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 .
Applicants’ amendment to the claims filed on 11/08/2024 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 34-49 are pending.
Claims 1-33 are cancelled.
Priority
Acknowledgement is made of this national stage entry of PCT/AU2022/050999 of Non-provisional Application No. 18/686,731, filed on 8/25/2022, which claims foreign priority under 35 U.S.C. 119(a)-(d) to Australian Patent Application No. AU2021902788, filing date 8/26/2021. The certified copy has been filed in the present application on 2/26/2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/26/2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The Drawings filed on 2/26/2024 are acknowledged and accepted by the examiner.
Claim Objections
Claims 39, 49 is objected to because of the following informalities: incorrectly spelled terms “polymerisation” and “polymerise” (claim 39) and “dialysed” (claim 49). It is suggested Applicant correct the spelling to “polymerization” and “polymerize” (claim 39) and “dialyzed” (claim 49). Appropriate correction is suggested.
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 34-49 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.
Regarding claims 34, (claim 35 dependent thereof), 36 (claim 37dependent thereof), 38, 39 (claims 40-44 dependent thereof), claims 41, 47, 49, the recitation of the term "preferably" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed, thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). It is unclear the limitation of the claim and/or if the claim encompasses additional elements.
Regarding claim 37, the recitation of the phrase ‘predetermined viscosity’ and ‘a relatively constant temperature’ is indefinite because it is unclear what the scope of the phrase is intended to encompass structurally. It is unclear what the phrase ‘predetermined viscosity’ and ‘a relatively constant temperature’ is intended to encompass. It is unclear from the claims and specification what the phrase‘ predetermined viscosity’ and ‘a relatively constant temperature’ is referring to structurally and functionally. Accordingly, the metes and bounds upon which patent protection is sought cannot be ascertained from this phrase.
Regarding claim 39 (claim 40-44 dependent thereof), the term "more preferably" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed, thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). It is unclear the limitation of the claim and/or if the claim encompasses additional elements.
The phrase “increase in temperature” in claim 39 (claims 40-44 dependent thereof) is a relative phrase which renders the claim indefinite. The phrase “increase in temperature” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The phrase "increase in temperature” is a relative phrase that renders the claim indefinite because it is unclear whether it is broad or limited. See MPEP § 2173.05(b) III A.
Regarding claim 39 (claims 40-44 dependent thereof), the recitation of the phrase ‘a temperature of greater than 40C and less than or equal to 37C’ is indefinite because it is unclear what the scope of the phrase is intended to encompass structurally. It is unclear what the phrase a ‘temperature of greater than 40C and less than or equal to 37C’ is intended to encompass as a temperature of greater that 40C and less than or equal to 37C is not obtainable. It is unclear from the claims and specification what the phrase ‘a temperature of greater than 40C and less than or equal to 37C’ is referring to structurally and functionally. Furthermore, a temperature of >40C is a large range as its upper limit cannot be determined. In addition, a temperature of less than 37C is too broad such that its lower end is not clear. Accordingly, the metes and bounds upon which patent protection is sought cannot be ascertained from this phrase.
Regarding claim 44, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention or just mere examples, thus rendering the scope undiscernible. See MPEP § 2173.05(d).
Regarding claim 45 (claims 46-48 dependent thereof), the recitation of the phrase ‘predetermined concentration’ and ‘predetermined viscosity’ is indefinite because it is unclear what the scope of the phrase is intended to encompass structurally. It is unclear what the phrase ‘predetermined concentration’ and ‘predetermined viscosity’ is intended to encompass. It is unclear from the claims and specification what the phrase ‘predetermined concentration’ and ‘predetermined viscosity’ is referring to structurally and functionally. Accordingly, the metes and bounds upon which patent protection is sought cannot be ascertained from this phrase.
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.
Claim 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manickavasagam et al (US 2004/0167318 A1, Date of Publication: Aug. 26, 2004, cited on IDS dated 2/26/2024).
Claims 34 is drawn to a manufactured article, comprising a plurality of isolated and purified type I collagen fibrils derived from abalone in which there is association of collagen molecules from adjacent collagen fibrils and which contains ions or salts, preferably sodium chloride, within an intrafibrillar compartment.
With respect to claim 34, Manickavasagam teaches the purification of native type I collagen from abalone for the production of carbonless paper (para 0311). It is known by those of average skill in the art that collagen inherently comprises collagen molecules that are associated with adjacent collagen fibrils, contain sodium chloride ions and is arranged in intrafibrillar compartment. As such, absent evidence otherwise, it is the Examiner’s position that the collagen taught by Manickavasagam is comprised of sodium chloride ions, comprises collagen molecules that are associated with adjacent collagen fibrils and arranged in intrafibrillar compartment as said characteristics are inherent properties collagen.
