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 .
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.
Response to Amendment
The amendment filed July 2, 2026 has been entered. Claims 1-2, 4, 14 have been amended, claims 3, 5-8, 15-17 have been cancelled, and claims 13, 18-21 are withdrawn from consideration.. Applicant’s amendments to the claims have overcome all rejection/objections previously set forth in the Non-Final Office Action mailed February 4, 2026. Applicants cancellation of claims 3, 5-8, 15-17 have rendered the corresponding rejections/objections moot. As such, these rejections and objections are hereby withdrawn.
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
New rejections necessitated by Applicant’s amendment are addressed below.
Claims 1-2, 4, 9-12, 14 and 18-21 are pending in this application.
Priority
This application is a 371 of PCT/CN2021/140028 December 21, 2021 and claims foreign priority to CN2020115322304.4 filed December 22, 2020 and CN202011532338.3 filed December 22, 2020. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been received. The Examiner notes that no English language translation was provided.
Election
Applicant’s election with traverse of Group I claims 1-2, 4, 9-14, 18-21 and “an FA-polysialic acid-conjugated molecule” in the reply filed January 12, 2026 is acknowledged.
Claims 13 and 18-21 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant stated that claim 13 was encompassed by the elected species, however claim 13 is directed towards molecules wherein the calcification-inducing unit is a repeating sequence of polyglutamic acid or casein phosphopeptide, not an FA-polysialic acid conjugate as is elected. Thus, claim 13 was withdrawn as well. Election was made with traverse in the reply filed on January 12, 2026. Because applicant did not distinctly and specifically point out the supposed errors in the election requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Newly amended claims filed July 2, 2026 have limited claim 1 to a specific folic acid-polysialic acid-conjugated molecule having the formula
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The election was expanded to this molecule. This molecule was found to not be taught or suggested by the prior art, however, see issues below regarding 112(d)
Claims 1-2, 4, 9-12, and 14 are encompassed by the elected species and examined herein.
New Claim Rejections - 35 USC § 112 (d)
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 2, 4, 9-12, and 14 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 2, 4, 9-12, and 14 which ultimately depend from claim 1 drawn to a molecule, attempt to limit claim 1 further by structure by reciting features already in the compound of claim 1. Wherein the base claim 1 is drawn to a specific molecule, claims 2, 4, 9-12, and 14 fail to further limit claim 1. Claim 13, which is a withdrawn claim, would similarly be rejected for this reason.
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.
Note Regarding Withdrawn Claims
Claims 18-21 would be eligible for rejoinder, however claims 19 and 21 present further issues.
Claims 19 and 21 would be rejected under 112(b) as being indefinite.
Claim 19 recites “The oncology drug according to claim 18, wherein the molecule for inducing the spontaneous calcification of the tumor cells is administered by oral, intravenous, intratumoral, or lymph nodes”. However, claim 18 is drawn to an oncology drug comprising the molecule of claim 1. It is unclear how the oncology drug can be administered separately from the oncology drug.
Claim 21 recites “A method for preparing an oncology drug, comprising the following steps: preparing the oncology drug comprising the molecule for inducing the spontaneous calcification of the tumor cells as claimed in claim 1”. The claim fails to present any actual method steps in preparing the oncology drug other than preparing the oncology drug.
Allowable Subject Matter
Claim 1 is objected to as being an independent claim with rejected dependent claims, but would be allowable upon correction of dependent claims issues.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is Yoo (J. Controlled Release, 2004, cited in previous action) in view of Zhang (Asian Journal of Pharmaceutical Science, 2014, cited in previous action), and Liao (CN 110812494, cited on PTO-892, English translation provided on PTO-892).
Yoo teaches a folate-receptor targeted anticancer therapy utilizing a doxorubicin-polyethylene glycol-folate (DOX-PEG-FOL) conjugate (abstract). Yoo teaches the following synthesis of such a conjugate
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, wherein folate is conjugated to PEG and then conjugated to doxorubicin (pg. 250, figure 2). Yoo teaches folate receptors are overexpressed in several human tumors including ovarian and breast cancers (pg. 248, col. 1 para. 1). Yoo teaches such conjugates exposing folate on the surface can result in selective targeting behaviors against folate-positive cancer cells (pg. 248, cols. 1-2, bridging para.). Thus, the conjugate of Yoo, that possess a folate molecule (i.e. targeting functional unit), targets a molecular region of tumor cells, such as ovarian or breast.
Zhang (Asian Journal of Pharmaceutical Science, 2014) teaches polysialic acid (PSA) is an improvement to PEG in drug delivery systems (pg. 77, col. 1, last para., col. 2, para. 2). Zhang (Asian Journal of Pharmaceutical Science, 2014) teaches PSA on the surface of drugs/carriers will provide a water cloud barrier owing to its high hydrophilicity and chain flexibility (pg. 77, col. 2, para. 2). The cloud protects modified drugs/carriers from interacting with plasma proteins or macrophages, prolonging circulation half-life (pg. 77, col. 2, para. 2). Zhang (Asian Journal of Pharmaceutical Science, 2014) teaches PSA has potential to be conjugated to low molecular weight anti-cancer drugs, such as in a PSA-epirubic conjugate (pg. 77, col. 2, para. 5). Conjugation to epirubic resulted in improved anti-cancer activity as well as a significantly longer retention than free epirubic alone (pg. 77, col. 2, para. 5).
Liao teaches the preparation of a gold nanoparticle modified with folic acid-NH2 and wrapped with polyethylene glycol-b-polyethylene diethylaminoethyl acrylate deblock copolymer (abstract). Liao teaches the following synthesis (English translation abstract).
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Liao demonstrates FA-NH2 as an alternative to folic acid.
While it may have been prima facie obvious to a person of ordinary skill in the art to modify the teachings of Yoo by substituting PEG with pSA as suggested by Zhang and substitute the folate with folate-NH2 as an equivalent as taught by Liao, arriving at the claimed compound as an intermediate through the synthesis of Yoo. A person of ordinary skill in the art would not have expected the resulting intermediate FA-sialic acid to possess the ability to induce spontaneous calcification of tumor cells as demonstrated in the instant specification (pg. 15, para. 0075). It would have been improper hindsight to suggest a person of ordinary skill in the art would have the motivation to arrive at the claimed compound by introducing several modifications to the compound at Yoo and expect calcification of tumor cells without incorporation of the anticancer agent doxorubicin. Thus claim 1 would be allowable over the prior art.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s reply is considered to be a bona fide attempt at a response and is being accepted as a complete response. The 35 USC § 112(d) rejections are maintained for reason of record and foregoing discussion.
Conclusion
No claims are allowed in this action.
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.
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/S.L.G./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693
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