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 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.
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/17/2026 has been entered.
Claims 1, 4-5, 9-11, and 13-23 are pending in the instant application.
Priority
Application 18/046281 is a CIP of this application. This application does not claim priority to any previous application. Thus the priority date assigned is the effective filing date of 10/12/2022.
Election/Restriction
Applicant’s election without traverse of Group I, claims 1-14, and the species “composition comprising hyaluronic acid” in the reply filed on 1/9/2024 remains in effect.
Claims 4-5, 9, and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/9/2024.
claims 1, 10-11, 13-14, and 21-23
Claims 1, 10-11, 13-14, and 21-23 are examined herein.
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 1, 10-11, 13-14, and 21-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1
Claim 1 is drawn to an injectable gel comprising 0.0001-2 mg of IRAP and 0.0005-5 mg of PDGF wherein it is unclear if these values refer to (i) concentrations of these components within a certain quantity of gel; or (ii) desired dosages to inject to the patient. If (i), the value lacks a fixed quantity of gel to refer to (i.e. 2 mg per 1 g of gel). If (ii), the value lacks a reference to the patient (i.e. 2 mg per kg of patient body weight or 2 mg per patient). Because it is unclear what these values represent, one of skill in the art would not be apprised of the metes and bounds of this claim, thus rendering this claim indefinite. Dependent claims 10-11, 13-14, and 21-23 fail to cure these deficiencies, thus are also rendered indefinite.
Claim 1
Claim 1 is drawn to an injectable gel comprising “about” 0.0001-2 mg of IRAP and “about” 0.0005-5 mg of PDGF. The term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification provides an open definition of about spanning ±0.1% to ±20% of the value (instant spec pg 3, para 00011). The instant specification leaves it up to the practitioner to decide which definition of about to select from. For example, “about 500 ng” could include a breadth of 499.5 - 500.5 ng for one artisan, while another could employ a breadth of ±20%, such as 400 -600 ng. Dependent claims 10-11, 13-14, and 21-23 fail to cure these deficiencies, thus are also rendered indefinite.
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, 10-11, 14, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Lerouge et al. (WO2016098057) in view of Tomas et al. (doi: 10.1016/j.nano.2017.04.016), Massaro et al. (doi: 10.1021/acsmedchemlett.8b00465), Li et al. (doi: 10.1186/1749-799X-3-43), Thompson et al. (doi: 10.1016/0021-9797(92)90254-J), Akash (doi: 10.1007/s11095-012-0843-0), and Hou (doi: 10.1021/acsabm.8b00380). This rejection has been modified solely to address the amendments.
claim 1
Regarding claim 1, Lerouge teaches a gel that is flowable immediately after preparation and becomes a gel after a gelation time within a particular temperature range (pg 2, para 006). Lerouge teaches the gel composition is thermoresponsive (pg 58, para 00285), and can comprise a combination of therapeutic agents, such as an interleukin-1 receptor antagonist (IRAP) (pg 5, para 0029) and platelet-derived growth factor (PDGF) (pg 5, para 0029). Lerouge teaches the gel solution “includes growth factors [such as]… interleukin-1 receptor antagonists” (pg 14, para 00104). Lerouge teaches the gel solution “includes at least one bioactive agent… selected from the group consisting of …growth factors, … platelet-derived growth factors” (pg 11, para 0075). Lerouge teaches the composition may be injected using a needle (pg 10, para 0069). Lerouge teaches the composition has a low viscosity (i.e. is liquid) at room temperature, and gels at 37°C (pg 18, para 00135). Lerouge teaches the gel solution can be delivered as any other liquid used in medical treatment (pg 31, para 00191). Lerouge teaches their composition is also intended to be used as a means of delivering such therapeutic agents (IRAP and PDGF) to a localized area of the body (pg 5, para 0027-0029; pg 2, para 004-005; pg 9, para 0058). Furthermore, Lerouge also teaches the composition could be used to treat arthritis by injecting it into the affected joint (pg 35, para 00208). Lerouge teaches the composition can comprise hyaluronic acid (pg 36, para 00211; claim 31). Lerouge teaches the composition comprising 0.2- 4% w/v of the shear-thinning gelling agent, chitosan (claim 1). LeRouge teaches the bioactive agents were provided through PeproTech (pg 69, para 1), which is a subdivision of ThermoFisher Scientific who makes recombinant cytokines and other peptides for life sciences research (See PeproTech as evidentiary reference), thus satisfying the limitation of the bioactive agents, IRAP/PDGF, being “artificially manufactured” as there is no mention in the specification of LeRouge nor in PeproTech for extracting these peptides from their native sources.
