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 .
Status of Claims
Claims 1-22 are cancelled.
Claims 23-34 are new and pending.
Election/Restrictions
Applicant's election with traverse of Group I, drawn to claims 23-30 and 33, in the reply filed on 10/16/2025 is acknowledged. The traversal is on the ground(s) that there would be no additional burden to examine claims 31 and 32 under the Applicant’s election, as each of these claims rely on the same limitations. Upon reconsideration, claims 31 and 32 are examined as part of Group I.
Applicant further traverses on the ground that new claims 23-34 do recite special technical features that are patentable over the prior art cited in the restriction requirement mailed 07/21/2025 (US 6,897,064 B2, hereinafter Yoshioka). This is not found persuasive. It is noted that cell population obtained by using the method according to claim 23, as recited in line 2 of claim 34, is a product-by-process limitation. Therefore, the shared technical feature among the claims is a cell population incubated in a thermoreversible polymer solution in a gel state, not the method of claim 23. See MPEP 2113. As set forth in the restriction requirement, the shared technical feature of a cell population incubated in a thermoreversible polymer solution in a gel state does not make a contribution over the prior art in view of Yoshioka. Therefore, the shared technical feature is not a special technical feature, and there is lack of unity a posteriori. The requirement is still deemed proper and is therefore made FINAL.
Claim 34 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/16/2025.
Information Disclosure Statement
An information disclosure statement (IDS) was received on 03/29/2023 and 12/17/2025. All references have been considered. However, due to the voluminous number of references in the IDS, and the limited time available for review, the references have been only briefly considered. It is noted that multiple documents do not appear to be reasonably pertinent to the patentability of the present claims, such as Ajuwon et al., “The regulation of IGF-1 by leptin in the pig is tissue specific and independent of changes in growth hormone” (IDS 12/17/25, reference 46). See also, Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948 (S.D. Fla. 1972) regarding applicant' s duty of disclosure.
Priority
The instant application is a 371 of PCT/JP2021/034677 filed 09/22/2021, which claims priority to JAPAN 2021-069260 filed 04/15/2021 and JAPAN 2020-158938 filed 09/23/2020.
Claim Objections
Claims 24 and 28 are objected to because of the following informalities:
Claim 24: The phrase “the gene expression selected from the group” (line 7) should be corrected to “wherein the gene is selected from the group” because the Markush group in lines 7-8 consist of gene names, not gene expressions. Furthermore, “from a a 2D culture” (lines 6-7) should be corrected to remove the duplicate “a.” Appropriate corrections are required.
Claim 28: As with claim 24, the phrase “the gene expression is selected from the group” (lines 1-2) should be corrected to “the gene is selected from the group.” Furthermore, “miR21” in line 2 should be corrected to “miR-21.” Appropriate corrections are required.
Claim Interpretation
Claim 23 recites the phrase for use in a cell therapy (lines 2 and 8-9), which is a recitation of intended use for the cell population. The intended use does not impose additional limitations to the method as claimed, and therefore is not given patentable weight. See MPEP 2111.02(II).
Claim Rejections - 35 USC § 112(a)
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.
Claims 23-33 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Independent claim 23, which is new and replaces cancelled independent claim 11, recites the limitation “providing a second cell population having an increased tissue regeneration capacity” in line 5. This limitation constitutes new matter. Claims 24-33 are included in the rejection because they depend, either directly or indirectly, from claim 23.
Applicant’s argument that support for this amendment can be found in at least paragraphs [0013], lines 1-3 (provide high quality cell population); and [0003], in entirety, is not found persuasive.
Lines 1-3 of paragraph 0013 recites:
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Paragraph 0003, in entirety, recites:
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Neither of the paragraphs cited by Applicant recite a second cell population, let alone a second cell population having an increased tissue regeneration capacity; rather, both paragraphs point to a singular cell population. The specification does not recite “providing a second cell population having an increased tissue generation capacity.” Searching the word “second” in the instant specification yielded one result in paragraph 177, regarding a normalization standard in mRNA quantification, not a cell population.
The phrase “second cell population” does not appear in cancelled claims 11-22. Independent claim 11, which is identical to cancelled independent claim 1, is drawn to:
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The phrase “second cell population” does not appear in applications to which the instant applications claim priority. The instant application is a 371 of PCT/JP2021/034677, which claims priority to JAPAN 2021-069260 and JAPAN 2020-158938. A search for the word “second” in the certified translation of PCT/JP2021/034677, provided by Applicant on 03/22/2023, yielded two results in paragraphs 109 (“millisecond”) and 121 (“second RNA”), neither of which relate to a cell population. JAPAN 2021-069260 and JAPAN 2020-158938 are in Japanese, and Applicant did not provide English translations, so a word search was not conducted for these documents.
Therefore, Applicant does not have support for “providing a second cell population having an increased tissue regeneration capacity,” either in the specification, cancelled claims, or in documents to which the instant application claims priority.
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) and In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)). (Refer to MPEP 2163.02). The proscription against the introduction of new matter in a patent application serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
Applicant, thus, should amend these claims or convincingly demonstrate support.
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 23-33 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claim 23 is indefinite for the following reasons:
Claim 23 recites the limitation “to create a supply of cells enriched with the healthy cells that function normally from the second cell population” (lines 7-8). The specification does not define what is meant by “cells that function normally,” and therefore, the metes and bounds of this limitation are unclear. Furthermore, it is unclear what the phrase “from the second cell population” refers to in this context.
