Ook over your action nNotice 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 .
Election/Restrictions
Applicant’s election without traverse to Group I, encompassed in claims 1-10, in the reply filed 04 Mar 2026 is acknowledged.
Claims 11-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed 04 Mar 2026.
Claims 1-10 are pending and under consideration.
Claim Objections
Claims 4-5 and 7 are objected to because of the following informalities:
Regarding claims 4 and 7, the first instance of any abbreviation recited in the claims should be accompanied by the full, written out term, then the abbreviation may be used alone thereafter.
Regarding claim 5, the word “Dalton” is missing after 550000 and the second recitation of “or a sodium salt thereof” appears to be unnecessary.
Regarding claim 7 fourth par., a comma is missing between lutein and alpha-tocopherol.
Appropriate correction is required.
Claim Interpretation
The recitations “for preserving corneal tissues in vitro” and “said preservation solution being capable ... and approximately +37°C” in claim 1 are statements of intended use. Statements reciting purpose or intended use may impose structural limitations. However, in the instant case it is unclear what structural limitations the recitations are intended to impart on the preservation solution claimed. For the purposes of examination, the recitations are interpreted to not impose any structural limitations and are not given patentable weight. See MPEP § 2111.02.
The recitations “preferably between 30000 and 200000 Dalton” in claim 1, “preferably selected from at least one of polysaccharides or glycosaminoglycans” in claim 6, and “preferably MEM” in claim 7 are interpreted to not be required, and thus are not given patentable weight.
Claim Rejections - 35 U.S.C. § 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.
Claims 1-10 are rejected under 35 U.S.C. § 112(b) for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-10 are rejected under 35 U.S.C. § 112(b) as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. Claim 1 recites elements of the preservation solution as approximately 0.05 to approximately 15 percent weight/volume (% w/v) of culture medium, approximately 0.05 to approximately 20% w/v of at least one polymeric compound, and approximately 0.05 to approximately 5% w/v of at least one synthetic nutrient protein. Solutions for preservation of cells typically have a density about that of water, 1 g/mL. The elements of claim 1 amount to between 0.15 and 40 g of components per 100 mL of total solution. This leaves 60 to 99.85 percent of the elements of the preservation solution unclaimed. Based on comparative examples in the specification, Example 1 and Example 2, it appears the omitted element is sterile deionized water (pp. 44-45).
Claims 1-10 are rejected under 35 U.S.C. § 112(b) because the recitations “for preserving corneal tissues in vitro” and “said preservation solution being capable ... and approximately +37°C” in claim 1 render the claims indefinite. Statements reciting purpose or intended use may impose structural limitations; however, in the instant case it is unclear what structural limitations the recitations are intended to impart on the preservation solution claimed. See MPEP § 2111.02.
Claims 1 and 6-7 are rejected under 35 U.S.C. § 112(b) on the basis that the use of the term "preferably" renders the claim indefinite. It is unclear whether the limitation(s) following the phrase are required parts of the claimed invention. A broad claim limitation followed by a narrower limitation or preferred embodiment within a single claim leads to confusion over the intended scope of the claim. See MPEP § 2173.05 subsections (c), (d), and (h).
Regarding claim 1, it is unclear whether the intended scope of the mean molecular weight for the at least one polymer compound having oncotic properties is between 20000 and 550000 Dalton or between 30000 and 200000 Dalton.
Regarding claim 6, it is unclear whether the plurality of polymer compounds must be selected from a polysaccharide or glycosaminoglycan.
Regarding claim 7, it is unclear whether the culture medium must be MEM or may be selected from MEM, M-199, DMEM, IMDM, or RPMI 1640.
Claim 2 is rejected under 35 U.S.C. § 112(b) on the basis that it contains an improper Markush grouping of alternatives. Serum is a composition comprising proteins, not a protein itself. It is thus unclear as to whether the intended scope of the claim is drawn to a nutrient protein of fetal or embryonic animal origin or to the grouping of alternative sera.
