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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 11/2/2025 is acknowledged.
Claim 13-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II and III, and there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/2/2025.
Status of Claims
Withdrawn: 13-20
Examined Herein: 1-12
Priority
Acknowledgment is made of applicant's claim for priority under based upon an application filed in KR10-2021-0192357 on 12/30/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/9/2022 and 9/6/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings received on 6/9/2022 are accepted.
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 1-12 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, 5, 10 and 11 recite the term “provided to.” This term is not a conventionally used claim term, the general meaning of the term is not commensurate with the manner it is used in the instant claims, and the specification does not provide any further clarification. As a result, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear whether “provided to” is intended to impose a functional limitation on a respective claim element or describe a non-limiting capability of a respective claim element without imposing a structural feature. Further clarification is requested. Dependent claims fall therewith. For examination purposes, the term “provided to” is interpreted as reciting a non-limiting description.
Claim 6 recites the limitation “an amino group (-NH2)” and “a thiol group (-SH).” Claim 7 additionally recites the limitation “a thiol group (-SH),” “an amine group (-NH2),” and “a carboxyl group (-COOH).” It is unclear why -NH2, -SH, and -COOH are in parentheses and how this limits the claim, if at all. For example, it is unclear whether “an amino group” is limited to unsubstituted -NH2 substituent or encompasses amino groups with substituted substituents (e.g. methylamine, which has the chemical formula -CH3NH2). Further clarification is requested. For examination purposes, these limitations are interpreted as encompassing their respective groups with additional substituents.
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 1-3, 5, 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US 2021/0046443 A1, Filed 8/7/2020), in view of Kang (Remote Control of Heterodimeric Magnetic Nanoswitch Regulates the Adhesion and Differentiation of Stem Cells, 4/22/2018, Journal of the American Chemical Society, 140:5909-5913).
With respect to claim 1, Kim discloses a nanosatellite complex for regulating cell adhesion and differentiation comprising:
a core-shell-type magnetic particle (an iron oxide nanoparticle/silica core-shell nanoparticle); [Kim, 0085-0088, 0093]
a gold nanoparticle (a gold nanoparticle functionalized with a Raman molecule and shell made of gold and silver) connected to one side of the magnetic particle; [Kim, 0092-0099]
a second linker, -SH-PEG-COOH-, connecting between the gold nanoparticle and a ligand, cyclo(-RGDyK); [Kim, 0129]
and the ligand connected to the gold nanoparticle via the second linker; [Kim, 0129]
wherein the gold nanoparticle is connected to the ligand via the second linker to form a nanoassembly; [Kim, 0129]
the magnetic particle is conjugated to the nanoassembly to form a nanosatellite structure; [Kim, Figure 5 & 0096-0099]
and the nanoassembly comprises multiple gold nanoparticles, one second linker is connected between each gold nanoparticle and the ligand, and multiple nanoassemblies are comprised in the nanosatellite structure. [Kim, Figure 5 & 0129]
With respect to claim 2, Kim discloses the magnetic particle is composed of:
a core composed of iron oxide; and a shell provided to cover an outer surface of the core and comprising silica. [Kim, 0085-0088, 0093]
With respect to claim 3, Kim discloses the gold nanoparticles have an average diameter of about 13 nm. [Kim, Figure 4, S3] Kim further discloses the gold nanoparticles may have an average diameter of 5 nm to 500 nm. [Kim, 0069]
With respect to claim 5, the limitation “wherein the nanoassemblies are provided to completely cover an outer surface of the magnetic particle” recites a non-limiting description. The claim scope is not limited by claim language that does not limit a claim to a particular structure. The limitation “provided to” seemingly describes an intended capability of the nanoassemblies rather than imposing a structural requirement that the nanoassemblies cover the outer surface of the magnetic particle. Therefore, this limitation is not given patentable weight.
With respect to claim 6, Kim discloses the magnetic particle has an average diameter of about 150 nm and comprises an amine group (-NH2) on the surface thereof. [Kim, Figure 1(b)(1), 0099] Kim further discloses the magnetic nanoparticles may have an average diameter of 10 nm to 500 nm. [Kim, 0037]
With respect to claim 8, Kim discloses the ligand is cyclo(-RGDyK), which is a cyclic RGD ligand. [Kim, 0129]
Kim does not disclose that the complex comprises a substrate or a first linker connecting between the substrate and the gold nanoparticle.
