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 .
Claim Status
Claims 1-13 were canceled.
Claims 14-29 are pending and under consideration.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 12/1/2025 is acknowledged. The traversal is on the ground(s) that the elected invention in Group I features the use of a protein comprising SEQ ID NO: 1, which is the feature of the non-elected claims in Group II. Therefore, the claims could be examined together without imposing a serious search burden.
This argument is found persuasive and the amended independent claims 14, 22 and 26 do not recite SEQ ID NO: 7 and SEQ ID NO: 5 which were cited as prior art in restriction requirement filed on 9/30/2025. Therefore, Restriction Requirement filed on 9/30/2025 has been withdrawn and all claims have been rejoined.
Claim Rejections - 35 USC § 112
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.
Claims 14-29 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.
Independent claims 14, 22 and 26 recite “SEQ ID NO: 1”. Instant specification disclosed that SEQ ID NO: 1 corresponds to the minimal useful sequence from MS3_013701 and SEQ ID NO: 6 corresponds to the sequence of MS3_013701 (page 5; reproduced below).
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561
1099
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Therefore, SEQ ID NO: 1 is subset of SEQ ID NO: 6 according to instant specification. However, according to instant sequence listing, SEQ ID NO: 1 has 345 amino acids and SEQ ID NO: 6 has 225 amino acids. Therefore, SEQ ID NO: 1 cannot be subset of SEQ ID NO: 6. This is also supported by sequence alignment between SEQ ID NO: 1 and SEQ ID NO: 6 as shown below. SEQ ID NO: 1 and SEQ ID NO: 6 do not have any significant sequence similarity. Therefore, it is unclear if SEQ ID NO: 1 is the minimal useful sequence from MS3_013701 as disclosed by instant specification.
Furthermore, claims 17-19 recite SEQ ID NO: 2-10. According to instant specification at page 5 as discussed above, SEQ ID NO: 2 must be subset of SEQ ID NO: 7. However, as shown below, SEQ ID NO: 2 and SEQ ID NO: 7 do not have any significant sequence similarity. Therefore, it is unclear if SEQ ID NO: 2 is the minimal useful sequence from Sh-TSP-2 and it is unclear if SEQ ID NO: 7 is the sequence of Sh-TSP-2.
Likewise, according to instant specification at page 5 as discussed above, SEQ ID NO: 4 must be subset of SEQ ID NO: 9. However, as shown below, SEQ ID NO: 4 and SEQ ID NO: 9 do not have any significant sequence similarity. Therefore, it is unclear if SEQ ID NO: 4 is the minimal useful sequence from MS3_10385 as disclosed by instant specification and it is unclear if SEQ ID NO: 9 is the sequence of MS3_10385.
Likewise, according to instant specification at page 5 as discussed above, SEQ ID NO: 5 must be subset of SEQ ID NO: 10. However, as shown below, SEQ ID NO: 5 and SEQ ID NO: 10 do not have any significant sequence similarity. Therefore, it is unclear if SEQ ID NO: 5 is the minimal useful sequence from MS3_10186 as disclosed by instant specification and it is unclear if SEQ ID NO: 10 is the sequence of MS3_10186.
Sequence alignment between SEQ ID NO: 1 and SEQ ID NO: 6
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308
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Sequence alignment between SEQ ID NO: 2 and SEQ ID NO: 7
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210
993
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Sequence alignment between SEQ ID NO: 3 and SEQ ID NO: 8
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315
975
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Sequence alignment between SEQ ID NO: 4 and SEQ ID NO: 9
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208
964
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Sequence alignment between SEQ ID NO: 5 and SEQ ID NO: 10
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197
941
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Claim 17 recites “wherein (a) further comprises contacting said biological sample with a further protein having a sequence comprising a sequence chosen from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, and SEQ ID NO: 10.” Therefore, claim 17 encompasses a method wherein (a) further comprises contacting said biological sample with a further protein having a sequence comprising SEQ ID NO: 1. Because claim 17 recites “(a) further comprises contacting said biological sample with a further protein” and claim 14 already recited contacting said biological sample with a protein having sequence of SEQ ID NO: 1, it seems that Applicant intends that claim 17 recites (a) further comprises contacting said biological sample with a protein with SEQ ID NO different from SEQ ID NO: 1 already recited by claim 14. It is unclear how claim 17 further comprises contacting sample with a further protein of SEQ ID NO: 1 because step (a) of claim 14 already recited contacting sample with a protein of SEQ ID NO: 1.
Dependent claims are also rejected because they depend from independent claims 14, 22 or 26, and therefore contain same claim limitation as independent claims 14, 22 or 26.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645