DETAILED ACTION
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 30 has been canceled. Claims 1-29, 31-42 remain pending.
Applicant's arguments filed 5-27-25 have been fully considered but they are not persuasive.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
Upon further review, SEQ ID NO: 3 (1401 nt) is 86% identical to SEQ ID NO: 4 (1401 nt); they do not share any common structures or functions:
PNG
media_image1.png
836
354
media_image1.png
Greyscale
Nucleotides 1-1401 of SEQ ID NO: 3 are equivalent to nucleotides 1-1401 of SEQ ID NO: 13 (3177 nt). It is unclear what SEQ ID NO: 13 encodes
Nucleotides 1-1401 of SEQ ID NO: 3 are equivalent to nucleotides 1-1401 of SEQ ID NO: 14 (3213 nt).
SEQ ID NO: 3 is only 86% identical to nucleotides 1-1401 of SEQ ID NO: 15 (3177 nt).
SEQ ID NO: 3 is only 86% identical to nucleotides 1-1401 of SEQ ID NO: 16 (3213 nt).
SEQ ID NO: 17 does not share any significant similarity with SEQ ID NO: 3 or 4.
SEQ ID NO: 18 does not share any significant similarity with SEQ ID NO: 3 or 4.
Nucleotides 1-1401 of SEQ ID NO: 3 are equivalent to nucleotides 2382-3782 and 5389-6789 of SEQ ID NO: 22 (10784 nt).
Nucleotides 1-1401 of SEQ ID NO: 3 are equivalent to nucleotides 2046-3446 of SEQ ID NO: 23 (3968 nt).
Nucleotides 1-1401 of SEQ ID NO: 3 are equivalent to nucleotides 1056-2456 of SEQ ID NO: 24 (2996 nt).
Nucleotides 1-1401 of SEQ ID NO: 3 found in nucleotides 2046-3446 and 5053-6453 of SEQ ID NO: 25 (6993 nt).
Applicants elected Group II, claims 12, 13, 25-30, drawn to a nucleic acid encoding FVII, in the reply filed on 10-31-24 without traverse.
The response filed 5-27-25 argues claims 31-42 (newly filed with the election on 10-31-24) should have been examined with Group II. Applicants’ argument is not persuasive. The burden to search and examine all of the sequences in claims 12 and 31-42 together is simply undue. The first species, SEQ ID NO: 3, and sequences that contain SEQ ID NO: 3, i.e. SEQ ID NO: 13 and 22 were examined together. Applicants argue SEQ ID NO: 14, 23-25 also comprise SEQ ID NO: 3; however, the proteins encoded by each of the sequences appear to be fusion proteins having different structures and uses each of which requires separate searches and considerations for examination. An extensive search within the specification has been conducted, but the specification does not clearly set forth how SEQ ID NO: 3 relates to any of SEQ ID NO: 13-18, 22-25, where exactly they share structures, and how they are related. Much clarification is still required. Without more guidance, the office is left to patch together and compare each sequence which is too burdensome.
Claim 25 requires SEQ ID NO: 3 or 4 because it uses the word “and” to tie the promoter of SEQ ID NO: 10 or 21 “and” the coding sequence of SEQ ID NO: 3 or 4. While it says “the polynucleotide has at least one or more of following”, it does not use proper Markush group. So the promoter in a) and the coding sequence of b) MUST occur in claim 25.
Applicants have provided no evidence of why any fusion protein encoded in-part by SEQ ID NO: 3 should be examined together when the fusion proteins as a whole all have different structures/functions and require separate searches. Applicants have provided no evidence of how SEQ ID NO: 13-18, 22-25 relate to SEQ ID NO: 3 or why they should be examined together. Applicants have provided no evidence of how SEQ ID NO: 4 relates to SEQ ID NO: 3 or why they should be examined together.
Much simplification and clarification of this claim set is required. Hopefully the metes and bounds of the patentably distinct groups will emerge one day, but they remain unclear.
Claims 1-11, 14-24 remain withdrawn because they are drawn to Groups I, III, and IV. Claims 31-42 remain withdrawn because they are directed to independent and distinct species that was not required in the claims under consideration in the restriction. The sequence search burden and the examination burden for considering each and every species now claimed is undue.
The species of SEQ ID NO: 3, 13, 22 remain under consideration as they relate to SEQ ID NO: 3 because SEQ ID NO: 13 and 22 contain SEQ ID NO: 3. SEQ ID NOs: 3, 13, 22 are found in claims 25-31, 33, 39.
