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 .
Receipt is acknowledged for IDS filed 01/15/2025 and 10/05/2026.
Claims 1-20 are pending.
Priority
This application is a 371 of PCT/US2023/071909 filed 08/09/2023 which claims benefit of 63/396,367 filed 08/09/2022.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The browser executable code, in the section on references are active executable codes embedded in the specification disclosure. While it is in the section of references, the reference section is part of the disclosure and not submitted in 1449.
Correction is respectfully requested.
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 14-20 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 14 recites “…of any one of claim 1 …” in an attempt to construct the claim as multiple dependent form. However, only claim 1 is named and the other half of the “any one of” is not identified. It is unclear what the other claims of the “any one of” is.
Claim 14 is examined as method of making the composition of claim 1.
Correction is respectfully requested.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6 and 8-9 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Khademosseini et al. (US 20180360930 A1) as evidenced by Inmaculada Aranaz et al. “Chitosan: An Overview of Its Properties and Applications” in Polymers, 2021, 13, 3256, pp 1-27.
For claim 1, Khademosseini discloses shear thinning composition that comprises gelatin or gelatin derivative and silicate nanoparticles/silicate nanoplatelets (see the whole document with emphasis on at least paragraphs [0019]-[0023]) and the shear thinning composition further comprises chitosan (paragraphs [0074], [0140], [0172], [0189], [0198]) and the shear thinning composition is loaded into a catheter or syringe for delivery to the site of treatment (paragraphs [0017], [0018], [0065], [0068], [0185], [0188], claims 46, 50). Chitosan is a cationic polymer as evidenced by Inmaculada Aranaz (see the whole document with emphasis on sections 2.2 (page 3) and section 7 (page 16)).
For claim 2, the silicate nanoparticle/nanoplatelet in Khademosseini has diameter ranging from 5 nm to 60 nm or 20 nm to 30 nm (paragraphs [0024], [0127], [0128], claims 76-78) with this range being a species of the claimed range of 5 nm to 150 nm.
For claims 3-5, the silicate nanoparticles in Khademosseini’s is present at 0.5% to about 30% (paragraph [0020]). In an embodiment, the shear thinning comparison comprises about 3% to about 11% gelatin (paragraph [0019]), 6.75 wt% gelatin and about 2.25 wt% silicate nanoparticles/nanoplatelets or about 2.25 wt% gelatin and about 6.75 wt% silicate nanoparticles/nanoplatelets (paragraph [0131]). For the gelatin, about 3% to about 11%, 6.75% and 2.25 % and are all points within the claimed range of 1% to 30% of claim 3 and is not more than 18% as claimed in claim 5. For the silicate nanoparticles/nanoplatelets, the 6.75 wt% silica nanoparticles/nanoplatelets is a specific point within the claimed range of from 5% to 45% of Claim 3 and is less than or not more than 9 wt% of claim 4. In another embodiment, cationic polymer chitosan is present at 8% (paragraphs [0074], [0140]) and the 8% is at least 5% and less than 10% as claimed in claim 3.
For claim 6, the zeta potential of silicate nanoparticles/nanoplatelets of Khademosseini is -39 mV (paragraph [0222]) which is at least -10 mV claimed in claim 6.
For claim 8, the shear thinning composition of Khademosseini comprises therapeutic agent selected from the group consisting of antimicrobial agent, antibacterials agent, antifungal agent, anti-inflammatory agent, antiviral agent, regenerative agent, hemostatic agent, and magnetic agent (paragraphs [0011], [0012], [0016], [0112], [0116], claims 28, 30, 37).
For claim 9, the shear thinning composition Khademosseini is loaded into a catheter or syringe for delivery to the site of treatment (paragraphs [0017], [0018], [0065], [0068], [0185], [0188], claims 46, 50).
Therefore, Khademosseini as evidenced by Inmaculada Aranaz teaches all the elements of claims 1-6 and 8-9.
