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 .
Status of Claims
The preliminary amendment of 12/14/2023 is acknowledged. Claims 1-2, 7, 9-10, 14, 17-18 are amended. Claims 1-20 are currently pending and are examined on the merits herein.
Priority
The instant application filed 12/14/2023, is a 371 filing of PCT/KR2022/012636, filed 08/24/2022, which claims foreign priority to KR10-2021-0130366, filed 09/30/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/14/2023, 07/29/2024, 10/10/2024, and 02/14/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Interpretation
Claims 1 and 2 define a metal ion and an organic crosslinking agent as being contained in both the core and the shell of the micro particles. Since there is no differentiation between the metal ions in the shell versus the core nor the organic crosslinker in the shell versus the core, the Examiner is interpreting the metal ions and organic crosslinker to be the same in both the shell and core.
Claims 4 and 5 define polymer matrices, in which the respective biopolymers are crosslinked in an amount of more than 50% by volume with respect to the total volume of the polymer matrix. This is being interpreted as a degree of crosslinking such that 50% of the polymer in the core/shell matrix is crosslinked by the metal ion and organic crosslinking agent.
Claim Objections
Claim 9 is objected to because it contains a typographical error. Please add a space between “mM” and “when”.
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 6-7, 9-10, and 17-20 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 6 recites micro particles having an average diameter of at least 1 um without reciting an upper limit for said range. As such the scope of the claim is unclear.
Claim 7 recites wherein a thickness of the shell is 95% or less of the longest diameter of the polymer microparticles, which includes 0%, meaning the shell would not be present. As such, this range contradicts the presence of a shell, as defined in the independent claim, making the claim unclear.
Claim 9 recites micro particles having a compressive strength of at least 0.1 mN without reciting an upper limit for said range. As such, the scope of the claim is unclear.
Claim 10 recites “(length-diameter ratio)”. The use of parentheses renders the claim indefinite because it is unclear whether the limitation inside the parentheses is part of the claimed invention.
Claim 17 recites a medical composition comprising the micro carrier of claim 1 while claim 19 recites a medical article comprising the medical composition of claim 17. Since claim 19 does not define any additional components that would differentiate the medical article from the medical composition, it is unclear how the two differ. For the sake of compact prosecution, the medical composition and article of claims 17 and 19 will be interpreted as the same.
Claim 18 recites a cosmetic composition comprising the micro carrier of claim 1 while claim 20 recites a cosmetic article comprising the cosmetic composition of claim 18. Since claim 20 does not define any additional components that would differentiate the cosmetic article from the cosmetic composition, it is unclear how the two differ. For the sake of compact prosecution, the cosmetic composition and article of claims 18 and 20 will be interpreted as the same.
Claim Rejections - 35 USC § 102
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.
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)(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 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kim, Y., et al. (US 12296054 B2, filed 06/01/2021, PTO-892), hereinafter Kim.
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Kim discloses microcarriers in the form of polymeric microparticles (col. 2, lines 22-26).
Regarding claims 1 and 3: The polymeric microparticles having a core-shell structure, comprising: a core including a first biocompatible polymer, a metal ion, and an organic crosslinking agent containing at least one reactive functional group; and a shell surrounding all or part of the core and including a second biocompatible polymer, a metal ion, and an organic crosslinking agent containing at least one reactive functional group, wherein the first biocompatible polymer comprises hyaluronic acid, and the second biocompatible polymer comprises gelatin (claim 9). Such a particle reads on the instantly claimed micro particles wherein the gelatin reads doubly on the second biocompatible biopolymer in the shell and a cell adhesion-inducing layer on the surface of the polymer micro particles.
Regarding claim 2: The core comprises a polymer matrix in which the first biocompatible polymer is crosslinked through the metal ion and the organic crosslinking agent containing at least one reactive functional group, and the shell comprises a polymer matrix in which the second biocompatible polymer is crosslinked through the metal ion and the organic crosslinking agent containing at least one reactive functional group (claim 10).
Regarding claim 4: The core contains a polymer matrix in which hyaluronic acid is crosslinked through the metal ion and the organic crosslinking agent containing at least one reactive functional group, in an amount of more than 50% by volume of with respect to the total volume of the polymer matrix contained in the core (claim 11).
Regarding claim 5: The shell contains a polymer matrix in which gelatin is crosslinked through the metal ion and the organic crosslinking agent containing at least one reactive functional group, in an amount of more than 50% by volume with respect to the total volume of the polymer matrix contained in the shell (claim 12).
Regarding claim 6: Polymeric microparticles may have the average diameter in distilled water of 1 μm or more (col. 12, lines 9-10).
Regarding claim 7: The shell is 95% or less of a longest diameter of the polymeric microparticles, based on a cross section having the longest diameter of the polymeric microparticles (claim 13).