The species of SEQ ID NO: 4, 14-18, 22-25 in claims 32, 34-38, 40-42 remain withdrawn. See 37 CFR 1.142(b) and MPEP § 821.03.
Claims 1-11, 14-24, 32, 34-38, 40-42 have been withdrawn. A number of these claims are mislabeled as “previously presented” but should be labeled ---Withdrawn---.
Claims 12, 13, 25-31, 33, 39 are under consideration.
Claim Objections/Interpretations
Claim 12 lists SEQ ID NO: 3, 4 which encode FVII and SEQ ID NOs: 13-18 which encode FVII and albumin (pg 37, 1st full paragraph).
Claim 12 should indicate what is encoded by the DNA in claim 12.
The two concepts in claim 12 should be distinguished and separated, e.g. ---An isolated DNA encoding factor VII comprising the nucleic acid sequence of SEQ ID NO: 3 or 4--- and ---An isolated polynucleotide encoding factor VII and albumin comprising the nucleic acid sequence of SEQ ID NO: 13, 14, 15, 16, 17, or 18--- would be clear.
Claim 12 lists SEQ ID NOs: 13-18 which encode a fusion protein comprising FVII and albumin; the sequence encoding the FVII portion of the fusion protein consists of SEQ ID NO: 3.
The phrase “the nucleotide sequence selected from the group consisting of SEQ ID NO: 3” in claim 12 makes the claim awkward. The phrase “the nucleotide sequence selected” lacks antecedent basis. No sequence has been selected yet in the independent claim. The specification is limited to ---DNA comprising the nucleotide sequence of SEQ ID NO: 3, 4, 13, 14, 15, 16, 17, 18, 22, 23, 24, or 25---. Using proper Markush language, claim 12 would have to be ---DNA comprising a nucleotide sequence selected from the group consisting of the nucleic acid sequences of SEQ ID NO: 3, 4, 13, 14, 15, 16, 17, 18, 22, 23, 24, and 25---.
The wording of claim 13 is awkward because of the wording in claim 12. Claim 13 does not refer clearly to “the nucleic acid sequence of SEQ ID NO: 22”. Claim 13 uses “consisting of” instead of “comprising” as in claim 12 which is fine, except that the wording of claim 12 is confusing. If applicants are simply trying to limit claim 13 to SEQ ID NO: 22, then it is unclear why “consisting of” language is necessary: just say ---The isolated DNA of claim 12 comprising the nucleic acid sequence of SEQ ID NO: 22---. If applicants are attempting to distinguish claims 13 and 39, both limited to SEQ ID NO: 22, then claim 13 should be ---The isolated DNA of claim 12 consisting of the nucleic acid sequence of SEQ ID NO: 22--- and claim 39 should be ---The isolated DNA of claim 12 comprising the nucleic acid sequence of SEQ ID NO: 22---. As written, it is unclear whether “wherein the nucleic sequence is SEQ ID NO: 22” in claim 39 is open or closed claim language.
The phrase “for a factor VII (FVII) protein” in claim 25 is an intended use and makes the claim unclear. The phrase “polynucleotide comprising a coding sequence for a [FVII] protein, wherein the polynucleotide has at least one or more of the following features” in claim 25 includes numerous redundances and can be written more clearly as ---An isolated polynucleotide comprising a nucleic acid sequence encoding factor VII (FVII) comprising a nucleic acid sequence---.
To tie claim 25 more clearly to claim 12 in one Patentably Distinct Group, claim 25 can be written more clearly as ---An isolated polynucleotide sequence encoding [FVII] comprising a nucleic acid sequence that is at least 95% identical to the nucleic acid sequence of SEQ ID NO: 3 or 4---.
Assuming both items a) and b) in claim 25 are required, the phrase “a coding sequence for factor VII (FVII) protein” in lines 1-2 of claim 25 is redundant and should be combined with item b) of claim 25 for simplicity. The claim should also say the polynucleotide encodes functional FVII, i.e. ---An isolated polynucleotide comprising a) a nucleotide sequence that is at least 95% identical to the nucleic acid sequence of SEQ ID NO: 3 or 4 encoding a functional factor VII (FVII) operably linked to b) a promoter comprising the nucleic acid sequence of SEQ ID NO: 10 or 21---.
