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 .
Status of Application
Receipt of the Amended Claims filed on December 16, 2024 is acknowledged.
Claims 1-17 are pending in this application.
Claims 14 and 16 have been amended.
No claims have been cancelled.
All pending claims are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed on December 16, 2024; March 18, 2025; and July 8, 2026 is acknowledged. Signed copies are attached to this office action.
Claim Objections
Claims 3 and 16 are objected to because of the following informalities:
Regarding claim 3, the claim does not read well. It is suggested the claim be amended to recite “wherein the particles comprise an adeno-associated virus (AAV).”
Regarding claim 16, the claim does not read well. It is suggested the claim be formatted as bullets, such as:
A kit for forming the carrier material according to claim 1, comprising:
a composition A containing a first branched polymer unit having a total of two or more boronic acid-containing groups on side chains or terminals, and;
a composition B containing a second branched polymer unit having a total of two or more diol groups on side chains or terminals;
wherein the carrier material has a finite zero-shear viscosity of greater than 500 Pa . s, and a polymer content (c) in the carrier material is greater than or equal to an overlapping concentration (c*) of the polymer units.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 15 is 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. The claim recites “A treatment method comprising applying the composition according to claim 14 to an affected part.”. However, not “treatment” was identified and no “part” was identified. The instant claims do not even require the composition be applied to a living organism. A review of the specification discloses only the treatment of skin ulcers with a composition comprising adeno-associated particles. No additional conditions were recited or contemplated with the specification. Therefore, the specification only provides written description for the treatment of skin ulcers with adeno-associated particles.
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 2-3, 5-6, and 14 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.
Regarding claims 5 and 6, the claims recite the first branch polymer unit is di, tri, or tetra branched polyethylene glycol and the second branched polymer unit is a di, tri, or tetra branched polyethylene glycol or di branched polyvinyl alcohol. However, claim 1 requires the first branched polymer unit has a total of two or more boronic acid containing groups on side chains or terminals and the second branched polymer unit has a total of two or more diol groups on side chains or terminals. However, branched polyethylene glycol or polyvinyl alcohol do not meet the limitations recited in claim 1. Clarification is requested.
Regarding claims 2-3 and 14, the claim recites the limitation "the particles", however, claim 1 does not have a positive recitation of particles. The claim recites the intended use of “for locally releasing particles”, however, no particles are actually contained with the carrier material of claim 1. There is insufficient antecedent basis for this limitation in the claims. It is suggested the claims to positively recite the presence to particles.
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.
Claim 13 is 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 1, from which 13 depends is drawn to a composition of matter. The instant claim does not recite additional components of the claim but rather recites an intended use of the composition. 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.
Claim Rejections - 35 USC § 102
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.
Claims 1,3-10, and 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sakai et al. (WO 2022/092043).
Sakai discloses a polymer material comprising a plurality of polymer units, wherein the polymer material contains a solvent, the polymer units contain first polymer units having one or more boronic-acid-containing groups in a side chain or a terminal, and second polymer units having one or more polyol groups in a side chain or a terminal, the polymer content of the polymer material being no greater than double the overlap concentration of the polymer units (abstract).
The polymer unit is preferably a hydrophilic polymer. As the hydrophilic polymer, a polymer having an affinity for water known in the art can be used, but a biocompatible polymer having a polyalkylene glycol skeleton or a polyvinyl skeleton is preferable. The polymer having a polyalkylene glycol skeleton is preferably a polymer species having a plurality of branches of a polyethylene glycol skeleton, and in particular, a bifurcated, 3-branched, 4-branched, or 8-branched polyethylene glycol is preferable .
The polyol group present in the second polymer unit is not particularly limited as long as it is a functional group having two or more hydroxyl groups (OH groups) such as a diol, but a sugar alcohol having a sugar-derived structure is preferable (section 1-1).
