A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/1/2026 has been entered.
DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claim filed on 5/1/2026 is acknowledged.
3. Claims 6 and 12-31 have been cancelled.
4. Claims 1-5, 7-11 and 32 are pending in this application.
5. Applicant elected with traverse of Group 1 (claims 1-11) and elected SEQ ID NO: 11 as species of human MASP-2 inhibiting-protein in the reply filed on 8/27/2021.
Restriction requirement was deemed proper and made FINAL in the previous office actions. The instant claims 1-5, 7-11 and 32 are drawn to a human MASP-2 inhibiting protein containing any of the sequences according to formula (Ih): X1CRX2X3X4X5 (Ih) where X1 is F, Y, L, P, Q, M, V, W, A, T and X2 is A, G, S, T and X3 is V, A, I, L, M, D, H, S and X4 is K, I, Q, R, H, S, F, M, N, L, V and X5 is R, V, I, K, M, Q, E, F, L, N, Y, D, S, H, or a salt, ester or pharmaceutically acceptable prodrug thereof, and having sequence segments having at least 80% sequence identity to the sequence of SEQ ID NO: 11, wherein the determination of said at least 80% sequence identity, does not include the sequence segment of Ih which is conserved, and wherein the Ih segment in SEQ ID NO: 11 is in the kunitz domain and is the segment from position 13 to position 19, and wherein the Ih segment is loop sequence, wherein said sequence segments are a continuous 12-amino acid segment positioned immediately preceding the Ih segment and a continuous 39-amino acid segment positioned immediately following the Ih segment which when combined have the at least 80% sequence identity to the corresponding combined 12-amino acid and 39-amino acid segments of SEQ ID NO: 11 and wherein the kunitz structure is maintained; a pharmaceutical composition containing one or more proteins, or a salt, ester or pharmaceutically acceptable prodrug thereof according to a claim 1 and at least one pharmaceutically acceptable additive; and a kit containing at least one protein, or a salt, ester or pharmaceutically acceptable prodrug thereof according to a claim 1 and one or more additional components. A search was conducted on the elected species; and this appears to be free of prior art. A search was extended to the genus in claim 1; and this too appears to be free of prior art. Claims 1-5, 7-11 and 32 are examined on the merits in this office action.
Please note: This application is transferred to the current Examiner after the filing of Appeal brief. In addition to the rejection affirmed by the patent trial and appeal broad, various new issues have been noticed by the current Examiner.
Non-compliant Amendment
6. The claim filed on 5/1/2026 is a non-compliant amendment. In the claim filed on 5/1/2026, claim 1 recites “human MASP-2 inhibiting protein”. However, this recitation is the same as what in claim 1 of the claim filed on 8/22/2023. Furthermore, claim 9 or 10 has the status identifier of “(Previously Presented)”. However, it appears changes have been made and indicated as underline in both claims. Applicant is required to correct this error (see MPEP § 714).
Sequence Non-Compliance
7. This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below. All sequences disclosed in the application must comply with the requirements of 37 C.F.R. 1.821-1.825, not only those recited in the claims.
In the instant case, instant Figure 2 discloses both peptide sequence and nucleic acid sequence. However, these sequences are not disclosed in the filed sequence listing.
All such sequences are relevant for the purposes of building a comprehensive database and properly assessing prior art. It is therefore essential that all sequences, whether only disclosed or also claimed, be included in the database.
Claim Interpretations
8. With regards to the protein recited in instant claim 4, the Examiner is interpretating the protein in claim 4 is one that in addition to meeting all the structural limitations of instant claim 1, also needs to meet the limitations of instant SEQ ID NO: 22 except amino acids 13-19 of instant SEQ ID NO: 22.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (a)
Written Description
9. The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
10. (Revised due to the change of Examiner) Applicant is required to cancel the new matter in the reply to this Office Action.
Claims 1-5, 7-11 and 32 remain 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 claims contain 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, at the time the application was filed, had possession of the claimed invention.
