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 . Claims included in the prosecution are claims 35-50 and 54-59.
Election/Restrictions
Applicant’s election without traverse of Group I and an injectable material in the reply filed on 07/13/2026 is acknowledged.
Accordingly, claims 51-53 and 60-65 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Applicant is advised that should claim 50 be found allowable, claim 54 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 41 and 58 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.
Regarding claim 41, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 58 recites wherein the scaffold material is composed of a single particle having a single pore. The claim is indefinite since it contradicts with claim 35. claim 35 requires the scaffold material to consist essentially of a plurality of particles and claim 35 requires the particles to have a plurality of interconnected pores.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 35-50 and 54-59 are rejected under 35 U.S.C. 103 as being unpatentable over Griffin et al. (WO 2016/011387 A1, Jan. 21, 2016) (IDS refence) (hereinafter Griffin) in view of Bellas et al. (US 2014/0308362, Oct. 16, 2014) (IDS reference) (hereinafter Bellas) and Kaully et al. (US 2011/0293722, Dec. 1, 2011) (IDS reference) (hereinafter Kaully).
Griffin discloses a microporous gel system comprising an aqueous solution (i.e., claimed liquid containing material) containing a plurality of microgel particles (i.e., claimed scaffold material). The microgel particles act as gel building blocks that anneal to one another to form a covalently-stabilized scaffold of microgel particles having interstitial spaces therein. Annealing of the microgel particles occurs after exposure to an annealing agent that is endogenously present or exogenously added (abstract). The scaffold is a hydrogel (¶ [0010]). The microgel particles may be made from any synthetic or natural polymer capable of forming a hydrogel. Suitable polymers include hyaluronic acid (i.e., glycosaminoglycan) and gelatin (¶ [0090]). The microgel particles can be injected and molded into any desired shape (¶ [0088]). The precursor materials prior to final annealing are flowable and can be delivered as paste, slurry, or even injected to the delivery site of interest (¶ [0085]). The precursor materials can be applied using a syringe device into a treatment site where the microgel conforms to the shape of the injection site (¶ [0126], Fig. 6B). Cells can be introduced into the aqueous solution (i.e., liquid containing material is a cell suspension) to enable encapsulation of these cells within the microgel particles such that encapsulated cells can produce factors to enhance wound healing or cell ingrowth (¶ [00108]). Cells may also be initially adhered to microgel particles (¶ [0083]). In one or more embodiments, the microgel particles comprise cell adhesive peptides exposed on a surface thereof (¶ [0013]). The microgel particles are purified (¶ [00124]). The microgel particles are biodegradable (claim 22). The scaffold may be present in tissues 21 days after injection (¶ [00127]). The microgel particles are 30 to 150 µm in diameter (¶ [00133]).
Griffin differs from the instant claims insofar as not disclosing wherein the microgel particles have a plurality of interconnected pores in their core and on their surfaces that are connected to an environment external to said particles.
However, Bellas discloses silk fibroin particles having porous structures, to mimic the structural morphology of a native tissue, to modulate the degradation rate/volume retention rate of the silk fibroin particles, and/or to modulate release profile of an active agent embedded therein, if any. The term “porous” is generally used to describe a structure having a connected network of pores or void spaces (which can, for example, be openings, interstitial spaces or other channels) throughout its volume (¶ [0050]).
Accordingly, it would have been prima facie obvious to have formulated the microgel particles of Griffin to have interconnected pores motivated by the desire to mimic the structural morphology of a native tissue, to modulate the degradation rate/volume retention rate of the particles, and/or to modulate release profile of the cells embedded therein as taught by Bellas.
The combined teachings of Griffin and Bellas do not teach wherein the pores have a mean pore diameter between 1 µm and 2 mm and wherein the particles have a ratio of mean pore diameter to wall thickness of at least 3.
However, Kaully discloses a macroporous hydrogel sponge having a pore diameter of 50-1000 µm (abstract). The hydrogel sponge may be in dry form suitable for injection after wetting (¶ [0020]). Most of the pores in coarse grain sponges were ~400-600 µm, while the ones of finer pore sponges were ~100-400 µm. The wall thickness of the coarse pores is ~50 µm and the one of the fine pores is ~ 20 µm (¶ [0142]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the microgel particles to have a pore size of 50-1000 µm since this is a known and effective pore size for porous hydrogel materials that are injected into the body as taught by Kaully.
It would have been prima facie obvious to one of ordinary skill in the art to have formulated the microgel particles to have a ratio of mean pore diameter to wall thickness of 5 since an effective pore size for porous hydrogel materials that are injected into the body may be 100 µm and an effective wall thickness for porous hydrogel materials with a pore size of 100 µm may be 20 µm as taught by Kaully, thus a ratio between pore diameter and pore wall thickness of 5 would have been obvious.
In regards to instant claim 35 reciting elastically compressible particles, the instant specification discloses on page 14, lines 4-11 wherein hydrogels have elastic mechanical properties. The instant specification further discloses on page 14, lines 23-24 wherein examples of hydrogels include natural polymers. Griffin discloses microgel particles formed from natural polymers capable of forming hydrogels. Therefore, since Griffin disclose substantially the same particles as the claimed invention, one of ordinary skill in the art would reasonably conclude that the microgel particles of Griffin are elastically compressible like the claimed invention.
In regards to instant claim 36 reciting wherein the particles are hydrated to a w/w ratio between the liquid and the particles of between 1000 and 1, Griffin discloses wherein the precursor material prior to final annealing is flowable and can be delivered as paste or slurry. Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed ratio depending on the form of the precursor material desired.
In regards to instant claim 41 reciting wherein the scaffold material is coated on the bioactive molecule, Griffin discloses wherein cells may be initially adhered to microgel particles. Thus, the cells (i.e., bioactive molecule) have microgel particles (i.e., scaffold material) on its surface (i.e., coated).
In regards to instant claims 48 and 55, Griffin discloses substantially the same particles as the claimed invention (i.e. particles formed form substantially the same hydrogel forming material as the claimed invention). Therefore, one of ordinary skill in the art would reasonably expect the microgel particles of Griffin to have substantially the same properties as the claimed invention.
In regards to instant claim 58, by Griffin disclosing a plurality of particles, a single particle is also taught. It would also have been obvious to have a single pore since pores can modulate release profile of an active agent embedded therein as taught by Bellas and a single pore can modulate release profile of an active agent embedded therein.
In regards to instant claim 59 reciting between 0.1% and 10% dry material content, since the microgel particles (i.e., dry material) are used to form a scaffold, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount depending on size of the scaffold desired.
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 35-50 and 54-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent Nos. 11,219,703 and 12,109,330. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite additional functional limitations) and thus read on the instant claims.
Conclusion
Claims 35-50 and 54-59 are rejected.
Claims 51-53 and 60-65 are withdrawn.
No claims are allowed. (IDS
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/TRACY LIU/Primary Examiner, Art Unit 1614
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