Absent evidence otherwise, it is the Examiner’s position that the recitation ‘preferably’ is the same as optionally. As such, the recitation ‘preferably sodium chloride’ within the instant application is not a required limitation.
For the reasons stated herein, the teachings of Manickavasagam anticipate claim 34.
Claims 36, 39-44, 49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manickavasagam et al (US 2004/0167318 A1, Date of Publication: Aug. 26, 2004, cited on IDS dated 2/26/2024).
Claims 36, 39-44 are drawn to a method of preparing the manufactured article of claim 34, comprising the steps of: a) providing a plurality of isolated and purified type I collagen fibrils derived from abalone; and b) forming the isolated and purified type I collagen fibrils into a manufactured article which contains ions or salts, preferably sodium chloride, within an intrafibrillar compartment.
Claim 49 is drawn to a method of isolating type I collagen fibrils from abalone, comprising the steps of: a) preparing a collagen-containing portion of abalone for extraction; b) contacting the collagen-containing portion with a weak acid solution to provide an acidic type I collagen fibril solution; c) separation insoluble material from the acidic type I collagen fibril solution; d) adjusting the pH of the acidic type I collagen fibril solution to a pH just below the isoelectric point of abalone collagen, preferably to about 4.0; and e) precipitating native type I collagen fibrils by addition of a salt, preferably sodium chloride; wherein the precipitated native type I collagen fibrils are not dialysed against water.
With respect to claims 36, 49, Manickavasagam teaches a method for isolating a collagen-derived protein fraction from a marine invertebrate (abalone) for the production of carbonless paper, pharmaceuticals and cosmetics (para 0311), comprising the steps of: 1) preparing a collagen-containing portion of said marine invertebrate for extraction; 2) treating the collagen-containing portion with a weak acid solution in order to solubilise a collagen-derived protein fraction (type I abalone collagen); and 3) collecting the collagen-derived protein fraction (Manickavasagam: claim 1, para 0040, para 0052). Manickavasagam further teaches the insoluble fraction may be isolated from solution (para 0024). In isolating native collagen it is preferable that the pH of the native collagen-containing weak acid solution be adjusted from time to time (para 0031). The pH may be adjusted to around 3.5 (para 0031). Absent evidence otherwise, it is the Examiner’s position that a pH of 3.5 is below the isoelectric point of abalone collagen and ‘about’ a pH of 4.0 as recited in the instant application. Manickavasagam further teaches the utilization of salt (sodium chloride) to precipitate the native collagen (para 0034, 0036). The precipitated collagen may be dialized against water (para 0036). It is the Examiner’s position that the teaching ‘may be dialized’ means the collagen may or may not be dialyzed. As such, it is the Examiner’s position that Manickavasagam teaches the collagen is not dialysed against water.
With respect to claims 39, 43-44, Manickavasagam teaches a method wherein carbonless paper (sheet), pharmaceuticals cosmetics (para 0311) biomedical devices (cell growth matrices, prosthetic devices, synthetic skin, and dressings for wounds) (para 0304) are formed by dissolving freeze dried collagen in water to produce a collagen solution (para 0292). Absent evidence otherwise, it is the Examiner’s position that the biomedical devices (cell growth matrices, prosthetic devices, synthetic skin, and dressings for wounds) (para 0304) taught by Manickavasagam a manufactured articles for implantation into an animal. Manickavasagam further teaches particles were removed at 25C (para 0284). Absent evidence otherwise, it is the Examiner’s position that the manufactured products carbonless paper, pharmaceuticals and cosmetics (para 0311) would necessarily have to be shaped from the collagen in order to produce the manufactured product. Manickavasagam further teaches the abalone gelatin gelled at room temperature in a matter of minutes which shows good gelling properties (para 0299). In order to collect native collagen, the temperature should preferably be maintained below 25 ° C (para 0029). When gelatin is to be collected, the temperature for the extraction is preferably 40°C or above (para 0029).
With respect to claims 40-42, Manickavasagam teaches the pH of the slurry was adjusted to 3.5 (para 0122). The pH of the solution was changed from 2.8 to 6.0 with a small of amount of 1 M sodium hydroxide to stop the enzymatic action of the pepsin (para 0259). Afterwards, The collagen samples were transferred into freeze drying bottles, frozen in liquid nitrogen and freeze dried for 16 hours (para 0262). Absent evidence otherwise, it is the Examiner’s position that freeze drying the collagen samples ‘shapes’ them as the physical properties of the collagen is being changed. Since Manickavasagam teaches the structure of a manufactured article, comprising a plurality of isolated and purified type I collagen fibrils derived from abalone, it is the Examiner’s position that said composition would necessarily have a concentration of greater than 35mg/ml.