The MPEP states that “The introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112, first paragraph. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a “laundry list” disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not “reasonably lead” those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967) (“If n-propylamine had been used in making the compound instead of n-butylamine, the compound of claim 13 would have resulted. Appellants submit to us, as they did to the board, an imaginary specific example patterned on specific example 6 by which the above butyl compound is made so that we can see what a simple change would have resulted in a specific supporting disclosure being present in the present specification. The trouble is that there is no such disclosure, easy though it is to imagine it.”) (emphasis in original). In Ex parte Ohshiro, 14 USPQ2d 1750 (Bd. Pat. App. & Inter. 1989), the Board affirmed the rejection under 35 U.S.C. 112, first paragraph, of claims to an internal combustion engine which recited “at least one of said piston and said cylinder (head) having a recessed channel.” The Board held that the application which disclosed a cylinder head with a recessed channel and a piston without a recessed channel did not specifically disclose the “species” of a channeled piston.” (see MPEP § 2163).
In the instant case, claims 1-5, 7-11 and 32 are drawn to a human MASP-2 inhibiting protein containing any of the sequences according to formula (Ih): X1CRX2X3X4X5 (Ih) where X1 is F, Y, L, P, Q, M, V, W, A, T and X2 is A, G, S, T and X3 is V, A, I, L, M, D, H, S and X4 is K, I, Q, R, H, S, F, M, N, L, V and X5 is R, V, I, K, M, Q, E, F, L, N, Y, D, S, H, or a salt, ester or pharmaceutically acceptable prodrug thereof, and having sequence segments having at least 80% sequence identity to the sequence of SEQ ID NO: 11, wherein the determination of said at least 80% sequence identity, does not include the sequence segment of Ih which is conserved, and wherein the Ih segment in SEQ ID NO: 11 is in the kunitz domain and is the segment from position 13 to position 19, and wherein the Ih segment is loop sequence, wherein said sequence segments are a continuous 12-amino acid segment positioned immediately preceding the Ih segment and a continuous 39-amino acid segment positioned immediately following the Ih segment which when combined have the at least 80% sequence identity to the corresponding combined 12-amino acid and 39-amino acid segments of SEQ ID NO: 11 and wherein the kunitz structure is maintained.
With regards to the recited “having sequence segments having at least 80% sequence identity to the sequence of SEQ ID NO: 11, wherein the determination of said at least 80% sequence identity, does not include the sequence segment of Ih which is conserved, and wherein the Ih segment in SEQ ID NO: 11 is in the kunitz domain and is the segment from position 13 to position 19, and wherein the Ih segment is loop sequence, wherein said sequence segments are a continuous 12-amino acid segment positioned immediately preceding the Ih segment and a continuous 39-amino acid segment positioned immediately following the Ih segment which when combined have the at least 80% sequence identity to the corresponding combined 12-amino acid and 39-amino acid segments of SEQ ID NO: 11 and wherein the kunitz structure is maintained”, the recitation has never been explicitly disclosed and/or discussed in the instant specification. The detailed explanations are as followings:
Lack of Ipsis Verbis Support
The specification is void of any literal support for the limitation “having sequence segments having at least 80% sequence identity to the sequence of SEQ ID NO: 11, wherein the determination of said at least 80% sequence identity, does not include the sequence segment of Ih which is conserved, and wherein the Ih segment in SEQ ID NO: 11 is in the kunitz domain and is the segment from position 13 to position 19, and wherein the Ih segment is loop sequence, wherein said sequence segments are a continuous 12-amino acid segment positioned immediately preceding the Ih segment and a continuous 39-amino acid segment positioned immediately following the Ih segment which when combined have the at least 80% sequence identity to the corresponding combined 12-amino acid and 39-amino acid segments of SEQ ID NO: 11 and wherein the kunitz structure is maintained” recited in instant claims. Therefore, the instant specification fails to provide literal support to such limitation.
Lack of Implicit or Inherent Support
“While there is not in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure.” See MPEP § 2163. Thus support can be furnished implicitly or inherently for a specifically claimed limitation.
Instant SEQ ID NO: 11 is 58 amino acids in length and consists of the amino acid sequence KPDFCFLEEDPGFCRAVKRRYFYNNQTKQCERFKYGGCLGNMNNFETLEE CKNICEDG, wherein amino acids 13-19 (underlined) is the Ih segment. The limitation above requires the instant claimed human MASP-2 inhibiting protein comprises sequence segments that are at least 80% identical to the amino acid sequence KPDFCFLEEDPGRYFYNNQTKQCERFKYGGCLGNMNNFETLEECKNICEDG (instant SEQ ID NO: 11 without the Ih segment), wherein the sequence segments are a continuous 12-amino acid segment positioned immediately preceding the Ih segment and a continuous 39-amino acid segment positioned immediately following the Ih segment which when combined have the at least 80% sequence identity.