As the polymer unit constituting the polymer material, Terra-PEG-GDL having a polyol group (ring-opening structure of gluconolactone) at the end of 4-branched tetrapolyethylene glycol, and fluoro at the end. Terra-PEG-FPBA having a phenylboronic acid group was synthesized (section 1.1. Preparation of polymer material).
The polymer content is not more than twice the overlapping concentration (c * ) of the polymer units (≦ 2c* ). This makes it possible to reduce the osmotic pressure of the desired polymer solution to a desired range while maintaining physical properties such as viscosity (section 1-2).
Regarding claim 3, as noted in the 112(b) rejection above, particles are not included in the matrix of claim 1.
Regarding claim 4, as noted above, a polyethylene glycol or polyvinyl backbone is disclosed.
Regarding claim 5, as noted above, a bifurcated, 3-branched, 4-branched, or 8-branched polyethylene glycol.
Regarding claim 6, the second polymer can have one or more branches (section 1-1).
Regarding claim 7, the hydrophilic polymer has an average molecular weight of 5 X 103 to 1 X 105 (section 1-1).
Regarding claim 8, the boronic acid-containing group present in the first polymer unit is not particularly limited as long as it has a structure having boronic acid, but for example, arylbononic acid, preferably arylboronic which may be substituted with a halogen atom (section 1-1).
Regarding claim 9, as noted above, the polyol group present in the second polymer unit is not particularly limited as long as it is a functional group having two or more hydroxyl groups (OH groups) such as a diol, but a sugar alcohol having a sugar-derived structure is preferable.
Regarding claim 10, in addition to the first and second polymer units, a third polymer unit having one or more boronic acid-containing groups or polyol groups at the side chain or the terminal can be further used (section 1-1).
Regarding claim 13, the claim recites an intended use of the composition and therefore is not given patentable weight.
Regarding claim 14, compositions comprising the polymer matrix are disclosed (1-3).
Regarding claim 15, the composition is disclosed as a substitute of hyaluronate injections, such as use as knee cartilage (background).
Regarding claim 16-17, Sakai discloses a kit containing the polymers (section 1-3).
Sakai does not disclose the polymer material has a finite zero shear viscosity higher than 500 Pa·s. However, the polymer materials containing tetra-PEG-GDL, tetra-PEG-FPBA, and a solvent are the same as the polymer units and the carrier materials containing tetra-PEG-GDL, tetra- PEG-FPBA, and a solvent as prepared in the description of the instant application. Therefore, it is necessarily also has a finite zero shear viscosity higher than 500 Pa-s.
Claim Rejections - 35 USC § 103
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.
Claim 1-10 and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sakai et al. (WO 2022/092043) in view of Davis et al. (WO 2010019718).
The teachings of Sakai are discussed above.
Sakai does not disclose the particle size of the polymeric matrix.
Davis discloses carrier nanoparticles comprising a polymer containing a polyol coupled to a polymer containing a boronic acid, configured to present the polymer containing a boronic acid to an environment external to the nanoparticle and related compositions, methods and systems (abstract).
The polymer containing a polyol suitable to form the nanoparticles comprise polymers presenting at least a portion of the hydroxyl functional groups for a coupling interaction with at least one boronic acid of a polymer containing a boronic acid (paragraph 0051).
Structural units forming polymers containing polyols comprise monomeric polyols including polyethers include but are not limited to diols, such as polyethylene glycol, polypropylene glycol, and poly(tetramethylene ether) glycol (paragraph 0053).
The at least one boronic acid of the polymer containing a boronic acid is bound to hydroxyl groups of the polymer containing a polyol with a reversible covalent linkage (paragraph 0058).
Nanoparticles to be used in several therapeutic applications typically have a size of about 200 nm or below, and the ones used, in particular, for delivery associated to cancer treatment typically have a diameter from about 1 to about 100 nm (paragraph 0041).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have selected a particle size such as that disclosed by Davis in the composition of Sakai since they may utilize an array of different strategies to package, transport, and deliver an agent to specific targets, such as carrying and delivering a wide range of molecules of various sizes, dimensions, and chemical nature to predetermined targets.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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