Claim 23 recites the limitation “extending the average telomere length of the second cell population over the first cell population” (lines 11-12). It is unclear, in light of the specification, what is encompassed by the step of “extending the average telomere length,” and therefore, the metes and bounds of this limitation are not well defined. Furthermore, it is unclear what is meant by the phrase “the second cell population over the first cell population.”
Claim 23 recites the limitation “obtaining a normal cell morphology in the 3D thermoreversible polymer gel culture as compared to creating an abnormal cell morphology in a 2D culture” (lines 14-15). The specification does not define “normal cell morphology” or “abnormal cell morphology,” and therefore, the metes and bounds of this limitation are unclear.
Claims 24-33 are included in the rejection because they depend, either directly or indirectly, from claim 23.
Claim 24 recites the limitation “increasing the culturing time of the first cell population in a 3D thermoreversible polymer gel culture to at least 42 days before the cell therapy; wherein, the increasing of the culturing time to at least 42 days before the cell therapy results in an increase in the expression of genes from the second cell population from the 3D thermoreversible polymer gel culture when compared to the expression of genes from a 2D culture” (lines 2-7). The metes and bounds of this limitation are unclear, as the first portion (lines 2-3) recite culturing the first cell population in a 3D culture, but the second portion (lines 4-7) recite the effects of the 3D culturing on the second cell population, which is then measured in relation to the effects of culturing the second cell population in a 2D culture.
Claim 26 recites the limitation "the block copolymer" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitation “The method according to claim 23, the first cell population including pluripotent stem cells and somatic stem cells that are maintained or increased in content in the second cell population when compared to culturing the first cell population in a 2D culture” (lines 1-4), which is indefinite. First, there is insufficient antecedent basis for the limitation "the first cell population including pluripotent stem cells and somatic stem cells" in lines 1-2. Claim 23 recites “a first cell population from a biological tissue” (line 3), but does not recite that the first cell population includes pluripotent stem cells and somatic stem cells. Furthermore, it is unclear what is meant by the phrase “that are maintained or increased in content in the second cell population when compared to culturing the first cell population in a 2D culture,” and therefore, the metes and bounds of the claim are indefinite.
Claim 29 recites the limitation "the second cell population from which senescent cells have been removed" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 23 recites the limitation “removing the senescent cells from the first cell population” (line 10), but does not recite a step of removing senescent cells from the second cell population.
Claim 30 recites the limitation "the thermoreversible polymer that removes the senescent cells" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 23 recites “3D thermoreversible polymer gel culture” in lines 6-7 and 13, but does not recite that the 3D thermoreversible polymer gel culture removes senescent cells, or otherwise plays a role in removing senescent cells.
Improper Markush Grouping Rejection
Claim 23 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of a shape of the cells constituting the cell population, nuclear localization, and size ratio between the cell and the nucleus in lines 15-17 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: cell shape, nuclear localization, and size ratio between the cell and the nucleus encompass completely different aspects of cell morphology. Furthermore, cell shape is an aspect of cell morphology, per se, whereas nuclear localization affects cell morphology.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 31 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 31 is drawn to “A production method of cell population, comprising the method of claim 23.” The preamble “A production method of cell population” does not amount to an active step, and therefore, claim 31 does not specify a further limitation of the subject matter of claim 23. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 32 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (specifically, a natural phenomenon) without significantly more.
Claim Interpretation: Claim 32 is drawn to a cell population produced by the method according to claim 31. Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. As such, the broadest reasonable interpretation of claim 32 is a cell population with an increased tissue regeneration capacity.
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. Here, the claim recites a cell population with an increased tissue regeneration capacity. Because a cell population is a composition of matter, the claim falls within a statutory category. (Step 1: YES)
Step 2A, Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(II) and the October 2019 Update, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim. Because claim 32 recites a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). MPEP 2106.04(c)(I)(A). The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II).
Here, the closest natural counterpart to the cell population of claim 32 is a naturally occurring cell population with an increased tissue regeneration capacity, per se. The art, as exemplified in Poss (Nature Reviews Genetics, 2010, 11(10): 710-722) teaches that certain animal tissues, such as axolotl limbs and mouse blood and liver, have increased regeneration capacity (p 711, col 1, para 1-2; Table 1). The claimed cell population is identical to a naturally occurring cell population with an increased tissue regeneration capacity, thus there is no marked difference between the claim and product of nature. Accordingly, the claim recites a judicial exception (natural phenomenon), and the analysis must therefore proceed to Step 2A, Prong Two. (Step 2A, Prong One: YES)
Step 2A, Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. 2019 PEG Section III(A)(2), 84 Fed. Reg. at 54-55. The claims do not integrate the product into a practical application because the claims are to the cell population, per se, and do not recite additional elements beyond the judicial exception. (Step 2A, Prong Two: NO)
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. The claim does not recite any elements in addition to the judicial exception of a cell population with an increased tissue regeneration capacity, so there are no additional elements that add significantly more to the judicial exception. (Step 2B: NO)
The claim is not patent eligible.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Risa Takenaka whose telephone number is (571)272-0149. The examiner can normally be reached M-F, 12-7 EST.
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/RISA TAKENAKA/Examiner, Art Unit 1632
/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632