Claims 4, and 7 are rejected under 35 U.S.C. § 112(b) on the basis that the use of parentheticals renders the claims indefinite. It is unclear whether the limitations within the parentheticals are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 4, it is unclear how the parentheticals relate to the preceding terms. Presumably, the parentheticals are molecular weights, but even under that assumption is unclear whether the recited values are limitations on the weights of the recited polymers.
Regarding claim 7, the fourth paragraph recites “alpha-tocopherol (vitamin E)”. However, alpha-tocopherol is just one species of the genus of compounds referred to in the art as vitamin E, which includes multiple tocopherols and tocotrienols. Therefore, it is unclear whether the scope of the claim is limited to alpha-tocopherol or the entire genus of vitamin E analogues.
Regarding claim 7, the fourth paragraph recites “Trolox (analogue of water-soluble vitamin E)”. It is unclear whether the breadth of the claim is limited only to Trolox or encompasses other water-soluble analogues of vitamin E.
Claim 4 contains the trademark/trade name Ficoll. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. § 112(b). See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, not the goods themselves. Thus, a trademark or trade name does not identify or describe the associated goods. In the present case, the trademark/trade name is used to identify/describe a copolymer of sucrose and epichlorohydrin and, accordingly, the identification/description is indefinite.
Claim 4 contains the trademark/trade names polysucrose 400, Ficoll PM400, Ficoll PM70, PVP360, and PVP40. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. § 112(b). See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, not the goods themselves. Thus, a trademark or trade name does not identify or describe the associated goods. In the present case, the trademark/trade names are used to identify/describe commercially available polysucroses and polyvinyl pyrrolidones and, accordingly, the identification/description is indefinite.
Claim 5 is ejected under 35 U.S.C. § 112(b) on the basis that the intended scope of the claim is unclear. Claim 1 requires that the “at least one polymer compound having oncotic properties” have a “mean molecular weight between 20000 and 550000 Dalton, preferably between 30000 and 200000 Dalton”. However, claim 5 requires that the polymer compound be hyaluronic acid and have “a molecular weight between approximately 5000 Dalton and approximately 550000 [Dalton]”, which is a broader scope than the claim 1, from which claim 5 depends. Therefore, it is unclear whether the intended scope of claim 5 encompasses hyaluronic acid with molecular weight between approximately 5000 Dalton and 20000 Dalton or greater than 550000 Dalton. See MPEP 2173.05(f).
Claim 7 contains the trademarks/trade names MEM, M-199, DMEM, IMDM, and RPMI 1640. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. § 112(b). See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, not the goods themselves. Thus, a trademark or trade name does not identify or describe the associated goods. In the present case, the trademark/trade name is used to identify/describe basal media for cell culture and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. § 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. § 112(d) or as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 requires that the “at least one polymer compound having oncotic properties” have a “mean molecular weight between 20000 and 550000 Dalton, preferably between 30000 and 200000 Dalton”. However, claim 5 requires that the polymer compound have “a molecular weight between approximately 5000 Dalton and approximately 550000 [Dalton]”, which is a broader scope than the claim 1, from which claim 5 depends. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 U.S.C. § 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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-10 are rejected under 35 U.S.C. § 103.
Claims 1-2 and 6-8 are rejected under 35 U.S.C. § 103 as being unpatentable over Quang (T. Quang, FR 2,949,118 A1, 2011), as evidenced by Price (P.J. Price and E.A. Gregory, In Vitro, 1982) and He (X.M. He and D.C. Carter, Nature, 1992).
Quang discloses a deturgescence solution for storing human corneal tissue 24 to 72 h prior to transplant (claims 1 and 8) (par. 4 and 10). The solution comprises components that constitute a nutrient base that can be used for cell culture, including amino acids, glucose, ionic compounds, and metals (culture medium for biological tissues, claim 1) (par. 59-64 and Example 4 Table). The solution further comprises 40 to 60 g/L dextran (4 to 6 percent weight/volume (%w/v), a polysaccharide oncotic polymer, claim 6), 18 to 22 mL/L fetal calf serum (1.8 to 2.2% w/v, oncotic polymer molecular weight between 20 and 550 kDa and nutrient protein of fetal or embryonic origin, claims 1-2), 50 to 70 mg/L penicillin G (50 to 70 μg/mL, penicillin, claim 7 second par.), 90 to 110 mg/L streptomycin sulfate (90 to 110 μg/mL, streptomycin, claim 7 second par.), 10 to 20 mg/L nystatin (10 to 20 μg/mL, claim 7 third par.), 0.3 to 0.4 mg/L myoinositol (0.3 to 0.4 μg/mL, other name for i-inositol, claim 7 fifth par.), 3000 to 3050 mg/L sodium bicarbonate (0.300 to 0.305% w/v, claim 7 sixth par.), and 100 to 120 mg/L sodium pyruvate (0.010 to 0.012% w/v, claim 7, seventh par.) (Example 4 Table).
