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 .
Status of the Claims
Claims 1, 3-10 and 12-23 are currently pending.
Claims 1, 21, have been amended.
Claims 12-14 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 2 and 11 has been cancelled
Claim 23 is newly added.
Claims 1, 3-10 and 15-20, and 22-23 have been considered on the merits.
Priority
Receipt is acknowledged of the certified copy of translation of the JP2019-069972, required by 37 CFR 1.55.
Withdrawn Rejections
The rejections made under 35 U.S.C. 103 regarding claim 21 have been withdrawn in light of the amendments made on 06/09/2026.
New and Maintained Rejections Necessitated by Amendment
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-5, 9-10, 19, and 22 remain rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kelly et al (US20170232144A1), and new claim 23 is newly rejected as being anticipated by Kelly et al as evidenced by Buehler et al (PNAS, 2006).
Claim Interpretation: Claim 1 recites the limitations of a fragmented collagen component having an average length of 5 µm to 50 µm and an average diameter of 50 nm to 30 µm. Therefore, a collagen particle which has a spherical shape with a diameter of anywhere between 5 µm to 30 µm would read on the fragmented collagen component of claim 1 having an average length of 5 µm to 50 µm and an average diameter of 50 nm to 30 µm.
Regarding claim 1, Kelly teaches a method of producing a three-dimensional tissue construct ([0003]), comprising culturing cells in an injectable liquid gel base including fragmented collagen components derived from cartilage extracellular matrix (ECM) ([0006]/[0053]/[0116]), and an aqueous medium ([0102]), mixing the ECM/cell mixture with fibrinogen to form a ECM/cell/fibrinogen mixture and subsequently adding thrombin to the mixture to cause gelation to occur ([0118]). Fibrin is also disclosed ([0050]). Further, Kelly also teaches a step of mixing fibrinogen before culturing with the fragmented collagen components, to obtain a first mixture and adding thrombin of a second mixture to cause gelation as required by claim 1 ([0118]). Kelly teaches that the fragmented collagen components have an average particle size of 10-200 microns which meets the limitations of claim 1, wherein the fragmented collagen component has an average length of 5 µm to 50 µm and an average diameter of 50 nm to 30 µm ([0014]). More specifically, Kelly teaches a particle size of between 10-30 µm which falls within the overlap of the claimed length and diameter measurements ([0014]/[0033]). Additionally, Kelly teaches that the collagen components are derived from a non-human animal as required by claim 1 ([0094]).
Regarding claim 3, Kelly teaches that the components are cross-linked ([0011]).
Regarding claim 4, Kelly teaches a fragmented collagen particle size of between 10-30 µm which falls within the claimed length of between 10-50 µm ([0014]/[0033]).
Regarding claim 5, Kelly teaches that the cells are extracellular matrix producing cells ([0053]/[0054]).
Regarding claim 9, Kelly teaches that the content of the fragmented collagen components is 200-500 mg/ml which corresponds to a mass% of 20-50 mass% which falls within the range of 0.33-90 mass% ([0102]).
Regarding claim 10, Kelly teaches that the content of the fragmented collagen components is 200-500 mg/ml which corresponds to a mass% of 20-50 mass% which falls within the range of 0.5-90 mass% ([0116]/[0102]).
Regarding claims 19 and 22, Kelly teaches mixing fibrinogen with the fragmented collagen components and mixing thrombin as an activator mixture and then combining the fibrinogen mixture with the thrombin activator mixture to obtain the culture injectable liquid gel base ([0050]-[0052]).
Regarding claim 23, Kelly meets the limitation of the fragmented collagen components having a fibrous shape as evidenced by Buehler et al. Buehler teaches “collagen, the most abundant protein on earth, is a fibrous structural protein” (pg. 12285, col. 1, para 2; and Fig. 1).
Therefore, Kelly anticipates the claims.
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.
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 6-7, 15, 18, and 20 remain rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al (US20170232144A1), as applied to claims 1, 3-5, 9-10, 19, and 22 in the 102 rejection above, and in view of Bhatia (US20080181935A1; reference of record).
Regarding claims 6-7, 15, 18, and 20-21, the limitations of the independent claim have been taught above by Kelly.
Regarding claim 20, Kelly teaches first mixing fibrinogen with the fragmented collagen components and second mixing thrombin as an activator mixture and then combining the fibrinogen mixture with the thrombin activator mixture to obtain the culture injectable liquid gel base ([0050]-[0052]).
