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 1-11 and 13) in the reply filed on 11/5/2025 is acknowledged.
Claims 12 and 14-21 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 1-11 and 13 have been considered on the merits.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Written Description
Claims 1-11 and 13 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.
Claim 1 discloses a method for generating highly potent stem cells from somatic cells comprising; subjecting a population of somatic cells to partial protease digestion, preparing a cell suspension of the somatic cells in a medium, subjecting the cell suspension to ANY environmental pressures sufficient to erase epigenetic programming, and transferring the cells to a growth medium to generate highly potent stem cells.
The scope of “environmental pressures” of claim 1 is therefore extremely broad to encompass any known stress to the somatic cells. As the claim requires that the environmental pressures need to erase epigenetic programming, there would be a specific condition including parameters (e.g. an amount and duration of the energy, etc.) exerted by the environmental pressures to achieve the claimed result of erasing epigenetic programming.
The “environmental pressures” is further limited to one or more of acoustic energy, a change in chemical composition, electromagnetic energy, mechanical stress, thermal stress or any combination thereof (claim 2); or acoustic energy, mechanical stress, and thermal stress (claim 7).
The instant claims do not require any specific parameters or conditions for each of these listed species of environmental pressures, but discloses only the outcome of the exposing the cells to the environmental pressures, i.e. erasure of epigenetic programming.
The terms “acoustic energy”, “a change in chemical composition”, “electromagnetic energy”, “mechanical stress” and “thermal stress” disclosed in claims 2 and 7 are extremely broad to encompass any sound, any electromagnetic energy, any change in chemical composition, any stress that is mechanical or thermal nature would be encompassed by the claimed terms.
The scope of “acoustic energy” does not limit to ultrasonic wave as exemplified in the instant specification. Rather it encompasses any sound and there is no description how to achieve the intended outcome using any sound energy. However, the specification does not provide sufficient written description to the entire scope of the “acoustic energy” that can erase epigenetic programming of the cells.
The scope of “a change in chemical composition” is extremely broad as it would encompass from a mere addition of a factor or ingredient in the culture medium to genetic engineering of the cells. There is no disclosure what type of change in chemical composition would necessarily and sufficiently produce the claimed cells from somatic cells. It appears that there is only a single example of “a change in chemical composition”, i.e. ATP in the medium (claim 9).
The scope of “mechanical stress” required in claim 1 is extensive. While pipetting is exemplified in the specification, however, the scope of “mechanical stress” is not limited to pipetting and there is no guidance how to produce the claimed outcome of erasing epigenetic programming by any known mechanical stress in the art.
The scope of “electromagnetic energy” is broad as it would encompass any light including visible light, X-ray, UV light, microwave or radio wave, etc. The instant specification fails to provide parameters for these species of electromagnetic energy in order to obtain the desired outcome of erasing epigenetic programming to produce highly potent stem cells from somatic cells.
Similarly, there is no sufficient written description with regard to the range of temperature (thermal stress) to be considered as sufficient to erase epigenetic programming. It is well known in the art that cells let alone somatic cells would behave differently to the temperature expressing heat shock proteins. There is no guidance with regard to the range of temperature to be considered as “thermal stress” as claimed.
The instant specification does not provide sufficient written description to the parameters or conditions of the environmental pressures that would render the pressures for the intended results of erasing epigenetic programming to determine that applicant has a possession on the entire scope of the claimed environmental pressures.
The instant specification discloses various embodiments that require a series of ultrasound, pipetting followed by heat and/or cold shock (paras. [0125]-[0127]). It appears that the protocol for erasing epigenetic programming by environmental pressures (so called “Janus protocol”; para.[0098]) is a sequence of cavitation (ultrasound), high temperature (heat shock), low temperature (cold shock) and protease digestion.
It is noted that the instant specification discusses “Janus protocol”, and the protocol appears to be disclosed in para. [0363a] and the cell engineering protocol involves specific steps for producing cunctipotent cells, early zygote/oocyte and PGC cells. However, the specification does not provide any other than the specific protocol disclosed in the paragraph [0343a].
