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 .
Claim Status
Claims 23-24, 26, 28, 30, 32, 35-38, 41 and 43-44 are rejected.
No claims are allowed.
Modified Claim Rejections - 35 USC § 103
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 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 23-24, 26, 28, 30, 32, 35-36, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al., (WO 2015/160793 A1, Oct. 22, 2015) (hereinafter Jiang), in view of Christman et al. (US 2014/0178450 A1, June 26, 2014) (cited by applicant on IDS 09/21/2022) (hereinafter Christman) and Chen et al., (US 2007/0178159 A1, Aug. 2, 2007) (cited by applicant on IDS 09/21/2022) (hereinafter Chen).
Jiang teaches biocompatible copolymers and compositions comprising the copolymers. Compositions comprising the copolymers can be used for wound treatment, as a cellular growth matrix to repair or niche and for injection into cardiac tissue (i.e., soft tissue) to repair and mechanically support damaged tissue. The copolymers comprise numerous ester linkages so that the copolymers are erodeable in situ (Abstract). The copolymers remain fluid below physiological temperature (e.g., 37° C. for humans) or at or below room temperature (e.g., 25° C.), solidify (into a hydrogel) at physiological temperature, and degrade and dissolve at physiological conditions in a time-dependent manner ([0013]). The copolymers are reversibly-gelling ([0078]). The copolymer can comprise N-isopropylacrylamide (NIPAAm) residues, acrylic acid (AAc) residues, polyester macromer hydroxyethyl methacrylate-poly(trimethylene carbonate) (HEMA-PTMC) macromer residues, and MAA monomers ([0014]). Copolymers formed from NIPAAm and monomers with degradable side chains comprise another category of NIPAAm-based bioabsorbable, thermally responsive hydrogels. Hydrolytic removal of hydrophobic side chains (i.e., labile sidebranch) increases the hydrophilicity of the copolymer, making the polymer backbone soluble. The most investigated biodegradable monomers include 2- hydroxyethyl methacrylate- polytrimethylene carbonate (HEMA-PTMC) ([0006]). HEMA-poly(trimethylene carbonate) (HEMA-PTMC) macromers are examples of residues that comprise ester linkages and a polymer backbone ([0068]). The copolymers undergo sol-gel transition at lower critical solution temperatures of 12.4, 14.0, and 16.2°C respectively and solidifies immediately upon being placed in a 37°C water bath ([00101]).
Jiang differs from the instant claims insofar as not disclosing wherein the copolymer is combined with an ECM material.
However, Christman discloses compositions comprising decellularized extracellular matrix (ECM) derived from skeletal muscle or other suitable tissue for treating, repairing or regenerating defective, diseased, damage, ischemic, ulcer cells, tissues or organs (Abstract). The decellularized extracellular matrix may be derived from another suitable tissue, including but not limited to, liver tissue ([0016]). The composition can be formulated to be in liquid form at room temperature, typically 20° C. to 25° C., and in gel form at a temperature greater than room temperature or greater than 35° C (i.e., reverse-gelling) ([0017]). The skeletal tissue is first decellularized, leaving only the extracellular matrix. The skeletal muscle extracellular matrix is then lyophilized, ground up, and digested with pepsin (i.e., acid protease) at a low pH, between about pH 1-4 ([0045]) to form a liquid ([0091]). A liquid version of skeletal muscle matrix can form a porous scaffold upon injection, which promotes cellular infiltration to the damaged area (¶ [0084]). The amount of ECM in the total composition is greater than 1% ([0049]). The composition can comprise a decellularized skeletal muscle ECM and a synthetic or naturally occurring polymer from animal and non-animal sources. The composition can be a multi-material by linking the ECM and another polymer material, for example, via reaction with amines, free thiols, or short peptides that can be self-assembled with the ECM ([0052]).
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. Christman discloses wherein the composition comprises a decellularized liver tissue ECM and a synthetic or naturally occurring polymer from animal and non-animal sources. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated the copolymer of Jiang into the composition of Christman since it is a known and effective polymer for tissue repair. One of ordinary skill in the art would have had a reasonable expectation of success since the composition of Christman is reverse-gelling and the copolymer of Jiang is also reverse-gelling.
The combined teachings of Jiang and Christman do not disclose wherein the composition further comprises a biocompatible porogen that dissolves in vivo within 48 hours.