However, with respect to claim 1, Kang discloses a nanosatellite complex for regulating cell adhesion and differentiation comprising:
A glass substrate,
A magnetic particle (MNC);
a gold nanoparticle connected to one side of the magnetic particle;
a first linker connecting between the substrate and the gold nanoparticle;
a second linker, thiol-PEG, connecting between the gold nanoparticle and a ligand, GCGYGRGDSPG; and
the ligand connected to the gold nanoparticle via the second linker;
wherein the gold nanoparticle is connected to the ligand via the second linker to form a nanoassembly,
the magnetic particle is conjugated to the nanoassembly to form a nanosatellite structure,
the nanoassembly comprises multiple gold nanoparticles, one second linker connected between each gold nanoparticle and the ligand, and
multiple nanoassemblies are comprised in the nanosatellite structure. [Kang, Page 5910, Scheme 1 and Figure 1]
Modifying the complex disclosed by Kim by conjugating the gold nanoparticle of the nanosatellite structure to a glass substrate via a first linker, results in the complex of claim 1.
It would be obvious to one of ordinary skill in the art to modify the complex disclosed by Kim by conjugating the nanosatellite structure to a substrate via a first linker and have a reasonable expectation of success. Kim discloses a nanosatellite structure comprising a gold nanoparticle conjugated to a magnetic nanoparticle and a RGD ligand via a second linker. Kang also discloses a nanosatellite structure comprising a gold nanoparticle conjugated to a magnetic nanoparticle and a RGD ligand via a second linker. Kang discloses the nanosatellite structure is further conjugated to a glass substrate via a first linker. So, Kang establishes that a nanosatellite structure, like the nanosatellite structure disclosed by Kim may be conjugated to a glass substrate via a first linker. Thus, the combined teachings of Kim and Kang suggest the nanosatellite structure disclosed by Kim, may be conjugated to a glass substrate via a first linker. Therefore, it is reasonable to expect the complex disclosed by Kim may be modified by conjugating the nanosatellite structure to a glass substrate via a first linker. One would have been motivated to do so because it is prima facie obvious to combine teachings when some advantage or expected beneficial result would have been produced by their combination. In the instant case, Kang discloses conjugating RGD-coated nanoparticles to a substrate enables the investigation of the effect of coupling strength, micro/nanospacing and density, and order/disorder of bioactive ligands on cellular adhesion and spreading. [Kang, Page 5909, Col. 2, Paragraph 2] Therefore, one would have been motivated by the expectation that the aforementioned modification would enable such investigations on cellular adhesion and spreading to be carried out with respect to the RGD-coated nanoparticles disclosed by Kim.
Claims 1-3, 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Kang, as applied to claims 1-3, 5, 6, and 8 above, and further in view of Lundgren (US 2017/0241896 A1, 8/24/2017) and Albutt (Surface chemistry modification of glass and gold for low density neural cell culture, 3/27/2014, University of Nottingham, Item ID: 13823).
With respect to claim 7, Kim discloses the second linker, -SH-PEG-COOH, has a structure of Formula 1:
wherein R1 is a thiol group (—SH), R2 is one of a carboxyl group (—COOH), and n is 113. [Kim, 0129]
Kim further discloses the gold nanoparticles are capable of being functionalized with thiol groups on the surface thereof. [Kim, 0129]
With respect to claim 9, Kim and Kang disclose a surface of the nanosatellite structure that faces the substrate is spaced apart from the substrate with the first linker interposed therebetween.
With respect to claim 10 and 11, the limitation “the nanosatellite structure is provided to be spaced apart from one side of the substrate” recites a non-limiting description. The claim scope is not limited by claim language that does not limit a claim to a particular structure. The limitation “provided to” seemingly describes an intended capability of the nanosatellite structure rather than imposing a structural requirement that the nanosatellite structure is spaced apart from one side of the substrate. Therefore, this limitation is not given patentable weight.
