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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR
1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/19/2025 has been entered.
Response to Amendment
The amendment filed on 12/19/2025 has been entered into the prosecution of the application.
Rejection for claims 1-2, 6-12,16-18, 22-25, 27, and 29 is withdraw under 35 U.S.C. 112(b) by removing the term “dry”. However, the term “essentially” renders another claim rejection, see below.
Currently, claim(s) 1-2, 6-12, 16-18, 22-25, 27, and 29 is/are pending.
Claim Objections
Claim(s) 24-25 is/are objected to because of the following informalities:
As to claims 24-25, please include “-“ between the numbers and the letters as used commonly in chemical names in the art of chemistry (for instance, “1,2-propanediol” instead of “1,2 propanediol”, as currently written).
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.
Claim(s) 1-2, 6-12, 16-18, 22-25, 27, and 29 is/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.
As to claim 1, the phrase "essentially" in ln. 4 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 2, 6-12, 16-18, 22-25, 27, and 29 are rejected for dependent on claim 1.
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.
Claim(s) 1-2, 22-25, 27, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stephen Livesey of US 2003/0035843 A1 (hereinafter, Livesey) in view of Bin Tian of US 2013/0289695 A1 (hereinafter, Tian) and Douglas Cali of US 2003/0028247 A1 (hereinafter, Cali).
As to claim 1, Livesey teaches to a method of providing features on an implantable material, the method comprising:
providing an implantable material comprising a decellularized sterilized mammalian tissue having an extracellular matrix (Livesey, paragraph [0011], teaches to providing an implantable material comprising a decellularized mammalian tissue having an extracellular matrix, as Livesey teaches to animal tissues chemically treated are commonly used as replacements for defective human heart valves; Livesey, paragraph [0003], teaches that tissues have an extracellular matrix).
Livesey does not explicitly teach in which aqueous components have been essentially removed by a treatment solution comprising one or more polyols which remain within a plurality of interstitial spaces of the extracellular matrix.
In an analogous art, Tian teaches to in which aqueous components have been essentially removed by a treatment solution comprising one or more polyols which remain within a plurality of interstitial spaces of the extracellular matrix (Tian, paragraph [0008], teaches to in which aqueous components have been essentially removed by a treatment solution comprising one or more polyols which remain within a plurality of interstitial spaces of the extracellular matrix, as Tian teaches to a method of treating a biological tissue that enables dry storage, wherein the method comprises contacting the biological tissue with a non-aqueous solution comprising a polyhydric alcohol and a C1-C3 alcohol and removing a portion of the treatment solution from the solution-treated biological tissue; Tian, paragraph [0015], teaches that the polyhydric alcohol is glycerol and the C1-C3 alcohol is propylene glycol).
Both Livesey and Tian relate to treating a biological tissue of a mammal for preparation or storage (Tian, paragraph [0014]). Livesey does not explicitly teach a dry storage using glycerol and propylene glycol. Livesey, paragraph [0051], does teach using cryoprotectants that may include glycerol and propylene glycol. Livesey, paragraph [0052], teaches that the cryosolution may also include dry protectant compounds. The dry protectant of Livesey does not explicitly teach including glycerol. Tian teaches treating a biological tissue with glycerol for preparation or storage.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Livesey with the treatment of Tian for preparing biological tissues for surgical implantation.
Livesey in view of Tian does not explicitly teach and; providing one or more features on the implantable material by application of a laser treatment directly on the implantable material; wherein said laser treatment comprises a CO2 laser treatment
In an analogous art, Cali teaches to and; providing one or more features on the implantable material by application of a laser treatment directly on the implantable material; wherein said laser treatment comprises a CO2 laser treatment (Cali, paragraphs [0021] and [0051], teaches to providing one or more features on the implantable material by application of a laser treatment directly on the implantable material; wherein said laser treatment comprises a CO2 laser treatment, as Cali teaches to pericardium tissues being advantageously laser cut with a CO2 laser).
