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 November 24, 2025 is acknowledged.
New claims 22-23 have been added.
Claims 1, 3-11 and 14-23 are pending in this application.
Priority
Applicant claims foreign priority to CHINA 202010956519.2 (09/11/2020). 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 filing date of instant application is 09/13/2021 until the foreign priority date is perfected.
Restriction
6. Applicant's election with traverse of Group 1 (claims 1, 3-4 and 14-15) and election of SEQ ID NO: 1 as the species of the amino acid sequence, and the peptide as the species from a peptide or a nucleotide in the reply filed on November 24, 2025 is acknowledged. The traversal is on the ground(s) that “the claimed peptides and nucleotides share the inherent functional encoding relationship as a special technical feature that constitutes the inventions’ contribution over the prior art. This contribution (i.e., enabling cell/tissue destruction via triggering collapse of the cell membrane system) has already been recognized in the Written Opinion of the International Searching Authority (ISA), which confirmed the novelty and inventiveness of the subject matter.” Applicant argues that the ISA issued a Written Opinion that did not identify any lack of unity of invention. This is not found persuasive because lack of unity of invention involves more than “contribution over the art”. The lack of unity of invention in the US practice has been established in the previous office action. The peptides and nucleotides do not share a common structure. Therefore, there is lack of unity of invention.
The requirement is still deemed proper and is therefore made FINAL. Claims 5-11 and 16-23 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. A search was conducted on the elected species, SEQ ID NO: 1 and this appears to be free of prior art. A search was extended to SEQ ID NO: 29 and this too appears to be free of prior art. The election of species between SEQ ID NOs: 1 and 29 is hereby withdrawn. Claims 1, 3-4 and 14-15 are examined on the merits in this office action.
Objections
7. The drawings are objected to because there are shadings in the drawings that are improper. 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.
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. 112(b)
8. 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.
9. Claims 1, 3-4 and 14-15 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.
10. Claim 1 recites, “An amino acid sequence that can destroy cells...and can further comprise the effect of tissue damage…” It is unclear what is encompassed with the word “can”. The phrase “can” is not an absolute phrase. Can does not state what actually occurs. The specification does not fully define what is meant by “can”. Because claims 3-4 and 14-15 depend from indefinite claim 1 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112, second paragraph.
11. Claim 3 recites, “The amino acid sequence of claim 1, wherein the amino acid sequence is selected from the following group…(2) a derived protein or homologous protein of the Mdpcd1-303 protein fragment…” It is unclear what proteins of Mdpcd1-303 protein fragments are encompassed within “homologous protein of the Mdpcd1-303”. The terms homology, similarity and identity have different definitions. For example, Kanduc reference (Journal of Peptide Science, 2012, 18: 487-494) teaches that “homology is a concept of quality” (see p. 487, left column, Introduction). Kanduc reference teaches that “homology indicates an ancient common origin and temporal evolution and refers to structural characteristic…homology retains the original meaning of having a common evolutionary origin…It is important to note that homologous structures do not imply sequence similarity as a necessary condition” (see p. 488, left column). Additionally, Pearson reference (Current Protocols in Bioinformatics, 2013, Supplement 42: 3.1.1-3.1.8, pp. 1-8, enclosed) teaches that “homologous sequences do not always share significant sequence similarity; there are thousands of homologous protein alignments that are not significant, but are clearly homologous based on statistically significant structural similarity or strong sequence similarity to an intermediate sequence…” (see p. 2, 1st full paragraph). Therefore, it is unclear what sequences are encompassed within “homologous protein of the Mdpcd1-303”. Therefore, the metes and bounds of the claim is unclear.
12. Claim 4 recites, “The amino acid sequence of claim 3…the homologous protein comprises a Ptpcd1-296 protein fragment…” It is unclear what proteins of Ptpcd1-296 protein fragments are encompassed within “homologous protein of the Ptpcd1-296”. The terms homology, similarity and identity have different definitions. For example, Kanduc reference (Journal of Peptide Science, 2012, 18: 487-494) teaches that “homology is a concept of quality” (see p. 487, left column, Introduction). Kanduc reference teaches that “homology indicates an ancient common origin and temporal evolution and refers to structural characteristic…homology retains the original meaning of having a common evolutionary origin…It is important to note that homologous structures do not imply sequence similarity as a necessary condition” (see p. 488, left column). Additionally, Pearson reference (Current Protocols in Bioinformatics, 2013, Supplement 42: 3.1.1-3.1.8, pp. 1-8, enclosed) teaches that “homologous sequences do not always share significant sequence similarity; there are thousands of homologous protein alignments that are not significant, but are clearly homologous based on statistically significant structural similarity or strong sequence similarity to an intermediate sequence…” (see p. 2, 1st full paragraph). Therefore, it is unclear what sequences are encompassed within “homologous protein of the Ptpcd1-296”. Therefore, the metes and bounds of the claim is unclear.