Price provides that albumin in fetal bovine serum (FBS, another term for fetal calf serum) has a mean concentration of 2.3% w/v (Table 1 p.577). Thus, a solution with 1.8 to 2.2% FCS would comprise about 0.0414 to 0.0506% w/v albumin. Because the specification does not provide a definition by which the inventor considers values to be approximate, it is considered that 0.0414 to 0.0506% w/v albumin as taught by Quang is within the range of approximately 0.05% to approximately 5% w/v of a nutrient protein as required by claim 1.
He provides that albumin has a molecular weight of 65 kDa, contributes to the colloid osmotic pressure (also known as oncotic pressure in the art) in blood, and, being a protein, is a polymer of amino acids (Introduction, p. 209). Therefore, albumin is an oncotic polymer with a molecular weight within the claimed range of between 20 and 500 kDa as required by claim 1. Furthermore, the exemplary solution taught by Quang comprises dextran and albumin (a plurality of oncotic polymers, claim 6).
Quang does not teach approximately 0.05 to approximately 15% w/v culture medium as required by claim 1 or the specific base used in the exemplary medium as required by claim 7.
However, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium "as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.").It is routine procedure to optimize component amounts to arrive at an optimal product that is superior for its intended use, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP § 2144.05.
Furthermore, Quang teaches that the nutrient base may comprise one of any alternative commercially available cell culture media, including Iscove’s Modified Eagle’s Medium (IMDM) and M-199 medium, that provide the same function of providing necessary nutrients and may be supplemented if necessary (claim 7 first par.) (par. 64).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to vary the concentration of the culture medium and to use IMDM or M-199 medium taught by Quang to arrive at the claimed invention. One would be motivated to vary the concentration of cell culture medium as optimization of component concentrations is routine in the development of corneal preservation solutions. One would be motivated to select IMDM or M-199 as the base medium because Quang teaches those media provide the same basic ingredients required for cell culture and may be supplemented. One would have a reasonable expectation of success in making the combination as optimization of solution components is routine in medium development and because Quang teaches that the base media are known, commercially available substitutes that perform the same function.
Claims 1-3 and 5 are rejected under 35 U.S.C. § 103 as being unpatentable over Böhnke (M. Böhnke, et al., Fortschr Opthalmol, 1991, cited in IDS), as evidenced by Price (P.J. Price and E.A. Gregory, In Vitro, 1982).
Böhnke discloses a corneal preservation solution comprising minimal essential medium with Earle’s salts (MEM-Earle, culture medium for biological tissues, claim 1), 1% weight/volume (%w/v) hyaluronic acid with molecular weight 250 kDa (a glycosaminoglycan oncotic polymer with molecular weight 20 to 550 kDa, claims 1, 3, and 5), and 2% w/v fetal calf serum (FCS, nutrient protein of fetal or embryonic origin, claims 1-2) (Abstract).
Price provides that albumin in fetal bovine serum (FBS, another term for FCS) has a mean concentration of 2.3% w/v (Table 1 p.577). Thus, a solution with 2% FCS would comprise about 0.046% w/v albumin. Because the specification does not provide a definition by which the inventor considers values to be approximate, it is considered that 0.046% w/v albumin as taught by Böhnke is within the range of approximately 0.05% to approximately 5% w/v of a nutrient protein as required by claim 1.
Böhnke does not teach approximately 0.05 to 15% w/v of a culture medium for biological tissues as required by claim 1.
However, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium "as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.").It is routine procedure to optimize component amounts to arrive at an optimal product that is superior for its intended use, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP § 2144.05.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to optimize the concentration of culture medium taught by Böhnke to arrive at the claimed invention. One would be motivated to vary the concentration of cell culture medium as optimization of component concentrations is routine in the development of corneal preservation solutions. One would have a reasonable expectation of success in making the combination because optimization of component concentrations is routine.
Claims 1-2, and 4, are rejected under 35 U.S.C. § 103 as being unpatentable over Lindstrom (R.L. Lindstrom, US 4,695,536 A, 1987) in view of Soll (D.B. Soll, et al., US 7,601,487 B2, 2009) and as evidenced by Price (P.J. Price and E.A. Gregory, In Vitro, 1982).
Lindstrom teaches a corneal preservation solution comprising minimum essential medium (MEM) with Earle’s salts (MEM-Earle, culture medium for biological tissues, claim 1), 1 to 10%w/v chondroitin sulfate (glycosaminoglycan polymer with oncotic properties, claim 1), fetal calf serum (FCS, 10% w/v, nutrient protein of fetal or embryonic origin, claims 1-2) (col. 4 lines 24-32).
Price provides that albumin in fetal bovine serum (FBS, another term for FCS) has a mean concentration of 2.3% w/v (Table 1 p.577). Thus, a solution with 10% FCS would comprise about 0.23% w/v albumin, which is within the range of approximately 0.05% to approximately 5% w/v of a nutrient protein as required by claim 1.
Lindstrom does not teach approximately 0.05 to 15% w/v of a culture medium for biological tissues as required by claim 1, a molecular weight for chondroitin sulfate as required by claim 1, or a polymer selected from polysucrose 400, Ficoll PM400, Ficoll PM70, polyvinyl pyrrolidone PVP360, or polyvinyl pyrrolidone PVP40 as required by claim 4.
However, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium "as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.").It is routine procedure to optimize component amounts to arrive at an optimal product that is superior for its intended use, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP § 2144.05.
Soll teaches that chondroitin sulfate can have a molecular weight of 20 to 100 kDa (col 4 lines 41-48). Therefore, the molecular weight of the chondroitin sulfate taught by Lindstrom is within the claimed range of 20 to 550 kDa for the oncotic polymer required by claim 1.
Lindstrom further teaches that chondroitin sulfate “provides for the maintenance of corneal deturgescence during storage” and that any similar high molecular weight molecule can perform the same function, including polysaccharides (which includes polysucroses) and polyvinyl pyrrolidone (claim 4).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to optimize the concentration of culture medium taught by Lindstrom and to substitute chondroitin sulfate for a polysucrose or polyvinyl pyrrolidone to arrive at the claimed invention. One would be motivated to vary the concentration of cell culture medium as optimization of component concentrations is routine in the development of corneal preservation solutions. One would be motivated to substitute chondroitin sulfate for a polysucrose or polyvinyl pyrrolidone as Lindstrom teaches that the three molecule classes all perform the same function. One would have a reasonable expectation of success in making the combination because optimization of component concentrations is routine and because Lindstrom teaches that any like high molecular weight molecule can perform the function of corneal deturgescence.
Claims 1 and 9-10 are rejected under 35 U.S.C. § 103 as being unpatentable over Lindstrom (R.L. Lindstrom, US 4,695,536 A, 1987) and Soll (D.B. Soll, et al., US 7,601,487 B2, 2009) as evidenced by Price (P.J. Price and E.A. Gregory, In Vitro, 1982), and in further view of Thareja (T. Thareja, et al., Br J Ophthalmol, 2020) and Wesselingh (J.A. Wesselingh and H.W. Frijlink, CRC Press, 2008).
Lindstrom, Soll, and Price teach a corneal preservation solution as discussed in the rejection of claim 1 under 35 U.S.C. § 103 above. The corneal preservation solution taught by Lindstrom further comprises 0.25 μg/mL amphotericin B (antimycotic substance, claim 9) (col. 4 lines 24-34). Lindstrom further teaches a corneal preservation system for human corneal tissue comprising a storage container (or vial) and the preservation solution (claims 9-10) (Abstract and col. 1 lines 28-34).
