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 .
DETAILED ACTION
This action is in response to papers filed on July 10, 2024. It is noted that claim 1, 8, 10, 12 and 13 are independent claims.
Thus, claims 1-13 are under examination to which the following grounds of rejection are applicable. Claims 1, 8, 10, 12, and 13 are independent claims.
Priority
This instant application is a 35 U.S.C. 371 national stage filing of International Application PCT/KR2023/000638 filed on January 13, 2023. The International Application claims priority to Korean Application 10-2022-0005526 January 13, 2022.
Receipt is acknowledged of certified untranslated copies of Korean Application 10-2022-0005526 required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, the earliest effective filing date for the instant application is January 13, 2022.
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 1-13 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 is indefinite in its recitation of “a decellularized muscle tissue-derived extracellular matrix (MEM)” and the metes and bounds of how extracellular matrix can be "derived from" the a decellularized muscle tissue and still meet the intended limitation of the claim are not clear. It is not possible to know the metes and bounds of a "derivative" because any given starting material can have many divergent derivatives depending on the process of derivatization. This rejection could be overcome by 'Substituting "isolated" for "derived" in the claim.
Claim 5 uses parentheses to comments on or qualify part of the sentences. It is unclear whether the limitations in parentheses are meant to be limitations in the claims or whether they are only suggestions/examples. As such, the metes and bounds of the claims cannot be determined.
Regarding claim 8 and 10, it is indefinite in its recitation of the phrase “treating or preventing” as it fails to distinctly point out the claimed invention. It is unclear if the invention is drawn to a method of treating muscle diseases or preventing muscle disease. The claimed product and method otherwise imply treating a subject by way of prevention if the subject, in fact, does not have a muscle disease or muscle damage. Appropriate amendments are required.
Claims 2-4, 6-7, 9, and 11-13 are rejected insofar that they depend on claims 1, 8 and 10.
The Examiner notes that claim 2 is a product by process claim where the hydrogel is formed by cross-linking but does not require to be crosslinked.
Claim Rejections - 35 USC § 112(a): Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Moreover, Claims 10-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the claims , while being enabling for
treating muscular atrophy, sarcopenia and muscle loss in a mouse animal model,
does not reasonably provide enablement for treating or preventing of ALL muscular diseases in any subject other than a human subject as described in claim 10. The Specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The criteria for enablement set out In re Wands, MPEP 2162.01(a), considers the following
factors:
Breadth of the Claims
The claims are directed broadly to a hydrogel composition administered to a subject to treat or prevent ANY muscular disease. As such, the breadth of the claims is great.
State of Prior Art
Lee et al. (Published 2020. Cited in IDS filed 7/10/2024. Methods. 2020 Jan 15;171:77-85) teaches a hydrogel composition for treating a muscle defect in a rabbit model (pp. 77, Abstract, “We also investigated the feasibility in a rabbit tibialis anterior (TA) muscle defect model. The IGF-1/dECM had a significantly greater number of myofibers when compared to both collagen and dECM groups at 1 and 2 months after implantation. We demonstrated that this novel muscle-specific scaffolding system could effectively promote the muscle tissue regeneration in situ.”) Further, Cho et al. (Published: 2019. Cited in IDS filed 7/10/2024. Korean Application: KR 20190115036 A) teaches application of a pyrogallol-modified hydrogel to a murine muscular ischemic model (para 0038, “Figure 16 shows the VEGF delivery and therapeutic effects of a hydrogel using NaIO in a mouse model of hindlimb ischemia, comprising… Immunostained image of muscle in ischemic leg for α-SMA (arteriole formation) and vWF (capillary formation). Black arrows indicate the formation of arterioles (α-SMA positive) and capillaries (vWF positive) in ischemic tissue, respectively (scale bar = 100 µm). (f) indicates the number of lumens stained α-SMA positive and vWF positive capillaries in ischemic muscle”). These teachings establish that it is unclear whether hydrogel compositions can treat or prevent the entire scope of muscular disease, and if the composition can facilitate treating AND preventing.