13. Claim 4 recites the limitation "and wherein the Mdpcd1-18 protein fragment has the amino acid sequence shown in SEQ ID NO: 3…the Ptpcd1-296 protein fragment has the amino acid sequence shown in SEQ ID NO: 5…" in the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 4 depends from claim 3, which depends from claim 1. Claim 1 explicitly recites “…and wherein the amino acid sequence comprises the amino acid sequence shown in SEQ ID NO: 1 and/or SEQ ID NO: 29.” SEQ ID NO: 3 and SEQ ID NO: 5 lacks antecedent basis for SEQ ID NO: 29. Instant claim 1 recites that the amino acid sequence comprises the amino acid sequence shown in SEQ ID NO: 1 and/or SEQ ID NO: 29”. Thus, the SEQ ID NOs: 3 and 5 must either comprise SEQ ID NO: 1 or SEQ ID NO: 29. However, Instant SEQ ID NO: 3 is an 18 residue peptide sequence having the sequence MCPTKQKHRSSVAEHAGK. Instant SEQ ID NO: 29 is a 268 residue protein sequence. SEQ ID NO: 3 and SEQ ID NO: 29 has the following sequence alignment:
PNG
media_image1.png
758
742
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Greyscale
. Instant SEQ ID NO: 5 is a 296 residue protein sequence. SEQ ID NO: 5 and SEQ ID NO: 29 has the following sequence alignment:
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682
706
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Greyscale
. Since the SEQ ID NOs: 3 and 5 do not comprise instant SEQ ID NO: 29, there is lack of antecedent basis.
U.S.C. 112(d)
14. 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.
15. Claim 4 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.
16. Claim 4 recites the limitation "and wherein the Mdpcd1-18 protein fragment has the amino acid sequence shown in SEQ ID NO: 3…the Ptpcd1-296 protein fragment has the amino acid sequence shown in SEQ ID NO: 5…" in the claim. Claim 4 depends from claim 3, which depends from claim 1. Claim 1 explicitly recites “…and wherein the amino acid sequence comprises the amino acid sequence shown in SEQ ID NO: 1 and/or SEQ ID NO: 29.” SEQ ID NO: 3 and SEQ ID NO: 5 lacks antecedent basis for SEQ ID NO: 29. Instant claim 1 recites that the amino acid sequence comprises the amino acid sequence shown in SEQ ID NO: 1 and/or SEQ ID NO: 29”. Thus, the SEQ ID NOs: 3 and 5 must either comprise SEQ ID NO: 1 or SEQ ID NO: 29. However, Instant SEQ ID NO: 3 is an 18 residue peptide sequence having the sequence MCPTKQKHRSSVAEHAGK. Instant SEQ ID NO: 29 is a 268 residue protein sequence. SEQ ID NO: 3 and SEQ ID NO: 29 has the following sequence alignment:
PNG
media_image1.png
758
742
media_image1.png
Greyscale
. Instant SEQ ID NO: 5 is a 296 residue protein sequence. SEQ ID NO: 5 and SEQ ID NO: 29 has the following sequence alignment:
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682
706
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Greyscale
. SEQ ID NO: 2 and SEQ ID NO: 5 has the following alignment:
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796
718
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Greyscale
. Since the SEQ ID NOs: 3 and 5 do not comprise instant SEQ ID NO: 29, and SEQ ID NO: 5 does not comprise SEQ ID NO: 2, claim 4 does not further limit instant claims 1 and 3.
IMPROPER MARKUSH
17. Claims 14 and 15 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, amino acid sequences and nucleotide sequences and vectors do not share a common core structure. Peptide sequences involve amino acids and amide bonds; Nucleotide sequences involve sugars, bases, phosphates and glycosidic bonds. No common core structure is shared by peptides and nucleotides.
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).
Closest Art
18. The closest art to instant SEQ ID NO: 1 is Goldman et al (US Patent No. 9315822). Goldman et al teach a 302 residue protein sequence comprising a sequence PSKQRHRSS that has 77.8% sequence identity to SEQ ID NO: 1 (see SEQ ID NO: 303, residues 3-11).
19. The closest art to instant SEQ ID NO: 29 is Goldman et al (US Patent No. 9315822). Goldman et al teach a 302 residue protein sequence that has 77.9% sequence identity to instant SEQ ID NO: 29 (see SEQ ID NO: 303, residues 31-297).
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
12/09/2025