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
Claims 1-9 are currently pending in this application.
Claim Objections
Claims 1-9 are objected to because of the following informalities:
In claim 1, the preamble phrase “A manufacturing method of artificial skin” is grammatically unclear, and would be clearer if rephrased with a verb after “of”: e.g., “of making artificial skin,” “of generating artificial skin,” or “of producing artificial skin.” Alternatively, “A method of manufacturing artificial skin” would be clear as well. Similarly, each of claims 2-9 recites the related phrase “the manufacturing method of artificial skin.”
Claim Interpretation
Claim 1 recites the phrase “preparing the induced pluripotent stem cells (iPSCs) of a donor, which is interpreted to mean obtaining a population of iPSCs from a donor or donors, such as via expressing the four Yamanaka factors and via forming an embryoid body or bodies (see instant pg. 6, 4th para. ([0037]); pg. 7, 3rd para. ([0040]); pg. 8, 1 st para. ([0044])).
In claim 1, the phrase “performing differentiating” is interpreted as necessarily comprising culturing iPSCs in a differentiation cell culture medium known in the prior art at physiological conditions and for a sufficient time to create differentiated fibroblasts or keratinocytes.
In claim 1, the manufacturing step comprising co-culturing is interpreted as necessarily comprising contacting the cells together with a single cell culture medium for a duration of time at physiological conditions.
Although the order of steps is generally only limited by logic or grammar (MPEP 2111.01.II), the performing differentiating step in claim 1 is interpreted as implicitly occurring after the preparing step (see instant FIG. 13).
In the claims, the term “injecting” is interpreted to mean extruding, spraying, dribbling, or dripping the cells away from a 3D printer, such as in a solution or bioink and/or by an inkjet or via a nozzle of the 3D printer (see instant FIG. 12; pg. 14, para. 2-6 ([0069]-[0073])).
In claim 3, the term “pattern forms” is interpreted as meaning the extruded (injected) cells are made to form a pattern(s), e.g., layers, wrinkles, and/or wavy (see pg. 14, para. 6 ([0073])).
In claim 5, the DMEM of claim 4 is interpreted as further comprising Ham’s F-12 (DMEM/F12) and the fibroblast differentiating is performed for a duration of at least 21 days as recited.
In claim 6, the phrase “DMEM is added with 5% of the FBS etc.” is interpreted as meaning iPSCs are cultured in (1) DMEM comprising 5% FBS, 5 µg/mL of insulin and 10 ng/mL of EGF from the start of performing fibroblast differentiating to day 3; (2) DMEM comprising 5% FBS, 5 µg/mL of insulin, 10 ng/mL EGF and 5 ng/mL of BMP4 from day 4 to day 6; (3) DMEM comprising 5% FBS and 1% NEAA from day 7 to day 13; and (4) DMEM comprising 5% FBS, 5 µg/mL of insulin and 10 ng/mL of the EGF from day 14 to day 21; further wherein there is no BMP4 present from days 1-3 and 7-21, and no insulin or EGF present from days 7-13.
In claim 8, the DMEM of claim 7 is interpreted as further comprising Ham’s F-12 (DMEM/F12) and the keratinocyte differentiating is performed in the DMEM for 7 days, and the total duration of keratinocyte differentiating is for at least 21 days as recited.
In claim 9, the phrase “the medium is added with 2% of the FBS etc.” is interpreted as meaning iPSCs are cultured in (1) a DMEM or dkSFM medium comprising 2% FBS, 5 µg/mL of insulin, 25 ng/mL EGF, 25 ng/mL BMP4 and 1 µg/mL retinoic acid (retinol acid) from the start of performing keratinocyte differentiating to day 7; (2) a DMEM or dkSFM medium comprising 5 µg/mL of insulin, 20 ng/mL EGF and 20 ng/mL of BMP4 from day 8 to day 15; (3) a DMEM or dkSFM medium comprising 5 µg/mL of insulin, 20 ng/mL EGF and 10 ng/mL of BMP4 from day 16 to day 17; and (4) a DMEM or dkSFM medium comprising 5 µg/mL of insulin, 20 ng/mL EGF, 10 ng/mL of BMP4, 1.2 mM CaCl2 from day 18 to day 21; further wherein there is no FBS present from days 8-21 and no retinol acid present from days 16-21.
35 USC § 112(a), Scope of Enablement
Claims 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification does not enable any person, skilled in the art to which it pertains or with which it is most nearly connected to, to sequentially differentiate the same iPSCs into keratinocytes and then into fibroblasts.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). The court in Wands states that "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue.' Not 'experimentation;" (Wands, 8 USPQ2d 104). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighting many factual considerations." (Wands, 8 USPQ2d 1404).
The factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation required is “undue” include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Furthermore, the USPTO does not have laboratory facilities to test if an invention will function as claimed when working examples are not disclosed in the specification. Therefore, enablement issues are raised and discussed based on the state of knowledge pertinent to an art at the time of the invention. And thus, skepticism raised in the enablement rejections are those raised in the art by artisans of expertise.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention:
Claim 1 is directed to a method of generating an artificial skin culture comprising fibroblasts and keratinocytes by performing differentiating iPSCs into fibroblasts and keratinocytes simultaneously or sequentially.
Breadth of the claims
In claim 1, “the iPSCs” are differentiated into both fibroblasts (S120) and keratinocytes (S140) either simultaneously or sequentially. While differentiating a single cell population (the iPSCs) simultaneously into two different cell types is clear, if this is performed sequentially then reuse of the same antecedent “the iPSCs” implies a first differentiating of iPSCs into one cell type, then somehow de-differentiating or transdifferentiating them, to finally performing differentiating again (a second differentiating) into a second cell type. Thus, the breadth of the claim encompasses differentiating the same iPSCs into keratinocytes and then into fibroblasts, as well as vice versa, into fibroblasts and then into keratinocytes.
The state of the art:
Although the art teaches some differentiating fibroblasts function as mitotic fibroblast stem cells and non-terminally differentiated fibroblasts show cell fate plasticity (Bayreuther et al., J Cell Sci Suppl. 1988:10: 115-30 at Abstract, Table 1; Talbott et al., Cell Stem Cell 29: 1161-80 (2022) at pg. 1165, Overview of fibroblasts), the prior art does not teach keratinocytes can be dedifferentiated or transdifferentiated into fibroblasts. Thus, this aspect of keratinocytes in vitro must be shown to a reasonable extent so that one of the ordinary skills in the art would be able to practice the invention without any undue burden being on such Artisan.
The amount of direction and guidance and working examples provided by Applicant:
Nowhere does the specification provide any working example of a method of converting iPSC-derived keratinocytes into fibroblasts or back into stem cells capable of differentiating into fibroblasts.
Thus, there is no evidence in the instant application or the prior art of any method or culture conditions for performing differentiating iPSCs into keratinocytes and then sequentially differentiating into fibroblasts. There is no evidence in the art or the instant application that the method recited in claim 1 would predictably differentiate keratinocytes from the iPSCs and then sequentially differentiate such keratinocytes into fibroblasts, either directly or via an intermediate stage(s). Thus, extensive experimentation would be required to determine how to differentiate keratinocytes from iPSCs and then sequentially differentiate such keratinocytes into fibroblasts.
Given the lack of working examples, the limited guidance provided in the specification, the silence of the prior art, and the broad scope of the claims, undue and/or unreasonable experimentation would have been required for one skilled in the art to performed the claimed methods to produce the recited cell types sequentially in that specific order.
Claim Rejections - 35 USC § 112(b)
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 1-9 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.
In claims 1 and 3, the term “injecting” is used to mean extruding or dribbling from a 3D printer output, such as a liquid or colloid onto a flat surface (120) (pg. 14, para. 2-6 ([0069]-[0073])). However, the ordinary meaning of “injecting” means into something, e.g., into the flat plate 120. If the applicant acts as her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). In the instant case, there is no such redefinition, and, thus, the term “injecting” as used in the claims is indefinite. Claims 2 and 4-9 are included in this rejection for depending from indefinite claim 1.
Both claims 4 and 7 further comprise an additional step to the method of claim 1 of “adding” a factor to a medium not mentioned in claim 1, thus there is no clear linkage of these claims to any claim from which they depend. Claims 4 and 7 are each rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: (1) how the adding or DMEM is incorporated into the performing differentiating fibroblasts from the iPSCs (S140) step, and (2) how the adding or DMEM and dkSFM culture medium is incorporated into the performing differentiating keratinocytes from the iPSCs (S120) step.
