DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-30 as originally filed on 11/05/2024 are currently pending and under consideration on the merits.
Information Disclosure Statement
No information disclosure statement has been filed in the instant application. Applicant is reminded of the duty to disclose information material to patentability as set forth in 37 C.F.R 1.56 and M.P.E.P. § 2001-2002.
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 9, 16-22, 24-28, and 30 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.
The term “about” in claims 15, 24, and 25 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree (such as but not limited to a controlling definition), and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Correction is required.
Claim 9 recites “vegetable yeast extract”, which blurs the metes and bounds of the claims because “vegetable extract” and “yeast extract” have different and mutually exclusive plain meanings in this art as
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, claims 16 and 25 recite the broad recitation of a “plant protein” and “plant protein hydrolysate” respectively, and the claims also recites “soy meal” 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. It is particularly unclear if claims 16 and 25 intended to recite the combination of soy meal with an additional plant protein or plant protein hydrolysate or not. Clarification and/or correction is required.
In so much that claims 17-22, 24-28, and 30 depend from either claim 16 or claim 25 and do not resolve the point of confusion, these claims must be rejected with claims 16 and 25 as indefinite.
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.
Claims 1, 4-12, 14-16, 19-22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Price et al. (US 6,103,529; Reference A) in view of Grillberger et al. (US 2006/0094104; Reference B) and as evidenced by Kwon et al. (Enzyme and Microbial Technology (2000), 26, 209-215; Reference U).
This rejection addresses the embodiment of yeast extract for claim 9.
Kwon teaches that HY-SOY is a commercially available product that is an enzymatically hydrolysate of soybean meals (p213, 1st paragraph under subheading 3.5). Therefore, any teaching in the prior art towards HY-SOY as evidenced by Kwon will read on the soy meal of claims 1 and 15.
Price teaches an aqueous basal nutrient/culture composition devoid of animal-derived proteins comprising at least two amino acids (inclusive of L-cysteine), thiamine, magnesium salt (as MgCl2 and MgSO4), calcium salt (as CaCl2), ferric salt (as ferric citrate), NaCl, D-glucose, sodium pyruvate, and one nutritive extract selected from yeast extract, soy hydrolysates (HY-SOY, as evidenced by Kwon), and rice hydrolysates, and wherein the composition is free of animal-derived products (Abstract, and Examples 1 and 2), reading in-part on claims 1 and 16, and reading on claims 4-11, and 19-21. Price teaches that yeast extract, rice hydrolysates, and enzymatic soy meal hydrolysates are equivalents, in so much that they all have similar effects on average mammalian cell count (e.g. VERO cells) and relative growth efficiency (e.g. RGE) (Examples and 4), reading on claims 1, 12, 16, and 22. Price teaches embodiments wherein the culture medium is formulated in dry form (Col. 11, lines 36-48), reading on the dry powder embodiment of claim 14. Price at Example 1 teaches a basal nutrient/culture composition devoid of animal-derived proteins comprising 20 liters of water and:
Defined quantities of amino acids comprising L-alanine (0.22 g, equating to 0.01 g/L), L-arginine HCl, L-asparagine HCl, L-aspartic acid, L-cysteine-HCl·H2O (0.610 g; equating to 0.030 g/L), glycine, L-glutamnic (sic) acid (likely a typo for L-glutamic acid), L-histidine HCl * H2O, L-isoleucine, L-leucine, L-lysine HCl, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine-disodium salt, and L-valine,
thiamine HCl (0.0062 g, equating to 0.00061 g/L),
MgSO4 (2.45 g; equating to 0.1225 g/L),
ferric citrate chelate (0.015 g; equating to 0.00075 g/L and 0.000075 g per 100 ml and thus 0.000075% w/v),
NaH2PO4 (7.494 g; equating to 0.375 g/L),
NaCl,
CaCl2 (3.00 g; equating to 0.15 g/L),
MgCl2 (3.125 g; equating to 0.156 g/L),
D-glucose (97.56 g; equating to 4.88 g/L), and
sodium pyruvate (3.75 g; equating to 0.188 g/L and 0.018 g per 100 ml and thus 0.018% w/v),
200 mg/L of either yeast extract, soy hydrolysates (HY-SOY®), and rice hydrolysates (Abstract, and Examples 1 and 2; equating to 0.2 g per L or 0.02 g per 100 ml and so 0.02% w/v).
