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 .
Election/Restrictions
Applicant’s election without traverse of the species identified as “MHP1-7 (other name: MPH1-can), which is an oligopeptide obtained by acetylating the N-terminus of MHP1 (SEQ ID NO:12) and amidating the C-terminus of MHP1” in the reply filed on 1/2/26 is acknowledged.
Applicant also states that claims 1-16 are readable on the elected species.
Priority
The instant application, filed 03/22/2023 is a National Stage entry of PCT/JP2021/035368 , International Filing Date: 09/27/2021
claims foreign priority to 2020-168029, filed 10/02/2020.
Information Disclosure Statement
The Examiner has considered the reference(s) provided in the 3/22/23, 10/17/23 and 5/9/24 Information Disclosure Statements, and provides a signed and dated copy of each herewith.
Claim Interpretation
The claims during prosecution must be given their broadest reasonable interpretation in light of the specification (MPEP 2111).
Claim 1’s “Wnt signaling pathway inhibitor” is not defined in the specification so is given the ordinary and customary meaning based on reasonable interpretation of this term, namely that the claimed inhibitor has a property of inhibiting, to any degree, a Wnt signaling pathway.
There are multiple transitions in claim 1 – a “comprising” immediately after “Wnt signaling pathway inhibitor” and before “an oligopeptide”, then this oligopeptide is stated to be “consisting of an amino acid sequence containing …”. This containing is another transition about which para 96 states, “In the present specification, the terms “containing,” “comprising,” and “having” include: the concepts of “containing,” “including,” “consisting essentially of,” and “consisting only of.”” Apart from defining “containing” to include the concept of itself - “containing,” from this statement “containing” is interpreted as an equivalent of “comprising” (at least based on “including” being reasonably interpreted to be equivalent to “comprising”, see below), and by virtue of the indicated alternatives, such as “consisting only of”, may be more narrowly limited, so that the transition “containing,” as well as “comprising” has multiple alternative breadths.
It is generally established that the transitional limitation 'comprises' is similar to limitations, such as, 'has', 'includes', 'contains', or 'characterized by', and represents open-ended claim language and therefore does not exclude additional, unrecited elements. See M.P.E.P 2111.03. See Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ('comprising' leaves 'the claim open for the inclusion of unspecified ingredients even in major amounts'). On the other hand, the limitation 'consisting of' represents closed claim language and excludes any element, step, or ingredient not specified in the claim. In re Gray, 53 F.2d520, 11 USPQ 255 (CCPA 1931); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948).
Based on the above, it appears that claim 1’s line 2’s combination of “consisting of” followed shortly by “containing”, particularly given para 96, leaves open whether the only components of the oligopeptide’s amino acid sequence are a DE loop sequence of RANKL protein and a β-strand D sequence of RANKL protein. The use of such “consisting” is further strained when considering claim 5 adds a β-strand E sequence of RANKL protein to the amino acid sequence of the claim 1 oligopeptide.
The examiner notes that the oligopeptide size limits of claims 11 and 12 appear to require that “containing” for these claims is interpreted as “comprising”, which in one sense obviates the ordinary and customary significance of the earlier claim 1 line 2 “consisting of”.
In view of the above and rejection(s) below pertaining to the combined use and/or alternative meanings of such transitions in claim 1, applicant may consider appropriate amendments to claim 1.
Claim 3’s limitation, narrowing one to three to two to three amino acids, is interpreted to further limit part (d) of claim 1, but not to eliminate the alternative (c) as an alternative for the β-strand D sequence.
Claim Rejections - 35 USC § 101
This analysis expands beyond the elected species for the sake of compact prosecution and a complete record.
This section addresses the interpretation of claim 1 based on the claim 1 line 1 ‘comprising’ transition allowing for additional amino acids at the N- and/or C-termini of the oligopeptide of claim 1, such that the full-length protein RANKL is encompassed by the structural portion of the claim 1 limitations.
Assuming that is the case, the question arises whether a nature-based product rejection under 35 USC 101 is appropriate. Based on the examiner’s searches, although claim 1 is a composition of matter (Step 1, yes), because at Step 2A Prong One a markedly different analysis is made, see MPEP 2106.04(c), and because the examiner has determined that there is no reasonable basis to consider that full length RANKL protein is a Wnt pathway inhibitor, see for instance Kovacs et al. Int. J. Mol. Sci. 2019, 20, 4653, 28 pages, copy provided, the claim is not directed to a judicial exception.
Claim Rejections - 35 USC § 112
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 5, 6, 11 and 12 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.
The rejections under this section are based on the claim 1 line 2 “containing” transition interpreted as the alternative “consisting only of”, see Claim Interpretation above. When so interpreted, the only components of the oligopeptide are combinations of (a) or (b) of claim 1 with (c) or (d) of claim 1.
Under such interpretation, as to claims 5 and 6, these improperly fail to include all the limitations of claim 1 upon which they depend by extending the scope of what is included in the oligopeptide.
