molecule, such as water or methanol, is produced as a byproduct) (https://en.wikipedia.org/wiki/Condensation_polymer#:~:text=In%20polymer%20chemistry%2C%20condensation%20polymers,is%20produced%20as%20a%20byproduct). The term “narrow-band monomer” and “general monomer” have not been clearly defined in the specification and thus various types of monomers with various band gaps without any clear limitation are encompassed by the terms. Therefore, claim 1 encompasses condensation of extremely a large number of polymers encompassed by “general monomer” with extremely a large number of monomers encompassed by undefined “narrow-band monomer” to provides the undefined “condensed” chromophoric polymer”.
However, throughout the specification the “narrow-band monomer” and the “general monomer” for the condensed polymer is very limited to a few polymeric compositions of BODIPY or squaraine with PFBT, and the disclosure are not representative of the large number of various distinct monomers for providing condensed polymers having specific properties as encompassed by the claims.
A written description of a chemical genus “requires a precise definition, such as by structure, formula, [or] chemical name” of the claimed subject matter sufficient to distinguish it from other materials. Regents of the Univ. of Cal. v. Eli Lilly & Co., 199 F.3d 1559, 1568 (Fed. Cir. 1997). The Federal Circuit reflected on Eli Lilly in Ariad while explaining how to sufficiently describe of a genus of compounds:
We held that a sufficient description of a genus instead requires the disclosure of
either a representative number of species falling within the scope of the genus or
structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. at 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
A "representative number of species" must typify the entire claimed genus and account for variation between the species of the genus.
[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated. Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004).
This genus encompasses an untenable number of compounds, due to the number of possible permutations based on all of the combinations of the variables contained in the genus. Few of disclosed species cannot possibly typify the entire genus claimed or account for all of the variation between species of such a large genus.
Chemistry is generally considered to be unpredictable and/or have unpredictable factors. See, e.g.,In re Carleton, 599 F.2d 1021, 202 USPQ 165, 170 (CCPA 1979) ("Although there is a vast amount of knowledge about general relationships in the chemical arts, chemistry is still largely empirical, and there is often great difficulty in predicting precisely how a given compound will behave.”). The pharmaceutical art, that is the use of a chemical compound to affect a desired physiological activity, is generally considered to be unpredictable and/or have unpredictable factors. See, e.g., In re Fisher, 427 F.2d 833, 839 (CCPA 1970) (“In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved (emphasis added); In re Bowden, 183 F.2d 115, 86 USPQ 419, 423 (“chemical reactions frequently are unpredictable”).
Considering the unpredictability found in organic synthesis, exchanging even one substituent for another cannot be considered a foregone conclusion. Accordingly, when a claim presents a genus with substantial variation as that currently presented by Applicant, the disclosure must adequately reflect such variation with a representative number of species. The lack of any disclosure of examples may be considered in determining whether a claimed invention was adequately described. Boston Scientific Corp. v. Johnson & Johnson, 647 F.3d 1353 (Fed. Cir. 2011).
Applicant may overcome this rejection by limiting the scope of the claimed genus in accord with the claimed species, taking connectivity into account.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-7, 14-18 and 20-21 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Haugland et al (US 5,723,218; cite # 7 in the IDS filed 05/15/25 of 16 pages) in view of Wu et al (J. Am. Chem. Soc 2010; Cite # 8 in the IDS filed 05/15/2025 of 8 pages).