Claim(s) 1 and 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sadaf Samimi Gharaie et al. “Smart Shear-Thinning Hydrogel as Injectable Drug Delivery Systems” in Polymers 2018, 10, 1317, pp 1-15, provided by applicant in 1449.
For claim 1, Gharaie discloses shear thinning composition comprising gelatin and laponite for localized drug delivery, and chitosan and poly N-isopropylacrylamide-co-Acrylic acid (PNIPAM) particles to the shear-thinning gel to render it pH-responsive, and silicate nanoplatelets (see the whole document with emphasis on the Title and abstract). Because the hydrogel is an injectable drug delivery system, it flows that the hydrogel is biocompatible.
For claim 7, the composition of Gharaie further undergoes degradation and selling studies in buffer solution in which electrostatic attraction between gelatin and laponite was detected (see the whole document with emphasis on page 11 of 15) with the buffer meeting the imitation of pH adjusting agent of claim 7.
For claim 8, the composition of Gharaie comprises Rhodamine B (Rd) which is released at various pH (see the whole document with emphasis on the abstract and section 2.1 on page 2 of 15) with the Rhodamine B (Rd) meeting the limitation of therapeutic agent of claim 8.
Gharaie teaches claims 1 and 7-8.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1, 7 and 10-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khademosseini et al. (US 20180360930 A1) as evidenced by Inmaculada Aranaz et al. “Chitosan: An Overview of Its Properties and Applications” in Polymers, 2021, 13, 3256, pp 1-27, as applied to claim 1.
Khademosseini has been describe above to anticipate claim 1.
Claims 7 and 10 and 14 depend on claim 1. Claims 11-13 depend directly or indirectly on claim 10. Claims 15-20 depend directly or indirectly on claim 14.
Khademosseini has been described above to disclose shear thinning composition comprising silicate nanoparticles/nanoplatelets, gelatin and chitosan cationic polymer and the shear thinning composition is preloaded into a catheter for delivery of the composition to site needing treatment such as in the treatment of vascular disorders, cancers, infections, abscesses, and fistulas (see the whole document with emphasis on the abstract, paragraphs [0011], [0012], [0016]-[0024], [0065], [0068], [0074], [0140], [0112], [0116], [0172], [0189], [0198], [0185], [0188], [0127], [0128], [0131], [0222], claims 46, 50, 76-78).
For claim 7, Khademosseini differs from claim 7 because Khademosseini does not specifically state that the shear thinning composition contains pH adjusting agent or viscosity adjusting agent. However, Khademosseini teaches that its composition has viscosities (paragraph [0123]) such as viscosity as a function of injection rate (shear rate) (paragraph [0072]), viscosity that changes (paragraphs [0201], [0203]) and viscosity that changes according to temperature changes and applied torques (paragraph [0225]). These conditions that influence/affect or effect viscosity can be considered viscosity adjusting agents. Therefore, before the effective date of the invention the artisan would reasonably expect these conditions affecting the viscosity would predictably affect the viscosity of the shear thinning composition as viscosity adjusting agents.
For claim 10, Khademosseini delivers the shear thinning composition to sites needing treatment such as vascular disorders, cancers, infections, abscesses, and fistulas using catheter preloaded with the shear thinning composition. Khademosseini differs from claim 10 in that Khademosseini does not specifically state applying force to second end of the vessel. However, the vessel in claim 10 is a catheter according to instant claim 13. Khademosseini uses catheter for administering the shear thinning composition to the treatment such, hence preselected. Hence, the catheter of Khademosseini, which is the claimed vessel, would also have two ends and the delivery or application of the composition would require application of force because Khademosseini teaches applying force/pressure to allow the composition to flow during application (paragraphs [0049], [0116], [0136], [0228], claims 1 and 105). Therefore, before the effective date of the invention, the artisan would reasonably expect that application of pressure/force to the end of the catheter would effectively predictably inject the composition through the catheter onto the preselected site.
For claim 11, the site of application such as aneurysmal site is in vivo.