There is no other disclosure with regard to the conditions that can be used for the series of environmental pressures (e.g. strength, duration, temperatures, etc.). As the claims do not disclose any parameters/conditions for the environmental pressures to achieve the erasure of epigenetic programming, the scope of the environmental pressures would be extensive combinations of each individual condition, and yet, there is no guidance other than a single example of the specific condition for generating the claimed “highly potent” stem cells from somatic cells.
Therefore, the scope of the instant claims is broad to encompass that any one of the environmental pressures would sufficiently erase epigenetic programming under a certain condition. However, the specification fails to provide sufficient written description what would be sufficient for any one of the known environmental pressures encompassed by the instant claims.
Claims 5-6 disclose that the claimed method would product totipotent or cunctipotent stem cells. The instant specification provides the definition to the term “totipotent” referring to a cell that has the potential to develop into any cell found in a body, such as a body of a mammal. However, there is no definition given to the term “cunctipotent” and thus, the term “cunctipotent” is not known in the art and the instant specification does not provide any written description how to determine what kind of stem cells would be considered as “cunctipotent”. It is noted that Example 1 of the instant specification is directed to produce cunctipotent cells and Example 2 is directed to produce pluripotent stem cells. Paragraphs [0287-0292] disclose that the engineered cells are confirmed and assessed for the cunctipotency as well as pluripotency. However, these paragraphs are silent how the cells are determined as cunctipotent, rather the disclosure appears to be directed to pluripotency (see para. [0292]).
There is no sufficient written description how to determine the engineered cells are totipotent or cunctipotent. The instant specification discloses that Epinul cells are positive for nuclear Oct-4, Oct-4A, Nanog, Sox-2, and TERT detected by RT-PCR and immunostaining (para. [0100]), and these markers are known to be pluripotent stem cell or embryonic stem cell markers (see Kim at para. [0140]).
M.P.E.P. §2163 states “To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.”
M.P.E.P. § 2163 also recites, “An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention… one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process.” and further, “The description needed to satisfy the requirements of 35 U.S.C. 112 "varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084.< Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art. In most technologies which are mature, and wherein the knowledge and level of skill in the art is high, a written description question should not be raised for claims >present in the application when originally filed,< even if the specification discloses only a method of making the invention and the function of the invention. See, e.g., In re Hayes Microcomputer Products, Inc. Patent Litigation, 982 F.2d 1527, 1534-35, 25 USPQ2d 1241, 1246 (Fed. Cir. 1992) ("One skilled in the art would know how to program a microprocessor to perform the necessary steps described in the specification. Thus, an inventor is not required to describe every detail of his invention. An applicant's disclosure obligation varies according to the art to which the invention pertains. Disclosing a microprocessor capable of performing certain functions is sufficient to satisfy the requirement of section 112, first paragraph, when one skilled in the relevant art would understand what is intended and know how to carry it out."). In contrast, for inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession.”
Based on the above discussion, it is the Examiner’s position that the instant specification failed to provide sufficient written description to support the entire scope of the claimed invention.
Scope of Enablement
Claim 6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for producing the highly potent stem cells that are totipotent, does not reasonably provide enablement for producing cunctipotent cells. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized in In re Wands, 858 F.2d 731, 737, 8 USPQd 1400, 1404 (Fed. Cir. 1988) (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. While all of these factors are considered, a sufficient number are discussed below so as to create a prima facie case.
The instant claims disclose a method for generating highly potent stem cells from somatic cells comprising; subjecting a population of somatic cells to partial protease digestion, suspending the cells in a medium, exposing the cell suspension to environmental pressures sufficient to erase epigenetic programming, and transferring the cells to a growth medium to generate highly potent stem cells, and the environmental pressures comprise one or more of acoustic energy, a change in chemical composition, electromagnetic energy, mechanical stress, thermal stress or any combination thereof (claim 2); or acoustic energy, mechanical stress, and thermal stress (claim 7).
Claim 6 discloses that the claimed method would product totipotent or cunctipotent stem cells. The instant specification provides the definition to the term “totipotent” referring to a cell that has the potential to develop into any cell found in a body, such as a body of a mammal. There is no disclosure in the instant specification that the engineered cells would have the capability to develop into any cell. Rather, the specification appears to disclose that the engineered cells have pluripotency.
