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 .
DETAILED ACTION
The amendment to the claims filed after non-final office action on October 10, 2025 is acknowledged. Claims 1, 3, 6-9, 12, 14, were amended, claims 2,. 5, 10-11 were canceled and claims 1, 3-4, 6-9, 12-31 are pending in the instant application. The restriction was deemed proper and made final previous office action.
The was restriction deemed proper and made FINAL in the previous office action. Claims 12, 14-23, 26-31 are withdrawn as being drawn to a non-elected species/invention. Claims 1, 3-4, 6-9, 13, 24-25 are examined on the merits of this office action.
*Please note that the response to Applicant’s arguments are moot light of amendment of the claims and withdrawal of the previous rejections. New rejections are presented below due to amendment of the claims filed October 10, 2025.
Withdrawn Rejections/Objections
The rejection of claims 1-11, 13, 24-25 under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter is withdrawn in view of amendment of the claims filed October 10, 2025.
The rejection of claims 1-11, 13, 24-25 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of amendment of the claims filed October 10, 2025.
The rejection of claims 1-2, 5-11, 13, 24-25 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of amendment of the claims filed October 10, 2025.
The rejection of claim(s) 1-11, 13, 24-25 under 35 U.S.C. 102(a)(1) as being anticipated by Lucas (US20030092620 A1) is withdrawn in view of amendment of the claims October 10, 2025 to require wherein the inhibitor comprises one of SEQ ID Nos:1, 3, 4, 6, 9, 10 and 12.
New Rejections
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 1, 3-4, 6-9, 13, 24-25 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 1 claims “a nucleic acid molecule encodes a nucleotide sequence”, which is scientifically incorrect and unclear. A nucleic acid molecule is a nucleotide sequence, and a nucleotide sequence encodes a polypeptide, not another nucleotide sequence. As written, the claim does not clearly identify what is being encoded or what structural features define the nucleic acid. Accordingly, the metes and bounds of the claim are uncertain. Claims 3-4, 6-9, 13, 24-25 are also rejected due to their dependence on claim 1 and not further clarifying this point of confusion. A potential suggested amendment to overcome this issue could be “A nucleic acid molecule comprising a nucleotide sequence selected from the group consisting of….”
Additionally, claim 1 claims a nucleic acid comprising SEQ ID NO:1. However, SEQ ID NO:1 in the sequence listing does not match the nucleotide in Figure 1. In particular, SEQ ID NO:1 contains (i) an AGG codon that encodes arginine (see position 636-638 and missing T at position 255 in sequence listing), whereas Figure 1 (see line 5, CCCTCC and line 1 CTCGAG) discloses GAG codon encoding glutamic acid (Glu) at the corresponding position and (ii) a codon missing a thymine compared to the sequence show in figure 1. Furthermore, dependent claim 7 recites the polypeptide encoded by the nucleic acid and specifies a Glu residue at the corresponding amino acid position, which is incompatible with the AGG (Arg) codon presently listed in SEQ ID NO:1. These conflicting disclosures render the identity of the claimed nucleic acid and encoded polypeptide unclear, such that one of ordinary skill in the art cannot ascertain the metes and bounds of the claimed invention. The same applies for SEQ ID NO:10. As compared to SEQ ID NO:10 in Figure 7, T is missing from position 128, G missing from 255, A missing from 380, C is missing from 508, C is missing from 634 and T is missing at position 762 in the sequence listing. Thus, SEQ ID NO:10 in the listing does not match up to SEQ ID NO:10 of Figure 7B.
In addition, the amino acid sequence for SEQ ID NO:11 appears to be different from the amino acid in sequence in figure 7C. The sequence is missing a glycine at position 128 and Asparagine at position 254 compared to the SEQ ID NO:11 of figure 7C. For examination purposes, the sequence for SEQ ID NO:11 will be interpreted using the sequence from Figure 7C as it corresponds more accurately to the DNA sequence. Applicant is further advised to review and correct the entire sequence listing, as additional discrepancies may be present.
Claims 3-4, 6-9, 13, 24-25 are also rejected due to their dependence on claim 1 and not further clarifying this point of confusion.
