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 claim sets filed on December 20, 2023 and May 2, 2024 are acknowledged. Claims 26-28, 30-36, 38, 39, 41-43, 45-47, 49, and 50 are pending in the application. Claims 1-25, 29, 37, 40, 44, and 48 have been cancelled.
Claim Objections
Claims 26 and 42 are objected to because of the following informalities:
In claim 26 at line 3, it is suggested to insert “interleukin 1 beta” before “IL-1β”.
In claim 26 at line 3, it is recommended to place parenthesis “( )” around “IL-1β”.
In claim 26 at line 3, it is suggested to insert “interleukin 8” before “IL-8”.
In claim 26 at line 3, it is recommended to place parenthesis “( )” around “IL-8”.
In claim 26 at line 3, it is suggested to insert “tumor necrosis factor-receptor 2” before “TNFR2”.
In claim 26 at line 3, it is recommended to place parenthesis “( )” around “TNFR2”.
In claim 42 at line 2, it is suggested to insert “interleukin 1 beta” before “IL-1β”.
In claim 42 at line 2, it is recommended to place parenthesis “( )” around “IL-1β”.
In claim 42 at lines 2-3, it is suggested to insert “interleukin 8” before “IL-8”.
In claim 42 at lines 2-3, it is recommended to place parenthesis “( )” around “IL-8”.
In claim 42 at line 3, it is suggested to insert “tumor necrosis factor-receptor 2” before “TNFR2”.
In claim 42 at line 3, it is recommended to place parenthesis “( )” around “TNFR2”.
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 26-28, 30-36, 38, 39, 41-43, 45-47, 49, and 50 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 26 recites “the risk” at line 1. This recitation lacks antecedent basis as a risk has not previously been mentioned in the claim. Therefore, the scope of claim 26 is indefinite.
For the purpose of the examination, the recitation of “the risk” at line 1 of claim 26 (emphasis added) is interpreted as “a risk” (emphasis added).
Claim 26 also recites “the step” at lines 3-4. This recitation lacks antecedent basis as a step has not previously been mentioned in the claim. Therefore, the scope of the claim is indefinite.
For the purpose of the examination, the recitation of “comprising the step of administering” at lines 3-4 of claim 26 (emphasis added) is interpreted as “comprising administering”.
Claim 27 recites “compared to the absence of extensively hydrolysed casein” at lines 3-4, and this claim depends upon claim 26. It is unclear what is intended by this recitation. More specifically, it is unclear what the comparison encompasses and what the extensively hydrolysed casein is absent from. Therefore, the metes and bounds of claim 27 cannot be ascertained.
For the purpose of the examination, the recitation of “compared to the absence of extensively hydrolysed casein” at lines 3-4 of claim 27 (emphasis added) is interpreted as “compared to the intestinal epithelium of a preterm infant that has not been administered the extensively hydrolysed casein” (emphasis added).
Claims 28, 30, and 31 are not specifically discussed but are rejected due to their dependence on claim 26.
Claim 32 recites “compared to the absence of extensively hydrolysed casein” at line 3, and this claim depends upon claims 31 and 26. It is unclear what is intended by this recitation. More specifically, it is unclear what the comparison encompasses and what the extensively hydrolysed casein is absent from. Therefore, the metes and bounds of claim 32 cannot be ascertained.
For the purpose of the examination, the recitation of “compared to the absence of extensively hydrolysed casein” at line 3 of claim 32 (emphasis added) is interpreted as “compared to the gut barrier integrity and/or intestinal cell viability of a preterm infant that has not been administered the extensively hydrolysed casein” (emphasis added).
Claim 33 is not specifically discussed but is rejected due to its dependence on claim 26.
Claim 34 recites “compared to the absence of extensively hydrolysed casein” at lines 2-3, and this claim depends upon claims 33 and 26. It is unclear what is intended by this recitation. More specifically, it is unclear what the comparison encompasses and what the extensively hydrolysed casein is absent from. Therefore, the metes and bounds of claim 34 cannot be ascertained.
For the purpose of the examination, the recitation of “compared to the absence of extensively hydrolysed casein” at lines 2-3 of claim 34 (emphasis added) is interpreted as “compared to the gut barrier permeability of a preterm infant that has not been administered the extensively hydrolysed casein” (emphasis added).
Claim 35 is not specifically discussed but is rejected due to its dependence on claim 26.
Claim 36 recites “compared to the absence of extensively hydrolysed casein” at lines 2-3, and this claim depends upon claims 35 and 26. It is unclear what is intended by this recitation. More specifically, it is unclear what the comparison encompasses and what the extensively hydrolysed casein is absent from. Therefore, the metes and bounds of claim 36 cannot be ascertained.
