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 Status
The response of 12/29/2025 has been entered. Claims 1-8, 11-12, 14-17, 19-20, 22, and 30-33 are pending in this US patent application. Claims 1-8 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 07/21/2025.
Claims 11-12, 14-17, 19-20, 22, and 30-33 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statements filed in this application on 10/02/2024, 02/25/2025, and 07/25/2025 have been received and considered.
Withdrawn Objections/Rejections
All objections to and rejections of claims 13, 18, and 21 set forth in the previous Office action are withdrawn in light of the amendment of 12/29/2025, which canceled these claims.
The rejections of the claims under 35 U.S.C. 112(b) as being indefinite for incorporating a variety of indefinite language as set forth in the previous Office action are withdrawn in light of the amendment of 12/29/2025, which corrected the indefinite language.
Claim Interpretation
Amended claim 11 recites a step of culturing hiPSCs in 3D-suspension conditions “to form mammospheres” and culturing mammospheres in 3D-suspension conditions “to generate the lactocytes.” The phrases “to form mammospheres” and “to generate the lactocytes” represent the intended results of the positively recited steps of “culturing hiPSCs in 3D-suspension conditions” and “culturing the mammospheres in the 3D-suspension conditions,” respectively. A clause in a method claim does not receive weight when it simply expresses the intended result of a process step positively recited. See MPEP § 2111.04. As such, any prior art that teaches the positively recited steps of claim 11 will be interpreted to read on the entirety of claim 11, regardless of whether the prior art specifically recites “mammospheres” or “lactocytes.”
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.
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) 11-12, 14-17, 19-20, and 22 remain rejected, and claims 30-33 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over international patent application publication WO 2018/140647 filed by Qu et al., published 08/02/2018 (cited on the IDS filed 10/26/2022), in view of Sharma et al., J. Biomol. Structure and Dynamics 33(12): 2633-2654 (2015; cited on the IDS filed 10/26/2022).
Please note that this rejection has been slightly augmented to incorporate discussion of the newly-added limitations in the claims of 12/29/2025. However, because the basis of the rejection is unchanged, the rejection has been maintained.
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 method includes culturing induced pluripotent stem cells (iPSCs) in a culture medium, which can be MammoCult, for about 8-12 days to generate embryoid bodies (EBs) (page 2, lines 11-15; cf. claim 31; cf. step A)i) of claim 11; the Examiner notes that any container in which culturing takes place may be interpreted as “a bioreactor”). This culturing step takes place in ultra-low attachment plates (i.e., in 3D-suspension culture; page 3, lines 25-28; cf. step A) of claim 11; the Examiner notes that the embryoid bodies may be interpreted as “mammospheres” and “lactocytes”). Prior to use, the iPSCs are maintained in mTeSR1 medium (page 19, lines 17-23; cf. step A)i) of claim 12; the Examiner notes that mTeSR1 medium contains the ingredients recited in step A)i) of instant claim 12) and are then suspended in the complete MammoCult medium, which contained the basal medium, proliferation supplements, heparin, and hydrocortisone, for EB formation (page 20, lines 3-6; cf. step A) of claim 11 and A)i) of claim 12). The EBs are then 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 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 and 32-33 and steps ii) and iii) of claim 12; the Examiner notes that the teaching of “complete EpiCultB medium” indicates that the medium contains the basal EpiCult medium and the EpiCult proliferation supplement). The method produces mammary cell organoids (page 3, line 1; cf. step A) of claim 11).
However, Qu does not 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 and 32-33). One step of the Western blotting procedure involved the addition of skim milk for blocking (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, it would have been obvious to one of ordinary skill in the art 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 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 valuable information regarding the production of milk proteins from mammary organoids. 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.
While Qu does not teach that the iPSCs are maintained in mTeSR medium for two days prior to EB formation as recited in instant claim 12 or that the formation of EBs takes place for 42 days as recited in instant claim 30, the recited incubation times would be within the realm of routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 part II A. It would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal times for which to incubate the iPSCs and EBs because the time period for which cells are cultured is an art-recognized, result-effective variable known to affect the number of available cells, which would have been optimized in the art to provide the desired number of cells.
