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 .
Claim Status
Applicants’ amendments and arguments filed 1/5/26 are acknowledged. Any objection or rejection from the 10/7/25 office action that is not addressed below is withdrawn based on the amendments.
Claim 4 has been canceled.
Claims 7-8 remain directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Inventions 1 (claims 1-3 and 5-6) and 2 (claims 7-8) are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the process can be practiced with a materially different product such as minoxidil.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 7-8 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 1-3 and 5-6 are being examined.
Priority
The priority information is provided in the filing receipt dated 5/9/22.
Claim Interpretation
Claim 1 recites ‘consists of the amino acid sequence of SEQ ID NO:1’. Since SEQ ID NO:1 is 7 amino acids in length and consisting of is closed language, claim 1 has been interpreted as requiring a peptide that consists of the heptapeptide sequence as set forth in SEQ ID NO:1.
Claim Rejections - 35 USC § 112
This rejection is a new rejection necessitated by amendment. Claim 1 no longer recites ‘optionally wherein the N- or C-terminus of the peptide is modified’.
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.
Claims 2-3 and 5-6 are 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 1 recites ‘consists of the amino acid sequence of SEQ ID NO:1’. Since SEQ ID NO:1 is 7 amino acids in length and consisting of is closed language, claim 1 has been interpreted as requiring a peptide that consists of the heptapeptide sequence as set forth in SEQ ID NO:1.
As set forth in MPEP 2111.03 II the transitional phrase ‘consisting of’ excludes any element not specified in the claim. As such, claim 1 does not encompass the protecting groups of claims 2-3 (and dependent claims 5-6). Claim 1 expressly refers to ‘amino acid’ sequence where peptides are known to include an NH2 at the N-terminal end and a COOH at the C-terminal end.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
Claims were previously rejected under 35 USC 101. Since the claims have been amended, the rejection is updated to correspond to the instant claims.
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 5-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (product of nature) without significantly more. The claim(s) recite(s) peptides/compositions which correspond to products of nature (fragments of natural protein as discussed in detail below). This judicial exception is not integrated into a practical application because there is no additional elements that apply or use the judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception as discussed below.
This 101 rejection is consistent with the most recent training provided by the office which will be referred to as 'guidance' (see MPEP 2106).
In comparison to the subject matter eligibility test as set forth in the guidance, the claims are drawn to peptides/compositions. Thus the answer to step 1 is yes.
Instant SEQ ID NO:1 is of sequence TKVFPQD. BLAST search results for TKVFPQD (retrieved from https://blast.ncbi.nlm.nih.gov/Blast.cgi on 10/9/24, 31 pages; previously cited) reveal that the TKVFPQD is a sequence that occurs in numerous proteins including leukemia inhibitor factor receptor (see pages 13-15), phosphatidylinositol phosphatase PTPRQ (see pages 10-11) and YSIRK-type signal peptide-containing protein (see pages 11-13).
Thus in relation to prong one of step 2a of the guidance the answer is yes because the peptides correspond to portions of natural proteins (i.e. products of nature which are a natural phenomenon).
In relation to prong two of step 2a, claims 1 and 5-6 are product claims and do not require any additional elements that apply the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Thus the answer to prong two of step 2a is no.
The instant claims recite SEQ ID NO:1 which is a fragment of a known protein. The Myriad Supreme Court decision (Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 12-398 (2013)) stated: “Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together” (page 2 and 14). In the instant case, applicants’ claims are not saved by the fact that the peptides of the instant claims can correspond to fragments (the protein with severed bonds).
Instant claims 2-3 are not included in the instant rejection because they require structural modifications (at either the N-terminal end or C-terminal end) as compared to the natural protein.
In relation to step 2b, claims 5-6 refer to compositions. The compositions can correspond to the peptide in water which itself is naturally occurring. The claims do not require any additional features that add significantly more to the exceptions.
The instantly claimed compositions are like the novel bacterial mixture of Funk Brothers which contained multiple naturally occurring components, which was held ineligible because each species of bacteria in the mixture (like each component in the peptide composition) continued to have “the same effect it always had”, i.e., it lacked markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), discussed in Myriad Genetics, 133 S. Ct. at 2117 (explaining that the bacterial mixture of Funk Brothers “was not patent eligible because the patent holder did not alter the bacteria in any way”).
Further, there is no evidence of any markedly different characteristic. There is no indication that mixing of the peptide and an excipient (such as water) changes the structure, function or other properties of the peptide or the water. MPEP 2106.04(c) II C recognizes that a change cannot be an inherent or innate characteristic on the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart.
The figures and specification provide examples of properties of the peptide. There do not appear to be any comparisons to any full length protein.
Rooda et al. (‘Has-mir-548 family expression in human reproductive tissues’ BMC Genomic Data v22(40) pages 1-13, 2021; previously cited) teach that LIFR (leukemia inhibitor factor receptor) is essential for ovarian follicle activation and growth (abstract).
Wang et al. (‘Leukemia inhibitory factor, a double-edged sword with therapeutic implications in human diseases’ Molecular Therapy v31(2) February 2023 pages 331-343; previously cited) teach LIFR (leukemia inhibitor factor receptor) and recognize beta-catenin as being downstream of LIFR (figure 2). Such information appears to be consistent with example 2 (specifically the last complete paragraph on page 12 of the specification) and figure 1 of the specification. Further, Wang et al. teach that LIF enhances expression of c-myc (page 332 2nd column). Such information appears to be consistent with the first complete paragraph on page 13 of the specification. Wang et al. also teaches that LIF activates VEGF (page 337 last paragraph of column 1). Such information appears to be consistent with the first complete paragraph on page 14 of the specification.
The claims clearly tie up practical applications. Thus the answer to step 2b is no because there is not adequate evidence to conclude that the claims include significantly more than the judicial exception.
Response to Arguments - 101
Applicant's arguments filed 1/5/26 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants argue about structural differences as compared to the full length protein, instant claims 2-3 are not included in the 101 rejection.
Although applicants argue that SEQ ID NO:1 is shorter than the full length polypeptide, as set forth in the previous office action 'Myriad's claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together'. In the instant case, applicants' claims are not saved by the fact that the peptides of the instant claims can correspond to fragments (the protein with severed bonds). MPEP 2106.04(b) II recognizes that product of nature exceptions include non-naturally occurring products that lack markedly different characteristics. In the instant case, the claimed peptide has an identical amino acid sequence with the natural sequence. Although applicants make assertions about structural differences, no actual data or evidence appears to be of record related to structural differences.
Although applicants argue about functional features, MPEP 2106.04(c)II recites how to perform the markedly different characteristic analysis. In the instant case, it is unclear what comparison is being made. Although applicants refer to full length LIFR it is unclear where specific comparisons are made with respect to the various activities recited. Further, instant SEQ ID NO:1 appears in numerous other proteins as discussed above.
MPEP 2106.04(c) recites “The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, the inventor must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.”
In the instant case, applicants refer to SEQ ID NO:1 as a functional unit (page 6 2nd paragraph). Since the claimed sequence is described as a functional unit it would seem that such description is consistent with an inherent or innate characteristic of the natural protein.
A loss of function due to a loss of a functional domain does not show that there is anything different about the claimed peptide. It is known that a fragment is of a different size and excludes certain functional domains because it is a fragment. As the Myriad decision informed us, merely excising a fragment from a larger entity does not necessarily make the fragment one which is markedly different.
Although applicants argue about utilizing natural products, instant claim 1 is not a use claim. It is a product claim.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658