Regarding claim 8: The organic crosslinking agent containing at least one reactive functional group comprises a crosslinking agent having 1 to 30 carbon atoms and containing at least one reactive functional group (claim 14).
Regarding claim 9: The polymeric microparticles may have an average compressive strength of 0.1 mN or more when deformed to a level of 25% of the average diameter (col. 12, lines 48-55).
Regarding claim 10: The polymeric microparticles may have a sphericity degree of 0.9 or more and 1.0 or less (col. 12, lines 40-41).
Regarding claim 11: The shell of the microparticles above comprises gelatin which is a claimed cell adhesion material.
Regarding claim 12: As established above, the gelatin shell also reads on the cell adhesion-inducing layer of the instant invention. The shell is taught in certain embodiments to be as thin as 0.01% of the longest diameter of the microparticles (col. 12, lines 24-25). The average diameter of the microparticles is between 1 and 450 μm (col. 12, lines 8-14). Thus, if the longest diameter of the microparticle is 450, for example, and the shell is 0.01% of that, then the shell (i.e., the cell adhesion inducing layer) would be 0.045 μm thick (i.e., 45 nm), which falls within the instantly claimed range.
Regarding claim 13: The polymeric microparticles have an average diameter in distilled water of 1 μm or more and 450 μm or less (col. 12, lines 8-14), which falls within the instantly claimed range.
Regarding claim 14: Since the composition anticipated by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Regarding claims 15-16: The polymeric microparticles of Kim are used in cell culture mediums (col. 18-19, lines 64-10). The resulting cell cultures which comprise polymeric microparticles and cells read on the instantly claimed cell composite.
Regarding claims 17-20: Kim teaches polymeric microparticles with excellent mechanical strength and cell adhesion, as well as medical compositions, cosmetic compositions, medical articles and cosmetic articles comprising the same (col. 14, lines 39-44).
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.
1. Claims 1-2 and 6-20 are rejected under 35 U.S.C. 103 as being unpatentable over Park, K., et al. (US 20110263018 A1, 10/27/2011, IDS dated 12/14/2023), hereinafter Park.
Park discloses a core-shell structured microcapsule type delivery system comprising a polymeric microsphere comprising a first component which is encapsulated by another polymer comprising a second component (abstract).
Regarding claim 1: Park discloses a microcapsule-type system for growth factor delivery which has a core-shell structure ([0012]), thereby reading on a microcarrier comprising microparticles having a core-shell structure as instantly claimed. In order to further delay the release of the growth factor loaded in a shell, the microcapsule is coated. Such coatings include chitosan, gelatin, collagen, poly-L-lysine, dextran sulfate, etc. ([0022]; claims 8 and 21), thereby reading on the instantly claimed cell-adhesion-inducing layer. While this layer is not explicitly taught for cell-adhesion, it comprises the same cell adhesion materials as instantly claimed meaning such a layer would inherently possess cell adhesion properties. The core and shell are made of any biodegradable polymers as long as they are not toxic to humans ([0014]) (i.e., biocompatible). The microcapsule is provided by preparing a polymeric microsphere or solution and then encapsulating the first polymer by electrodropping the polymer microsphere into another polymer (abstract). Examples 1-3 teach microcapsules with a PLGA core and an alginate shell (Ex. 1-3). Thus, Park teaches a core comprising a first biocompatible polymer and shell comprising a second biocompatible polymer. Examples 2 and 3 teach electrodropping the core-shell structures into a CaCl2 solution to initiate crosslinking (Ex. 2-3). While Examples 2 and 3 of Park do not explicitly define wherein the metal ions are incorporated into both the core and shell of the microcapsules, it is reasonable that the ions would diffuse into the core as evidenced by the instant specification. The instant specification teaches a similar process to that of Park in which a solution comprising two biocompatible polymers is formed into a droplet by an encapsulator device and added to an FeCl3 solution (Ex. 1 of Spec.). As such, Examiner has reason to believe that the calcium ions of Park would be incorporated into the microcapsules in the same manner as the iron ions are incorporated in the instant invention.
Park further teaches that in order to enhance the mechanical properties of the microcapsule-type growth factor delivery system, microcapsules that have been prepared can be treated with a crosslinking agent such as ethyldimethylaminopropyl carbodiimide, genipin, or glutaraldehyde ([0023]; claim 22), all of which read on an organic crosslinking agent containing at least one reactive functional group.
The teachings of Park differ from that of the instant invention in that Park does not explicitly teach a microcapsule which comprises both a metal ion and an organic crosslinking agent, nor wherein the core and shell polymers are crosslinked by both as defined in claims 1 and 2.