Lindstrom does not teach a tablet comprising a lubricating substance, an aggregating substance, a disaggregating substance, and an additive selected from an antibiotic, an antimycotic, and an antioxidant as required by claim 9.
Thareja teaches that a kit has been developed called Kerasave, which comprises a corneal preservation solution and a dissolvable tablet comprising the antimycotic amphotericin B (p. 1038). Thareja further teaches that use of a dissolvable tablet circumvents the instability of amphotericin B in solution, which degrades quickly enough to fall below the minimal inhibitory concentration required to control contamination from clinically relevant fungal species within the time course that many corneas are stored prior to transplant (p. 1038). Kerasave significantly prolonged shelf life of corneal tissue for transplant (Thareja p. 1038). The other components of the Kerasave tablet were not disclosed in Thareja.
Wesselingh teaches that the common classes of materials for creating a pharmaceutical tablet, in addition to the active pharmaceutical ingredient, include binders (compounds with aggregating properties), disintegrants (compounds with disaggregating properties), and lubricants (a compounds with lubricating properties) (claim 9) (p. 4). Wesselingh further teaches that lubricants are added to aid in manufacturing so the tablet can be easily removed from the tableting machine (p. 5). Wesselingh further teaches that disintegrants are added to improve rate of tablet dissolution (p. 5). Wesselingh further teaches that binders are added to render the formulation compactible so as to form a stable tablet (p. 5).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the corneal preservation solution and bottle taught by Lindstrom with the amphotericin B tablet taught by Thareja and the tablet formulation taught by Wesselingh to arrive at the claimed invention. One would be motivated to make the combination as Thareja teaches that addition of a tablet comprising amphotericin B is a known technique to improving similar corneal preservation solutions for the purpose of reducing fungal contamination. One would be motivated to formulate the tablet comprising amphotericin B with a lubricating substance, and an aggregating substance, and a disaggregating substance as Wesselingh teaches that lubricating substances and aggregating substances enable and improve manufacture of tablets and that disaggregating substances aid dissolution of tablets that would otherwise dissolve very slowly. One would have a reasonable expectation of success in making the combination because Thareja teaches that addition of a tablet comprising amphotericin to a corneal preservation solution improves the shelf life of corneal tissues for transplant and overcomes the instability of amphotericin B in solution and because Wesselingh teaches that lubricating substances, aggregating substances, and disaggregating substances are generic, standard ingredients in manufacture and use of pharmaceutical tablets.
Double Patenting
Claims 1-10 of this application is patentably indistinct from claims 1, 5, 8-10, and 12 of Application No. 18/506,219. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
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 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 8-10, and 12 of copending Application No. 18/506,219 (reference application, hereafter ‘219) in view of Steen (S. Steen, US 7,255,983 B2, 2007) and Karnieli (O. Karnieli, Cytotherapy, 2017). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 of '219 is drawn to a preservation solution comprising approximately 0.05 to approximately 15% weight/volume (% w/v) culture medium, approximately 0.05 to approximately 20% w/v of at least one oncotic polymer with molecular weight between 5 and 550 kDa, and approximately 0.05 to approximately 5% w/v of a nutrient protein of uniquely synthetic origin. Claim 8 of ‘219 further comprises the preservation solution of claim 1 of '219, wherein the nutrient protein is recombinant human serum albumin (rHSA) and the oncotic polymer is hyaluronic acid with molecular weight of approximately 50 to approximately 150 kDa.
Each element of claim 8 is recited in claims 1, 3, and 5-6 of the immediate application except that claims 1-3 and 5-6 require that the nutrient protein be of fetal or embryonic origin rather than a recombinant protein and that the molecular weight of the oncotic polymer have a molecular weight of 20 to 550 kDa. Claim 2 further requires animal serum.
Claim 5 of ‘219 further comprises the preservation solution of claim 1 of '219, wherein the oncotic polymer(s) comprises at least one of a polysaccharide, polysucrose, Ficoll, a glycosaminoglycan or salt thereof and preferably polysucrose 400, Ficoll PM400, Ficoll PM70, polyvinyl pyrrolidone PVP360, or polyvinyl pyrrolidone PVP40.