The phrase “the precursor FVIII coding sequence [singular] selected from the group consisting of” in item b) of claim 25 is grammatically incorrect because there are a plurality of sequences to choose from in the Markush Group. This assumes SEQ ID NO: or any sequence that is 95% identical to SEQ ID NO: 3 must be a “precursor FVII”; however, it is unclear whether this is the case because 95% identity encompasses taking of the 5’ end encoding the pre-pro sequence. Like claim 12, claim 25 does not require the vector is capable of functional expression of an FVII or an FVII precursor.
Claim 27 is limited to a nucleic acid sequence encoding a fusion protein comprising FVII and albumin encoded by the amino acid sequence of SEQ ID NO: 11 or 12 (pg 37, 2nd paragraph). The specification says “1) SEQ ID NO:1 and SEQ ID NO:5 (referred to herein as SEQ ID NO:11) or ii) SEQ ID NO:1 and SEQ ID NO:7 (referred to herein as SEQ ID NO:12)” none of which comprise SEQ ID NO: 3 or 4 as claimed.
Claim 27 does not clearly refer to “the precursor FVII” in item b) of claim 25.
Claim 28 lists SEQ ID NOs: 13-18 which are coding sequence for FVII and albumin (pg 37, 1st full paragraph). Referring to them as “the coding sequence” (claim 28) “comprising a precursor FVII coding sequence” (claim 25) is inaccurate. Claim 28 should be drawn to ---An isolated polynucleotide encoding a fusion protein comprising factor VII and albumin comprising the nucleic acid sequence of SEQ ID NO: 13, 14, 15, 16, 17, or 18---.
The structure of the polynucleotide in claim 29 cannot be envisioned from the specification or the art at the time of filing. Pg 78, last full paragraph, contemplates the structure, but it is unclear when and why to “transcription units” comprising SEQ ID NO: 3 would be operably linked to two different promoters and in the same polynucleotide.
It is unclear whether “wherein the nucleic sequence is SEQ ID NO: 22” in claim 39 is open or closed claim language. If applicants are attempting to distinguish claims 13 and 39, both limited to SEQ ID NO: 22, then claim 13 should be ---The isolated DNA of claim 12 consisting of the nucleic acid sequence of SEQ ID NO: 22--- and claim 39 should be ---The isolated DNA of claim 12 comprising the nucleic acid sequence of SEQ ID NO: 22---. If both use closed claim language, then claim 39 is a substantial duplicate of claim 13.
Claim Rejections - 35 USC § 112
Written Description
Claims 13, 25-31, 33, 39 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 claim(s) contains 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
A) The specification lacks written description for DNA comprising SEQ ID NO: 3, 4, 13-18, 22, 23, 24, or 25 consisting of SEQ ID NO: 22 as required in claim 13. Claim 13 requires the DNA “consists” of SEQ ID NO: 22; however, SEQ ID NO: 22 is limited to an “FVII-9 Expression vector” comprising a FVII ORF (pg 111, Table 5) which is limited to DNA encoding FVII consisting of SEQ ID NO: 3 (see alignment above). The specification does not teach SEQ ID NO: 22 has anything to do with SEQ ID NO: 4, 13-18, 22, 23, 24, or 25. The specification does not teach SEQ ID NO: 22 contains SEQ ID NO: 4, 13-18, 22-25 as broadly encompassed by claim 13. Claim 13 is not clearly and positively further limiting SEQ ID NO: 3. Accordingly, the specification lacks written description for DNA consisting of SEQ ID NO: 22 that comprises SEQ ID NO: 3, 4, 13-18, 22, 23, 24, or 25 as broadly encompassed by claim 13 other than SEQ ID NO: 3.
Claim 39 has been included because it is limited to SEQ ID NO: 22.
Response to arguments
Applicants argue the deletion of “essentially” overcomes the rejection (pg 14 of the response filed 5-27-25). Applicants’ argument is not persuasive because of the formatting of claims 12 and 13.
B) The specification lacks written description for any sequence encoding FVII as broadly encompassed by claim 25 other than an isolated polynucleotide comprising DNA encoding FVII comprising the nucleic acid sequence of SEQ ID NO: 3 operably linked to a promoter comprising the nucleic acid sequence of SEQ ID NO: 10 or 11.
Claim 25 is drawn to isolated polynucleotide comprising a coding sequence for a factor VII (FVII) protein, wherein the polynucleotide has at last one or more of the following features:(a) a promoter operably linked to the coding sequence, wherein the promoter comprises the nucleotide sequence of SEQ ID NO:10 or SEQ ID NO:21; and(b) the coding sequence comprises the precursor FVII coding sequence selected from the group consisting of:(i) SEQ ID NO:3,(ii) a nucleotide sequence that is at least 95% identical to SEQ ID NO:3,(iii) SEQ ID NO:4, and(iv) a nucleotide sequence that is at least 95% identical to SEQ ID NO:4.