The concentrations of Price as set forth above reads on the magnesium salt, calcium salt, saccharide (e.g. glucose), at least two amino acids, and pyruvate concentrations of claims 15 and 24 and reads in-part on the soy meal, yeast extract, and ferric salt concentrations of claim 15. Price teaches the composition would be useful for culturing animal cells such as VERO cells (Example 6), reading in-part on the soy meal concentrations of claims 10 and 23.
Price teaches preferred yeast extract concentrations of 10-8000 mg/L (Col. 11, lines 17-35; equating to 0.01-8 g/L), reading on the yeast extract concentration of claims 15 and 24. Price teaches preferred plant hydrolysate concentrations of 10-1000 mg/L (Col. 11, lines 17-35; equating to 0.01-1 g/L and 0.001-0.1 g per 100 ml and so 0.001-0.1% w/v), reading in-part on the plant protein hydrolysate concentration of claim 24. Price teaches preferred ferric citrate concentrations of 0.01-2 mg/L (Table 1 in Col. 10; equating to 0.00001-0.002 g/L and 0.000001-0.0002 g per 100 ml and so 0.000001-0.0002% w/v), reading on the ferric citrate concentrations of claims 15.
Regarding claim 1 and 16, Price does not teach the enzymatic soy meal hydrolysates and yeast extract in a single embodiment. Regarding claims 12, 15, 16, and 22, Price does not teach the rice hydrolysates, enzymatic soy meal hydrolysates and yeast extract in a single embodiment. However, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). See M.P.E.P. § 2144.06. In this case, Price teaches that yeast extract, rice hydrolysates, and enzymatic soy meal hydrolysates are equivalents, in so much that they all have similar effects on average mammalian cell count (e.g. VERO cells) and relative growth efficiency (e.g. RGE), and so the combination of enzymatic soy meal hydrolysates and yeast extract for claim 1 and the combination of enzymatic soy meal hydrolysates, yeast extract, and rice hydrolysates must be held as prima facie obvious absent any showing of non-obviousness to the contrary.
Regarding claim 1 and 16, Price does not teach growing or propagating Streptococcus sp. microorganisms. Regarding claims 15 and 24, Price does not teach the claimed soy meal concentrations. Regarding claims 24, Price does not teach the claimed plant protein hydrolysate concentrations.
Grillberger teaches methods of cell culture with compositions comprising animal protein-free media comprising plant and/or yeast-derived hydrolysates (Abstract). Grillberger teaches that culture media compositions comprising animal protein-free media comprising plant and/or yeast-derived hydrolysates would be useful in methods of culturing mammalian cells, insect cells, avian cells, bacterial cells, and yeast cells (¶0047). Grillberger teaches that preferred plant-derived protein hydrolysates, preferably obtained from soy, in animal protein-free cell culture medium would be about 0.05-5% w/v (¶0032 and ¶0039), reading on the soy meal concentrations of claims 15 and 24, and the plant protein concentrations of claim 24.
Regarding claim 1 and 16, It would have been obvious to a person of ordinary skill in the art before the invention was filed to further culture bacteria with Price’s media composition in view of Grillberger. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both the composition of Price and Grillberger are directed towards basic and essential nutrients and comprise animal protein-free media, and because Grillberger teaches that said composition would be useful to culture bacteria. The skilled artisan would have been motivated to do so because Grillberger teaches that animal protein-free media compositions would be useful to culture bacteria, thus predictably improving the utility of Price’s media composition.
Regarding the soy meal concentrations of claims 15 and 24 and the protein hydrolysate concentrations of claim 24, it would have been obvious before the invention was filed to further substitute the soy meal concentrations of Grillberger for the soy meal concentrations and rice hydrolysate of Price in Price’s culture media composition. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because both Price and Grillberger are directed in-part towards animal protein-free media comprising plant derived hydrolysates The skilled artisan would have been motivated to do so because Grillberger teaches that 0.05-5% w/v is a preferable concentration for both soy meal hydrolysates and plant protein hydrolysates, and so the substitution would predictably yield 0.05-5% w/v concentration for soy meal hydrolysates (for claim 10) and the combination of soy meal hydrolysates and plant protein hydrolysates (for claim 23) in Price’s media composition. See M.P.E.P. § 2143(I)B).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the invention was filed.
Claims 2, 3, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Price and Grillberger as evidenced by Kwon as applied to claims 1 and 16 above, and further in view of in view Bailey et al. (US 5,314,822; Reference C).