Kim does not disclose the first linker has a structure of Formula 1, wherein R1 is one of a thiol group (—SH) and an amine group (—NH2), R2 is one of a carboxyl group (—COOH), an amine group (—NH2) and a succinimidyl ester group, and n is a number ranging from 113 to 450. Kim also does not disclose the first linker is elastic and a length thereof is reversibly changed by application of a magnetic field or the first linker is compressed by applying a magnetic field to the other side of the substrate, and the nanosatellite structure moves in a direction toward the substrate to facilitate stem cell adhesion and differentiation/moves in a direction away from the substrate to inhibit stem cell adhesion and differentiation.
However, with respect to claim 7, Lundgreen discloses a solid surface (substrate) may be conjugated to a gold nanoparticle by functionalizing the solid surface and/or nanoparticle with a compound such as an amino terminated group, an aminosilane, or a malemide-PEG group, and binding the functionalized compounds together via applicable forces. [Lundgren, 0014, 0022,0043, 0044] Lundgren further discloses the nanoparticle and the solid surface may each be functionalized with a same or different compound. [Lundgren, 0046] Moreover, Lundgren discloses the solid surface may consist of metal, ceramics, such as glass, or polymer material. [Lundgren, 0043]
Albutt discloses, in one embodiment, a solid glass or gold surface may be amino terminated via APTMS or APDES silanisation. A heterobifunctional linker, mal-PEG-NHS, may be used to attach a molecule with a surface thiol group to the amino terminated surfaces. [Albutt, Page 36, Paragraph 5 - Page 37, Paragraph 1 and Figure III.2]
PNG
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487
632
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[Albutt, Figure III.2]
Modifying the complex disclosed by Kim and Kang by conjugating the nanosatellite structure to an amino terminated substrate via a first linker mal-PEG-NHS results in the first linker of claim 7, which has a structure of Formula I; wherein R1 is an amine group, R2 is a succinimidyl ester group, and n is 113.
It would be obvious to one of ordinary skill in the art to modify the complex disclosed by Kim and Kang by conjugating the nanosatellite structure to an amino terminated substrate via a first linker mal-PEG-NHS and have a reasonable expectation of success. Kim and Kang disclose a complex comprising gold nanoparticles (a part of a nanosatellite structure) conjugated to a glass substrate via a first linker. Kim and Kang disclose the gold nanoparticles are capable of being functionalized with thiol groups on the surface thereof. Lundgren discloses that a gold nanoparticle may be functionalized with a thiol group and bound to a solid surface (e.g., glass substrate) functionalized with an amino terminated group and/or maleimide-PEG compound. Albutt demonstrates a specific embodiment of this conjugation, wherein an APTMS-functionalized glass substrate that bears surface amino groups is coupled with a mal-PEG-NHS linker and forms a thioether bond with a molecule having thiol groups on the surface thereof. So, Kim and Kang disclose a gold nanoparticle having thiol groups on the surface thereof conjugated to a glass substrate, and Lundgren and Albutt disclose that a molecule bearing surface thiol groups may be conjugated to an amino-terminated glass substrate via a mal-PEG-NHS linker. Thus, the combined teachings of Kim, Kang, Lundgren and Albutt suggest that the thiol surface group of the gold nanoparticle of the nanosatellite structure disclosed by Kim and Kang may form a thioether bond with the maleimide group of a mal-PEG-NHS linker conjugated to an amino terminated glass substrate. Therefore, it is reasonable to expect the complex disclosed by Kim and Kang may be modified by conjugating the nanosatellite structure to an amino-terminated substrate via a first linker, mal-PEG-NHS. One would have been motivated to do so because it is prima facie obvious to combine teachings when some advantage or expected beneficial result would have been produced by their combination. In the instant case, Kang discloses that PEG linkers control the motion of the molecule to which they are bound reversibly by an external magnetic field. [Kang (Supplementary), Page S2, Paragraph 3] Therefore, one would have been motivated by the expectation that the mal-PEG-NHS linker would enable reversible control of the gold nanoparticle’s motion by an external magnetic field.