For the purpose of the examination, the recitation of “compared to the absence of extensively hydrolysed casein” at lines 2-3 of claim 36 (emphasis added) is interpreted as “compared to the intestinal cell viability of a preterm infant that has not been administered the extensively hydrolysed casein” (emphasis added).
Claim 38 recites “compared to the absence of extensively hydrolysed casein” at line 4, and this claim depends upon claim 26. It is unclear what is intended by this recitation. More specifically, it is unclear what the comparison encompasses and what the extensively hydrolysed casein is absent from. Therefore, the metes and bounds of claim 38 cannot be ascertained.
For the purpose of the examination, the recitation of “compared to the absence of extensively hydrolysed casein” at line 4 of claim 38 (emphasis added) is interpreted as “compared to the intestinal epithelium of a preterm infant that has not been administered the extensively hydrolysed casein” (emphasis added).
Claims 39 and 41 are not specifically discussed but are rejected due to their dependence on claim 26.
Independent claim 42 recites “the risk” at line 1. This recitation lacks antecedent basis as a risk has not previously been mentioned in the claim. Therefore, the scope of claim 42 is indefinite.
For the purpose of the examination, the recitation of “the risk” at line 1 of claim 42 (emphasis added) is interpreted as “a risk” (emphasis added).
Claims 43, 45-47, and 49-50 are not specifically discussed but are rejected due to their dependence on claim 42.
Claim Rejections - 35 USC § 102
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.
Claims 26-28, 30-36, 38, 39, 41-43, 45, 46, 49, and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hondmann et al. WO 2014150558 (hereinafter “Hondmann”).
With respect to claim 26, Hondmann relates to a method of reducing intestinal inflammatory response, reducing intestinal tissue damage, modulating intestinal epithelial response, and reducing the expression of IL-8, IL-1β, TNF-α, and/or TNF-β in pediatric subjects including preterm infants (paragraphs [0001]-[0005], [0009], [0049], [0050], and [0069]).
Regarding “for reducing a risk of intestinal inflammation, intestinal tissue damage, or both; improving gut barrier function; and/or downregulating expression of IL-1β, IL-8, TNFR2, or any combination thereof in a preterm infant” in the preamble of claim 26, it is noted that this claim language 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 “the method comprising administering extensively hydrolysed casein to the preterm infant” in claim 26, Hondmann teaches administering extensively hydrolysed casein to the preterm infant (paragraphs [0001], [0005], [0009], [0042], [0047], [0049], [0050], and [0077]).
With respect to claim 27, Hondmann is relied upon for the teaching of the method of claim 26 as addressed above.
Regarding the claim language of wherein reducing the risk of intestinal inflammation, intestinal tissue damage, or both comprises a decrease in the expression of one or more IL-1β, IL-8, and TNFR2, in the intestinal epithelium of the preterm infant, by 1% to 100%, compared to the intestinal epithelium of a preterm infant that has not been administered the extensively hydrolysed casein in claim 27, it is noted that this claim language relates to the resulting effect of practicing the claimed method. 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 the claimed result since Hondmann teaches a method that is identical to the presently claimed method as addressed above in claim 26, and Hondmann teaches reducing the expression of IL-8, IL-1β, TNF-α, and/or TNF-β as well as modulating intestinal epithelial response in pediatric subjects including preterm infants (paragraphs [0001]-[0005], [0009], [0049], [0050], and [0069]).
With respect to claim 28, Hondmann is relied upon for the teaching of the method of claim 26 as addressed above.
Regarding the recitation of wherein reducing the risk of intestinal inflammation, intestinal tissue damage, or both, in a preterm infant comprises reducing the risk of necrotising enterocolitis (NEC), systemic infection, or both in claim 28, it is noted that this recitation relates to the resulting effect of practicing the claimed method. 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 the claimed result since Hondmann teaches a method that is identical to the presently claimed method as addressed above in claim 26, and Hondmann teaches reducing intestinal inflammatory response as well as reducing intestinal tissue damage in pediatric subjects including preterm infants (paragraphs [0001]-[0005], [0009], [0049], [0050], and [0069]).
With respect to claims 30 and 31, Hondmann is relied upon for the teaching of the method of claim 26 as addressed above.
Regarding the recitation of wherein improving gut barrier function comprises improving intestinal cell viability in the preterm infant in claim 30 and wherein improving gut barrier function comprises improving gut barrier integrity in the preterm infant in claim 31, it is noted that this recitation relates to the resulting effect of practicing the claimed method. 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 the claimed results since Hondmann teaches a method that is identical to the presently claimed method as addressed above in claim 26, and Hondmann teaches modulating intestinal epithelial response in pediatric subjects including preterm infants (paragraphs [0001]-[0005], [0009], [0049], [0050], and [0069]).
With respect to claim 32, Hondmann is relied upon for the teaching of the method of claim 31 as addressed above.