In the instant case, the instant specification discloses peptides of SEQ ID NOs: 11-20 as examples of instant claimed human MASP-2 inhibiting protein. However, each of peptides of SEQ ID NOs: 12-20 comprises the defined sequence segments having 100% sequence identity to the amino acid sequence KPDFCFLEEDPGRYFYNNQTKQ CERFKYGGCLGNMNNFETLEECKNICEDG (instant SEQ ID NO: 11 without the Ih segment). The instant specification further discloses peptide of SEQ ID NO: 22 consisting of the amino acid sequence XXXXCXXXXXXGXCXXXXXXXXXXXXXXX CXXFXXXGCXXXXXXXXXXXXCXXXCXXX, wherein amino acids 13-19 (underlined) correspond to the Ih segment, and wherein each X is any amino acid, not present, or defined variables. Therefore, it is determined that the instant specification fails to provide any implicit or inherent support to a human MASP-2 inhibiting protein comprises the defined sequence segments that is at least 80% identical to the amino acid sequence KPDFCFLEEDPGRYFYNNQTKQCERFKYGGCLGNMNNFETLEECKNI CEDG (instant SEQ ID NO: 11 without the Ih segment).
Taken all these together, the instant specification fails to provide any types of support to the limitation “having sequence segments having at least 80% sequence identity to the sequence of SEQ ID NO: 11, wherein the determination of said at least 80% sequence identity, does not include the sequence segment of Ih which is conserved, and wherein the Ih segment in SEQ ID NO: 11 is in the kunitz domain and is the segment from position 13 to position 19, and wherein the Ih segment is loop sequence, wherein said sequence segments are a continuous 12-amino acid segment positioned immediately preceding the Ih segment and a continuous 39-amino acid segment positioned immediately following the Ih segment which when combined have the at least 80% sequence identity to the corresponding combined 12-amino acid and 39-amino acid segments of SEQ ID NO: 11 and wherein the kunitz structure is maintained” recited in instant claims.
Response to Applicant's Arguments
11. Applicant argues that: 1. Written Description Support in the Specification; and 2. At least 80% sequence identity portion is merely a rephrasing of the terminology used in the original specification.
12. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant's arguments about instant rejection, the Examiner would like to point out that the instant rejection is a new matter rejection. The rejection is based on the fact that the instant specification fails to provide any type of support to the limitation “having sequence segments having at least 80% sequence identity to the sequence of SEQ ID NO: 11, wherein the determination of said at least 80% sequence identity, does not include the sequence segment of Ih which is conserved, and wherein the Ih segment in SEQ ID NO: 11 is in the kunitz domain and is the segment from position 13 to position 19, and wherein the Ih segment is loop sequence, wherein said sequence segments are a continuous 12-amino acid segment positioned immediately preceding the Ih segment and a continuous 39-amino acid segment positioned immediately following the Ih segment which when combined have the at least 80% sequence identity to the corresponding combined 12-amino acid and 39-amino acid segments of SEQ ID NO: 11 and wherein the kunitz structure is maintained” recited in instant claims.
In the instant case, the Examiner understands that instant specification discusses protein that are sequentially analogous to instant SEQ ID NOs: 11-20. However, the Examiner would like to point out the instant specification fails to discuss sequence identity, including any percentage of sequence identity to any protein/peptide. Furthermore, one of ordinary skilled in the art would understand and reasonably expect the meaning of the term “sequentially analogous” is very different from that of “at least 80% identical to the amino acid sequence KPDFCFLEEDPGRYFYNNQTKQCER FKYGGCLGNMNNFETLEECKNICEDG (instant SEQ ID NO: 11 without the Ih segment)”; and there is not any type of rephrasing and/or rewording between these two terms. Furthermore, as stated in Section 10 above, in the instant case, based on the disclosure of instant specification, it is the Examiner’s position that the instant specification fails to provide any types of support to the limitation “having sequence segments having at least 80% sequence identity to the sequence of SEQ ID NO: 11, wherein the determination of said at least 80% sequence identity, does not include the sequence segment of Ih which is conserved, and wherein the Ih segment in SEQ ID NO: 11 is in the kunitz domain and is the segment from position 13 to position 19, and wherein the Ih segment is loop sequence, wherein said sequence segments are a continuous 12-amino acid segment positioned immediately preceding the Ih segment and a continuous 39-amino acid segment positioned immediately following the Ih segment which when combined have the at least 80% sequence identity to the corresponding combined 12-amino acid and 39-amino acid segments of SEQ ID NO: 11 and wherein the kunitz structure is maintained” recited in instant claims. Such position has been affirmed by the patent trial and appeal broad on 3/2/2026.
