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 .
Response to Election/Restriction filed on June 10, 2026 is acknowledged.
Claims 1-17 are pending in this application.
Restriction
Applicant's election with traverse of Group 1 (claims 1-12, 14-15 and 17) and election of 90% identity to SEQ ID NO: 17 as the species of a peptide, 100% identity to SEQ ID NO: 17 and SEQ ID NO: 18 for part (b) of claim 1, 90% identity to SEQ ID NO: 17 for the component involved in a cleaning agent, and polyester as the species in the reply filed on June 10, 2026 is acknowledged. The traversal is on the ground(s) that all claims depend from independent claim 1. Additionally, Applicant argues that the Office has not established that the peptide as claimed in claim 1 lacks a distinguishing technical feature despite the assertion that the peptides described and claimed “represent only a small portion of the compound structures and does not constitute a structurally distinctive portion in view of the different amino acid contents”. This is not found persuasive because lack of unity of invention and species was established in the previous office action. The peptide sequences involve different amino acid contents and there is no common core sequence shared among the peptide sequences. For example, claim 1(a) involves different positively charged amino acid residues, different uncharged amino acid residues, (X4)n wherein n is up to 46. Furthermore, SEQ ID NO: 16 has the sequence RSIVTFSLRQNAQLA and SEQ ID NO: 18 has the sequence GLHTSATNLYLH. When SEQ ID NOs: 16 and 18 are compared, there is no core sequence shared by the two peptide sequences. Therefore, there is lack of unity of invention.
The requirement is still deemed proper and is therefore made FINAL. Claims 13 and 16 are withdrawn from consideration, pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Claim 15 is withdrawn from further consideration as being drawn to nonelected species (Applicant did not elect fully defined components involved in the cleaning agent). Claims 1-12, 14 and 17 are examined on the merits in this office action.
Priority
5. Applicant claims foreign priority to Germany 10 2021 133 434.9 (12/16/2021). The certified copy has been received by the Office. However, a certified English translation has not been provided. Therefore, the foreign priority date has not been perfected. Thus, the effective priority date of instant application is 12/07/2022 until the foreign priority date is perfected.
Objections
6. The abstract is objected to for the following minor informality:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
In the instant case, the abstract recites, “The invention relates to a peptide as described herein. The invention further relates to a detergent…” at line 1 of the abstract. Applicant should correct these informalities. See MPEP 608.01(b). For example, the abstract is recommended to be amended to recite, “Peptides for detergent or cleaning agent…are described.”
7. The drawings are objected to because the figure is too dark and therefore, the details of what Applicant is referring to is hard to see. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
8. The specification is objected to for containing referring to sequences without also identifying them by the sequence identifier assigned to them in the sequence listing as required by 37 CFR 1.821(d). The specification discloses peptide sequences, and these are missing their respective sequence identifiers. For example, paragraph [0102] of instant specification 2024/0376152 A1 disclose peptide sequences, but these are missing their sequence identifiers. The examiner would like to bring the applicant’s attention to the following excerpt from MPEP §2422.03:
37 CFR 1.821(d) requires the use of the assigned sequence identifier in all instances where the description or claims of a patent application discuss sequences regardless of whether a given sequence is also embedded in the text of the description or claims of an application. This requirement is also intended to permit references, in both the description and claims, to sequences set forth in the "Sequence Listing" by the use of assigned sequence identifiers without repeating the sequence in the text of the description or claims. Sequence identifiers can also be used to discuss and/or claim parts or fragments of a properly presented sequence. For example, language such as "residues 14 to 243 of SEQ ID NO:23" is permissible and the fragment need not be separately presented in the "Sequence Listing." Where a sequence is embedded in the text of an application, it must be presented in a manner that complies with the requirements of the sequence rules.
The applicant is therefore required to amend the specification to comply with 37 CFR 1.821(d).
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
9. Claim 4 is objected to for the following: Claim 4 appears to be missing the term “or” in between (i) and (ii). Applicant is required to correct this error.
