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 May 11, 2026 is acknowledged.
Claims 2-7 and 16-17 have been cancelled.
Claims 1, 8-12, 14-15 and 18-20 are pending in this application.
Priority
5. Applicant claims foreign priority to EP 21165998.2 (3/30/2021). The certified copy has been received by the Office. The foreign priority document is in English. Thus, the priority date of instant application is March 30, 2021.
Restriction
6. Applicant’s election without traverse of Group 1 (claims 1-8, 14, 16-19, currently 1, 8, 14 and 18-19) and the election of SEQ ID NO: 60 as the fibril peptide species in the reply filed on May 11, 2026 is acknowledged. Restriction is deemed to be proper and is made FINAL in this office action. Claims 9-12, 15 and 20 are withdrawn from consideration, pursuant to 37 CFR 1.142(b),as being drawn to nonelected inventions, there being no allowable generic or linking claim. Claims 1, 8, 14 and 18-19 are examined on the merits in this office action.
Objections
7. 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 present invention relates to a fibril peptide consisting of a sequence of from 8 to 20 amino acids and wherein said fibril peptide comprises the amino acid sequence RTIFIISM or a sequence at least 75% identical thereto” at lines 1-4 of the abstract. Further, at line 5, the abstract recites, "The present invention further relates to a method…”; at line 7, the abstract recites, “contacting said host cell…”; at line and at line 8, the abstract recites, “…according to any one of claims 1 to 8”; and at line 9, the abstract recites, “b) delivering said cargo into said host cell…” The abstract recites legal phraseology “said” throughout the abstract. The terms “relates to” should be avoided. Additionally, the recitation of “any one of claims 1 to 8” should be removed from the abstract. Applicant should correct these informalities. See MPEP 608.01(b).
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.
Rejections
U.S.C. 102
8. 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.
9. 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.
10. Claim(s) 1, 8, 14 and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ghayur et al (WO 01/58956, filed with IDS or US 2013/0101595).
11. Ghayur et al teach a 14 residue peptide sequence NAPRTIFIISMYKD (see SEQ ID NO: 39, page 13, Table 5, 12th peptide sequence). Instant SEQ ID NO: 60 has the sequence RRTIFIISM. The peptide sequence of SEQ ID NO: 39 of Ghayur has 87.5% sequence identity to instant SEQ ID NO: 60 (see bold type print). The peptide sequence of SEQ ID NO: 39 of Ghayur is from 8 to 20 amino acids, meeting the limitation of instant claim 1. Therefore, the peptide taught in Ghayur must have the same activity and functionality as instant SEQ ID NO: 60, meeting the limitation of instant claims 8 and 18-19. 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)).” Thus, since Ghayur et al teach a peptide comprising from 8 to 20 amino acids and a sequence having at least 75% identity to instant SEQ ID NO: 60, the reference anticipates instant claims 1, 8 and 18-19.
Ghayur et al further teach solvents (see for example, pp. 19-21) and diluents for, for example edible carrier (see p. 22, lines 3-12, for example), meeting the limitation of instant claim 14.
Additionally, for a better understanding of how the examiner views the claim 14, it should be noted that the claim is to a product, and products are not limited or novel based on the product’s non-functional instructions on how to use the product by being in a kit. “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.” In re Ngai, 367 F.3d 1336, 2004 WL 1068957 (Fed. Cir. May 13, 2004). Since Ghayur et al teach all of the active components, the reference anticipates instant claims 1, 8, 14 and 18-19.
12. Claim(s) 1, 8, 14 and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ushio et al (US 2007/0031403).
13. Ushio et al teach a 14 residue peptide sequence TIFIISMYKDSQPR (see SEQ ID NO: 16). Instant SEQ ID NO: 60 has the sequence RRTIFIISM. The peptide sequence of SEQ ID NO: 16 of Ushio et al has 75% sequence identity to instant SEQ ID NO: 60 (see bold type print). The peptide sequence of SEQ ID NO: 16 of Ushio et al is from 8 to 20 amino acids, meeting the limitation of instant claim 1. Therefore, the peptide taught in Ushio et al must have the same activity and functionality as instant SEQ ID NO: 60, meeting the limitation of instant claims 8 and 18-19. 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)).” Thus, since Ushio et al teach a peptide comprising from 8 to 20 amino acids and a sequence having at least 75% identity to instant SEQ ID NO: 60, the reference anticipates instant claims 1, 8 and 18-19.
Ushio et al further teach physiologically acceptable carriers, adjuvants, excipients, diluents and/or stabilizers (see for example paragraph [0057]), meeting the limitation of instant claim 14.
Additionally, for a better understanding of how the examiner views the claim 14, it should be noted that the claim is to a product, and products are not limited or novel based on the product’s non-functional instructions on how to use the product by being in a kit. “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.” In re Ngai, 367 F.3d 1336, 2004 WL 1068957 (Fed. Cir. May 13, 2004). Since Ushio et al teach all of the active components, the reference anticipates instant claims 1, 8, 14 and 18-19.
14. Claim(s) 1, 8, 14 and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bam et al (US 2005/0008615).
15. Bam et al teach a 9 residue peptide sequence TIFIISMYK (see SEQ ID NO: 16). Instant SEQ ID NO: 60 has the sequence RRTIFIISM. The peptide sequence of SEQ ID NO: 16 of Bam et al has 75% sequence identity to instant SEQ ID NO: 60 (see bold type print). The peptide sequence of SEQ ID NO: 16 of Bam et al is from 8 to 20 amino acids, meeting the limitation of instant claim 1. Therefore, the peptide taught in Bam et al must have the same activity and functionality as instant SEQ ID NO: 60, meeting the limitation of instant claims 8 and 18-19. 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)).” Thus, since Bam et al teach a peptide comprising from 8 to 20 amino acids and a sequence having at least 75% identity to instant SEQ ID NO: 60, the reference anticipates instant claims 1, 8 and 18-19.
Bam et al further teach physiologically acceptable carriers, excipients, diluents such as saline, buffered saline, dextrose, water, glycerol, ethanol, and combinations thereof (see for example paragraph [0060]), meeting the limitation of instant claim 14.
Additionally, for a better understanding of how the examiner views the claim 14, it should be noted that the claim is to a product, and products are not limited or novel based on the product’s non-functional instructions on how to use the product by being in a kit. “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.” In re Ngai, 367 F.3d 1336, 2004 WL 1068957 (Fed. Cir. May 13, 2004). Since Bam et al teach all of the active components, the reference anticipates instant claims 1, 8, 14 and 18-19.
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
5/26/2026
Prosecution Insights