Thus, with respect to claim 9, Kim, Kang, Lundgren, and Albutt disclose a surface of the nanosatellite structure that faces the substrate is spaced apart from the substrate with the first linker, mal-PEG-NHS, interposed therebetween. The first linker comprises PEG, which is inherently elastic. Therefore, the first linker is elastic. As a result, a length thereof is necessarily reversibly changed.
With respect to claim 10 and 11, Kim, Kang, Lundgren, and Albutt disclose the first linker is mal-PEG-NHS and comprises PEG, which is inherently elastic. Therefore, the first linker is elastic. As a result, the first linker is necessarily stretched or compressed.
With respect to claim 9, 10, and 11, the limitation “by application of any applicable force, including a magnetic field” (claim 9) and “by applying a magnetic field to the other side of the substrate and the nanosatellite structure moves in a direction [toward or away from] the substrate” (claim 10 & 11) recites a product by process limitation. These limitations describe how the product, the first linker, is stretched or compressed when an external stimulus is applied and how the nanosatellite structure behaves as a result. However, the patentability of a product is based on the product itself and does not depend on its method of production. MPEP 2113 If the product in the product-by-process claim is obvious from a product of the prior art, the claim is unpatentable even though the prior art product was manipulated by a different external stimulus. In the instant case, the claimed product, a stretchable or compressible first linker, is the same as the product of the prior art, a mal-PEG-NHS linker, which is also elastic when an external stimulus is applied. Because these process-type limitations do not result in a structurally distinct product, they do not confer patentability. Thus, the burden shifts to Applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product.
The limitations “to facilitate stem cell adhesion and differentiation” and “to inhibit stem cell adhesion and differentiation” recites an intended use. A recitation of intended use must result in a structural difference between the instant application and the prior art in order to patentably distinguish the instant application from the reference application. Otherwise, the preamble is not considered a limitation and is of no significance to claim construction. The instant complex recites the exact same structural limitations as the complex disclosed by Kim, Kang, Lundgren, and Albutt. Thus, this limitation does not distinguish the claimed complex from the prior art.
Claims 1-6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Kang, as applied to claims 1-3, 5, 6, and 8 above, and further in view of Sun (US 2021/0346478 A1, Published 11/11/2021).
With respect to claim 1, Kim and Kang disclose the teachings above.
With respect to claim 4, Kim and Kang disclose a plurality of the nanoassemblies are adjacent to each other. [Kim, Figure 5]
Kim and Kang do not disclose the distance between the gold nanoparticles in each of the nanoassemblies adjacent to each other is 3 nm to 4 nm, 15 nm to 20 nm, or 18 nm to 22 nm.
However, with respect to claim 4, Sun discloses a nano-satellite complex comprising a biocompatible coating surrounding a nanoparticle, core satellite particles attached to the biocompatible coating, and antigenic peptides conjugated to the satellite particles. Sun further discloses in one embodiment the nanoparticle core is Fe3O4, the satellite particles are gold nanoparticles, and the average distance between the gold nanoparticle is 5-20 nm. [Sun, 0012, 0014]
Modifying the complex disclosed by Kim and Kang so that the distance between the gold nanoparticles in each of the nanoassemblies adjacent to each other is 5 nm to 20 nm, results in the complex of claim 4.
It would be obvious to one of ordinary skill in the art to modify the complex disclosed by Kim and Kang so that the distance between the gold nanoparticles in each of the nanoassemblies adjacent to each other is 5 nm to 20 nm and have a reasonable expectation of success. Kim and Kang disclose a nanosatellite complex comprising a biocompatible silica coating surrounding a Fe3O4 nanoparticle, gold nanoparticles attached to the coating, and an antigenic peptide, cyclo(-RGDyK), conjugated to the gold nanoparticles. Sun discloses a nano-satellite complex comprising a biocompatible coating surrounding a Fe3O4 nanoparticle, core satellite particles (gold nanoparticles) attached to the coating, and antigenic peptides conjugated to the satellite particles. Sun further discloses the average distance between the gold nanoparticles is 5-20 nm. So, Kim/Kang and Sun both disclose a nanosatellite complex with a substantially similar structure, and Sun further discloses the distance between the gold nanoparticles on the structure may be 5-20 nm. Thus, the combined teachings of Kim/Kang and Sun suggest the distance between the gold nanoparticles on the nanosatellite complex disclosed by Kim/Kang may be 5-20 nm. One would have been motivated to do so because it is prima facie obvious to combine teachings when some advantage or expected beneficial result would have been produced by their combination. In the instant case, Sun discloses the distance between gold nanoparticles present on an iron oxide core is a results-effective variable that influences receptor cross-linking. Sun further discloses a distance between the gold nanoparticles within the range of 5 nm to 20 nm is optimal for crosslinking. [Sun, 0061, 0090] Therefore, one would have been motivated by the expectation that the aforementioned modification would enable the complex to achieve optimal cross-linking.
