DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
Applicant’s election of Group I, claim(s) 1-12 in the reply filed on May 21, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claim(s) 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. The requirement is still deemed proper and is therefore made FINAL.
Claim(s) 1-12 are examined on the merits.
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) 2-3, 5, 7 and 10-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim(s) 2-3 are indefinite because there is a lack of antecedent basis for the phrase “the intestinal mucosa”.
Claim 2 is indefinite because claim 2 does not reference a particular step. For the sake of examination purposes, claim 2 is interpreted to reference step (1) of claim 1.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 5 recites the broad recitation “comprises 25 to 50 weight percent of proteins and amino acids”, “30 to 60”, and the claim also recites “preferably 35 to 50 weight percent of water and/or 7.5 to 30 weight percent of inorganic salts” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. In addition, claim 5 is indefinite because the phrase “preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Moreover, “and/or” is considered indefinite because it is unclear if information after the “and/or” are required or optional. Thus, the metes and bounds of the claim are unclear.
In the present instance, claim 7 recites the broad recitation “12oC to 12oC”, “preferably from 10oC to 10oC” and the claim also recites “particularly preferably from 5oC to 5oC, to form the precipitate in step (3).” The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. In addition, claim 7 is indefinite because the phrases “preferably” and “particularly preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
In the present instance, claim 10 recite the broad recitation “less than 25 weight percent of inorganic salts”, “particularly preferably less than 20 weight percent of inorganic salts” and the claim also recites “very particularly preferably less than 17.5 weight percent of inorganic salts”. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. In addition, claim 10 is indefinite because the phrases “particularly preferably” and “very particularly preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
In the present instance, claim 11 recite the broad recitation “less than 25 weight percent of inorganic salts” and the claim also recites “particularly preferably less than 20 weight percent of inorganic salts”. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. In addition, claim 10 is indefinite because the phrase “particularly preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
In the present instance, claim 12 recites the broad recitation “reduced by at least 25%” and the claim also recites “preferably by at least 35% and most preferably by at least 40%, with respect to the proportion of inorganic salts”. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. In addition, claim 10 is indefinite because the phrase “preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In addition, “and/or” is considered indefinite because it is unclear if information after the “and/or” are required or optional. Thus, the metes and bounds of the claim are unclear.
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.
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) 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Vosburgh (WO 9412524 A1) in view of Ye (CN 105265754 A – English translation provided) and Zhang (CN 103349151 A – English translation provided).
Vosburgh teaches protein hydrolysate derived from animal tissue having [a] mucosal component (page 3). Vosburgh teaches [that] protein hydrolysate by definition consists of a mixture of amino acids and short chain peptides obtained by the hydrolysis of various animal and vegetable proteins (page 3). Vosburgh teaches [that] a preferred source of the mucosa raw material is government inspected pork intestines… prior to digestion, the raw material may initially be subjected to ultrafiltration to reduce the water and salt content of the tissue. Vosburgh teaches that typical raw materials envisioned for use in the process are livestock by-products, including gastrointestinal, tracheal or bronchial tissues, or other offal or non-offal tissues (page 9). Vosburgh teaches [that] the extracted constituents and extracting salts are separated from the tissues in a conventional manner, such as by centrifuge or filtration (page 10). Vosburgh teaches [that] the mucosa and the digest solution also generally contain an additional salt component [such as] sodium bisulfite ([i.e. an inorganic salt]) (page 4). Vosburgh teaches [that] the raw material may be extracted [is] an extracting salt, such as guanidine hydrochloride, is added. The extracted constituents and extracting salts are separated from the tissues in a conventional manner, such as by centrifuge or filtration (page 10). Vosburgh teaches [that] the protein hydrolysate, thus isolated, is void of these impurities ([which also includes heparin as an impurity]) (page 8). Vosburgh teaches [that] alternatively, other conventional separation techniques such as filtration or precipitation may be utilized to separate the "impurities" from the digest solution containing the protein hydrolysate (page 11).
Vosburgh does not explicitly teach a method that comprises the steps provided within that of claim 1 of the present invention. Vosburgh does not teach that a microfiltration unit or a chamber filter press is used for filtering the composition (also stated within claim 4 of the present invention). Vosburgh does not teach that the composition provided in step (1) comprises 25 to 50 weight percent of proteins and amino acids, 30 to 60, preferably 35 to 50 weight percent of water and/or 7.5 to 30 weight percent of inorganic salts (as stated within claim 5 of the present invention). Vosburgh does not teach a filter having a pore size greater than 2 µm is used to filter the composition in step (2) (as stated within claim 6 of the present invention). Vosburgh does not teach that the filtrate obtained in step (2) is cooled to a temperature in the range of from 12.5oC to 12oC, preferably from 10oC to 10oC and particularly preferably from 5oC to 5oC, to form the precipitate in step (3) (as stated within claim 7 of the present invention). Vosburgh does not teach at least 50 weight percent of the precipitate obtained in step (4) consists of inorganic salts of the elements sodium and sulphur and also chlorine (as stated within claim 8 of the present invention). Vosburgh does not teach that the separation of the precipitate formed in step (3) is carried out by centrifugation in step (4) (as stated within claim 9 of the present invention). Vosburgh does not teach that the liquid phase obtained in step (4) contains less than 25 weight percent of inorganic salts, particularly preferably less than 20 weight percent of inorganic salts, very particularly preferably less than 17.5 weight percent of inorganic salts, based on the dry mass (as stated within claim 10 of the present invention). Vosburgh does not teach that the filter cake obtained in step (2) contains less than 25 weight percent of inorganic salts, particularly preferably less than 20 weight percent of inorganic salts, based on the dry mass (as stated within claim 11 of the present invention). Vosburgh does not teach that the proportion of inorganic salts in the dry mass of the liquid phase obtained in step (4) and/or in the dry mass of the filter cake obtained in step (2) is reduced by atleast 25%, preferably by at least 35% and most preferably by at least 40%, with respect to the proportion of inorganic salts in the dry mass of the composition used (as stated within claim 12 of the present invention).
