DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Application
The status of the claims stands as follows:
Pending claims: 1-10
Canceled claims: None
Currently rejected claims: 1-10
Allowed claims: None
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 2, and 5-7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hartmann et al. (EP 1 637 043 A1) in view of Dos Santos et al. (Dos Santos, M. M. and Martinez, F. E., “Human Milk Concentrate for Preterm Infants,” Nutrition Research, Vol. 16, No. 5, pp. 769-772, 1996).
Regarding claim 1, Hartmann et al. discloses a method for promoting growth of a premature infant, comprising administering to a premature infant a concentrated human milk nutritional formulation comprising 24 kcal/ounce ([0009], [0010], [0021], [0022], [0026]), where the formulation is derived from pooled human milk from at least one qualified donor ([0015]-[0017], [0021], [0039]); comprises human milk protein, fat, and carbohydrates ([0010], [0017]); and has reduced bioburden in comparison to raw human milk ([0018]).
Though Hartmann et al. is considered to implicitly disclose standardization of the composition from multiple donors based on the disclosed average of macronutrients in human milk ([0022]) and the instruction to achieve particular levels of fortification ([0021], [0026]), the limited instruction in the reference regarding the performance of a standardization step would prompt a practitioner to consult an additional resource, such as Dos Santos et al., for further detail regarding such a practice. Dos Santos et al. discloses a concentrated human milk composition (p. 769, ¶1) and further suggests that the utilization of a “well equipped human milk bank with a good number of donors,” where the milk is pooled, would be expected to cause the pooled milk to exhibit a more uniform nutrient profile (p. 771, ¶5). A skilled practitioner would thus recognize that the average macronutrient profile disclosed in Hartmann et al. should be read as implicitly teaching the standardization of milk pooled from multiple donors.
As for claim 2, Hartmann et al. discloses the composition as comprising human milk protein at a concentration of about 20-70 mg/ml ([0022], where human milk with an initial concentration of 1g/l00ml protein was enriched with 1.5g protein/l00ml, providing a total of 2.5g/100 ml protein, where such units convert to 25 mg/mL protein); human milk carbohydrates at a concentration of about 70-115 mg/mL ([0022], where human milk has an average concentration of 7.0g/100ml lactose, or 70 mg/mL lactose); and human milk fat at a concentration of about 35-85 mg/mL ([0022], where human milk has an average concentration of 3.8g/100ml fat, or 38 mg/mL fat).
As for claim 5, Hartmann et al. discloses the fortifier as comprising only human components ([0013], [0016]), which indicates the composition does not comprise xenogeneic components.
As for claim 6, Hartmann et al. discloses the composition as comprising adding minerals, such as calcium ([0006]).
As for claim 7, Hartmann et al. discloses the concentrated formulation as being an ultrafiltered formulation ([0037], [0042]).
Claims 3 and 4 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hartmann et al. (EP 1 637 043 A1) in view of Dos Santos et al. (Dos Santos, M. M. and Martinez, F. E., “Human Milk Concentrate for Preterm Infants,” Nutrition Research, Vol. 16, No. 5, pp. 769-772, 1996) as applied to claim 1 above, and further in view of Barrett-Reis et al. (U.S. 6,294,206 B1).
Regarding claims 3 and 4, Hartmann et al. and Dos Santos et al. disclose the method of claim 1.
The cited prior art does not disclose the osmolality of the composition as being less than about 400 mOsm/Kg H2O (claim 3) or from about 310-380 mOsm/Kg H2O (claim 4).
However, Barrett-Reis et al. discloses a human milk fortifier for infants (C4, L65 – C5, L6) as having a preferred osmolality of about 300-400 mOsm/kg H2O and further notes that the osmolality is critical for infants’ tolerance of ingestion of the composition (C9, L35-L43). Since Hartmann et al. is silent on osmolality, a skilled practitioner would incorporate the range disclosed in Barrett-Reis et al, which renders the claimed osmolalities of less than about 400 mOsm/Kg H2O (claim 3) and about 310-380 mOsm/Kg H2O (claim 4) obvious to a skilled practitioner.
Claims 8-10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hartmann et al. (EP 1 637 043 A1) in view of Dos Santos et al. (Dos Santos, M. M. and Martinez, F. E., “Human Milk Concentrate for Preterm Infants,” Nutrition Research, Vol. 16, No. 5, pp. 769-772, 1996) and JHL (“AIDS and Human Milk: Government and Organizational Policy Statements and Selected Reactions,” J. Human Lact., 4(2), pp. 57-66, 1988) and Medo (U.S. 2002/0182243 A1).
Regarding claim 8, Hartmann et al. discloses a method for making an improved concentrated human milk nutritional formulation ([0009]), the method comprising collecting and pooling milk ([0024], where a mother produces 300 ml/day; [0045], where a sample of 500 ml was produced) from qualified human milk donors ([0018]-[0019]), processing the pooled milk comprising concentrating the nutrients in the pooled qualified milk to comprise 24 kcal/ounce to obtain the concentrated, pooled qualified milk ([0015], [0017], [0021]), and treating the milk to reduce bioburden to produce the improved standardized concentrated human milk nutritional formulation ([0018]) that comprises human milk protein, fat, and carbohydrates ([0010], [0017]).