However, Chen discloses a viscous gel formed from a combination of a biodegradable polymer, a biocompatible solvent, and a hydrophilic porogen forming a porous scaffold in situ (Abstract). The porogen is selected to impart porosity to the porous scaffold in situ by leaching. The size of the porogen particles typically controls the size of the pores formed in the porous scaffold. The pore size may be between 1 µm to about 1000 µm. The pore density may be in a range from 1% to 70% of the total mass of the composition ([0030]). The porogen can be inorganic salts or sugars ([0031]). Examples of sugars include mannitol ([0032]). When making the composition, porogen particles are added to the viscous gel and the mixture is thoroughly blended ([0041]).
As discussed above, Christman discloses wherein the skeletal muscle matrix can form a porous scaffold upon injection. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated the porogen of Chen into the composition of Christman since this is another known and effective method for providing a porous scaffold upon injection as taught by Chen.
In regards to instant claims 23, 30, and 37 reciting having a size sufficient to allow infiltration of the composition upon dissolution of the porogen, as noted in the instant specification in paragraph [0076], porogen particles can be any size effective to produce pores of an adequate size to infiltrate the matrix in vivo once the porogen dissolves. As an example, particle/pore size of between 30 μm and 300 μm (micrometers, microns) is expected to be effective. Therefore, since Chen teaches a porogen that results in a pore size between 1 µm to about 1000 µm upon leaching (i.e., dissolution), the porogen of Chen is one that has a size sufficient to allow infiltration of the composition upon dissolution of the porogen.
In regards to instant claims 23 and 30 reciting a biocompatible porogen that dissolves in vivo within 48 hours, as noted in paragraph [0037] of the instant specification, mannitol is used as the porogen for the claimed invention. Therefore, since Chen teaches mannitol as the porogen, the porogen of Chen is one that dissolved in vivo within 48 hours.
In regards to instant claims 23, 24, 30, and 37reciting wherein the composition forms a gel at 37°C within one hour or within ten minutes, Christman discloses wherein the composition comprises greater than 1% ECM and Chen discloses wherein pore density may be 1%. Thus, it would have been obvious to one of ordinary skill in the art that the composition of the prior art may comprise mostly of the copolymer of Jiang. Jiang discloses wherein the copolymer solidifies immediately upon being placed in a 37°C water bath. Therefore, since the composition of the prior art may comprise mostly of the copolymer of Jiang and the copolymer of Jiang solidifies immediately upon being placed in a 37°C water bath, it would have been obvious to one of ordinary skill in the art that the composition of the prior art would form a gel at 37°C immediately, which is within the claimed time frames.
In regards to instant claim 23 and 30 reciting from 10% to 94.9% of the polymer and from 5% to 65% of the biocompatible porogen, Chen discloses wherein pore density may range from 1% to 70%. Thus, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed porogen amount depending on the pore density desired. After arriving at the claimed porogen amount and knowing that Christman discloses greater than 1% ECM, one of ordinary skill in the art would have been able to arrive at the claimed amount of polymer since it is the remaining amount.
In regards to instant claims 30 and 35 reciting mixing the polymer and ECM material and later mixing in the biocompatible polymer, this step would have been obvious to one of ordinary skill in the art since adding porogen particles to a polymer blend is a known and effective method of incorporating porogen to a polymeric material as taught by Chen above.
2. Claims 37-38, 40-41, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al., (WO 2015/160793 A1, Oct. 22, 2015) (hereinafter Jiang) in view of Christman et al. (US 2014/0178450 A1, June 26, 2014) (cited by applicant on IDS 09/21/2022) (hereinafter Christman), Chen et al., (US 2007/0178159 A1, Aug. 2, 2007) (cited by applicant on IDS 09/21/2022) (hereinafter Chen), and further in view of Friess et al., (US 2009/0209660 A1, Aug. 20, 2009) (hereinafter Friess).
The teachings of Jiang, Christman, and Chen are discussed above. Jiang, Christman, and Chen do not teach a kit comprising one or more vessels wherein the components of the instant composition are contained together or in separate vessels, or wherein the polymer and ECM are contained in a vessel separate from the porogen particles.
However, Friess discloses a biomaterial which is composed of at least one polymer ([0087]). The material may be a hydrogel for tissue regeneration ([0088]). The material is a polymer liquid ([0089]) and forms a macroporous matrix after in situ hardening of the material ([0090]). It includes porogenic substances such as sugars or salts of crystal size ([0107]). An embodiment of the invention includes a kit comprising separate receptacles for the active agent and the biomaterial to increase the shelf-life time of the kit and/or active agent ([0056]).
Accordingly, it would have been prima facie obvious to one of ordinary skill to have formulated the composition in a kit wherein the polymer and ECM are contained in a vessel separate from the porogen particles to extend the shelf-life of the kit, as taught by Friess.
