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 .
Formal matters
1. The Art Unit location of your application in the USPTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Art Unit 1675.
Election/Restrictions
2. Applicant’s election without traverse of Group I in the reply filed on July 27, 2026, is acknowledged.
3. Claims 27-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 27, 2026.
4. Claims 1-16, 26, 30 and 31 are under examination.
Specification
5. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, see p. 54. 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 Objections
6. Claims 14-16 are objected to because of the following informalities: the claims recite limitations polypeptide comprises SEQ ID NO: 5, GEM F comprises SEQ D NO: 2 etc.. Applicant is advised that “SEQ ID NO” is a sequence identifier and not a product. Amending the claims to recite polypeptide comprising (or consisting of) the amino acid sequence of SEQ ID NO: would overcome this ground of objection.
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.
7. Claims 1-16, 26, 30 and 31 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.
8. Claim 1, as amended, is vague and indefinite for reasons that follow. The claim encompasses a polypeptide comprising two to six modules comprising at least module F. It is not obvious what embodiment comprises module F. Amendment to the claim to recite “wherein the polypeptide comprises,” or “further comprises,” or “wherein at least one module is module F” would overcome the rejection.
9. Claim 14 is interpreted as an attempt to define the structure of the claimed recombinant polypeptide by what it is not rather than by what it is. Further, it is not obvious what stands for “a mixed portion.” This renders the claim indefinite.
10. Claims 2-13, 15, 16, 26, 30 and 31 are indefinite for being dependent from indefinite claim(s).
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.
11. Claims 1-15, 26, 30 and 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Product claim(s) 1-15, 26, 30 and 31 are directed to naturally occurring polypeptides. The claim(s) does/do not include additional elements that are sufficient to amount for the product to be recognized as markedly different for reasons that follow.
The subject matter eligibility under 35 U.S.C. 101 of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring products) was confirmed by the U.S. Supreme Court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. , 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. , 132 S. Ct. 1289, 101 USPQ2d 1961 (2012). "[L]aws of nature, natural phenomena, and abstract ideas" are not patentable. Diamond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. (2010). "Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work." Gottschalkv. Benson, 409 U. S. 63, 67 (1972).
In the instant case, based upon an analysis with respect to the claim as a whole, claims 1-15, 26, 30 and 31 are determined to be directed to a judicial exception. The rationale for this determination is explained below in view of controlling legal precedent set forth in 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 74618) dated December 16, 2014 and 2019 Revised Patent Subject Matter Eligibility Guidance (84 FR 50) dated January 07, 2019.
The instant claims 1-15, 26, 30 and 31 encompass a composition of matter. (Step 1: Yes).
Next, Step 2 is a two-prong analysis from Alice Corp. (also called the Mayo test) to determine whether the claim is directed to laws of nature, a natural phenomenon (product of nature), and abstract ideas (the judicially recognized exceptions). (In Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014) the Supreme Court sets forth a two-step test for determining patent eligibility. First, determine if the claims encompass a judicial exception (a natural phenomenon/law of nature/abstract idea). If so, then ask whether the remaining elements/steps, either in isolation or combination with the other non-patent-ineligible elements, are sufficient to ‘“transform the nature of the claim’ into a patent-eligible application.” Id. at 2355 (quoting Mayo, 132 S. Ct. at 1297). Put another way, there must be a further “inventive concept” to take the claim into the realm of patent eligibility. Id. at 2355.
In the instant case, claims 1-15, 26, 30 and 31 encompass polypeptides which, by broadest reasonable interpretation and consistent with the specification as originally filed, read on full length of a naturally occurring human PGRN polypeptide of SEQ ID NO: 1. The specification explains that the GEMs are fragments, or smaller domains, of PGRN, p. 2. Thus, because the claims encompass PGRN polypeptide, which is a product of nature, the claims are directed to a judicial exception. (Step 2A: Yes).
Next, claims 1-15, 26, 30 and 31 do not recite any elements, or combinations of elements to add significantly more to the exception and to ensure that the claimed products are markedly different from their naturally occurring counterparts. (Step 2B: No).
Thus, for reasons fully explained above, claims 1-15, 26, 30 and 31 do not satisfy the requirement of 35 U.S.C. 101 and are therefore rejected.
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.
12. Claim(s) 1-15, 26, 30 and 31 is/are rejected under 35 U.S.C. 102(a) as being anticipated by US Patent 7,427,595.
Claims 1-15, 26, 30 and 31 are broadly drawn to a polypeptide comprising granulin/epithelin modules, GEMs, which are domains or fragments of progranulin, or proepithelin, polypeptide. Therefore, by broadest reasonable interpretation, the claimed polypeptides read on the full length of progranulin. US Patent 7,427,595 discloses a polypeptide of SEQ ID NO: 1, proepithelin, which is 100% identical to the instant polypeptide of SEQ ID NO: 1, see below. With respect to claim 26, the ‘595 patent describes pharmaceutical compositions comprising proepithelin at c. 21-22.
Patent No. 7427595
GENERAL INFORMATION
APPLICANT: Zhu, J.
APPLICANT: Ding, A.
APPLICANT: Nathan, C.
TITLE OF INVENTION: Use of proepithelin to promote wound repair and reduce inflammation
SEQ ID NO 1
LENGTH: 593
TYPE: PRT
ORGANISM: Homo sapiens
Query Match 100.0%; Score 355; Length 593;
Best Local Similarity 100.0%;
Matches 57; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Conclusion
13. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
September 2, 2026
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