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 .
DETAILED ACTION
Applicant’s response filed April 28, 2025, has been considered. Rejections and/or objections not reiterated from the previous office action mailed November 8, 2024, are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The amended claims filed on April 28, 2025, have been acknowledged. Claims 3-4, 6-9, and 11-13 were cancelled. Claims 1-2, 5, and 10 were amended. Claims 1-2, 5, and 10 are pending and examined on the merits.
Priority
Acknowledgment is made of Applicant’s claim for priority from PCT/JP2017/030496 filed on August 25, 2017. While a certified copy of the patent application PCT/JP2017/030496 is provided with the instant application, a certified English translation of said patent application has not been provided.
Withdrawn Claim Rejections - 35 USC § 112
The prior rejection of claims 1, 2, and 5 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant(s) regard as their invention is withdrawn in light of Applicant’s amendments to claim 1 to recite that the composition comprises an effective amount of in vitro cultured dental pulp stem cells.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, and 5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant(s) regard as their invention. This is a new rejection made in response to Applicant’s amendments to claims 1 and 5. Applicant’s traversal has been considered but is moot in response to the new rejection.
A claim may be rendered indefinite by reference to an object that is variable. (MPEP §2173.05(b)). Claims 1 and 5 recite “an effective amount of in vitro cultured dental pulp stem cells”, which renders the claim indefinite because the DPSC cell number is defined by reference to an object that is variable and the relationship between the limitation and the object is not sufficiently defined. For example, a dosage wherein the reference object for defining an effective amount is a human infant (~2-20 kg) varies significantly compared to a reference object for defining an effective amount of an adult human (~60-80 kg) or a teenager (~30-70 kg). Furthermore, the effective amount will differ based on a multitude of variables, including administration route (intravenous and intra-artery would require different amounts of cells) and administration site (systemic intravenous administration may require a larger dose than local administration). Therefore, the metes and bounds of the DPSC cell number varies according to the multitude of unspecified variables associated with “an effective amount”. See MPEP §2173 (b), section II Miyazaki, 89 USPQ2d at 1212. In Brummer, the Board held that a limitation in a claim to a bicycle that recited “said front and rear wheels so spaced as to give a wheelbase that is between 58 percent and 75 percent of the height of the rider that the bicycle was designed for” was indefinite because the relationship of parts was not based on any known standard for sizing a bicycle to a rider, but on a rider of unspecified build. Brummer, 12 USPQ2d at 1655.
Claim 2 is also rejected because of its dependency on claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. This is a new rejection made in response to Applicant’s amendment to claims 1 and 5 that is substantially similar to a previous rejection. Any aspect of Applicant’s traversal that is relevant to the rejection as newly written is addressed below.
Claim 1 recites a “composition for liver tissue regeneration in a human, wherein the composition comprises an effective amount of in vitro cultured dental pulp stem cells isolated from human permanent tooth, whose liver tissue is to be regenerated, as an effective component, and a pharmaceutically acceptable carrier or additive.” Claim 5 recites a “composition for treatment of a human liver disease comprising an effective amount of in vitro cultured dental pulp stem cells isolated from human permanent tooth, whose liver disease is to be treated, as an effective component, and a pharmaceutically acceptable carrier or additive.” The phrases a "composition for liver tissue regeneration in a human” from claim 1 and a “composition for treatment of a human liver disease” from claim 5 are intended use limitations, which does not contain any further structural limitations with respect to the claimed human dental pulp stem cell (see MPEP §2114). The claims recite isolated and cultured dental pulp stem cells which are not markedly different from their naturally occurring counterpart. This judicial exception is not integrated into a practical application because the natural product is not linked to a particular technology. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are well-understood, routine and conventional in cell biology.
Applicant is directed to the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on 1/07/2019, which is found at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf; and the October 2019 Update: Subject Matter Eligibility, which is found at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf.