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include both a metal ion and organic crosslinking agent in the microcapsules of Park and to crosslink the core/shell polymers via both agents, since metal ions and organic agents are known and routine for crosslinking the microcapsules of Park. One of ordinary skill in the art would have been motivated to provide metal ions and an organic crosslinking agent in the core and shell of the microcapsules and to crosslink the respective polymers via the metal ion and organic crosslinking agent in order to enhance the mechanical properties of the microcapsules as taught by Park. One of ordinary skill in the art would have had a reasonable expectation of success in using a metal ion and organic crosslinker to crosslink the core and shell polymers of Park since crosslinking polymers via metal ions and organic crosslinkers is well characterized in the art and both are taught by Park as acceptable means of crosslinking microcapsules of the invention. As such, the entirety of claims 1 and 2 are obvious in view of Park.
Regarding claims 6 and 13: The microcapsules of Park have a diameter ranging from 100 to 400 um (claim 5), which falls within the instantly claimed range. While Park does not explicitly measure the particle diameter in distilled water, one of ordinary skill in the art would expect the particles to be the same size regardless of being measured in water since size is an inherent property of the particles.
Regarding claim 7: Example 2 of Park teaches wherein core PLGA microspheres are about 100 um in size and final core-shell microcapsules are between 200 and 300 um. The shell thickness therefore ranges from 100 to 200 um, respectively, which is 95% or less of the total size (i.e., diameter) of the core-shell microcapsules. Park also teaches that the electrodropping conditions (i.e., voltage and spray rates, nozzle sizes, etc.) may be tuned to influence the size of the microcapsules. Thus, it would have been well within the abilities of an ordinary artisan to optimize the thickness of the microcapsule shell depending on the desired size of the final product. As such, one of ordinary skill in the art would have arrived at the instantly claimed thickness through no more than routine experimentation. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 8: The organic crosslinking agents taught by Park include ethyldimethylaminopropyl carbodiimide, genipin, and glutaraldehyde, all of which comprise between 1 and 30 carbon atoms.
Regarding claim 9: Since the composition made obvious by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Regarding claim 10: Park further teaches if the core is made of a polymer microsphere, various shapes of microspheres can be premade and loaded into the microcapsule. In addition, if the release pattern varies depending on the shape of the microsphere, the shape of the microsphere can be optimized, and thus a microcapsule providing desired release profiles with credibility can be prepared ([0029]). As such, one of ordinary skill in the art would have been motivated based on the teachings of Park to optimize the shape of the microcapsule in order to provide the desired release profile, thereby arriving at the claimed sphericity of 0.9 to 1.0. The optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B).
Regarding claim 11: As discussed above, core-shell microcapsules may include coatings with material selected from the group of chitosan, gelatin, collagen, poly-L-lysine, dextran sulfate, etc. ([0022]; claims 8 and 21), all of which read on the instantly claimed cell adhesion materials.
Regarding claim 12: As discussed above, the coating layer is added to further delay the release of the growth factor loaded in a shell. The coating layer can be formed by inducing physical adsorption or chemical reaction, while the thickness thereof can be manipulated ([0022]). It is well within the abilities of an ordinary artisan to optimize the thickness of the coating layer depending on the desired structure and release profile of the final product. As such, one of ordinary skill in the art would have arrived at the instantly claimed range of 1 to 10,000 nm through no more than routine experimentation. The optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B).
Regarding claim 14: Since the composition made obvious by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Regarding claim 15: The recitation of “for cell culture” is a recitation of intended use. Since the prior art makes obvious every structural element of the instantly claimed micro carrier, the product of the prior art must inherently be able to carry out the same function as the instantly claimed product. Despite this stipulation, Example 5 of Park teaches a three-dimensional scaffold for the cultivation of stem cells, using alginate beads containing stem cells and core-shell microcapsules of the invention (M1 and M2). Thus, it would have been prima facie obvious to one of ordinary skill in the art to use the microcapsules made obvious by Park as micro carriers for cell culture since this is a known and routine use for such microcapsules in the art.
Regarding claim 16-20: The alginate beads of Example 5 which comprise stem cells and core-shell microcapsules read on a cell composite comprising a microcarrier. It would have been prima facie obvious to one of ordinary skill in the art to use the microcapsules made obvious above in the cell composites taught by Park since this a known and routine application for such microcapsules. While Park does not explicitly teach cells to be adhered onto the surface of the microcapsules, the microcapsules of Park comprise the same cell adhesion layer as instantly claimed. Thus, it is inherent that cells would adhere onto the surface as instantly claimed. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Regarding claims 17-20: Since the medical composition/article and cosmetic composition/article are only defined as comprising the micro carrier of claim 1, then any biocompatible composition comprising the micro carrier, including the micro carrier itself, reads on these compositions/articles. Since the microcarrier of claim 1 is made obvious above as well as cell composites comprising it, so are the medical and cosmetic compositions/articles.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Park as applied to claims 1-2 and 6-20 above, and further in view of Zhou, Z., et al. (2015). Preparation of gelatin/hyaluronic acid microspheres with different morphologies for drug delivery. Polym. Bull. 72, 713–723.