Lerouge is silent on the shape of the nanomaterial that the gel is made of or its electrostatic properties towards recombinant factors. Lerouge does not teach a particular w/v% of a disk-shaped nanomaterial, nor a particular w/v% of hyaluronic acid. Lerouge is also silent on the quantity of IRAP and PDGF within the gel/administered to the patient.
Tomas teaches a synthetic smectite clay nanomaterial (abstract) comprising crystals that are 25 nm in diameter and 0.92 nm in height), having an empirical formula of Na+0.7[(Si8Mg5.5Li0.3)O20(OH)4]−0.7 where the presence of lithium cations that randomly substitute those of magnesium in the structure, called Laponite (pg 2408, col 1-2). The empirical formula of which meets the limitation of silicate. Tomas teaches Laponite is composed of disk-shaped crystal stacks (pg 2408, col 2). Tomas teaches Laponite as a vehicle for delivering drugs that are electrostatically bound to it (pg 2409, col 2, para 2-pg 2410, col 2, para 2; Fig 3, reproduced below).
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Tomas teaches Laponite is a thixotropic gel that experiences a viscosity decrease under shear stress, i.e., is shear-thinning (pg 2409, col 1, para 1).
Massaro teaches a method of treating osteoarthritis comprising intraarticular delivery of nanodisc-shaped laponite-based hydrogel containing kartogenein (abstract, TOC graphic reproduced below). Masaro teaches the Laponite as being disk shaped (pg 421, col 1, para 3).
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Massaro teaches injecting the hydrogel directly into the affected tissue in order to reduce systemic side effects and to reduce the frequency of injections (pg 419, col 1, para 1). Massaro teaches Laponite is a thixotropic hydrogel that can be injected using 21 gauge needles, thus are a convenient platform for delivering tissue-regenerating substances to joints affected by osteoarthritis (pg 420, col 1, para 1). Massaro teaches the aqueous dispersion contains 0.1 wt% (0.1% w/v) of laponite (pg 420, Table 1). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In the instant case, the Massaro’s Laponite content of 0.1% w/v overlaps with the instantly claimed disk-shaped silicate nanomaterial content of 0.05-2% w/v. Thus is considered obvious. See MPEP § 2144.05(I).
Li teaches treating individuals with osteoarthritic knees via injecting hyaluronic acid into their joints, resulting in reduced pain (review). Li teaches injecting a 6 mL solution containing 90 mg (1.5 % w/v) of hyaluronic acid into the joint (pg 2, col 2, para 2). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In the instant case, the Li’s hyaluronic acid dosage concentration of 1.5% w/v overlaps with the instantly claimed hyaluronic acid dosage concentration of 0.2-1.5% w/v. Thus is considered obvious. See MPEP § 2144.05(I).
Akash teaches adding 1 mg IRAP (a.k.a. IL-1Ra) per gram of thermosensitive gel (pg 3476, col 2, para 1), generating a sustained-release anti-inflammatory formulation of IRAP that improves its therapeutic potential at lower dosages relative to systemic injections of IRAP (pg 3484, col 1, para 2). Absent the evidence of criticality, the dosage of Akash anticipates that instantly claimed. See MPEP § 2144.05(I).