Briefly summarized here, the new guidance cites a two part test: is the claimed invention directed to a statutory class of invention (Step 1), if so then is the claimed invention as a whole directed to a law of nature, natural phenomena, or an abstract idea (i.e. set forth or described in the claim) (Step 2A, prong one), if so then is the claimed invention recite additional elements that integrate the judicial exception into a practical application (Step 2A, prong two), if not then does the claim as a whole amount to significantly more than the judicial exception (Step 2B).
In regard to Step 1, Claims 1 and 5 are drawn to a composition of matter-a cell.
In regard to Step 2A prong one, Claims 1 and 5 are drawn to a nature-based product which is not markedly different from its naturally occurring counterpart. Specifically, independent claims 1 and 5 are directed to a population of in vitro cultured dental pulp stem cells. These claims encompass isolated dental pulp stem cells, which is a naturally occurring product. Because instant claims are directed to a nature-based product, i.e., a dental pulp stem cell, the nature-based product is analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in their natural state. The specification teaches that “dental pulp stem cells can be easily collected from deciduous teeth and extracted teeth which have conventionally been discarded, such as milk teeth and wisdom teeth, those stem cells are expected to be useful for tissue generation, or for prevention or treatment of a disease” (paragraph 0003). None of the claimed compositions recite any transformation of the dental pulp stem cells that would make them materially different from those found in nature. There is no indication in the specification that isolating said cells results in the cells having any characteristics (structural, functional, or otherwise) that are different from the naturally occurring cells in their natural state.
Although the claims recite an unspecified amount of cells (effective amount), this does not change the stem cells themselves, only the number of stem cells. As such, the claimed human dental pulp stem cells are isolated from a natural source, teeth, and not materially changed from a natural product in any of the claimed compositions (claims 1 and 5). Because there is no difference between the claimed and naturally occurring cells, the claimed cells do not have markedly different characteristics, and thus are a “product of nature” exception. Accordingly, instant claims are directed to a judicial exception.
In regard to Step 2A prong two, the judicial exception is not integrated into a practical application. In particular, claims 1 and 5 recite a two additional elements- that the cells are in vitro cultured and are with a pharmaceutically acceptable carrier or additive. The term pharmaceutically acceptable carrier or additive is extremely broad and encompasses many types of sterile physiological solutions, including culturing buffers. Thus, merely placing the natural product into a generic buffer so that the cell may survive and be cultured does not add a meaningful limitation as it is a nominal extra-solution component of the claim as is a necessary precursor for all of the uses of the cell, and is nothing more than an attempt to generally link the cell product to a particular biotechnology. Furthermore, there is no time frame associated with the culturing, thus, encompassing culturing the cells for less than a minute. Clearly, culturing the natural cell in vitro and combining the natural cell in a pharmaceutically acceptable carrier or additive on its own does nothing to improve a technology, effect a particular treatment, or implement with a particular device to provide a meaningful limitation on the judicial exception.
Furthermore, this judicial exception is not integrated into a practical application because applicants do not claim any application of their dental pulp stem cells, only intended uses. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional structural limitations recited in claims 1 and 5 do not materially transform the dental pulp stem cells in any way so that they would be structurally distinct from those found in nature. Although claim 1 recites an unspecified amount of cells (effective amount), this does not change the stem cells themselves, only the number of stem cells.
In regard to Step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As stated supra, claims 1 and 5 recite two additional elements- that the cell is cultured in vitro and is with a pharmaceutically acceptable carrier or additive. As discussed above with respect to the integration of the natural product into a practical application, the additional elements of in vitro culture of the cells and of combining the cells with a pharmaceutically acceptable carrier or additive amounts to a nominal extra-solution component of the claim as is a necessary precursor for all of the uses of the cell, and is nothing more than an attempt to generally link the cell product to a particular biotechnology. Furthermore, the amount of cells does not change the stem cells themselves, only the number of stem cells.
