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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-14) in the reply filed on 07/01/2026 is acknowledged.
Claims 1-17 are currently pending.
Claims 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/01/2026.
The Restriction Requirement is made Final.
Claims 1-14 have been examined on their merits.
Information Disclosure Statement
The information disclosure statement filed 05/18/2026 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language (Russian Office action). It has been placed in the application file, but the reference which is the Russian Office Action, has not been considered.
Claim Objections
Claims 1, 5-6 and 12-13 are objected to because of the following informalities:
Regarding claim 1, the terms “Culturing” and “Secreting” should not be capitalized. Claims consist of a single sentence and only capitalizing verbs suggests new sentences.
Regarding claims 5-6, the abbreviations LTF and MFGE8 should be spelled out at their first occurrence in the claims for proper form. Thereafter the use of the abbreviations in the claims will be understood.
Regarding claim 12, in step ii) the word “cells” is missing from between “incubating the” and “in EpiCultB medium” and appears to be a typo.
Regarding claim 13, the claim should start with the word “The” as it is dependent upon the method of claim 1.
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, 7, 11-12 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.
Claim 1 recites the limitation "said lactocytes" in line 5 of the claim. There is insufficient antecedent basis for this limitation in the claim as there is no previous recitation of lactocytes, only “lactocyte mammary-like organoids” in lines 3-4.
For examination purposes, “said lactocytes” is interpreted as referring to the “lactocyte mammary-like organoids”.
Claims 7 and 11-12 contain the trademark/trade names “Mammocult”, “MammocultB”, “EpicultB” or “Epicult”.
Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe specific culture media and supplements that are required for the performance of the instantly claimed method, and, accordingly, the identification/description is indefinite.
Appropriate correction is required.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1, 4-6, 8 and 14 are rejected under 35 U.S.C. 102(a)(1) and 35 USC 102(a)(2) as being anticipated by Hassiotou (US 2014/0086882-previously cited).
Regarding claims 1, 4-6, 8 and 14, Hassiotou disclose a milk-like product obtained from a culture of milk-secreting lactocytes (mammary-like gland organoids), wherein the lactocytes were obtained by culturing human mammary epithelial cells in a culture medium (page 11 para 99).
Since the product produced is described as a milk-like product secreted from the organoids it is expected that these organoids also express milk proteins naturally found in milk, such as LTF (lactoferrin) and MFGE8 (milk fat globule-EGF factor8) (induced to express milk proteins), baring evidence to the contrary. The production of the milk-like product from the organoids is also expected to include increased mRNA expression of milk proteins after the induction of their expression (post-induction) compared to before the induction of milk protein expression (pre-induction) baring evidence to the contrary.
Therefore, the teaching of Hassiotou anticipates Applicant’s invention as claimed.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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(s) 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Qu et al (WO 2018/140647-from IDS filed 04/26/2026) in view of Sharma et al (J. Biomol. Structure and Dynamic 2015).
Regarding claims 1-14, Qu teaches methods and compositions related to the generation of mammary cells from pluripotent stem cells (see entire document, including page 1, lines 5-6). The EBs produced from the iPSCs are differentiated into mammary cells in the presence of a substrate, including collagen I and/or Matrigel, in a differentiation medium including EpiCultB medium. The mammary cells comprise breast cells expressing milk protein, luminal cells expressing mammary gland positive cell markers EpCAM and CK18, and basal cells expressing CK14 and P63 (page 2, lines 15-30; cf. claims 14-15). The differentiation takes place for about 30 days and enriches for non- neural ectoderm cells (page 9, lines 6-10; cf. step Aii) of claim 11). For differentiation, the EBs are embedded in a mixed gel of Matrigel and collagen I, and the embedded EBs are cultured in complete EpiCultB medium supplemented with pTHrP for 5 days, and then cultured in complete EpiCultB medium in the presence of hydrocortisone, insulin, FGF10, and HGF for 20 days, and finally cultured in complete EpiCultB medium containing prolactin, hydrocortisone, insulin, and FBS for 5 days to induce milk protein expression (page 11, lines 15-28; cf. claims 17-18 and 21 and steps ii) and iii) of claims 12 and 13; the teaching of "complete EpiCultB medium" indicates that the medium contains the basal EpiCult medium and the EpiCult proliferation supplement; also any lactocyte produced by the method detailed by Qu would be capable of producing milk proteins that could be isolated, which qualifies as a "human milk like product"). The method produces mammary cell organoids (lactocyte mammary gland-like organoids) (page 3, line 1; cf. step A) of claim 11).
