DETAILED ACTION
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.
Claim Status
Applicant’s preliminary amendment of 07/29/2025 is acknowledged. Claims 2-3, 7, 9, 14-15, 22, 25, 27-30, 34-35, 38-39, and 41-42 are amended, and claims 4-6, 8, 10-13, 16-21, 23-24, 26, 31-33, 36-37, 40, and 43-70 are cancelled. Claims 1-3, 7, 9, 14-15, 22, 25, 27-30, 34-35, 38-39, 41-42, and 71 are currently pending and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/US2023/024125 filed on 06/01/2023 and claims domestic benefit to U.S. Application No. 63/348,119 filed on 06/02/2022 as reflected in the filing receipt dated on 08/08/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/29/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Specification
The use of the term “Laponite”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. In this case, Applicant’s statement that LAPONITE® corresponds to “hemostatic silicate nanodisks” does not adequately define the generic identity of the chemical [instant specification, pg. 35, line 10].
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1-2, 29, 42, and 71 are objected to because of the following informalities:
Claim 1 contains an extraneous space between the terms “25” and “°C” which should be removed.
Claim 2 is missing a comma between the terms “a poly(acrylamide)” and “a poly(caprolactam)” which should be added.
Claim 29 recites the limitation “between 10 and 1000 Pa”. To clarify the unit modifying “10”, the claim should read “between 10 Pa and 1000 Pa”.
Claims 42 and 71 each contain extraneous spaces between the terms “32” and “°C” and between “37” and “°C” which should be removed.
Claim Rejections - 35 USC § 112(b)
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 15, 28, and 30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation “wherein the plurality of nanoparticles comprises a synthetic smectic clay, a ceramic nanoparticle, a metal nanoparticle, a polymeric nanoparticle, a lipid nanoparticle, a carbon-based nanoparticle, a Laponite”. Because the list does not comprise a grammatical conjunction, such as “and” or “or”, it is unclear if the plurality of nanoparticles must comprise all of the listed elements or only one of them. For the purposes of compact prosecution in the prior art rejections below and consistent with Applicant’s claims as originally filed (see claims 15-21 of the claim set dated 11/25/2024, which include individual claims reciting each of the nanoparticle choices), the Examiner is interpreting the claim to mean that only one of the listed elements is required.
Further, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 15 recites the broad recitation “a synthetic smectic clay”, and the claim also recites “a Laponite” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Additionally, claim 15 contains the trademark/trade name “Laponite”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a species of the instantly claimed plurality of nanoparticles and, accordingly, the identification/description is indefinite.
Claim 28 recites that the solution “comprises a hydrogel between 32°C and 37°C”. It is unclear whether the solution must comprise a hydrogel at all temperatures within the instantly claimed range, or whether a solution comprising a hydrogel at any temperature within the range is sufficient to meet the claim. For example, does a solution having a gelation temperature of 36°C (i.e., comprises a hydrogel at 36°C and 37°C) meet the claim? Therefore, the scope of the claim is indefinite. For the purposes of compact prosecution in the prior art rejections below, the Examiner is interpreting the claim to mean that a solution comprising a hydrogel at any temperature within the claimed range is sufficient to meet the claim.
Claim 30 recites the limitations “between 1 Pa and 100 Pa sec” and “between 1 Pa and 1000 Pa second”, wherein “Pa” is a unit of pressure or stress and “Pa sec” is a unit of dynamic viscosity. The claim is indefinite because it is unclear how a range can encompass more than one quantity of measure. For the purposes of compact prosecution in the prior art rejections below and because the claim recites that each range corresponds to a viscosity, the Examiner is interpreting the unit “Pa” to mean “Pa sec”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 14-15, 22, 27-29, and 42 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Shoichet et al. (US20130189230A1; published: 06/25/2013; PTO-892).
Shoichet, throughout the reference, teaches an injectable composition comprising: a polymer composition comprising: at least one thermal gelling polymer, at least one anionic gelling polymer, and a water-based carrier; and at least one cell type [abstract; claims]. The reference further teaches that the injectable compositions are shear-thinning, thixotropic, and resorbable and ultimately form a hydrogel system [abstract].
Regarding claim 1: In Shoichet’s examples, the polymers are dissolved in the carrier [0072]. Shoichet further teaches that the injectable composition can be used to co-deliver cells and pharmaceutical agents encapsulated in micron-sized particles or nanoparticles, which are dispersed (i.e., suspended) in the polymer [claim 68; 0059]. Therefore, an ordinarily skilled artisan could readily envision an embodiment wherein the injectable composition comprises nanoparticles.
