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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/17/2026 has been entered.
Drawings
The drawings submitted on 08/24/2022 are accepted.
Priority
This application claims benefit of priority to Provisional Application 62/983,077 filed on 02/28/2020 and is also a 371 of PCT/US2021/019338 filed on 02/24/2021.
Amendment and Claim Status
In the reply filed on 04/17/2026, Applicant amended claims 1-4, 7 and 13 and canceled claims 8-11, 16 and 18-19. Claims 4-6, 12-15 and 17 were previously withdrawn by the Examiner as not being encompassed by the elected group.
Claims 1-7, 12-15 and 17 are currently pending.
Claims 4-6, 12-15 and 17 are withdrawn from consideration.
Claims 1-3 and 7 are under examination.
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.
Claim 3 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.
Claim 3 recites “the recombinant Fibcd1 fragment of claim 1, wherein said fragment comprises residues 241-457 of SEQ ID NO: 2, or an ortholog thereof.” Claim 1 recites “… fragment (i) comprises a fibrinogen-related domain consisting of residues 241-457 of Fibcd1 of SEQ ID NO: 2, or an ortholog thereof …” Thus, claim 3 fails to further limit the subject matter of the claim upon which it depends because claim 1 already requires the fragment to comprise residues 241-457 of SEQ ID NO: 2, or an ortholog thereof.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandes et al. (US 20020168716 A1, 11/14/2002) (Of Record).
Regarding claims 1 - 3, Fernandes et al. disclose novel amino acid sequences for mammalian polypeptides that have sequence similarity to human microfibril-associated glycoprotein 4 (MAG4) (See entire document, Abstract). Fernandes et al. disclose SEQ ID NO: 26 which shares 100% sequence identity with residues 241-457 of the Fibcd1 fragment of instant SEQ ID NO: 2 and lacks N-terminal residues 1-175 of instant SEQ ID NO: 2. As shown below in the alignment, Qy represents instant SEQ ID NO: 2 and Db represents SEQ ID NO: 26 of Fernandes et al.
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356
592
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Fernandes et al. further disclose fusion of a 6x His tag and T7 epitope to a protein for protein analysis via Western blotting (Paragraph [0459]). The T7 epitope reads on a label and an epitope tag.
Fernandes et al. do not disclose a Fibcd1 fragment that has a length of at least 270 amino acid residues.
However, as discussed above, Fernandes et al. do disclose SEQ ID NO. 26 which is 269 amino acids in length and further the fusion of a 6x His tag and T7 epitope for protein analysis. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have fused SEQ ID NO. 26 with a 6x His tag and a T7 epitope motivated by the desire to analyze the protein and the addition of the 6x His tag and T7 epitope would create a protein with a length of at least 270 amino acid residues as the 6x His tag is 6 histidines in length and the T7 epitope is an 11 amino acid polypeptide sequence. Additionally, SEQ ID NO. 26 of Fernandes et al. with the addition of the 6x His tag and T7 epitope would still be less than 400 amino acid residues in length.
Regarding claim 7, Fernandes et al. disclose the proteins of the invention, and derivatives, fragments, analogs and homologs thereof, can be incorporated into pharmaceutical compositions suitable for administration (Paragraph [0236]). Further, such compositions comprise the protein and a pharmaceutically acceptable carrier (Paragraph [0236]).
USC § 103 - Response to Arguments
Applicant's arguments filed 04/17/2026 have been fully considered but they are not persuasive.
Applicant argued on Pages 2-3 that claim 1, as-amended, recites the fragment “has a length of at least 270 amino acid residues, wherein the fragment further comprises ubiquitination …” However, claim 1, as amended, does not recite “further comprises,” it simply states “has a length of at least 270 amino acid residues, wherein the fragment comprises ubiquitination …” Thus, the prior art of record, being Fernandes et al., still reads on the claims as-amended.
Conclusion
Claims 1-3 and 7 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY T WHITE whose telephone number is (571)272-0683. The examiner can normally be reached Monday - Friday 8:30 - 5:00 EST.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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