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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1, 3, 6, 13-14, 16-20, and 64 in the reply filed on 09 March 2026 is acknowledged.
Claims 32, 34, 36, 52-53, 65-66, 69, and 103 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 on 09 March 2026.
Claim Status
Claims 2, 4-5, 7-12, 15, 21-31, 33, 35, 37-51, 54-63, 67-68, and 70-102 were previously canceled, claims 1, 3, 6, 13-14, 16-17, 19-20, 32, 34, 36, 52, 64-65, and 69 were previously amended, claim 103 was new in the claim set from 12 June 2024, claims 32, 34, 36, 52-53, 65-66, 69, and 103 have been withdrawn, and claims 1, 3, 6, 13-14, 16-20, and 64 have been considered on their merits.
Claim Objections
Claim 6 is objected to because of the following informalities: claim 6 recites “wherein the platelet lysate is any one or more of…”, the list following this limitation recites components of platelet lysate and should read as such.
Claims 13 and 14 are objected to because of the following informalities: claims 13 and 14 reuses the same roman numeral identifiers as claim 3 and claim 13, from which they depend. It is improper to reuse the same label for limitations which do not correspond to each other.
Appropriate correction is required.
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 13 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 includes limitations comprising values which are excluded by claim 3, from which it depends. Therefore, it is not clear what the scope of the claim is because the values presented in claim 13 are lower than that of claim 3. The limitations of claim 13 include values less than 6 mg/ml type IV collagen, both 3 mg/ml and 4 mg/ml are below the range presented in claim 3.
Claim 14 includes limitations comprising values which are excluded by claim 13, from which it depends. Therefore, it is not clear what the scope of the claim is because the values presented in claim 14 are broader than that of claim 13. The limitations of claim 14 include values less than 3 mg/ml type IV collagen, values higher than 0.1 M sodium ions, and values above 0.02 calcium ions; all of which exceed the ranges presented in claim 13.
The language of a claim must make it clear what subject matter the claim encompasses to adequately delineate its "metes and bounds". See, e.g., the following decisions: In re Hammack, 427 F 2d. 1378, 1382, 166 USPQ 204, 208 (CCPA 1970); In re Venezia 530 F 2d. 956, 958, 189 USPQ 149, 151 (CCPA 1976); In re Goffe, 526 F 2d. 1393, 1397, 188 USPQ 131, 135 (CCPA 1975); In re Watson, 517 F 2d. 465, 477, 186 USPQ 11, 20 (CCPA 1975); In re Knowlton 481 F 2d. 1357, 1366, 178 USPQ 486, 492 (CCPA 1973).
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claims 13 and 14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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 14, which depends from claim 13, requires the limitation wherein the solution comprises: less than 24 mg/ml type IV collagen, more than 0.04 M sodium ions, and more than 0.008 M calcium ions. This limitation does not further limit claim 13, as all of the alternative limitations already require less than 24 mg/ml type IV collagen, more than 0.04 M sodium ions, and more than 0.008 M calcium ions.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, and 64 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okano et al. (US 9981064 B2, 29 May 2018, IDS ref.).
Regarding claim 1, Okano teaches cultivating corneal endothelial cells on a cell culture support comprising a substrate having a surface covered with a polymer (Column 3, lines 4-19). Okano teaches the substrate for cultivating corneal endothelial cells on adhesive proteins such as collagen IV, collagen I, collagen III, laminine, fibronectin, and Matrigel are advantageous to keep cell morphology intact (Column 8, lines 17-21). Specifically, Okano teaches corneal endothelial cells were cultured in a collagen IV coated flask comprising a medium of DMEM and FCS at 37°C (column 9, lines 37-45). Okano teaches the polymer to be used may be a homopolymer or a copolymer wherein the polymers may be crosslinked to the extent that will not impair their properties (Column 6, lines 44-59). Crosslinked polymers would necessarily comprise a crosslinking agent.
Regarding claim 3, Okano teaches the medium comprises fetal calf serum (FCS) (column 9, lines 37-45), which reads on the limitations of claim 3 (vii). The other limitations of claim 3 are presented in the alternative, as such, are not required by the claim.
Claim 64 recites a product-by-process limitation. Product-by-process limitations are considered only in as far as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore, if the product, as claimed, is the same or obvious over a product of the prior art (i.e., is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP 2113. In the instant case Okano teaches a construct comprising type IV collagen, a crosslinking agent, and endothelial cells as discussed in the rejection of claim 1.
