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 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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-8 and 10, in the response dated 3/23/2026, is acknowledged.
The applicant also elected the following species for the purposes of search and examination:
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wherein m1=227, n1=30, p₁=0.5.
Applicant states that this structure is identified as the first structure in claim 5. However, the first structure in claim 5 recites m1=44-226, n1=50-300, p₁=0.5-5. As such, it is unclear what applicant has cited as the elected species. Since the elected structure is within the ranges of Formula I, claim 1, the structure described by the applicant is considered the elected species.
Claims 9 and 11-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claim Status
Claims 1-12 are pending.
Claims 9 and 11-12 are withdrawn.
Claims 1-8 and 10 are examined on the merits in this prosecution.
Information Disclosure Statement (IDS)
The information disclosure statement filed 12/29/2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because: 1. The listed foreign patents have not been received by the office; and 2. The Du reference provided by the applicant is not cited on the IDS. See MPEP 609.04(a)(II). It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609 ¶ C(1).
CLAIM REJECTIONS
Rejections Under 35 U.S.C. 112
Scope of Enablement Rejection
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 and 10 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for functionalized diblock copolymers comprising: m1 = 111; n1 = 77-157; p1 = 3; q1 = 10; r1 = 3-80, does not reasonably provide enablement for preparing polymers comprising the claimed ranges. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (Bd Apls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,5) the state of the prior art,6) the relative skill of those in the art,7) the predictability of the art, and8) the breadth of the claims.
The instant specification fails to provide guidance that would allow the skilled artisan to practice the instant invention without resorting to undue experimentation, as discussed in the subsections set forth hereinbelow.
1. The nature of the invention, state of the prior art, relative skill of those in the art, and the predictability of the art
While the relative skill of those in the art is high, this is outweighed by the highly unpredictable nature of the invention. The prior art recognizes that the ability of a given polymer to comprise the claimed polyethylene blocks, but the ability to synthesize the chains given the extreme ranges of the polyethylene blocks, combined with the innumerable numbers of potential groups A1, B1, C1, D1, E1, T1, and EG1, cannot be predicted a priori, and thus must be determined empirically on a case-by-case basis. See for example Zhao (Bioconjugate Chem. 2008, 19, 849–859), see the discussion section in the left column of page 850, which discloses that the synthesis of a PEG polymer is difficult when the sites for drug molecule attachment were too close to each other, causing steric hindrance among the functional groups and resulted in incomplete conjugation of drug molecules, and further teaches that when the two aromatic molecules are close to each other, the π-π stacking phenomenon may be an issue that could impact the aqueous solubility of the polymers, a problem that may become a bigger concern in the case of the delivery of very insoluble drug molecules.
2. The breadth of the claims
The rejected claims are extremely broad and inclusive of any and all possible A1, B1, C1, D1, E1, T1, and EG1 groups, wherein the lack of limiting definitions for each of these elements, as well as the broad ranges claimed for m1, n1, p1, q1, and r1.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides limited guidance for selecting any particular A1, B1, C1, D1, E1, T1, and EG1 groups, as well as m1, n1, p1, q1, and r1.
4. The quantity of experimentation necessary
Applicant fails to provide information allowing the skilled artisan to ascertain which A1, B1, C1, D1, E1, T1, and EG1 groups and m1, n1, p1, q1, and r1 ranges, can be used to successfully assemble the claimed polymers. In the instant case, only a limited number of polymers are exemplified in the specification working examples. It is noted that these examples are neither exhaustive, nor define the class of polymers required. The instant claims are very broad, as discussed above, encompassing an overwhelming number of possible species, necessitating an exhaustive and undue search for all the embodiments suitable to practice the claimed invention. Accordingly, applicant has failed to provide information sufficient to practice the claimed invention absent resorting to undue experimentation.
Indefiniteness Rejection
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.
Claims 1-8 and 10 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
For claim 1, the metes and bounds of the terms: “co”, “protonatable groups,” “degradability-regulating groups,” “fluorescent molecular groups,” “delivery molecular groups,” “hydrophilic or hydrophobic groups,” and “capping groups,” are not defined, leading to ambiguity regarding the scope of the invention. For example, “protonatable groups” comprise both simple amines and nitrogen-containing heterocycles, many of which are known toxins. “Fluorescent molecular groups” encompass many compounds which may be diagnostic contrast agents, tumor-targeting markers, or medicines such as doxorubicin. The term “hydrophilic or hydrophobic groups” literally encompasses any chemical entity.
For claim 2, it is unclear what applicant is claiming by the term “polyethylene glycol block” since the polymer of claim 1 comprises multiple polyethylene blocks.
Claim 3 contains a number of trademark/trade names including QXL, QSY, BHQ, and “Iowa Black”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe chemical compounds and, accordingly, the identification/description is indefinite.
Obviousness Rejection
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
1) Claims 1-2, 4, 6-8, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (CN 103055321 (A), cited on IDS; citations below from the machine translation provided by EPO).
Wang teaches a macromolecular bonding medicine comprising Adriamycin (a.k.a. doxorubicin). Wang teaches the structure as a diblock polymer (Abstract). The structure shown below, structure C on page 30,
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Pg 30, structure C
where m=45-113, x and y=25-150 (pg 9, [0032]).
For claim 2, Wang teaches the molecular weight of the polyethylene glycol monomethyl ether block corresponding to a number-average molecular weight of 2,000-5,000 g/mol, while the molecular weight of the polyphosphate corresponds to a number-average molecular weight of 6,925-27,700 g/mol (pg 6, [0018]), overlapping the claimed ranges. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
For claim 4, Yang teaches a formula that overlaps the limitations of Formula I, m1=22~1136, n1=10~500, 01=0, p1=0.5~50, q1=0, r₁=1~200.
For claim 6, Yang teaches polymer particles (pg 6, [0015]).
For claim 7, Yang teaches polymer particle size of about 30 nm, overlapping or within the claimed range (pg 6, [0015]).
For claim 8, Yang teaches the macromolecular bonded drug biodegrades in vivo (pg 10, [0040]).
For claim 10, Yang teaches (pgs 9-10):
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The examiner acknowledges that some picking and choosing was used to arrive at the instantly claimed composition in view of Yang. However, the claimed combination of components, including each of the diblock polymers, is taught as known and used for administration of a medicine. It is also noted that the method of making the diblock copolymer of Yang is identical or essentially identical to the claimed copolymer. It would have therefore been prima facie obvious to a person having ordinary skill in the art to prepare the claimed diblock copolymer with a reasonable expectation of success, and that copolymer would have the same utility and properties as that claimed.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
Prosecution Insights