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.
Status of Claims
Claims 1-18 are pending. Claims 9-11 and 17-18 are withdrawn. Claims 1-8 and 12-16 are under examination.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-8 and 12-16) in the reply filed on 08/07/20206 is acknowledged.
Claims 9-11 and 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse.
Claim Rejections - 35 USC § 112
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 1-8 and 12-16 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.
The MPEP states that the purpose of the 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 by him. 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 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. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163.
MPEP § 2163 further states that, for a claimed genus, the written description requirement 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:
The claims are drawn to a particle comprising a rare earth complex, wherein the particle has a particle size distribution of 0.1 or less in terms of polydispersity index measured by dynamic light scattering, and wherein the particle has a hydrophilic polymer on a surface thereof. The claims also recite that the particle has a polarization anisotropy of 0.1 or more with equation 4.
The claims as a whole cover a genus of hydrophilic polymer particles containing a rare earth complex. Explicit in the claims is that such particle would possess certain functional characteristics; namely, the particle size distribution of 0.1 or less and has a polarization anisotropy of 0.1 or more.
Level of skill and knowledge in the art:
Clogston teaches polymer nanoparticles have challenges and limitations (at abstract). In particular, DLS analysis of plasma or serum alone, results in a multimodal size distribution (intensity-weighed distribution), making reliable and conclusive size measurement of nanoparticles challenging (at pg. 193, middle of para. 3). Clogston teaches surface characterization is one of the biggest challenges for nanoparticles and there are a plethora of challenges toc consider at pg. 195, last para). Clogston teaches that the density, distribution, and presentation of the coating and targeting ligand can all be important (at pg. 196, para. 1). Clogston further teaches the surface moieties may have varied densities and distribution, resulting in heterogeneous nanoparticle populations with altered biodistribution and biocompatibility. Furthermore, the activity and stability of a targeting ligand may be different when bound to the nanoformulation, the active site may become inaccessible, or the ligand may cleave prematurely before reaching the intended site (at pg. 196, para. 1) (Clogston et al., “Physicochemical Characterization of Polymer Nanoparticles: Challenges and Present Limitations” Vauthier and G. Ponchel (eds), Polymer Nanoparticles for nanomedicines, Sringer, pgs. 187-203, published 2016).
(2) Disclosure of method of making the claimed invention:
The specification only discloses a specific combination of polymers and rare earth complex (at para. [0080] and Table 1, as filed 11/29/2023) to produce the claimed property as a particle, affinity particle and test reagent.
Meanwhile, MPEP has stated that written description for a genus can be achieved by a representative number of species within a broad generic limitation. However, it is unquestionable that the claims are broad and generic to the particle and affinity particle being expressed to produce the claimed ability/function. The possible structural variations are limitless to the combinations of polymers that would have side chains that do not satisfy the claimed expression and particle size distribution of 0.1 or less. The claims lack written description because there is no disclosure of a correlation between function and structure of generic particles. In particular, Clogston teaches polymer nanoparticles have challenges and limitations on the surface to satisfy ligand attachment. Coupled with the challenges in producing polymer particles for ligand attachments, the still artisan would not be able to establish structure and function of a generic particle comprising rare earth complex with hydrophilic polymer.
Consequently, the skill artisan would not be able to envision the claimed structures of the affinity particle because the art recognizes the inconsistency of producing polymer nanoparticles to achieve consistent functional aspects. In light of the teachings, the skill artisan would face an undue burden of examination in extrapolating from the myriad of combinations of structures as claimed. The person cannot envision the detailed chemical structures until reduction to practice has occurred, regardless of the simplicity of the method to produce the claimed particle.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claimed invention and does not reasonably 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 polymer to produce the claimed properties and function.
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 1-8 and 12-16 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 and 3 recite a particle with a particle size distribution of 0.1 or less in terms of polydispersity index and such particles also have a polarization anisotropy. The claims are unclear to the metes and bounds of the structures from the rare earth complex and hydrophilic polymer to form the claimed characteristics of the particles (i.e., polarization anisotropy of 0.1 and 1.0). Because the polarization anisotropy is dependent on fluorescence intensity, it is unclear to the structure of the complex coupled with hydrophilic polymer (as claimed) to provide the characteristics that distinguish the properties of polarization anisotropy, for example, 0.1 and 1, or properties of particle size distribution of 0.1 and 0.0001. Thus, the particle’s property as claimed is incomplete and omitting essential elements, such omission amounting to a gap between the elements to provide the outcome of different polarization anisotropy as claimed. Claims 2 and 4-8 are rejected as being dependent on claim 1. Claims 12-16 are rejected for the same reasons stated in 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 1-5, 7-8, 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakahama et al. (US2010/0330704A1, published 12/30/2010).