Response to Applicant’s Arguments
Applicant argues that the skilled artisan would, as of the filing date of the present application, not have had any expectation that the combination of a reverse-gelling polymer, a reverse-gelling ECM composition, and a porogen, would be able to predictably provide a reverse-gelling system that gels as shown in the present application, that exhibits useful structural characteristics and a predictable degradation rate as shown in FIGS. 2A-2B of the present application as explained in the Declaration submitted August 22, 2025.
Applicant’s argument has been fully considered but found not to be persuasive. The claims as currently recited do not require the composition to exhibit the structural characteristics and a predictable degradation rate as shown in FIGS. 2A-2B of the present application (i.e., compressive modulus and degradation time, respectively). Further, the Declaration submitted August 22, 2025 asserts that Miao does not teach a reverse gelling composition and thus does not support the predictability of combining the teaching of Jiang and Christman (page 4, bullet 10). However, Miao is not cited as prior art in the rejections but is cited as evidentiary in response to applicant's argument that one of skill would naturally have considered reverse-gelling unpredictable due to the hydrophilic and hydrophobic characteristics of the ECM, which would be expected to disrupt a reverse-gelling polymer, due to interference with the hydrophilic- hydrophobic transition that occurs at gelling. The Office has previously presented a further evidentiary reference, such as Shortkroff et al., US 2013/0259910 A1, published 10/06/2015, that support the reasoning for maintaining support that reverse gelling behavior would have been predictable in the presence of ECM.
Applicant argues that indeed, thermo-reversible hydrogels are even exemplified in Shortkroff, but no porogen is discussed, so this document cannot show predictability asserted in the Office Action.
Applicant’s argument has been fully considered but found not to be persuasive. As discussed above, the Declaration submitted August 22, 2025 asserts that Miao does not teach a reverse gelling composition and thus does not support the predictability of combining the teaching of Jiang and Christman (page 4, bullet 10). Jiang and Christman are cited as prior art documents that when combined, teach a composition comprising a reverse gelling copolymer and ECM. Shortkroff et al. teaches a method for preparing an implant for tissue or cartilage repair comprising providing an acellular three-dimensional scaffold comprising a plurality of pores (Claim 25), wherein the acellular, three-dimensional scaffold comprises a thermo-reversible hydrogel (Claim 26). The double-structured tissue implant comprises a primary scaffold and a secondary scaffold consisting of a soluble collagen (i.e., an ECM component) solution in combination with a non-ionic surfactant generated and positioned within the primary scaffold (Abstract). Accordingly, the successful combination of collagen (i.e., an ECM component) and a thermo-reversible hydrogel was previously known in the art, thus the reverse gelling behavior would be predictable to one of ordinary skill. However, if Applicant’s argument is that the porogen introduces unpredictability, Applicant has not provided any factual evidence establishing unobviousness since the Declaration submitted August 22, 2025 asserts the unpredictability of combining the teaching of Jiang and Christman, which do not teach a porogen. Thus, Applicant’s arguments are unpersuasive and the rejection is maintained.
Applicant argues that in Shortkroff, the embodiment described in paragraph [0122] (e.g., PLURONIC and collagen in the secondary scaffold), this secondary scaffold is precipitated, not gelled. Moreover, as described in Shortkroff, PLURONIC is used for its surfactant properties, specifically for the formation of micelles (para. [0129]). Lastly, the "primary scaffold" in Shortkroff is collagen/collagen-based (para. [0067]). Thus, there is no disclosure of a reverse-gelling polymer, reverse-gelling ECM, and porogen,
Applicant’s argument has been fully considered but is not found to be persuasive. One of ordinary skill in the art would have a reasonable expectation of success in combining collagen (i.e., ECM) with a reverse gelling polymer since Shortkroff teaches that a suitable surfactant is preferably a polymeric compound such as a PLURONIC®-type polymer (i.e., known as a reverse gelling polymer in the art) ([0080]). The primary scaffold loaded with the Basic Solution (neutralized collagen/surfactant solution) is placed in an incubator at a temperature from about 25° C. to about 38° C until the precipitation of the neutralized collagen solution into a solid secondary scaffold occurs (i.e., reverse gelatin) ([0180]). Thus, a primary scaffold comprising a reverse gelling polymer and collagen (i.e., ECM) forms the secondary scaffold through reverse gelation. Accordingly, one of ordinary skill in the art would reasonably consider that one would get predictable results when combining a reverse gelling polymer with an ECM, according to the teachings of Shortkroff.
