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 .
DETAILED ACTION
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Status of Claims
Claims 1-4, 7-9, 11-18 and 20-35 are currently pending in the instant application. Claims 1, 3, 8, 11 and 15 have been amended by Applicants’ amendment filed 10-02-2025. No claims have been added or canceled by Applicants’ amendment filed 10-02-2025.
Applicant's election of Group I without traverse of claims 1-22, directed to a method to detect the presence of one or more allergen molecules in a composition of mammalian milk; and the election without traverse of Species as follows:
Species (A): wherein the detection sites detect a defined fragment of a selected portion of DNA, RNA or amino acid (claim 5);
Species (B): wherein first active binding site does not bind to a naturally occurring fragment of the mammalian milk (claim 4);
Species (C): further comprising detecting the presence of a third allergen molecule (claim 12);
Species (D): detecting a panel of at least two allergen molecules (claim 15);
Species (E): wherein a particular DNA or RNA fragment is associated with a particular allergen molecule (claim 17);
Species (F): wherein the one or more allergen has an amino acid sequence shown in any of the Figures (claim 18);
Species (G): wherein the detected fragment defines a selected portion of a DNA, RNA or amino acid sequence (claim 27);
Species (H): wherein the origin/source of the allergen molecule is mammalian milk (claim 28);
Species (I): wherein the plurality of DNA, RNA or amino acid fragments comprise overlapping portions (claim 34), in the reply filed July 26, 2023 was previously acknowledged.
Claims 23-35 were previously withdrawn by Applicant from further consideration pursuant to 37 CFR 1.142(b) in the reply filed 07-26-2023 as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 2-4, 7-9, 11-14, 16-18 and 20-22 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim.
The restriction requirement is still deemed proper and is therefore made FINAL.
The claims will be examined insofar as they read on the elected species.
A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Therefore, claims 1 and 15 are under consideration to which the following grounds of rejection are applicable.
Priority
The present application filed May 18, 2020 claims the benefit of US Provisional Patent Application 62/849,032, filed May 16, 2019.
Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications including the as-filed Specification, filed May 18, 2020, and US Provisional Patent Application 62/849,032, filed May 16, 2019, fail to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application. The specific method steps recited in independent claim 1 does not have support for; a fragment of amino acids comprising a sequence TPEVDDEALEKFDK (SEQ ID NO: 463)” and/or “a quantity of unadulterated human milk”.. Therefore, the priority date for the presently claimed invention is May 18, 2020, the filing date of the claims comprising these limitations in US Patent Application 16/877,379.
Applicants are invited to specifically indicate the location of the cited phrase pertinent to claim 1 of the instant application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on April 22, 2025 has been considered. An initialed copy of the IDS accompanies this Office Action.
Withdrawn Objections/Rejections
Applicants’ amendment and arguments filed October 2, 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
Double Patenting
The provisional rejection of claims 1 and 15 is withdrawn on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of copending US Patent Application No. 17/611,894
due to Applicant’s filing of a terminal disclaimer on October 2, 2025.
Claim Rejections - 35 USC § 102
The rejection of claims 1 and 15 is withdrawn under 35 U.S.C. 102(a1)/(a2) as being anticipated by Keim et al. (Pediatrics, 2015, 135(5), 1-6) as evidenced by Sun et al. (Royal Society of Chemistry Advances, 2015, 5, 4886-4893); and Germond et al. (hereinafter “Germond”) (US Patent Application Publication 20040071714, published April 15, 2004); and Dekker et al. (hereinafter “Dekker”) (Nutrients, 2020, 1169, 1-17).
Keim does not teach detecting an allergen comprising SEQ ID NO: 463 in “unaltered” human milk.
In view of the withdrawn rejection, Applicant’s arguments are rendered moot.
