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 .
The amendment filed January 30, 2026. Claims 1-3, 5, 7-9, and 11-23 are pending in the application. Claims 4, 6, and 10 have been cancelled. Claims 14 and 15 are withdrawn from consideration.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1 at line 10, it is recommended to amend “animal” after “the” and before “from” to “mammal”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5, 7-9, 11-13, and 16-23 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.
Independent claim 1 recites “i.e. 37⁰C, more or less 5⁰C” at line 11. It is unclear what is intended by this recitation. More specifically, this phrase renders the claim indefinite because it is unclear whether the recitation following the phrase is part of the claimed invention. Therefore, the scope of the claim is indefinite.
For the purpose of the examination, the recitation “mineralized connective tissue is derived i.e. 37⁰C, more or less 5⁰C” (emphasis added) at line 11 of claim 1 is interpreted as “mineralized connective tissue is derived”.
Claim 1 also recites “the form” at line 19. This recitation lacks antecedent basis as there is no prior mention of a form. Additionally, it is uncertain what is encompassed by this limitation. Therefore, the scope of claim 1 is indefinite.
For the purpose of the examination, the recitation of “in the form of a unique cycle” (emphasis added) at line 19 of claim 1 is interpreted as “in a unique cycle”.
Claims 2, 3, 5, 7-9, 11-13, and 16-23 are not specifically discussed but is rejected due to their dependence on claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
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.
Claims 1-3, 7-9, 11, 13, 16, 17, 19-21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Meisner et al. WO 2017198351 (hereinafter “Meisner”) (refer to the corresponding machine translation) in view of Manickavasagam US 20040167318 (hereinafter “Manickavasagam”).
With respect to claim 1, Meisner teaches a process for producing a collagen material from animal raw material (paragraphs [0001], [0005], and [0015]).
It is noted that the recitation of “for manufacturing compounds of interest from at least one mineralized connective tissue, said compounds of interest comprising at least collagen” in the preamble of claim 1 is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding said manufacturing method comprises a step of supplying said at least one mineralized connective tissue which is selected from bones derived from mammals, a solid/liquid extraction step, in which said at least one mineralized connective tissue is mixed with an eluent suitable for extracting said compounds of interest from said at least one mineralized connective tissue to said eluent, during the solid/liquid extraction step, the temperature of the eluent is maintained at a value corresponding to the physiological temperature of the animal from which said at least one mineralized connective tissue is derived, a step of separating the eluent, containing said compounds of interest, from said at least one mineralized connective tissue in claim 1, Meisner teaches providing animal raw material comprising collagen, such as bones from mammals, contacting the raw material with an aqueous extraction solution, and separating the raw material from the extraction solution comprising the collagen (paragraphs [0001], [0005], [0007], [0015], and [0022]).
Meisner does not expressly disclose during the solid/liquid extraction step, the temperature of the eluent is maintained at a value corresponding to the physiological temperature of the animal from which said at least one mineralized connective tissue is derived. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the temperature of extraction solution through routine experimentation during the extraction step in the method of Meisner with the expectation of successfully preparing a functional collagen containing product. One of ordinary skill in the art would have been motivated to do so because Meisner teaches properties of the collagen material produced by the method can be influenced by the extraction conditions such as the particular temperature (paragraph [0021]), and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[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 II).
Regarding the recitation of wherein said solid/liquid extraction step comprises successive operations of adjusting the pH of said eluent, separated by a time interval, each of said pH adjustment operations comprises an addition of an acid in the mineralized connective tissue/eluent mixture, to reduce the pH of said eluent until reaching a pH value lower than or equal to 5.5 in claim 1, Meisner does not expressly disclose this limitation.
Manickavasagam teaches a process of obtaining collagen from animal material. The animal material comprising collagen is treated with a solution to extract the collagen. Adjustments to the pH of the extraction solution during extraction of the collagen from the animal material may be made by adding acid at certain periods throughout the process to reduce the pH to around 3.5 (Abstract; and paragraphs [0024], [0031], and [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Manickavasagam, to select the step of adjusting the pH during the extraction step in the method of Meisner with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Meisner and Manickavasagam similarly teach processes of obtaining collagen from animal material, Manickavasagam teaches adjusting the pH to around 3.5 during the extraction to separate the extractable collagen from the animal material (paragraphs [0031] and [0032]), Meisner teaches the pH of the extraction solution is preferably 3.5 to 5.5 and the properties of the collagen material produced can be influenced by the extraction conditions such as the pH value (paragraphs [0021]-[0022]), and said modification would amount to the use of a known step for its intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success with said modification. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007).