Amount of Direction Provided by the Inventor
The specification provides insufficient direction and guidance to enable a person of ordinary skill in the art to practice the full scope of the claimed invention. Although the claims broadly encompass treating or preventing of ANY muscular disease, the Specification only provides working examples for muscular atrophy and sarcopenia in a mouse model (para 0151, “After fixing a mouse's leg with surgical staples for three weeks to induce disuse skeletal muscle atrophy, which reduced the weight of the TA muscle by about 25%, each of the 2% (w/v) hydrogels was intramuscularly injected to the TA muscle in a volume of 50 μl, and then the TA muscle tissue was extracted in week 2 to compare the weight with the normal tissue (the leg muscle on the opposite side of the same subject used without causing any damage).”; para 0155, “ PBS and MEM, MEM-CA, and MEM-PG hydrogels were applied to a mouse model of sarcopenia, and the biocompatibility was evaluated.”). The Specification is silent on whether this hydrogel can be used to treat other muscular diseases, and be used to prevent muscular disease.
Presence or Absence of Working Examples
The specification only provides working examples for implanting the hydrogel within a sarcopenia and muscular atrophy mouse model in Examples 2 and 5 (para 0151, “After fixing a mouse's leg with surgical staples for three weeks to induce disuse skeletal muscle atrophy, which reduced the weight of the TA muscle by about 25%, each of the 2% (w/v) hydrogels was intramuscularly injected to the TA muscle in a volume of 50 μl, and then the TA muscle tissue was extracted in week 2 to compare the weight with the normal tissue (the leg muscle on the opposite side of the same subject used without causing any damage).”; para 0155, “ PBS and MEM, MEM-CA, and MEM-PG hydrogels were applied to a mouse model of sarcopenia, and the biocompatibility was evaluated.”). The Specification fails to teach whether this invention can be applied to other muscular diseases. Moreover, the examples recited in the Specification are not representative of the full scope of the claims, which encompass treating AND preventing of any muscular disease.
Quantity of Experimentation Necessary
A person with ordinary skill in the art would not reasonably expect that the hydrogel composition of Examples 2 and 5, would result in the prevention and treatment of other muscular diseases. A person with ordinary skill in the art would have to perform undue, substantial, experimentation to fully encompass the scope of the claims.
Conclusion
In light of the unpredictability surrounding the claimed subject matter and the lack of adequate guidance, one wishing to practice the presently claimed invention would be unable to do so without engaging in undue experimentation. It is especially noted that applicants provide no data, examples, figures, etc. demonstrating that the hydrogel composition can treat and prevent all muscular disease, and if this can be applied to the full scope of the claims. In the absence of such information, a person of ordinary skill in the art would reasonably require an undue quantity of experimentation.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (Published 2020. Cited in IDS filed 7/10/2024. Methods. 2020 Jan 15;171:77-85) in view of Cho et al. (Published: 2019. Cited in IDS filed 7/10/2024. Korean Application: KR 20190115036 A)
It is noted that although the Korean Application (KR 20190115036 A) is cited in the IDS filed on 7/10/2024, the Examiner has provided a machine translation of the Korean Application noted in the PTO-892 Form.
The applied Cho and Lee references have a common 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)(1). The publication dated for Cho and Lee are October 10, 2019 and January 15, 2020 respectively. The earliest effective filing date of the instant application is January 13, 2022.
Therefore rejection under 35 U.S.C. 103 CANNOT 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); 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 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. See generally MPEP § 717.02. Because the reference qualifies as prior art under 102(a)(1), the provisions of MPEP 717.02 do not apply.
Regarding claim 1, Lee teaches a hydrogel composition comprising a muscle-derived decellularized extracellular matrix (Abstract, "In order to avoid this limitation, we developed a novel cell-free muscle-specific scaffolding system that consisted of a skeletal muscle-derived decellularized extracellular matrix (dECM) and a myogenic factor, insulin growth factor-1 (IGF-1)."; pp. 80, col 2, “In this study, we examined the rheological properties and mechanical stiffness of the dECM hydrogel (5mg/mL).”).
However, Lee does not teach that the hydrogel is modified with a catechol or pyrogallol.
