DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to claims filed 8/19/2026.
Claims 1-6, 8, 13, 15 and 17-20 are pending.
This application is a 371 filing of PCT/EP2022/080086 filed 10/27/2022 which claims benefit to EP21205096.7 filed 10/27/2021 which is filed in English.
Information Disclosure Statement
An information disclosure statement filed 10/12/2026 has been identified and the documents considered. The corresponding signed and initialed PTO Form 1449 has been mailed with this action. Initials indicate that the document has been considered. The document not provided with an English translation has not been considered.
Response to Amendments
Applicants’ amendments have been effective in overcoming several of the objections and rejections under 35 USC 112, second paragraph. Those maintained are so noted as maintained. New objections and 112 second rejections are marked as new.
The rejections under 35 USC 112, 4th paragraph are overcome.
It is newly noted that in fact the double patenting rejection based upon 18/705,374 should be extended to now amended claim 1. As this rejection could have bene made in the previous action, this action is non-final.
Claim Objections
Claims 2, 5, 8, 9 and 18-20 are objected to because of the following informalities: Claim 1 part B is newly objected based on amendment for reciting “RA is added to the culture medium”. The claim construct simultaneously indicates the cells are cultured for 10 days without RA and RA is then added and that the culture medium already comprises the RA from the start. It is clear from the disclosure that the intent is that the cells are cultured in cultured medium and after 10 days until day 15 cultured in RA. This can be corrected by reciting in step A that the cells are cultured in culture medium and then moving the phrase beginning with “wherein RA is added to the culture medium” to part A). This is true of claims 8 and 9.
Claim 18 is newly objected to based on amendment for omission of a preposition (should be “in”) prior to “a 3D culture system” in line 6.
It is noted that once an abbreviation is provided, thereafter reference to the abbreviation should be used for consistency. This is true of mammospheres and embryoid bodies in claim 4, 5, 18, 19 and 20, for example. This objection is maintained. This means that once the abbreviation is provided, only the abbreviation should be used.
Appropriate correction is required.
Claim Rejections - 35 USC § 112, second paragraph
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 2, 4 and 17-19 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 2 as amended as a whole lacks clarity. The claim recites steps said to be part of A) in claim 1 but there is no indication of the overlap. It is not clear if this is done in concert with the already recited steps of claim 1 or if they are ancillary. In other words, the cells are cultured to produce EB and the relationship with the produced non-neural ectoderm cells is not clear. These appear as two separate processes.
Claim 4 as amended lacks proper antecedent basis for the recitation of “the EBs” in part (ii). There are EBs in part A of claim 1 and in part B (i) of claim 4 and the claim does not clarify to which the reference intends.
Claim 17 remains rejected as vague and indefinite in that the metes and bounds of the term “derived from” are unclear. It is unclear the nature and number of steps required to obtained a “derivative” of miPSCs. The term implies a number of different steps that may or may not result in a change in the functional characteristics of the organoids from the source that it is “derived from”.
Claims 18 and 19 are meant to limit claim 17. However, the overlap between the steps of claim 17 and that of claims 18 and 19 are unclear. This rejection is maintained for its basis and reworded based upon applicants’ amendment where necessary. These claims recite steps with little overlap. First, claim 17 refers to miPSC and claims 18 and 19 to hiPSC which confuses whether there is overlap between the claims. Secondly, claim 18 leads to formation of non-neural ectoderms and then mammospheres and claim 19 to EB but it is unclear how this relates to the lactocyte mammary like gland organoids. Finally, the claims conclude with formation of lactocytes which are milk producing cells. However, lactocytes are not mentioned in claim 17 which generates lactocyte mammary like gland organoids. While these may be related, the claims do not provide a clear indication of how.
Response to Arguments
The rejection to claim 17 is maintained. Applicants argue that the term “derived from” can be formulated from the disclosure as steps to culture miPSC to form the organoids is provided for in the disclosure. This rejection is not due to lack of description but rather clarity of the term “derived from”. It has been determined that this term is unclear as this implies a non-specific relationship between the starting element and the end element wherein the steps and process involved in derivatives is not clear. A claim is definite if it informs those skilled in the art about the scope of the invention with reasonable certainty wherein the claim leaves the scope to guesswork. There is no clear unambiguous meaning of how to derive the organoid from the miPSC. The metes and bounds of the process of deriving are not clear.