However, Qui does not specifically teach the secretion of a milk like product from the organoids.
Sharma teaches that mammary organoids can be induced to secrete milk proteins by culturing the cells in a protein induction medium containing insulin, hydrocortisone, progesterone, beta-estradiol, FBS, and prolactin for at least seven days (see entire document, including page 3634, right column, paragraph 4; page 2637, left column, paragraph 1; cf. step B) of claim 11 and step iv) of claim 12). RNA and casein protein were isolated from the cells following culture (page 2637, left column, paragraph 2, and right column, paragraph 2; cf. claims 19-20). One step of the Western blotting procedure involved the addition of skim milk for blocking (further treated to generate a modified product) (page 2637, right column, paragraph 2; cf. claim 22).
While Qu does not teach the inclusion of progesterone and beta-estradiol in the medium for milk protein expression or expressing proteins for seven days, one of ordinary skill in the art would have been motivated to do so because Sharma teaches that these ingredients and culture times can be used for the secretion of milk products from mammary organoids.
One of ordinary skill in the art would also be motivated to perform the PCR and Western blotting reactions of Sharma to determine the amount of RNA and protein expression in the cells in the mammary organoids of Qu because Sharma teaches that doing so can provide beneficial and valuable information regarding the induction and production of milk proteins from mammary organoids. This would render obvious the observation of well-known mammary gland cell markers and mRNA expression of well-known milk proteins such as lactoferrin (page 5 and page 19 of Sharma) and MFGE8 expected after the induction of milk protein products. One of ordinary skill in the art would have a reasonable expectation that adding the progesterone/beta-estradiol of Sharma to the expression medium of Qu for the seven days of Sharma would successfully result in the secretion of a human milk product from the organoids of Qu and that performing the PCR and Western blotting of Sharma on the organoids of Qu would successfully provide valuable information regarding the production of milk proteins by the organoids.
Therefore, the combined teachings of Qu et al and Sharma et al render obvious Applicant’s invention as claimed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 13-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13-20 and 22 of copending Application No. 19/478619.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application are drawn to a method for producing an isolated human breast milk exosome comprising culturing mammary epithelial cells in a culture medium to generate lactocyte mammary-like gland organoids and secreting a mammalian milk product from the organoids and purifying the exosomes from the milk product to remove impurities (modifying the product). Additional claims include wherein step A is no longer than 14 days and conducted in 3D suspension culture conditions.
The claims of the copending application anticipate the current claims.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Langit et al., “ISOLATED HUMAN SECRETED PROTEINS, NUCLEIC ACID MOLECULES ENCODING HUMAN SECRETED PROTEINS, AND USES THEREOF”, WO 03/006482
Discloses lactadherin (also known as milk fat globule -EGF factor 8 or MFGE8) as expressed on the surface of mammary epithelial cells and secreted as a major glycoprotein in human milk (page 3 lines 5-12).
Silver et al., “Infant Feed and Method” US 2017/0172167
Discloses the fortification of milk products in order to enhance nutrition and health of infants.
Streuli et al., “Control of Mammary Epithelial Differentiation: Basement Membrane Induces Tissue-specific Gene Expression in the Absence of Cell-Cell Interaction and Morphological Polarity”, The Journal of Cell Biology, 1991, Volume 115, Number 5, pp. 1383-1395.
Discloses culture of mammary epithelial cells.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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