Claim Rejections - 35 USC § 103
The rejection of claims 1 and 15 is withdrawn under 35 U.S.C. 103 as being unpatentable over by Martin-Munoz et al. (European Annals of Allergy and Clinical Immunology, 2016, 48(4), 123-128) in view of Zhang et al. (Trends in Analytical Chemistry, 2019, 114, 278-292) as evidenced by Cheng et al. (Food Chemistry, 2015, 199, 799-808); and Chan (Harvard School of Public Health, 2023, 1-5); and Germond et al. (hereinafter “Germond”) (US Patent Application Publication 20040071714, published April 15, 2004); and Dekker et al. (hereinafter “Dekker”) (Nutrients, 2020, 1169, 1-17).
The combined references of Martin-Munoz and Zhang do not teach detecting an allergen comprising SEQ ID NO: 463 in “unaltered” human milk.
In view of the withdrawn rejection, Applicant’s arguments are rendered moot.
The rejection of claims 1 and 15 is withdrawn under 35 U.S.C. 103 as being unpatentable over by Martin-Munoz et al. (hereinafter “Marin-Munoz”) (European Annals of Allergy and Clinical Immunology, 2016, 48(4), 123-128) in view of Zhang et al. (hereinafter “Zhang”) (Trends in Analytical Chemistry, 2019, 114, 278-292); and further in view of Germond et al. (hereinafter “Germond”) (US Patent Application Publication 20040071714, published April 15, 2004) as evidenced by Cheng (hereinafter “Cheng”) (Food Chemistry, 2015, 199, 799-808); and Chan (Harvard School of Public Health, 2023, 1-5); and Germond et al. (hereinafter “Germond”) (US Patent Application Publication 20040071714, published April 15, 2004).
The combined references of Martin-Munoz, Zhang and Germond do not teach detecting an allergen comprising SEQ ID NO: 463 in “unaltered human” milk.
In view of the withdrawn rejection, Applicant’s arguments are rendered moot.
Maintained Objections/Rejections
Claim Rejections - 35 USC § 112(a) – New Matter
The rejection of claims 1 and 15 is maintained under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
MPEP § 2163.II.A.3.(b) states, “when filing an amendment an applicant should show support in the original disclosure for new or amended claims” and “[i]f the originally filed disclosure does not provide support for each claim limitation, or if an element which applicant describes as essential or critical is not claimed, a new or amended claim must be rejected under 35 U.S.C. 112, para. 1, as lacking adequate written description”. According to MPEP § 2163.I.B, “While there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure” and “The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117”.
The claim contains subject matter that was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art (hereafter the Artisan), that the inventor(s), at the time the application was filed, had possession of the claimed invention. 37 CFR §1.118 (a) states that "No amendment shall introduce new matter into the disclosure of an application after the filing date of the application". Claim 1 recites in part: “a quantity of unaltered human milk” in lines 6 and 12. Upon review of the instant as-filed Specification, support was not found for the limitation of “a quantity of unaltered human milk” as recited in instant claim 1. The instant as-filed Specification, filed May 18, 2020 recites, “exposing the plurality of detection sites to a quantity of mammalian milk; detecting presence of a first allergen molecule” (paragraph [00123]); “each of the plurality of detection sites configured to detect presence of one or more allergen molecules when exposed to a quantity of mammalian milk” (paragraph [00145]); and “each respective sequence fragment shown in Figs. 8-59 includes a sequencing identification no. (Seq. Id No.) for ease of reference” (paragraph [0069]). No such corresponding teaching regarding a quantity of unadulterated human milk is taught by the instant as-filed Specification.
A claim-by-claim analysis and for dependent claim 1, and a method step by method step analysis regarding where support can be found in the originally filed specification is respectfully suggested. See MPEP § 2163 particularly § 2163.06.
Claims 1 and 15 will remain rejected until Applicant cancels all new matter.
Response to Arguments
Applicant’s arguments filed October 2, 2025 have been fully considered but they are not persuasive. Applicants essentially assert that: (a) support for a quantity of unaltered human milk can be found in paragraphs [0074] and [0122], particularly in the teaching of:
“The parents have no way of determining what substances were consumed by the milk donating mother prior to pumping human milk and thus have no knowledge of what allergens may exist in the milk. Currently, there are no systems in place for such parents to analyze the milk for allergen or contaminants” (paragraph [0074]); and
“exposing the plurality of detection sites to a quantity of mammalian milk” (paragraph [0122]).
