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 amendment filed 12/18/2024 wherein claims 4, 5, 8, 9, 11, and 13-15 were amended.
Note(s): Claims 1-15 are pending.
Priority
This application is a 371 of PCT/US2022/053685 filed 12/21/2022;
PCT/US2022/053685 claims benefit to PRO 63/329,695 filed 4/11/2022; and
PCT/US2022/053685 claims benefit to PRO 63/296,662 filed 1/05/2022.
Note(s): The earliest effective filing date is 1/5/2022 as the pending invention is fully supported in the provisional application filed 63/296,662.
Claim Interpretation
Independent claim 1 is directed to a complex comprising a substituted cyclodextrin and a close-dodecaiodododecaborate or a salt thereof.
Claim 11 is directed to a method comprising administering the complex of claim 1.
Information Disclosure Statement
The information disclosure statement filed 12/18/2024 was considered.
Written Description Rejection
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 11-15 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant is reminded that an inventor is entitled to a patent to protect his work only if he/she produces or has possession of something truly new and novel. The invention being claimed must be sufficiently concrete so that it can be described for the world to appreciate the specific nature of the work that sets it apart from what was before. The inventor must be able to describe the item to be patented with such clarity that the reader is assured that the inventor actually has possession and knowledge of the unique composition that makes it worthy of patent protection. The pending application does not sufficiently describe the invention as it relates to methods other than a method of x-ray imaging wherein the complex of claim 1 is utilized. Thus, what the reader gathers from the instant application is a desire/plan/first step for obtaining a desired result. While the reader can certainly appreciate the desire for achieving a certain end result, establishing goals does not necessarily mean that an invention has been adequately described.
While compliance with the written description requirements must be determined on a case-by-case basis, the real issue here is simply whether an adequate description is necessary to practice an invention described only in terms of its function and/or based on a disclosure wherein a description of the components necessary in order for the invention to function are lacking. In order to satisfy the written description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. In other words, the specification should describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that the inventor created what is the claimed. Thus, the written description requirement is lacking in the instant invention since the various terms set forth above are not described in a manner to clearly allow persons of ordinary skill in the art to recognize that Applicant invented what is being claimed.
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 7 and 11-15 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.
Claim 7: The claim is ambiguous because there is no period at the end of the sentence. Thus, it is unclear whether or not Applicant intended to incorporate additional text or not.
Claims 11-15: Claim 11 is ambiguous because it is unclear for what purpose the method is being performed. Thus, since claims 12-15 depend upon claim 15 for clarity, those claims are ambiguous as well as all method claims.
Claims 13-15: The claims are ambiguous because they each refer back to claim 1 which is a product, not method claim. Thus, the ‘the method’ appearing in the claims lack antecedent basis. Did Applicant intend for the claims to depend upon claim 11?
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Assaf et al (Angew. Chem. Int. Ed., 2015, Vol. 54, pages 6852-6856) in view of Loftsson et al (US 2018/0147297).
Independent claim 1 is directed to a complex comprising a substituted cyclodextrin and a close-dodecaiodododecaborate or a salt thereof.
Claim 2 is directed to the complex according to claim 1, wherein the substituted cyclodextrin is substituted with a hydroxy-substituted alkyl.
Claim 3 is directed to the complex according to claim 2, wherein the substituted cyclodextrin comprises 2-hydroxypropyl cyclodextrin.
Claim 4 is directed to the complex according to claim 1 wherein the substituted cyclodextrin is a gamma cyclodextrin.
Claim 5 is directed to the complex according to claim 1 wherein the substituted cyclodextrin is substituted at the 2 position, the 3 position, the 6 position, or a combination thereof.
Claim 6 is directed to the complex of claim 5 wherein the cyclodextrin has a formula
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253
277
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.
Claim 7 is directed to the substitute cyclodextrin of claim 6 having a formula
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242
375
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Greyscale
Claim 8 is directed to the complex of claim 1 wherein the complex comprises a salt of closo-dodecaiodododecaborate.
Claim 9 is directed to the complex of claim 1 comprising a 1:1 ratio of the substituted cyclodextrin to closo-dodecaiodododecaborate.
Claim 10 is directed to a composition comprising a substituted cyclodextrin, a closo-dodecaiodododecaborate salt, and a pharmaceutically acceptable excipient.
Assaf et al is directed to dodecaborate clusters conjugated to cyclodextrin. The dodecaborate clusters may incorporate iodo to generate closo-dodecaiodododecaborate structures. The cyclodextrin may be alpha, beta, or gamma (see entire document, especially, abstract; page 6852, Figure 1; page 6853, Table 1 and Figure 3). In addition, Assaf et al disclose that cyclodextrins are well known for encapsulating a wide range of hydrophobic organic and organometallic compounds in their cavity (page 6852-6853, bridging paragraph).