Regarding claims 1-5, 14, and 17, Haugland discloses a polymer dot comprising: a polymer (col. 1, In. 32-38: col. 4. In. 41-49; col. 12, In. 1-12: polymer microparticles having a diameter as low as 0.01 micrometers (10 nanometers) and labeled with a dye comprising a narrow-band monomer (col. 4, In. 41-47; col. 5, In. 58 to col. 7, In. 67), the polymer having an emission spectrum with a full width half maximum (FWHM) of less than about 70 nm (Figs. 1-4; col. 4, In. 65 to col. 5, In. 53). Haugland discloses wherein the polymer further comprises a first general monomer, a second general monomer or a combination thereof, and wherein the first and second general monomer have an emission spectrum with a full width half maximum of greater than 70 nm (col. 4, In. 47-53). Haugland further teaches that the polymer comprises a quantum yield greater than about 10%, greater than about 20%, greater than about 30%, greater than about 40%, greater than about 50%, greater than about 70%, or greater than about 90% (col. 6, In. 7-9). Haugland teaches that the narrow-band monomer, the first general monomer, the second general monomer, or a combination thereof are integrated into the backbone of the chromophoric polymer (col. 12, In. 35 to col. 13, In. 15). Haugland teaches that the polymer further comprises a functional group rendering the surface of the polymer available for conjugation or bioconjugation (col. 4, In. 54-58: col. 12, In. 20-28) wherein the functional group is a hydrophilic functional group (col. 4, In. 54-58; col. 12. In. 20-28) selected from the group consisting of carboxylic acid or salts thereof, amino, mercapto, azido, aldehyde, ester, hydroxyl, carbonyl, sulfate, sulfonate, phosphate, cyanate, and succinimidyl ester (col. 4, In. 54-58: col. 12, In. 20-28).
Haugland does not mention the polymeric composition as condensed, however, Haugland discloses polymer microparticles and polymer microparticle would obviously be considered as condensed polymer because microparticle formation would require aggregation/condensation and because the specification does not clearly define condensation and does not have clear description or guidance to exclude the particle of Hoagland as not having condensed polymer. Hougland discloses polymeric particle formed from covalent bond formation among the monomers (col.7) and thus condensation is present among the monomers in in the polymeric particle.
Haugland does not mention the ratio of narrow-band monomer to the general monomer and does not disclose the polymer dot having a functional monomer.
Wu teaches polymer dots for biological imaging (Title). Wu teaches modifying the polymer dot by including polymer having PEG chain and functional group and teaches that different functional groups can be used (page 15411, 2nd col.). Wu specifically discloses polymer dots comprising functional monomer having water soluble group including COOH terminus (
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) for providing water soluble functionalized polymer useful for various biological imaging and specific targeting by tagging specific binding group to the terminal carboxylic functional group (Abstract and Scheme 1).
Since Haughland taches various percentages of quantum yield, and teaches incorporation of polymeric dyes by copolymerization with other polymerizable monomers (col.1, ln 45-55; col.4, lines ln 40-55; col.10, ln 36-62 and col.12, ln 51-65), one of ordinary skilled in the art can easily envisage various proportions of the various components of the polymerizable monomers and polymerizable dyes for optimization absent showing of unexpected advantages with a particular proportions with particular monomers. Moreover, since Haugland teaches that the polymer further comprises a functional group rendering the surface of the polymer available for conjugation or bioconjugation (col. 4, In. 54-58: col. 12, In. 20-28) including carboxylic acid functional group, it would be obvious to one of ordinary skilled in the art before the effective filing date of claimed invention to easily envisage including functionalized monomer including PEG containing functionalized monomer as taught by Wu with the condensed polymer of Haughland with the expectation of expanding the arsenal of polymer dot of Haughland with various condensed polymer for conjugation with various specific finding molecules for various biological applications with a reasonable expectation of success. The combination of the reference of Haughland with the reference of Wo would provide a condensed chromophoric polymer comprising a narrow-band maonomer integrated into the chromophoric polymer and a functional monomer that provides a reactive functional group suitable for bioconjugation wherein the condensed chromophoric polymer is a semiconducting polymer as the polymer of Wu is a semiconducting polymer.
Regarding claims 6-7, Haugland teaches that the narrow-band monomer is a BODIPY derivative (col. 4, In. 41-47; col. 5, In. 58-60) and wherein the BODIPY derivative is integrated into the chromophoric polymer by attachment to R1 , R2A, R2B, R3A, R3B, R4A, R4B or a combination thereof (col. 6, In. 10 to col. 7, In. 67 and col. 12, In. 35-59).
In regards to claims 15-16, Haugland disclosed that the particles are attached to biomolecules wherein the biomolecules include protein, peptide, and nucleic acid (col. 13, lines 33-49) and Wu teaches attaching various biomolecules including antibody (Scheme 1).