Applicant argues that amended the claims require that the biodegradable, biocompatible, gelling polymer comprises a backbone comprising at least N-isopropylacrylamide (NIPAAm) and a labile, hydrophobic sidebranch joined to the backbone through an ester, amide, carbonate, or anhydride linkage, the ECM is solubilized by digestion with an acid protease at pH 1 to 4, and the porogen has been specified as having a size sufficient to allow infiltration of the composition upon dissolution of the porogen.
Applicant’s argument has been fully considered but is not found to be persuasive. As discussed above, Jiang teaches that the copolymer is biocompatible, erodeable in situ, and reverse gelling. Further, the copolymer can comprise N-isopropylacrylamide the copolymer comprises NIPAAm residues, acrylic acid (AAc) residues, polyester macromer hydroxyethyl methacrylate-poly(trimethylene carbonate) (HEMA-PTMC) macromer residues, and MAA monomers and copolymers formed from NIPAAm and monomers with degradable side chains comprise another category of NIPAAm-based bioabsorbable, thermally responsive hydrogels. Hydrolytic removal of hydrophobic side chains (i.e., labile sidebranch) increases the hydrophilicity of the copolymer, making the polymer backbone soluble. The most investigated biodegradable monomers include 2- hydroxyethyl methacrylate- polytrimethylene carbonate (HEMA-PTMC). HEMA-poly(trimethylene carbonate) (HEMA-PTMC) macromers are examples of residues that comprise ester linkages and a polymer backbone, thus meeting the limitations of the amended claims. Further, as discussed above, the skeletal muscle extracellular matrix is then lyophilized, ground up, and digested with pepsin (i.e., acid protease) at a low pH, between about pH 1-4 to form a liquid (i.e., solubilized), meeting the limitations of the amended claims. Finally, as discussed above, as noted in the instant specification in paragraph [0076], porogen particles can be any size effective to produce pores of an adequate size to infiltrate the matrix in vivo once the porogen dissolves. As an example, particle/pore size of between 30 μm and 300 μm (micrometers, microns) is expected to be effective. Therefore, since Chen teaches a porogen that results in a pore size between 1 µm to about 1000 µm upon leaching (i.e., dissolution), the porogen of Chen is one that has a size sufficient to allow infiltration of the composition upon dissolution of the porogen, meeting the limitations of the amended claims.
Applicant argues that by the newly introduced claim amendments, the features of the reverse-gelling system contribute to the ability to use lower molecular weight components to the polymer (the hydrophobic nature of the side chain), the unexpected predictability of reverse gelling that is described in the application and in the Declaration, as well as the tunable degradation (based on the labile nature of the sidechain, which, as cleaved, increases the hydrophilicity of the system and thus the degradability) and structural characteristics described in the present application (e.g., the elastic modulus of well over 50 kPa).
Applicant’s argument has been fully considered but is not found to be persuasive. Applicant has not provided any objective evidence supporting Applicant’s assertion. Therefore, since Applicant’s argument is merely speculative, Applicant’s argument is unpersuasive.
Applicant argues that Chen teaches a porogen that leaches, which is a distinct process. To this point, Chen teaches that the porogen includes a mineral, to mimic a bone-like material, providing such an environment is not consistent with a dissolution to leave a porous composition as recited in the pending claims.
Applicant’s argument has been fully considered but is not found to be persuasive. As evidenced by British Columbia/Yukon Pressbooks, (Chapter IV: Introduction to Leaching, accessed March 11, 2026), leaching is the dissolution of solid materials into solution (page 1, Introduction). Thus, it is well known in the art that leaching is a process that results in the dissolution of a material. Further, Chen teaches that the porogen may optionally include a mineral, such as tricalcium phosphate (TCP) to better mimic a bone-like material when applied for bone growth ([0031]). Thus, a mineral, such as tricalcium phosphate (TCP) is not required. As discussed above, Chen teaches a porogen that results in a pore size between 1 µm to about 1000 µm upon leaching (i.e., dissolution), the porogen of Chen is one that has a size sufficient to allow infiltration of the composition upon dissolution of the porogen, meeting the limitations of the amended claims. Further, Applicant has not provided any objective evidence supporting Applicant’s assertion that the porogen of Chen provides an environment is not consistent with a dissolution to leave a porous composition as recited in the pending claims. Therefore, since Applicant’s argument is merely speculative, Applicant’s argument is unpersuasive.