For claim 12, Khademosseini contemplates treating traumatic aneurysm (claim 3, 11, 16, paragraph [0005]-[0007], [0109], [0142]).
For claim 13 and 18, Khademosseini teaches applying the shear thinning composition with catheter (paragraphs [0017], [0018], [0065], [0068], [0185], [0188], claims 46, 50).
For claim 14, Khademosseini disclose shear thinning composition comprising silicate nanoparticles/nanoplatelets, gelatin and chitosan cationic polymer and the shear thinning composition is preloaded into a catheter for delivery of the composition to site needing treatment such as in the treatment of vascular disorders, cancers, infections, abscesses, and fistulas (see the whole document with emphasis on the abstract, paragraphs [0011], [0012], [0016]-[0024], [0065], [0068], [0074], [0140], [0112], [0116], [0172], [0189], [0198], [0185], [0188], [0127], [0128], [0131], [0222], claims 46, 50, 76-78).
Khademosseini does not specifically state that the silicate nanoparticles/nanoplatelets, gelatin and chitosan cationic polymer are combined to form the shear thinning composition. However, because Khademosseini discloses shear thinning composition comprising silicate nanoparticles/nanoplatelets, gelatin and chitosan cationic polymer, it would be inherently obvious that the components of the shear thinning compositions have been combined to from the composition. Silicate nanoparticles/nanoplatelets, gelatin and chitosan cationic polymer are inherently combined in the shear thinning composition of Khademosseini.
For claim 15, it would be predictable that the surface properties and/or median diameter relative amounts and/or the components, Silicate nanoparticles/nanoplatelets, gelatin and chitosan cationic polymer, of the shear thinning composition of Khademosseini have been selected to tune or modulate one or more of the properties because the combination of these components resulted in the shear thinning composition in Khademosseini.
For claim 16, the composition of Khademosseini is a shear thinning composition such that the method form combining the components of the composition, Silicate nanoparticles/nanoplatelets, gelatin and chitosan cationic polymer, would have been selected such as to form the composition having desired flow rate produced under an injection force (see paragraph [0206], [0231]-[0232]). There is no factual showing that the flow rate of 2 mL/min provides unexpected results.
Form claim 17, the zeta potential of silicate nanoparticles/nanoplatelets of Khademosseini is -39 mV (paragraph [0222]) which is a point within the claimed range of -30 mV to -40 mV.
For claim 19, the silicate nanoparticle/nanoplatelet in Khademosseini has diameter ranging from 5 nm to 60 nm or 20 nm to 30 nm (paragraphs [0024], [0127], [0128], claims 76-78) with this range being a species of the claimed range of 5 nm to 150 nm; the silicate nanoparticles/nanoplatelets at 6.75 weight% (paragraph [0131]) is a specific point within the claimed range of from 5% to 45%; cationic polymer chitosan is present at 8% (paragraphs [0074], [0140]) and the 8% is at least 5% and less than 10% as claimed; gelatin at about 3% to about 11%, 6.75% and 2.25 % (paragraphs [0019], [0131]) are all points within the claimed range of 1% to 30%.
For claim 20, the silicate nanoparticles/nanoplatelets at 6.75 weight% (paragraph [0131]) is not more than 9 wt% as claimed; gelatin at about 3% to about 11%, 6.75% and 2.25 % (paragraphs [0019], [0131]) are all not more than 18% as claimed.
Therefore, Khademosseini as evidenced by Inmaculada Aranaz renders claims 7 and 10-20 prima facie obvious.
Claim Objections
Claims 18 and 19 are objected to because of the following informalities:
Claim 18 does not end in a period.
Claim 19 has an internal period after 150 nm in line 3 of the claim.
MPEP 608.01(m) [R-10.2019] requires that a claim must begin with a capital letter and end with a period and that periods may not be used elsewhere in the claims except for abbreviations. See Fressola v.Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). “Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation,” see 37 CFR 1.75(i).
Appropriate correction is required.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