Taken all these together, the rejection is deemed proper and is hereby maintained.
New Objections
13. The specification is objected to for the following minor informality: The specification discloses the amino acid sequence of SEQ ID NO: 22 with the definitions for x1, x2 and many others on page 24, lines 1-15 of instant specification. However, the variables in the amino acid sequence of instant SEQ ID NO: 22 on page 24 are either x or X. There is no x1, x2 and so on in the amino acid sequence of instant SEQ ID NO: 22. Applicant is required to correct this error.
Please note: The 108-page specification filed on 7/8/2019 is used for instant examination.
14. The specification is objected to for the following minor informality: The specification recites “http://merops.sanger.ac.uk/inhibitors/” on page 38, line 3; and “http://weblogo.berkeley.edu/logo.cgi” on page 58, line 6 of instant specification. The embedded hyperlinks and/or other forms of browser-executable code are impermissible and require deletion. It is suggested that Applicant places a URL between these symbols “< >” to inactivate the hyperlinks. Applicant is required to correct these errors..
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 (see MPEP § 608.01).
15. The drawings are objected to for the following minor informality:
Figure 2 discloses both peptide sequence and nucleic acid sequence. However, these sequences are not disclosed in the filed sequence listing; and they are missing the respective sequence identifier. Applicant is required to amend Figure 2 to comply with 37 CFR 1.821(c) and 1.821(d).
Figure 4 discloses a peptide sequence. However, it is missing the sequence identifier. Applicant is required to amend Figure 4 to comply with 37 CFR 1.821(d).
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.
16. Claim 1 is objected to for the following minor informality: Claim 1 contains the acronym “MASP-2”. An acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, i.e., mannose-binding protein-associated serine protease 2 (MASP-2). The abbreviation can be used thereafter.
Furthermore, Applicant is suggested to amend claim 1 as "A human mannose-binding protein-associated serine protease 2 (MASP-2) inhibiting protein comprising the sequence according to formula (Ih): X1CRX2X3X4X5 (Ih), wherein: X1 is F, Y, L, P, Q, M, V, W, A, or T; X2 is A, G, S, or T; X3 is V, A, I, L, M, D, H, or S; X4 is K, I, Q, R, H, S, F, M, N, L, or V; and X5 is R, V, I, K, M, Q, E, F, L, N, Y, D, S, or H; or a salt, ester or pharmaceutically acceptable prodrug thereof, and comprising sequence segments having at least 80% sequence identity to the sequence of SEQ ID NO: 11, wherein the determination of said at least 80% sequence identity does not include the sequence segment of Ih which is conserved…".
17. Claims 2 and 3 are objected to for the following minor informality: Applicant is suggested to amend claims 2 and 3 as "…wherein the protein comprising the sequence selected from:…".
18. Claim 4 is objected to for the following minor informality: Applicant is suggested to amend claim 4 as "…wherein the protein is a Kunitz domain protein and comprises the amino acid sequence of SEQ ID NO: 22, and wherein the sequence between position 13 to position 19 of SEQ ID NO: 22 consists of the amino acid sequence of formula (Ih)".
19. Claim 5 is objected to for the following minor informality: Claim 5 contains the acronym “TFPI-D2”. An acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, i.e., tissue factor
pathway inhibitor (TFPI)-D2. The abbreviation can be used thereafter.
20. Claim 7 is objected to for the following minor informality: Applicant is suggested to amend claim 7 as " The protein according to claim 1, wherein the protein comprises the amino acid sequence selected from the group consisting of SEQ ID NOs: 11-20".
21. Claim 8 is objected to for the following minor informality: Applicant is suggested to amend claim 8 as "A pharmaceutical composition comprising one or more protein according to claim 1 or a salt, ester or pharmaceutically acceptable prodrug thereof; and at least one pharmaceutically acceptable additive".