The teachings of Park are discussed above.
Park further teaches wherein the core or shell may be prepared from natural polymers selected from gelatin and hyaluronic acid ([0014]-[0016]; claim 7).
The teachings of Park differ from that of the instant invention in that Park does not explicitly teach a microcapsule wherein the first biocompatible polymer in the core comprises hyaluronic acid and the second biocompatible polymer in the shell comprises gelatin, as defined in claim 3. Nor does Park teach wherein the hyaluronic acid and gelatin are crosslinked in an amount of more than 50% by volume of the total polymer matrix in the core and shell, respectively, as defined in claims 4-5.
Zhou teaches gelatin/hyaluronic acid microspheres for drug delivery using glutaraldehyde as a cross-linker (abstract). Because of its biodegradability, biocompatibility, and nonimmunogenicity, gelatin is widely used in pharmacy and medicine as a carrier in controlled release drug delivery systems, dressings for wound healing, etc. (p. 2, Intro., para. 2). As one of the main components of the extracellular matrix, hyaluronic acid (HA) has high capacity for lubrication, water sorption and water retention. HA is an attractive building block for new biocompatible and biodegradable polymers with possible applications in drug delivery, tissue engineering, and visco supplementation. HA is a particularly attractive hydrogel material for tissue scaffolds and wound healing dressings (intro, para. 3). To improve the material properties used for controlled drug delivery, Gel and HA should be chemically cross-linked using glutaraldehyde (GA) or 1-ethyl-(3-3-dimethylaminopropyl) carbodiimide (EDC) (into, para. 4).
It would have been prima facie obvious to one of ordinary skill in the art to select hyaluronic acid as the first biocompatible polymer since hyaluronic acid is a known and routine polymer used in microsphere carriers as taught by Zhou. It would have been obvious to select hyaluronic acid as the polymer in the microcapsule core of Park given HA’s suitability for drug delivery and tissue engineering applications as taught by Zhou. Additionally, HA is taught by Park as an exemplary polymer for the microcapsule core. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
It would have been prima facie obvious to one of ordinary skill in the art to select gelatin as the second biocompatible polymer since gelatin is a known and routine polymer used in microsphere carriers as taught by Zhou. It would have been obvious to select gelatin as the polymer in the microcapsule shell of Park given gelatin’s suitability as a carrier in pharmacy and medicine as taught by Zhou. Additionally, gelatin is taught by Park as an exemplary polymer for the microcapsule shell. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Regarding claims 4 and 5, as established in the above rejection, it would have been obvious to crosslink the core/shell polymers via metal ions and an organic crosslinking agent in order to increase the mechanical properties of the microcapsule as taught by Park. Zhou further teaches that cross-linking Gel and HA with glutaraldehyde is necessary to improve the material properties of the particles. Thus, it would have been prima facie obvious to one of ordinary skill in the art to crosslink the specific polymers taught by Zhou (i.e., hyaluronic acid and gelatin) at a high amount since crosslinking enhances the mechanical and material properties of the microcapsules. An ordinary artisan would have been further motivated to optimize the amount of crosslinking in the core/shell polymer matrices depending on the desired mechanical and material properties of the final product. As such, one of ordinary skill in the art would have arrived at the instantly claimed degree of crosslinking (i.e., > 50%) through no more than routine experimentation. The optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B).
One of ordinary skill in the art would have had a reasonable expectation of success in providing a core-shell microcapsule with crosslinked hyaluronic acid in the core and crosslinked gelatin in the shell since these are acceptable natural polymers to be used in the core-shell microcapsules of Park and the use of HA and gelatin together in a crosslinked microsphere is known and taught by Zhou.
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.
1. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 12,296,054. Although the claims at issue are not identical, they are not patentably distinct from each other because US’054 recites polymeric microparticles having a core-shell structure, comprising: a core including a first biocompatible polymer, a metal ion, and an organic crosslinking agent containing at least one reactive functional group; and a shell surrounding all or part of the core and including a second biocompatible polymer, a metal ion, and an organic crosslinking agent containing at least one reactive functional group, wherein the first biocompatible polymer comprises hyaluronic acid, and the second biocompatible polymer comprises gelatin (conflicting claim 9). Since the cell adhesion-inducing layer of the instant invention is defined in claim 11 as including gelatin, the gelatin in the shell of the conflicting claims doubly reads on the shell and a cell adhesion-inducing layer formed on the surface of the polymer microparticles.
Conclusion
No claims are allowed.
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/SUSANNAH S ARMSTRONG/ Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616