Under such interpretation, as to claims 11 and 12, these do not further limit what is allowed by claim 1 as to the size/length of the oligopeptide, which by calculation cannot exceed 22 amino acids.
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 § 112
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 1-16 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
Further, to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include: a) the scope of the invention; b) actual reduction to practice; c) disclosure of drawings or structural chemical formulas; d) relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation; e) method of making the claimed compounds; f) level of skill and knowledge in the art; and g) predictability in the art.
(1) Scope of the invention/Partial structure:
The claimed “Wnt signaling pathway inhibitor” of claim 1 must comprise an oligopeptide as set forth in claim 1, but given the “comprising transition” is not limited to only that oligopeptide. That is, additional amino acids or other components can be present, and as such a large genus of diverse species is possible, so long as they possess the property of being an inhibitor of Wnt signaling pathway. As to the claim 1 oligopeptide, given the use of “containing” in line 2, and as evidenced by claims 5, 6, 10 and 11, the use of “consisting of” before that “containing” in claim 1 line 2 does not constrain the size of the oligopeptide to only the maximum allowed by claim 1 (a) through (d). Such oligopeptide, when considering the genus, represents a partial structure that itself is allowed amino acid substitution, deletion, addition or insertion, see (b) and (d).
(2) Level of skill and knowledge in the art/predictability in the art:
The level of skill in the art is high.
However, the predictability of adding or otherwise modifying an oligopeptide and retaining a property such as inhibitor of Wnt signaling pathway is low, at least due to the known effects of changes of amino acids, see Malovichko and Zhu, ACS Omega 2017, 2, 5445−5452, copy provided.
(3) Relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation:
As noted, claim 1 requires each species of its genus to have the property of inhibitor of Wnt signaling pathway.
Several oligopeptides are shown to have this property, and the specification and claims limit modification of certain leucines, and to not comprise, be free from, a CD loop sequence of RANKL protein. However, there is a paucity of guidance about what is critical to maintain the noted property when expanding the structures across the allowed genus of claim 1 as far as size/length, diversity of amino acids apart from the oligopeptide (that is, the N- and/or C-terminus of the oligopeptide), and also modifications allowed by (b) and (d) of claim 1 within the oligopeptide. Pertaining to disclosure of structure required for function, there is no relevant disclosure of critical sequence/amino acids/patterns across the breadth of possible modifications to maintain the inhibitor property.
The importance of structure/function correlations has been highlighted by the courts (Abbvie Deutschland v. Janssen Biotech and Centorcor Biologics, App. No. 2013-1338, -1346 (Fed. Cir. , July 1, 2014)). The Abbvie case involved antibodies and written description. The court stated: “We have held that “a sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Id. at 1350 (quoting Eli Lilly, 119 F.3d at 1568– 69).”. The courts then further stated: “With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus.” (emphasis added) and then state: " Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Ariad, 598 F.3d at 1351 (“[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1352 (Fed. Cir. 2011).
In the instant case, one could not visualize or recognize a sufficient number of species representative of the claimed genus with the property as claimed.
(5) Method of making the claimed invention/actual reduction to practice:
The method of making peptides is routine, and not a critical factor in this analysis. The specification describes the production of several peptides and evaluates these, but as set forth herein they are not representative of the claimed genus.
As stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claims 1-16 are broad and generic, with respect to all possible peptides encompassed by the claims. Moreover, the specification lacks sufficient variety of species to reflect this variance in the genus. While having written description of compounds identified in the specification, including drawings and examples, the specification does not provide sufficient descriptive support for the myriad of species embraced by the claims.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals Appellant hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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.
Claim(s) 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US PGPUB No. 20180147259, published 5/31/18, inventors Shimamura et al. (‘259).
Claim 1 is as follows:
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503
969
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SEQ ID NO:1 is: Ser Ile Lys Ile Pro Ser Ser.
SEQ ID Nos. 2 to 5 are as follows:
2: Leu Met Val Tyr Val Val Lys Thr
3: Tyr Leu Gln Leu Met Val Tyr Val Val Lys Thr
4: Leu Met Val Tyr Val Thr Lys Thr
5: Tyr Leu Gln Leu Met Val Tyr Val Thr Lys Thr.
The elected species SEQ ID NO:12 is: Leu Met Val Tyr Val Val Lys Thr Ser Ile Lys Ile Pro Ser Ser His Asn Leu Met Lys Gly Gly Ser Thr Lys Asn Trp Ser Gly Asn, in which SEQ ID NO:1 is underlined and SEQ ID NO:2 attached directed to the N-terminus of SEQ ID NO:1 is double underlined.
The elected species also comprises an acetyl group at the N-terminus and its C-terminus is amidated.
SEQ ID NO:10 of the ‘259 is identical to amino acid sequence of instant and elected SEQ ID NO:12:
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861
820
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The ‘259 specifically teaches its SEQ ID NO:10, also identified as “MHP1”, and is among a relatively small group, nine, specifically synthesized oligopeptides, see para 119 at Example 1. This SEQ ID NO:10 oligopeptide also was evaluated in Examples 2-10 and 12-18.