In regards to claims 4 and 18, Haughland teaches that the chromophoric polymer is a conjugated polymer (col. 7, lines 23-31).
In regards to claim 21, Hougland does not teach that the polymer is stable over a period of greater than about one month. Haughland, however, throughout the reference teach that the microparticle have superior photostability compared to microparticles containing other dyes such as fluorescene (col. 9, ln. 15-37; claims 1, 14, 20). Since Haughland teaches that the microparticle is highly photostable, it would be highly expected that the microparticle would be stable over a period of greater than one month if proper storage condition is maintained as the storage stability would depend on the solvent and the storage condition and the claims do not provide any storage conditions. The Patent and Trademark Office does not have the facilities and resources to provide the factual evidence needed in order to establish that there is a difference. The burden is upon applicant to present such factual evidence. See e.g. In re Best (195 USPQ 430 (CCPA 1977)) or Ex parte Phillips (28 USPQ2d 1302 (BPAI 1993)).
Claims 1-7, 14-18 and 20-21 are rejected under pre-AIA 103 (a) as obvious over Thivierge et al (Macromolecules 2011; Cite # 47 in the IDS filed 05/15/2023) in view of Wu et al (J. Am. Chem. Soc 2010; Cite # 8 in the IDS filed 05/15/2025 of 8 pages).
In regards to claims 1-7, 14-18 and 20, Thivierge discloses polymer dot comprising homopolymer of a narrow-band monomer (BODIPY)
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or a co-polymer comprising a narrow-band monomer (e.g. BODIPY, i.e. a narrow band monomer) and general monomers (e.g. fluorene)
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. Thivierge discloses the polymer dots having an emission spectrum with a full width half maximun (FWHM) of less than about 70nm (Table 1 and Fig.1). Thivierge discloses the polymer dot comprises fluorene (i.e. a general monomer) and fluorene polymer is considered in the specification as semiconducting polymers (see paragraph 136 of the specification). Thiverge teaches that BODIPY 2b has an extremely high molar absorptivity and an exceptional quantum yield (page 4013, 1st col.). Thiverge teaches that the ETE% is a measure of the quantum yield of the cassette when irradiated at the donor (page 4013, 2nd col.) and Table 2 shows greater than about 10% ETE for the polymers.
Thivierge does not mention the polymeric composition as condensed but, however, Thivierge discloses polymer microparticles and polymer microparticle would obviously be considered as condensed polymer because microparticle formation would require aggregation/condensation and because the specification does not clearly define condensation and does not have clear description or guidance to exclude the particle of Thivierge as not having condensed polymer. Thivierge discloses polymeric particle formed from covalent bond formation among the monomers (Scheme 1) and discloses that addition of THF solution of the polymer to water (i.e. aqueous solution) gave particle of 48.4± 13.3nm (page 4014) and thus condensation is highly expected to be present in the polymeric particle of Thivierge and thus one of ordinary skilled in the art would not be able to distinguish the polymeric particle of Thivierge from the polymer dot of claim 1.
Thivierge does not mention the ratio of narrow-band monomer to the general monomer as claimed and does not disclose the polymer having a functional monomer having a COOH terminus.
Wu teaches polymer dots for biological imaging (Title). Wu teaches modifying the polymer dot by including polymer having PEG chain and functional group and teaches that different functional groups can be used (page 15411, 2nd col.). Wu specifically discloses polymer dots comprising functional monomer having water soluble group including COOH terminus (
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) for providing water soluble functionalized polymer useful for various biological imaging and specific targeting by tagging specific binding group to the terminal carboxylic functional group (Abstract and Scheme 1).