Claims 7-8 each recites the term “dkSFM” regarding a culture medium. A person of ordinary skill in the art reading the claim would not understand the metes and bounds of a “dkSFM” medium and this term is not defined by the instant specification. If “dkSFM” is an abbreviation or reference to another term (e.g., a type of keratinocyte maintenance or differentiation medium), then the full term needs to be spelled out at least once in the claim set so that a person of ordinary skill in the art would understand the scope of the limitation.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (Kim et al., Stem Cell Research & Therapy, 2018, Vol. 9, No. 217, pp. 1-10; IDS ref.) in view of Kim2 (Kim et al., Stem Cells Int 2016: 1329459 (2016)) and Daikuara (Daikuara et al., Advanced Functional Materials, 2022, Vol. 32, pp 1-24, published 1/14/2022; IDS ref.).
The claims are interpreted as set forth in a previous section.
Regarding claims 1-2, Kim teaches a method of making an artificial skin (e.g., a skin organoid) comprising co-culturing keratinocytes and fibroblasts differentiated from iPSCs, the method comprising the steps of: (1) preparing iPSCs, (2) differentiating fibroblasts and keratinocytes from the iPSCs, and (3) producing the artificial skin by co-culturing the fibroblasts and keratinocytes after layering the keratinocytes on top of fibroblast layers (pg. 2, left col., last para, to pg. 3, left col., 1st para.; pg. 6, left col., last para., to right col., 1st para.; Fig. 4). The iPSCs in Kim (pg. 2, left col., 3rd para.) were obtained from a human donor as reported in Kim2 (Fig. 1).
Regarding claim 1, Kim does not teach using a 3D printer to extrude the cells, such as before the co-culturing step.
However Daikuara teaches 3D printing skin cells, including fibroblasts and keratinocytes using a 3D printer (Abstract, pg. 8, left col., 2nd para.; Fig. 3-5).
It would have been prima facie obvious to one of ordinary skill in the art before the effective time of filing to make the artificial skin taught by Kim using a 3D printer as known in the art to print the fibroblasts and keratinocytes. One of ordinary skill in the art with the goal of mimicking natural skin would be motivated by teaching 3D bioprinting allows spatial distribution of cells into custom-made patterns structures mimicking living skin (Abstract).
Regarding claim 2, Kim2 teaches the donor is a single human (Fig. 1).
Regarding claim 3, Kim teaches producing the artificial skin in a 3-D patterned form comprising a fibroblast layer covered by a keratinocyte layer, and, similarly, Daikuara teaches an artificial skin model made with a 3D printer by bioprinting a fibroblast compartment followed by inket printing keratinocytes (pg. 8, left col., 2nd para.).
Regarding claim 4, Kim teaches differentiating IPSCs into fibroblasts in DMEM/F12 comprising fetal bovine serum (FBS), insulin, epidermal growth factor (EGF), BMP4, and/or NEAA (FDM1 And FDM2) (pg. 2, left col., last para.).
Regarding claim 5, Kim teaches differentiating IPSCs into fibroblasts in DMEM/F12 comprising 5% fetal bovine serum (FBS) for at least 21 days wherein the DMEM/F12 is at a ratio of 3:1 from days 1-6, 1:1 from days 7-13, and 3:1 from days 14-21 (pg. 2, left col., last para.).
Regarding claim 6, Kim teaches differentiating IPSCs into fibroblasts in (1) DMEM comprising 5% FBS, 5 µg/mL of insulin and 10 ng/mL of EGF from the start of performing fibroblast differentiating to day 3; (2) DMEM comprising 5% FBS, 5 µg/mL of insulin, 10 ng/mL EGF and 5 ng/mL of BMP4 from day 4 to day 6; (3) DMEM comprising 5% FBS and 1% NEAA from day 7 to day 13; and (4) DMEM comprising 5% FBS, 5 µg/mL of insulin and 10 ng/mL of the EGF from day 14 to day 21 (pg. 2, left col., last para., to right col., 1st para.).
Regarding claims 7-8, Kim teaches differentiating IPSCs into keratinocytes in DMEM/F12 comprising FBS, insulin, retinol acid (retinoic acid), BMP4, and EGF for days 1-7 and then in dkSFM (defined keratinocyte serum-free media) from days 8-21 (KDM2 and KDM3) (pg. 2, right col., 2nd para.).
Thus, the claimed invention as a whole is prima facie obvious prior to the earliest effective filing date in the absence of evidence to the contrary.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Kim2 and Daikuara as applied above, and further in view of Moukachar (Moukachar, Ahmad 2021. “Developing a 3D bio-printed human skin model.” PhD Thesis, Cardiff University).