Hou teaches adding 20 ug per mL of hydrogel (pg 1432, col 2, para 4) in order to prepare a controlled-release formulation of PDGF to promote wound healing at the injection site (pg 1436, col 1, para 3). Hou teaches the injectable hydrogel generates a temporary matrix at the injection site promoting the recruitment of fibroblasts to accelerate the healing process where it is needed (abstract). Absent the evidence of criticality, the dosage of Hou anticipates that instantly claimed. See MPEP § 2144.05(I).
It would have been obvious to combine the teachings of Lerouge, Tomas, Massaro, and Li because (1) Lerouge teaches delivering IRAP and PDGF directly into an arthritic joint using an injectable, gel; (2) Tomas teaches that laponite is a thixotropic gel that is configured to electrostatically bind drug molecules; (3) Massaro teaches the quantity of laponite needed for osteoarthritic injections; (4) Li teaches the benefits of injecting hyaluronic acid into the joints of arthritic patients and the effective dosages of hyaluronic acid that elicit a therapeutic effect in those with osteoarthritis; (5) Akash teaches a 1 mg IRAP per gram of thermosensitive gel is effective in generating an improved anti-inflammatory formulation over injection of IRAP; and (6) Hou teaches 20 ug per mL of gel is effective to promote fibroblast recruitment to the area to promote healing at the injection site. One of skill in the art would have had a reasonable expectation of success because Lerouge teaches that IRAP and PDGF are effective treatments for osteoarthritis, Li teaches that hyaluronic acid is also an effective treatment, and the references of Tomas has demonstrated the capacity of laponite to bind a drug and Li teaches the successful delivery of a drug into a joint using a laponite-based hydrogel. In addition, the references of Akash and Hou provide exemplary dosages of IRAP and PDGF, respectively, that are known to elicit a therapeutic effect when incorporated into an injectable gel.
claim 10, 11
Regarding claims 10 and 11, Tomas teaches a laponite containing hydrogel, which does contain the disk-shaped nanomaterial as instantly claimed (abstract). Tomas teaches laponite hydrogels deswell in response to external temperatures, resulting in a phase transition near 40°C, which is close to human physiological temperature, thus have been selected for use in drug delivery because of this sol-gel formation (pg 2413, col 2, para 2). Because the composition instantly claimed and that of Tomas comprise the same ingredients, the compositions must have the same properties. “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP § 2112.01(II). Thus while Tomas does not disclose the Young’s Modulus for the composition at temperatures below 39°C, it is expected to still be a liquid between the range of 0-39°C as Tomas describes the liquid-gel transition temperature occurs at 40°C, as a result of deswelling.
claim 13
Regarding claim 13, Lerouge teaches the composition may include an anti-inflammatory therapeutic agent (pg 5, para 0029). While it is believed the teachings of Lerouge fully anticipate the instant claim, in the alternative, it would have been obvious to take the teachings of Lerouge to incorporate an anti-inflammatory agent to the gel composition in order to locally treat inflammation because Lerouge teaches that the composition is effective for targeting a drug to the area of the body that it is injected into (pg 9, para 0058) and Lerouge teaches that such inflammatory compounds can be incorporated into the gel (pg 5, para 0029). One of skill in the art would have had a reasonable expectation of success because Lerouge generated the gel composition and teaches that it is effective for local delivery of an anti-inflammatory drug.
claim 14
Claim 14 is drawn to the medicinal properties of the composition of claim 1, such as reducing ECM degradation. These are properties are understood to be inherent to the structure of the composition, thus no additional structure beyond what is recited in claim 1 is required to produce such functions. Regarding these properties, Lerouge teaches that extracellular matrix (ECM) compounds may be included in the composition (pg 6, para 0036), as a method of promoting tissue protection and healing (pg 14, para 00102). Thus meeting the limitation of treating/reducing ECM degradation. Lerouge teaches injecting the composition into the affected site, possibly presenting a physical barrier (pg 14, para 001012). Lerouge teaches using the composition to regenerate cartilage in case of joint trauma or arthritis (pg 35, para 00208), thus meeting the limitation of being injectable at an osteoarthritic site.
claim 21
Regarding claim 21, Tomas teaches Laponite crystals are 25 nm in diameter and 0.92 nm in height) (pg 2408, col 1-2).