Regarding wherein the solid/liquid extraction step is carried out in a unique cycle in which said at least one mineralized connective tissue is mixed with a determined amount of eluent which is completely introduced at the beginning of the solid/liquid extraction step in claim 1, Meisner teaches contacting the raw material with an aqueous extraction solution in the extraction step and is silent with respect to adding additional extraction solution during the extraction step (paragraphs [0007] and [0015]).
Meisner does not expressly disclose a determined amount of extraction solution was used. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the quantity of extraction solution through routine experimentation in the method of modified Meisner with the expectation of successfully preparing a functional collagen containing product. One of ordinary skill in the art would have been motivated to do so because Meisner teaches properties of the collagen material produced by the method can be influenced by the extraction conditions (paragraph [0021]), and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[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 II).
With respect to claim 2, modified Meisner is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the recitation of wherein the pH adjustment operations are configured to maintain the pH of said eluent at a pH value lower than or equal to 5.5 in claim 2, it is noted that this recitation relates to functional language. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Additionally, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) and MPEP 2111.04.
Absent any clear and convincing evidence to the contrary, the method would naturally arrive at this claimed feature since Meisner as modified by Manickavasagam teaches a method that is substantially similar to the presently claimed method as addressed above in claim 1. Also, as demonstrated above in claim 1, the secondary reference Manickavasagam is relied upon for the teaching of the pH adjustment since Manickavasagam teaches adjustments to the pH of the extraction solution during extraction of the collagen from the animal material may be made at certain periods throughout the process to reduce the pH to around 3.5 (paragraphs [0031] and [0032]), and this teaching in Manickavasagam meets claim 2.
With respect to claim 3, modified Meisner is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the recitation of wherein the time interval between two pH adjustment operations is from one to five hours in claim 3, Meisner as modified by Manickavasagam teaches this limitation since Manickavasagam is relied upon for the teaching of the pH adjustments as addressed above in claim 1, and Manickavasagam teaches pH adjustments may be made after two to twelve hours (paragraphs [0031]-[0032]). As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to claim 7, modified Meisner is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the recitation of wherein each of the pH adjustment operations comprises an addition of an acid selected from inorganic acids in claim 7, Meisner as modified by Manickavasagam teaches this limitation since Manickavasagam is relied upon for the teaching of the pH adjustments as addressed above in claim 1, and Manickavasagam teaches acid, such as hydrochloric acid, is added during the pH adjustments (paragraphs [0031]-[0032]).
With respect to claim 8, modified Meisner is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the recitation of wherein the solid/liquid extraction step is carried out over a period of time of at least 5 days in claim 8, modified Meisner teaches this limitation since Meisner teaches extraction time is up to 30 hours and is preferably carried out two to eight times (paragraphs [0019] and [0023]). As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to claim 9, modified Meisner is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the recitation of wherein during the solid/liquid extraction step, the mineralized connective tissue/eluent mass ratio is comprised within a range from 1/5 to 1/40 w/w in claim 9, Meisner does not expressly disclose the ratio of raw material to extraction solution in the extraction step. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the ratio of extraction solution and raw material (bone) through routine experimentation during the extraction step in the method of modified Meisner with the expectation of successfully preparing a functional collagen containing product. One of ordinary skill in the art would have been motivated to do so because Meisner teaches properties of the collagen material produced by the method can be influenced by the extraction conditions (paragraph [0021]), and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[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 II).
With respect to claim 11, modified Meisner is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the recitation of wherein the solid/liquid extraction step is implemented under pseudo-static conditions or stirring conditions in claim 11, modified Meisner teaches this limitation since Meisner teaches extracting collagen from the animal raw material with an extraction solution and is silent with respect to agitation during the extraction (paragraphs [0007] and [0015]).
With respect to claim 13, modified Meisner is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the recitation of wherein, initially, the eluent has an NaCl concentration lower than 60 g/L in claim 13, it is noted that the claimed amount of NaCl in the eluent includes zero. Thus, modified Meisner teaches this limitation since the aqueous extraction solution of Meisner does not include NaCl (paragraph [0020]).
