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 Claims
The amendments and arguments filed on 12/29/2025 are acknowledged and have been fully considered. Claims 1,11, 32, and 36 have been amended. Claims 20-22,32-36 and 43 have been withdrawn. Claims 5, 8-10, 12-13, 15-18, 23-31, 37-42 have been canceled. Applicants’ amendments are supported by the originally filed disclosure.
No new matter has been added.
Thus, claims 1-4, 6-7, 11, 14, and 19 will be examined on the merits herein.
Rejections Maintained and Made Again in view of Applicant’s Amendments
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(s) 1-4, 6-7, 11, 14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Le Couteur et al (US 20210161894 A1; also available as WO 2019109124 A1) in view of Chen (US 20110014296 A1).
Le Couteur discloses compositions comprising conjugates of quantum dots and a therapeutic are used to modulate the fenestration porosity, frequency or diameter of liver endothelial cells (abstract). Le Couteur teaches the quantum dot may be an Ag2S, InP/ZnS or CuInS/ZnS quantum dot ([0008]). Le Couteur discloses the average diameter of the quantum dot may be about 2 nm, 3 nm, 4 nm, 5 nm, 6 nm, 7 nm, 8 nm, 9 nm, 10 nm, 11 nm, 12 nm, 13 nm, 14 nm, 15 nm, 16 nm, 17 nm, 18 nm or 20 nm ([0010]). Le Couteur teaches the subject may be an aged subject or a subject with an age-related disease or condition ([0018]). The age-related disease or condition may be selected from type 2 diabetes, insulin resistance, fatty liver, liver fibrosis and liver cirrhosis ([0018]). Le Couteur discloses standard conjugation chemistry may be used for conjugation of the functionalised Ag2S QDs to a therapeutic ([0110]). Preparation of a therapeutic-QD conjugate includes the steps of providing a QD, providing a coupling agent, providing a therapeutic or derivative thereof and incubating the mixture to form a crude therapeutic-QD conjugate ([0110]). Alternatively the functionalised Ag2S QDs may be reacted with a coupling agent before the addition of the therapeutic ([0110]). Le Couteur discloses the QDs, therapeutics and therapeutic conjugates described herein may be administered as a formulation comprising a pharmaceutically effective amount of the compound in association with one or more pharmaceutically acceptable excipients including carriers, vehicles and diluents ([0138]). The term ‘excipient’ herein means any substance, not itself a therapeutic agent, used as a diluent, adjuvant, or vehicle for delivery of a therapeutic agent to a subject or added to a pharmaceutical composition to improve its handling or storage properties or to permit or facilitate formation of a solid dosage form such as a tablet, capsule, or a solution or suspension suitable for oral, parenteral, intradermal, subcutaneous, or topical application ([0138]). Le Couteur discloses polymers ([0138]). Le Couteur teaches oral formulation ([0138] - [0141]).
However, it does not expressly disclose including a peptide or protein such as insulin, growth hormone, fibroblast growth factor, a glucagon-like peptide nor polymers such as chitosan, galactose or glucose. Chen et al remedy this deficiency.
Chen discloses a nanodevice and method for in vivo monitoring and release of drugs (see entire document, for instance, abstract). Chen teaches quantum dots (see entire document, for instance, [0007]- [0008]). Chen discloses compound or composition useful for the treatment and/or prevention of conditions in a variety of therapeutic areas and can be administered to a living organism, especially animals such as mammals, particularly humans ([0040]). The drug useful herein includes, but is not limited to, peptide analogs such as exenatide, liraglutide, hormone such as insulin, epidermal growth factor (EGF) ([0040]). Chen teaches polymeric material that may be used for forming the core phase of the nanosphere includes chitosan (see entire document, for instance, [0038]). Chen discloses encapsulating a drug in the polymeric (see entire document, for instance, [0036]). Chen teaches oral administration ([0052]).
It would have been obvious to utilize chitosan as taught in Chen in the composition of Le Couteur. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention to use Ag2S quantum dots tether the insulin to biopolymers such as chitosan for the targeted delivery of the drugs for oral delivery. One would have been motivated to do so since it is an easier administration of medication.
