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
This application is a 371 of PCT/JP2021/046462.
The amendment filed on October 6, 2025 has been entered.
Election/Restrictions
Applicant's election with traverse of Group 39 (claim 5) in the reply filed on October 6, 2025 is acknowledged. The traversal is on the ground(s) that (A) restriction is only proper if the claims of the restricted groups are independent or patentably distinct and there would be a serious search burden and refers to MPEP 803, (B) the examiner has not provide any indication that the content of the claims interpreted in the light of the description was considered in in making the assertion of lack of unity and therefor has not met the burden necessary to support the assertion, (C) unity of invention exists between Groups 1-114 because there is a technical relationship that involves the same special technical feature and it is this technical feature that defines the contribution which each of the groups taken as a whole makes over the prior art and refers to 37 CFR 1.475(a), and (D) search of all the claims would not impose a serious burden and proteins and nucleic acids are so linked as to form a single general inventive concept.
This is not found persuasive.
(A) The instant application is a national stage of a PCT application and Unity of Invention under PCT applies, not Restriction Practice. Therefore, section 803 of the MPEP and determination of whether claims of the restricted groups are independent or patentably distinct do not apply.
(B) The instant application is a national stage of a PCT application and Unity of Invention under PCT applies, not Restriction Practice. Therefore, section 803 of the MPEP does not apply. Further, although the claims are interpreted in light of the specification, limitations from the specification were not read into the claims.
(C) PCT Internation Search and Preliminary Examination (ISPE) Guidelines (Part III. Chapter 10 Unity of Invention. July 1, 2025 - form PTO-892. ) states:
Combinations of Different Categories of Claims
10.21 Example 1
Claim 1: A method of manufacturing chemical substance X.
Claim 2: Substance X.
Claim 3: The (method of) use of substance X as an insecticide.
Unity exists a priori between claims 1, 2 and 3 because the special technical feature common to all the claims is substance X. However, if substance X does not define a contribution over the prior art, there would not be a special technical feature common to all the claims. Accordingly, unity may be lacking.
In the instant, the technical feature linking Groups 1-114 is one of the 19 proteins recited in claim 1. However, all 19 proteins were known in the prior art (see UniProtKB Database. 2019 – cited previously on form PTO-892). Since the technical feature does not define a contribution over the prior art, the is no special technical feature common to all the claims. As such, unity of invention exists “a posteriori,” and the lack of unity is proper.
(D) The instant application is a national stage of a PCT application and Unity of Invention under PCT applies, not Restriction Practice. Therefore, section 803 of the MPEP does not apply. Further, the proteins recited in claim 1 and the nucleic acid share a technical feature since the nucleic acids encode the corresponding proteins. However, all 19 proteins were known in the prior art (see UniProtKB Database. 2019 – cited previously on form PTO-892). Since the technical feature does not define a contribution over the prior art, the is no special technical feature between the proteins and nucleic acids encoding the proteins. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-4 and 6-8 are 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 October 6, 2025.
Status of Claims
Claims 1-8 are pending.
Claims 1-4 and 6-8 are withdrawn.
Claim 5 is under examination.
Claim for Foreign Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 13, 2023, November 22, 2024, and September 30, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, page 75 for example. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation “an active fragment thereof”. The metes and bounds of the limitation in the context of the above claim are not clear. The specification at paragraph [0019] describes “active fragment” as fragments comprising a partial region retaining an activity of the full-length protein. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See MPEP 2111.01 Section II. Therefore, it is unclear what activity or activities are retained by the claimed fragment. Clarification is requested.
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.
Claim 5 is 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.
MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.'' The limitation “an active fragment thereof” is indefinite, see the 112(b) rejection above. Therefore, claim 5 has been broadly interpreted to encompass a method of any transplantation to a subject by culturing any cell in the presence of any progranulin or any fragments of said any progranulin having unknown activity. Thus, the claims are drawn to a method of cell transplantation to a subject by culturing a genus of cells in the presence of a genus comprising a progranulin having unknown structure or genus of fragments of any progranulin having unknown structure and having unknown activity.