Each element of Claim 5 of ‘219 is recited in claims 3 and 4 of the immediate application except that claims 3 and 4 require that the nutrient protein be of fetal or embryonic origin rather than a recombinant protein and that the molecular weight of the oncotic polymer have a molecular weight of 20 to 550 kDa.
Claim 9 of ‘219 further comprises the preservation solution of claim 1 of '219, wherein the culture medium is selected from MEM, M-199, DMEM, IMDM, and RPMI 1640. Claim 9 of '219 additionally recites approximately 1 to approximately 1000 pg/mL of at least one antibiotic, approximately 0.05 to approximately 15 pg/mL of at least one antimycotic, approximately 1 μg/L to approximately 500 g/L of at least one antioxidant, approximately 5 μg/L to approximately 30 g/L of calciferol, i-inositol, inosine, or L-alanyl-L-glutamine, approximately 0.1 to approximately 5% w/v sodium bicarbonate, and approximately 0.01 to approximately 2% w/v sodium pyruvate.
Each element of claim 9 of ‘219 is recited in claim 7 of the immediate application except that claim 7 requires that the nutrient protein be of fetal or embryonic origin rather than a recombinant protein and that the molecular weight of the oncotic polymer have a molecular weight of 20 to 550 kDa.
Claim 10 of ‘219 further comprises the preservation solution of claim 1 of '219, wherein the solution is suitable for storing human corneal tissue.
Each element of claim 10 of ‘219 is recited in claim 8 of the immediate application except that claim 8 requires that the nutrient protein be of fetal or embryonic origin rather than a recombinant protein and that the molecular weight of the oncotic polymer have a molecular weight of 20 to 550 kDa.
Claim 12 of ‘219 is drawn to a preservation system for human corneal tissue comprising the preservation solution of claim 1 of ‘219, a bottle containing the preservation solution, and a tablet.
Each element of claim 12 of ‘219 is recited in claims 9-10 of the immediate application except that claims 9-10 requires that the nutrient protein be of fetal or embryonic origin rather than a recombinant protein and that the molecular weight of the oncotic polymer have a molecular weight of 20 to 550 kDa.
However, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium "as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.").It is routine procedure to optimize component amounts to arrive at an optimal product that is superior for its intended use, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP § 2144.05. Therefore, the claimed range of molecular weight for the oncotic polymer of '219 is not patentably distinct from that of the immediate application.
Furthermore, Steen teaches that for tissue preservation solutions, a primary function of albumin is to maintain correct oncotic pressure and that recombinant human albumin has the same physical action as albumin derived from fetal animal serum (col. 4 lines 12-18 and 26-56). Furthermore, Karnieli teaches that recombinant albumin is a substitute when formulating media without serum and that use of albumin not sourced from serum is often impractical in early development and academic settings because the increased cost compared to serum (pp. 160 and 166).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to optimize the molecular weight of the oncotic polymer of '219 and to substitute the recombinant human serum albumin (rHSA) of '219 with fetal or embryonic animal serum or albumin derived from fetal or embryonic animal serum as taught by Steen and Karnieli to arrive at the claimed invention. One would be motivated to optimize the molecular weight of the oncotic polymer as component optimization is routine. One would be motivated to substitute the rHSA with albumin derived from fetal or embryonic animal serum as Karnieli teaches that serum is less expensive than recombinant albumin. One would have a reasonable expectation of success in making the combination because component optimization is routine and because Steen teaches that recombinant and animal-derived albumins perform the same physical actions in tissue preservation solutions.
Conclusion
No claim is allowed.
References cited but not relied upon by the examiner:
Giurgola, L., Gatto, C., Parel, J.-M., Miller, D. & D’Amato Tóthová, J. Antimycotic Efficacy and Safety of a New Cold Corneal Storage Medium by Time–Kill and Toxicity Studies. Cornea 38, 1314–1321 (Year: 2019)
Tran, K. D. et al. Efficacy and Safety of Various Amphotericin B Concentrations on Candida albicans in Cold Storage Conditions. Cornea 39, 110–117 (Year: 2020)
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/Eric B Wright/ Examiner, Art Unit 1632 /VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632