22. Claim 11 is objected to for the following minor informality: Applicant is suggested to amend claim 11 as "A kit comprising one or more protein according to claim 1 or a salt, ester or pharmaceutically acceptable prodrug thereof; and one or more…”.
23. Claim 32 is objected to for the following minor informality: Applicant is suggested to amend claim 32 as "…wherein the continuous 12-amino acid segment immediately preceding the Ih segment and the continuous 39-amino acid segment immediately following the Ih segment are the non-modified parts of a TFPI-D2 sequence".
New Rejections
Obviousness Double Patenting
24. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
25. Claims 1, 4, 5, 8-11 and 32 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2, 10, 11, 14-16 and 19-24 of co-pending Application No. 19/114995.
26. Instant claims 1, 4, 5, 8-11 and 32 are drawn to a human MASP-2 inhibiting protein containing any of the sequences according to formula (Ih): X1CRX2X3X4X5 (Ih) where X1 is F, Y, L, P, Q, M, V, W, A, T and X2 is A, G, S, T and X3 is V, A, I, L, M, D, H, S and X4 is K, I, Q, R, H, S, F, M, N, L, V and X5 is R, V, I, K, M, Q, E, F, L, N, Y, D, S, H, or a salt, ester or pharmaceutically acceptable prodrug thereof, and having sequence segments having at least 80% sequence identity to the sequence of SEQ ID NO: 11, wherein the determination of said at least 80% sequence identity, does not include the sequence segment of Ih which is conserved, and wherein the Ih segment in SEQ ID NO: 11 is in the kunitz domain and is the segment from position 13 to position 19, and wherein the Ih segment is loop sequence, wherein said sequence segments are a continuous 12-amino acid segment positioned immediately preceding the Ih segment and a continuous 39-amino acid segment positioned immediately following the Ih segment which when combined have the at least 80% sequence identity to the corresponding combined 12-amino acid and 39-amino acid segments of SEQ ID NO: 11 and wherein the kunitz structure is maintained; a pharmaceutical composition containing one or more proteins, or a salt, ester or pharmaceutically acceptable prodrug thereof according to a claim 1 and at least one pharmaceutically acceptable additive; and a kit containing at least one protein, or a salt, ester or pharmaceutically acceptable prodrug thereof according to a claim 1 and one or more additional components.
27. Claims 1, 2, 10, 11, 14-16 and 19-24 of co-pending Application No. 19/114995 are drawn to human MASP-2 inhibiting protein, pharmaceutical composition and/or kit comprising such human MASP-2 inhibiting protein; and methods of using such human MASP-2 inhibiting protein.
SEQ ID NOs: 2-9 and many others recited in claims of co-pending Application No. 19/114995 meet the limitations of the human MASP-2 inhibiting protein recited in instant claims 1, 4, 5 and 32.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Examiner’s Notes
28. The human MASP-2 inhibiting protein and pharmaceutical composition and kit comprising such human MASP-2 inhibiting protein recited in instant claims 1-5, 7-11 and 32 are free of prior art. The closest prior art is Markland et al (US 2003/0165896 A1). Markland et al teach a protein of SEQ ID NO: 1, which is 304 amino acids in length and comprises the amino acid sequence that is about 87% identical to instant SEQ ID NO: 11, as shown below with Qy being instant SEQ ID NO: 11 and Db being SEQ ID NO: 1 in Markland et al:
PNG
media_image1.png
128
586
media_image1.png
Greyscale
, for example, pages 24-25, SEQ ID NO: 1. The protein of SEQ ID NO: 1 in Markland et al fails to teach the sequence of formula (Ih) in instant claimed protein. And there is no teaching, motivation, or other type of suggestion to modify the protein SEQ ID NO: 1 in Markland et al and arrive at the human MASP-2 inhibiting protein and pharmaceutical composition and kit comprising such human MASP-2 inhibiting protein recited in instant claims 1-5, 7-11 and 32. Therefore, the human MASP-2 inhibiting protein and pharmaceutical composition and kit comprising such human MASP-2 inhibiting protein recited in instant claims 1-5, 7-11 and 32 are both novel and unobvious over the prior arts of record. And the claimed human MASP-2 inhibiting protein and pharmaceutical composition are markedly different from what exist in nature.
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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