10. Claim 12 is objected to for the following minor informality: claim 12 contains the acronym “LSEP”, and an acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, i.e., low surface energy polymers (LSEP). The abbreviations can be used thereafter.
Rejections
U.S.C. 112(b)
11. 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.
12. Claims 1-12, 14 and 17 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.
13. Claim 1 recites, “A peptide for adhesion…(a) the amino acid sequence in N- to C-terminal orientation has the following sequence: (C)mX1X2X3(X4)nX5(C)o, where…each X4 is independently of one another any amino acid…n is an integer from 0 to 46…” The metes and bounds of the claim is indefinite since the (X4)n is unclear. The variable X4 is in parenthesis and the “n is an integer from 0 to 46” is outside the parenthesis. Thus, this implies that X4 is repeated 0 to 46 times. However, since X4 is inside the parenthesis, when n is 46, then it implies that X4 is repeated 46 times. Therefore, X4 cannot be “independent of one another any amino acid”. X4 must be the same amino acid residue from the formula recited in the claim. The formula does not correspond to the sequences being claimed and disclosed in the instant specification. Therefore, the metes and bounds of the claim 1(a) is indefinite. Because claims 2-12, 14 and 17 depend from indefinite claim 1 without clarifying the point of confusion, these claims are also rejected under 35 U.S.C. 112(b).
14. Claim 11 recites the limitation "the RAL motif" and “the EAL and/or QAL motif” in the claim, line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 11 depends from claim 1. Claim 1 does not recite “RAL motif” or “EAL and/or WAL motif”. Therefore, there is lack of antecedent basis.
15. Claim 11 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 11 recites, “The peptide according to claim 1…as well as variants thereof, which have at least 90%, sequence identity to the specified sequence, with the RAL motif, and also the EAL and/or QAL motif, if present, being invariable.” The metes and bounds of the claim is unclear. It is unclear if the “at least 90% sequence identity” is to the RAL motif, EAL or QAL motif or to the SEQ ID NOs: 1-15 and/or 16-17?
16. Claim 12 recites parenthetical expression “(blended fabric)". The metes and bounds of claim 12 is rendered vague and indefinite by the parenthetical recitation of "(blended fabric)” because it is unclear as to whether the limitation is part of the instantly claimed subject matter. See MPEP § 2173.05(d).
U.S.C. 112(a)
17. 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.
18. Claims 1-12, 14 and 17 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 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 (1997); In re Gosteli, 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.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gostelli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618.
In the instant case, the claims are drawn to “A peptide for adhesion…(a) the amino acid sequence in N- to C-terminal orientation has the following sequence: (C)mX1X2X3(X4)nX5(C)o, where…each X4 is independently of one another any amino acid…n is an integer from 0 to 46…” (claim 1); “The peptide according to claim 1, where the peptide has the amino acid sequence…as well as variants thereof…” (see claim 11). The generic statements the amino acid sequence in N- to C-terminal orientation has the following sequence: (C)mX1X2X3(X4)nX5(C)o, where…each X4 is independently of one another any amino acid…n is an integer from 0 to 46 and variants thereof do not provide ample written description for the compounds since the claims do not describe a single structural feature. The specification does not clearly define or provide examples of what qualify as compounds of the claimed invention.
As stated earlier, 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 claims 1 and 11 are broad generics with respect all possible compounds encompassed by the claims. The possible structural variations are limitless to any class of peptide or a peptide-like molecule that can form cross-linking or can be cross-linked, and make up the class of proteases. It must not be forgotten that the MPEP states that if a peptide is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. Here, though the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond compounds disclosed in the examples in the specification. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus since the specification does not provide any examples of derivatives. The specification is void of organic molecules that functions as a peptide-like molecule that qualify for the functional characteristics claimed as a peptide or a peptide-like molecule or other peptidic molecules that can be cross-linked, and other synthetic peptide or peptide-like molecule that can function as proteases.