Kelly does not teach that the cells further comprise one or more kinds of cells selected from vascular endothelial cells, cancer cells, cardiomyocytes, smooth muscle cells, fibroblasts and epithelial cells as required by claim 6. Kelly does not teach that the cells comprise at least vascular endothelial cells and fibroblasts as required by claim 7. Kelly does not teach wherein the culture liquid is in the form of liquid droplets as required by claim 15. Kelly does not teach wherein the cells are uniformly distributed in the three dimensional tissue construct as required by claim 18. Kelly does not teach that the cells include vascular endothelial cells as required by claim 21.
However, Bhatia teaches about method of preparing compositions employing collagen for the augmentation or replacement of mammalian tissue (abstract). Bhatia, like Kelly, teaches a form of fragmented collagen component by tissue homogenization ([0089]), however Bhatia does not disclose the particle size or dimensions. However, Bhatia states that the “collagen composition of the invention is expected to have an enhanced clinical utility as a wound dressing, for augmenting or replacing hard and/or soft tissue repair, as compared to other biomaterials known in the art” ([0245]).
Regarding claims 6-7, Bhatia teaches that cells which can be included in the liquid culture are fibroblasts, endothelial cells, and stem cells (extracellular matrix producing cells) as required by claims 6-7 ([0187]/[0148]).
Regarding claim 15, Bhatia teaches that the culture liquid is in the form of liquid droplets ([0182]).
Regarding claim 18, Bhatia teaches that the cells are uniformly distributed in the three-dimensional tissue construct ([0144]).
One of ordinary skill in the art would find it obvious at the time of the effective filling date to combine the method of making 3D collagen-based tissue construct taught by Kelly and the method of making a collagen-based tissue constructs taught by Bhatia to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Bhatia states that the “collagen composition of the invention is expected to have an enhanced clinical utility as a wound dressing, for augmenting or replacing hard and/or soft tissue repair, as compared to other biomaterials known in the art” ([0245]). One of ordinary skill in the art would have a reasonable expectation of success when combining Kelly with Bhatia because both Kelly and Bhatia teach the formation of 3D tissue constructs from collagen constructs and Bhatia teaches the necessary information for the culturing of additional cell types such as fibroblasts, endothelial cells, and stem cells.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 8 and 16 remain rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al (US20170232144A1), in view of Bhatia (US20080181935A1; reference of record), as applied to claims 6-7, 15, 18, and 20 above, and in further view of Li et al (Journal of Cancer, 2011, reference of record).
Regarding claims 8 and 16, the limitations of the independent claim 1 are taught above.
Bhatia teaches that the cells are fibroblasts as required by claim 16 ([0187]/[0148]).
Kelly and Bhatia do not teach that the content of the fibroblasts is greater than or equal to 25% based on a number of whole cells as required by claims 8 and 16.
However, Li teaches a method co-culturing fibroblast cells with epithelial cancer cells on 3D culture systems with different ratios of fibroblasts. Li reports optimizing the ratio of fibroblasts to epithelial cells to form spheroids with the desired characteristics (pg. 462, column 1, para. 1). Li teaches ratios of fibroblasts including 16.6%, 33.3% and 50% fibroblasts as required by claims 8 and 16 (pg. 462, column 1, para. 1).
One of ordinary skill in the art would find it obvious at the time of the effective filling date to modify the method and fibroblasts taught by Kelly and Bhatia with the fibroblast ratios taught by Li to arrive at the instant invention. One of ordinary skill in the art would find it obvious to make this modification because Li teaches that “[t]he higher the ratio of fibroblasts (MEF) in the mixture, the more ductal/tubular network formed among the aggregates” (pg. 462, col. 1, para 1). One of ordinary skill in the art would have a reasonable expectation of success when combining Li with Kelly and Bhatia because Bhatia teaches that cells included in the liquid culture could be fibroblasts and epithelial cells and Li teaches the successful 3D culture of fibroblasts and epithelial cells, forming physiologically relevant networks.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claim 17 remain rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al (US20170232144A1), in view of Bhatia (US20080181935A1; reference of record), and Li et al (Journal of Cancer, 2011, reference of record).