With respect to claims 1 and 4, Nakahama teaches to produce the composite particles each containing the particles and the polymer compound, characterized in that the dispersoid has a single-peak particle size distribution and a dispersity calculated from a number average hydrodynamic particle size and a weight-average hydrodynamic particle size is 1.5 or less (see abstract). Nakahama teaches in the atom-transfer radical polymerization, a transition metal complex serves as a catalyst to these functional groups, an activated species capable of initiating living polymerization is generated (at paras. [0211]-[0212]). Nakahama further teaches gadolinium (at para. [0152]), which also reads on rare earth element (see instant claim 4). Nakahama teaches the surface treatment has a hydrophilic treatment (at para. [0154]). Nakahama teaches measured is based on a dynamic light scattering (at para. [0204]).
With respect to claim 2, Nakahama teaches the polymer is polystyrene and siloxanes (at paras. [0164]-[0165]).
With respect to claim 3, Nakahama teaches TMR sensor has a magnetic anisotropy in the element in-plane direction (at para. [0239]). Meanwhile, as stated above, Nakahama teaches all the elements of the claimed particle. Thus, it would have the claimed polarization anisotropy.
With respect to claim 5, Nakahama teaches the hydrophilic portion derived from methacrylic acid is a carboxyl group (at bottom of para. [0252]).
With respect to claim 7, Nakahama teaches the average particle size is 175 nm (at para. [0241]).
With respect to claim 8, as stated above, Nakahama teaches all the elements of the claimed particle. Thus, it would have the claimed properties. Meanwhile, the recitation of particle is added to 60 µL of a buffer solution mixed with 16µL of serum and the mixture is left to stand at 37oC for 5 minutes is intended use. Because Nakahama’s particles read on the claimed product, it would be capable of performing the intended use.
With respect to claims 12-13, as stated above, Nakahama teaches all the elements of the claimed particle. Nakahama teaches the surface of the particle is modified with an antibody.
With respect to claim 14, as stated above, Nakahama teaches all the elements of the claimed particle. Nakahama further teaches PBS buffer solution and dispersion solution of the particle by DLS (at para. [0306]).
With respect to claim 15, as stated above, Nakahama teaches all the elements of the claimed a test reagent. Thus, it would have the claimed properties. Meanwhile, the recitation of “for in vitro diagnosis” and “for detection of an antigen or an antibody in a specimen by an agglutination method” are directed to intended use. Because Nakahama’s reagents read on the claimed product, it would be capable of performing the intended use.
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 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Nakahama et al. (US2010/0330704A1, published 12/30/2010), as applied to claim 1 or 14 above, and further in view of Mabilat et al. (Patent No. US5723344, published 03/03/1998).
Nakahama has been discussed in the above rejection. Nakahama further teaches the carboxylic acid amide is N-vinyl pyrrolidone (at para. [0125]), but does not exemplify the hydrophilic polymer is polyvinyl pyrrolidone (claim 6) and a kit comprising a cased enclosing the test reagent (claim 16).
Mabilat teaches a device for capturing a target molecule for the purpose of detecting it and/or assaying it with a plurality of ligands covalently coupled to N-vinyl pyrrolidone (at abstract). Mabilat teaches the ligand is an antibody (at col. 1, lines 45- 53). Claim 13 of Mabilat teaches a kit comprising a container containing the ligand and N-vinyl pyrrolidone (at col. 22, lines 8-12).
Thus, 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 particle as taught by Nakahama with N-vinyl pyrrolidone coating as taught by Mabilat because Nakahama teaches the potential of N-vinyl pyrrolidone polymer for conjugation and Mabilat teaches that N-vinyl pyrrolidone polymer covalently couples to a plurality of antibody ligands. Additionally, it would have been obvious to have placed the test reagent as taught by Nakahama into a kit comprising containers as taught by Mabilat because it has been recognized in the art to place reagents into containers for kit purposes.
The person would have a reasonable expectation of success in using N-vinyl pyrrolidone polymer and kit comprising containers because it has been well understood in the art to conjugate antibodies and react nanoparticles in specific elements.