As discussed below, it is not clear if totipotent stem cells are different from cunctipotent stem cells in the application as it appears these two terms are used interchangeably. However, if they are two different sets of stem cells produced by the claimed invention, then the instant specification fails to provide enabling disclosure to produce “cunctipotent” stem cells by using the claimed method.
Vacanti et al. (US2015/0110749; IDS ref.) teach that environmental stresses or stimuli demethylate regions of the genome associated with dedifferentiation causing the cells to display markers of known dedifferentiation pathways (para. [0045]). Vacanti et al. also teach that environmental stimuli includes trauma, mechanical stimuli, chemical exposure, ultrasonic stimulation, oxygen-deprivation, nutrient-deprivation, radiation, exposure to extreme temperatures, etc. (para. [0084]). These environmental stresses or stimuli taught by Vacanti et al. would produce pluripotent stem cells (para. [0005]) or totipotent stem cells (para. [0073]).
Kim (US 2017/0327814; IDS ref.) teach a method of producing pluripotent stem cells from somatic cells such as fibroblasts using ultrasonic wave energy.
Baek et al. (2014, ACS Nano; IDS ref. of the parent case 15/805020) teach that somatic cells can be reprogrammed into a pluripotent stem cells by electromagnetic fields (see entire document).
The specification discloses that the engineered stem cells are different from the pluripotent stem cell or embryonic stem cells by virtue of the pre-embryonic, germline stem cell phenotype (para. [0098]). Thus, the claimed method would produce stem cells having pre-embryonic and germline stem cell phenotype. However, there is disclosure in the specification what these pre-embryonic and germline stem cell phenotype or markers.
There is no definition given to the term “cunctipotent” in the instant specification and the “cunctipotent cell” is not known in the art at the time of filing and the instant specification does not provide criteria how to determine the engineered cells as cunctipotent.
While the above cited references utilize “environmental pressures” to demethylate DNA for epigenetic erasure to dedifferentiate somatic cells to pluripotent stem cells, however, none discussed any potential of generating “cunctipotent” stem cells as claimed.
There is no prior art teaching to support that the production of “cunctipotent” stem cells by using any environmental pressures as claimed. The term “cunctipotent stem cell” in claim 6 is not utilized in the art and there is no definition given in the instant specification, and thus, there is no way to determine whether or not the cells produced by the claimed method would belong to the alleged “cunctipotent” stem cells. Since the term “highly potent stem cells” is not particularly defined, and thus, the scope of the terms is understood any “stem cells” produced by the environmental pressures, the scope of the “highly potent stem cells” would encompass alleged “cunctipotent”, totipotent, pluripotent, or multipotent stem cells. As discussed above, the production of pluripotent stem cells from somatic cells using environmental pressures sufficient to erase epigenetic programming is known in the art.
It is understood that only specific parameters/conditions of the environmental pressures were able to produce pluripotent stem cells in the prior art discussed, and only the specific protocol (i.e. “Janus protocol”) of the instant application would be sufficiently and necessarily produce claimed “cunctipotent” cells. However, the specification failed to show how the produced cells are considered as claimed “cunctipotent” stem cells.
Thus, it is highly unpredictable that any environmental pressures at any condition would be sufficient to erase epigenetic programming to produce cunctipotent cells without undue experimentations. Considering highly unpredictable nature of dedifferentiation of somatic cells into the claimed stem cells, it is not conceivable that any condition/parameter of environmental pressures would be able to produce the claimed outcome other than the specific protocol (Janus protocol) disclosed in the instant specification.
The instant specification discloses a specific protocol involves 19 steps for producing “cunctipotent cells”, early zygote/oocyte and PGC cells according to the paragraph [0343a]. While these steps are specifically producing the claimed cells, however, there is no example, guidance or working embodiments in the instant specification showing that the produced cells are cunctipotent.