Both Livesey in view of Tian and Cali relate to surgical implantation (Cali, paragraph [0005]). Livesey in view of Tian does not explicitly teach using a CO2 laser for laser cutting a biological tissue. Livesey in view of Tian does teach to the biological tissue prepared for storage or preparation for surgical implantation. Cali teaches to using a CO2 laser for surgical implantation of a biological tissue for providing an implantable medical prosthesis.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Livesey in view of Tian with the CO-2 laser treatment of Cali for achieving precision and consistency for providing improved surgical implantation.
As to claim 2, Livesey in view of Tian and Cali teaches to the method of claim 1, wherein the CO2 laser treatment includes laser cutting (Cali, paragraph [0051], teaches to wherein the CO2 laser treatment includes laser cutting, as Cali teaches to CO2 laser cutting).
As to claim 22, Livesey in view of Tian and Cali teaches to the method of claim 1, wherein the solution of one or more polyols includes one or more polyols other than glycerol and glycerol (Tian, paragraphs [0008] and [0015], teaches to wherein the solution of one or more polyols includes one or more polyols other than glycerol and glycerol, as Tian teaches to a polyhydric alcohol, including a propylene glycol and a glycerol)
As to claim 23, Livesey in view of Tian and Cali teaches to the method of claim 22, wherein the glycerol is present in an amount in a range of 1 vol. % to 50 vol. % of the mixture and the one or more polyols other than glycerol are present in an amount in a range of 50 vol. % to 99 vol. % of the mixture (Tian, paragraph [0008], teaches to wherein the glycerol is present in an amount in a range of 1 vol. % to 50 vol. % of the mixture and the one or more polyols other than glycerol are present in an amount in a range of 50 vol. % to 99 vol. % of the mixture, as Tian teaches that the polyhydric alcohol concentration can be 40-95% and the C1-C3 alcohol concentration can be 5-60% by volume).
As to claim 24, Livesey in view of Tian and Cali teaches to the method of claim 22, wherein the one or more polyols other than glycerol includes at least one of 1,2 propanediol, 1,2 octanediol, 1,4 butanediol, fructose, xylitol, mannitol, sorbitol, lactulose lactic acid, maltose, glucose, galactose erythritol, lactobionic acid or its salts, and hyaluronic acid (Tian, paragraphs [0008] and [0015], teaches to using a 1,2-propanediol, as Tian teaches to a polyhydric alcohol, including a propylene glycol and a glycerol; 1,2-propanediol is commonly known as propylene glycol)
As to claim 25, Livesey in view of Tian and Cali teaches to the method of claim 22, wherein the one or more polyols other than glycerol are selected from the group consisting of 1,2 propanediol, 1,4 butanediol, lactobionic acid and its salts, and combinations thereof (Tian, paragraphs [0008] and [0015], teaches to using a 1,2-propanediol, as Tian teaches to a polyhydric alcohol, including a propylene glycol and a glycerol; 1,2-propanediol is commonly known as propylene glycol).
As to claim 27, Livesey in view of Tian and Cali teaches to the method of claim 1, wherein the implantable material includes bovine pericardium comprising a thickness between 0.2 mm and 0.7 mm (Tian, paragraph [0032], Table 2, teaches to wherein the implantable material includes bovine pericardium comprising a thickness between 0.2 mm and 0.7 mm. as Tian teaches to bovine pericardium tissue comprising a thickness of 0.38 mm, for example).
Where the only difference between the prior art and the instant claim is a recitation of relative dimension of the claimed structure and a structure having the claimed relative dimensions would not perform differently than the prior art structure, the claimed structure is not patentably distinct from the prior art structure. Please see MPEP § 2144.04(IV)(A).
As to claim 29, Livesey in view of Tian and Cali teaches to an implantable heart valve having a plurality of prosthetic valve leaflets made of an implantable material having features provided by the method of claim 1 (Livesey, paragraph [0010], teaches to an implantable heart valve having a plurality of prosthetic valve leaflets made of an implantable material having features provided by the method of claim 1, as Livesey teaches to a prosthetic heart valve, utilized for aortic heart valve replacement procedures; synthetic materials being made with low immunogenicity; Livesey, paragraph [0011], teaches to animal tissues being commonly used as replacements for defective human heart valves; see rejection for claim 1 above), wherein each leaflet features laser cut edges, and one or more laser cut through holes providing sewing locations (Cali, paragraph [0005], teaches to wherein each leaflet features laser cut edges, and one or more laser cut through holes providing sewing locations, as Cali teaches to an artificial heart valve being implanted to replace a defective natural heart valve; Cali, paragraph [0022], teaches to a plurality of leaflets being laser cut edges).