Claim Interpretation: Claim 17 recites the limitations of a fragmented collagen component having an average length of 5 µm to 50 µm and an average diameter of 50 nm to 30 µm. Therefore, a collagen particle which has a spherical shape with a diameter of anywhere between 5 µm to 30 µm would read on the fragmented collagen component of claim 1 having an average length of 5 µm to 50 µm and an average diameter of 50 nm to 30 µm.
Regarding claim 17, Kelly teaches a method of producing a three-dimensional tissue construct ([0003]), comprising culturing cells in an injectable liquid gel base including fragmented collagen components derived from cartilage extracellular matrix (ECM) ([0006]/[0053]/[0116]), fibrin ([0050]), and an aqueous medium ([0102]). Kelly also teaches a step of mixing fibrinogen before culturing with the fragmented collagen components and adding thrombin to cause gelation as required by claim 17 ([0118]). Kelly teaches that the fragmented collagen components have an average particle size of 10-200 microns which meets the limitations of claim 17, wherein the fragmented collagen component has an average length of 5 µm to 50 µm and an average diameter of 50 nm to 30 µm ([0014]). More specifically, Kelly teaches a particle size of between 10-30 µm which falls within the overlap of the claimed length and diameter measurements ([0014]/[0033]). Additionally, Kelly teaches that the collagen components are derived from a non-human animal as required by claim 17 ([0094]).
Kelly does not teach wherein the culture liquid is in the form of liquid droplets or that the cells include fibroblasts as required by claim 17.
However, Bhatia teaches about method of preparing compositions employing collagen for the augmentation or replacement of mammalian tissue (abstract). Bhatia, like Kelly, teaches a form of fragmented collagen component by tissue homogenization ([0089]), however Bhatia does not disclose the particle size or dimensions. However, Bhatia states that the “collagen composition of the invention is expected to have an enhanced clinical utility as a wound dressing, for augmenting or replacing hard and/or soft tissue repair, as compared to other biomaterials known in the art” ([0245]).
Regarding claim 17, Bhatia teaches that cells which can be included in the liquid culture are fibroblasts, endothelial cells, and stem cells (extracellular matrix producing cells) ([0187]/[0148]).
Regarding claim 17, Bhatia teaches that the culture liquid is in the form of liquid droplets ([0182]).
One of ordinary skill in the art would find it obvious at the time of the effective filling date to combine the method of making 3D collagen-based tissue construct taught by Kelly and the method of making a collagen-based tissue constructs taught by Bhatia to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Bhatia states that the “collagen composition of the invention is expected to have an enhanced clinical utility as a wound dressing, for augmenting or replacing hard and/or soft tissue repair, as compared to other biomaterials known in the art” ([0245]). One of ordinary skill in the art would have a reasonable expectation of success when combining Kelly with Bhatia because both Kelly and Bhatia teach the formation of 3D tissue constructs from collagen constructs and Bhatia teaches the necessary information for the culturing of additional cell types such as fibroblasts, endothelial cells, and stem cells.
Kelly and Bhatia do not teach wherein the content of the fibroblasts is greater than or equal to 25% based on a number of whole cells as required by claim 17.
However, Li teaches a method co-culturing fibroblast cells with epithelial cancer cells on 3D culture systems with different ratios of fibroblasts. Li reports optimizing the ratio of fibroblasts to epithelial cells to form spheroids with the desired characteristics (pg. 462, column 1, para. 1). Li teaches ratios of fibroblasts including 16.6%, 33.3% and 50% fibroblasts as required by claim 17 (pg. 462, column 1, para. 1).
One of ordinary skill in the art would find it obvious at the time of the effective filling date to modify the method and fibroblasts taught by Kelly and Bhatia with the fibroblast ratios taught by Li to arrive at the instant invention. One of ordinary skill in the art would find it obvious to make this modification because Li teaches that “[t]he higher the ratio of fibroblasts (MEF) in the mixture, the more ductal/tubular network formed among the aggregates” (pg. 462, col. 1, para 1). One of ordinary skill in the art would have a reasonable expectation of success when combining Li with Kelly and Bhatia because Bhatia teaches that cells included in the liquid culture could be fibroblasts and epithelial cells and Li teaches the successful 3D culture of fibroblasts and epithelial cells, forming physiologically relevant networks.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claim 21 is newly rejected under 35 U.S.C. 103 necessitated by amendment as being unpatentable over Kelly et al (US20170232144A1), in view of Bhatia (US20080181935A1; reference of record), and Suggs et al (US8921103 B2).