MPEP 2163 I. states that 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.
MPEP 2163. II.A.3.(a) sates that “Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that inventor had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention.
According to MPEP 2163.II.A.3.(a).ii), “Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus…Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’"
The recitations of “cell”, “subject”, and “progranulin” fail to provide a sufficient description of the genus as it merely describes the functional features of the genus without providing any definition of the structural features of the species within the genus. The specification does not specifically define any of the species that fall within the genus. The specification does not define any structural features commonly possessed by members of the genus that distinguish them from others. One skilled in the art therefore cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus.
Human progranulin was known in the art, see Mason (US 2022/0111005 – form PTO-892) and Todokoro (JP 2012165660- form PTO-892. English Translation of JP 2012165660. Retrieved from google patents on November 3, 2025 - form PTO-892). However, a method of cell transplantation to any subject by culturing any cell in the presence of any progranulin or any fragment of any progranulin was not known in the art.
The specification is limited to a method of neuronal cell transplantation to a mouse subject by culturing neuron cells in the presence of the human progranulin of SEQ ID NO:90 or the mouse progranulin of SEQ ID NO:89. While MPEP 2163 acknowledges that in certain situations “one species adequately supports a genus,” it also acknowledges that “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.” In view of the widely variant species encompassed by the genus, the above example is not enough and does not constitute a representative number of species to describe the whole genus. Therefore, the specification fails to describe a representative species of the claimed genus.
Further, the claimed invention requires a defined set of cells, subject, and progranulin. Although the specification discloses exemplary cells, subject, and progranulin, “laundry list” disclosure of every possible moiety does not necessarily constitute a written description of every species in a genus because it would not “reasonably lead” those skilled in the art to any particular species, see Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) or MPEP 2163. While the exemplary cells, subject, and progranulin were known in the art and disclosed in the Examples of the instant specification, this knowledge alone would not allow one level of skill in the art to immediately envisage the claimed genus.
Given this lack of description of the representative species encompassed by the genus of the claims, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that applicants were in possession of the inventions of claim 5.
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 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.
Claim(s) 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Todokoro (JP 2012165660- form PTO-892. English Translation of JP 2012165660. Retrieved from google patents on November 3, 2025 - form PTO-892).
Regarding claim 5, Todokoro discloses a method of cell transplantation to a subject comprising (1) culturing a cell in the presence of a progranulin and (2) transplanting the cell to the subject (abstract, Claims 1-7, middle of page 2, 2nd-3rd full paragraphs at page 3).
Therefore, the reference of Todokoro anticipates claim 5.
Claim(s) 5 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Mason (102(a)(1) & 102(a)(2): WO 2020/160458. 102(a)(2): US 2022/0111005 - form PTO-892. US 2022/0111005 is used for specific passages of Mason).
Regarding claim 5, Mason discloses a method of cell transplantation to a subject comprising (1) culturing a cell in the presence of a progranulin and (2) transplanting the cell to the subject (abstract, [0007]-[0009], [0042], [0046], [0049], [0054]-[0062], [0090], [0108], [0159], [0168], [0269], [0274]). Since the progranulin is secreted into the cell culture ([0027], [0151], [0205], [0269]), the cell is cultured in the presence of progranulin.
Therefore, the reference of Mason anticipates claim 5.
Claim(s) 5 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lundkvist (WO 2021/258074 – form PTO-892).
Regarding claim 5, Lundkvist discloses a method of cell transplantation to a subject comprising (1) culturing a cell in the presence of a progranulin and (2) transplanting the cell to the subject (abstract, [0003], [0016], and Example 29).
Therefore, the reference of Lundkvist anticipates claim 5.
Conclusion
Claims 1-8 are pending.
Claims 1-4 and 6-8 are withdrawn.
Claim 5 is rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YONG D PAK whose telephone number is (571)272-0935. The examiner can normally be reached M-Th: 5:30 am - 3:30 pm.
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/YONG D PAK/Primary Examiner, Art Unit 1652