Claim Rejections - 35 USC § 112, first paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-6, 8, 13, 15 and 17-20 are rejected 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 rejection is maintained. The issues have been updated to reflect the amended claims wherein some details have been added. The following specifics remain.
The instant claims are drawn to a method of reprogramming cells to form mammary gland cells (claim 1) and a mammalian milk-like product). Hence, the claims are directed to cell reprogramming in vitro. The following issues with the claims and description exist.
Claim 1 part B) remains rejected as lacking description as the claim is drawn to the goal of generating a population of mammary gland cells without steps to achieve this. It appears that elements in claims 3-5 might be necessary to accomplish this goal but the claims simply recite “growing the EBs to generate a population of mammary gland cells”. Claims 3-5 indicate that a step of growing is not enough. Claims 10-13 remain rejected as they recite properties that require these steps to lead to the formation of the mammary gland cells.
Claim 2 is newly rejected for reciting steps to lead to non-neural ectoderm. It appears that the steps overlap with those of claim 1 based upon a reading of the disclosure.
[¶0258-259] A)i) is defined as follows: [0259] i) generation of embryoid bodies (EBs) from hiPSCs by incubation in standard iPSC medium E8 comprising DMEM/F12, L-ascorbic acid-2-phosphate magnesium, sodium selenium, FGF2, insulin, NaHCO.sub.3 and transferrin, TGFβ1 or NODAL for two days, and producing mEBs (mammospheres) highly enriched in non-neural ectodermal cells by incubation of EBs in MammoCultB medium supplemented with MammoCult proliferation supplement, hydrocortisone and heparin for 10 days
Hence the steps in claim 2 appear to be a necessary part of claim 1 and their omission leads to a missing component in claim 1.
Claim 15 remains rejected for reciting a goal that lacks steps. The claim indicate similar to claim 1 a goal without the means to achieve this goal of forming lactocyte mammary like gland organoids form the mammary gland cells. This is true of claim 17 that states “generating” lactocyte mammary like gland organoids from mIPSC. Similarly, claim 17 recites “secreting the mammalian milk like product from the lactocyte mammary gland like organoids. Neither of these goals recite steps.
It is not enough to indicate what applicants would like to have happened without the means to accomplish the goals.
From the previous rejection-
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Critical elements are provided in the disclosure. The scope of the invention is extremely broad in that the base steps are broad and lack specificity of steps. Dependent claims provide some specificity of steps, however, the claim construction is inconsistent and confusing leading to gaps. Some of the issues have been presented above wherein besides clarification, the claims lack adequate. These issues are presented below. Specifically, the claims broadly claim the methods with details more specifically provided in claims 19 and 20 that appear to be necessary to reprogram the hiPSC cells. These steps are shown below. However, as set forth above it is not clear how the steps of claim 19 and 20 fit into claim 17.
Claims 1-13, 15, 17 and 18 lack details that as set forth in the disclosure are necessary to compete the method. To this end, the MPEP provides such guidance (emphasis added). If the application as filed does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. For example, if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function. Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Compare Fonar, 107 F.3d at 1549, 41 USPQ2d at 1805 (disclosure of software function adequate in that art). As recited, claims 1-13, 15, 17 and 18 lack critical steps that as shown in the disclosure are critical for the full performance of the methods.
Response to Arguments
In situations where an invention is claimed broadly, a written description rejection is appropriate to ensure that patent claims are commensurate in scope with the examples and guidance provided in the specification. This ensures that the claims are directed to subject matter which applicants possessed. In this case, applicants claim the invention broadly by claiming an outcome without claiming steps to achieve this outcome. The Federal Circuit has repeatedly emphasized that the purpose of this requirement is to ensure that the inventor was in possession of the claimed invention when the application was filed and not merely a hoped-for result.
