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 .
Priority
This application is a continuation of Application No. 17/728399 (filed on 4/25/2022), which is a continuation of Application No. 16/238826 (filed on 1/03/2019), which in turn is a continuation of Application No. 15/127707 (filed on 9/20/2016). The latter application is a national stage entry of PCT/US2015/021732 (filed on 3/20/2015), which claims priority benefit of U.S. Provisional Application No. 61/968716 (filed on 3/21/2014) under 35 U.S.C. 119(e).
Information Disclosure Statement
The two information disclosure statements (IDSs) filed on 3/28/2025 are in compliance with the provisions of 37 C.F.R. 1.97. All cited references have been fully considered.
Specification
The specification is objected to because of the following informality: the table below par. [00131] is labeled as “Table 4” even though it is only preceded by Table 1 and Table 2. To resolve this issue, applicant should amend the label of the third table as “Table 3”.
Claim Objections
Claim 1 is objected to because of the following informality: incorrect spelling. The term “gellable” should be amended to “gelable”.
Claim 5 is objected to because of the plural term “pancreases”. It is recommended that said term be amended to “pancreas” since all other organs/tissues are recited in singular form. Such amendment would also align with claim 15.
Claim 9 is objected to because a colon (“:”) is missing before limitations (a)-(d), while claim 20 has one. To maintain consistency, a colon should be added after the phrase “wherein the scaffold comprises” in claim 9.
Claims 9 and 20 are objected due to the following informalities: limitation (a) requires that the scaffold comprises “one or more” of the listed materials but the conjunction used before the last one is “and/or”. It is recommended that “and/or” be amended to “and” since limitation (a) recites a closed group of alternatives.
Claims 9 and 20 are also objected because of unnecessary use of the article “a” before “stainless steel”.
Claims 10-11 are objected to since the steps are preceded by a colon but they are separated by a comma. To correct this informality, replace each comma with a semicolon.
Claim 11 is objected to because there should no space between the temperature numerical value and degree symbol, as well as between the degree symbol and abbreviation for Celsius. Applicant should amend “25 ° C” to “25°C”.
Double Patenting
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-20 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 of prior U.S. Patent No. 12,005,158. This is a statutory double patenting rejection.
Like the instant application, U.S. 12,005,158 is drawn to a gelable extracellular matrix composition, a biocompatible scaffold coated with said composition, and a method of preparing an extracellular matrix-derived gelable composition. All limitations recited in the claims of the U.S. patent are identical to the instant claims.
Nonstatutory 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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,213,526.
U.S. 10,213,526 is directed to a method of preparing an extracellular matrix-derived gel comprising, in order: (i) solubilizing extracellular matrix (ECM) that has not been dialyzed by digestion with an acid protease in an acidic solution to produce a digest solution, (ii) drying the digest solution, and (iii) terminally sterilizing the dried digest. The method can additionally comprise (iv) hydrating and neutralizing the sterilized dried digest to a pH between 7.2 and 7.8 to produce a neutralized digest solution, and (v) gelling the solution at a temperature greater than 25°C. In an embodiment, the neutralized digest solution is maintained at or below 25°C before gelation, or gelled at 30°C or higher. Furthermore, the method can comprise administering the neutralized digest solution to a patient. The method can further comprise integrating one or more of a cell, a drug, a cytokine, and a growth factor into the gel. It can also further comprise coating a matrix of a biocompatible scaffold with the solubilized ECM and gelling the matrix. In one aspect, the biocompatible scaffold is coated either with the digest solution between the solubilizing step and the drying step, or with either the sterilized digest solution or the neutralized digest solution after the step of hydrating the digest solution and before the neutralized digest solution is gelled.
The biocompatible scaffold comprises: (a) one or more of a cobalt-chrome alloy, a stainless steel, titanium, tantalum, and/or a titanium alloy, that optionally comprises non-metallic and metallic components; (b) an inorganic mineral comprising calcium; (c) a ceramic; and/or (d) a polymer.
The ECM can be derived from mammalian tissue including urinary bladder, spleen, liver, heart, central nervous system, adipose tissue, bone, pancreas, ovary, small intestine, large intestine, or colon. In some embodiments, the ECM is comminuted or not terminally sterilized, dialyzed or subjected to a cross-linking process prior to the solubilizing step. In another embodiment, the ECM is digested using pepsin wherein solubilization is performed at a pH of 2 or higher, or at a pH between 3 and 4.
Although the claims at issue are not identical, they are not patentably distinct from each other because one embodiment specifies that the dried digest is sterilized using gamma radiation, ethylene oxide, supercritical CO2, and/or electron beam radiation. The latter satisfies the instant application’s requirement that step (iii) in claim 10 is carried out with “electron beam radiation”.
Hence, the U.S. patent reads on the instant application’s method of preparing an ECM-derived gelable composition, as well as the claimed gelable ECM composition resulting from said method.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,413,375 in view of Bates et al. (WO 2008/092011 A2; IDS-cited).
U.S. patent is drawn to a gelable extracellular matrix (ECM) composition comprising a decellularized, enzymatically digested, dried, terminally sterilized, intact ECM, wherein said composition is capable of forming a gel upon hydration, neutralization to pH 7.2-7.8, and warming to a temperature greater than 25°C. The composition further comprises a protease, which can be pepsin or trypsin. In some embodiments, the composition is in the form of a solution that forms a gel upon warming to a temperature greater than 25°C, or upon neutralization to pH 7.2-7.8 followed by warming to a temperature greater than 25°C.
One aspect of the ECM is that it is bioactive (the term “bioactive” is interpreted to mean “biologically active”). The ECM can be derived from urinary bladder, spleen, liver, heart, pancreases, ovary, small intestine, large intestine, colon, esophagus, central nervous system tissue, adipose tissue, dermis, or bone, such as from a human, monkey, pig, cow, or sheep.
The U.S. patent does not disclose that the composition is coated on a biocompatible scaffold.
Scaffolds comprising ECM, however, are known and conventional in the art as shown by Bates et al.. Bates et al. provides a wound dressing or medical product comprising a carrier formed from a natural, bioremodelable material and formulated to deliver a biocidal bismuth thiol agent and/or other biofilm inhibiting/wound healing agents, wherein the carrier is preferably formed from an ECM material (par. [0011]) like fluidized ECM or ECM gel (par. [00107]). In one embodiment, a dried or gelled layer of fluidized ECM is positioned between two substrate layers, or adhered to one or more base substrate layers (par. [0061], [00109]). Applicable substrates include biopolymers and synthetic polymers (par. [0062]) such as polyethylene and polyolefin (par. [0068]).
Accordingly, a person with ordinary skill in the art would have applied the U.S. patent’s gelable ECM in combination with a biofilm inhibiting or wound healing agent on one or more substrate layers and have reasonable expectation that the resulting product would be useful for protecting or healing wounds. Combining prior art elements according to known methods to yield predictable results is the rationale supporting obviousness.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Badylak et al. (Pub. No. US 10,736,991 B2) discloses solubilized extracellular matrix (ECM) composition comprising intact ECM, as well as methods of preparing and using them (Abstract). But unlike the claimed invention, the disclosed composition is non-gelling due to the ECM being sterilized prior to solubilization using an acid protease. Comparison of this prior art and instant application indicates that the property of being able to form a gel depends on how the composition is prepared (particularly, the specific sequence of processing steps).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651
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