Thus, the reference anticipates the subject matter of claims 1, 3, and 64.
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.
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Okano et al. (US 9981064 B2, 29 May 2018, IDS ref.) as applied to claims 1, 3, and 64 above, and further in view of Patel et al. (WO 2016/178586 A2, published 10 November 2016).
Okano et al. anticipate the subject matter of claims 1, 3, and 64, and thus also, render them obvious.
Regarding claim 6, Okano is silent to a construct comprising components of platelet lysate.
However, Patel teaches compositions comprising collagen for repair or augmentation of tissues of the body, to include the tissues of the cornea (Abstract). Patel teaches the collagen solution is 3 mg/ml to 10 mg/ml (para. [0030]). Patel teaches when referring to the cornea, includes the corneal endothelium (para. [00130]). Patel teaches the collagen was crosslinked with riboflavin and UV-A (para. [0058] and [0096]). Patel teaches type I collagen is the most dominant collagen type in the cornea and the methods of the composition can be used with other types of collagens such as type IV collagen (para. [00142]). Patel teaches the collagen composition comprises a growth factor selected from the group consisting of FGF, VEGF, PDGF, EGF, IGF, TGF, and HGF growth factors (components of platelet lysate), among others (para. [0060]).
Therefore, it would have been obvious to one of ordinary skill in the art to include the components of platelet lysate of Patel with the composition of Okano with a reasonable expectation of success because both Okano and Patel teach crosslinked collagen compositions. One would be motivated to include the components of platelet lysate of Patel with the composition of Okano because components of platelet lysate such as the growth factors of Patel are well known in the art to support cellular growth and maintenance.
Regarding claim 16, Okano does not specifically describe a multilayered construct. However, Patel teaches the construct comprises collagen with more than two layers (Fig. 5-7, para. [0099]-[00101]). Patel teaches the collagen was crosslinked with riboflavin and UV-A (para. [0058] and [0096]). Patel teaches type I collagen is the most dominant collagen type in the cornea and the methods of the composition can be used with other types of collagens such as type IV collagen (para. [00142]). Therefore, Patel teaches the construct comprising more than two layers comprising type IV collagen and crosslinking agent, wherein the two or more layers have been crosslinked to at least one other layer.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Okano et al. (US 9981064 B2, 29 May 2018, IDS ref.) in view of Patel et al. (WO 2016/178586 A2, published 10 November 2016) as applied to claims 1, 3, 6, and 64 above, and further in view of Darmoc et al. (US 2012/0230977 A1, published 13 September 2012).
Okano et al. anticipate the subject matter of claims 1, 3, and 64, and thus also, render them obvious.
Regarding claims 13 and 14, Patel teaches the collagen solution, to include type IV collagen, is 3 mg/ml to 10 mg/ml (para. [0030]). However, Okano in view of Patel are silent to calcium and sodium ions.
Darmoc teaches compositions comprising type I collagen crosslinked with UV irradiation and photochemical crosslinking including photo initiators such as riboflavin (para. [0062] and [0069]). Darmoc teaches collagen in solution is used in the generation of the composition wherein the adjustment of pH using NaOH (sodium ions) and/or HCl to approximately 6.5-8 and optionally adding calcium ions, or similar charged particles or ions, during precipitation (Fig. 1 and para. [0064]). Darmoc teaches during precipitation, the microfibrils begin to associate and form a staggered fibrillar structure, wherein increase in pH upon precipitation gives an overall neutral charge to fibrils which decrease the solubility of collagen fibrils (para. [0064]).
Darmoc is silent to the concentration of said sodium and calcium ions, however, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). 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."). As such, the optimum concentration of sodium and calcium ions to arrive at the desired pH of the collagen solution is considered a result-effective variable. A person of ordinary skill in the art would have been motivated to arrive at the desired ion concentration out of the course of routine optimization, in order to achieve the desired pH of the collagen solution. Adjusting the pH of such solutions would allow for control of the collagen microfibril structure, as taught by Darmoc.