This rejection addresses the embodiment of Streptococcus pneumoniae for claims 2 and 17.
The teachings of Price and Grillberger as evidenced by Kwon are relied upon as set forth above. Grillberger as cited above towards bacterial culture methods reads in-part on claims 2, 3, 17, and 18.
Regarding claims 2, 3, 17, and 18, Price and Grillberger do not teach Streptococcus pneumoniae.
Bailey teaches methods of culturing S. pneumoniae in culture medium containing no complex animal components (Abstract), reading on claims 2, 3, 17, and 18. Bailey teaches a culture medium comprising soy peptone (HY-SOY) as a substitute for animal-derived peptone and trypticase (Example 1), reading on claims 2, 3, 17, and 18. Bailey teaches obtaining an S. pneumoniae inoculum, and contacting said S. pneumoniae inoculum with a culture medium comprising soy peptone (HY-SOY), L-cysteine, and yeast extract and optionally further comprising calcium, magnesium, and sodium salts (Col. 2, line 48 through Col .3, line 15), reading on claims 2, 3, 17, and 18. Bailey teaches that S. pneumoniae advantageously produces pneumococcal capsular polysaccharide with can then be harvested and used to prepare vaccines and that elimination of animal components is advantageous to reduce the dangers of contamination with reactive blood group substances or adventitious agents in final vaccine products (Col. 1, line 62 through Col. 2, line 16), reading on claims 2, 3, 17, and 18.
Regarding claims 2, 3, 17, and 18, it would have been obvious before the invention was filed to substitute the bacterial cells of Grillberger with the S. pneumoniae of Bailey in Price’s culture methods. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because Grillberger teaches that culture media compositions comprising animal protein-free media comprising plant and/or yeast-derived hydrolysates would be useful in methods of culturing mammalian cells, insect cells, avian cells, bacterial cells, and yeast cells, and because both Price and Bailey recite highly similar culture compositions (e.g. coextensive to yeast extract, soy peptones/hydrolysates, L-cysteine, and various salts). The skilled artisan would have been motivated to do so because Bailey teaches that S. pneumoniae advantageously produces pneumococcal capsular polysaccharide with can then be harvested and used to prepare vaccines and that elimination of animal components is advantageous to reduce the dangers of contamination with reactive blood group substances or adventitious agents in final vaccine products, and so the substitution would be advantageous for the reasons given by Bailey to then cultivate the S. pneumoniae of Bailey in the animal protein-free media comprising plant and/or yeast-derived hydrolysates of Price.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the invention was filed.
Claims 13 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Price and Grillberger as evidenced by Kwon as applied to claims 1, 12, 16, and 22 above, and further in view of in view Guerry et al. (WO 2017/079456; Reference N).
The teachings of Price and Grillberger as evidenced by Kwon are relied upon as set forth above.
Regarding claims 13,and 23, Price and Grillberger do not teach Streptococcus pneumoniae.
Guerry teaches methods of making immunogenic synthetic constructs capable of inducing an immune response against C. jejuni (Abstract). Guerry teaches methods of producing a capsule polysaccharide vaccine against C. jejuni, the method comprising culturing C. jejuni in a culture medium comprising atholate as a tryptone substitute (¶00274), reading on claims 13 and 23
Regarding claims 13 and 23, it would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the rice hydrolysate of Price with the atholate of Guerry in Price’s culture composition and methods in view of Grillberger. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because both Price and Guerry are directed in-part towards animal protein-free media comprising plant hydrolysates The skilled artisan would have been motivated to do so because the substitution of one known plant protein hydrolysates for another would predictably yield a culture media comprising a plant protein hydrolysate. The rice hydrolysate of Price and the atholate of Guerry both explicitly taught as being useful for THE SAME PURPOSE as a plant protein hydrolysate additive to culture media compositions. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 25-28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Price et al. (US 6,103,529; Reference A) in view of Grillberger et al. (US 2006/0094104; Reference B) and Bailey et al. (US 5,314,822; Reference C) and as evidenced by Kwon et al. (Enzyme and Microbial Technology (2000), 26, 209-215; Reference U).
This rejection addresses the embodiment of yeast extract for claim 9.
Kwon teaches that HY-SOY is a commercially available product that is an enzymatically hydrolysate of soybean meals (p213, 1st paragraph under subheading 3.5). Therefore, any teaching in the prior art towards HY-SOY as evidenced by Kwon will read on the soy meal of claim n25.