The specification is limited to SEQ ID NOs: 1-27. The specification does not describe any peptides having repeats of amino acid residues for the variable (X4)n, wherein n is 0 to 46. For the variable (X4)n, wherein n is 0 to 46, if n is 20 and X4 is the amino acid residue Arg (R), then the sequence would have RRRRRRRRRRRRRRRRRRRR in the sequence of the formula (C)mX1X2X3(X4)nX5(C)o. Description of SEQ ID NOs: 1-27 is not sufficient to encompass numerous other peptides that belong to the same genus. For example, there are varying lengths, varying amino acid compositions, and numerous distinct qualities that make up the genus. There is not sufficient amount of examples provided to encompass the numerous characteristics of the whole genus claimed.
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 appellants 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.
Please note: for the purposes of art, the Examiner has searched sequence of instant SEQ ID NOs: 16-18, for example, that reads on (C)mX1X2X3(X4)nX5(C)o, wherein X4 is independent of each other and can be repeated 0 to 46 times (i.e., X4X4X4X4, etc).
U.S.C. 102
19. 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.
20. 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.
21. Claim(s) 1-2, 4, 10-12 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou et al (Oncotarget, 2017, 8(50): 87095-87106).
22. Zhou et al teach a peptide sequence that is 100% identical to instant SEQ ID NO: 18 (GLHTSATNLYLH) (see p. 87096, right column, RESULTS, “Selection of peptide specific for FGFR2”), meeting the limitation of instant claims 1-2, 12 and 14. Since Zhou et al teach a peptide sequence that is 100% identical to instant SEQ ID NO: 18, the peptide would inherently have all of the activities and functionalities of instant SEQ ID NO: 18. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).” Because Zhou et al teach ALL of the active components of instant claims, Zhou et al anticipates instant claims 1-2, 12 and 14.
23. Claims 1-2, 4, 10 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taden et al (DE 10 2012 110 664, published May 8, 2014, English translation used and enclosed herein).
24. Taden et al teach peptide within the scope of (C)mX1X2X3(X4)nX5(C)o, including the sequence RSIVTFSLRQNR wherein m and o are 0, X1 is R, X2 is S, X3 is I, (X4)8 is VTFSKLQN, and X5 is R (see paragraphs 3, 4, 24, 51, 52, and Tables 1 and 2). Because Taden et al teach a peptide within the scope of (C)mX1X2X3(X4)nX5(C)o, Taden et al anticipates instant claims. Since Taden et al teach a peptide sequence that is within the scope of (C)mX1X2X3(X4)nX5(C)o, the peptide would inherently have all of the activities and functionalities of instant peptides. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).” Because Taden et al teach ALL of the active components of instant claims, Taden et al anticipates instant claims 1-2, 4, 10 and 14.
25. Claims 1, 2, 4, 10 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taden et al (WO 2014/072313, published May 15, 2014, English translation used and enclosed herein).
26. Taden et al teach a peptide within the scope of (C)mX1X2X3(X4)nX5(C)o, including the sequence RSIVTFSLRQNR wherein m and o are 0, X1 is R, X2 is S, X3 is I, (X4)8 is VTFSKLQN, and X5 is R (see paragraphs 3, 4, 24, 51, 52, and Tables 1 and 2). Because Taden et al teach a peptide within the scope of (C)mX1X2X3(X4)nX5(C)o, Taden et al anticipates instant claims. Because Taden et al teach a peptide within the scope of (C)mX1X2X3(X4)nX5(C)o, Taden et al anticipates instant claims. Since Taden et al teach a peptide sequence that is within the scope of (C)mX1X2X3(X4)nX5(C)o, the peptide would inherently have all of the activities and functionalities of instant peptides. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).” Because Taden et al teach ALL of the active components of instant claims, Taden et al anticipates instant claims 1-2, 4, 10 and 14.
27. Claims 1-2, 4, 10 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balaoing et al (PLoS ONE, 2015, 10(6): e0130749, pp. 1-16).