Claim Interpretation: Claim 21 recites the limitations of a fragmented collagen component having an average length of 5 µm to 50 µm and an average diameter of 50 nm to 30 µm. Therefore, a collagen particle which has a spherical shape with a diameter of anywhere between 5 µm to 30 µm would read on the fragmented collagen component of claim 1 having an average length of 5 µm to 50 µm and an average diameter of 50 nm to 30 µm.
Regarding claim 21, Kelly teaches a method of producing a three-dimensional tissue construct ([0003]), comprising culturing cells in an injectable liquid gel base including fragmented collagen components derived from cartilage extracellular matrix (ECM) ([0006]/[0053]/[0116]), and an aqueous medium ([0102]), mixing the ECM/cell mixture with fibrinogen to form a ECM/cell/fibrinogen mixture and subsequently adding thrombin to the mixture to cause gelation to occur ([0118]). Fibrin is also disclosed ([0050]). Further, Kelly also teaches a step of mixing fibrinogen before culturing with the fragmented collagen components, to obtain a first mixture and adding thrombin of a second mixture to cause gelation as required by claim 21 ([0118]). Additionally, Kelly teaches that the collagen components are derived from a non-human animal as required by claim 21 ([0094]). Kelly teaches that the fragmented collagen components have an average particle size of 10-200 microns which meets the limitations of claim 21, wherein the fragmented collagen component has an average length of 5 µm to 50 µm and an average diameter of 50 nm to 30 µm ([0014]). More specifically, Kelly teaches a particle size of between 10-30 µm which falls within the overlap of the claimed length and diameter measurements ([0014]/[0033]). Kelly teaches that the collagen components are crosslinked by heat ([0103]).
Kelly does not teach that the cells include vascular endothelial cells as required by claim 21.
However, Bhatia teaches about method of preparing compositions employing collagen for the augmentation or replacement of mammalian tissue (abstract). Bhatia, like Kelly, teaches a form of fragmented collagen component by tissue homogenization ([0089]), however Bhatia does not disclose the particle size or dimensions. However, Bhatia states that the “collagen composition of the invention is expected to have an enhanced clinical utility as a wound dressing, for augmenting or replacing hard and/or soft tissue repair, as compared to other biomaterials known in the art” ([0245]).
Regarding claim 21, Bhatia teaches that cells which can be included in the liquid culture are fibroblasts, endothelial cells, and stem cells (extracellular matrix producing cells) ([0187]/[0148]).
One of ordinary skill in the art would find it obvious at the time of the effective filling date to combine the method of making 3D collagen-based tissue construct taught by Kelly and the method of making a collagen-based tissue constructs taught by Bhatia to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Bhatia states that the “collagen composition of the invention is expected to have an enhanced clinical utility as a wound dressing, for augmenting or replacing hard and/or soft tissue repair, as compared to other biomaterials known in the art” ([0245]). One of ordinary skill in the art would have a reasonable expectation of success when combining Kelly with Bhatia because both Kelly and Bhatia teach the formation of 3D tissue constructs from collagen constructs and Bhatia teaches the necessary information for the culturing of additional cell types such as fibroblasts, endothelial cells, and stem cells.
Kelly teaches that the content of the fragmented collagen components in the aqueous medium can be between 10-50% wt (100-500 mg/ml; [0102]), however, Kelly and Bhatia do not explicitly teach that the content of fragmented collagen components in the aqueous medium is between 0.33-1% mass with respect to the mass of the aqueous medium as required by claim 21.
However, Suggs teaches a method of culturing adipocyte stem cells in a three-dimensional tissue construct on a 0.5% weight (5 mg/ml) fibrillated collagen gel (see Col. 11, para 2). Suggs teaches that their method has the benefit of producing a dermal equivalent for an allograft operation comprising a hydrogel matrix (col. 2, para 5).
One of ordinary skill in the art would find it obvious at the time of the effective filling date to modify the method for producing a 3D tissue construct using fragmented/fibrillated collagen taught by Kelly and Bhatia with the fragmented/fibrillated collagen concentration taught by Suggs to arrive at the instant invention. One of ordinary skill in the art would find it obvious to make this modification because Suggs teaches that their method has the benefit of producing a dermal equivalent for an allograft operation comprising a hydrogel matrix (col. 2, para 5). One of ordinary skill in the art would have a reasonable expectation of success when combining Suggs with Kelly and Bhatia because Kelly and Suggs teach the necessary information and methods of producing tissue constructs with fragmented/fibrillated collagen.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments, see Remarks, pg. 12, filed 06/09/2026, with respect to the rejection(s) of claim 21 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Suggs et al (US8921103 B2).