Since Thivierge teaches that variations of the acceptors would enable tuning of fluorescence outputs (page 4012, 2nd paragraph of 2nd col.) and since Thivierge teaches optimization by utilizing various fluorene:BODIPY ratios used in polymerization (page 4013, last paragraph of 1st col.), various ratios of the narrow-band unit and the general monomer would be obvious to one of ordinary skilled in the art absent showing unexpected advantages with a particular ratio. Moreover, since Thivierge discloses polymer dot comprising a functional group (e.g. nitro) available for conjugation {page 4012, see copolymer (AB)n} and also teaches that the polymer dot offers potential for fluorescent probe design, one of ordinary skilled in the art can easily envisage attaching various biomolecules (binding partner) to polymer dot utilizing the available functional group and or providing the polymer dots with various other functional group for attaching to various biomolecule binding partners with the expectation of utilizing the polymer dots as prove for analyte detection with a reasonable expectation of success. Moreover, it would be obvious to one of ordinary skilled in the art before the effective filing date of claimed invention to easily envisage including functionalized monomer including PEG containing functionalized monomer as taught by Wu with the condensed polymer of Thivierge with the expectation of expanding the arsenal of Thivierge with various condensed polymer for conjugation with various specific finding molecules for various biological applications with a reasonable expectation of success. The combination of the reference of Thivierge with the reference of Wu would provide a condensed chromophoric polymer comprising a narrow-band maonomer integrated into the chromophoric polymer and a functional monomer that provides a reactive functional group suitable for bioconjugation wherein the condensed chromophoric polymer is a semiconducting polymer as the polymer of Wu is a semiconducting polymer.
In regards to stability of the polymer dot (claim 21), Thivierge teaches the polymer dot potential for fluorescent probe design, which indicates that the polymner dot would be expected to be quite stable. However, stability depends on the solvent and the storage condition and the claims do not provide any storage conditions. The Patent and Trademark Office does not have the facilities and resources to provide the factual evidence needed in order to establish that there is a difference. The burden is upon applicant to present such factual evidence. See e.g. In re Best (195 USPQ 430 (CCPA 1977)) or Ex parte Phillips (28 USPQ2d 1302 (BPAI 1993)).
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 1-7, 14-18 and 20-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-48 of U. S. Patent No. 10,150,841 Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of claimed polymer dot are fully encompassed by the cited claims of US Patent '841. Claims 5 and 6 disclose condensed polymer comprising BIDIPY (narrow-band monomer) and claims 8 and 37 disclose squaraine (narrow-band monomer) wherein the polymer having an emission with full width maximum of less than about 70nm (see claim 36). Claims 14-16 and 49 of the copending application teach the polymer comprising various functional groups including carboxyl groups. Further, throughout the claims of US patent ‘841, the various limitations of the cited instant claims are disclosed or are obvious in view of the disclosed claims of the US patent ‘841.
Claims 1-7, 14-18 and 20-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-48 of U. S. Patent No. 11,697,713 Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of claimed polymer dot are encompassed by the cited claims of US Patent '713. Claims 1, 5, 12 and 14 or US patent ‘713 disclose condensed polymer comprising BIDIPY (narrow-band monomer) and claims 1 and 12 teaches general monomer selected from fluorene among others wherein the polymer having an emission with full width maximum of less than about 70nm and wherein the ratio of the number of narrow-band monomer to the general monomer is 1:20 to 1:1000 (see claims 1 and 12) . Claims 6 and 24 teaches the polymer comprising functional monomer that provides reactive functional group for bioconjugation and claims 7 and 25 teaches various biomolecules for bioconjugation. Further, throughout the claims of US patent ‘713, the various limitations of the cited instant claims are disclosed or are obvious in view of the disclosed claims of the US patent ‘713.
Response to argument
Applicant's arguments filed 10/27/2025 have been fully considered but are not persuasive to overcome the rejections of 08/04/2026.
In regards to 35 USC 112 (b) for narrow band monomer, Applicant cited paragraphs [0011] and [0136] and argued that when read in view of at least the noted portions of the specification, the recitation of “narrow band monomer” is clearly defined as an energy acceptor configured to receive energy from a general monomer of the condensed chromophoric polymer, further configured to provide, in pdot form, narrow emission, i.e. having a FWHM of less than 70 nm.