28. Balaoing et al teach a peptide within the scope of (C)mX1X2X3(X4)nX5(C)o, including the sequence RKRLQVQLSIRT wherein m and o are 0, X1 is R, X2 is L, X3 is Q, (X4)6 is VQLSIR, and X5 is T and cysteine can be added to the N-terminus bound to plastic polymers (see abstract and Material and Methods). Because Balaoing et al teach a peptide within the scope of (C)mX1X2X3(X4)nX5(C)o, Balaoing et al anticipates instant claims. Because Balaoing et al teach a peptide within the scope of (C)mX1X2X3(X4)nX5(C)o, Balaoing et al anticipates instant claims. Since Balaoing et al teach a peptide sequence that is within the scope of (C)mX1X2X3(X4)nX5(C)o, the peptide would inherently have all of the activities and functionalities of instant peptides. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).” Because Balaoing et al teach ALL of the active components of instant claims, Balaoing et al anticipates instant claims 1-2, 4, 10 and 14.
DOUBLE PATENTING
29. 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.
30. Claims 1-12, 14 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18564739 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
31. Instant claims are drawn to:
PNG
media_image1.png
554
574
media_image1.png
Greyscale
.
32. Copending claims are drawn to:
PNG
media_image2.png
506
566
media_image2.png
Greyscale
.
33. Instant claims and copending claims are drawn to the same peptides of formula (C)mX1X2X3(X4)nX5(C)o, and instant sequences (e.g., SEQ ID NOs: 16, 17 and so on). Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims and vice versa.
34. Claims 1-12, 14 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/492505 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
35. Instant claims are drawn to:
PNG
media_image1.png
554
574
media_image1.png
Greyscale
.
36. Copending claims are drawn to:
PNG
media_image3.png
718
594
media_image3.png
Greyscale
.
37. Instant claims and copending claims are drawn to the same peptides of formula (C)mX1X2X3(X4)nX5(C)o, and instant sequences (e.g., SEQ ID NOs: 16, 17 and so on). Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims and vice versa.
38. Claims 1-12, 14 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/128006 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
39. Instant claims are drawn to:
PNG
media_image1.png
554
574
media_image1.png
Greyscale
.
40. Copending claims are drawn to:
PNG
media_image4.png
602
576
media_image4.png
Greyscale
.
41. Instant claims and copending claims are drawn to the same peptides of formula (C)mX1X2X3(X4)nX5(C)o, and instant sequences (e.g., SEQ ID NOs: 16, 17 and so on). Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims and vice versa.
42. Claims 1-12, 14 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10494622. Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of US Patent claims and vice versa.
43. Instant claims are drawn to:
PNG
media_image1.png
554
574
media_image1.png
Greyscale
.
44. US Patent claims are drawn to peptides of (C)mX1X2X3(X4)nX5(C)o, including SEQ ID NO: 4, wherein m and o are 0, X1 is K, X2 is L, X3 is F, (X4)n is KTIVTLSLLISGTLLFSQSAA, and X5 is A.
45. Instant claims and US Patent claims share a peptides of (C)mX1X2X3(X4)nX5(C)o, including SEQ ID NO: 4, wherein m and o are 0, X1 is K, X2 is L, X3 is F, (X4)n is KTIVTLSLLISGTLLFSQSAA, and X5 is A. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of US Patent claims and vice versa.
46. Claims 1-12, 14 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9803183. Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of US Patent claims and vice versa.
47. Instant claims are drawn to:
PNG
media_image1.png
554
574
media_image1.png
Greyscale
.
48. US Patent claims are drawn to peptides of (C)mX1X2X3(X4)nX5(C)o, including SEQ ID NO: 2, wherein m and o are 0, X1 is K, X2 is P, X3 is L, (X4)n is SKGGILVKKVLIAGAVGTAVLFGTLSSGIPGLPAAD, and X5 is A.
49. Instant claims and US Patent claims share a peptides of (C)mX1X2X3(X4)nX5(C)o, including SEQ ID NO: 2, wherein m and o are 0, X1 is K, X2 is P, X3 is L, (X4)n is SKGGILVKKVLIAGAVGTAVLFGTLSSGIPGLPAAD, and X5 is A. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of US Patent claims and vice versa.