Therefore, Claims 1 and 5 are directed to a natural cell product, that is not markedly different from its natural counterpart, is not integrated into a practical application, and does not include elements that amount to significantly more than the natural product itself and do not qualify as patent eligible subject matter under 35 U.S.C. § 101.
Response to Arguments
Applicant's arguments filed December 18, 2025, have been fully considered.
Applicant argues that the amendment to recite that the dental pulp stem cells isolated from human permanent teeth are cultured in vitro overcomes the prior 101 rejection (page 5, paragraph 7-page 6, paragraph 4).
Applicant's arguments have been fully considered but they are not persuasive.
The amendment to claims 1 and 5 to recite dental pulp stem cells isolated from human permanent teeth does not overcome the 101 rejection as applicant does not show or argue that the isolated dental pulp stem cells from a natural source (human teeth) have any characteristics (structural, functional, or otherwise) that are different from the naturally occurring cells in their natural state. As stated in the rejection above, claims 1 and 5 recite the additional element that the cells are in vitro cultured. Merely placing the natural product into a generic buffer so that the cell may survive and be cultured does not add a meaningful limitation as it is a nominal extra-solution component of the claim as is a necessary precursor for all of the uses of the cell, and is nothing more than an attempt to generally link the cell product to a particular biotechnology. Furthermore, there is no time frame associated with the culturing, thus, encompassing culturing the cells for less than a minute. Clearly, culturing the natural cell in vitro on its own does nothing to improve a technology, effect a particular treatment, or implement with a particular device to provide a meaningful limitation on the judicial exception.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ikeda et al. (Differentiation 76: 495-505. 2008). This is a new rejection made in response to Applicant’s amendment to claims 1 and 5 that is substantially similar to a previous rejection. Any aspect of Applicant’s traversal that is relevant to the rejection as newly written is addressed below.
Regarding claim 1, Ikeda teaches a composition of tooth germ progenitor cells (TGPCs; also known as dental pulp stem cells), from discarded human third molar, commonly called as wisdom teeth. The cells were isolated from dental mesenchyme (dental papilla or pulp). Ikeda teaches that they cultured the isolated TGPCs for expansion in vitro (abstract, page 496, column 1, paragraph 4, page 496, column 2, paragraphs 2-4, and Title). The specification teaches that wisdom teeth are considered to be a type of permanent tooth (paragraph 0013). TGPCs were examined by the transplantation into a carbon tetrachloride (CCl4)-treated liver injured rat to determine whether this novel cell source might be useful for cell-based therapy to treat liver diseases. The TGPCs prevented the progression of liver fibrosis in the liver of CCl4-treated rats and contributed to the restoration of liver function (abstract). Immunocompromised Fisher 344 rats aged 9 weeks were administered 1 x 107 TGPCs were transplanted by injection into the portal vein (page 498, column 2, paragraph 2). As the 1 x 107 TGPCs prevented the progression of liver fibrosis in the liver of CCl4-treated rats, this amount is considered to fall under the limitation of an effective amount.
Regarding the limitation in claims 1 and 5 directed to a pharmaceutically acceptable carrier, Ikeda teaches that PBS was injected in control mice (page 498, column 2, paragraph 2). Although not specifically stated, it would have been immediately apparent to one of ordinary skill that the TGPCs were injected in PBS to match the controls as this is a common procedure within the field.
Regarding the limitation in claim 1 “a composition for liver tissue regeneration in a human”, this limitation is considered to be an “intended use” of the claimed composition, and not found to add any structural limitations. See MPEP 2111.02. Nevertheless, Ikeda does disclose using human dental pulp stem cells to treat liver disease.
Regarding claim 2, the TGPCs injected into the rats were either induced to differentiate into hepatocyte like cells (hepatic induction) or not prior to injection (page 498, column 2, paragraph 2). Ikeda teaches that the hepatic induction procedure differentiated the cells into cells with morphological, phenotypic, and functional characteristics of hepatocytes (page 501, column 1, paragraph 1).