Together, the injectable composition of Shoichet reads on the instantly claimed article comprising a thermos-responsive polymer dissolved in solution and a plurality of nanoparticles suspended in the solution, wherein the solution is thixotropic.
Regarding the limitation wherein the solution comprises a lower critical solution temperature (LCST) of at least 25°C: In an exemplary embodiment, the composition is a moderately viscous solution at room temperature of 25°C, and heating to 37°C results in formation of a gel, indicating that the material would gel upon injection at an injured site [0075-0077]. Therefore, the LCST of the solution is necessarily between 25°C and 37°C, which lies within and thus reads on the instantly claimed range, which prevents the sol-to-gel transition from occurring prior to injection.
Regarding claims 2-3: Shoichet teaches that the thermal gelling polymer is selected from a limited list including poly(N-isopropyl acrylamide) and copolymers of poly(N-isopropyl acrylamide) [claim 57]. Therefore, one of ordinary skill in the art could readily envision an embodiment wherein the thermal gelling polymer comprises poly(N-isopropyl acrylamide).
Regarding claim 14: In an exemplary embodiment, the thermal gelling polymer methylcellulose (MC) is dissolved in media at a concentration of 0.5 wt.% [0072; claim 57]. Because the reference teaches that media is a water-based carrier [claim 60], and an ordinarily skilled artisan would recognize would recognize that the density of water is ~1 g/mL, the concentration of thermal gelling polymer dissolved in solution is ~0.5 g/dL, which lies within and thus reads on the instantly claimed range.
Regarding claim 15: Shoichet teaches that the nanoparticles are selected from nanospheres, nanorods, and liposomes [claim 68; 0059]. Therefore, one of ordinary skill in the art could readily envision an embodiment wherein the nanoparticles are liposomes, which read on the instantly claimed lipid nanoparticles.
Regarding claim 22 and 42: Shoichet teaches that there may be a non-covalent interaction between the particles/rods/liposomes and the polymers to promote the distribution of the particles throughout the gel and expressly contemplates cationic and/or anionic charged particles [0031]. Regarding the “wherein” clause recited in claim 42: Because the reference teaches that the solution obtains a hydrogel state at 37°C, wherein the thermal gelling polymer is inherently no longer fully soluble in water, the prior art thermal gelling polymer dissolved in thixotropic solution is capable of becoming insoluble within the claimed temperature range and thus meets the claim.
Regarding claim 27: Shoichet teaches an exemplary injectable composition that exhibits thixotropic properties at a shear rate of between 0.1 1/s and 1 1/s at 37°C [0075; Fig. 1b]. While the reference is silent as to the behavior of the solution when nanoparticles are included, thixotropy is expressly taught as key feature of the reference’s injectable solution [abstract; 0075]. Therefore, the reference clearly contemplates embodiments wherein even if additional components are added, its thixotropic property is maintained. Moreover, because the prior art teaches a thixotropic article having the same structural features as the instantly claimed article, an ordinarily skilled artisan would reasonably conclude that the properties Applicant discloses and/or claims are necessarily present at the claimed shear rate. See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (MPEP 2112.01).
Regarding claim 28: As discussed above, the reference teaches that the solution comprises a hydrogel at 37°C [0075], which lies within and thus reads on the instantly claimed range.
Regarding claim 29: Shoichet teaches exemplary injectable compositions wherein a storage modulus (G’) of slightly above 10 Pa is achieved at 37°C, which lies within and thus reads on the instantly claimed range [Fig. 14]. While the reference is silent as to the storage modulus of the solution when nanoparticles are included, the reference expressly teaches that experiment simulates conditions of in vivo injection, which is the ultimate purpose of the prior art composition [0056]. Therefore, the reference clearly contemplates embodiments wherein even if additional components are added, its exemplary mechanical properties, including storage modulus, are maintained. Moreover, because the prior art teaches an article having the same structural features as the instantly claimed article, an ordinarily skilled artisan would reasonably conclude that the properties Applicant discloses and/or claims are necessarily present. See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (MPEP 2112.01).
Claim 71 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maeda et al. (Polymers, vol. 11, pg. 1-13; published: 02/02/2019; PTO-892) as evidenced by Jatav et al. (Applied Clay Science, vol. 97-98, pg. 72-77; published: 06/21/2014).
Maeda, throughout the reference, teaches thermosensitive laponite/poly(ethylene glycol)-b-poly(D,L-lactide-co-glycolide) (laponite/PEG-b-PLGA) hydrogels with a gelation temperature around physiological temperature [abstract].