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stephen Livesey of US
2003/0035843 A1 (hereinafter, Livesey) in view of Bin Tian of US 2013/0289695 A1 (hereinafter, Tian) and Douglas Cali of US 2003/0028247 A1 (hereinafter, Cali), as applied to claim 1 above, and in further view of Donald Guzik of US 2002/0091441 A1 (hereinafter referred to as Guzik).
As to claim 6, Livesey in view of Tian and Cali does not explicitly teach wherein laser cutting comprises laser cutting a line feature on the implantable material.
In an analogous art, Guzik teaches to wherein laser cutting comprises laser cutting a line feature on the implantable material (Guzik, paragraph [0093], Fig. 6, teaches to wherein laser cutting comprises laser cutting a line feature on the implantable material, as Guzik teaches to an example of a template for the cutting of leaflets in which the lines in pattern 298 mark the cutting line for the focused beam to follow, for example, through the motion of a stylus or the like directing the beam).
Both Livesey in view of Tian and Cali and Guzik relate to laser cutting a biological tissue. Livesey in view of Tian and Cali does not explicitly teach a line feature. Livesey in view of Tian and Cali does teach laser cutting using a CO2 laser. Guzik, paragraph [0050], teaches to laser cutting a line feature for implanting a tissue heart valve.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Livesey in view of Tian and Cali with the laser cutting a line feature of Guzik for surgical implantation.
As to claim 7, Livesey in view of Tian, Cali, and Guzik teaches to the method of claim 6, wherein laser cutting the line feature includes laser cutting a perimeter and/or an edge of an element out of the implantable material (Guzik, paragraphs [0100] - [0102] and Figs. 10-11, teaches to wherein laser cutting the line feature includes laser cutting a perimeter and/or an edge of an element out of the implantable material, as Guzik teaches to the aortic wall can be trimmed using a focused beam, wherein Guzik, paragraph [0071], teaches that the laser beam will generally cauterize the edge being cut while not damaging the surrounding tissue).
As to claim 8, , Livesey in view of Tian, Cali, and Guzik teaches to the method of claim 6, wherein laser cutting the line feature includes laser cutting a closed loop feature on the implantable material (Guzik, paragraph [0106] and Figs. 15-18, teaches to wherein laser cutting the line feature includes laser cutting a closed loop feature on the implantable material, as Guzik teaches to slits 370 and slots 372, wherein Guzik, paragraph [0103], teaches that slits may be formed using a focused beam apparatus).
As to claim 9, Livesey in view of Tian, Cali, and Guzik teaches to the method of claim 8, wherein laser cutting the closed loop feature includes laser cutting one or more through holes (Guzik, paragraph [0106] and Figs. 15-18, teaches to wherein laser cutting the line feature includes laser cutting a closed loop feature on the implantable material, as Guzik teaches to slits 370 and slots 372, wherein Guzik, paragraph [0103], teaches that slits may be formed using a focused beam apparatus).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stephen
Livesey of US 2003/0035843 A1 (hereinafter, Livesey) in view of Bin Tian of US 2013/0289695 A1 (hereinafter, Tian) and Douglas Cali of US 2003/0028247 A1 (hereinafter, Cali), as applied to claim 1 above, and in further view of M-300 Laser Platform (Universal Laser Systems, “M-300 Laser Platform, Installation and Operations Manual” (May 2000)), and Randall Andrews of US 2003/0118229 A1 (hereinafter, Andrews).
