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 .
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 1-33 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1, 6, 7, 10, 14, 18, 20, 26, 27, 30, the phrase “and/or” renders the claim indefinite because it is unclear which elements of the claims are part of the claimed invention.
Regarding claims 8-10 & 28-30, the phrase “optionally” renders the claims indefinite because the claims include optional elements, which make the scope of the claim unascertainable.
Claims 31-33 are unclear what the applicant is trying to claim.
Allowable Subject Matter
Claims 1, 14 & 20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1:
The publication entitled “Fecal Microbiomes in Premature Infants With and Without Parenteral Nutrition-Associated Cholestasis” by Mokha et al. IDS 02/16/2024 (hereinafter 'Mokha') discloses a method for predicting parenteral nutrition associated cholestasis (PNAC) and/or assessing risk of PNAC in a subject (a methodological model for the evaluation of changes in the fecal microbiome that may play a role in the development of cholestasis at any age; page 230, first column, second paragraph), the method comprising screening a sample (102 fecal samples from 8 cases and 10 controls were analyzed; abstract) from a subject believed to be at risk for PNAC (stool samples from premature infants who developed direct bilirubin 1.5 mg/dL while receiving PN were classified as precholestasis, cholestasis, or postcholestasis; abstract) for one or more biomarkers of PNAC, the biomarkers comprising one or more fecal biomarkers (neonates who develop PNAC, compared to those who do not, show significantly different fecal microbiomes preceding the biochemical detection of cholestasis; abstract). Mokha does not disclose the fecal biomarkers being fecal metabolites.
The publication entitled “Gram-negative microbiota blooms in premature twins discordant for parenteral nutrition associated cholestasis” by Hourigan et al. IDS 02/16/2024 (hereinafter 'Hourigan') discloses a method for predicting parenteral nutrition associated cholestasis (PNAC) and/or assessing risk of PNAC (to determine if a microbiota signature predicts PNAC; abstract) in a subject, the method comprising screening a sample from a subject (we examined the composition of stool microbiota from premature twins discordant for PNAC; abstract) believed to be at risk for PNAC for one or more biomarkers of PNAC (twin sets were selected for discordance for PNAC, i.e., twin pairs simultaneously receiving PN but only one twin developed PNAC; page 3, second paragraph). Hourigan does not disclose the biomarkers comprising one or more fecal metabolites.
The publication entitled “Total parenteral nutrition-associated cholestasis and risk factors in preterm infants” by Alkharfy et al. IDS 02/16/2024 (hereinafter 'Alkharfy') discloses a method for predicting parenteral nutrition associated cholestasis (PNAC) and/or assessing risk of PNAC (the aims of this study was to determine the incidence of total parenteral nutrition-associated cholestasis and to develop a possible predictive model for its occurrence; abstract) in a subject (307 patients were included and their medical records were reviewed; page 294, second column, second paragraph). Alkharfy does not disclose the method comprising screening a sample from a subject believed to be at risk for PNAC for one or more biomarkers of PNAC, the biomarkers comprising one or more fecal metabolites.
Mokha, Hourigan, and Alkharfy either alone or in combination fail to disclose fecal biomarkers being fecal metabolites in the claim. While Mokha, Hourigan, and Alkharfy disclose a method for predicting parenteral nutrition associated cholestasis (PNAC) and/or assessing risk of PNAC in a subject, the method comprising screening a sample from a subject believed to be at risk for PNAC for one or more biomarkers of PNAC, the biomarkers comprising one or more fecal biomarkers, they do not disclose the fecal biomarkers being fecal metabolites. Thus, it would not have been obvious to a person of ordinary skill in the art, at the time of invention, to have implemented treatment method of claim 1 because the references of record fail to disclose all the elements.
Regarding claim 14:
Mokha discloses a biomarker (neonates who develop PNAC, compared to those who do not, show significantly different fecal microbiomes preceding the biochemical detection of cholestasis; abstract) for predicting parenteral nutrition associated cholestasis (PNAC) and/or assessing risk of PNAC in a subject (a methodological model for the evaluation of changes in the fecal microbiome that may play a role in the development of cholestasis at any age; page 230, first column, second paragraph). Mokha does not disclose a biomarker comprising one or more fecal metabolites.
Hourigan discloses a method for predicting parenteral nutrition associated cholestasis (PNAC) and/or assessing risk of PNAC (to determine if a microbiota signature predicts PNAC; abstract) in a subject (we examined the composition of stool microbiota from premature twins discordant for PNAC; abstract). Hourigan does not disclose a biomarker comprising one or more fecal metabolites.