The level of one of ordinary skill in the art at the time of invention was advanced, being that of a person holding a Ph.D. or an M.D.; however, because of the immaturity of the art, and its unpredictability and limited disclosure in the specification, one of skill in the art at the time of invention by Applicant would not have been able to make and/or use the invention claimed, to its fully-claimed scope, without undue experimentation.
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 1-11 and 13 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 pre-AIA the applicant regards as the invention.
Claim 1 discloses the term “highly potent stem cell”. The term "highly potent" in the claims is a relative term which renders the claim indefinite. The term "highly potent" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 6 discloses the term “cunctipotent”, and it appears that the instant specification utilizes the term interchangeable with the term “totipotent”. It is not clear if the term is intended to point the same meaning of “totipotent”, or if not, what the intended scope of the “cunctipotent” cell is. The term “cunctipotent cell” does not appear in the prior art search, and thus, it appears the term is not utilized in the art. There is no particular definition given in the instant specification. Clarification is required. For search purpose, the term “cunctipotent” is interpreted the same as “totipotent”.
Claim 8 discloses a wherein clause directed to the series of ultrasonic and pipetting steps being followed by a heat shock step and a cold shock step. It is not clear if this is directed to the step of exposing the cell suspension to environmental pressures or it is directed to a separate step in addition to the steps of claim 1. Clarification is required.
Claim 9 discloses the term “the medium”. It is not clear if the “medium” refers to “a medium” in the step of preparing a cell suspension or “a growth medium” in the step of transferring the cells. Clarification is required.
Claim 13 discloses the term “environmental factors”. It is not clear what subject matter this term intends to point out. Is this term different from “environmental pressures” of claim 10 or this is meant to be a differentiation factor? Clarification is required. The language of a claim must make it clear what subject matter the claim encompasses to adequately delineate its "metes and bounds".
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (WO 2016/089178, IDS ref.; English translation is relied on US 2017/0327814, supra) in view of Vacanti et al. (supra) in further view of Chatterjee et al. (2016, Methods Mol Biol.; IDS ref.)
Kim teaches a method of producing pluripotent cells by applying energy such as ultrasonic waves to differentiated cells (i.e. somatic cells) including human dermal fibroblast cells (see abstract; para. [0100]).
Kim teaches that a cell culture medium and differentiated cells are mixed and energy is applied to the resulting mixture (para. [0085]), and these teachings meet the step of suspending the cells in a medium and exposing the cell suspension to environmental pressures.
Regarding the limitation of “environmental pressures sufficient to erase epigenetic programming”, since the method steps of Kim are able to produce pluripotent cells (so-called “Physics cells”, see para. [0084]), the ultrasonic waves utilized in the method of Kim are considered to meet the limitation.
Regarding the step of subjecting a population of somatic cells to a partial protease digestion (claim 1), Kim do not particularly teach the limitation.
However, it is extremely well known in the art that the differentiated cells utilized in Kim’s method (i.e. human dermal fibroblasts) are typically grown as an adherent culture (monolayer culture), and the fibroblasts need to be harvested in order to carry out the steps taught by Kim. As Kim teach that the method utilize a suspension culture to form spheroids (para. 118), one skilled in the art would recognize that the fibroblasts would be treated with a protease/proteinase (e.g. trypsin) for dissociation and a suspension culture. Thus, it would have been obvious to a person skilled in the art to treat the human dermal fibroblasts of Kim with a proteinase (e.g. trypsin) to partially digest and release the cells from the culture plate prior to mix the cells with the cell culture medium (i.e. human ES cell medium; see Fig. 1; para. [0121]) for suspension culture to form spheroids.
Regarding the step of transferring the cells to a growth medium to generate highly potent stem cells, Kim teach that the viable cells after the ultrasound stimulation were selected and cultured for 6 days in human ES cell culture medium (para. [0121]), and this step is considered to meet the limitation.
Regarding the wherein clause of claim 2, it is considered that the limitation is directed to the results of the ultrasonic wave energy treatment as environmental pressures. Since Kim teach the same ultrasonic wave energy that is capable of producing pluripotent stem cells from human dermal fibroblast, the ultrasonic wave energy or ultrasound stimulation taught by Kim would meet the limitation of claim 2.