Regarding claim 71: Maeda teaches that the laponite/PEG-b-PLGA nanocomposites are formed by dissolving PEG-b-PLGA in water to form a solution, which is blended with a suspension of Laponite XLG® in water [pg. 2, sec. 2.1; pg. 3, sec. 2.3]. Laponite XLG® has a chemical formula of Na0.7Si8Mg5.5Li0.3O20(OH)4, wherein upon dispersing in the aqueous media, the Na---+ ions dissociate rendering a permanent negative charge to the faces of Laponite particles, as evidenced by Jatav [pg. 72, r. col.; pg. 73, l. col.]. At a temperature of 37°C, a solution comprising 3 wt.% PEG-b-PLGA and 1.0 wt.% laponite is able to form a hydrogel [pg. 7, Fig. 5].
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 14-15, 22, 27-30, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Shoichet et al. (US20130189230A1; published: 06/25/2013; PTO-892).
Shoichet teaches the invention(s) of claims 1-3, 14-15, 22, 27-29, and 42 as discussed in detail above and further incorporated herein.
Regarding claim 30: Shoichet is silent as to the viscosity of the polymer solution at 25°C and 37°C when nanoparticles are included. However, the reference does teach that the strength of the gel can be tuned through compositional adjustment [0110]. For example, increasing the content of hyaluronic acid enhances gelation via viscosity [0110]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manipulate the viscosity of the composition comprising nanoparticles in order to improve the strength of the hydrogel at 37°C while ensuring that the solution at 25°C can be injected without putting lethal stress on the cells.
Claims 1-3, 14-15, 22, 25, 27-30, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Shoichet et al. (US20130189230A1; published: 06/25/2013; PTO-892), as applied to claims 1-3, 14-15, 22, 27-30, and 42 above, and further in view of Baumann et al. (Biomaterials, vol. 31, pg. 7631-7639; published: 07/24/2010; PTO-892).
Shoichet teaches the invention(s) of claims 1-3, 14-15, 22, 27-30, and 42 as discussed in detail above and further incorporated herein.
However, Shoichet is silent as to the concentration of nanoparticles in the injectable composition and, thus, does not expressly teach the further limitations of claim 25.
Baumann also teaches hyaluronate/methylcellulose (HAMC)-based injectable hydrogels for therapeutic delivery in spinal cord injury [abstract]. The reference teaches that dispersion of 10 wt.% poly(lactide-co-glycolide) (PLGA) nanoparticles in the biopolymer matrix increases the stiffness of the hydrogel while maintaining its thermo-responsiveness, suggesting that the composite remains injectable [pg. 7632, sec. 2.1-2.2; pg. 7633, sec. 3.1; Fig. 1].
Regarding claim 25: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manipulate the concentration of nanoparticles within the injectable composition of Shoichet, using 10 wt.% (also written as 10 g/dL, based on the density of a water-based solution being ~ 1 g/mL) nanoparticles as a starting point for routine optimization, which closely approaches the instantly claimed range, in order to achieve a desired gel strength. There is a reasonable expectation of success because Baumann teaches that nanoparticles are known to influence the rheological properties of thermo-responsive hydrogels comprising the same features as Shoichet without affecting the injectability of the hydrogel.
Claims 1-3, 7, 9, 14-15, 22, 27-30, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Shoichet et al. (US20130189230A1; published: 06/25/2013; PTO-892), as applied to claims 1-3, 14-15, 22, 27-30, and 42 above, and further in view of Madduma-Bandarage (J. Appl. Polym. Sci., vol. 138, pg. 1-23; published: 12/17/2020; PTO-892).
Shoichet teaches the invention(s) of claims 1-3, 14-15, 22, 27-30, and 42 as discussed in detail above and further incorporated herein.
However, Shoichet does not expressly teach wherein the composition comprises a poly(N-vinyl caprolactam) as recited in claim 7, or a poly(methyl vinyl ether) or a poly(2-ethoxyethyl vinyl ether) as recited in claim 9.
Madduma-Bandarage, throughout the reference, teaches that hydrogels can be modified to introduce new properties or enhance existing features to suit the desired applications and challenges of synthetic polymer hydrogels [abstract].
Regarding temperature-responsive hydrogels, Madduma-Bandarage teaches that poly(N-isopropyl acrylamide) (PNIPAM), poly(N,N-diethyl acrylamide) (PDEAM), poly(methyl vinyl ether) (PMVE), and poly(N-vinylcaprolactam) (PVC) are all suitable polymers with lower critical solution temperature responsiveness for use in delivery systems that deliver drugs, small molecules, growth factors, genes, nanoparticles, and so forth [pg. 12, section 5.4].
