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 July 8, 2025 is acknowledged.
Claim 13 has been cancelled.
Claims 11-12 and 14-29 are pending in this application.
Restriction
Applicant’s election without traverse of 100% sequence identity to SEQ ID NO: 3 (N- to C-terminal order, EAIPMAIPPEVKF) as the species of a peptide sequence, HCQ as the species of a therapeutic agent, SEQ ID NO: 60/P-selectin as the other targeting peptide sequence, and deep vein thrombosis (DVT) as the species of a disease caused by neutrophil activation or inflammatory diseases accompanied by neutrophil activation in the reply filed on July 8, 2025 is acknowledged. Restriction is deemed to be proper and is made FINAL in this office action. Applicant indicates that claims 11-12, 14-26 and 28-29 read on the elected species. Claim 27 is withdrawn from further consideration as being drawn to nonelected species. A search was conducted on the elected species, SEQ ID NO: 3 and art was found on a peptide comprising instant SEQ ID NO: 3. Claims 15-18 are withdrawn from further consideration as being drawn to nonelected species. Claims 11-12, 14, 19-26 and 28-29 are examined on the merits in this office action.
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 abstract appears to be an incomplete sentence. Applicant should correct these informalities. See MPEP 608.01(b).
7. The specification is objected to for 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, FIG. 3C and 3F of instant specification US 2023/0235022 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.
8. Claims 11-12 are objected to for the following reasons: Claims 11 and 12 recite, “an amino acid sequence at least 60% identical to the amino acid sequence of SEQ ID NO: 1” and “an amino acid sequence at least 70% identical to the amino acid sequence of SEQ ID NO: 1”, respectively. Applicant is suggested to amend the claims to recommended to amend the claim 11 to recite, for example, “…wherein each of the targeting peptides comprising an amino acid sequence that has at least 60% identity to the amino acid sequence of SEQ ID NO: 1”.
9. Claim 14 is objected to for the following: Claim 14 recites, “The composition of claim 11…EAIX1X2X3IPPEVK (SEQ ID NO: 2) or a retro-inverso amino acid sequence of SEQ ID NO: 2…” The SEQ ID NO: 2 in the sequence listing is as follows:
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. The sequence recited in the claim is not the same as the one filed in the sequence listing.
10. Claims 20, 26 and 29 are objected to for the following minor informality: claim 20 contains the acronym “PEG”; claim 26 contains the acronym “GPIIb-IIIa-binding peptide”; claim 29 contains the acronyms “SLE” and “DIC”, and an acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, e.g., vasopressin-1 receptor agonist (V-1 receptor agonist). The abbreviations can be used thereafter.
11. Claim 24 is objected to for the following: Claim 24 recites,
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. The claim is too wordy and Applicant is recommended to amend the claim to recite, for example, “The composition of claim 11, wherein the nanoparticle and/or microparticle construct further comprises additional targeting peptide conjugated to the surface of the nanoparticle and/or microparticle construct that is different than the targeting peptide of an amino acid sequence that has least 60% identity to SEQ ID NO: 1.
12. Claim 28 is objected to for the following: claim 28 recites, “The composition of claim 11, for use in treating diseases caused by…” Applicant is recommended to amend the claim 28 to recite, “The composition of claim 11 for treating diseases caused by…”
Rejections
U.S.C. 112
13. 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.
14. Claims 14 and 20 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.
Claim 14 recites,
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. The SEQ ID NO: 2 in the sequence listing is as follows:
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. The sequence recited in the claim is not the same as the one filed in the sequence listing. Therefore, the metes and bounds of the claim is unclear.
15. Claim 20 recites, “The composition of claim 11, wherein the targeting peptide includes CG residues linked to the 1E residue of the amino acid sequence that links the targeting peptide to a PEG linker conjugated to the surface…” Instant SEQ ID NO: 1 is a 13 residue peptide having the sequence EAIPMSIPPEVKF. A peptide having at least 60% sequence identity to SEQ ID NO: 1 implies that 5 residues can be different, including the Glu “E” residues. Therefore, if the peptide having at least 60% identity to SEQ ID NO: 1 has 1E or both E residues substituted, it is unclear what “1E” the claim is referring to. The metes and bounds of the claim is unclear.