Though Hartmann et al. is considered to implicitly disclose standardization of the composition based on the disclosed average of macronutrients in human milk ([0022]) and the instruction to achieve particular levels of fortification ([0021], [0026]), the limited instruction in the reference regarding the performance of a standardization step would prompt a practitioner to consult an additional resource, such as Dos Santos et al., for further detail regarding such a practice. Dos Santos et al. discloses a concentrated human milk composition (p. 769, ¶1) and further suggests that the utilization of a “well equipped human milk bank with a good number of donors,” where the milk is pooled, would be expected to cause the pooled milk to exhibit a more uniform nutrient profile (p. 771, ¶5). A skilled practitioner would thus recognize that the average macronutrient profile disclosed in Hartmann et al. should be read as implicitly teaching the standardization of milk pooled from multiple donors.
Hartmann et al. also does not explicitly disclose the donors as having been qualified by interview and by screening one or more biological samples from each of the donors for viral/bacterial pathogens, where the biological samples comprise blood, wherein the donors are qualified if they indicate they are not chronically ill and the samples are negative for pathogens, wherein the milk collected from the qualified donors is screened for drugs of abuse and milk that contains evidence of drugs of abuse is discarded, and wherein the milk collected is matched to a qualified donor by comparing molecular markers in the collected milk with molecular markers obtained from one or more biological samples collected from the qualified donor.
Regarding qualification via interview, JHL discloses that milk donors for pooled milk donations should be screened in the interest of excluding donors infected with HIV (p. 58, column 2, ¶3; p. 62, column 1, ¶4). JHL also discloses that “[p]recautions to verify the health of donors are already routine in most facilities” in discussing banks of donated human milk (p. 61, column 1, ¶2). JHL further discloses instances wherein human milk donors have undergone HIV blood tests to ensure they are not infected (p. 63, column 2, ¶2). JHL also notes a milk bank that added questions to a “health history questionnaire regarding high risk factors, including blood transfusion, contact with AIDS patient, use of IV drugs, and multiple sex partners” (p. 65, column 2, ¶1). JHL provides a list of recommendations for “protecting donor milk: verbal history screening, serum testing of all donors, and pasteurization of the milk” (p. 65, column 2, ¶4).
It would have been obvious to one having ordinary skill in the art to qualify donors by interview and by screening donors’ blood. Hartmann et al. discloses a concern about “bacterial, viral and other contamination of donor milk” and an aim to avoid such donor milk ([0028]). A skilled practitioner would thus be motivated to consult JHL for further instruction regarding precautions related to eliminating contaminants in donor milk. Since JHL discloses numerous instances of qualifying milk donors via verbal screening and/or blood testing, the claimed steps of qualifying a donor via an interview to determine whether they are chronically ill and screening a blood sample for viral and bacterial pathogens is considered obvious.
As for the step of testing milk for drugs, Medo discloses screening human donor milk for pathogens and drugs of abuse ([0032]).
It would have been obvious to one having ordinary skill in the art to screen the milk of Hartmann et al. for drugs of abuse according to Medo. As noted previously, Hartmann et al. suggests a sterilization step in order to “eliminate concerns about possible bacterial, viral or other contaminations” ([0028]). Given the concern about bacterial and viral contaminations described in Hartmann et al., a skilled practitioner would be motivated to consult and apply the testing protocol of Medo to the donor milk of Hartmann et al. Such screening would implicitly involve discarding of milk samples wherein the donor tested positive for pathogens or drugs of abuse. The step of screening the donor milk of Hartmann et al. for drugs of abuse would thus be obvious to a skilled practitioner.
As for step of matching the milk with the donor via comparison of molecular markers, Hartmann et al. discloses a preference for the fortifier to be produced from the same individual as the one who produces the milk to be fortified in order reduce possible immunological interferences ([0016]). Hartmann et al. also discloses a preferred fortifier that is enriched in an immunologically-active component ([0017]).
In light of the stated preference for immunologically-active components being in the fortifier and the concern regarding immunological interferences, a skilled practitioner would be motivated to ensure donor milk is from a qualified donor (i.e., the mother from which the milk was initially collected) via any known method for linking the donor to the donated milk, including the identification of immunologically-active components that would be considered a form of genetic markers. The claimed step of matching collected milk to a qualified donor by comparing molecular markers is thus considered obvious to a skilled practitioner.
As for claim 9, Hartmann et al. discloses the formulation as comprising about 24 kcal/ounce ([0021]).
As for claim 10, Hartmann et al. discloses the formulation as comprising about 20 kcal/ounce ([0021]).
Conclusion
This is a continuation of applicant's earlier Application No. 17/719,098. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY P MORNHINWEG whose telephone number is (571)270-5272. The examiner can normally be reached 8:30AM-5:00PM.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793
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