As to claim 10, Livesey in view of Tian and Cali teaches to the method of claim 1, wherein the CO2 laser treatment utilizes a CO2 laser having a wavelength comprised between 9000 nm and 12000 nm (Cali, paragraph [0045], teaches to wherein the CO2 laser treatment utilizes a CO2 laser having a wavelength comprised between 9000 nm and 12000 nm, as Cali teaches to a wavelength of 10.6 μm; 10.6 microns is equivalent to 10600 nm), a maximum rated power comprised between 15 and 40 W (Cali, paragraph [0045], teaches to M-series laser engraving and cutting system available from Universal Laser Systems, Inc., wherein the device employs a 30 W).
Livesey in view of Tian and Cali does not explicitly teach, a maximum rated processing velocity comprised between 1500 mms and 2300 mm/s, and a lens focal length comprised between 10 mm to 50 mm.
In an analogous art, M-300 Laser Platform teaches to a lens focal length comprised between 10 mm to 50 mm (M-300 Laser Platform, Appendix B – Specifications, teaches to lenses available that can be used together with the laser system, wherein the focal length may be 38.1 mm).
Both Livesey in view of Tian and Cali and M-300 laser Platform relate to laser cutting. Livesey in view of Tian and Cali does not teach to a working condition of a laser cutting machine. Livesey in view of Tian and Cali does teach to laser cutting using a M-series laser system. M-300 Laser Platform teaches the working conditions of a specific model.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Livesey in view of Tian and Cali with the working conditions of M-300 Laser Platform for laser cutting or engraving.
Livesey in view of Tian, Cali, and M-300 Laser Platform does not explicitly teach a maximum rated processing velocity comprised between 1500 mms and 2300 mm/s, and a lens focal length comprised between 10 mm to 50 mm.
In an analogous art, Andrews teaches to a maximum rated processing velocity comprised between 1500 mms and 2300 mm/s, and a lens focal length comprised between 10 mm to 50 mm (Andrews, paragraph [0072], teaches to a maximum rated processing velocity comprised between 1500 mms and 2300 mm/s, and a lens focal length comprised between 10 mm to 50 mm, as Andrews teaches to Lacent 1000’s cutter positioning system capable of travelling at velocities up to 1500 mm per second).
Both Livesey in view of Tian, Cali, and M-300 Laser Platform and Andrews relate to laser cutting. Livesey in view of Tian, Cali, and M-300 Laser Platform does not explicitly teach a specific velocity. Livesey in view of Tian, Cali, and M-300 Laser Platform does teach using a laser cutting machine. Andrews teaches using a laser machine capable of achieving a specific laser cutting speed.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Livesey in view of Tian, Cali, and M-300 Laser Platform with the working conditions of Andrews for laser cutting or engraving.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stephen Livesey of US
2003/0035843 A1 (hereinafter, Livesey) in view of Bin Tian of US 2013/0289695 A1 (hereinafter, Tian) and Douglas Cali of US 2003/0028247 A1 (hereinafter, Cali), as applied to claim 1 above, in view of Donald Guzik of US 2002/0091441 A1 (hereinafter referred to as Guzik), as applied to claims 6 and 7 above, and in further view of M-300 Laser Platform (Universal Laser Systems, “M-300 Laser Platform, Installation and Operations Manual” (May 2000)) and Takashi Matsumoto of US 2003/0052104 A1 (hereinafter, Matsumoto).
As to claim 11, Livesey in view of Tian, Cali, and Guzik does not specify parameters for the laser treatment. Livesey in view of Tian, Cali, and Guzik does not explicitly teach wherein laser cutting perimeter and/or the edge comprises operating a CO2 laser according to the following parameters:
Power: 40% to 60% of maximum rated power
Velocity: 2% to 10% of maximum rated processing velocity
Frequency: 1 kHz to 10 kHz
Number of passes: 1 to 10
Lens focal length: 25.4 mm
However, Cali, paragraph [0045], teaches to M-series laser engraving and cutting system available from Universal Laser Systems, Inc. The Office notes that the recited method of the instant claim can be reached by one of ordinary skill in the art by simply choosing a different laser operating conditions to implement the recited method of laser treatment claimed in claim 1.
A particular parameter can be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, and the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation (please refer to MPEP § 2144.05(II)(B)).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to have discovered the optimum or workable ranges, including values within the claimed range, through routine experimentation. In addition, see below.