The above arguments have fully been considered but are not found persuasive because, the cited paragraphs are for some embodiment and not for all embodiments and descriptions with the preamble “for example”, “in one embodiment” or “in some embodiment”, are not considered clear definition when the claim language or term is broader than the embodiments. Se MPEP 2111.01(II). "Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment." Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004). See also Liebel-Flarsheim Co. v. Medrad Inc., 358 F.3d 898, 906, 69 USPQ2d 1801, 1807 (Fed. Cir. 2004) (discussing recent cases wherein the court expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment); E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) ("Interpretation of descriptive statements in a patent’s written description is a difficult task, as an inherent tension exists as to whether a statement is a clear lexicographic definition or a description of a preferred embodiment.
In regards to 35 USC 112 (b) for condensed chromophoric polymer, Applicant cited Fig. 24 C and paragraph [0260] and argued that the when viewed in the context of specification of the present application, the claim term is defined. Fig. 24C shows a schematic illustration of squaraine based narrow emissive polymer dots and Pdot-bioconjugates for specific cellular targeting and the schematic illustration of one embodiment is not a clear definition for “condensed chromophoric polymer”. Paragraph in the preamble recites “In one aspect” of making a polymer dot, comprising providing a solvent solution comprising a chromophoric polymer being in elongated coil form and comprising a narrow-band monomer, wherein the chromophoric polymer includes an emission spectrum with a full half maximum (FWHM) of less than about 70nm and mixing the solvent solution comprising the chromophoric polymer with a miscible solvent to form a condensed chromophoric polymer, wherein the condensed chromophoric polymer includes an emission spectrum with a FWHM less than about 70nm.
The above arguments have fully been considered but are not found persuasive because, the cited figure and paragraph are for one aspect and not for all aspects and descriptions with the preamble “for example”, “in one embodiment”, “in some embodiment” or “in one aspect”, are not considered clear definition when the claim language or term is broader than the embodiments. Se MPEP 2111.01(II). "Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment." Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004). See also Liebel-Flarsheim Co. v. Medrad Inc., 358 F.3d 898, 906, 69 USPQ2d 1801, 1807 (Fed. Cir. 2004) (discussing recent cases wherein the court expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment); E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) ("Interpretation of descriptive statements in a patent’s written description is a difficult task, as an inherent tension exists as to whether a statement is a clear lexicographic definition or a description of a preferred embodiment.
In regards to rejection under 35 USC 112 (a), Applicant argued that in addition to the BODIPY and squaraine units, Examples 9 and 22 describing polymers dots comprising quantum dots and metal complexes and Chem Sci. (2017, 8, 3390), submitted in IDS, demonstrates that pdots comprising porphyrin-based monomers according to amended Claim 1 provide emission having a FWHM of less that 70 nm.
The above arguments have fully been considered but are not found persuasive because according to amended Claim 1, porphyrin-based monomers are not in the claim and the claim is not limited to having FWHM of less than 70 nm as asserted by Applicant’s. Furthermore, as asserted by Applicant’s the recitation of “condenced chromophoric polymer”, “polymer dot” or ‘narrow-band monomer” are not limited to FWHM of less than 70 nm.
According to MPEP 2145 “Consideration of Applicant's Rebuttal Arguments,” arguing limitations which are not claimed is improper:
“Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In reVan Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) (Claims to a superconducting magnet which generates a “uniform magnetic field” were not limited to the degree of magnetic field uniformity required for Nuclear Magnetic Resonance (NMR) imaging. Although the specification disclosed that the claimed magnet may be used in an NMR apparatus, the claims were not so limited.); Constantv. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1571-72, 7 USPQ2d 1057, 1064-1065 (Fed. Cir.), cert. denied, 488 U.S. 892 (1988) (Various limitations on which appellant relied were not stated in the claims; the specification did not provide evidence indicating these limitations must be read into the claims to give meaning to the disputed terms.); Ex parteMcCullough, 7 USPQ2d 1889, 1891 (Bd. Pat. App. & Inter. 1987) (Claimed electrode was rejected as obvious despite assertions that electrode functions differently than would be expected when used in nonaqueous battery since “although the demonstrated results may be germane to the patentability of a battery containing appellant’s electrode, they are not germane to the patentability of the invention claimed on appeal.”).