Tomas does not teach the thickness of the Laponite crystals in aqueous dispersion.
Thompson teaches aqueous dispersions of Laponite can contain crystals with an average thickness in the range of 2-4 nm (abstract).
It would have been obvious to combine the teachings of Lerouge, Tomas, Massaro, Li, and Thompson because (1) Lerouge teaches injectable gels are effective at delivering drugs; (2) Tomas teaches Laponite as an exemplary injectable gel capable of drug delivery having a thickness of ~1 nm; and (3) Thompson teaches the nanoparticles of Laponite can have variable thickness when in aqueous dispersion, within the range of 2-4 nm. One of skill in the art would have had a reasonable expectation of success because the property of Laponite’s thickness in the presence of water is a known property of Laponite.
claim 22
Regarding claim 22, Tomas teaches Laponite comprising crystals that are approximately 25 nm in diameter and 0.92 nm in height) (pg 2408, col 1-2).
claim 23
Regarding claim 23, Tomas teaches a synthetic smectite clay nanomaterial (abstract) comprising crystals that are 25 nm in diameter and 0.92 nm in height), having an empirical formula of Na+0.7[(Si8Mg5.5Li0.3)O20(OH)4]−0.7 where the presence of lithium cations that randomly substitute those of magnesium in the structure, called Laponite (pg 2408, col 1-2).
Non-Statutory 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.
18/046281
Claims 1, 10-11, 13-14, and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/046281 in view of Lerouge et al. (WO2016098057), Tomas et al. (doi: 10.1016/j.nano.2017.04.016), Massaro et al. (doi: 10.1021/acsmedchemlett.8b00465), Li et al. (doi: 10.1186/1749-799X-3-43), Thompson et al. (doi: 10.1016/0021-9797(92)90254-J), Akash (doi: 10.1007/s11095-012-0843-0), and Hou (doi: 10.1021/acsabm.8b00380). Although the claims at issue are not identical, they are not patentably distinct from as explained in the claim-by-claim analysis:
claim 1, 2
Regarding instant claim 1, the reference claims a composition comprising IRAP, PDGF, and HA within a thermoresponsive gel (claim 1). The reference claims comprising laponite (claim 7).
Lerouge teaches the composition is suitable as an injectable thermogel (pg 1, para 003; pg 10, para 0069). Lerouge teaches a gel that is flowable immediately after preparation and becomes a gel after a gelation time within a particular temperature range (pg 2, para 006). Lerouge teaches the gel composition is thermoresponsive (pg 58, para 00285), and can comprise a combination of therapeutic agents, such as an interleukin-1 receptor antagonist (IRAP) (pg 5, para 0029) and platelet-derived growth factor (PDGF) (pg 5, para 0029). Lerouge teaches the composition may be injected using a needle (pg 10, para 0069). Lerouge teaches the composition has a low viscosity (i.e. is liquid) at room temperature, and gels at 37°C (pg 18, para 00135). Lerouge teaches the gel solution can be delivered as any other liquid used in medical treatment (pg 31, para 00191). Lerouge teaches their composition is also intended to be used as a means of delivering such therapeutic agents (IRAP and PDGF) to a localized area of the body (pg 5, para 0027-0029; pg 2, para 004-005; pg 9, para 0058). Furthermore, Lerouge also teaches the composition could be used to treat arthritis by injecting it into the affected joint (pg 35, para 00208). Lerouge teaches the composition can comprise hyaluronic acid (pg 36, para 00211; claim 31). Lerouge teaches the composition comprising 0.2- 4% w/v of the shear-thinning gelling agent, chitosan (claim 1). LeRouge teaches the bioactive agents were provided through PeproTech (pg 69, para 1), which is a subdivision of ThermoFisher Scientific who makes recombinant cytokines and other peptides for life sciences research (See PeproTech as evidentiary reference), thus satisfying the limitation of the peptides being “artificially manufactured” as there is no mention in the specification of LeRouge nor in PeproTech for extracting peptides from their native sources.