Absent evidence otherwise, it is the Examiner’s position that the recitation ‘preferably’ is the same as optionally. As such, the recitation ‘preferably below room temperature and more preferably at 40C’ and ‘preferably to a temperature of greater than 40C and less than or equal to 37C’ are not required limitations of the claim. Furthermore, the recitation ‘preferably to about 4.0’ within the instant application claim 49 is not a required limitation. Furthermore, the recitation ‘preferably sodium chloride’ within the instant application is not a required limitation. In addition, the recitation ‘preferably to about 7.4’ is not a required limitation of the claim.
For the reasons stated herein, the teachings of Manickavasagam anticipate claims 36, 39-44, 49.
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.
Claim 34-35, 45-48 are rejected under 35 U.S.C. 103 as being unpatentable over Tao et al (US 2014/0199276 A1, Date Published: Jul. 17, 2014, Examiner cited) {herein Tao} in view of Manickavasagam et al (US 2004/0167318 A1, Date of Publication: Aug. 26, 2004, cited on IDS dated 2/26/2024).
Claims 34-35 are drawn to a manufactured article, comprising a plurality of isolated and purified type I collagen fibrils derived from abalone in which there is association of collagen molecules from adjacent collagen fibrils and which contains ions or salts, preferably sodium chloride, within an intrafibrillar compartment.
Claims 45-47 are drawn to a bioink for a 3D bioprinter comprising isolated and purified type I collagen fibrils derived from abalone and a solvent, wherein the bioink has a predetermined concentration of abalone collagen fibrils and a predetermined viscosity that is low enough that the bioink can be bioprinted at a temperature below the denaturation temperature of abalone collagen and wherein a printed article contains ions or salts within an intrafibrillar compartment.
Claim 48 is drawn to a cartridge containing the bioink of claim 45, wherein the cartridge is adapted to fit into a 3D bioprinter to provide bioink for bioprinting.
With respect to claims 34-35, 45-48, Tao teaches manufactured purified and isolated collagen coated substrate as a paper replacement (para 0039 and 0063) and ink (para 0033) for a 3D printer (para 0038). Said ink is within a cartridge (para 0039). Furthermore, Tao teaches said collagen is of any type (para 0082). Absent evidence otherwise, it is the Examiner’s position that the collagen taught by Tao comprises Type I collagen fibrils as Tao teaches the collagen is of any type (para 0082). Furthermore, it is known by those of average skill in the art that collagen inherently comprises collagen molecules that are associated with adjacent collagen fibrils, contain sodium chloride ions and is arranged in intrafibrillar compartment. As such, absent evidence otherwise, it is the Examiner’s position that the collagen taught by Tao is comprised of sodium chloride ions, comprises collagen molecules that are associated with adjacent collagen fibrils and arranged in intrafibrillar compartment as said characteristics are inherent properties of collagen. Tao further teaches said collagen is utilized as a scaffold for tissue structures (para 0084). Absent evidence otherwise, it is the Examiner’s position that the ink is a bioink and the printer is a bioprinter as the ink is comprised of collagen, which is organic matter, and Tao teaches a 3D printer is utilized as a tool to print using the collagen (bioink) (para 0038). Tao further teaches that the print head is the device within an inkjet printer that sprays ink for printing (para 0033). Absent evidence otherwise, it is the Examiner’s position that the collagen (bioink) has a ‘predetermined concentration’ and ‘predetermined viscosity’ low enough that the bioink can be bioprinted at a temperature below the denaturation temperature of abalone collagen as Tao teaches the collagen (ink) having a viscosity that is low enough under the printing conditions to pass through the nozzle of the print head, and that can gel to a stable shape during and/or after printing (para 0057). Tao further teaches the collagen (ink) is comprised of gluronic acid (para 0134) of which is known by those of ordinary skill in the art to be a weak acid. Furthermore, viscosities of the ink are typically within the range of from about 0.5 to about 50 centipoise (para 0057).
Absent evidence otherwise, it is the Examiner’s position that the recitation ‘preferably’ is the same as optionally. As such, the recitation ‘preferably, the pH of the solution is about 3.5’ within the instant application claim 47 is not a required limitation.