Cho teaches a hyaluronic acid-based hydrogel modified with a catechol group or a pyrogallol to address concerns with biological toxicity and crosslinking (page 17, para 0004, “In addition, there were limitations in applying it as a various medical material because it was not easy to control the crosslinking or physical properties to suit the intended use. Therefore, there is still a need for the development of technology that can easily control the physical properties of hyaluronic acid hydrogels while maintaining excellent biocompatibility.”; para 0005, “As a result, a hyaluronic acid-based hydrogel platform technology modified with a pyrogallol group was developed, and the present invention was completed based on this.”). Moreover, Cho teaches catechol-modified hydrogels (para 0112, “PG groups, like catechol groups, can also induce strong binding of growth factors to hydrogel structures.”; para 0113, “Previous studies have confirmed that catechol-modified polymers exhibit strong tissue adhesion through high binding affinity to various nucleophiles of oxidized catechol within proteins.”)
It would have been obvious for a skilled artisan to modify the hydrogel composition of Lee and use the hyaluronic acid-based hydrogel modified with a pyrogallol group or catechol group as it was shown to enhance cross-linking and decreasing biological toxicity. There would have been reasonable expectations of success in combining these teachings as one of ordinary skill in the art would recognize to combine known elements in the art to give predictable results
Regarding claim 2, the combined teachings of Lee and Cho render obvious the claimed hydrogel composition of claim 1. Moreover, Cho teaches a hydrogel modified with both an pyrogallol or a catechol with crosslinking (page 22, para 0038, “Figure 17 illustrates the preparation of tissue-adhesive HA-PG hydrogels using NaOH-mediated crosslinking.”; para 0093, “at which the storage modulus curve and the loss modulus curve intersected, it took about 2 to 3 minutes when crosslinked with NaOH and about 30 seconds when using HA-CA”; para 0005, "As a result, a hyaluronic acid-based hydrogel platform technology modified with a pyrogallol group was developed, and the present invention was completed based on this."; para 0112, “PG groups, like catechol groups, can also induce strong binding of growth factors to hydrogel structures.”; para 0113, “Previous studies have confirmed that catechol-modified polymers exhibit strong tissue adhesion through high binding affinity to various nucleophiles of oxidized catechol within proteins.”)
Regarding claim 3, the combined teachings of Lee and Cho render obvious the claimed hydrogel composition of claim 1. Moreover, Cho teaches a catechol group-modified decellularized MEM (MEM-CA derivative) is contained in an amount of 0.1% to 4% by weight compared to the total volume of the hydrogel composition (para 0093, “at which the storage modulus curve and the loss modulus curve intersected, it took about 2 to 3 minutes when crosslinked with NaOH and about 30 seconds when using HA-CA”; para 0096, “In addition, based on the above results, the differences in physical properties of hydrogels cross-linked with NaIO4 according to the molecular weight (40, 200, 500 kDa) and concentration (1% (w/v), 2% (w/v)) of hyaluronic acid derivatives were examined.”)
Regarding claim 4, the combined teachings of Lee and Cho render obvious the claimed hydrogel composition of claim 1. Moreover, Cho teaches a pyrogallol group-modified decellularized MEM (MEM-PG derivative) is contained in an amount of 0.1% to 4% by weight compared to the total volume of the hydrogel composition (para 0032, " In one embodiment of the present invention for this purpose, the molecular weight of the hyaluronic acid derivative may be 10,000 Da to 2,000,000 Da, and the pyrogallol group substitution rate of the hyaluronic acid derivative may be 0.1% to 50%, preferably 1% to 30%, and more preferably 2% to 20%. In another embodiment of the present invention, the hyaluronic acid derivative may be contained in an amount of 0.1% (w/v) to 15% (w/v) with respect to the total filler composition. ")
Regarding claim 5, the combined teachings of Lee and Cho render obvious the claimed hydrogel composition of claim 1. Moreover, Cho teaches wherein the hydrogel composition has a G'' (storage modulus) higher than G" (loss modulus) (Fig 6b. See below)
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Regarding claim 6, the combined teachings of Lee and Cho render obvious the claimed hydrogel composition of claim 1. Moreover, Cho teaches the hydrogel modified with a catechol group (para 0096, “As a result, as shown in Figure 9, the hydrogel formed by NaOH and HA-CA (NaIO) exhibited excellent adhesion, whereas the hydrogel formed by NaIO4 showed almost no adhesion.”; para 0093, “at which the storage modulus curve and the loss modulus curve intersected, it took about 2 to 3 minutes when crosslinked with NaOH and about 30 seconds when using HA-CA”; para 0096, “In addition, based on the above results, the differences in physical properties of hydrogels cross-linked with NaIO4 according to the molecular weight (40, 200, 500 kDa) and concentration (1% (w/v), 2% (w/v)) of hyaluronic acid derivatives were examined.”). Moreover, Cho teaches that elastic modulus can change depending on crosslinking method and other varying factors that influence hydrogel composition (para 0091, “Specifically, changes in hydrogel formation and elastic modulus over time were compared according to the crosslinking method, and elasticity, adhesion, swelling, and degradation patterns were analyzed separately according to the crosslinking method and the degree of substitution of 5' hydroxydopamine.”).
