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 .
Specification
The disclosure is objected to because of the following informalities:
The specification filed 10/05/2023 contains paragraph numbers in the middle of sentences throughout the specification, for example see paragraphs [0002]-[0003], [0004]-[0007], [0009]-[0010], etc. Applicant should fix the paragraph numbers throughout the specification to not be in the middle of sentences. Appropriate correction is required. It is noted that the specification filed 10/16/2025 does not contain any paragraph numbers, however the amendment to the specification does not show that the paragraph numbers were stricken out.
The amendment filed 10/16/2025 is not entered because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
Pg. 1 of the specification has been amended to recite “whereby the optimum ratio of lysozyme to immunoglobulin to lactoferrin is 1:1.6:2.6”. While the ratio is supported by table 1 of the originally filed specification, the originally filed specification does not recite that the ratio of lysozyme to immunoglobulin to lactoferrin in table 1 is “an optimum ratio”, therefore including such new language is considered new matter and as such must be deleted.
Pg. 8 of the specification has been amended to recite “the optimal ratios of lysozyme to immunoglobulin to lactoferrin of 1:1.6: 2.6 also cater for premature newborns and newborns with a low immune system”. However, while the ratio is supported by table 1 of the originally filed specification, the originally filed specification does not recite that the ratio of lysozyme to immunoglobulin to lactoferrin in table 1 is “an optimum ratio”, and that the ratio also “cater for premature newborns and newborns with a low immune system” therefore including such new language is considered new matter and as such must be deleted.
Pgs. 1, 2, and 7 remove language from the specification, and this amendment raises an issue of new matter because amending the specification by removing preferred embodiments and optional language improperly changes the scope of what was originally taught by the specification. Applicant should keep the original language to not improperly change the scope of what was originally taught in the specification.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claims 8 and 16 are objected to because of the following informalities:
Regarding claim 8, claim 8 recites “The composition which is substantially set forth in Table 1”. MPEP 2173.05 (s) recites regarding references to Figures or Tables “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience”. In this case since the table is in words it is seen that there is not a non-practical way to define the invention in words. In order to overcome the objection, the desired composition from Table 1 should be written out in the claims.
Regarding claim 16, claim 16 recites “The infant formula of claim 10, substantially as set forth in Table 1. Claim 16 is objected to for the same reasons given above as for claim 8. 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 1, 3-4, 6, 8-10, 13, 15, 16, and 20-22 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.
Regarding claims 1, 3, 4, 6, 13, 15, 20, 21, the phrases "such as" and “preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 8, claim 8 recites “The composition which is substantially set forth in Table 1 (concentration in amount per 100mL formula)”. It is first noted that claim 8 has been amended and does not depend from claim 1. Table 1 contains compositions for concentrations for amount/gm powder, concentration for amount in 100mL formula and concentration in amount/100kcal, thus it is unclear which composition claim 8 is referring to, the powder or formula or amount based on kcal. Third it is unclear what is meant by “substantially set forth in Table 1”, it is unclear if for a composition that all the components are required in the specific amounts in the table or if some components can be missing and the amounts slightly different from that in Table 1. Fourth it is unclear if “(concentration in amount per 100mL formula)” is required because the paratheses raises speculation as to the units being required.
Regarding claim 10, the phrase “particularly” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 16, claim 16 recites “The infant formula of claim 10, substantially as set forth in Table 1 (concentration in amount per 100mL formula)”. It is unclear what is meant by “substantially set forth in Table 1”, it is unclear if for a composition that all the components are required in the specific amounts in the table or if some components can be missing and the amounts slightly different from that in Table 1. Claim 16 is additionally rejected for the same reasons give above as for claim 8.
Claims 9 and 22 are rejected by virtue of their dependence on a rejected base claim
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.
Claims 1, 3, 4, 6, 8, 9, 13, 15, 16, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. US 2003/0074700 in view of Huber-Haag US 2017/0000182.
Regarding claim 1, Huang discloses a composition for use as an infant formula comprising lysozyme ([0369]). Huang discloses the composition comprises lactoferrin (claim 2, 3). Huang discloses that the composition can comprise immunoglobulin ([0130], [0131], [0377], claim 1, 13, 14 [0252], [0296]).
Claim 1 differs from Huang in the recitation that the composition specifically comprises vitamins.
Huber-Haag disclose that convention infant formula preparations include vitamins ([0137]). It would have been obvious to one of ordinary skill in the art to modify the composition of Huang to comprise vitamins as taught by Huber-Haag in order to provide suitable nutrients for an infant utilizing the formula. It has been held that “Combining prior art elements according to known methods to yield predictable results” supports a conclusion of obviousness (MPEP 2143.I.A).