In an analogous art, M-300 Laser Platform teaches to a laser wattage of 40, power of 60%, speed of 2.1%, and pass time of 1 (M-300 Laser Platform, 6-20 Sample Materials, Perforated Vector Cutting).
M-300 Laser Platform discloses a “tickle” for small pulses for high-speed cutting and engraving (M-300 Laser Platform, System Operation 3-17). M-300 Laser Platform teaches that tickle frequency can be anything from “2kHz” up to “10 kHz” (M-300 Laser Platform, System Operation 3-17).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to have modified the method of Livesey in view of Tian, Cali, and Guzik to have optimized the laser cutting characteristics for the thickness and nature of the tissue (Guzik, paragraph [0075]) and with the working conditions of the M-300 Laser Platform to have enabled moving laser in both X and Y directions, coordinate movement of the mirror and focusing lens in providing one or more features on the implantable material.
Livesey in view of Tian, Cali, Guzik, and M-300 Laser Platform do not disclose focal length of 25.4 mm. However, M-300 Laser Platform teaches that using a shorter focal length lens can be beneficial (M-300 Laser Platform, Section 8, Engraving Quality).
In an analogous art, Matsumoto discloses a focal length of the collecting lens 42 being about 1 inch (25.4 mm) (Matsumoto, paragraph [0071]).
Both Livesey in view of Tian, Cali, Guzik, and M-300 Laser Platform and Matsumoto relate to laser cutting. Livesey in view of Tian, Cali, Guzik, and M-300 Laser Platform does not explicitly teach a focal length of a specified value. Livesey in view of Tian, Cali, Guzik, and M-300 Laser Platform does teach using a M-series laser engraving and cutting system. Matsumoto teaches to a shorter focal length lens.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to combine the capacity of the working conditions of the laser system used by Livesey in view of Tian, Cali, Guzik, and M-300 Laser Platform with the focal length of Matsumoto for decreasing the focal point diameter of the laser (Matsumoto, paragraph [0071]).
As to claim 12, Livesey in view of Tian, Cali, and Guzik does not specify parameters for the laser treatment. Livesey in view of Tian, Cali, and Guzik does not explicitly teach wherein laser cutting perimeter and/or the edge comprises operating a CO2 laser according to the following parameters:
Power: 40% to 50% of maximum rated power
Velocity: 0.5% to 2% of maximum rated processing velocity
Frequency: 1 kHz to 10 kHz
Number of passes: 1
Lens focal length: 25.4 mm
However, Cali, paragraph [0045], teaches to M-series laser engraving and cutting system available from Universal Laser Systems, Inc. The Office notes that the recited method of the instant claim can be reached by one of ordinary skill in the art by simply choosing a different laser operating conditions to implement the recited method of laser treatment claimed in claim 1.
A particular parameter can be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, and the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation (please refer to MPEP § 2144.05(II)(B)).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to have discovered the optimum or workable ranges, including values within the claimed range, through routine experimentation. In addition, see below.
In an analogous art, M-300 Laser Platform teaches to a laser wattage of 30, power of 50%, speed of 1.2%, and pass time of 1 (M-300 Laser Platform, 6-19 Sample Materials, Vector Cutting).
M-300 Laser Platform discloses a “tickle” for small pulses for high-speed cutting and engraving (M-300 Laser Platform, System Operation 3-17). M-300 Laser Platform teaches that tickle frequency can be anything from “2kHz” up to “10 kHz” (M-300 Laser Platform, System Operation 3-17).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to have modified the method of Livesey in view of Tian, Cali and Guzik to have optimized the laser cutting characteristics for the thickness and nature of the tissue (Guzik, paragraph [0075]) and with the working conditions of the M-300 Laser Platform to have enabled moving laser in both X and Y directions, coordinate movement of the mirror and focusing lens in providing one or more features on the implantable material.
Livesey in view of Tian, Cali, and Guzik and M-300 Laser Platform do not disclose focal length of 25.4 mm. However, M-300 Laser Platform teaches that using a shorter focal length lens can be beneficial (M-300 Laser Platform, Section 8, Engraving Quality).