Therefore, it would be obvious for a skilled artisan to modify the composition of the hydrogel composition such that the hydrogel composition modified with a catechol has an elastic modulus of 400-2000Pa, based on influential considerations of the design of the hydrogel. Moreover, the elastic modulus presents as a result-effective variable that a skilled artisan would routinely optimize for the sake of improving crosslinking and adhesion.
Regarding claim 7, the combined teachings of Lee and Cho render obvious the claimed hydrogel composition of claim 1. Moreover, Cho teaches a pyrogallol group-modified decellularized MEM (MEM-PG derivative) is contained in an amount of 0.1% to 4% by weight compared to the total volume of the hydrogel composition (para 0032, " In one embodiment of the present invention for this purpose, the molecular weight of the hyaluronic acid derivative may be 10,000 Da to 2,000,000 Da, and the pyrogallol group substitution rate of the hyaluronic acid derivative may be 0.1% to 50%, preferably 1% to 30%, and more preferably 2% to 20%. In another embodiment of the present invention, the hyaluronic acid derivative may be contained in an amount of 0.1% (w/v) to 15% (w/v) with respect to the total filler composition. "). Moreover, Cho teaches that elastic modulus can change depending on crosslinking method and other varying factors that influence hydrogel composition (para 0091, “Specifically, changes in hydrogel formation and elastic modulus over time were compared according to the crosslinking method, and elasticity, adhesion, swelling, and degradation patterns were analyzed separately according to the crosslinking method and the degree of substitution of 5' hydroxydopamine.”).
Therefore, it would be obvious for a skilled artisan to modify the composition of the hydrogel composition such that the hydrogel composition was an elastic modulus of 1200-2800Pa, based on influential considerations of the design of the hydrogel. Moreover, the elastic modulus presents as a result-effective variable that a skilled artisan would routinely optimize for the sake of improving crosslinking and adhesion.
The Court has stated that generally such differences amount to mere optimization and will not support patentability unless there is evidence indicating the claimed feature is critical. “[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). (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). In KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421.
MPEP § 2144 sets forth Applicant' s burden for rebuttal of a prima facie case of obviousness based upon routine optimization. Applicant must provide either a showing that the particular amount or range recited within the claims is critical; and/or a showing that the prior art reference teaches away from the claimed amount.
Regarding claim 8, the combined teachings of Lee and Cho render obvious the claimed hydrogel composition of claim 1. Moreover, Cho teaches the hydrogel composition of claim 1 (Claim 1 "A method for preparing a hyaluronic acid hydrogel, comprising cross-linking a hyaluronic acid derivative modified with a pyrogallol group, wherein the hyaluronic acid derivative is a hyaluronic acid modified with a pyrogallol group."; crosslinking (para 0004, “In addition, there were limitations in applying it as a various medical material because it was not easy to control the crosslinking or physical properties to suit the intended use. Therefore, there is still a need for the development of technology that can easily control the physical properties of hyaluronic acid hydrogels while maintaining excellent biocompatibility.”; para 0005, “As a result, a hyaluronic acid-based hydrogel platform technology modified with a pyrogallol group was developed, and the present invention was completed based on this.”). Moreover, Cho teaches catechol-modified hydrogels reading on the composition of claim 8 (para 0112, “PG groups, like catechol groups, can also induce strong binding of growth factors to hydrogel structures.”; para 0113, “Previous studies have confirmed that catechol-modified polymers exhibit strong tissue adhesion through high binding affinity to various nucleophiles of oxidized catechol within proteins.”)