Ye teaches a method for extracting protein and amino acid from pig small intestine mucosa enzymolysis waste liquid (abstract). Ye teaches [a number of steps within the method such as] filtering and concentrating the clear solution and filtrate through micro-filtration membrane concentrating, then through nano-filtration membrane concentrating and filtering the concentrated solution, spraying and drying to obtain the small peptide protein feed (page 2).
Zhang teaches a method of polypeptide albumen powder [being] extracted from porcine small intestine submucosa (abstract). Zhang teaches [the method of extraction which includes] filtering, cooling the filtrate to 55 degrees centigrade (55oC) (page 1).
The method as taught by Vosburgh for obtaining a protein hydrolysate from the intestinal mucosa from a slaughtered animal that consists of amino acids, inorganic salts, water and proteins (intrinsically) can be modified to further include the method teachings from Ye and Zhang. With the combination of all of the aforementioned references, Vosburgh’s method would produce the same or very similar limitations as the claims of the present invention. The combined aforementioned references could be structured to discuss Vosburgh’s method of obtaining a protein hydrolysate by: beginning with a source of mucosa raw material that would be subjected to a digestion that would contain amino acids, inorganic salts (i.e. sodium bisulfite) and intrinsically contain proteins and some water (as a result of the water and salt content of the tissue and the need to remove salt) as taught by Vosburgh with additional knowledge that the components such as amino acids and proteins come as a result of being isolated from heparin during extraction. In addition, more information can be added to include that the raw material from intestinal mucosa can be extracted using a salt such as guanidine hydrochloride also taught by Vosburgh. Within Vosburgh’s method, Vosburgh’s method can include that it would be obvious to use Ye’s method of filtering the solution of the extracted material using a micro-filtration membrane as taught by Ye which is known to a person of ordinary skill in the art and in chemistry to intrinsically produce a filtrate and a filter cake because there is a solution passing through a type of medium that would result in leaving the “filter cake” on the medium and the leftover would be the “filtrate” (or solution). In addition, one would reasonably expect that if a micro-filtration unit is used for filtration, it would intrinsically possess a pore size greater than 2 µm. Ye’s method of obtaining the filtrate and filter cake would be followed by Zhang’s method which would also include filtration and following cooling of the filtrate. One of ordinary skill in the art and in chemistry would reasonably expect to cool down Vosburgh’s filtrate and allowing that filtrate to precipitate and subjecting that precipitate to centrifugation (outside of only using filtration or centrifugation for separating the extracted constituents which is taught in Vosburgh) in order to further separate out “impurities” from the solution that contains the protein hydrolysate as taught by Vosburgh in which, the solution would be present in the form of a liquid phase and also in the form of a pellet that may both naturally contain a lower salt content that can intrinsically contain inorganic salts that would include but are not limited to elements sodium, sulfur and chlorine. Thus, one would reasonably expect to use the combination of all of the aforementioned reference to produce a composition the same or similar to the claims of the present invention that includes a protein hydrolysate (or peptone) in the form of a composition that is isolated from intestinal mucosa of animals that contains a variety of compounds, minerals, salts and proteins.
Regarding claim(s) 1, 5, 7, 8, 10, 11 and 12, the combined aforementioned references does not explicitly teach the mass of proteins and amino acids in the dry mass of said composition is 30 to 70 weight percent and the mass of inorganic salts in the dry mass of said composition is at least 7.5 weight percent [and that] cooling the filtrate to a temperature in the range of -15oC to 15oC to form a precipitate (as stated within claim 1 of the present invention), does not teach weight percent of proteins and amino acids, water and/or inorganic salts (as stated within claim 5 of the present invention), does not teach the filtrate cooling temperatures (as stated within claim 7 of the present invention), does not teach the weight percent of the inorganic salts of the elements sodium, sulfur and chlorine and the general weight percent of inorganic salts based on dry mass (as stated within claim(s) 8 and 10-11 of the present invention, respectively) and does not explicitly teach the proportion of inorganic salts in the dry mass of the liquid phase and/or in the dry mass of the filter cake (as stated within claim 12 of the present invention) in the ranges provided by the applicant in the claims of the present invention. However, as discussed in MPEP section 2144.05(II)(A), “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. ‘[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).” The references teach the use of each of the ingredients in a composition. Varying the concentration of ingredients within a composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention. Thus, one of ordinary skill in the art and in chemistry would reasonably expect to optimize temperatures when obtaining a filtrate (liquid) and a filter cake when conducting a filtration using a solution that consists of extracted raw material from the intestinal mucosa from an animal that was set to be slaughtered. In addition, one of ordinary skill would reasonably expect to optimize the components (in the form of percentages) desired within a dry mass and a liquid solution such as amino acids, protein, inorganic salts and water content in order to achieve the ideal product for use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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