The present application makes clear that the system is intended for at home use by parents who cannot defat breast milk or extract DNA, where the system tests breast milk and not DNA of breast milk or defatted breast milk (Applicant Remarks, pg. 7 through pg. 8).
Regarding (a), although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26USPQ2d 1057 (Fed. Cir. 1993). Instant claim 1 does not recite determining substances consumed by a milk donating mother, home testing, pumping human milk, donating human milk, parent’s analyzing milk, a child with a dairy allergy, etc. Additionally, the paragraphs cited by Applicant do not define and/or clarify the meaning of the term “unaltered human milk”.
Moreover, the as-filed Specification and original claims do not teach or define the term “unaltered human milk.” However, it is known in the art that several studies have documented the presence of variable amounts of intact food allergens in breast milk, including ovalbumin, gliadin, peanut, and cow’s milk proteins as evidenced by Picariello (pg. 1, Introduction, first full paragraph). Furthermore, cow milk proteins and peptides including b-Lactoglobulin are naturally secreted in the milk of a majority of women who orally ingest cow’s milk as evidenced by Sorva (Abstract) and Matangkasombut (Abstract). Thus, it is unclear what constitutes “unaltered human milk”, and whether the term refers to unpasteurized human milk; human milk consisting only of human proteins, fats, etc.; milk within the body of a human female; milk obtained directly from a human female; human milk that has not been processed by any method (e.g., filtered, extracted, fractionated, pasteurized, etc.). Because the as-filed Specification and original claims do not teach, define and/or support the term “unaltered human milk,” the claims remain rejected.
Claim Rejections - 35 USC § 112(b)
The rejection of claims 1 and 15 is maintained under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 is indefinite for the recitation of the term “unaltered human milk” such as recited in claim 1, line 6 because the meaning of the term “unaltered human milk” is unclear given that the term is not taught in the as-filed Specification. Moreover, it is known in the art that cow milk proteins and peptides including b-Lactoglobulin are naturally secreted in the milk of a majority of women who orally ingest cow’s milk as evidenced by Sorva (Abstract) and Matangkasombut (Abstract). Moreover, the as-filed Specification teaches the detection of DNA and RNA; mass spectrometry analysis; extraction, etc. (paragraphs [0093];[0103]; and [0113]). Thus, it is unclear whether the term “unaltered human milk” refers to: human milk consisting of only the mother’s proteins, carbohydrates, antibodies, etc.; human milk obtained directly from a lactating female; human milk that is digested or partially digested; human milk that has not been filtered, purified, processed and/or otherwise treated, or to some other type of human milk and, thus, the metes and bounds of the claim cannot be determined.
Claim 1 is indefinite for the recitation of the term “the quantity of human milk” such as recited in claim 1, lines 9-10 and 12. There is insufficient antecedent basis for the term “the quantity of human milk” in the claim because claim 1, line 6 recites the term “a quantity of unaltered human milk”.
Claim 15 is indefinite insofar as it depends from instant claim 1.
Claim Rejections - 35 USC § 102
The rejection of claims 1 and 15 is maintained under 35 U.S.C. 102(a1)/(a2) as being anticipated by Martin-Munoz et al. (European Annals of Allergy and Clinical Immunology, 2016, 48(4), 123-128; of record) as evidenced by Germond et al. (hereinafter “Germond”) (US Patent Application Publication 20040071714, published April 15, 2004; of record); and Dekker et al. (hereinafter “Dekker”) (Nutrients, 2020, 1169, 1-17; of record).