Regarding claim 9, the combined teachings of Lee and Cho render obvious the claimed hydrogel composition of claim 1 and 8. Moreover, Lee teaches that the hydrogel composition was used to treat a muscular defect (pp. 83, col 2, “Moreover, in vivo implantation of IGF-1/dECM scaffold in the rabbit TA muscle defect model showed an acceleration in the new muscle formation”)
Regarding claim 10 and 11, the combined teachings of Lee and Cho render obvious the claimed hydrogel composition of claim 1. Moreover, Lee teaches that the hydrogel was implanted onto a rabbit model (pp. 83, col 2, “Moreover, in vivo implantation of IGF-1/dECM scaffold in the rabbit TA muscle defect model showed an acceleration in the new muscle formation”).
Regarding claims 12 and 13, the combined teachings of Lee and Cho render obvious the claimed hydrogel composition of claim 1. Moreover, Cho teaches a hyaluronic acid-based hydrogel modified with a catechol group or a pyrogallol to address concerns with biological toxicity and crosslinking (para 0004, “In addition, there were limitations in applying it as a various medical material because it was not easy to control the crosslinking or physical properties to suit the intended use. Therefore, there is still a need for the development of technology that can easily control the physical properties of hyaluronic acid hydrogels while maintaining excellent biocompatibility.”; para 0005, “As a result, a hyaluronic acid-based hydrogel platform technology modified with a pyrogallol group was developed, and the present invention was completed based on this.”). Moreover, Cho teaches catechol-modified hydrogels (para 0112, “PG groups, like catechol groups, can also induce strong binding of growth factors to hydrogel structures.”; para 0113, “Previous studies have confirmed that catechol-modified polymers exhibit strong tissue adhesion through high binding affinity to various nucleophiles of oxidized catechol within proteins.”).
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.
Claim 1-13 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 18/475303 (reference application) in view of Lee et al. (Published 2020. Cited in IDS filed 7/10/2024. Methods. 2020 Jan 15;171:77-85). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons that follow.
Claim 1 of copending application 18/475303 is directed to: A composition for hydrogel, comprising: a phenol derivative-modified, tissue-derived extracellular matrix.
Claim 2 of copending application 18/475303 further limits the composition of claim 1 to
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Claim 1 of the invention is directed to:
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Claim 1 of co-pending application 18/475303 does not require a decellularized muscle extracellular matrix.
Lee teaches a hydrogel composition comprising a decellularized muscle tissue derived extracellular matrix (Abstract, "In order to avoid this limitation, we developed a novel cell-free muscle-specific scaffolding system that consisted of a skeletal muscle-derived decellularized extracellular matrix (dECM) and a myogenic factor, insulin growth factor-1 (IGF-1)."; pp. 80, col 2, “In this study, we examined the rheological properties and mechanical stiffness of the dECM hydrogel (5mg/mL).”). Further, Lee teaches that the dECM scaffold increase cellular proliferation (Abstract, “The cell viability in all scaffolds had over 90% at 1, 3, and 7 days in culture. The cell proliferation in the IGF-1/dECM was significantly increased when compared with other groups.”)
It would have been obvious to modify the hydrogel composition of Application
‘303 to further comprise a dECM of Lee to increase cellular proliferation in hydrogel structure.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Katriel B Kasayan whose telephone number is (571)272-1402. The examiner can normally be reached 10-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria G Leavitt can be reached at (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATRIEL BARCELLANO KASAYAN/ Examiner, Art Unit 1634
/MARIA G LEAVITT/ Supervisory Patent Examiner, Art Unit 1634
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