Regarding claims 7 and 9: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the thermal gelling polymer in the injectable composition of Shoichet, which as discussed above can include PNIPAM, with the PVC or PMVE of Madduma-Bandarage according to known methods to yield the predictable result of a temperature-responsive hydrogel delivery system. An ordinarily skilled artisan would have been motivated to exchange the thermal gelling polymer in order to tune the chemical and physical properties of the hydrogel system, as Shoichet teaches that gel properties such as strength can be tuned through compositional adjustment [0110]. There is reasonable expectation of success because like the inverse thermal gelling polymers of Shoichet, the polymers of Madduma-Bandarage are thermo-responsive in the same manner (e.g., they decrease in solubility upon an increase in temperature) and are useful as delivery systems in a physiologically relevant context.
Claims 1-3, 14-15, 22, 27-30, 34-35, and 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Shoichet et al. (US20130189230A1; published: 06/25/2013; PTO-892), as applied to claims 1-3, 14-15, 22, 27-30, and 42 above, and further in view of Mayer (Stroke, vol. 38, pg. 763-767; published: 2007; PTO-892).
Shoichet teaches the invention(s) of claims 1-3, 14-15, 22, 27-30, and 42 as discussed in detail above and further incorporated herein.
The reference further teaches that injectable hydrogels offer the potential of minimally invasive cell delivery through a needle or catheter into a cavity resulting from disease, aging, or injury [0003]. The in situ thermogelling cell delivery device of Shoichet is particularly useful in the central nervous system, such treatment after stroke injury [0042; 0058; 0063].
However, Shoichet does not expressly teach that the injectable composition comprises one or more clotting factors as recited in claims 34-35, or that the composition is a hemostatic agent as recited in claim 41.
Mayer teaches that intracerebral hemorrhage is the least treatable form of stroke with a high mortality rate, and clinical evidence suggests that treatment with recombinant activated factor VII in intracerebral hemorrhage patients results in reduced mortality and significantly improved functional outcome among survivors by reducing bleeding and hematoma growth [abstract; pg. 765].
Regarding claims 34 and 35: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the injectable composition of Shoichet by further including the recombinant activated factor VII of Mayer because the prior art teaches that the drug is useful in limiting bleeding and reducing hematoma growth in stroke patients, which would provide an additional therapeutic benefit to the composition’s cell-mediated repair aspect. There is a reasonable expectation of success because Shochiet expressly teaches that its delivery system can be used to co-deliver cells and pharmaceutical agents encapsulated in nanoparticles, and all components are useful for the same purpose of treatment following stroke.
Regarding claim 41: Because the composition taught by the combination of Shoichet and Mayer is capable of controlling bleeding, it meets the limitation of a hemostatic agent.
Claims 1-3, 14-15, 22, 27-30, 38-39, and 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Shoichet et al. (US20130189230A1; published: 06/25/2013; PTO-892), as applied to claims 1-3, 14-15, 22, 27-30, and 42 above, and further in view of Sprigg et al. (The Lancet, vol. 391, pg. 2107-2115; published: 05/16/2018; PTO-892).
Shoichet teaches the invention(s) of claims 1-3, 14-15, 22, 27-30, and 42 as discussed in detail above and further incorporated herein.
The reference further teaches that injectable hydrogels offer the potential of minimally invasive cell delivery through a needle or catheter into a cavity resulting from disease, aging, or injury [0003]. The in situ thermogelling cell delivery device of Shoichet is particularly useful in the central nervous system, such treatment after stroke injury [0042; 0058; 0063].
However, Shoichet does not expressly teach that the injectable composition comprises one or more antifibrinolytic agents as recited in claims 38-39, or that the composition is a hemostatic agent as recited in claim 41.
Sprigg teaches that tranexamic acid can prevent death due to bleeding after trauma and post-trauma hemorrhage [pg. 2107, “Background”]. In patients with stroke due to intracerebral hemorrhage, treatment with tranexamic acid resulted in significant reductions in secondary outcomes including early death, hematoma expansion, and serious adverse events [pg. 2113, “Discussion”]. Sprigg acknowledges that because tranexamic acid is inexpensive, easy to administer, and safe, even a modest treatment effect could have important impact [pg. 2114, last para.].
Regarding claims 38 and 39: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the injectable composition of Shoichet by further including the tranexamic acid of Sprigg because the prior art teaches that the drug is useful in attenuating secondary outcomes following stroke, which would provide an additional therapeutic benefit to the composition’s cell-mediated repair aspect. There is a reasonable expectation of success because Shochiet expressly teaches that its delivery system can be used to co-deliver cells and pharmaceutical agents encapsulated in nanoparticles, and all components are useful for the same purpose of treatment following stroke.
Regarding claim 41: Because the composition taught by the combination of Shoichet and Sprigg is capable of controlling bleeding, it meets the limitation of a hemostatic agent.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
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