Claim 3 claims “the factor D is a mature factor D” and claim 4 (which is dependent on claim 3) claims “wherein the mature factor D is a mature human factor D”. Claim 1 defines the inhibitor as a nucleic acid molecule encoding factor D. The nucleotide sequences disclosed in claim 1 encode the protein including the signal and activation peptide. The nucleic acid molecule would not encode the mature factor D polypeptide without post-translation modification of the signal peptide and pro-peptide. Because the claim requires a nucleic acid molecule to encode a polypeptide that cannot be directly encoded by the nucleic acid, the relationship between the nucleic acid of claim 1 and the mature factor D of claims 3-4 is unclear. The metes and bounds of claims 3-4 cannot be determined.
Claim 7 recites the limitation "the nucleic acid molecule encoding factor D or a fragment thereof” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 was does not recite or claim “nucleic acid molecule encoding factor D or a fragment thereof”. It is suggested that claim 7 be amended as follows “The inhibitor of claim 1, wherein the nucleic acid molecule encoding factor D encodes an amino acid sequence selected from the group consisting of ….” or something similar.
Claim 9 claims “the nucleic acid molecule encoding factor D is encoded in a vector”. A nucleic acid molecule is itself a nucleotide sequence and is not something that is “encoded” by a vector. Rather, a vector contains or carries a nucleic acid molecule. Accordingly, the relationship between the nucleic acid molecule and the vector is unclear, and the metes and bounds of the claim cannot be determined. A suggested fix would be “wherein the nucleic acid molecule encoding factor D is contained in a vector selected from the group consisting of….”
Claim 25 claims “A cell comprising a nucleic acid molecule encoding at least one factor B inhibitor of claim 1”. However, claim 1 defines the factor B inhibitor as a nucleic acid molecule encoding factor D. As written, claim 25 therefore requires a nucleic acid molecule that “encodes” another nucleic acid molecule. A nucleic acid sequence encodes a polypeptide, not another nucleic acid, and the relationship required by the claim is biologically impossible. Accordingly, the scope of the claim cannot be determined and the claim is indefinite. A suggested amendment could be “A cell comprising the nucleic acid molecule encoding factor D of claim 1”.
Claim Rejections - 35 USC § 112
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.
Claims 3-4 are 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.
Claim 1 is directed to a nucleic acid molecule encoding full length factor D. Claims 3-4 recite that the factor D is a mature factor D, which is a different polypeptide lacking the signal peptide and activation peptide encoded by claim 1. Accordingly, the subject matter of claims 3-4 does not fall within the scope of claim 1 (cannot comprise the sequences listed in claim 1) and thus does not further limit claim 1.
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.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1, 7, 9, 13 ,24-25 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Spiegelman (US20170072028 A1).
Claim interpretation: The sequence listings are not accurate with regards to the sequences and SEQ ID Nos found in the figures (see above 112 (b) rejection). As compared to SEQ ID NO:10 in Figure 7, T is missing from position 128, G missing from 255, A missing from 380, C is missing from 508, C is missing from 634 and T is missing at position 762 in the sequence listing for SEQ ID NO:10. Thus, SEQ ID NO:10 in the listing does not match up to SEQ ID NO:10 of Figure 7B. In addition, the amino acid sequence for SEQ ID NO:11 appears to be different from the amino acid in sequence in figure 7C. The sequence is missing a glycine at position 128 and Asparagine at position 254 compared to the SEQ ID NO:11 of figure 7C. For examination purposes, the sequence for SEQ ID NO:11 will be interpreted using the sequence from Figure 7C as it corresponds more accurately to the DNA sequence.
Regarding claims 1 and 13, Spiegelman teaches a nucleic acid sequence comprising SEQ ID NO:3 which is identical to instant SEQ ID NO:10 as presented in Figure 7C (see claims 1, 10, SEQ ID NO:3). Regarding claim 7, Spiegelman teaches the encoded peptide comprising instant SEQ ID NO:11 as compared to the instant SEQ IDNO:11 listed in Figure 7 with 100% sequence identity (see SEQ ID NO:4, claim 10). Please note that “factor D” is synonymous with Adipsin.
Regarding the limitations of “inhibitor factor B” in instant claim 1, Spiegelman teaches the identical peptide/nucleotide sequence of the instant claims and thus, inherently has the property of inhibiting factor B.
Regarding claims 9, 24-25, Spiegelman teaches wherein the nucleic acid sequence is in an expression vector or a cell (see claims 1, 10, also “section II, Recombinant expression vectors and Host cells, paragraph 0017).
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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/ERINNE R DABKOWSKI/ Examiner, Art Unit 1654