Claims 1-3, 5, 6, 8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Kang, as applied to claims 1-3, 5, 6, and 8 above, and further in view of Khatua (In Situ Magnetic Control of Macroscale Nanoligand Density Regulates the Adhesion and Differentiation of Stem Cells, 5/14/2020, Nano Letters, 20:4188-4196).
With respect to claim 1, Kim and Kang dsiclsoed the teachings above.
Kim and Kang do not disclose a density of the nanosatellite structure provided on the substrate is 1.0 nanosatellite structure/µm² to 6 nanosatellite structures/µm².
However, with respect to claim 12, differences in density will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such density is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the workable density by routine experimentation. MPEP 2144.05(II)(A) The general conditions of instant claim 1 are disclosed by Kim and Kang, as explained above. Thus, it is not inventive to discover the workable density of the nanosatellite structure on the substrate is about 1.0 nanosatellite structure/µm2 to 6 nanosatellite structures/µm2.
A person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range because Khatua discloses a complex for regulating cell adhesion and differentiation comprising a substrate, a core-shell-type magnetic nanoparticle, and a ligand grafted with a polyethylene glycol (PEG) linker, thereby forming a nanoassembly. [Khatua, Page 4189, Scheme 1] Khatua discloses the particle density of the complex on the substrate is about 3 to 17 particles/µm2. [Khatua, Page 4190, Figure 1d] So, Kim/Kang and Khatua each disclose a complex for regulating cell adhesion and differentiation comprising a substrate, a core-shell-type magnetic nanoparticle, and a ligand grafted with a PEG linker. Khatua discloses 3 to 17 particles/um2 is a workable density for the complex on the substrate. Therefore, it is reasonable to expect that a density falling within this range, like 1.0 to 6 particles (or nanosatellite structures)/µm2, would be a workable density for the complex on the substrate disclosed by Kim/Kang. It would have been routine optimization to arrive at the claimed invention because Khatua discloses that nanoligand density is a results-effective variable that modulates cell adhesion and optimizing this density to achieve a desired reversible motion of the nanoligand is routinely performed in the art. [Khatua, Pag1 4190, Col. 1, Paragraph 2]
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 1-12 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-12 of copending Application No. 17/834,314 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the reference claims.
Claims 1-9 and 12 of the instant application and the reference application recite substantially identical limitations and differ only by the preamble recited in claim 1. The preamble of the instant application recites the limitation “a nanosatellite-substrate complex for regulating stem cell adhesion and differentiation,” while the preamble of the reference application recites the limitation “a nanosatellite-substrate complex for regulating macrophage adhesion and polarization.” Claims 1, 10, and 11 of the instant application and the reference application also recite substantially identical limitations and differ only by the preamble in claim 1 (as described above) and by a limitation recited in claim 10 an 11. Claim 10 of the instant application recites the limitation “to facilitate stem cell adhesion and differentiation,” while claim 10 of the reference application recites the limitation “to promote macrophage adhesion and M2 polarization.” Claim 11 of the instant application recites the limitation “to inhibit stem cell adhesion and differentiation,” while claim 11 of the reference application recites the limitation “to inhibit macrophage adhesion and promote macrophage M1 polarization.” However, these limitations merely recite an intended use. A recitation of intended use must result in a structural difference between the instant application and the reference application in order to patentably distinguish the instant application from the reference application. Otherwise, the preamble is not considered a limitation and is of no significance to claim construction. The instant application recites the exact same structural limitations as the reference application. Thus, the two applications are patentably indistinguishable.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618