Regarding claims 1 and 15, Martin-Munoz et al. teach that food proteins ingested by women who are breastfeeding are absorbed and excreted into breast milk antigenically active, wherein eczema, colic, diarrhea and vomiting are frequent symptoms in exclusively breastfed infants, but rarely food allergy has been demonstrated in this group (interpreting allergen proteins as amino acids corresponding to a first allergen molecule, claim 1) (pg. 123, col 1, first partial paragraph). Martin-Munoz et al. teach food sensitization studies in infants and looked for hidden allergens in the breast milk identifying the responsible food allergens there, wherein breast milk samples (≥ 30 ml) were collected from the babies’ mothers: (A) samples collected 24 hours after following a diet free of any suspected food, including those for which the infant had a positive skin prick test (SPT) or specific IgE (sIgE); and (B) samples collected at 2-hour intervals up to 8 h post-dietary challenge with each one of the suspected implicated foods (250 ml cow’s milk, 1 hen’s egg, 100 g of hake or 30 g of peanuts); and that skin tests (SPT) were conducted with cow’s milk, a-lactalbumin (Bos d 4), b-lactoglobulin (Bos d 5), bovine serum albumin (Bos d 6) and casein (Bos d 8); hen’s egg white; hake; lentil and peanut, such that skin prick-by-prick tests (SPPT) with corresponding collected samples of the mother’s breast milk were performed on the infants (interpreting a skin test to be a substrate having a plurality of detection sites configured to detect the presence of one or more allergen molecules; and detecting the presence of a first allergen molecule; and a fragment defines a portion of an amino acid sequence; excludes a portion of an amino acid sequence; and cow’s milk protein including comprising b-lactoglobulin having SEQ ID NO: 463, egg, and legume; and where at least two allergens are detected at their own detection site, claims 1 and 15) (pg. 124, col 1, first partial paragraph); wherein bovine proteins comprise the peptide sequence TPEVDDEALEKFDK as evidenced by Dekker (pg. 6, Table 2); and wherein cow’s milk protein is known to inherently contain b-lactoglobulin comprising a fragment having SEQ IDE NO: 16 as evidenced by Germond (interpreted as SEQ ID NO: 463) (paragraph [0021]; [0048]; Figure 1; and SEQ ID NO: 16).
Martin-Munoz et al. meets all the limitations of the claims and, therefore, anticipates the claimed invention.
Response to Arguments
Applicant’s arguments filed October 2, 2025 have been fully considered but they are not persuasive. Applicants essentially assert that: (a) none of the cited references teach a method of detecting allergens in unaltered human milk including because milk was defatted by centrifugation (Applicant Remarks, pg. 10, second full paragraph; and last full paragraph).
Regarding (a), Applicant’s assertion that none of the cited references teach a method of detecting allergens in unaltered human milk including because milk was defatted by centrifugation, is not found persuasive. As an initial matter, Martin-Munoz is referring to the defatting of the cow’s milk, and not defatting the human milk sample. This is how the different portions of cow’s milk are separated as evidenced by Neyestani (pg. 204, col 2, second full paragraph). To that end, Martin-Munoz teaches that:
Skin tests: SPT with cow’s milk, a-lactalbumin (Bos d 4), b-lactoglobulin (Bos d 5), bovine serum albumin (Bos d 6) and casein (Bos d8); hen’s egg white; hake; lentil; and peanut and skin prick-by-prick tests (SPPT) with corresponding collected sample of the mother’s breast milk were performed on infants (pg. 124, col 1, first full paragraph).
Additionally, the Examiner contends that Martin-Munoz teaches all of the limitations of the claims. For example:
Martin-Munoz teaches:
That food proteins ingested by women who are breastfeeding are absorbed and excreted into breast milk antigenically active (interpreted as unaltered human milk).
Food sensitization studies in infants and looked for hidden allergens in the breast milk identifying the responsible food allergens there, wherein breast milk samples (≥ 30 ml) were collected from the babies’ mothers, where samples collected at 2-hour intervals up to 8 h post-dietary challenge with each one of the suspected implicated foods (250 ml cow’s milk, 1 hen’s egg, 100 g of hake or 30 g of peanuts); and that skin tests (SPT) were conducted with allergens including cow’s milk, a-lactalbumin (Bos d 4), b-lactoglobulin (Bos d 5), bovine serum albumin (Bos d 6) and casein (Bos d 8) (interpreting a skin test to be a substrate having a plurality of detection sites configured to detect the presence of one or more allergen molecules; and detecting the presence of a first allergen molecule; and a fragment defines a portion of an amino acid sequence; excludes a portion of an amino acid sequence; and cow’s milk protein including comprising b-lactoglobulin having SEQ ID NO: 463, egg, and legume; and where at least two allergens are detected at their own detection site).