Tomas teaches a synthetic smectite clay nanomaterial (abstract) comprising crystals that are 25 nm in diameter and 0.92 nm in height), having an empirical formula of Na+0.7[(Si8Mg5.5Li0.3)O20(OH)4]−0.7 where the presence of lithium cations that randomly substitute those of magnesium in the structure, called Laponite (pg 2408, col 1-2). The empirical formula of which meets the limitation of silicate. Tomas teaches Laponite is composed of disk-shaped crystal stacks (pg 2408, col 2). Tomas teaches Laponite as a vehicle for delivering drugs that are electrostatically bound to it (pg 2409, col 2, para 2-pg 2410, col 2, para 2; Fig 3, reproduced below).
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Tomas teaches Laponite is a thixotropic gel that experiences a viscosity decrease under shear stress, i.e., is shear-thinning (pg 2409, col 1, para 1).
Massaro teaches a method of treating osteoarthritis comprising intraarticular delivery of a laponite-based hydrogel containing kartogenein (abstract). Massaro teaches injecting the hydrogel directly into the affected tissue in order to reduce systemic side effects and to reduce the frequency of injections (pg 419, col 1, para 1). Massaro teaches Laponite is a thixotropic hydrogel that can be injected using 21 gauge needles, thus are a convenient platform for delivering tissue-regenerating substances to joints affected by osteoarthritis (pg 420, col 1, para 1). Massaro teaches the aqueous dispersion contains 0.1 wt% (0.1% w/v) of laponite (pg 420, Table 1). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In the instant case, the Massaro’s Laponite content of 0.1% w/v overlaps with the instantly claimed disk-shaped silicate nanomaterial content of 0.05-2% w/v. Thus is considered obvious. See MPEP § 2144.05(I).
Li teaches treating individuals with osteoarthritic knees via injecting hyaluronic acid into their joints, resulting in reduced pain (review). Li teaches injecting a 6 mL solution containing 90 mg (1.5 % w/v) of hyaluronic acid into the joint (pg 2, col 2, para 2). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In the instant case, the Li’s hyaluronic acid dosage concentration of 1.5% w/v overlaps with the instantly claimed hyaluronic acid dosage concentration of 0.2-1.5% w/v. Thus is considered obvious. See MPEP § 2144.05(I).
Akash teaches adding 1 mg IRAP (a.k.a. IL-1Ra) per gram of thermosensitive gel (pg 3476, col 2, para 1), generating a sustained-release anti-inflammatory formulation of IRAP that improves its therapeutic potential at lower dosages relative to systemic injections of IRAP (pg 3484, col 1, para 2). Absent the evidence of criticality, the dosage of Akash anticipates that instantly claimed. See MPEP § 2144.05(I).
Hou teaches adding 20 ug per mL of hydrogel (pg 1432, col 2, para 4) in order to prepare a controlled-release formulation of PDGF to promote wound healing at the injection site (pg 1436, col 1, para 3). Hou teaches the injectable hydrogel generates a temporary matrix at the injection site promoting the recruitment of fibroblasts to accelerate the healing process where it is needed (abstract). Absent the evidence of criticality, the dosage of Hou anticipates that instantly claimed. See MPEP § 2144.05(I).