With respect to claim 16, modified Meisner is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the recitation of wherein each of said pH adjustment operations comprises an addition of an acid in the mineralized connective tissue/eluent mixture, to reduce the pH of said eluent until reaching a pH value lower than or equal to 4 in claim 16, Meisner as modified by Manickavasagam teaches this limitation since Manickavasagam is relied upon for the teaching of the adjustments to the pH of the extraction solution during extraction of the collagen from the animal material as addressed above in claim 1, and Manickavasagam teaches the pH is adjusted with the addition of acid at certain periods throughout the process to reduce the pH to around 3.5 (paragraphs [0031] and [0032]).
With respect to claim 17, modified Meisner is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the recitation of wherein each of said pH adjustment operations comprises an addition of an acid in the mineralized connective tissue/eluent mixture, to reduce the pH of said eluent until reaching a pH value ranging from 2 to 4 in claim 17, Meisner as modified by Manickavasagam teaches this limitation since Manickavasagam is relied upon for the teaching of the adjustments to the pH of the extraction solution during extraction of the collagen from the animal material as addressed above in claim 1, and Manickavasagam teaches the pH is adjusted with the addition of acid at certain periods throughout the process to reduce the pH to around 3.5 (paragraphs [0031] and [0032]).
With respect to claim 19, modified Meisner is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the recitation of wherein said mineralized connective tissues derived from mammals are selected from bones of cattle or pigs in claim 19, modified Meisner teaches this limitation since Meisner teaches the animal raw material (bone) used in the method are from cows and pigs (paragraphs [0005], [0007], [0015], and [0022]).
With respect to claim 20, modified Meisner is relied upon for the teaching of the method of claim 19 as addressed above.
Regarding the recitation of wherein said mineralized connective tissues derived from mammals are selected from adult cattle over 5 years old in claim 20, modified Meisner teaches this limitation since Meisner teaches the animal raw material used in the method may be from cows (paragraphs [0005], [0007], [0015], and [0022]), and Manickavasagam teaches collagen may be obtained from adult bovine materials which is interpreted to include materials from a cattle at least one year of age (paragraphs [0009] and [0024]).
With respect to claim 21, modified Meisner is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the recitation of wherein said mineralized connective tissue derived from mammals are selected from bones in claim 21, Meisner teaches animal raw material, such as bones, may be from mammals (paragraphs [0005], [0007], [0015], and [0022]).
With respect to claim 23, modified Meisner is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the recitation of further comprising a step of drying the compounds of interest in claim 23, modified Meisner teaches this limitation since Meisner teaches the produced collagen containing material may be dried (paragraph [0015]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Meisner et al. WO 2017198351 (hereinafter “Meisner”) (refer to the corresponding machine translation) in view of Manickavasagam US 20040167318 (hereinafter “Manickavasagam”) as applied to claim 1 above, and in further view of Young US 3532593 (hereinafter “Young”).
With respect to claim 5, modified Meisner is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the recitation of wherein during each pH adjustment operation, the pH of the eluent is measured, and, following each measurement, a suitable amount of acid is added so as to reduce the pH of the eluent to a predetermined target pH value in claim 5, Meisner as modified by Manickavasagam teaches a suitable amount of acid is added to reduce the pH of the extraction solution during the extraction step since Manickavasagam is relied upon for the teaching of the pH adjustments as addressed above in claim 1, and Manickavasagam also teaches adding amounts of acid at certain periods throughout the process to reduce the pH to around 3.5 (paragraphs [0031], and [0032]).
However, modified Meisner does not teach the pH of the extraction solution is measured during each pH adjustment.
Young teaches a method of purifying collagen. Animal material, such as bone, is treated with acid to lower the pH to about 4.5 or lower. In one example, the pH is checked through the process and adjusted with acid (C1, L68-69; C3, L2, L69-C3, L3; C3, L27-30; and C4, L24-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Young, to select the step of measuring the pH during the pH adjustments in the method of modified Meisner based in its suitability for its intended purpose with the expectation of successfully preparing a collagen containing product. One of ordinary skill in the art would have been motivated to do so because Meisner and Young similarly teach processes of obtaining collagen from animal material, Meisner teaches the pH of the extraction solution is preferably 3.5 to 5.5 and the properties of the collagen material produced can be influenced by the extraction conditions such as the pH value (paragraphs [0021]-[0022]), Young teaches the process purifies the collagen by removing the undesirable fat from the collagen containing materials (C1, L68-69; and C3, L23-27), and said modification would amount to the use of a known step for its intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success with said modification. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007).
Claims 12, 18, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Meisner et al. WO 2017198351 (hereinafter “Meisner”) (refer to the corresponding machine translation) in view of Manickavasagam US 20040167318 (hereinafter “Manickavasagam”) as applied to claim 1 above, and in further view of Kuster US 3580725 (hereinafter “Kuster”).
