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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the substitute specification and amendment filed 6/14/2022 wherein claims 1, 6, 7, 10, 14-18, 20, and 25-28 were amended and claims 3-5, 19, 21-24, and 30 were canceled. In addition, Applicant acknowledges the amendment filed 8/28/2025 which is a duplicate of that filed 6/14/2022.
Note(s): Claims 1, 2, 6-18, 20, and 25-29 are pending.
Priority
This application is a 371 of PCT/CN2020/078743 filed 3/11/2020 which claims benefit to CHINA CN201911242386.6 filed 12/6/2019.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 USC 119 (a) – (d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
While a certified copy of the prior document was submitted, an English language translation is not of record. Should Applicant desire to obtain the benefit of foreign priority under 35 USC 119 (a) – (d) prior to declaration of an interference, a certified English language translation of the foreign application should be submitted. 37 CFR 41.154(b) and 41.202(e). Failure to prove the certified translation may result in no benefit being accorded for the non-English document.
Note(s): The earliest effective filing date is 3/11/2020 as the PCT document fully supports the claimed invention. It should be noted that no English language translation is of record for the foreign priority document.
Claim Interpretation
It should be duly noted that the metes and bounds of independent claim 1 could not be obtained. However, the claim is directed to a polyethylene glycol conjugated drug of Formula (I),
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wherein the variables are as defined therein.
Claim 16 is directed to treating and/or prevention a disease by administering the conjugated drug of independent claim 1.
Claim 17 is directed to an injection solution.
Claim 18 is directed to a method of preparing the conjugated drug of independent claim 1.
Claim 20 is directed to a method of preparing the conjugated drug of independent claim 1 as set forth therein.
Claim 25 is directed to a method of preparing the conjugated drug of independent claim 1 as set forth therein.
Claim 26 is directed to a method of preparing the conjugated drug of independent claim 1 as set forth therein.
Claim 27 is directed to a method of preparing the conjugated drug of independent claim 1 as set forth therein.
Claim 28 is directed to compounds as set forth therein.
Claim 29 is directed to compounds as set forth therein.
Applicant’s Election
Applicant's election without traverse of Group I (pending claims 1, 2, 6-15, and 17) filed 8/28/2025 is acknowledged. The restriction requirement is still deemed proper and is therefore made FINAL.
Applicant elected the of Compound 10,
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wherein PEG has an average molecular weight of 40,000; PCB is palbociclib; and SB7 is SB-743921. The search was not extended beyond Applicant’s elected species because prior art was found to reject the claims. Thus, the search was not further extended.
According to Applicant in the response filed 8/28/2025, claims 1, 2, 6, 7, 9, 14, 15, and 17 read on the elected species.
Withdrawn Claims
Claims 8, 10-13, 16, 18, 20, and 25-29 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention/species.
Information Disclosure Statement
The information disclosure statement filed 6/14/2022 was considered.
Improper Multiple Dependent Claim
Claim 14 is in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n).
112 Second Paragraph 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, 2, 6, 7, 9, 14, 15, and 17 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.
Claims 1, 2, 6, 7, 9, 14, 15, and 17: Independent claim 1 is ambiguous for the following reasons: (1) according to MPEP 2173.05(h), while a Markush grouping may include a large number of alternatives, and not necessarily be indefinite under, in certain circumstances, a Markush group may be so expansive that a skilled artisan cannot determine the metes and bounds of the claimed invention. In the pending claims, the invention is directed to conjugated drugs of formula
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wherein PEG is a single or multi-arm polyethylene glycol segment, j is any number of PEG arms;
X1 is
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but when j is greater than 1, there are multiple X1s present and each X1 is independently selected;
Y is Lys or Glu, but when j is greater than 1, there are multiple Y groups present and each Y is independently selected;
X2 is
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, but when j is greater than 1, there are multiple Ys present and each Y is independently selected;
W1 is
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, but when j is greater than 1, multiple W1s are present and each W1 is independently selected;
Q is
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;
each Z0, Z1, and Z2 is independently
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and when multiple Z0, Z1, and Z2 variables are present, they are independently selected;
each N1, N2, and N3 is independently Gly or GFLG (glycine-phenylalanine-leucine-glycine) and when multiple N1, N2, and N3 variables are present, they are independently selected;
AC1, AC2, and AC3 are any drug molecules and when multiple AC1, AC2, and AC3 variables are present, they are independently selected;
W2 is
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, but when j is greater than 1, there are multiple W2 groups present and each W2 is independently selected;
Q’ is
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;
each Z0’, Z1’, and Z2’ is independently
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and when multiple Z0’, Z1’, and Z2’ groups are present, they are independently selected;
each N1’, N2’, and N3’ is independently Gly or GFLG (glycine-phenylalanine-leucine-glycine) and when multiple N1’, N2’, and N3’ variables are present, they are independently selected;
each AC1’, AC2’, and AC3’ is independently any drug molecules and when multiple AC1’, AC2’, and AC3’ variables are present, they are independently selected.
Thus, the claim encompasses a conjugated drug defined by multiple Markush groups and subgroups thereof. As a result, pending claim 1 encompasses a massive number of distinct alternative members such that one skilled in the art cannot determine the metes and bounds of the claim. Thus, due to an inability to envision all of the compounds defined by the Markush groups, the claim is deemed to be vague and indefinite.