In an analogous art, Matsumoto teaches to a focal length of the collecting lens 42 being about 1 inch (25.4 mm) (Matsumoto, paragraph [0071]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to combine the capacity of the working conditions of the laser system used by Livesey in view of Tian, Cali, Guzik and M-300 Laser Platform with the focal length of Matsumoto for decreasing the focal point diameter of the laser (Matsumoto, paragraph [0071]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stephen Livesey of US
2003/0035843 A1 (hereinafter, Livesey) in view of Bin Tian of US 2013/0289695 A1 (hereinafter, Tian) and Douglas Cali of US 2003/0028247 A1 (hereinafter, Cali), as applied to claim 1 above, and in further view of Julie A. Benton of US 2015/0100118 A1 (hereinafter referred to as Benton).
As to claim 16, Livesey in view of Tian and Cali does not explicitly teach wherein providing the one or more features on the implantable material by the CO2 laser treatment includes laser ablation to provide sculpture features on the implantable material comprising at least one of a contoured sculptured pattern, a deformation pattern, or a layer ablation.
In an analogous art, Benton teaches to the method of claim 1, wherein providing the one or more features on the implantable material by the CO2 laser treatment includes laser ablation to provide sculpture features on the implantable material comprising at least one of a contoured sculptured pattern, a deformation pattern, or a layer ablation (Benton, paragraphs [0029] and [0043], teaches to wherein providing the one or more features on the implantable material by the CO2 laser treatment includes laser ablation to provide sculpture features on the implantable material comprising at least one of a contoured sculptured pattern, a deformation pattern, or a layer ablation, as Benton teaches to laser ablation, and as Benton, paragraph [0029], Fig. 1A-1B teaches to a plurality of parallel grooves 120, wherein the leaflets are made of biological tissue, preferably bovine pericardium).
While the applicant is allowed to become a lexicographer, the term “layer ablation” has not been positively defined by the claim(s) or the instant specification. Under the broadest reasonable interpretation, the term is interpreted to be at least inclusive of “laser ablation.” Benton, paragraph [0047], teaches that laser ablation is understood to be advantaged if performed on a substantially dehydrated or dry tissue.
Both Livesey in view of Tian and Cali and Benton relate to implanting biological tissues for bioprostheses (Benton, paragraph [0002]). Livesey in view of Tian and Cali does not explicitly teach providing a contoured pattern. Livesey in view of Tian and Cali does teach that the tissue can be laser cut using a CO2 laser. Livesey in view of Tian and Cali does teach preparing a dried tissue. Benton teaches that laser ablation is understood to be advantaged if performed on a substantially dehydrated or dry tissue (Benton, paragraph [0047]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified the method of Livesey in view of Tian and Cali with the method of Benton to provide laser treatment for providing a contoured biological tissue for a bioprostheses, such as a bioprosthetic heart valve.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stephen Livesey of US
2003/0035843 A1 (hereinafter, Livesey) in view of Bin Tian of US 2013/0289695 A1 (hereinafter, Tian) and Douglas Cali of US 2003/0028247 A1 (hereinafter, Cali), as applied to claim 1 above, in view of Julie A. Benton of US 2015/0100118 A1 (hereinafter referred to as Benton), as applied to claim 16 above, and in further view of M-300 Laser Platform (Universal Laser Systems, “M-300 Laser Platform, Installation and Operations Manual” (May 2000)), and Randall Andrews of US 2003/0118229 A1 (hereinafter, Andrews).
As to claim 17, Livesey in view of Tian, Cali, and Benton does not explicitly disclose the recited maximum operating conditions of a laser source apparatus. However, Cali, paragraph [0045], teaches to M-series laser engraving and cutting system available from Universal Laser Systems, Inc. The Office notes that the recited method of the instant claim can be reached by one of ordinary skill in the art by simply choosing a different laser operating conditions to implement the recited method of laser treatment claimed in claim 1.
A particular parameter can be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, and the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation (please refer to MPEP § 2144.05(II)(B)).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to have discovered the optimum or workable ranges, including values within the claimed range, through routine experimentation. In addition, see below.