Regarding the claim language of wherein improving gut barrier integrity comprises an increase in gut barrier integrity of 1% to 100%, an increase in intestinal cell viability of 1% to 100%, or both, compared to the gut barrier integrity and/or intestinal cell viability of a preterm infant that has not been administered the extensively hydrolysed casein in claim 32, it is noted that this claim language relates to the resulting effect of practicing the claimed method. 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 the claimed result since Hondmann teaches a method that is identical to the presently claimed method as addressed above in claims 26 and 31, and Hondmann teaches modulating intestinal epithelial response in pediatric subjects including preterm infants (paragraphs [0001]-[0005], [0009], [0049], [0050], and [0069]).
With respect to claim 33, Hondmann is relied upon for the teaching of the method of claim 26 as addressed above.
Regarding the recitation of wherein improving gut barrier integrity comprises reducing intestinal permeability in the preterm infant in claim 33, it is noted that this recitation relates to the resulting effect of practicing the claimed method. 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 the claimed result since Hondmann teaches a method that is identical to the presently claimed method as addressed above in claim 26, and Hondmann teaches modulating intestinal epithelial response in pediatric subjects including preterm infants (paragraphs [0001]-[0005], [0009], [0049], [0050], and [0069]).
With respect to claim 34, Hondmann is relied upon for the teaching of the method of claim 33 as addressed above.
Regarding the claim language of wherein reducing intestinal permeability comprises a decrease in gut barrier permeability of 1% to 100%, compared to the gut barrier permeability of a preterm infant that has not been administered the extensively hydrolysed casein in claim 34, it is noted that this claim language relates to the resulting effect of practicing the claimed method. 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 the claimed result since Hondmann teaches a method that is identical to the presently claimed method as addressed above in claims 26 and 33, and Hondmann teaches modulating intestinal epithelial response in pediatric subjects including preterm infants (paragraphs [0001]-[0005], [0009], [0049], [0050], and [0069]).
With respect to claim 35, Hondmann is relied upon for the teaching of the method of claim 26 as addressed above.
Regarding the recitation of wherein improving gut barrier integrity comprises improving intestinal cell viability in the preterm infant in claim 35, it is noted that this recitation relates to the resulting effect of practicing the claimed method. 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 the claimed result since Hondmann teaches a method that is identical to the presently claimed method as addressed above in claim 26, and Hondmann teaches modulating intestinal epithelial response in pediatric subjects including preterm infants (paragraphs [0001]-[0005], [0009], [0049], [0050], and [0069]).
With respect to claim 36, Hondmann is relied upon for the teaching of the method of claim 35 as addressed above.
Regarding the claim language of wherein improving intestinal cell viability comprises an increase in intestinal cell viability of 1% to 100%, compared to the intestinal cell viability of a preterm infant that has not been administered the extensively hydrolysed casein in claim 36, it is noted that this claim language relates to the resulting effect of practicing the claimed method. 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 the claimed result since Hondmann teaches a method that is identical to the presently claimed method as addressed above in claims 26 and 35, and Hondmann teaches modulating intestinal epithelial response in pediatric subjects including preterm infants (paragraphs [0001]-[0005], [0009], [0049], [0050], and [0069]).
With respect to claim 38, Hondmann is relied upon for the teaching of the method of claim 26 as addressed above.
Regarding the claim language of wherein downregulating expression of IL-1β, IL-8, TNFR2, or any combination thereof comprises a decrease in the expression of one or more of IL-1β, IL-8, TNFR2, in the intestinal epithelium of the preterm infant, by 1% to 100%, compared to the intestinal epithelium of a preterm infant that has not been administered the extensively hydrolysed casein in claim 38, it is noted that this claim language relates to the resulting effect of practicing the claimed method. 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 the claimed result since Hondmann teaches a method that is identical to the presently claimed method as addressed above in claim 26, and Hondmann teaches reducing the expression of IL-8, IL-1β, TNF-α, and/or TNF-β as well as modulating intestinal epithelial response in pediatric subjects including preterm infants (paragraphs [0001]-[0005], [0009], [0049], [0050], and [0069]).
With respect to claim 39, Hondmann is relied upon for the teaching of the method of claim 26 as addressed above.
Regarding the recitation of wherein the extensively hydrolysed casein comprises at least three peptides selected from SEQ ID NO: 1 to SEQ ID NO: 68 in claim 39, Hondmann teaches the extensively hydrolysed casein comprises at least three peptides selected from SEQ ID NO: 1 to SEQ ID NO: 68 (paragraphs [0001], [0006], [0007], [0047], [0070], [0072]-[0073] Tables 1 and 2, and [0077]).
With respect to claim 41, Hondmann is relied upon for the teaching of the method of claim 26 as addressed above.