Regarding claims 3-4, the human dermal fibroblasts of Kim meet the limitations.
Regarding claims 5-6 directed to the highly potent stem cell being totipotent or cunctipotent cells, while Kim does not teach the limitations, however, as the Kim’s method is identical to the claimed method, the results are expected the same. Thus, the produced cells by the Kim’s method would include totipotent or cunctipotent cells. This is supported by the teaching of Vacanti et al. Vacanti et al. teach that the reprogramming somatic cells by using stress including mechanical stimuli, chemical exposure, ultrasonic stimulation, extreme temperature, etc. can produce totipotent stem cells (para. 162, 184, 231; p.52, claim 75, 86-87 and 90). It is noted that the term “cunctipotent” is interpreted the same as “totipotent”. Thus, it is the Examiner’s position that the method of Kim in view of Vacanti et al. would meet the limitations of claims 5-6.
Regarding the acoustic energy, mechanical stress and thermal stress (claim 7), Kim does not particularly teach the limitation.
Vacanti et al. teach a method of reprogramming somatic cells to pluripotent stem cells by using environmental stimuli including ultrasonic stimulation (para. [0005], [0006], [0084]), and the environmental stimuli include any unphysiological stress in tissue or cell culture such as mechanical stimuli, chemical exposure, ultrasonic stimulation, exposure to extreme temperatures, dissociation, trituration, physical stress, etc. and multiple environmental stimuli can be applied to a cell concurrently or separately (para. [0084]).
It would have been obvious to a person skilled in the art to use multiple environmental stimuli including ultrasonic stimulation and trituration/dissociation (i.e. pipetting; mechanical stress), and extreme temperature (i.e. thermal stress) for the method of Kim based on the teaching of Vacanti et al. with a reasonable expectation of success.
Regarding claim 8 directed to the cell suspension being subjected to acoustic energy and mechanical stress prior to subjecting to thermal stress, Kim in view of Vacanti et al. do not teach the limitation.
However, it would have been prima facie obvious to a person skilled in the art to carry out the steps in any order, and thus, the acoustic energy and mechanical stress can be applied to the cells prior to thermal stress in the absence of any evidence to the contrary.
M.P.E.P. § 2144 recites, “The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law…If the facts in a prior legal decision are sufficiently similar to those in an application under examination, the examiner may use the rationale used by the court.” In In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946), the court found that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930), the court found that selection of any order of mixing ingredients is prima facie obvious.
Regarding the presence of ATP in a culture medium for the step of applying environmental pressure (claim 9), Kim do not teach the limitation.
Vacanti et al. teach the use of ATP to induce the generation of pluripotent cells (para. [0091]).
It would have been obvious to a person skilled in the art to use ATP as taught by Vacanti et al. for the method of Kim with a reasonable expectation of success since ATP is useful in the method of producing pluripotent stem cells from somatic cells using environmental stimuli as taught by Vacanti et al.
Regarding the culture medium with LIF (claim 10), Kim do not teach the limitation. However, it is known in the art that induced pluripotent stem cells derived from somatic cells (iPSCs) are cultured in high glucose DMEM, and recombinant Leukemia Inhibitory Factor (LIF) according to Chatterjee et al. (see p.4, 2.3. Medium and Growth factors; (m) iPS cell complete medium). Thus, it would have been obvious to a person skilled in the art to use high glucose for the ES cell culture medium of Kim with a reasonable expectation of success.
Regarding claim 11 directed to the step of treating the cell suspension with proteinase K after subjecting the cell suspension to the environmental pressure and before transferring the cells to the growth medium, Kim teach that DNA was extracted from the Physics spheroids (i.e. cell suspension after ultrasonic stimuli) by using proteinase K and the methylation of OCT3/4 and NANOG DNAs in the Physics spheroid was analyzed (para. 146). This teaching would meet the limitation of claim 11.
Regarding the claims directed to the step of differentiating the highly potent stem cells (claim 13), Kim teach in vitro differentiation of Physics cells into a neuronal or cardiac lineage (see Example 4).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631