(2) The claim is ambiguous because it repeatedly discloses various conditions when j is greater than 1 which implies that j may be zero. However, there are no conditions present when j is equal to zero.
(3) In addition, claim 1 is ambiguous because of the phrase ‘for example...’ (see lines 5, 28-29, and 45-46). Specifically, Applicant is respectfully reminded that regarding claim 1, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
(4) Also, claim 1 is ambiguous because throughout the claims the phrase ‘such as 2, 4, or 8’ appears (see lines 7, 10, 12-13, 16, and 33). Applicant is respectfully reminded that regarding claim 1, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Since claims 2, 6, 7, 9, 14, 15, and 17 depend upon independent claim 1 for clarity, those claims are also vague and indefinite.
Claims 8, 9, 15, and 17: The claims are ambiguous because they read on the broad invention, but also include preferred embodiments within the claims as well. Applicant is respectfully reminded that a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims recite broad drug conjugates, and the claims also recite preferred embodiments which are narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 14: The claim is ambiguous because the species listed therein that correspond to various compounds (01, 21, 31, and 41) are not consistent with the structures that appear in the specification. Should compounds 01, 21, 31, and 41 be 10, 12, 13, and 14, respectively.
Claim 17: The claim is ambiguous because it depends upon two different claims. Applicant is respectfully requested to review MPEP
103 Rejection
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 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, 2, 6, 7, 9, 14, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Chongqing Upgra Biological Sci & Tech., Ltd (CN107679948A).
Independent claim 1 is directed to a polyethylene glycol conjugated drug of Formula (I),
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wherein the variables are as defined therein.
Claim 2 is directed to a conjugated drug having at least one of the 15 various characteristic listed therein. One of the characteristic is a single arm PEG.
Claim 6 is directed to a conjugated drug wherein PEG is a single arm and X1 is present.
Claim 7 is directed to Y is Lys.
Claim 9 is directed to a conjugated drug wherein X2, X1, W1 and W2 are defined therein.
Claim 14 is directed to a species that is consistent with Compound 10 of the disclosure. The compound in the claim is listed as 01.
Claim 15 is directed to a pharmaceutical composition comprising the conjugated drug.
Claim 17 is directed to an injection solution of claim 1.
Note(#1): Claims 1, 2, 6, 7, 9, 14, and 15 all read on Applicant’s elected species (Compound 10).
Note(#2): Both the non-English and English translations of CN107679948A are included. While the English translation is referenced herein, the rejection is made over the non-English document which contains the formula that read on the pending invention.
CN107679948A is directed to polyethylene glycol containing conjugated that have anticancer activity. Applicant’s species is rendered obvious as the document discloses that the compounds contain a PEG that is single or multi-armed conjugated to carboxyl, lysine, GFLG, and one or more drugs including those selected by Applicant (Palbociclib (PCB) and SB-743921 (SB)). See entire document including page 1/28, claims 1 (Note that claim 1 discloses that carboxyl groups are present) and 2 (Note that claim 2 discloses that a preferred peptide is GFLG); page 2/28, first two paragraphs (first paragraph disclose that glutamic acid as well as other amino acids may be present; second paragraph discloses PCB and SB-743921 as possible drugs); page 2/28, claims 3 and 4 (Note that PCB is a preferred drug in claim 3; claim 4 discloses that PEG is single or multi-armed); page 2/28, claim 5 (discloses that PEG with other components present also contains an anti-cancer medicine (drug); page 2/28, claims 3 and 6, PCB is listed as a preferred drug; page 6/28, lines 2 and 8, respectively disclose Palbociclib and SB-743921, respectively as drugs). The document discloses that the molecular weight of PEG may be 40,000 (page 7/28, fourteenth paragraph).
On page 3/28 (first paragraph), it is disclosed that it is preferred to have at least two cancer therapy drugs present (see also page 4/28, fifth paragraph). Pharmaceutical acceptable compositions may be generated from the conjugated drugs (page 4/28, see entire page, especially, third paragraph). On page 8/28, it is disclosed that the pharmaceutical composition are suitable for industrialized production and may be administered to subjects as a cancer treatment (see paragraphs ten and eleven). On page 5/28 (seventh paragraph), it is disclosed that any amino acid which includes lysine may be present as well as tetrapeptides (e.g., GFLG).
It would have been obvious to the skilled artisan that the elected species is encompassed by the pending invention as both the cited prior art ant Applicant disclose overlapping components that are present in the elected species. In addition, both drugs are listed as being recommended by CN107670048A. Thus, the limitations of the elected species (pending claims 1, 2, 6, 7, 9, 14, 15, and 17) are rendered obvious by the cited prior art.
Comments/Notes
Due to the complexity of the claims as detailed in the 112 rejection sections above, the metes and bounds of the invention could not be ascertained.
Conclusion
Claims 1, 2, 6, 7, 9, 14, 15, and 17 are rejected and claims 8, 10-13, 16, 18, 20, and 25-29 are withdrawn.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G. Hartley can be reached at (571)272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
December 11, 2025