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 1-8 and 12-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 11-15 of copending Application No. 18666177 (‘177).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending Application ‘177 recites:
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Thus, the copending Application would read on the structure of the instant claimed particle having the claimed particle size distribution. Note that copending formula recites “Eu” which is a rare earth element. Copending claim 2 recites the particle has a polarization anisotropy <r> of 0.01 or more, which is determined by equation (9). Copending claim 3 recites the particle includes a layer containing a hydrophilic polymer on an outside of the particle substrate. Copending claim 4 recites the hydrophilic polymer is polyvinylpyrrolidone. Copending claim 5 recites the particle has a ligand-bonding functional group capable of bonding a ligand to an outside of the particle substrate, and wherein the ligand-bonding functional group has at least one functional group selected from the group consisting of: a carboxy group; an amino group; a thiol group; an epoxy group; a maleimide group; and a succinimidyl group. Copending claim 6 recites wherein the particle has an average particle diameter of 50 nm to 300 nm. Copending claim 11 recites an affinity particle comprising: the particle of claim 5; and a ligand bonded to the ligand-bonding functional group. Copending claim 13 recites a test reagent for in vitro diagnosis comprising: the affinity particle of claim 11; and a dispersion medium for dispersing the affinity particle. Copending claim 15 recites a test kit for in vitro diagnosis comprising: the test reagent for in vitro diagnosis of claim 13; and a case enclosing the test reagent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8 and 12-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-16 of copending Application No. 18526055 (‘055).
Although the claims at issue are not identical, they are not patentably distinct from each other because copending Application ’055 recites a test kit for determining at least any one of the presence or absence, and a concentration, of a target substance, the test kit comprising: a first particle that specifically binds to the target substance; and a second particle that has a larger average particle diameter than that of the first particle and specifically binds to the target substance, wherein the first particle contains a rare earth complex, wherein the first particle has an average particle diameter of 10 nm or more and 1 μm or less, and wherein the second particle has an average particle diameter of 100 nm or more and 5 μm or less. Copending claim 4 recites the first particle contains polystyrene and a polymer having a siloxane bond, contains a hydrophilic polymer in a surface of the first particle, and contains a rare earth complex inside the first particle. Copending claim 4 recites the first particle contains polystyrene and a polymer having a siloxane bond, contains a hydrophilic polymer in a surface of the first particle, and contains a rare earth complex inside the first particle. Copending claim 5 recites the rare earth complex is a complex of a rare earth selected from the group consisting of: europium; terbium; neodymium; erbium; yttrium; lanthanum; cerium; samarium; gadolinium; dysprosium; thulium; ytterbium; and scandium. Copending claim 6 recites the first particle and the second particle form an aggregate via the target substance, wherein polarization anisotropy that the aggregate shows in a dispersion medium is increased by 0.004 or more as compared to polarization anisotropy that the first particle shows in the dispersion medium, and wherein the polarization anisotropies are each defined by the following equation 1. Copending claim 7 recites the average particle diameter of the first particle is 20 nm or more and 400 nm or less. the aggregate shows a polarization anisotropy of 0.1 or more in the dispersion medium. Copending claim 11 recites the average particle diameter of the first particle is 20 nm or more and 400 nm or less. Copending claim 14 recites at least any one of the first particle and the second particle has, on a particle surface thereof, a layer containing a hydrophilic polymer containing any one of an ether, a betaine, and a pyrrolidone ring. Copending claim 16 recites the test kit is enclosed in a case.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8 and 12-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-15 of copending Application No. 18310005 (‘005).
Although the claims at issue are not identical, they are not patentably distinct from each other because copending Application’005 recites a test kit to be used for analysis involving measuring a value (R) for polarization anisotropy through use of a luminescent reagent that binds with a target substance, to thereby determine at least any one of the presence or absence of the target substance and a concentration of the target substance, the test kit comprising: a first reagent including a luminescent reagent including: a luminescent particle substrate; and a hydrophilic layer arranged on an outside of the luminescent particle substrate; and a second reagent including a sensitizer containing a hydrophilic polymer. Copending claim 9 recites the hydrophilic polymer is at least one selected from the group consisting of: polyvinylpyrrolidone; sodium alginate; potassium alginate; ammonium alginate; lithium alginate; alginic acid; and polyoxazoline. Copending claim 10 the luminescent particle substrate contains a europium complex. Copending claims 11 and 15 recite the luminescent reagent includes a ligand that binds with the target substance.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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