However, Tao does not teach a plurality of isolated and purified type I collagen fibrils derived from abalone (claim 34, 45)
With respect to claims 34, 45, Manickavasagam teaches an isolated collagen-derived protein fraction from a marine invertebrate (abalone) for the production of carbonless paper, pharmaceuticals and cosmetics (para 0311).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Tao et al. of a manufactured purified and isolated collagen coated substrate as a paper replacement (para 0039 and 0063) and ink (para 0033) for a 3D printer (para 0038) or combine the teachings of Manickavasagam because Manickavasagam teaches an isolated collagen-derived protein fraction from a marine invertebrate (abalone) for the production of carbonless paper, pharmaceuticals and cosmetics (para 0311),
One of ordinary skill in the art would be motivated to either use the teachings of Tao et al. by itself or combine the teachings of Manickavasagam because Manickavasagam provides Tao the motivation to isolate and purify type I collagen fibrils from abalone since Manickavasagam teaches type I collagen fibrils from abalone produces gelatin that gels at room temperature, thus allowing for a novel, simple and cost effective process for the extraction of gelatin from abalone waste tissue (Manickavasagam: para 0299 and 0300). Furthermore, abalone collagen has good thermal properties (Manickavasagam: para 0252). One of ordinary skill in the art knowing the benefit of manufactured articles comprising purified type I collagen fibril from abalone based on the teachings of Tao and Manickavasagam would have a reasonable expectation of success to use the collagen fibrils taught by Manickavasagam because doing to would be time and cost effective since Manickavasagam teaches abalone collagen fibrils have good thermal properties which would allow for its utilization in the production of products that need to be produced under high heat. Additionally, since Manickavasagam teaches gelatin derived from abalone collagen fibrils solidify at room temperature, utilizing said collagen would not necessitate additional tools and equipment to induce jellification.
One of skill in the art would have a reasonable expectation of success to make and use the claimed manufactured article, comprising a plurality of isolated and purified type I collagen fibrils derived from abalone because Tao provides the basic manufactured articles and its uses and methods of making it. While Manickavasagam provides an isolated collagen-derived protein fraction from a marine invertebrate (abalone) for the production of carbonless paper, pharmaceuticals and cosmetics (para 0311)
Claims 36-44 are rejected under 35 U.S.C. 103 as being unpatentable over Tao et al (US 2014/0199276 A1, Date Published: Jul. 17, 2014, Examiner cited) {herein Tao} in view of Manickavasagam et al (US 2004/0167318 A1, Date of Publication: Aug. 26, 2004, cited on IDS dated 2/26/2024).
Claims 36-44 are drawn to a method of preparing the manufactured article of claim 34, comprising the steps of: a) providing a plurality of isolated and purified type I collagen fibrils derived from abalone; and b) forming the isolated and purified type I collagen fibrils into a manufactured article which contains ions or salts, preferably sodium chloride, within an intrafibrillar compartment.
With respect to claims 36-39, 41, 43-44, Tao teaches a method wherein a plurality of manufactured purified and isolated collagen coated substrate as a paper replacement (para 0039 and 0063) and ink (para 0033) for a 3D printer (para 0038) is produced. Said ink is within a cartridge (para 0039) and produced under wet conditions at room temperature (para 0090). The collagen is then incubated at 37C in an orbital shaker (para 0109). Since Tao teaches the collagen incubated at room temperature and then 37C, it is the Examiner’s position that the collagen would necessarily be induced to polymerize as recited in the instant application claim 39. Furthermore, Tao teaches said collagen is of any type (para 0082). Absent evidence otherwise, it is the Examiner’s position that the collagen taught by Tao comprises Type I collagen fibrils as Tao teaches the collagen is of any type (para 0082). Furthermore, it is known by those of average skill in the art that collagen inherently comprises collagen molecules that are associated with adjacent collagen fibrils, contain sodium chloride ions and is arranged in intrafibrillar compartment. As such, absent evidence otherwise, it is the Examiner’s position that the collage taught by Tao is comprised of sodium chloride ions, comprises collagen molecules that are associated with adjacent collagen fibrils and arranged in intrafibrillar compartments as said characteristics are inherent properties collagen. Said collagen is utilized as a scaffold for tissue structures (para 0084). Absent evidence otherwise, it is the Examiner’s position that the ink taught by Tao is a bioink and the printer is a bioprinter as the ink is comprised of collagen, which is organic matter, and Tao teaches a 3D printer is utilized as a tool to print using the collagen (bioink) (para 0038). Tao further teaches that the print head is the device within an inkjet printer that sprays ink for printing (para 0033). Absent evidence otherwise, it is the Examiner’s position that the collagen (bioink) has a ‘predetermined concentration’ and ‘predetermined viscosity’ low enough that the bioink can be bioprinted at a temperature below the denaturation temperature of abalone collagen as Tao teaches the collagen (ink) having a viscosity that is low enough under the printing conditions to pass through the nozzle of the print head, and that can gel to a stable shape during and/or after printing (para 0057). Tao further teaches the collagen (ink) is comprised of gluronic acid (para 0134) of which is known by those of ordinary skill in the art to be a weak acid. In addition, Tao teaches viscosities are typically within the range of from about 0.5 to about 50 centipoise (para 0057). Tao further teaches the biodegradable scaffold can be shaped and/or cast into a sheet by the addition of a base (para 0091). Since Tao teaches the shaping of the scaffold, it is the Examiner’s position that the pH of the collagen solution would necessarily be adjusted towards physiological pH prior to shaping the article by the addition of a base. Tao further teaches said sheet and/or scaffold can be implanted into an animal (para 0078, para 0080).