It would have been obvious to combine the teachings of the reference, Lerouge, Tomas, Massaro, and Li because (1) Lerouge teaches delivering IRAP and PDGF directly into an arthritic joint using an injectable, gel; (2) Tomas teaches that laponite is a thixotropic gel that is able to electrostatically bind drug molecules; (3) Massaro teaches the quantity of laponite needed for osteoarthritic injections; (4) Li teaches the benefits of injecting hyaluronic acid into the joints of arthritic patients and the effective dosages of hyaluronic acid that elicit a therapeutic effect in those with osteoarthritis; (5) the reference teaches the composition contains a two-dimensional silicate nanomaterial, IRAP, PDGF, and HA; (6) Akash teaches a 1 mg IRAP per gram of thermosensitive gel is effective in generating an improved anti-inflammatory formulation over injection of IRAP; and (7) Hou teaches 20 ug per mL of gel is effective to promote fibroblast recruitment to the area to promote healing at the injection site. One of skill in the art would have had a reasonable expectation of success because Lerouge teaches that IRAP and PDGF are effective treatments for osteoarthritis, Li teaches that hyaluronic acid is also an effective treatment, and the references of Tomas has demonstrated the capacity of laponite to bind a drug and Li teaches the successful delivery of a drug into a joint using a laponite-based hydrogel. In addition, the references of Akash and Hou provide exemplary dosages of IRAP and PDGF, respectively, that are known to elicit a therapeutic effect when incorporated into an injectable gel.
claim 10, 11
Regarding instant claims 10 and 11, the reference claims the gel is thermoresponsive, but does not describe at what temperature a gel is formed. Tomas teaches a laponite containing hydrogel, which does contain the disk-shaped nanomaterial as instantly claimed (abstract). Tomas teaches laponite hydrogels deswell in response to external temperatures, resulting in a phase transition near 40°C, which is close to human physiological temperature, thus have been selected for use in drug delivery because of this sol-gel formation (pg 2413, col 2, para 2). Because the composition instantly claimed and that of Tomas comprise the same ingredients, the compositions must have the same properties. “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP § 2112.01(II). Thus while Tomas does not disclose the Young’s Modulus for the composition at temperatures below 39°C, it is expected to still be a liquid between the range of 0-39°C as Tomas describes the liquid-gel transition temperature occurs at 40°C, as a result of deswelling.
claim 13
Regarding claim 13, the reference does not claim the composition can comprise an anti-inflammatory agent. Lerouge teaches the composition may include an anti-inflammatory therapeutic agent (pg 5, para 0029).
claim 14
Regarding instant claim 14, the reference claims the composition reduces ECM degradation (claim 12).
claim 21-23
Regarding instant claims 21-23, the reference claims the composition contains laponite (claim 7). The reference does not claim the particular properties of laponite, such as the size/dimensions/shape of the laponite crystals. Tomas teaches Laponite crystals are 25 nm in diameter and 0.92 nm in height) (pg 2408, col 1-2). Thompson teaches aqueous dispersions of Laponite can contain crystals with an average thickness in the range of 2-4 nm (abstract).
It would have been obvious to combine the teachings of the reference Lerouge, Tomas, Massaro, Li, and Thompson because (1) Lerouge teaches injectable gels are effective at delivering drugs; (2) Tomas teaches Laponite as an exemplary injectable gel capable of drug delivery having a thickness of ~1 nm; (3) Thompson teaches the nanoparticles of Laponite can have variable thickness when in aqueous dispersion, within the range of 2-4 nm; and (4) the reference claims the composition contains laponite. One of skill in the art would have had a reasonable expectation of success because the property of Laponite’s thickness in the presence of water is a known property of Laponite.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive.
103; pg 5, para 2
Applicant argues the combination of references fail to teach the newly added limitations regarding the concentrations of IRAP and PDGF.
The references of Akash and Hou have been added to the rejection to address these newly added limitations.
Double Patenting; pg 5, para 9
Applicant requests that the double patenting rejection over U.S. Patent Application No. 18/046281 be held in abeyance.
A request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see 37 CFR 1.111(b) and MPEP §714.02). Thus, the double patenting rejections of record have been maintained as no response to these rejections has been filled by applicant at this time.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA ANN ESSEX whose telephone number is 571-272-1103. The examiner can normally be reached Mon - Fri 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.A.E./
Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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