Claim 25 is not limited to an isolated polynucleotide comprising DNA encoding FVII comprising the nucleic acid sequence of SEQ ID NO: 3. The specification is limited to isolated DNA encoding FVII codon optimized for expression in mammalian cells comprising the nucleic acid sequence of SEQ ID NO: 3 (pg 2, 2nd paragraph). The specification and the art at the time of filing do not teach using any single nucleotide of SEQ ID NO: 3 broadly encompassed by claim 12. The specification and the art at the time of filing do not teach using any sequence that is 95% identical to SEQ ID NO: 3 that encodes FVII codon optimized for expression in mammalian cells as broadly encompassed by claim 25. Accordingly, the concept lacks written description other than an isolated polynucleotide comprising DNA encoding FVII comprising the nucleic acid sequence of SEQ ID NO: 3 operably linked to a promoter comprising the nucleic acid sequence of SEQ ID NO: 10 or 11.
Response to arguments
Applicants argue changing “a” to ---the--- overcomes the rejection (pg 14, 2nd para, of the response). Applicants’ argument is not persuasive because of the formatting 25.
C) The specification lacks written description for the polynucleotide of claim 27. Claim 27 is drawn to “The isolated polynucleotide of claim 25, wherein the FVII protein comprises SEQ ID NO:11 or SEQ ID NO:12”. However, SEQ ID NO: 11 and 12 are amino acid sequences of a fusion protein comprising FVII and albumin (pg 37, 2nd paragraph). The specification says “1) SEQ ID NO:1 and SEQ ID NO:5 (referred to herein as SEQ ID NO:11) or ii) SEQ ID NO:1 and SEQ ID NO:7 (referred to herein as SEQ ID NO:12)”. There is no indication that the FVII portion of SEQ ID NO: 11 and 12 are encoded by SEQ ID NO: 3 or 4 broadly encompassed by claim 27. Furthermore, there is nothing in the specification that says a sequence that is at least 95% identical to SEQ ID NO: 3 will result in a fusion protein with the amino acid sequence of SEQ ID NO: 11 or 12 as broadly claimed. Reference to SEQ ID NO: 3 for the fusion proteins of SEQ ID NO: 11 or 12 lacks written description and reference to any sequence that is at least 95% identical to SEQ ID NO: 3 resulting in fusion proteins of SEQ ID NO: 11 or 12 lacks written description.
Response to arguments
Applicants argue SEQ ID NO: 11 or 12 could be encoded by SEQ ID NO: 3 or 4 because they are amino acids (pg 14, 3rd para, of the response filed 5-27-25). Applicants’ argument is not persuasive because it is unfounded. There is nothing in the specification or of record that says SEQ ID NO: 11 or 12 are encoded by SEQ ID NO: 3 or 4.
D) The specification lacks written description for the polynucleotide of claim 28. Claim 28 is drawn to “The isolated polynucleotide of claim 25, wherein the coding sequence comprises a sequence selected from SEQ ID NO:13, SEQ ID NO:14, SEQ ID NO:15, and SEQ ID NO:16”. However, SEQ ID NO: 13-16 are nucleic acid sequences encoding a fusion protein comprising FVII and albumin (pg 37, 2nd paragraph). There is no indication that the FVII portion encoded by SEQ ID NO: 13-16 comprises SEQ ID NO: 4 broadly encompassed by claim 28 for reasons set forth above. Furthermore, there is nothing in the specification that says a sequence that is at least 95% identical to SEQ ID NO: 3 will result in a nucleic acid sequence encoding a fusion protein with the nucleic acid sequence of SEQ ID NO: 13-16 as broadly claimed. Reference to SEQ ID NO: 3 for the fusion protein coding sequences of SEQ ID NO: 13-16 lacks written description and reference to any sequence that is at least 95% identical to SEQ ID NO: 3 resulting in fusion protein coding sequences of SEQ ID NO: 13-16 lacks written description.
Response to arguments
Applicants argue deletion of SEQ ID NO: 17 and 18 in claim 28 overcomes the rejection (pg 14, last para, of the response filed 5-27-25). Applicants’ argument is not persuasive because of the formatting problems with claim 25 and the lack of a nexus between the sequences in claim 28 and 25. The claims do not make sense together.