Regarding the limitation in claim 5 “for prevention or treatment of a human liver disease”, this limitation is considered to be an “intended use” of the claimed composition, and not found to add any structural limitations. Nevertheless, Ikeda does disclose their dental pulp stem cells could be used to treat human liver disease. Ikeda teaches that multipotent TGPCs are one of the candidates for cell-based therapy to treat liver diseases and offer unprecedented opportunities for developing therapies in treating tissue repair and regeneration. Furthermore, Ikeda specifically identifies the need for development of an effective treatment for liver fibrosis for treating patients (i.e. humans) infected with hepatitis and the potential that their method could be useful to treat hepatitis patients (paragraph 496, column 1, paragraph 1, page 502, column 2, paragraph 4-page 504, column 1, paragraph 1, and abstract).
Response to Arguments
Applicant's arguments filed April 28, 2025, are acknowledged.
Applicant argues that Ikeda only shows that their method restored liver function in rats. Applicant argues that there is no disclosure or suggestion that the liver function of humans could be restored by application of the TGPCs and there are distinct anatomical differences between rats and humans, making it unclear whether this composition would work with humans (page 6, paragraph 8-page 7, paragraph 4).
Applicant's arguments have been fully considered but they are not persuasive.
As stated supra, regarding the limitation in claim 1 “a composition for liver tissue regeneration in a human” and claim 5 “for prevention or treatment of a human liver disease”, these limitations are considered to be an “intended use” of the claimed composition, and not found to add any structural limitations. See MPEP 2111.02. As this does not provide any structural limitations, the composition of Ikeda is considered to teach all of the structural limitations of the composition of claims 1-2 and 5. Whether these cells would restore liver function in a human is immaterial to the composition itself.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ikeda et al. (Differentiation 76: 495-505. 2008), Woods et al. (Transplantation 33: 123-126. 1982; referenced in IDS), and Cesta (Toxicologic Pathology 34: 455-465. 2006). This is a new rejection made in response to Applicant’s amendment to claim 10 that is substantially similar to a previous rejection. Any aspect of Applicant’s traversal that is relevant to the rejection as newly written is addressed below.
Ikeda teaches a composition of tooth germ progenitor cells (TGPCs; also known as dental pulp stem cells), from discarded human third molar, commonly called as wisdom teeth. The cells were isolated from dental mesenchyme (dental papilla or pulp). Ikeda teaches that they cultured the isolated TGPCs for expansion in vitro (abstract, page 496, column 1, paragraph 4, page 496, column 2, paragraphs 2-4, and Title). The specification teaches that wisdom teeth are considered to be a type of permanent tooth (paragraph 0013). TGPCs were examined by the transplantation into a carbon tetrachloride (CCl4)-treated liver injured rat (a non-human mammal) to determine whether this novel cell source might be useful for cell-based therapy to treat liver diseases. The TGPCs prevented the progression of liver fibrosis in the liver of CCl4-treated rats and contributed to the restoration of liver function (abstract). Immunocompromised Fisher 344 rats aged 9 weeks were administered 1 x 107 TGPCs were transplanted by injection into the portal vein (page 498, column 2, paragraph 2). As the 1 x 107 TGPCs prevented the progression of liver fibrosis in the liver of CCl4-treated rats, this amount is considered to fall under the limitation of an effective amount. Furthermore, as it pertains to the cell number alone, the specification discloses that a composition of 1x107 cells/ml is used “to provide the composition of the present invention” (page 14, lines 33-36).