Live in view of Tian, Cali, and Benton teaches to wherein the CO2 laser treatment utilizes a CO2 laser having a wavelength comprised between 9000 nm and 12000 nm (Cali, paragraph [0045], teaches to wherein the CO2 laser treatment utilizes a CO2 laser having a wavelength comprised between 9000 nm and 12000 nm, as Cali teaches to a wavelength of 10.6 μm; 10.6 microns is equivalent to 10600 nm), a maximum rated power comprised between 15 and 40 W (Cali, paragraph [0045], teaches to M-series laser engraving and cutting system available from Universal Laser Systems, Inc., wherein the device employs a 30 W).
Live in view of Tian, Cali, and Benton does not explicitly teach, a maximum rated processing velocity comprised between 1500 mms and 2300 mm/s, and a lens focal length comprised between 10 mm to 50 mm.
In an analogous art, M-300 Laser Platform teaches to a lens focal length comprised between 10 mm to 50 mm (M-300 Laser Platform, Appendix B – Specifications, teaches to lenses available that can be used together with the laser system, wherein the focal length may be 38.1 mm).
Both Live in view of Tian, Cali, and Benton and M-300 laser Platform relate to laser cutting. Live in view of Tian, Cali, and Benton does not teach to a working condition of a laser cutting machine Live in view of Tian, Cali, and Benton does teach to laser cutting using a M-series laser system. M-300 Laser Platform teaches the working conditions of a specific model.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Live in view of Tian, Cali, and Benton with the working conditions of M-300 Laser Platform for laser cutting or engraving.
Live in view of Tian, Cali, Benton and M-300 Laser Platform does not explicitly teach a maximum rated processing velocity comprised between 1500 mms and 2300 mm/s, and a lens focal length comprised between 10 mm to 50 mm.
In an analogous art, Andrews teaches to a maximum rated processing velocity comprised between 1500 mms and 2300 mm/s, and a lens focal length comprised between 10 mm to 50 mm (Andrews, paragraph [0072], teaches to a maximum rated processing velocity comprised between 1500 mms and 2300 mm/s, and a lens focal length comprised between 10 mm to 50 mm, as Andrews teaches to Lacent 1000’s cutter positioning system capable of travelling at velocities up to 1500 mm per second).
Both Live in view of Tian, Cali, Benton and M-300 Laser Platform and Andrews relate to laser cutting. Live in view of Tian, Cali, Benton and M-300 Laser Platform does not explicitly teach a specific velocity. Live in view of Tian, Cali, Benton and M-300 Laser Platform does teach using a laser cutting machine. Andrews teaches using a laser machine capable of achieving a specific laser cutting speed.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Live in view of Tian, Cali, Benton and M-300 Laser Platform with the working conditions of Andrews for laser cutting or engraving.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stephen Livesey of US
2003/0035843 A1 (hereinafter, Livesey) in view of Bin Tian of US 2013/0289695 A1 (hereinafter, Tian) and Douglas Cali of US 2003/0028247 A1 (hereinafter, Cali), as applied to claim 1 above, in view of Julie A. Benton of US 2015/0100118 A1 (hereinafter referred to as Benton), as applied to claim 16 above, in view of M-300 Laser Platform (Universal Laser Systems, “M-300 Laser Platform, Installation and Operations Manual” (May 2000)), and Randall Andrews of US 2003/0118229 A1 (hereinafter, Andrews), as applied to claim 17 above, and in further view of Takashi Matsumoto of US 2003/0052104 A1 (hereinafter, Matsumoto).
As to claim 18, Livesey in view of Tian, Cali, Benton, M-300 Laser Platform, and Andrews teaches to the method of claim 17, wherein laser ablation is provided according to the following parameters:
Power: 20% to 70% of maximum rated power (M-300 Laser Platform, 6-6 Sample Materials, Deep Raster Engraving, teaches to a power of 40% of maximum rated power)
Velocity: 20% to 65% of maximum rated processing velocity (M-300 Laser Platform, 6-6 Sample Materials, Deep Raster Engraving, teaches to a speed of 40%)
Frequency: 300 ppi to 1000 ppi (M-300 Laser Platform, 6-6 Sample Materials, Deep Raster Engraving, teaches to a frequency of 300)
Number of passes: 1 to 10 (M-300 Laser Platform, 6-6 Sample Materials, Deep Raster Engraving, teaches to a pass time of 1).