In claim 1A) the method requires only culturing the miPSCs in RA while 1B), the claims only recite “growing the cells” to generate the mammary gland cells. The step of culturing in RA and growing the EB is not sufficient to achieve the formation of mammary gland cells neither in the disclosure or in the publication provided to demonstrate support. As set forth above, claims 3-5 provide evidence that steps aside from growing are critical. Claim 15 indicate similar to claim 1 a goal without the means to achieve this goal of forming lactocyte mammary like gland organoids form the mammary gland cells. This is true of claim 17 that states “generating” lactocyte mammary like gland organoids from mIPSC. Similarly, claim 17 recites “secreting the mammalian milk like product from the lactocyte mammary gland like organoids. Neither of these goals recite steps. It is not enough to indicate what applicants would like to have happen without the means to accomplish the goals. As well, Qu teaches that
Although neural and non-neural ectoderm cells coexist at the same embryonic stage, in vitro studies have shown that the ‘‘default’’ differentiation for iPSCs is the neural lineage (Schwartz et al., 2008). To convert iPSCs to cells and organoids specific to tissues originating from non-neural ectoderm, a protocol that first enriches non neural ectoderm cells is an essential step.
These steps like those of the disclosure require more than growth, it appears that to enrich non-neural ectoderm and then mammary gland cells, there is a twostep process that reflects that in the disclosure. Hence, it appears that the generic term of culturing in RA and growing EB cells is not sufficient but rather those steps of claims 3-5 similar to those of Qu et al are “essential steps”. Similarly, claim 17 recites steps of secreting the milk like product from the organoids. But, the steps to complete both of these are incomplete.
Claims 10-13 recites outcomes inherent in the process of the claims. Hence, they are only described by the steps of the claims. There is no process or property other than differentiating the iPSC to the mammary gland cells.
Amendments to incorporate critical subject matter into claims 1, 15 and 17 would be sufficient to overcome these rejections as well as cancellation of claims 10-13.
Double Patenting
A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
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. See 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);and, 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
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Claims 1-6, 8-13, 15 and 17-20 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-4, 13-17, 21 and 23-28 of copending Application No. 18/705,367 as view Tang et al (Stem Cell Research, 2019, pages 1-4). This rejection is amended newly.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims of copending Application No. 18/705,367. That is, the cited claims of copending Application No. 18/705,367 anticipate and fall entirely within the scope of the rejected claims of the instant application. Specifically, copending Application No. 18/705,367 recites the same steps as claim 1 and 2 of the instant application of culturing mBSCs in culture media with RA to generate EB. Different from the instant claims, copending Application No. 18/705,367 also includes BMP4 and the mBSCs of the copending claims. However, as demonstrated by Tang et al, BM-iPSC are stem cells induced from breast milk and constitute iPSC. Copending claim 12 explicitly recites that the RA is added between days 10 and 15 as the amended claims recite. These then are a subset of iPSC cells. Dependent claims 5 and 26 provide the support for instant claims 2, 3 and 5. As to claim 8, upon reconsideration, there is a single dose that is listed in the disclosure and that is 1uM (see ¶0112, 0113, 0179, 0180, 440, 490). The steps of claims 4 of the instant claims are found in claim 29. Claim 17-20 are recited in copending claims 24-27 and 29 as is claim The remainder of the claims are similar except the copending Application No. 18/705,367 includes BMP4 and mBSCs.
Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the copending Application No. 18/705,367, then two different assignees would hold a patent to the claimed invention of copending Application No. 18/705,367, and thus improperly there would be possible harassment by multiple assignees.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
Copending applications 17/997,150 and 18/705,367 overlap with the instant claims in generating mammary like gland cells with mil producing capability. However, the copending claims do not rely on retinoic acid which is a main component of the instant claims.
Copending application 18/705374 and the prior art do not teach addition of retinoic acid between day 10-15 of the culture process to produce embryoid bodies from iPSC.
The instant claims differentiate themselves from the prior art by the inclusion of retinoic acid from day 10 to day 15, this is a 5
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/MARIA MARVICH/Primary Examiner, Art Unit 1634
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