Applicant argues that the amended features of the instant claims match the reverse-gelling system described in the Hayashi article (published in the peer-reviewed journal Advanced Healthcare Materials in 2025) wherein the authors found that the porous hydrogel with ECM (PME) exhibited both suitable stiffness and superior efficacy in LVEF and %FS, which is a surprising result.
Applicant’s argument has been fully considered but is not found to be persuasive. Applicant must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. See MPEP 716.02(e). Hayashi discloses that after myocardial infarction, rats are divided into four groups and administered: NP (non-porous hydrogel) without either ECM or porosity, PM (porous hydrogel) from the same synthetic copolymer with mannitol beads as porogens, and PME with porosity and ECM digest added to the synthetic copolymer, wherein poly(N-isopropylacrylamide-co-N-vinylpyrrolidone-co-MAPLA) is the copolymer. Regarding the suitable stiffness of the PME, Hayashi teaches that diastolic myofiber stress was more effectively reduced as the stiffness reached higher values in a range of 5–100 kPa and that one of the drawbacks of ECM hydrogel is its relatively low modulus in terms of mechanical support for the infarcted LV. The compression modulus of hydrogel NP the study was 272 ± 38 kPa, and the compression modulus of the PME was 87 ± 6 kPa despite the presence of ECM and the porous structures inside the hydrogel, still falling into the range of the simulated requirements above (page 7, 4.1. Stiffness). However, Hayashi has not shown wherein a porous hydrogel comprising ECM would not be expected to have a stiffness in a range of 5–100 kPa, and thus, Applicant has not compared the claimed subject matter with the closest prior art. As such, the teachings of Hayashi are not sufficient to overcome the rejection.
Regarding the superior efficacy in LVEF and %FS, as stated above, Applicant must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. See MPEP 716.02(e). Hayashi discloses that fractional shortening (%FS) and LVEF are calculated using parameters measured by echocardiogram (page 4, first paragraph). PME was superior to the other hydrogels in LVEF and %FS, and that a contributing effect to the functional improvement might be the angiogenesis promoted by adding ECM to PM (page 9, right column). Hayashi does not provide echocardiographic parameters for hydrogels comprising only ECM and hydrogels comprising only ECM and the synthetic copolymer poly(N-isopropylacrylamide-co-N-vinylpyrrolidone-co-MAPLA) for comparison. Thus, Applicant has not compared the claimed subject matter with the closest prior art and the teachings of Hayashi are not sufficient to overcome the rejection.
Further, purely arguendo, even if Applicant's showing is unexpected, whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. See MPEP 716.02(d). The PME of Hayashi comprises Poly(N-isopropylacrylamide-co-N-vinylpyrrolidone-co-MAPLA) copolymer, urinary bladder matrix (UBM) digest mixture, and mannitol (page 2, 2.1 Materials). However, the instant claims recite a biodegradable, biocompatible, gelling polymer composition comprising a backbone comprising at least N-isopropylacrylamide (NIPAAm) residues, further comprising a labile, hydrophobic sidebranch joined to the backbone through an ester, amide, carbonate, or anhydride linkage. One of ordinary skill in the art would not expect that each possible combination of residues and sidebranches recited in the instant claims would result in a polymer composition that behaves exactly as the polymer of Hayahsi, due to the unique properties of the side chains.
Additionally, the claimed porogens comprise a salt, sugar, polysaccharide, protein, or polypeptide. One would not reasonably expect that the use of any of the claimed porogens would provide the same results as the mannitol used by Hayashi since the claimed porogens represent distinct chemical classes with different dissolution behaviors.
Finally, the claims recite a solubilized extracellular matrix (ECM) material that is reverse gelling. One would not reasonably expect that any or all possible solubilized extracellular matrix (ECM) materials would produce the same results as the urinary bladder matrix (UBM) digest mixture used in the composition of Hayashi since ECM materials encompass a wide range of molecules with differing molecular weights, charges, crosslinking abilities and hydrophobicities.
For the foregoing reasons the rejection is modified and maintained.
Maintained 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 23-24, 26, 28, 30, 32, 35-38, 40-41, and 43-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,389,569 B2.
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 specific amounts of polymer composition, ECM material, and biocompatible porogen) and thus read on the instant claims.
Response to Applicant’s Arguments
Applicant argues that applicant will submit a Terminal Disclaimer, if appropriate, upon withdrawal of the statutory rejections.
Applicant’s argument has been fully considered but is not found to be persuasive. Applicant has not filed an appropriate terminal disclaimer. For the foregoing reasons the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.J.K./ Examiner, Art Unit 1614
/TRACY LIU/ Primary Examiner, Art Unit 1614