Alkharfy discloses a prediction parenteral nutrition associated cholestasis (PNAC) and/or assessing risk of PNAC (the aims of this study was to determine the incidence of total parenteral nutrition-associated cholestasis and to develop a possible predictive model for its occurrence; abstract) in a subject (307 patients were included and their medical records were reviewed; page 294, second column, second paragraph). Alkharfy does not disclose a biomarker or a biomarker comprising one or more fecal metabolites.
Mokha, Hourigan, and Alkharfy either alone or in combination fail to disclose a biomarker comprising one or more fecal metabolites in the claim. While Mokha, Hourigan, and Alkharfy disclose a biomarker for predicting parenteral nutrition associated cholestasis (PNAC) and/or assessing risk of PNAC in a subject, they do not disclose a biomarker comprising one or more fecal metabolites. Thus, it would not have been obvious to a person of ordinary skill in the art, at the time of invention, to have implemented treatment method of claim 14 because the references of record fail to disclose all the elements.
Regarding claim 20:
Mokha discloses parenteral nutrition associated cholestasis (PNAC) in a subject (a methodological model for the evaluation of changes in the fecal microbiome that may play a role in the development of cholestasis at any age; page 230, first column, second paragraph), predicting PNAC and/or assessing risk of PNAC in a subject (a methodological model for the evaluation of changes that may play a role in the development of cholestasis at any age; page 230, first column, second paragraph), comprising screening a sample (102 fecal samples from 8 cases and 10 controls were analyzed; abstract) from a subject believed to be at risk for PNAC (stool samples from premature infants who developed direct bilirubin 1.5 mg/dL while receiving PN were classified as precholestasis, cholestasis, or postcholestasis: abstract) for one or more biomarkers of PNAC (neonates who develop PNAC, compared to those who do not, show significantly different fecal microbiomes preceding the biochemical detection of cholestasis; abstract). Mokha does not disclose a method for treating and/or preventing parenteral nutrition associated cholestasis, the biomarkers comprising one or more fecal metabolites or taking a proactive mitigation measure with an alteration to an administered parenteral nutrition (PN) for subjects at high risk of developing PNAC.
Hourigan discloses a method comprising: predicting PNAC and/or assessing risk of PNAC in a subject (to determine if a microbiota signature predicts PNAC; abstract), comprising screening a sample from a subject (we examined the composition of stool microbiota from premature twins discordant for PNAC; abstract) believed to be at risk for PNAC for one or more biomarkers of PNAC (twin sets were selected for discordance for PNAC, i.e., twin pairs simultaneously receiving PN but only one twin developed PNAC; page 3, second paragraph). Hourigan does not disclose a method for treating and/or preventing parenteral nutrition associated cholestasis (PNAC) in a subject, the biomarkers comprising one or more fecal metabolites or taking a proactive mitigation measure with an alteration to an administered parenteral nutrition (PN) for subjects at high risk of developing PNAC.
Alkharfy discloses a method comprising: predicting PNAC and/or assessing risk of PNAC (the aims of this study was to determine the incidence of total parenteral nutrition-associated cholestasis and to develop a possible predictive model for its occurrence; abstract) in a subject (307 patients were included and their medical records were reviewed; page 294, second column, second paragraph). Alkharfy does not disclose a method for treating and/or preventing parenteral nutrition associated cholestasis (PNAC) in a subject, screening a sample from a subject believed to be at risk for PNAC for one or more biomarkers of PNAC, the biomarkers comprising one or more fecal metabolites; and taking a proactive mitigation measure with an alteration to an administered parenteral nutrition (PN) for subjects at high risk of developing PNAC.
Mokha, Hourigan, and Alkharfy either alone or in combination fail to disclose a method for treating and/or preventing parenteral nutrition associated cholestasis, the biomarkers comprising one or more fecal metabolites or taking a proactive mitigation measure with an alteration lo an administered parenteral nutrition (PN) for subjects at high risk of developing PNAC in the claim. While Mokha, Hourigan, and Alkharfy disclose parenteral nutrition associated cholestasis (PNAC) in a, predicting PNAC and/or assessing risk of PNAC in a subject, comprising screening a sample from a subject believed to be at risk for one or more biomarkers of PNAC, they do not disclose method for treating and/or preventing parenteral nutrition associated cholestasis, the biomarkers comprising one or more fecal metabolites or taking a proactive mitigation measure with an alteration to an administered parenteral nutrition (PN) for subjects at high risk of developing PNAC. Thus, it would not have been obvious to a person of ordinary skill in the art, at the time of invention, to have implemented treatment method of claim 20 because the references of record fail to disclose all the elements.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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