Assaf et al disclose that two gamma cyclodextrins were observed to cap a dodecaborate cluster tightly while the two wider cyclodextrin rims were held together by intermolecular hydrogen bonds. In addition, Assaf et al disclose that the complexation stoichiometry in the solid phase was 2:1 and differs from that established in an aqueous solution which was 1:1.
While Assaf et al disclose a complex comprising cyclodextrin conjugated to closo-iodododecarborate, the cyclodextrin therein is not substituted .
Loftsson et al is directed to cyclodextrin complexes that are used in combination with a pharmaceutically delivery agent (see entire document, especially, abstract; page 1-2, paragraph [0011]). The cyclodextrin my be used in various methods including producing a microsuspension, generating a microsuspension, generating a microparticle drug, drug, or polymer suspension (page 3, paragraph [0033] through page 4, paragraph [0038]). The cyclodextrin may be suspended in water (page 4, paragraph [0038]). The cyclodextrin may be complexed with a drug or substituted with 2-hydroxypropyl, 2-hydroxypropyl, sulfobutyl ether, sulfobutyl, or methylated substituents (page 6, paragraphs [0069], [0078], and [0079]; page 8, paragraph [0091]).
Possible acceptable mediums/excipients include water, preservatives, stabilizing agents, electrolytes, and combinations thereof (page 11, paragraphs [0129] – [0138]).
It would have been obvious to one of ordinary skill in the art prior to the effective date of the pending invention for one to modify the teachings of Assaf et al with Loftsson et al for the following reasons. (1) Assaf et al disclose that it is well known in the art to have a complex comprising cyclodextrin and closo-iodododecarborate and a composition comprising cyclodextrin, closo-iodododecarborate, and a pharmaceutical excipient (i.e., water) and salts thereof (claims 1 and 10). (2) Assaf et al disclose that the cyclodextrin that is generally used is gamma cyclodextrin (claim 3). (3) Assaf et al disclose that the complex ratio is 1:1 or 2:1 (claim 9). Based on the combined teachings of Assaf et al and (4) it would have been obvious to a skilled artisan replace the cyclodextrin of Assaf et al with the substituted cyclodextrin of Loftsson et al because both documents disclose that cyclodextrins are well known to enhance solubility and bioavailability of hydrophobic compounds and that cyclodextrins form inclusion compounds in aqueous solutions (Assaf et al, pages6852-6853, bridging paragraph; Loftsson et al, pages 1-2, paragraph [0011]). (5) Loftsson et al disclose that possible substitutions on the cyclodextrin include 2-hydroxypropyl (claims 2, 3, and 5) as well as the structure being methylated (page 8, paragraph [0091], see claims 6 and 7).
Claim 11 is directed to a method comprising administering the complex of claim 1 to a subject.
Claim 12 is directed to the method of claim 11 comprising imaging the subject by x-ray imaging.
Claim 13 is directed to the method wherein the composition is administered orally, by injection, or intravenously.
Claim 14 is directed to the method wherein an x-ray imaging is generated.
Claim 15 is directed to a method of generating an x-ray image.
In regard to claims 11-15, it is duly noted that the claims do not identify the specific method of interest for utilizing the complex/composition. In addition, claims 13-15, for example refer back to a compound, not method claim and as such it is unclear what is actually being claimed therein. However, based on the teachings of Assaf et al (page 6852, right column first complete paragraph), it would have been obvious to a skilled artisan to utilize the complex/composition of numerous applications in medicinal chemistry and material sciences as well as in neutron capture therapy of cancer which are known areas for using dodecaborate complexes (page 6852, right column, first complete paragraph). Furthermore, it would have been obvious to use x-ray analysis with the complex because Loftsson et al disclose in there composition comprising cyclodextrin the evaluation of the particle using Fourier transform infra-red spectroscopy (FTIR), differential scanning calorimetry (DSC), and x-ray analysis (page 17, paragraphs [0246] – [0247]).
For the reasons set forth herein and because both Assaf et al and Loftsson et al are based on compositions comprising cyclodextrins, the references may be considered to be within the same field of endeavor. Thus, the reference teachings are combinable. In addition, for the reasons supra, the limitations of claims 1-15 are met.
Comments/Notes
Both Hollow et al (Chem. Commun., January 19, 2022, Vol. 58, pages 2375-2378) and Marei et al (Chem. Commun., January 18, 2022, Vol. 58, pages 2363-2366) were made available to the public after Applicant’s effective filing date.
Conclusion
Claims 1-15 are rejected.
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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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
September 3, 2026
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