In regards to 103 rejection over Haugland in view of Wu, Applicant argued that Haughlan does not describe narrow-ban monomers as accepting energy from other monomers, as presently claimed and Haughland is silent with respect to condensed chromophoric polymer. Applicant argued that the declaration prepared by inventor Chiu explains that a low ratio or narrow-ban monomer provides polymer dots that exhibit a narrow emission of FWHM of less than about 70nm. Applicant argued that this application provides ample support that the recited ratio of narrow-band monomer to other monomers recited in independent Claim 1 provides FWHMs of less than about 70nm.
The above arguments have fully been considered but are not found persuasive. However, contrary to Applicant’s assertion, Haughland teaches dipyrrometheneboron difluride derivative compound incorporated into polymer microparticle comprising styrene monomers (polystyrene) (claims 1-3) and polystyrene particle incorporated with dipyrrometheneboron difluride derivative would be considered as in energy donor and acceptor configuration. In regards to condensed chromophoric polymer, Haugland teaches that the narrow-band monomer, the first general monomer, the second general monomer, or a combination thereof are integrated into the backbone of the chromophoric polymer (col. 12, In. 35 to col. 13, In. 15), and since claim 1 recites condensed chromophoric polymer comprising a narrow-band monomer and one or more general monomers, wherein the narrow-band monomer is integrated into the condensed chromophoric polymer, the disclosure of Haugland of dipyrrometheneboron difluoride derivative (i.e. a narrow band monomer) integrated into polymeric particle (condensed polymer) comprising polystyrene (claim 3) would be considered as the same composition. Since Haughland taches various percentages of quantum yield, and teaches incorporation of polymeric dyes by copolymerization with other polymerizable monomers (col.1, ln 45-55; col.4, lines ln 40-55; col.10, ln 36-62 and col.12, ln 51-65), one of ordinary skilled in the art can easily envisage various proportions of the various components of the polymerizable monomers and polymerizable dyes for optimization absent showing of unexpected advantages with a particular proportions with particular monomers. Note that as described in the 35 USC 112(b) rejection above, the narrow-band monomer and condensed polymer has not been clearly defined in the specification and the claims are not limited to certain combination of general monomer and narrow-band monomer in energy donor an receiving configuration with the recited ratio for an unexpected result. In regards to declaration, the declaration considered that claims recite emission spectrum with a FWHM of less than 70nm because the declaration recites “emission spectrum with a FWHM of less than about 70nm as recited by the instant claims” (see last 2 lines of paragraph 5), which is not in the independent claim 1. The declaration is based on claims having the limitation of FWHM of less than about 70nm, which is not in the independent claim and thus is ineffective.
In regards to the rejection over Thivierge, Applicant’s arguments are based on Thievierge do not have FWHM of less than about 70nm and the declaration recites “emission spectrum with a FWHM of less than about 70nm as recited by the instant claims” (see last 2 lines of paragraph 5), which is not in the independent claim 1. The declaration is based on instant claims having the limitation of FWHM of less than about 70nm (which is not in the independent claim 1) and based on this, the declaration showed that Thieverge nanoparticles of polymer have a FWHM of 80nm, which is greater than the about 70nm or less recited by the instant claims.
The above arguments have fully been considered but are not found persuasive because independent claim 1 and claims 2-7 and 14-21 dependent thereon, are not limited to the FWHM of 70nm or less as recited in the arguments and as recited in the declaration. According to MPEP 2145 “Consideration of Applicant's Rebuttal Arguments,” arguing limitations which are not claimed is improper. Moreover, as described in the 35 USC 112(b) rejection above, the narrow-band monomer and condensed polymer have not been clearly defined in the specification and the claims are not limited to certain combination of general monomer and narrow-band monomer in energy donor an receiving configuration with the recited ratio for that provides polymer dot of FWHM of 70nm or less. Prolymer dot having FWHM of 70nm or less are not commensurate in scope with the various types of narrow-band monomers as encompassed and the various types of general monomers as encompassed with the recited ratio as claimed.
In regards to double patenting rejections, the rejections have been maintained as not terminal disclaimers have been filed and a statement that Applicant will consider filing Terminal Disclaimers when the claims are otherwise in condition for allowance, is not persuasive to overcome the rejecitons.
Conclusion
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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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678