As noted above, the elected species comprises an acetyl group at the N-terminus and its C-terminus is amidated.
The ‘259 teaches “The C-terminus of the oligopeptide of the present invention may be a carboxyl group (—COOH), carboxylate (—COO.sup.−), amide (—CONH.sub.2), or ester (—COOR),” para 97, so clearly teaching C-terminus amidation for its oligopeptides, and “Furthermore, the oligopeptide of the present invention also includes those in which the amino group of the N-terminal amino acid residue is protected by a protecting group (e.g., C.sub.1-6 acyl groups such as C.sub.1-6 alkanoyl, including formyl and acetyl groups), etc.,” clearly teaching N-terminus acetylation of its oligopeptides.
Because the ‘259’s SEQ ID NO:10, also identified as “MHP1”, acetylated at its N-terminus and amidated at its C-terminus is at once envisaged, and is identical to the instantly elected species which otherwise meets all requirements of claim 1 (e.g., being a Wnt signaling pathway, this inherent in identical peptides), the ‘259 anticipates claim 1 when examining the elected species. As stated in MPEP 2112.01 II, “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.” (underline emphasis added). This provides technical reasoning based on identical structure.
The examiner notes that claim 1 extends in scope beyond claim 1 and the N- and C-termini teachings of the ‘259 are not required for a rejection beyond the elected species.
Claim 2 is anticipated on the same bases as claim 1, the examiner noting that the ‘259 SEQ ID NO:10 comprises instant SEQ ID NO:1, Ser Ile Lys Ile Pro Ser Ser.
Claim 3 is interpreted under this section to mean that the limitations of claim 3 further limit part (d) of claim 1, but do not restrict the selection of the β-strand D sequence to only (d), that is, that (c) is still an alternative. Based on this interpretation, the ‘259’s SEQ ID NO:10, acetylated at its N-terminus and amidated at its C-terminus, anticipates claim 3 on the same bases as claim 1.
Claim 4 also is anticipated on the same bases as claim 1, there being no substitutions or deletions of the leucine of SEQ ID NO:2 in the ‘259 SEQ ID NO:10 at the corresponding location.
The ‘259 SEQ ID NO:10 comprising His Asn Leu Met Lys Gly Gly Ser Thr (instant SEQ ID NO:6, identified in claims 5 and 6 as the β-strand E sequence) to the C-terminus of Ser Ile Lys Ile Pro Ser Ser (instant SEQ ID NO:1 and identified as the RANKL DE loop sequence) meets the limitations of claims 5 and 6, which are accordingly anticipated on the same bases as claim 1.
At least because applicant stated that its elected species reads on claim 7, as well as all other pending claims, the ‘259 anticipates claim 7 on the same bases as claim 1.
The ‘259 also anticipates claims 8-12 on the same bases as claim 1.
Claims 13 and 14 as clearly set forth are directed to the inhibitor according to claim 1 (via claim 13 for claim 14). As such claims 13 and 14 are rejected on the same bases as claim 1. Further regarding these claims’ “for use” language, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here the ‘259 teaches the same oligopeptide encompassed by instant claim 1. Further regarding the “for use” language, such language is not given weight as distinguishing from the oligopeptide structure(s) as they exist, including in the prior art ‘259.
Claims 15 and 16 also are rejected on the same bases as claim 1. These claims appear to want to impart a particular function or result, however the claimed oligopeptide, as well as the elected species, are anticipated by ‘259, and the ‘259 SEQ ID NO:10 oligopeptide, with or without the N- and C-termini modifications, inherently possesses the same properties as instant SEQ ID NO:12 with or without N- and C-termini modifications. Please note that for the purpose of examination under this section, the preamble intended uses are not limiting given that the preamble merely recites a potentially newly discovered property or use inherent in a prior art oligopeptide, see MPEP 2111.02, including “a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention.”
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10517926 in view of U.S. Patent No. 11819537. The reference patent claims claim oligopeptides that fall within the claimed genus of instant claim 1, and are identical with specifically claimed oligopeptides, such as reference patent SEQ ID NO:10 being identical with instant SEQ ID NO:12. With regard to the reference patent claimed oligopeptides having the property of inhibitor of Wnt pathway, as stated in MPEP 2112.01 II, “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.” (underline emphasis added). With regard to the acetylation and amidation of the elected species, the ‘537 teaches these for the same oligopeptides at paras 48 and 51.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11819537 in view of U.S. Patent No. 10517926. The reference patent claims claim oligopeptides that fall within the claimed genus of instant claim 1, and are identical with specifically claimed oligopeptides, such as reference patent SEQ ID NO:10 being identical with instant SEQ ID NO:12. With regard to the reference patent claimed oligopeptides having the property of inhibitor of Wnt pathway, as stated in MPEP 2112.01 II, “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.” (underline emphasis added). With regard to the acetylation and amidation of the elected species, the ‘926 teaches these for the same oligopeptides at paras 65 and 67.
Conclusion
No claim is allowed.
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/JOSEPH FISCHER/Examiner, Art Unit 1658