Therefore, claims 11-12, 14-17, 19-20, 22, and 30-33 are rendered obvious by Qu in view of Sharma and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 11-12, 14-17, 19-20, and 22 remain provisionally rejected, and claims 30-33 are newly provisionally rejected as necessitated by amendment on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 15, and 17-20 of copending Application No. 18/705359 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of ‘359 are narrower than the instant claims. As such, the instant claims are ‘anticipated’ by the cited claims of ‘359 and are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 11-12, 14-17, 19-20, and 22 remain provisionally rejected, and claims 30-33 are newly provisionally rejected as necessitated by amendment on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 9-10, 12, 14, 16, 19-27, and 29 of copending Application No. 18/705367 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of ‘367 are narrower than the instant claims. As such, the instant claims are ‘anticipated’ by the cited claims of ‘367 and are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 11-12, 14-17, 19-20, and 22 remain provisionally rejected, and claims 30-33 are newly provisionally rejected as necessitated by amendment on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 and 19-21 of copending Application No. 18/705371 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of ‘371 are narrower than the instant claims. As such, the instant claims are ‘anticipated’ by the cited claims of ‘371 and are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 11-12, 14-17, 19-20, and 22 remain provisionally rejected, and claims 30-33 are newly provisionally rejected as necessitated by amendment on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 13-21, and 23-29 of copending Application No. 18/705374 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of ‘374 are narrower than the instant claims. As such, the instant claims are ‘anticipated’ by the cited claims of ‘374 and are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 11-12, 14-17, 19-20, and 22 remain provisionally rejected, and claims 30-33 are newly provisionally rejected as necessitated by amendment on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/705362 in view of international patent application publication WO 2018/140647 filed by Qu et al., published 08/02/2018 (cited on the IDS filed 10/26/2022), in view of Sharma et al., J. Biomol. Structure and Dynamics 33(12): 2633-2654 (2015; cited on the IDS filed 10/26/2022), and Chen et al., Nat. Methods 8(5): 424-431 (2011).
The cited claims of ‘362 recite a method that is broader than the method recited in the instant claims but does not recite certain limitations that are instantly recited. However, the additional limitations found in the instant claims are taught in Qu, Sharma, and Chen, as discussed extensively above. As such, the instant claims are ‘rendered obvious’ by the cited claims of 362 in view of Qu, Sharma, and Chen and are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection.
Claims 11-12, 14-17, 19-20, and 22 remain provisionally rejected, and claims 30-33 are newly provisionally rejected as necessitated by amendment on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 17/996943 in view of international patent application publication WO 2018/140647 filed by Qu et al., published 08/02/2018 (cited on the IDS filed 10/26/2022), and Chen et al., Nat. Methods 8(5): 424-431 (2011).
The cited claims of ‘943 recite a method that encompasses the method recited in the instant claims, but the method recited in the instant claims includes numerous additional details. However, these additional details are taught in the Qu and Chen references discussed extensively above. As such, the instant claims are ‘rendered obvious’ by the cited claims of ‘943 in view of Qu and Chen and are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant has traversed the above rejection of the claims under 35 U.S.C. 103 as being unpatentable over Qu in view of Sharma. Applicant states that Qu and Sharma do not disclose using 3D suspension conditions throughout the entire process to generate lactocytes in a single step (remarks, pages 9-12). This argument has been fully considered but has not been found persuasive.
The Examiner notes that claim 11 does not, as Applicant asserts, preclude the use of a floating gel matrix during the process or require only “a single step” for the process. Claim 11 is recited using open-ended, “comprising” language, and so the presence of additional steps in a prior art method does not make the prior art unable to read on the claim. The claim also does not state that other culture conditions may be used outside of the “at least 10 days” for culturing mammospheres in 3D suspension conditions. 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, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant states that the claimed method allows for secretion of the milk like product outside of the cells into free medium, which is suitable for large-scale production of milk, unlike Qu’s method. Applicant states that the purpose of Qu is different from the purpose of the claimed method (remarks, pages 9-13). These arguments have been fully considered but have not been found persuasive.
The Examiner notes that the instant claims do not require the secretion “into free medium” or anything about large-scale production of the milk-like product. 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, 26 USPQ2d 1057 (Fed. Cir. 1993). The purpose of Qu’s invention is also not relevant to the steps of the instantly claimed method, which are rendered obvious by Qu in view of Sharma. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant asks that the double patenting rejections be withdrawn or held in abeyance until the claims are otherwise allowable (remarks, pages 13-14). The Examiner notes that the double patenting rejections will remain of record until overcome, for example, by amendment of either the instant claims or the copending claims or by the filing of a terminal disclaimer.
Therefore, the Examiner has maintained the rejections presented above.
Conclusion
No claims are allowed.
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 Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 04/02/2026