U.S.C. 112(d)
16. 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.
17. Claims 14 is 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. 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.
18. Claim 14 recites,
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. Claim 14 depends from claim 1. Claim 1 recites,
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. Instant SEQ ID NO: 1 has the sequence EAIPMSIPPEVKF. Therefore, the SEQ ID NO: 2 recited in claim 14 is broader than instant SEQ ID NO: 1 recited in claim 11.
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) 11-12, 14, 19, 21-23 and 28-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Collins et al (WO 2012/012146, filed with IDS).
22. Collins et al teach a peptide comprising instant SEQ ID NO: 3 (see for example, LEAIPMSIPPEVKFNKPFVFLM (SEQ ID NO; 29), LEAIPMSIPPEVKFNKPFVF (SEQ ID NO: 30), see paragraph [0098]), meeting the limitation of instant claims 11-12 and 14. Collins et al teach that slow release capsule, timed-release microparticles, and the like can also be employed (see paragraph [0060]), meeting the limitation of instant claims 11-12, 14, 19, 21-23 and 28-29. Collins et al further teach that liposomes can be used as a therapeutic delivery system (see paragraph [0068]), meeting the limitation of instant claim 21. Collins et al further teach additional therapeutic agents, such as chloroquine phosphate (see paragraph [0087]), meeting the limitation of instant claim 22. In regards to claims 28-29, Collins et al teach treating inflammatory diseases, for example, inflammatory bowel disease (see for example, Title, paragraphs [0002], [0004]-[0005]), meeting the limitation of instant claims 28-29. Additionally, instant claims 28-29 recite an intended use. With respect to the limitation “for use in treating diseases caused by” in instant claims 28-29, an intended use limitation does not impart patentability to product claims where the product is otherwise anticipated by the prior art. Since the reference teaches ALL of the active components, the reference anticipates instant claims 11-12, 14, 19, 21-23 and 28-29.
U.S.C. 103
23. 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.
24. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
25. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
26. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
27. Claim(s) 11-12, 14, 19-23 and 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collins et al (WO 2012/012146, filed with IDS) in view of Filpula et al (Advanced Drug Delivery Reviews, 2008, 60: 29-49).
28. Collins et al teach a peptide comprising instant SEQ ID NO: 3 (see for example, LEAIPMSIPPEVKFNKPFVFLM (SEQ ID NO; 29), LEAIPMSIPPEVKFNKPFVF (SEQ ID NO: 30), see paragraph [0098]), meeting the limitation of instant claims 11-12 and 14. Collins et al teach that slow release capsule, timed-release microparticles, and the like can also be employed (see paragraph [0060]), meeting the limitation of instant claims 11-12, 14, 19, 21-23 and 28-29. Collins et al further teach that liposomes can be used as a therapeutic delivery system (see paragraph [0068]), meeting the limitation of instant claim 21. Collins et al further teach additional therapeutic agents, such as chloroquine phosphate (see paragraph [0087]), meeting the limitation of instant claim 22. In regards to claims 28-29, Collins et al teach treating inflammatory diseases, for example, inflammatory bowel disease (see for example, Title, paragraphs [0002], [0004]-[0005]), meeting the limitation of instant claims 28-29. Additionally, instant claims 28-29 recite an intended use. With respect to the limitation “for use in treating diseases caused by” in instant claims 28-29, an intended use limitation does not impart patentability to product claims where the product is otherwise anticipated by the prior art. Since the reference teaches ALL of the active components, the reference anticipates instant claims 11-12, 14, 19, 21-23 and 28-29.
The difference between the reference and instant claims is that the reference does not teach PEG linker conjugation.
