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 February 10, 2026 is acknowledged. Claims 1, 22, 26 were amended, claims 2-6, 8-21, 23-25, 28-29 were canceled, claims 30-31 were newly added and claims 1, 7, 22, 26-27, 30-31 are pending in the instant application. The restriction was deemed proper and made final previous office action. Please note that claims 22 and 26 are now rejoined due to amendment of claims 1, 22 and 26.
Claims 7 and 27 remain withdrawn as being drawn to a non-elected species/invention. Claims 1, 22, 26, 30-31 are examined on the merits of this office action.
Withdrawn Rejections/Objections
The objection to claims 3 and 6 is withdrawn in view of amendment of the claims filed February 10, 2026.
The rejection of claims 1, 3, 6 under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter is withdrawn in view of amendment of the claims filed February 10, 2026.
The rejection of claims 1, 3 and 6 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of amendment of the claims filed February 10, 2026.
The rejection of claims 1, 3 and 6 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating patients with specific bone disease and inhibitors (i.e. bone cancer, RA, obesity with TM4SF19-Fc) does not reasonably provide enablement for treating/preventing any bone disease with ANY inhibitor encompassed by the claims is withdrawn in view of amendment of the claims filed February 10, 2026.
The rejection of claim(s) 1, 3 and 6 under 35 U.S.C. 102(a)(1) as being anticipated by Kim (US20190134192) is withdrawn in view of amendment of the claims filed February 10, 2026.
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New Rejections
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, 22 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.
In claim 1, element (A) recites “an EC2 polypeptide of human TM42F19 protein, said human EC2 polypeptide consisting of amino acid residues from 120 to 169 of human TM4SF19 protein, or a contiguous fragment thereof comprising amino acid residues from 145 to 169 of human TM4SF19 protein”. The phrase “a contiguous fragment thereof” refers back to the antecedent EC2 polypeptide “consisting of amino acid residues from 120 to 169,” which is a closed ended limitation. However, the fragment is further defined using the open ended transitional phrase “comprising amino acid residues from 145 to 169,” which permits the inclusion of additional amino acid residues beyond residues 145-169. Accordingly, it is unclear whether the claimed “contiguous fragment thereof” must be limited to a fragment within the closed sequence consisting of residues 120-169, or whether it may include additional amino acid residues extending beyond that sequence. This inconsistency renders the scope of the claim uncertain. Therefore, one of ordinary skill in the art could not clearly determine the metes and bounds of the claimed invention. A suggested amendment to overcome this rejection would be “…an EC2 polypeptide of human TM4SF19 protein, said human EC2 polypeptide consisting of amino acid residues 120-169 of human TM4SF19 protein, or a contiguous fragment of residues 120-169 of human TM4SF19 protein, wherein the fragment comprises amino acid residues 145-169…”
In claim 22, element (A) recites “an EC2 polypeptide of human TM42F19 protein, said human EC2 polypeptide consisting of amino acid residues from 120 to 169 of human TM4SF19 protein, or a contiguous fragment thereof comprising amino acid residues from 145 to 169 of human TM4SF19 protein”. The phrase “a contiguous fragment thereof” refers back to the antecedent EC2 polypeptide “consisting of amino acid residues from 120 to 169,” which is a closed ended limitation. However, the fragment is further defined using the open ended transitional phrase “comprising amino acid residues from 145 to 169,” which permits the inclusion of additional amino acid residues beyond residues 145-169. Accordingly, it is unclear whether the claimed “contiguous fragment thereof” must be limited to a fragment within the closed sequence consisting of residues 120-169, or whether it may include additional amino acid residues extending beyond that sequence. This inconsistency renders the scope of the claim uncertain. Therefore, one of ordinary skill in the art could not clearly determine the metes and bounds of the claimed invention. A suggested amendment to overcome this rejection would be “…an EC2 polypeptide of human TM4SF19 protein, said human EC2 polypeptide consisting of amino acid residues 120-169 of human TM4SF19 protein, or a contiguous fragment of residues 120-169 of human TM4SF19 protein, wherein the fragment comprises amino acid residues 145-169…”
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 26, 30-31 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.
Claims 26, 30-31 depends from claim 1 and further recites that “the fusion protein comprises any one of the amino acid sequences of SEQ ID NO:10, 13, 16 and 19”. However, claim 1 requires that the inhibitor comprises an EC2 polypeptide selected from specific amino acid residue ranges, namely (i) residues 120-169 or a fragment comprising residues 145-169 of human TM4SF19, or (ii) residues 116-165 of mouse TM4SF19. The amino acid sequence recited in SEQ ID Nos:13, 16 and 19 include EC2 regions that do not fall within the residue ranges recited in claim 1. Accordingly, the subject matter of claims 26, 30-31 is not fully encompassed by the limitations of claim 1. A dependent claim must further limit the subject matter of the claim upon which it depends. See 35 U.S.C. 112(d). Because claims 26, 30-31 recite subject matter that is broader than, or inconsistent with, the limitations of claim 1, they do not further limit the base claim and are therefore of improper dependent form
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERINNE R DABKOWSKI/ Examiner, Art Unit 1654
/LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654
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