Claim 2 recites that the peptide or protein is less than about 30 kDa in size. Looking to Applicants’ instant specification, the limitation appears to be a property that is tethered to and definitive of the instantly encompassed peptide or protein discussed therein (see Spec., pg. 4 line [00014] and pg. 27, line [000101]). As such, consistent with MPEP §2111.01(IV), §2112.01(I) and (II), and §2173.05(g), the Examiner submits that where Applicants’ defining peptide or protein are disclosed in the prior art, the recited limitation of claim 2, will also be considered to be met.
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
New Grounds of Rejection
Claim(s) 1-4, 6-7, 11, 14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Le Couteur et al (US 20210161894 A1; also available as WO 2019109124 A1) in view of Sung et al (US8137697B1).
The teachings of Le Couteur et al have been set forth above. Le Couteur discloses compositions comprising conjugates of quantum dots and a therapeutic are used to modulate the fenestration porosity, frequency or diameter of liver endothelial cells (abstract). Le Couteur teaches the quantum dot may be an Ag2S, InP/ZnS or CuInS/ZnS quantum dot ([0008]). Le Couteur discloses the average diameter of the quantum dot may be about 2 nm, 3 nm, 4 nm, 5 nm, 6 nm, 7 nm, 8 mn, 9 nm, 10 nm, 11 nm, 12 nm, 13 nm, 14 nm, 15 nm, 16 nm, 17 nm, 18 nm or 20 nm ([0010]). Le Couteur discloses polymers ([0138]). Le Couteur teaches oral formulation ([0138] - [0141]). Le Couteur teaches the subject may be an aged subject or a subject with an age-related disease or condition ([0018]). The age-related disease or condition may be selected from type 2 diabetes, insulin resistance, fatty liver, liver fibrosis and liver cirrhosis ([0018]).
However, it does not expressly disclose including a peptide or protein such as insulin, growth hormone, fibroblast growth factor, a glucagon-like peptide nor polymers such as chitosan, galactose or glucose. Sung et al remedy this deficiency.
Sung discloses a pharmaceutical composition of nanoparticles encapsulating a therapeutically effective amount of at least on bioactive agent, each nanoparticle comprising: a first component of a positively charged chitosan, a second component of a negatively charged substrate that complexes with said first component, at least one quantum dot in a core portion of said nanoparticles, and said at least one bioactive agent, wherein said bioactive agent is encapsulated within said nanoparticles (see entire document, for instance, claim 1). Sung teaches delivery of the biodegradable nanoparticles that encapsulate at least one bioactive agent of protein/peptides (see entire document, for instance, column 2, lines 57-59). Sung discloses bioactive agent comprises insulin or insulin analog (see entire document, for instance, claim 4). Sung teaches quantum dot (see entire document, for instance, column 6 lines 32-39). Sung discloses advantage of administering a protein or peptide via a biodegradable nanoparticle capable of producing an immune response is the ability to cause the immunogen to be effectively presented to the animal or human over an extended period of time (Column 28, lines19-24). Sung teaches chitosan blend serves as a stable polymer that coats on a quantum dot (column 37, lines 63-64).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention to utilize the Ag2S quantum dots of Le Couteur in the composition of Sung et al. One would have been motivated to do so in order to use Ag2S quantum dots tether the insulin to biopolymers such as chitosan for the targeted delivery of the drugs for a stable oral delivery.
Claim 2 recites that the peptide or protein is less than about 30 kDa in size. Looking to Applicants’ instant specification, the limitation appears to be a property that is tethered to and definitive of the instantly encompassed peptide or protein discussed therein (see Spec., pg. 4 line [00014] and pg. 27, line [000101]). As such, consistent with MPEP §2111.01(IV), §2112.01(I) and (II), and §2173.05(g), the Examiner submits that where Applicants’ defining peptide or protein are disclosed in the prior art, the recited limitation of claim 2, will also be considered to be met.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET JOSEPH whose telephone number is (571)270-1372. The examiner can normally be reached Monday and Thursday 0730-1730 Eastern.
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/JANET JOSEPH/Patent Examiner, Art Unit 1611
/TREVOR LOVE/Primary Examiner, Art Unit 1611
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