29. However, Filpula et al teach that releasable PEGylation provides a prodrug format that combines beneficial attributes of PEGylation with controlled release. The linker release mechanisms are shown to be kinetically controlled by the design of a hydrolytically labile center and side chains for the steric modulation of the intramolecular elimination reactions and linker self-immolation (see abstract, for example). Filpula et al teach that circulating half-life and AUC exposure could be extended about 100-fold from the rapidly clearing unmodified protein to the long circulating permanently PEGlyated derivatives (see p. 42, left column, 1st full paragraph).
30. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Collins et al and Filpula et al and incorporate PEG linker to provide a controlled release and increase the half-life of the composition. One of ordinary skill in the art would be motivated to combine with a reasonable expectation of success, since Filupla et al teach that circulating half-life and AUC could be extended about 100-fold from the unmodified protein.
31. Claim(s) 11-12, 14, 19-26 and 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collins et al (WO 2012/012146, filed with IDS) in view of Filpula et al (Advanced Drug Delivery Reviews, 2008, 60: 29-49), as applied to claims 11-12, 14, 19-23 and 28-29 above, further in view of Appeldoorn et al (US 2006/0217294).
32. The teachings of Collins et al in view of Filpula et al are described above. The difference between the references and instant claims is that the references do not teach additional targeting peptide, the elected species, SEQ ID NO: 60 (p-selectin, EWVDV).
33. However, Appeldoorn et al teach compounds which bind selectively to the adhesion molecule human P-selectin, wherein the compound comprise a peptide moiety (see abstract, for example). Appeldoorn et al teach that the compound EWVDV has an affinity for P-selectin (see paragraph [0015], for example). Appeldoorn et al further teach that the compounds is for preparing therapeutic compositions or medicaments to prevent or improve diseases and conditions involving the adhesion of leukocytes, such as monocytes and neutrophils, to the vascular endothelium and to platelets…treating disease in which the inhibition of P-selectin-mediated intracellular signaling is desirable (see paragraph [0081]). Appeldoorn et al teach that “these inflammatory responses, some of which also involve P-selectin-mediated platelet activation, are part of several pathological conditions…inflammatory bowel disease…” (see paragraph [0082] and claim 29, for example).
34. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Collins et al, Filpula et al, and Appeldoorn et al because Collins et al and Appeldoorn et al teach targeting peptides that bind to neutrophil surfaces; additionally, Filpula et al teach the benefits of adding a PEG linker to the composition. One of ordinary skill in the art would be motivated to combine the teachings of Collins et al and Appeldoorn et al with a reasonable expectation of success, since Appeldoorn et al teach additional neutrophil binding peptide (e.g., P-selectin binding peptide, EWVDV, which can treat inflammatory diseases, such as inflammatory bowel disease. Adding another compound that is known to treat the same disease or disorder would at least have an additive effect. The MPEP states, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). But see In re Geiger, 815 F.2d 686, 2 USPQ2d 1276 (Fed. Cir. 1987) (“Based upon the prior art and the fact that each of the three components of the composition used in the claimed method is conventionally employed in the art for treating cooling water systems, the board held that it would have been prima facie obvious, within the meaning of 35 U.S.C. 103, to employ these components in combination for their known functions and to optimize the amount of each additive....Appellant argues... hindsight reconstruction or at best,... obvious to try’.... We agree with appellant.”). Therefore, one of ordinary skill in the art would at least expect an additive effect.
Therefore, the combined arts are prima facie obvious over instant claims 11-12, 14, 19-26 and 28-29.
Improper Markush
35. Claims 11-12, 14, 19-26 and 28-29 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, peptides comprising at least 60% sequence identity to SEQ ID NO: 1 and peptides comprising at least 60% sequence identity to the retro-inverso of SEQ ID NO: 1 do not share a common core peptide sequence, since the N- to C-terminal sequences are different. Additionally, the diseases recited in claim 29 involve different patient population (different cells/organs, etc.,) and end points.
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.
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/JULIE HA/Primary Examiner, Art Unit 1654
10/08/2025