Regarding claims 3 and 4, claims 3 and 4 differs from Modified Huang in the recitation that modified Huang specifically discloses the claimed ranges of lysozyme and immunoglobin and lysozyme, however it is noted that immunoglobin and lysozyme are provided in the infant formula composition for nutritional purposes and it would have been obvious to one of ordinary skill in the art to routinely adjust the amounts of immunoglobin and lysozyme based on the nutritional benefits desired (MPEP 2144.05).
Regarding claim 6, Modified Huang suggests an infant formula including 0.15% lactoferrin (‘182, [0145], Table 8).
Regarding claim 8 claim 8 is rejected for the same reasons given below as for claim 16.
Regarding claim 9, Modified Huang discloses that the composition is a in a dry form that obviously can be reconstituted with water to produce an infant formula (‘700, [0128]) (‘182, [0128]).
Regarding claim 13 claim 13 differs from Huang in the recitation that the infant formula specifically has a concentration of immunoglobin that is about 0.01 to 0.25g/mL. The examiner initially notes that Huang does teach that immunoglobulins can be included in the formula ([0130], [0131] and claim 14)
Huber-Haag discloses adding bioactive ingredients to an infant formula, including 0.05g/mL -0.5g/mL IgG ([0060], [0064]). It would have been obvious to one of ordinary skill in the art to modify the composition of Huang to comprise 0.05g/mL -0.5g/mL IgG as taught by Huber-Haag in order to provide suitable nutrients for an infant utilizing the formula. It has been held that “Combining prior art elements according to known methods to yield predictable results” supports a conclusion of obviousness (MPEP 2143.I.A).
Regarding claim 15, claim 15 is rejected for the same reasons given above as for claim 1.
Regarding claim 16, claim 16 differs from Modified Huang in the recitation that the infant formula is substantially as set forth in table 1. It is additionally noted that it is unclear if the units in parentheses are required as discussed in the 112b rejection above. Huber-Haag discloses an infant formula that substantially as set forth in table 1 (see Table 1), additionally since Huber Haag discloses providing the formula which is substantially as set forth as amount per kcal of table 1 is reasonably expected that the formula would remain substantially as set forth in table 1 according to concentration in amount per 100ml formula. It would have been obvious to one of ordinary skill in the art to modify the composition of Huang to comprise ingredients as taught by Huber-Haag such that the infant formula is substantially as set forth in table 1 in order to provide suitable nutrients for an infant utilizing the formula. It has been held that “Combining prior art elements according to known methods to yield predictable results” supports a conclusion of obviousness (MPEP 2143.I.A).
Regarding claim 22, Modified Huang discloses that the composition is a in a dry form that obviously can be reconstituted with water to produce an infant formula (‘700, [0128]) (‘182, [0128]). Therefore, rendering the method of claim 22 obvious.
Claims 10, 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. US 2003/0074700.
Regarding claim 10, Huang discloses an infant formula comprising lysozyme ([0369]). Huang discloses the infant formula may also comprises lactoferrin ([0369]). Huang discloses that the composition can comprise immunoglobulin ([0130], [0131], [0377], claim 1, 13, 14 [0252], [0296]).
Claim 10 differs from Huang in the recitation that the lysozyme and immunoglobulin and lactoferrin are present in the claimed ratio. However, since each of the recited ingredients are provided for nutritional purposes, it would have been obvious to one of ordinary skill in the art to routinely vary the amounts of the claimed components and subsequently the ratio of the claimed components based on the nutritional benefits desired (MPEP 2144.05).
Regarding claim 20, Huang discloses that the concentration of lysozyme is 0.03 to 3g/L of formula, encompassing the claimed range of 0.1g/L to 1.5g/L ([0369]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05.I
Regarding claim 21, Huang discloses that the concentration of lactoferrin is about 0.3g/L to 3g/L ([0369]).
Response to Arguments
As there has been no argument presented to rebut the previous 112b rejections against claims 8 and 16 these have been maintained and new 112b rejections have been added, necessitated by amendment. Additionally, as there has been no specific arguments against the 103 rejection made, it has been substantially maintained with modifications only made to account for the newly added amendments.
Conclusion
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 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 ASHLEY AXTELL whose telephone number is (571)270-0316. The examiner can normally be reached M-F 9:00- 5:30.
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/A.A/
Ashley AxtellExaminer, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792