E) The specification lacks written description for the polynucleotide of claim 29. Claim 29 is drawn to “an isolated polynucleotide comprising an upstream transcription unit and a downstream transcription unit, wherein the upstream transcription unit comprises SEQ ID NO:10 operably linked to SEQ ID NO:3 and the downstream transcription unit comprises SEQ ID NO:21 operably linked to SEQ ID NO:3”. The concept is found on pg 78, last full paragraph, but it is unclear when and why to “transcription units” comprising SEQ ID NO: 3 would be operably linked to two different promoters and in the same polynucleotide. It is unclear if the polynucleotide expresses two sequences encoding FVII. It is unclear if the “transcription units” are somehow operably linked. It is unclear how far upstream/downstream the “transcription units” are from each other. Accordingly, the concept lacks written description.
Response to arguments
Applicants argue those of skill would know that a transcription unit with a promoter and coding sequence would express the protein and that multiple units within the same polynucleotide could be advantageous (pg 15, 1st para). Applicants’ argument is not persuasive because that’s not what claim 28 say. The formatting of claim 25 is problematic. Claims 28 does not have a nexus with claim 25.
Enablement
Claims 13, 25-31, 33, 39 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an isolated nucleic acid sequence encoding factor VII (FVII) comprising the nucleic acid sequence of SEQ ID NO: 3, and a vector comprising an isolated nucleic acid sequence encoding factor VII (FVII) comprising the nucleic acid sequence of SEQ ID NO: 3, wherein the vector has the nucleic acid sequence of SEQ ID NO: 22 does not reasonably provide enablement for the claims as written. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
A) The specification does not enable making/using DNA comprising SEQ ID NO: 3, 4, 13-18, 22, 23, 24, or 25 consisting of SEQ ID NO: 22 as required in claim 13. Claim 13 requires the DNA “consists” of SEQ ID NO: 22; however, SEQ ID NO: 22 is limited to an “FVII-9 Expression vector” comprising a FVII ORF (pg 111, Table 5) which is limited to DNA encoding FVII consisting of SEQ ID NO: 3 (see alignment above). The specification does not teach SEQ ID NO: 22 has anything to do with SEQ ID NO: 4, 13-18, 22, 23, 24, or 25. The specification does not teach SEQ ID NO: 22 contains SEQ ID NO: 4, 13-18, 22-25 as broadly encompassed by claim 13. Claim 13 is not clearly and positively further limiting SEQ ID NO: 3. Given the lack of guidance in the specification taken with the art at the time of filing, it would have required those of skill undue experimentation to determine how to make/use DNA consisting of SEQ ID NO: 22 that comprises SEQ ID NO: 3, 4, 13-18, 22, 23, 24, or 25 as broadly encompassed by claim 13 other than SEQ ID NO: 3.
Claim 39 has been included because it is limited to SEQ ID NO: 22.
Response to arguments
Applicants argue the deletion of “essentially” overcomes the rejection (pg 14 of the response filed 5-27-25). Applicants’ argument is not persuasive because of the formatting of claims 12 and 13.
B) The specification does not enable making/using any sequence encoding FVII as broadly encompassed by claim 25 other than an isolated polynucleotide comprising DNA encoding FVII comprising the nucleic acid sequence of SEQ ID NO: 3 operably linked to a promoter comprising the nucleic acid sequence of SEQ ID NO: 10 or 11.
Claim 25 is drawn to isolated polynucleotide comprising a coding sequence for a factor VII (FVII) protein, wherein the polynucleotide has at last one or more of the following features:(a) a promoter operably linked to the coding sequence, wherein the promoter comprises the nucleotide sequence of SEQ ID NO:10 or SEQ ID NO:21; and(b) the coding sequence comprises the precursor FVII coding sequence selected from the group consisting of:(i) SEQ ID NO:3,(ii) a nucleotide sequence that is at least 95% identical to SEQ ID NO:3,(iii) SEQ ID NO:4, and(iv) a nucleotide sequence that is at least 95% identical to SEQ ID NO:4.
Claim 25 is not limited to an isolated polynucleotide comprising DNA encoding FVII comprising the nucleic acid sequence of SEQ ID NO: 3. The specification is limited to isolated DNA encoding FVII codon optimized for expression in mammalian cells comprising the nucleic acid sequence of SEQ ID NO: 3 (pg 2, 2nd paragraph). The specification and the art at the time of filing do not teach using any single nucleotide of SEQ ID NO: 3 broadly encompassed by claim 12. The specification and the art at the time of filing do not teach using any sequence that is 95% identical to SEQ ID NO: 3 that encodes FVII codon optimized for expression in mammalian cells as broadly encompassed by claim 25. Given the lack of guidance in the specification taken with the art at the time of filing, it would have required those of skill undue experimentation to determine how to make/use any sequence as required in claim 25 other than an isolated polynucleotide comprising DNA encoding FVII comprising the nucleic acid sequence of SEQ ID NO: 3 operably linked to a promoter comprising the nucleic acid sequence of SEQ ID NO: 10 or 11.