Regarding claim 9, Kim teaches differentiating IPSCs into keratinocytes in (1) DMEM/F12 comprising 2% FBS, 5 µg/mL insulin, 20 ng/mL EGF, 25 ng/mL BMP4 and 1 µg/mL retinol acid (retinoic acid) for the first 7 days, (2) DMEM/F12 comprising 5 µg/mL insulin, 20 ng/mL EGF, 25 ng/mL BMP4 and 1 µg/mL retinol acid (retinoic acid) from days 8-11, (3) a medium comprising dkSFM (defined keratinocyte serum-free media) and DMEM/F12 as well as 20 ng/mL EGF and 25 ng/mL BMP4 from days 12-21 (pg. 2, right col., 2nd para.).
The combination of Kim, Kim2, and Daikuara does not teach wherein the keratinocyte differentiating media: (1) comprises the added insulin continuing through days 12-21, (2) 25 ng/ml of the EGF from the differentiation start day to day 7 (instead teaching 20 ng/mL), (3) 20 ng/ml of the BMP4 from day 8 to day 15 (instead teaching 25 ng/mL), (4) 10 ng/ml of the BMP4 from day 16 to day 21 (instead teaching 25 ng/mL), (5) 1 µg/ml of the retinol acid from days 12-15 (instead ending retinoic acid supplementation earlier at day 11).
However it is with the skills of one of ordinary skill in the art to use routine optimization to adjust these timing parameters and the concentrations of EGF up from 20 to 25 ng/mL and BMP4 down from 25 to 20 and 10 ng/mL (MPEP 2144.05(II) via routine experimentation of any results effective variable.
Although the combination of Kim, Kim2, and Daikuara does not teach wherein the keratinocyte differentiating media comprises (6) 1.2 mM of the CaCl2 from day 18 to day 21, the effects of calcium concentration on cultured keratinocytes was already appreciated in the prior art as shown in Moukachar.
Moukachar teaches extracellular calcium levels affect keratinocytes during in vitro culture, with 0.3-1.8 mM Ca2+ considered normal for most epidermal layers (e.g., the outer-most, living granulosom layer) and > 1.8 mM considered high and < 0.3 mM considered low, with intermediate concentrations promoting a balance between keratinocyte lineage proliferation and differentiation (FIG. 2.1, pg. 90, pg. 65, 84; FIG. 2.4-2.9, pg. 93-94). Note a prime facie case of obviousness exists where the prior art discloses a range the overlaps the value claimed (see MPEP 2144.05).
It would have been prima facie obvious to one of ordinary skill in the art before the effective time of filing to include additional calcium in the keratinocyte differentiation medium via added CaCl2 during the end stages (later days) of keratinocyte differentiation in view of Moukachar. One of ordinary skill in the art with a goal of mimicking native skin would be motivated by Moukachar teaching this lies with a range of extracellular Ca that promotes further keratinocyte differentiation, such as for employment in 3D printed, stratified keratinocyte tissue constructs (pg. 90).
Thus, the claimed invention as a whole is prima facie obvious prior to the earliest effective filing date 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2 and 4-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/280,218 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 3 and 6 of the reference application teaches a device specially adapted for use in a method of making artificial skin using 3D printing of both fibroblasts differentiated from induced pluripotent stem cells (iPSCs) and keratinocytes differentiated from iPSCs and then co-culturing these cells in a medium.
Instant claim 1 differs in that the method further comprises preparing the iPSCs and co-culturing these cells after printing. However it is implied that the method of using the device comprises obtaining the iPSCs (i.e., preparing) and, after printing to keep the printed living cells alive by incubating the cells in a medium, i.e., coculturing. Regarding instant claim 2, reference claim 2 teaches wherein the iPSC are obtained from a single donor. Regarding instant claims 4-9, reference claims 3-8 teach identical features. This is a provisional nonstatutory double patenting rejection because the reference application claims have not in fact been patented.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/280,218 as applied above, and further in view of Kim3 (Kim et al., Biofabrication 9:025034 (2017)).
Instant claim 3 differs from the reference claims in that the method further comprises 3D printing the two cell types in pattern forms. However Kim teaches 3D printing artificial human skin in a pattern form (layered) by a single-step process of inkjet dispensing keratinocytes uniformly on top of a extrusion-printed base layer comprising fibroblasts (dermal layer) to form a multilayer construct in culture (Fig. 1 and 6). It would have been prima facie obvious to one of ordinary skill in the art to use the device of the reference claims in a method of 3D printing a keratinocyte-fibroblast layered skin construct in view of Kim teaching this rapidly and inexpensively produces human skin models resembling native skin (pg. 2, right col., 1st para.; Abstract).
Conclusion
No claim is allowed.
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/ERIC J ROGERS/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638