Price teaches an aqueous basal nutrient/culture composition devoid of animal-derived proteins comprising at least two amino acids (inclusive of L-cysteine), thiamine, magnesium salt (as MgCl2 and MgSO4), calcium salt (as CaCl2), ferric salt (as ferric citrate), NaCl, D-glucose, sodium pyruvate, and one nutritive extract selected from yeast extract, soy hydrolysates (HY-SOY, as evidenced by Kwon), and rice hydrolysates, and wherein the composition is free of animal-derived products (Abstract, and Examples 1 and 2), reading in-part on claims 25-28 and 30. Price teaches that yeast extract, rice hydrolysates, and enzymatic soy meal hydrolysates are equivalents, in so much that they all have similar effects on average mammalian cell count (e.g. VERO cells) and relative growth efficiency (e.g. RGE) (Examples and 4), reading on claims 25 and 27. Price teaches embodiments wherein the culture medium is formulated in dry form (Col. 11, lines 36-48), reading on the dry powder embodiment of claim 14. Price at Example 1 teaches a basal nutrient/culture composition devoid of animal-derived proteins comprising 20 liters of water and:
Defined quantities of amino acids comprising L-alanine (0.22 g, equating to 0.01 g/L), L-arginine HCl, L-asparagine HCl, L-aspartic acid, L-cysteine-HCl·H2O (0.610 g; equating to 0.030 g/L), glycine, L-glutamnic (sic) acid (likely a typo for L-glutamic acid), L-histidine HCl * H2O, L-isoleucine, L-leucine, L-lysine HCl, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine-disodium salt, and L-valine,
MgSO4 (2.45 g; equating to 0.1225 g/L),
ferric citrate chelate (0.015 g; equating to 0.00075 g/L and 0.000075 g per 100 ml and thus 0.000075% w/v),
NaH2PO4 (7.494 g; equating to 0.375 g/L),
NaCl,
CaCl2 (3.00 g; equating to 0.15 g/L),
MgCl2 (3.125 g; equating to 0.156 g/L),
D-glucose (97.56 g; equating to 4.88 g/L), and
sodium pyruvate (3.75 g; equating to 0.188 g/L and 0.018 g per 100 ml and thus 0.018% w/v),
200 mg/L of either yeast extract, soy hydrolysates (HY-SOY®), and rice hydrolysates (Abstract, and Examples 1 and 2; equating to 0.2 g per L or 0.02 g per 100 ml and so 0.02% w/v).
The concentrations of Price as set forth above reads on salt, at least two amino acids, and pyruvate concentrations of claim 25 and reads in-part on the soy meal and yeast extract of claim 25. Price teaches the composition would be useful for culturing animal cells such as VERO cells (Example 6), reading in-part on the soy meal concentrations of claim 25.Price teaches preferred yeast extract concentrations of 10-8000 mg/L (Col. 11, lines 17-35; equating to 0.01-8 g/L), reading on the yeast extract concentration of claim 25.
Regarding claim 25, Price does not teach the rice hydrolysates, enzymatic soy meal hydrolysates and yeast extract in a single embodiment. However, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). See M.P.E.P. § 2144.06. In this case, Price teaches that yeast extract, rice hydrolysates, and enzymatic soy meal hydrolysates are equivalents, in so much that they all have similar effects on average mammalian cell count (e.g. VERO cells) and relative growth efficiency (e.g. RGE), and so the combination of enzymatic soy meal hydrolysates and yeast extract for claim 1 and the combination of enzymatic soy meal hydrolysates, yeast extract, and rice hydrolysates must be held as prima facie obvious absent any showing of non-obviousness to the contrary.
Regarding claim 25, Price does not teach growing or propagating Streptococcus sp. microorganisms. Regarding claim 25, Price does not teach the claimed soy meal concentrations. Regarding claims 25, Price does not teach the claimed plant protein hydrolysate concentrations.
Grillberger teaches methods of cell culture with compositions comprising animal protein-free media comprising plant and/or yeast-derived hydrolysates (Abstract). Grillberger teaches that culture media compositions comprising animal protein-free media comprising plant and/or yeast-derived hydrolysates would be useful in methods of culturing mammalian cells, insect cells, avian cells, bacterial cells, and yeast cells (¶0047). Grillberger teaches that preferred plant-derived protein hydrolysates, preferably obtained from soy, in animal protein-free cell culture medium would be about 0.05-5% w/v (¶0032 and ¶0039), reading on the soy meal and plant protein hydrolysate concentrations of claim 25.