Response to arguments
Applicants argue changing “a” to ---the--- overcomes the rejection (pg 14, 2nd para, of the response). Applicants’ argument is not persuasive because of the formatting 25.
C) The specification does not enable making/using the polynucleotide of claim 27. Claim 27 is drawn to “The isolated polynucleotide of claim 25, wherein the FVII protein comprises SEQ ID NO:11 or SEQ ID NO:12”. However, SEQ ID NO: 11 and 12 are amino acid sequences of a fusion protein comprising FVII and albumin (pg 37, 2nd paragraph). The specification says “1) SEQ ID NO:1 and SEQ ID NO:5 (referred to herein as SEQ ID NO:11) or ii) SEQ ID NO:1 and SEQ ID NO:7 (referred to herein as SEQ ID NO:12)”. There is no indication that the FVII portion of SEQ ID NO: 11 and 12 are encoded by SEQ ID NO: 3 or 4 broadly encompassed by claim 27. Furthermore, there is nothing in the specification that says a sequence that is at least 95% identical to SEQ ID NO: 3 will result in a fusion protein with the amino acid sequence of SEQ ID NO: 11 or 12 as broadly claimed. Reference to SEQ ID NO: 3 for the fusion proteins of SEQ ID NO: 11 or 12 is not enabled, and reference to any sequence that is at least 95% identical to SEQ ID NO: 3 resulting in fusion proteins of SEQ ID NO: 11 or 12 is not enabled.
Response to arguments
Applicants argue SEQ ID NO: 11 or 12 could be encoded by SEQ ID NO: 3 or 4 because they are amino acids (pg 14, 3rd para, of the response filed 5-27-25). Applicants’ argument is not persuasive because it is unfounded. There is nothing in the specification or of record that says SEQ ID NO: 11 or 12 are encoded by SEQ ID NO: 3 or 4.
D) The specification does not enable making/using the polynucleotide of claim 28. Claim 28 is drawn to “The isolated polynucleotide of claim 25, wherein the coding sequence comprises a sequence selected from SEQ ID NO:13, SEQ ID NO:14, SEQ ID NO:15, and SEQ ID NO:16”. However, SEQ ID NO: 13-16 are nucleic acid sequences encoding a fusion protein comprising FVII and albumin (pg 37, 2nd paragraph). There is no indication that the FVII portion encoded by SEQ ID NO: 13-16 comprises SEQ ID NO: 4 broadly encompassed by claim 28 for reasons set forth above. Furthermore, there is nothing in the specification that says a sequence that is at least 95% identical to SEQ ID NO: 3 will result in a nucleic acid sequence encoding a fusion protein with the nucleic acid sequence of SEQ ID NO: 13-16 as broadly claimed. Reference to SEQ ID NO: 3 for the fusion protein coding sequences of SEQ ID NO: 13-16 is not enabled and reference to any sequence that is at least 95% identical to SEQ ID NO: 3 resulting in fusion protein coding sequences of SEQ ID NO: 13-16 is not enabled.
Response to arguments
Applicants argue deletion of SEQ ID NO: 17 and 18 in claim 28 overcomes the rejection (pg 14, last para, of the response filed 5-27-25). Applicants’ argument is not persuasive because of the formatting problems with claim 25 and the lack of a nexus between the sequences in claim 28 and 25. The claims do not make sense together.
E) The specification does not enable making/using the polynucleotide of claim 29. Claim 29 is drawn to “an isolated polynucleotide comprising an upstream transcription unit and a downstream transcription unit, wherein the upstream transcription unit comprises SEQ ID NO:10 operably linked to SEQ ID NO:3 and the downstream transcription unit comprises SEQ ID NO:21 operably linked to SEQ ID NO:3”. The concept is found on pg 78, last full paragraph, but it is unclear when and why to “transcription units” comprising SEQ ID NO: 3 would be operably linked to two different promoters and in the same polynucleotide. It is unclear if the polynucleotide expresses two sequences encoding FVII. It is unclear if the “transcription units” are somehow operably linked. It is unclear how far upstream/downstream the “transcription units” are from each other. Accordingly, the concept is not enabled.