Livesey in view of Tian, Cali, Benton, M-300 Laser Platform, and Andrews does not explicitly teach to focal length of 25.4 mm. However, M-300 Laser Platform teaches that using a shorter focal length lens can be beneficial (M-300 Laser Platform, Section 8, Engraving Quality). Cali, paragraph [0045], teaches to M-series laser engraving and cutting system available from Universal Laser Systems, Inc. The Office notes that the recited method of the instant claim can be reached by one of ordinary skill in the art by simply choosing a different laser operating conditions to implement the recited method of laser treatment claimed in claim 1.
A particular parameter can be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, and the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation (please refer to MPEP § 2144.05(II)(B)).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to have discovered the optimum or workable ranges, including values within the claimed range, through routine experimentation. In addition see below.
In an analogous art, Matsumoto teaches to a focal length of the collecting lens 42 being about 1 inch (25.4 mm) (Matsumoto, paragraph [0071]).
Both Livesey in view of Tian, Cali, Benton, M-300 Laser Platform, and Andrews and Matsumoto relate to laser cutting. Livesey in view of Tian, Cali, Benton, M-300 Laser Platform, and Andrews does not explicitly teach a focal length of a specified value. Livesey in view of Tian, Cali, Benton, M-300 Laser Platform, and Andrews does teach using a M-series laser engraving and cutting system. Matsumoto teaches to a shorter focal length lens.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to combine the capacity of the working conditions of the laser system used Livesey in view of Tian, Cali, Benton, M-300 Laser Platform, and Andrews with the focal length of Matsumoto for decreasing the focal point diameter of the laser (Matsumoto, paragraph [0071]).
Response to Arguments
Applicant's arguments filed 12/19/2025 have been fully considered but they are not persuasive.
On pg. 6, the applicant asserts that Sun does not teach a motivation. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it is not the primary reference that needs to teach a motivation for the combination.
On pg. 7, the applicant asserts that claim 1, as amended, overcomes Guzik because Guzik does not explicitly teach laser cutting a polyol-preserved material. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Guzik does teach cutting of wet and/or wetted tissue materials and/or dehydrated material. As the applicant points out the dehydrated material is not the recited polyol-preserved material. However, they both are tissue materials suitable for surgical implantation. The combination does not require the materials to be exactly the same for the laser cutting, as along as the one of ordinary skill in the art would have some teaching, suggestion, or motivation to utilize laser cutting for tissue materials in the art of implantable biomedical devices.
On pg. 8, the applicant asserts that there is no motivation to combine Benton. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Benton teaches the performance of laser ablation to contour dehydrated or dry tissue, as admitted by the applicant. As the applicant points out the dehydrated material is not the recited polyol-preserved material. However, they both are tissue materials suitable for surgical implantation. The combination does not require the materials to be exactly the same for the laser cutting, as along as the one of ordinary skill in the art would have some teaching, suggestion, or motivation to utilize laser cutting for tissue materials in the art of implantable biomedical devices.
On pg. 8, the applicant further asserts that Benton does not teach a CO2 laser treatment and therefore lacks a motivation for the combination. Again, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Benton teaches to using a laser for the laser ablation. Paragraph [0008] of Benton teaches that the contouring can be performed with a laser. CO2 laser is a laser. The teachings of Benton do not make the teachings of Sun and Guzik inoperable.
In addition, upon further consideration, a new ground(s) of rejection is made. For instance, claim(s) 1-2, 22-25, 27, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stephen Livesey of US 2003/0035843 A1 (hereinafter, Livesey) in view of Bin Tian of US 2013/0289695 A1 (hereinafter, Tian) and Douglas Cali of US 2003/0028247 A1 (hereinafter, Cali).
Please refer to the rejection above.
Conclusion
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/JOHN LEE/Examiner, Art Unit 1794
/JAMES LIN/Supervisory Patent Examiner, Art Unit 1794