Bailey teaches methods of culturing S. pneumoniae in culture medium containing no complex animal components (Abstract), reading on claim 25. Bailey teaches a culture medium comprising soy peptone (HY-SOY) as a substitute for animal-derived peptone and trypticase (Example 1), reading on claim 25. Bailey teaches obtaining an S. pneumoniae inoculum, and contacting said S. pneumoniae inoculum with a culture medium comprising soy peptone (HY-SOY), L-cysteine, and yeast extract and optionally further comprising calcium, magnesium, and sodium salts (Col. 2, line 48 through Col .3, line 15), reading on claim 25. Bailey teaches that S. pneumoniae advantageously produces pneumococcal capsular polysaccharide with can then be harvested and used to prepare vaccines and that elimination of animal components is advantageous to reduce the dangers of contamination with reactive blood group substances or adventitious agents in final vaccine products (Col. 1, line 62 through Col. 2, line 16), reading on claim 25.
Regarding claim 25, it would have been obvious before the invention was filed to substitute the bacterial cells of Grillberger with the S. pneumoniae of Bailey in Price’s culture methods. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because Grillberger teaches that culture media compositions comprising animal protein-free media comprising plant and/or yeast-derived hydrolysates would be useful in methods of culturing mammalian cells, insect cells, avian cells, bacterial cells, and yeast cells, and because both Price and Bailey recite highly similar culture compositions (e.g. coextensive to yeast extract, soy peptones/hydrolysates, L-cysteine, and various salts). The skilled artisan would have been motivated to do so because Bailey teaches that S. pneumoniae advantageously produces pneumococcal capsular polysaccharide with can then be harvested and used to prepare vaccines and that elimination of animal components is advantageous to reduce the dangers of contamination with reactive blood group substances or adventitious agents in final vaccine products, and so the substitution would be advantageous for the reasons given by Bailey to then cultivate the S. pneumoniae of Bailey in the animal protein-free media comprising plant and/or yeast-derived hydrolysates of Price.
Regarding the soy meal and plant protein hydrolysate concentrations of claim 25, it would have been obvious before the invention was filed to further substitute the soy meal concentrations of Grillberger for the soy meal concentrations and rice hydrolysate of Price in Price’s culture media composition. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because both Price and Grillberger are directed in-part towards animal protein-free media comprising plant derived hydrolysates The skilled artisan would have been motivated to do so because Grillberger teaches that 0.05-5% w/v is a preferable concentration for both soy meal hydrolysates and plant protein hydrolysates, and so the substitution would predictably yield 0.05-5% w/v concentration for soy meal hydrolysates (for claim 10) and the combination of soy meal hydrolysates and plant protein hydrolysates (for claim 23) in Price’s media composition. See M.P.E.P. § 2143(I)B).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the invention was filed.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Price, Grillberger, and Bailey as evidenced by Kwon as applied to claim 25 above, and further in view of in view Guerry et al. (WO 2017/079456; Reference N).
The teachings of Price, Grillberger, and Bailey as evidenced by Kwon are relied upon as set forth above.
Regarding claim 25, Price, Grillberger, and Bailey do not teach atholate as a species of plant protein hydrolysate.
Guerry teaches methods of making immunogenic synthetic constructs capable of inducing an immune response against C. jejuni (Abstract). Guerry teaches methods of producing a capsule polysaccharide vaccine against C. jejuni, the method comprising culturing C. jejuni in a culture medium comprising atholate as a tryptone substitute (¶00274), reading on claims 13 and 23
Regarding claim 25, it would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the rice hydrolysate of Price with the atholate of Guerry in Price’s culture composition and methods in view of Grillberger and Bailey. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because both Price and Guerry are directed in-part towards animal protein-free media comprising plant hydrolysates The skilled artisan would have been motivated to do so because the substitution of one known plant protein hydrolysates for another would predictably yield a culture media comprising a plant protein hydrolysate. The rice hydrolysate of Price and the atholate of Guerry both explicitly taught as being useful for THE SAME PURPOSE as a plant protein hydrolysate additive to culture media compositions. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Conclusion
No claims are allowed. No claims are free of the art.
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 extension fee 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 date of this final action.
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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