Additionally, it would have been obvious to one of ordinary skill in the art to include the sodium and calcium ions of Darmoc with the composition of Okano in view of Patel with a reasonable expectation of success because Patel teaches the collagen gel can also be pH neutralized as needed, which may be achieved by incubation of the collagen gel with alkaline in liquid or vapor form, such as solutions of sodium hydroxide or calcium hydroxide (para. [00159]). One would be motivated to include the sodium and calcium ions of Darmoc with the composition of Okano in view of Patel because Darmoc teaches sodium and calcium ions can be utilized to control the structure of the collagen composition by adjusting the pH.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Okano et al. (US 9981064 B2, 29 May 2018, IDS ref.) in view of Patel et al. (WO 2016/178586 A2, published 10 November 2016) as applied to claims 1, 3, 6, and 64 above, and further in view of Williams et al. (EP 0518389 A2, published 16 December 1992, IDS ref.)
Okano et al. anticipate the subject matter of claims 1, 3, and 64, and thus also, render them obvious.
Regarding claims 17, 18, 19, and 20, Okano teaches the substrate for cultivating corneal endothelial cells on adhesive proteins such as collagen IV, collagen I, collagen III, laminine, fibronectin, and Matrigel are advantageous (Column 8, lines 17-21). Specifically, Okano teaches corneal endothelial cells were cultured in a collagen IV coated flask (column 9, lines 37-45). Okano teaches the polymer to be used may be a homopolymer or a copolymer wherein the polymers may be crosslinked to the extent that will not impair their properties (Column 6, lines 44-59). The teachings of Okano suggest a copolymer and both types of adhesive proteins such as collagen type IV and collagen type I.
Patel teaches the collagen solution, to include type I collagen, is 3 mg/ml to 10 mg/ml (claim 17) (para. [0030] and [0036]). Patel teaches type I collagen is the most dominant collagen type in the cornea and the methods of the composition can be used with other types of collagens such as type IV collagen (para. [00142]). Patel teaches the collagen gel can also be pH neutralized as needed, which may be achieved by incubation of the collagen gel with alkaline in liquid or vapor form, such as solutions of sodium hydroxide or calcium hydroxide (sodium or calcium ions) (para. [00159]).
Okano does not specifically teach the additional layer of type I collagen however, both Okano and Patel teach type I and type IV collagen can be used together.
Williams teaches a synthetic substrate and a type IV/V collagen surface layer seeded with a confluent monolayer of autologous endothelial cells, a base layer of interstitial collagen is adhered to the substrate, which is covalently bonded to the intermediate layer. Cross linking agent is glutaraldehyde is utilized to covalently bind the interstitial collagen base layer to the substrate, and the collagen intermediate layer to the base layer (claim 18 and claim 20(ii)) (Abstract). Williams teaches said surface layer comprising one or more underlayers of type I/III collagen with the top layer comprising type IV collagen, wherein the type I/III collagen was crosslinked by reaction with glutaraldehyde (claim 19) (p. 5, lines 48-51). This reads as the type I collagen was individually crosslinked with glutaraldehyde prior to crosslinking to the other layers. The limitations of claim 20 are presented in the alternative, as such the limitations of claim 20(i) are not required by the claim.
Patel is silent to the concentration of said sodium or calcium ions (claim 17).
However, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). 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."). As such, the optimum concentration of sodium and calcium ions to arrive at the desired pH of the collagen solution is considered a result-effective variable. A person of ordinary skill in the art would have been motivated to arrive at the desired ion concentration out of the course of routine optimization, in order to achieve the desired pH of the collagen solution.
Therefore, it would have been obvious to combine the teachings of Okano and Patel in view of Williams with a reasonable expectation of success because Williams teaches a layered construct comprising both type I and type IV collagen to promote the adhesion and proliferation of endothelial cells (p. 5, lines 51-57). One would be motivated to combine the teachings of Okano and Patel in view of Williams because Patel teaches type I collagen is abundant in the cornea and can be used with collagen type IV and Williams teach a construct comprising a type IV and type I collagen layer for culturing endothelial cells.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
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, 3, 6, 13-14, 16-20, and 64 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 10-12, 14-21, 24, 26-27, 30, 32, and 44 of copending Application No. 17/756,147 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
Regarding claims 1, 3, 6, 13-14, 17; reference claims 1, 10, 12 recite a composition comprising 3-15 mg/ml type I collagen (instant claim 17), 0.135-0.5 M sodium ions and/or 0.008-0.4 M calcium ions (instant claims 13-14 and 17), riboflavin (a crosslinking agent) (instant claims 1 and 3(v)), collagen IV (instant claim 1), fibrinogen (instant claim 6), and mammalian cells.
