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 .
Duty to Disclose
Applicants are kindly reminded of their duty to disclose pursuant to 37 C.F.R. 1.56 which encompasses the citation of references material to patentability of which Applicants are aware, such as references that may have been cited in the prosecution of the foreign applications or in the specification. Several foreign offices have completed search reports which claim priority to the same WIPO and foreign priority document as this application.
Information Disclosure Statement
The information disclosure statement filed 12/13/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Election/Restrictions
Applicant’s election without traverse of group I and the species of the third structure in claim 5 in the reply filed on 8/3/2026 is acknowledged.
Applicants’ election of species of the third structure in claim 5 is free of the prior art. As a result the search has been extended to a PEG-caprolactone block copolymer with any fluorescent group attached to the lactone by a linking group that does not include sulfur. If prior art is then found that anticipates or renders obvious the Markush-type claim with respect to a nonelected species, the Markush-type claim shall be rejected and claims to the nonelected species held withdrawn from further consideration. The prior art search, however, will not be extended unnecessarily to cover all nonelected species. Should applicant, in response to this rejection of the Markush-type claim, overcome the rejection, as by amending the Markush-type claim to exclude the species anticipated or rendered obvious by the prior art, the amended Markush-type claim will be reexamined. The ** > examination < will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during the reexamination that anticipates or renders obvious the amended Markush-type claim, the claim will be rejected and the action can be made final unless the examiner introduces a new ground of rejection that is neither necessitated by applicant’s amendment of the claims nor based on information submitted in an information disclosure statement filed during the period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p). See MPEP § 706.07(a). Amendments submitted after the final rejection further restricting the scope of the claim may be denied entry if they do not comply with the requirements of 37 CFR 1.116. See MPEP § 714.13.See MPEP 803.02. Claims 5 (withdrawn species) and 9-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
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 1-8 and 13 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.
In particular in claims 1-6,8 and 13, the recitation of diblock copolymer is confusing as the polymer clearly has at least three segments. The examiner suggests applicants simply change all instances of “diblock” to “block”.
Additionally the use of a tilde “~” for the numerical ranges in claim 1 is considered indefinite as tilde generally means approximate rendering the scope of the ranges recited uncertain. The examiner suggest simply deleting all instances of the tilde “~” and replacing them with a hyphen “-“. Claims 2-8 and 13 incorporate the indefiniteness be dependency.
Regarding claim 3 and 5, the phrases "preferably" and “includes” 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).
In claim 3, the recitation of "derivative " when referring to cholecterol renders the claim indefinite. The term “derivative” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what is encompassed and excluded by the limitation "derivative”. The Merriam-Webster' s Dictionary defines “derivative” as “a chemical substance related structurally to another substance and theoretically derivable from it” ([online], retrieved on 12/9/2015, at: http://www.merriamwebster.com /dictionary/derivative. Hence, one of ordinary skill would clearly recognize that derivatives or analogues of cholecterol would read on any of those compounds having any widely varying groups that possibly substitute the compound claimed. One of ordinary skill could not ascertain and interpret the metes and bounds of the patent protection desired as to these terms. Thus, it is unclear and indefinite as to how the “derivative” herein are encompassed thereby.
In claim 3, the recitation of “EG2”, does not seem to find antecedent basis in the claims.
Regarding claim 7, the phrase “and/or” used before the recitation “the targeting group is modified” is not clearly understood and confusing. The limitation of targeting groups is an optional feature as only the polymer particles of size 10-200 nm may be selected instead of targeting agent by using the phrase “and/or” found in line 2. If there is no targeting agent selected then there is no antecedent basis. The examiner suggests separating the three limitations in claim 7 into three separate claims.
In claim 8, the recitation of “polymer particles”, does not seem to find antecedent basis in the claims.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4,6-8 and 13 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Peng et al. “Methoxy poly(ethylene glycol)-b-poly(ε-caprolactone)
block-graft copolymers with pendant fluorescent groups: synthesis, characterization and cellular uptake”, J Polym Res (2013) 20:62.
Peng discloses degradable MPEG-PCL copolymers grafted with pyrene through ethylene and heterocyclic linkers as shown below:
PNG
media_image1.png
182
408
media_image1.png
Greyscale
, the formula with repeat units was MPEG45-b-PαN3CL49, is within the claimed range. See entire disclosure, especially abstract, scheme 1, ¶ bridging page 1 and 2, and ¶ bridging rt and lft col on page 2. Regarding claims 6-7, the polymers formed nanoparticles with diameters of more than 100 nm and less than 200 nm. See page 6 rt col 1st ¶.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAMES W ROGERS/ Primary Examiner, Art Unit 1618