Martin-Munoz teaches all of the limitations of the claims. Thus, the claims remains rejected.
New Objections/Rejections
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(2) Claims 1 and 15 are rejected under 35 U.S.C. 102(a1)/(a2) as being anticipated by Elisa System (Elisa System, 2007, 1-12). This is a new rejection necessitated by amendment of the claims in the response filed 10-02-2025.
Regarding claim 1, Elisa System teaches that the Elisa System Beta-Lactoglobulin Residue assay is an enzyme-linked immunosorbent assay (ELISA) that can be used to screen Food products and environmental samples for the presence of this potential allergen caused by cross-contamination with Dairy Products and raw materials, wherein milk from humans appears to be devoid of b-Lactoglobulin (interpreted as unadulterated human milk, claim 1) (pg. 1, Abstract, first and third full paragraphs). Elisa System teaches that human infants can develop an allergenic response to cow milk proteins, wherein b-Lactoglobulin is the primary antigenic component that stimulates the immune hypersensitivity response in an infant, such that the ELISA SYSTEMS is a rapid and reliable test which significantly reduces the time required to screen food products for the presence of b-Lactoglobulin including in terms of other milk products (interpreted as testing for the presence of an allergen molecule comprising TPEVDDEALEKFDK, claim 1) (pg. 1, Background, second and third full paragraphs). Elisa System teaches that the ELISA SYSTEM Milk Residue ELISA is a double antibody (sandwich) ELISA utilizing specific anti-b-Lactoglobulin antibodies coated into microwells, such that after addition of the sample and the enzyme conjugate, a positive reaction indicating the presence of b-Lactoglobulin produces a deep blue color (interpreted as human milk; interpreting microwells as a substrate comprising a plurality of detection sites; and detecting a presence of at least one allergen molecules; and b-Lactoglobulin, claim 1) (pg. 2, Principle and Procedure, first full paragraph). Steps 1-3 are shown below (pg. 2, last full paragraph):
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Elisa System teaches that reagents are supplied including test strips, microwells containing anti-b-Lactoglobulin antibodies, and a test strip holder (interpreted as detecting the presence of allergen molecules in human milk, claim 1) (pg. 3, Reagents Supplied).
Regarding claim 15, Elisa System teaches that samples including solid samples, liquid samples and swab samples; as well as, sample preparation including for the detection of polyphenols (interpreted as at least one additional allergen at a different detection site, claim 15) (pg. 6, entire page). Elisa System teaches that kits available include kids for the detection of almond, buckwheat, b-Lactoglobulin, casein, crustacean, egg, gluten, hazelnut, mustard peanut, sesame and soy (interpreted as detecting a presence of a second allergen molecule different from the first, claim 15) (pg. 12, last full paragraph).
Elisa System meets all the limitations of the claims and, therefore, anticipates the claimed invention.
The Examiner suggests that Applicant amend claim 1 to delete the term “unaltered” and to replace the term with specific limitations consistent with the as-filed Specification (e.g., providing a sample directly from a lactating human female wherein the sample has not been further purified, separated, processed, etc.). Moreover, the Examiner suggests that Applicant amend claim 1 to recite a specific substrate, detection sites, and method of detecting (e.g., dip assay, lateral flow assay, ELISA, MS, HPLC, etc.), wherein the novelty of the invention is recited.
Conclusion
Claims 1 and 15 remain rejected.
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 AMY M BUNKER whose telephone number is (313) 446-4833. The examiner can normally be reached on Monday-Friday (6am-2:30pm).
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/AMY M BUNKER/Primary Examiner, Art Unit 1684