Response to arguments
Applicants argue those of skill would know that a transcription unit with a promoter and coding sequence would express the protein and that multiple units within the same polynucleotide could be advantageous (pg 15, 1st para). Applicants’ argument is not persuasive because that’s not what claim 28 say. The formatting of claim 25 is problematic. Claims 28 does not have a nexus with claim 25.
Indefiniteness
Claims 13, 25-31, 33, 39 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.
A) The metes and bounds of DNA comprising SEQ ID NO: 3, 4, 13-18, 22, 23, 24, or 25 consisting of SEQ ID NO: 22 as required in claim 13. Claim 13 requires the DNA “consists” of SEQ ID NO: 22; however, SEQ ID NO: 22 is limited to an “FVII-9 Expression vector” comprising a FVII ORF (pg 111, Table 5) which is limited to DNA encoding FVII consisting of SEQ ID NO: 3 (see alignment above). The specification does not teach SEQ ID NO: 22 has anything to do with SEQ ID NO: 4, 13-18, 22, 23, 24, or 25. The specification does not teach SEQ ID NO: 22 contains SEQ ID NO: 4, 13-18, 22-25 as broadly encompassed by claim 13. Claim 13 is not clearly and positively further limiting SEQ ID NO: 3. Given the lack of guidance in the specification taken with the art at the time of filing, it would have required those of skill undue experimentation to determine how to make/use DNA consisting of SEQ ID NO: 22 that comprises SEQ ID NO: 3, 4, 13-18, 22, 23, 24, or 25 as broadly encompassed by claim 13 other than SEQ ID NO: 3.
Claim 39 has been included because it is limited to SEQ ID NO: 22.
Response to arguments
Applicants argue deletion of the term “essentially” overcomes the rejection. Applicants’ argument is not persuasive for reasons of record.
B) The concept of “The isolated polynucleotide of claim 25, wherein the FVII protein comprises SEQ ID NO:11 or SEQ ID NO:12” in claim 27 is indefinite. SEQ ID NO: 11 and 12 are amino acid sequences of a fusion protein comprising FVII and albumin (pg 37, 2nd paragraph). The specification says “1) SEQ ID NO:1 and SEQ ID NO:5 (referred to herein as SEQ ID NO:11) or ii) SEQ ID NO:1 and SEQ ID NO:7 (referred to herein as SEQ ID NO:12)”. However, there is no indication that the FVII portion of SEQ ID NO: 11 and 12 are encoded by SEQ ID NO: 3 or 4 broadly encompassed by claim 27. Furthermore, there is nothing in the specification that says a sequence that is at least 95% identical to SEQ ID NO: 3 will result in a fusion protein with the amino acid sequence of SEQ ID NO: 11 or 12 as broadly claimed. Therefore, using SEQ ID NO: 3 to encode the fusion proteins of SEQ ID NO: 11 is indefinite and using any sequence that is at least 95% identical to SEQ ID NO: 3 to encode the fusion proteins of SEQ ID NO: 11 or 12 is indefinite. Further limiting the structure of the protein (which does not exist in claim 25 – it’s only the nucleic acid sequence) in claim 27 fails to further limit the structure of the nucleic acid sequence in claim 25.
Response to arguments
Applicants argue the proteins of SEQ ID NO: 11 or 12 could be encoded by the nucleic acid sequences of SEQ ID NO: 3 or 4. Applicants’ argument is not persuasive because of the way claims 25 and 27 are written. Further limiting the structure of the protein (which does not exist in claim 25 – it’s only the nucleic acid sequence) in claim 27 fails to further limit the structure of the nucleic acid sequence in claim 25.
C) The concept of “The isolated polynucleotide of claim 25, wherein the coding sequence comprises a sequence selected from SEQ ID NO:13, SEQ ID NO:14, SEQ ID NO:15, and SEQ ID NO:16” in claim 28 is indefinite. SEQ ID NO: 13-16 are nucleic acid sequences encoding a fusion protein comprising FVII and albumin (pg 37, 2nd paragraph). There is no indication that the FVII portion encoded by SEQ ID NO: 13-16 comprises SEQ ID NO: 4 broadly encompassed by claim 28 for reasons set forth above. Furthermore, there is nothing in the specification that says a sequence that is at least 95% identical to SEQ ID NO: 3 will result in a nucleic acid sequence encoding a fusion protein with the nucleic acid sequence of SEQ ID NO: 13-16 as broadly claimed. Therefore, using fusion protein coding sequences of SEQ ID NO: 13-16 in claim 28 to describe FVII coding sequence comprising SEQ ID NO: 3 in claim 25 makes the claim illogical and indefinite. Using fusion protein coding sequences of SEQ ID NO: 13-16 in claim 28 to describe any sequence that is at least 95% identical to SEQ ID NO: 3 is illogical.