50. Claims 1-12, 14 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10065991. Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of US Patent claims and vice versa.
51. Instant claims are drawn to:
PNG
media_image1.png
554
574
media_image1.png
Greyscale
.
52. US Patent claims are drawn to peptides of (C)mX1X2X3(X4)nX5(C)o, including SEQ ID NOs: 9-19 (SEQ ID NO: 9 is SRARLFVVTYHK), wherein m and o are 0, X1 is R, X2 is L, X3 is F, (X4)n is VVTYH, and X5 is K.
53. Instant claims and US Patent claims share a peptides (C)mX1X2X3(X4)nX5(C)o, including SEQ ID NOs: 9-19 (SEQ ID NO: 9 is SRARLFVVTYHK), wherein m and o are 0, X1 is R, X2 is L, X3 is F, (X4)n is VVTYH, and X5 is K. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of US Patent claims and vice versa.
54. Claims 1-12, 14 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11046961. Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of US Patent claims and vice versa.
55. Instant claims are drawn to:
PNG
media_image1.png
554
574
media_image1.png
Greyscale
.
56. US Patent claims are drawn to peptides of (C)mX1X2X3(X4)nX5(C)o, including SEQ ID NO: 6, wherein m and o are 0, X1 is K, X2 is M, X3 is L, (X4)n is SMLTVMIASLFSSQAL, and X5 is A.
57. Instant claims and US Patent claims share a peptides of (C)mX1X2X3(X4)nX5(C)o, including SEQ ID NO: 6, wherein m and o are 0, X1 is K, X2 is M, X3 is L, (X4)n is SMLTVMIASLFSSQAL, and X5 is A. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of US Patent claims and vice versa.
58. Claims 1-12, 14 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12157870. Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of US Patent claims and vice versa.
59. Instant claims are drawn to:
PNG
media_image1.png
554
574
media_image1.png
Greyscale
.
60. US Patent claims are drawn to peptides of (C)mX1X2X3(X4)nX5(C)o, including SEQ ID NOs: 2-7 (SEQ ID NO: 3, RSVCRGIKLCRRRGGCYYKCTNRPY), wherein m and o are 0, X1 is R, X2 is S, X3 is V, (X4)n is CRGIKLCRRRGGCYYKCTNRP, and X5 is Y.
61. Instant claims and US Patent claims share a peptides of (C)mX1X2X3(X4)nX5(C)o, including SEQ ID NOs: 2-7 (SEQ ID NO: 3, RSVCRGIKLCRRRGGCYYKCTNRPY), wherein m and o are 0, X1 is R, X2 is S, X3 is V, (X4)n is CRGIKLCRRRGGCYYKCTNRP, and X5 is Y. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of US Patent claims and vice versa.
Improper Markush
62. Claims 1-12, 14 and 17 are rejected on the judicially created 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 Hazumi, 3 USPQ 2d 1059, 1060 (BPAI 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons: The compounds claimed do not share a common structural feature and a common use. For example, instant SEQ ID NO: 16 and 18 or SEQ ID NO: 17 and 18 do not share a common core sequence. Instant SEQ ID NO: 16 has the sequence RSIVTFSLRQNAQLA; instant SEQ ID NO: 18 has the sequence GLHTSATNLYLH. Instant SEQ ID NO : 17 has the sequence RSIVTFSLRQNSEQA; instant SEQ ID NO: 18 has the sequence GLHTSATNLYLH. Therefore, there is no common core sequence shared by SEQ ID NOs: 16 and 18; SEQ ID NOs: 17 and 18. As evidenced by Zhou et al (Oncotarget, 2017, 8(50): 87095-87106), instant SEQ ID NO: 18 is specific for FGFR2 (see p. 87096, right column).
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. § 134 and 37 CFR 41.31 (a)(1) (emphasis provided).
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JULIE HA/Primary Examiner, Art Unit 1654
7/31/2026
Prosecution Insights