Regarding the recitation of wherein the extensively hydrolysed casein is in the form of a reconstituted solution, wherein the reconstituted solution comprises extensively hydrolysed casein in the range of about 0.01 milligrams per millilitre (mg/mL) to about 0.50 grams per millilitre (g/mL) in claim 41, Hondmann teaches the extensively hydrolysed casein is in the form of a reconstituted solution, and the solution comprises 0.02, 0.08, or 100 mg/mL of extensively hydrolysed casein in some embodiments (paragraphs [0128], [0172], and [0185]).
With respect to claim 42, Hondmann relates to a method of reducing intestinal inflammatory response, reducing intestinal tissue damage, modulating intestinal epithelial response, and reducing the expression of IL-8, IL-1β, TNF-α, and/or TNF-β in pediatric subjects including preterm infants (paragraphs [0001]-[0005], [0009], [0049], [0050], and [0069]).
Regarding “for reducing a risk of intestinal inflammation, intestinal tissue damage, or both; improving gut barrier function; and/or downregulating expression of IL-1β, IL-8, TNFR2, or any combination thereof in a preterm infant” in the preamble of claim 42, it is noted that this claim language 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 the recitation of the method comprising administering a composition comprising extensively hydrolysed casein to the preterm infant in claim 42, Hondmann teaches administering to a preterm infant a composition comprising extensively hydrolysed casein (paragraphs [0001], [0005], [0009], [0042], [0047], [0049], [0050], and [0077]).
With respect to claim 43, Hondmann is relied upon for the teaching of the method of claim 42 as addressed above.
Regarding the recitation of wherein the extensively hydrolysed casein comprises at least three peptides selected from SEQ ID NO: 1 to SEQ ID NO: 68 in claim 43, Hondmann teaches the extensively hydrolysed casein comprises at least three peptides selected from SEQ ID NO: 1 to SEQ ID NO: 68 (paragraphs [0001], [0006], [0007], [0047], [0070], [0072]-[0073] Tables 1 and 2, and [0077]).
With respect to claim 45, Hondmann is relied upon for the teaching of the method of claim 42 as addressed above.
Regarding the recitation of wherein the composition is in the form of a reconstitutable powder, wherein the reconstitutable powder comprises extensively hydrolysed casein in the range of about 10 micrograms per 100 kilocalories (µg/100 kcal) to about 15 grams per 100 kilocalories (g/100 kcal) in claim 45, Hondmann teaches the composition is in the form of a reconstitutable powder, and the composition comprises extensively hydrolysed casein in the range of 1-7 grams per 100 kcal (paragraphs [0128] and [0190] Table 5).
With respect to claim 46, Hondmann is relied upon for the teaching of the method of claim 42 as addressed above.
Regarding the recitation of wherein the composition further comprises at least one prebiotic, wherein the at least one prebiotic comprises polydextrose, galactooligosaccharides, or a combination thereof in claim 46, Hondmann teaches the composition may also comprise a prebiotic component comprising polydextrose and/or galactooligosaccharide (paragraph [0108]).
With respect to claim 49, Hondmann is relied upon for the teaching of the method of claim 42 as addressed above.
Regarding the recitation of wherein the composition is a preterm infant formula or human milk fortifier in claim 49, Hondmann teaches the composition is a preterm infant formula or human milk fortifier (paragraphs [0049], [0050], and [0128]).
With respect to claim 50, Hondmann is relied upon for the teaching of the method of claim 42 as addressed above.
Regarding the recitation of wherein the composition is a synthetic composition in claim 50, Hondmann teaches the composition is synthetic (paragraphs [0042], [0048], [0077], and [0094]).
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 47 is rejected under 35 U.S.C. 103 as being unpatentable over Hondmann et al. WO 2014150558 (hereinafter “Hondmann”) as applied to claim 42 above, and in further view of Schoemaker et al. US 20180160714 (hereinafter “Schoemaker”).
With respect to claim 47, Hondmann is relied upon for the teaching of the method of claim 42 as addressed above.
Regarding the recitation of wherein the composition further comprises milk fat globule membrane (MFGM) in claim 47, Hondmann does not expressly disclose this recitation.
Schoemaker relates to a nutritional composition suitable for pediatric subjects including preterm infants. The composition may additionally comprise a protein equivalent source, such as extensively hydrolyzed casein protein, and milk fat globule membrane (paragraphs [0001], [0018], [0019], [0026], [0029], [0068], [0080], [0152], and [0153]).
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 Shoemaker, to select milk fat globule membrane based in its suitability for its intended purpose in the method of Hondmann with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Hondmann and Schoemaker similarly teach pediatric compositions comprising similar ingredients, Hondmann teaches the composition may also comprise a suitable lipid source known in the art such as milk fat as well as milk protein sources (paragraphs [0047] and [0095]), Schoemaker teaches the milk fat globule membrane comprises desirable components, such as proteins and lipids found in the milk fat globule membrane (paragraph [0080]), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected results. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
Conclusion
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/T.L.M/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793