Response to arguments
Applicants argue the deletion of SEQ ID NO: 17 and 18 overcomes the rejection. Applicants’ argument is not persuasive. SEQ ID NO: 4 is not under consideration. The amendment fails to address the lack of a nexus between SEQ ID NO: 13-16 and SEQ ID NO: 3.
D) The concept of “an isolated polynucleotide comprising an upstream transcription unit and a downstream transcription unit, wherein the upstream transcription unit comprises SEQ ID NO:10 operably linked to SEQ ID NO:3 and the downstream transcription unit comprises SEQ ID NO:21 operably linked to SEQ ID NO:3” in claim 29 is indefinite. The concept is found on pg 78, last full paragraph, but it is unclear when and why to “transcription units” comprising SEQ ID NO: 3 would be operably linked to two different promoters and in the same polynucleotide. It is unclear if the polynucleotide expresses two sequences encoding FVII. It is unclear if the “transcription units” are somehow operably linked. It is unclear how far upstream/downstream the “transcription units” are from each other. Therefore, the structure of the “transcription units” and their function cannot be determined.
Response to arguments
Applicants argue those of skill would know that a transcription unit within the same polynucleotide could be advantageous. Applicants’ argument is not persuasive because it does not address the metes and bounds of the claim.
Claim Rejections - 35 USC § 102
The rejection of claims 12, 30, 31 under 35 U.S.C. 102a1 as being anticipated by HUMFVII (1986) has been withdrawn. HUMFVII shares 68% homology with SEQ ID NO: 3 which is equivalent to isolated double stranded DNA comprising “a nucleotide sequence” of SEQ ID NO: 3 as previously encompassed by claims 12, 30, 31. However, claim 12 as newly amended is limited to DNA comprising “the” nucleotide sequence” of SEQ ID NO: 3 which is not taught by HUMFVII (1986).
The rejection of claims 12, 30, 31 under 35 U.S.C. 102a1 as being anticipated by BFB40229, 2018 has been withdrawn. BFB40229 shares 82% homology with SEQ ID NO: 3 which is equivalent to isolated double stranded DNA comprising “a nucleotide sequence” of SEQ ID NO: 3 as previously encompassed by claims 12, 30, 31. However, claim 12 as newly amended is limited to DNA comprising “the” nucleotide sequence” of SEQ ID NO: 3 which is not taught by BFB40229.
The rejection of claims 12, 13, 30, 31, 39 under 35 U.S.C. 102a1 as being anticipated by OR258373 (2018) has been withdrawn. OR258373 shares 99.9% homology with “a” nucleic acid sequence of SEQ ID NO: 22 which is not equivalent to isolated double stranded DNA comprising “the nucleotide sequence” of SEQ ID NO: 22 as required in claims 12, 30, 31.
Claim Rejections - 35 USC § 103
The rejection of claims 12, 25-27, 29-31 under 35 U.S.C. 103 as being unpatentable over the nucleic acid sequence encoding HUMFVII (1986) or BFB40229 in view of Martin (WO 2017072498) and BDW28575 has been withdrawn because HUMFVII (1986) or BFB40229 did not teach a nucleic acid sequence comprising “the” nucleic acid sequence of SEQ ID NO: 3 as newly required in claim 12.
The art at the time of filing did not teach or suggest a nucleic acid sequence comprising the nucleotide sequence of SEQ ID NO: 3 as required in claim 12. SEQ ID NOs: 13 and 22 are free of the prior art because they comprise the nucleotide sequence of SEQ ID NO: 3.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Inquiry concerning this communication or earlier communications from the examiner should be directed to Michael C. Wilson who can normally be reached at the office on Monday through Friday from 9:30 am to 6:00 pm at 571-272-0738.
Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public.
For all other customer support, please call the USPTO Call Center (UCC) at 800-786-9199.
If attempts to reach the examiner are unsuccessful, the examiner's supervisor, Tracy Vivlemore, can be reached on 571-272-2914.
The official fax number for this Group is (571) 273-8300.
Michael C. Wilson
/MICHAEL C WILSON/
Primary Examiner, Art Unit 1638