With respect to claim 12, modified Meisner is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the recitation of wherein the supply step comprises an operation of physico-chemical preparation of said at least one mineralized connective tissue, said preparation operation comprises a mechanical treatment operation ensuring a reduction of said at least one mineralized connective tissue into powder in claim 12, Meisner teaches the animal raw material is crushed to the desired particle size using a suitable grinding process (paragraphs [0005], [0015], and [0024]).
However, modified Meisner does not expressly disclose a mechanical treatment operation.
Kuster teaches the treatment of animal by-products, such as bone, and obtaining collagen from the by-products. The bone is comminuted in a pre-breaker to a particle size of about 2 inches or less (C1, L25-27 and 70-72; C3, L19-27, 34-35, and 66-71).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Kuster, to select the pre-breaker as the mechanical treatment operation in the method of modified Meisner with the expectation of successfully preparing a functional bone powder product. One of ordinary skill in the art would have been motivated to do so because Meisner and Kuster similarly teach obtaining collagen from comminuted animal raw material such as bone, Meisner teaches using a suitable grinding process to crush the animal raw material to the desired particle size (paragraphs [0005], [0015], and [0024]), Kuster teaches the bone particles are of uniform size for the process (C3, L34-35), and said modification would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success with said modification. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007).
With respect to claim 18, modified Meisner is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the recitation of wherein the solid/liquid extraction is implemented in a batch reactor in claim 18, modified Meisner does not expressly disclose this limitation.
Kuster teaches the treatment of animal by-products, such as bone, and obtaining collagen from the by-products. The animal by-product is placed in a chamber and treated with an aqueous acid solution to provide collagen (C1, L25-27; C3, L19-30, 36-38, and 66-69; and C5, L3-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Kuster, to select the chamber for the extraction step in the method of modified Meisner with the expectation of successfully preparing a functional collagen containing product. One of ordinary skill in the art would have been motivated to do so because Meisner and Kuster similarly teach obtaining collagen from animal raw material by contacting the material with an aqueous acidic solution (Meisner-paragraph [0020]), Meisner is not limited to any specific examples of a particular reactor used in the extracting step and teaches subjecting the animal raw material and extraction solution to extraction conditions (paragraphs [0015] and [0021]), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success in said modification. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007).
With respect to claim 22, modified Meisner is relied upon for the teaching of the method of claim 12 as addressed above.
Regarding the recitation of wherein the powder has a particle size ranging from 0.5 to 2 mm in claim 22, Meisner as modified by Kuster teaches limitation since Meisner teaches the animal raw material is crushed to the desired particle size using a suitable grinding process (paragraphs [0005], [0015], and [0024]). Additionally, Kuster is relied upon for the teaching of the mechanical treatment operation in claim 12 as addressed above, and Kuster also teaches the animal by-product is comminuted in a pre-breaker to a particle size of about 2 inches (about 50 mm) or less (C1, L25-27 and 70-72; C3, L19-27, 34-35, and 66-71). As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to Arguments
Applicant’s remarks filed January 30, 2026 are acknowledged
Due to the amendments to the claims, the claim objections and the 35 USC 112 rejection in the previous Office Action have been withdrawn (P6). However, the 35 USC 112 rejection and claim objections above are necessitated by the amendments to the claims.
Applicant’s arguments have been fully considered but they are unpersuasive.
Applicant argues Meisner fails to disclose, teach, or suggest several key limitations of amended claim 1 because Meisner teaches soft tissues (e.g., skin/subcutaneous tissue; pork rinds; split hide) and does not disclose using mineralized connective tissue such as bone as the starting material. Meisner teaches a temperature of 65⁰C as opposed to a low, physiological temperature (37⁰C + 5⁰C ). Meisner described repeated extractions (preferably “two to eight times”), which is contrary to the claimed “unique cycle” (P8-P10 and P13).
Examiner disagrees. While Meisner teaches preferably skin and subcutaneous tissues of mammals and preferably repeating the extraction step two to eight times (paragraphs [0019] and [0022]), Meisner is not limited to these preferred embodiments since the reference also teaches extracting raw animal material and the animal raw material, such as bones, may be from mammals (paragraphs [0005], [0007], [0015], and [0022]). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Additionally, although Meisner teaches a temperature of 65⁰C is used in the examples, Meisner is not limited to this disclosure since the reference also teaches properties of the collagen material produced by the method can be influenced by the extraction conditions such as the particular temperature (paragraph [0021]), and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Thus, one of ordinary skill in the art would have been motivated to optimize the temperature of extraction solution through routine experimentation during the extraction step in the method of Meisner with the expectation of successfully preparing a functional collagen containing product and arriving at the presently claimed invention. “[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 II).