Ikeda discloses their dental pulp stem cells could be used to treat human liver disease. Ikeda teaches that multipotent TGPCs are one of the candidates for cell-based therapy to treat liver diseases and offer unprecedented opportunities for developing therapies in treating tissue repair and regeneration. Furthermore, Ikeda specifically identifies the need for development of an effective treatment for liver fibrosis for treating patients (i.e. humans) infected with hepatitis and the potential that their method could be useful to treat hepatitis patients (paragraph 496, column 1, paragraph 1, page 502, column 2, paragraph 4-page 504, column 1, paragraph 1, and abstract). Furthermore, Ikeda suggests that their dental pulp stem cells are used in a method to treat human liver disease such as hepatocellular carcinoma (HCC) (Title, Abstract, Introduction, Discussion).
However, Ikeda is silent to the route of administration.
Nevertheless, Woods teaches that the retention of structural integrity and metabolic function by isolated hepatocytes after ectopic transplantation has been investigated in autografted rats. Rats were partially hepatectomized and isolated hepatocytes prepared from the excised liver lobes were implanted into their spleens. Histological examination of the spleens 7 or more weeks after implantation revealed aggregates of hepatocytes in the red pulp (abstract). 10 to 15 x 106 hepatocytes were injected directly into the splenic pulp through a 25-gauge needle (page 124, column 1, paragraph 2).
Cesta teaches that the red pulp is composed of a three-dimensional meshwork of splenic cords and venous sinuses. Blood from the red pulp collects in the venous sinuses which enter the trabeculae and merge into the trabecular veins. The trabecular veins then converge at the hilus to form the splenic vein which drains into the hepatic portal system. (page 455, column 2, paragraphs 2-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have chosen administering the stem cells to the spleen, as identified by Woods, in the method of treating liver disease by administering dental pulp stem cells of Ikeda to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to choose the spleen as the site of administration with a reasonable expectation of success because Woods has successfully reduced to practice that cells can be administered to the red pulp of the spleen as part of a method for regenerating the liver and Cesta teaches that blood from the red pulp collects in the venous sinuses which enter the trabeculae and merge into the trabecular veins. The trabecular veins then converge at the hilus to form the splenic vein which drains into the hepatic portal system. Therefore, it would have been obvious to choose to administer the dental pulp stem cells to the spleen as it was previously used to administer cells to regenerate the liver and the red pulp was known to drain into the hepatic portal system, allowing the cells to reach the liver. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed October 15, 2024, are acknowledged.
Applicant argues that the combined method of Ikeda, Woods, and Cesta neither discloses nor suggests treating humans to restore liver function. Furthermore, Applicant argues that the dental pulp stem cells are applied to the spleen in the present invention, whereas none of the citations discuss the site of application with respect to treating liver disease in humans (page 7, paragraph 7-page 8, paragraph 5).
Applicant’s arguments have been considered but are not found persuasive.
Although Woods and Cesta focus on performing their method in rats, rats are a well known animal model for developing pre-clinical methods that could be translated to treat human diseases. Furthermore, as stated in the rejection above, Ikeda discloses their dental pulp stem cells could be used to treat human liver disease. Ikeda teaches that multipotent TGPCs are one of the candidates for cell-based therapy to treat liver diseases and offer unprecedented opportunities for developing therapies in treating tissue repair and regeneration. Furthermore, Ikeda specifically identifies the need for development of an effective treatment for liver fibrosis for treating patients (i.e. humans) infected with hepatitis and the potential that their method could be useful to treat hepatitis patients (paragraph 496, column 1, paragraph 1, page 502, column 2, paragraph 4-page 504, column 1, paragraph 1, and abstract). Furthermore, Ikeda suggests that their dental pulp stem cells are used in a method to treat human liver disease such as hepatocellular carcinoma (HCC) (Title, Abstract, Introduction, Discussion).
Therefore, Ikeda clearly identifies the potential for their method to be translated to human treatments of liver disease. As such, it would have been obvious that the combined method of Ikeda, Woods, and Cesta could also be used in humans to treat liver disease.
As a further note, Applicant’s Examples in the specification also teach using an animal model (pigs) for developing and testing their method and does not provide any examples of performing their method in humans.
Conclusion
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.
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/KEENAN A BATES/Examiner, Art Unit 1631