The reference claims are silent to endothelial cells specifically, however, the reference specification indicates on p. 16, the type of cells utilized will generally depend on the specific purpose for which the composition is to be used and include endothelial cells (instant claim 1).
Regarding the type IV collagen concentration of instant claims 13-14, the reference claims are silent to the concentration.
However, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). 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."). As such, the optimum concentration of the type IV collagen is considered a result-effective variable. A person of ordinary skill in the art would have been motivated to arrive at the desired type IV collagen concentration out of the course of routine optimization, in order to achieve the desired collagen composition.
Regarding claims 16-20, reference claim 17 recites a method of preparing a composition comprising (i) providing a solution comprising type I collagen, one or more crosslinking agent, 0.135-5 M sodium ions; and/or 0.008-0.4 M calcium ions, (ii) applying the solution to a surface, and (iii) applying light capable of activating the crosslinking agents to the solution. Reference claim 18 recites, the method of claim 17, wherein applying the solution to a surface forms a layer and wherein steps (ii) and (iii) are repeated a plurality of times, wherein each layer is applied on top of the preceding layer. Reference claim 24 recites a method of claim 17 wherein the solution further comprises matrix proteins. Reference claim 26 recites a method of claim 24 wherein the matrix proteins comprise collagen type IV.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 6, 13-14, 16-20, and 64 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8, 12, 14-15, 17-21, 24-26, 28, 32, 34-35, 38, and 50 of copending Application No. 18/550,870 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
Regarding claim 1, reference claims 1, 2, and 8 recite a composition comprising type IV collagen, one or more crosslinking agent, and endothelial cells.
Regarding claims 3 and 6, reference claims 1 and 2 recite a composition comprising riboflavin (instant claim 3) and fibrinogen (instant claim 6).
Regarding claims 13 and 14, reference claim 1 recites a composition comprising 6-24 mg/ml type IV collagen and 0.04-0.15 M sodium ions and/or 0.008-0.4 M calcium ions. Additionally, reference claim 17 is identical to the limitations of instant claim 13.
Regarding claims 16, 17, and 20, reference claim 19 recite a method for preparing a composition, (i) providing a solution comprising, type IV collagen, one or more crosslinking agents, and 0.04-0.15 M sodium ions or 0.008-0.4 M calcium ions; (ii) applying the solution to a surface, and (iii) activating the one or more crosslinking agents. Reference claim 20 recites the method of claim 19, wherein applying the solution to a surface forms a layer, wherein steps (ii) and (iii) are repeated a plurality of times, wherein each layer is applied on top of the preceding layer (instant claim 16). Reference claims 32 and 34 recite the method of claim 19 wherein the solution further comprises matrix proteins, wherein the matrix protein comprises type I collagen (instant claim 17 and 20(ii)). As stated above the method for preparing a composition comprises 0.04-0.15 M sodium ions or 0.008-0.4 M calcium ions.
The reference claims are silent to the concentration of the type I collagen.
However, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). 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."). As such, the optimum concentration of the type I collagen is considered a result-effective variable. A person of ordinary skill in the art would have been motivated to arrive at the desired type I collagen concentration out of the course of routine optimization, in order to achieve the desired collagen composition.
Regarding claims 18 and 19, reference claim 19 recite a method for preparing a composition, (i) providing a solution comprising, type IV collagen, one or more crosslinking agents, and 0.04-0.15 M sodium ions or 0.008-0.4 M calcium ions; (ii) applying the solution to a surface, and (iii) activating the one or more crosslinking agents. Reference claim 20 recites the method of claim 19, wherein applying the solution to a surface forms a layer, wherein steps (ii) and (iii) are repeated a plurality of times, wherein each layer is applied on top of the preceding layer. This reads as each layer has been crosslinked to at least one other layer and a construct comprising a first layer comprising type IV collagen and the crosslinking agent that has been individually crosslinked prior to crosslinking to another layer.
Claim 64 recites a product-by-process limitation. Product-by-process limitations are considered only in as far as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore, if the product, as claimed, is the same or obvious over a product of the prior art (i.e., is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP 2113. In the instant case reference claims 1, 2, and 8 recite a composition comprising type IV collagen, one or more crosslinking agent, and endothelial cells.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/N.A.H./Examiner, Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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