Applicant argues Meisner does not disclose the iterative pH adjustment during a single extraction cycle. A skilled person would not have been motivated to combine Meisner and Manickavasagam. Manickavasagam fails to disclose, teach or suggest the limitations of amended claim 1. Manickavasagam does not teach or suggest using mineralized connective tissue from mammals as a starting material. Manickavasagam does not suggest selecting the specific physiological temperature of 37⁰C + 5⁰C nor abandoning Meisner’s high-temperature approach. There would be no reasonable expectation that a process optimized for abalone muscle at 4⁰C could be successfully adapted to extract collagen from hard, mineralized bone. Manickavasagam describes a single pH adjustment for an extraction step (e.g., adjusting a slurry to pH 3.5 and then stirring overnight), not successive pH adjustment operations separated by a time interval (P10-P11 and P13-P14).
Examiner disagrees. As previously addressed, modified Meisner teaches the claimed invention. 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, the motivation to combine the references is found within the references themselves as well as in the knowledge generally available to one of ordinary skill in the art.
Meisner does not expressly disclose iterative pH adjustment during a single extraction cycle. However, Manickavasagam is relied upon for this teaching. Although Manickavasagam teaches adjusting the slurry to pH 3.5 and then stirring overnight in the examples, Manickavasagam is not limited to the examples since Manickavasagam teaches adjustments to the pH of the extraction solution during extraction of the collagen from the animal material may be made by adding acid at certain periods throughout the process to reduce the pH to around 3.5 (Abstract; and paragraphs [0024], [0031], and [0032]). However, “Applicant must look to the whole reference for what it teaches. Applicant cannot merely rely on the examples and argue that the reference did not teach others.” In re Courtright, 377 F.2d 647, 153 USPQ 735,739 (CCPA 1967).
One of ordinary skill in the art would have been motivated to select the step of adjusting the pH during the extraction step in the method of Meisner with the expectation of successfully preparing a functional product because Meisner and Manickavasagam similarly teach processes of obtaining collagen from animal material, Manickavasagam teaches adjusting the pH to around 3.5 during the extraction to separate the extractable collagen from the animal material (paragraphs [0031] and [0032]), Meisner teaches the pH of the extraction solution is preferably 3.5 to 5.5 and the properties of the collagen material produced can be influenced by the extraction conditions such as the pH value (paragraphs [0021]-[0022]), and said modification would amount to the use of a known step for its intended use in a known environment to accomplish entirely expected result. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007).
Additionally, while Manickavasagam does not disclose all the features of the presently claimed invention, Manickavasagam is used as teaching reference, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981).
Applicant argues a skilled person starting from Meisner would not have been motivated to modify Meisner’s process to arrive at the claimed invention, even when considering the teachings of Kuster. Kuster fails to disclose, teach or suggest the limitations of amended claim 1. Kuster teaches away from low-temperature extraction of the invention. Kuster relies on gravity separation of solids (bone and collagen gravitating and being removed as a solid fraction), not chemical extraction into a liquid phase. Kuster describes a system with recycling/continuous or semi-continuous operation (including recycle loops), which is structurally and operationally distinct from the invention. Kuster teaches maintaining a pH range (e.g., pH 1-3) rather than performing successive pH adjustment operations as claimed (P11-P15).
Examiner disagrees. Modified Meisner teaches the claimed invention. 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, the motivation to combine the references is found within the references themselves as well as in the knowledge generally available to one of ordinary skill in the art.
As previously addressed, the secondary reference Kuster is relied upon for the teachings of dependent claims 12, 18, and 22. Although Kuster teaches different temperatures and process architecture, it appears these features are inappropriately incorporated into Meisner. Applicant is reminded as stated in MPEP 2145 III., “[t]he test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references.” In re Keller, 642 F.2d 413, 425 (CCPA 1981). See also In re Sneed 710 F.2d 1544, 1550 (Fed. Cir. 1983) (“[I]I is not necessarily that the inventions of the references be physically combinable to render obvious the invention under review.”); and In re Nievelt, 482 F.2d 965, 968 (CCPA 1973) (“Combining the teachings of references does not involve the ability to combine their specific structures.”).
Conclusion
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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/T.L.M/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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