Applicant's arguments filed 06/09/2026 have been fully considered but they are not persuasive.
Applicant argues (Remarks, pg. 9, last para spanning pg. 10 para 1-3) that the mixing order of the ECM/Cells/Thrombin/fibrinogen which has been adjusted in the newly amended claim 1 is no longer taught by Kelly.
In response, this argument is not found persuasive. Kelly teaches a method of producing a three-dimensional tissue construct ([0003]), comprising culturing cells in an injectable liquid gel base including fragmented collagen components derived from cartilage extracellular matrix (ECM) ([0006]/[0053]/[0116]), and an aqueous medium ([0102]), mixing the ECM/cell mixture with fibrinogen to form an ECM/cell/fibrinogen mixture and subsequently adding thrombin to the mixture to cause gelation to occur ([0118]). Therefore, Kelly anticipates the newly amended claim 1 and the arguments are not found persuasive.
Applicant argues (Remarks, pg. 10 last two para) that the fibrous shape of the instant collagen is “unlike the spherical particles in Kelly”, this fibrous structure functions as a “micro-scaffold”.
In response, this argument is not found persuasive. Although Kelly may use the generic term “particle”, collagen is an abundant and highly characterized protein in the art, and it is well known that the structure and shape of collagen is fibrous. This is evidenced by Buehler et al in the 102 rejection above. Kelly meets the limitation of the fragmented collagen components having a fibrous shape as evidenced by Buehler et al. Buehler teaches “collagen, the most abundant protein on earth, is a fibrous structural protein” (pg. 12285, col. 1, para 2; and Fig. 1). Fig. 1 of Buehler demonstrates the fibrous structure at the molecular (tropocollagen), fibril, and fiber structure. Therefore, this argument is not found persuasive.
Applicant argues (Remarks, pg. 11) that the selection of fibrous collagen shape and “extremely low concentration range: 0.22 to 1 mass%” results in “open vascular lumens” which are “remarkable and unpredictable effect from the perspective of a person skilled in the art”.
In response, the argument is not found persuasive. As described in point 20 above, Kelly meets the limitation of the fragmented collagen components having a fibrous shape as evidenced by Buehler et al. Buehler teaches “collagen, the most abundant protein on earth, is a fibrous structural protein” (pg. 12285, col. 1, para 2; and Fig. 1). Fig. 1 of Buehler demonstrates the fibrous structure at the molecular (tropocollagen), fibril, and fiber structure. Additionally, Kelly teaches that the content of the fragmented collagen components is 1-200 mg/ml which corresponds to a mass% of 0.1-20 mass% which falls within the range of 0.22-1 mass% ([0116]). Therefore, Kelly, alone, describes these limitations and would provide the same result. Therefore, the argument is not found persuasive.
Response to Declaration submitted by Dr. Michiya Matsusaki
The declaration provided by Dr. Matsusaki focuses on the low concentration range of 0.33 mass% to 1 mass % of fragmented collagen as claimed in newly amended and newly independent claim 21. Dr. Matsusaki recognizes that the cited art Kelly provides a broad concentration range of 1 mg/ml to 200 mg/ml for solubilized collagen and provides information on the failure to provide a 3D cell structure using the upper limit of 20 wt% collagen.
In response to the argument provided by Dr. Matsusaki, the range provided by Kelly does provide an overlap regardless of the evidence provided by the Liu article of dense packing of collagen at 20wt%. However, Dr. Matsusaki correctly identifies that this range of Kelly is drawn to solubilized collagen which is used in scaffold formation in Kelly and not employed as a slurry for the instant method to be carried out. Therefore, the rejection of claim 21, which claims the 0.33-1 mass% of fragmented collagen, has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Suggs et al (US8921103 B2).
The declaration provided by Dr. Matsusaki also describes that the range of fragmented collagen component of Kelly is too dense and fails to form an open vascular lumen (points 10-11) and that the density of the hydrogel also effects the pore size of the 3D structure (points 10-11).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the formation of a vascular lumen and specified pore sizes) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, this information is not found persuasive.
Conclusion
Claims 1, 3-10 and 15-22, and 23 remain rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
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