Absent evidence otherwise, it is the Examiner’s position that the recitation ‘preferably’ is the same as optionally. As such, the recitation ‘preferably sodium chloride,’ within the instant application claim 36 is not a required limitation. Furthermore, the recitation ‘preferably 40C’ is not a required limitation of the instant application (instant application claim 38). In addition, the recitation ‘preferably below room temperature and more preferably at 40C’ is not a required limitation of the instant application (instant application claim 39). Additionally, the recitation ‘preferably to about 7.4’ is not a required limitation of the instant application (instant application claim 41).
However, Tao does not teach a plurality of isolated and purified type I collagen fibrils derived from abalone (claim 36, 49). Tao does not teach wherein the pH of the collagen solution produced in step (a) is 3.5 (claim 40). Tao does not teach wherein the collagen solution has a concentration of greater than 35mg/ml (claim 42).
With respect to claim 40, although the references of Tao in view of Manickavasagam do not explicitly teach the limitations of claim 40, MPEP 2144.05 states"[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the pH of the collagen depending on the particular application. It would be routine for one to arrive at the pH for the application they intend on using the collagen. Therefore, the above invention would have been prima facie obvious.
With respect to claim 42, since Tao in view of Manickavasagam teaches the structure of a method for manufacturing articles comprising a plurality of isolated and purified type I collagen fibrils derived from abalone, it is the Examiner’s position that said composition would necessarily have a concentration of greater than 35mg/ml.
With respect to claim 36, Manickavasagam teaches a method wherein an isolated collagen-derived protein fraction from a marine invertebrate (abalone) for the production of carbonless paper, pharmaceuticals and cosmetics (para 0311).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Tao et al. of a manufactured purified and isolated collagen coated substrate as a paper replacement (para 0039 and 0063) and ink (para 0033) for a 3D printer (para 0038) or combine the teachings of Manickavasagam because Manickavasagam teaches a method of isolating collagen-derived protein fractions from a marine invertebrate (abalone) for the production of carbonless paper, pharmaceuticals and cosmetics (para 0311).
One of ordinary skill in the art would be motivated to either use the teachings of Tao et al. by itself or combine the teachings of Manickavasagam because Manickavasagam provides Tao the motivation to isolate and purify type I collagen fibrils from abalone since Manickavasagam teaches type I collagen fibrils from abalone produces gelatin that gels at room temperature, thus resulting in the development of a novel, simple and cost effective process for the extraction of gelatin from abalone waste tissue (Manickavasagam: para 0299 and 0300). Furthermore, abalone collagen has good thermal properties (Manickavasagam: para 0252). One of ordinary skill in the art knowing the benefit of manufactured articles comprising purified type I collagen fibril from abalone based on the teachings of Tao and Manickavasagam would have a reasonable expectation of success that using the collagen fibrils taught by Manickavasagam would be time and cost effective since Manickavasagam teaches abalone collagen fibrils have good thermal properties which would allow for its utilization in the production of products that need to be produced and/or utilized under high heat. Additionally, since Manickavasagam teaches gelatin derived from abalone collagen fibrils solidify at room temperature, utilizing said collagen would not necessitate additional tools and equipment to induce jellification.
One of skill in the art would have a reasonable expectation of success to make and use the claimed manufactured article, comprising a plurality of isolated and purified type I collagen fibrils derived from abalone because Tao provides the basic method of manufacturing articles and its uses and methods of making it. While Manickavasagam provides a method wherein an isolated collagen-derived protein fraction from a marine invertebrate (abalone) for the production of carbonless paper, pharmaceuticals and cosmetics (para 0311)
Conclusion
Status of claims
Claims 34-49 are pending.
Claims 1-33 are cancelled.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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/ERICA NICOLE JONES-FOSTER/ Examiner, Art Unit 1656
/MANJUNATH N RAO/ Supervisory Patent Examiner, Art Unit 1656