DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 19-20, 23, 25-28, and 33-40 are pending and represent all claims currently under consideration.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/29/2025 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks (pages 5-7) filed 09/29/2025, with respect to the rejection of claims 19-20, 23, 25-28, and 33-39 under 35 U.S.C. 103 over Nazhat, Jiang, and Santra have been fully considered and are persuasive due to the amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection of claims 19-20, 23, 25-28, and 33-40 is made in view of Nazhat, Kaplan, Jiang, and Santra.
New 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.
Claims 19, 28, 33, 37, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Nazhat (US 20140086874 A1; IDS reference, 09/28/2022), further in view of Kaplan (US 10933173 B2). Nazhat was previously cited by the Examiner.
Regarding claim 19, Nazhat teaches a biomaterial comprising a polypeptide fraction (Nazhat, claim 1) which can be hydrophilic peptides isolated from silk fibroin (i.e., “Cs”; Nazhat, page 1, paragraph 0011), and further teaches silk fibroin (i.e., “SF”) can be used to form a hydrogel (Nazhat, page 3, paragraph 0028). Nazhat does not specifically state that the hydrophilic peptide fraction has a higher hydrophilic content than pure silk fibroin as stated in claim 1, but Nazhat teaches the hydrophilic peptide fraction is digested from silk fibroin using alpha-chymotrypsin and isolated (Nazhat, page 3, paragraph 0028), matching the protocol described in the specification to be used to achieve the claimed “Cs” polypeptide fraction (page 3, line 10). Therefore it would be reasonable to expect the hydrophilic peptides taught by Nazhat to have the same property. Nazhat does not specify a microneedle which is made from the biomaterial, but does teach the biomaterial can be used as a medical device (Nazhat, page 3, paragraph 0031). Kaplan teaches a microneedle device that includes a microneedle body extending from a base to a penetrating tip formed from a silk fibroin based material (i.e., a microneedle made from a silk-based biomaterial; Kaplan, abstract), and describes the microneedle device as a biomedical device (Kaplan, column 27, lines 31-33).
Nazhat and Kaplan are considered to be analogous to the claimed invention, because both are in the same field of silk fibroin based biomaterials. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the silk biomaterial of Nazhat as a microneedle device as taught by Kaplan, because Nazhat teaches the use of the silk biomaterial as a medical device, and Kaplan teaches silk fibroin microneedles are highly stable and implantable and can be modulated to control the rate of active agent delivery (Kaplan, abstract).
Regarding claim 28, Nazhat and Kaplan together teach all the elements of the current invention as applied to claim 19. Nazhat further teaches the biomaterial may additionally include therapeutic agents (Nazhat, page 3, paragraph 0024).
Regarding claim 33, Nazhat and Kaplan together teach all the elements of the current invention as applied to claim 19. Kaplan further teaches the penetrating tip can have a diameter ranging from about 200 nm to about 30 micrometers (Kaplan, column 2, lines 37-42), which lies within the claimed range. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the silk biomaterial of Nazhat as a microneedle device with the diameter size as taught by Kaplan, because Nazhat teaches the use of the silk biomaterial as a medical device, and Kaplan teaches silk fibroin microneedles with the claimed tip diameter are highly stable and implantable and can be modulated to control the rate of active agent delivery (Kaplan, abstract).
Regarding claim 37, Nazhat and Kaplan together teach all the elements of the current invention as applied to claim 33. Kaplan further teaches the silk fibroin microneedles can comprise at least one active agent which can be proteins, peptides, and small molecules (Kaplan, column 10, lines 44-60). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the silk biomaterial of Nazhat as a microneedle device as taught by Kaplan with an active agent, because Nazhat teaches the use of the silk biomaterial as a medical device, and Kaplan teaches such silk fibroin microneedles to be highly stable and implantable and can be modulated to control the rate of active agent delivery (Kaplan, abstract).
Regarding claim 40, Nazhat and Kaplan together teach all the elements of the current invention as applied to claim 19. Kaplan further teaches the silk fibroin microneedles are fabricated using microneedle molds (Kaplan, column 4, lines 15-41). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the silk biomaterial of Nazhat as a microneedle device as taught by Kaplan as using the same method of fabrication, because Nazhat teaches the use of the silk biomaterial as a medical device, and Kaplan teaches such silk fibroin microneedles to be highly stable and implantable and can be modulated to control the rate of active agent delivery (Kaplan, abstract).
Claims 20, 23, 34-35, and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Nazhat (US 20140086874 A1; IDS reference, 09/28/2022) and Kaplan (US 10933173 B2) as applied to claims 19, 28, 33, 37, and 40, and further in view of Jiang (US 20110052695 A1). Nazhat and Jiang were previously cited by the Examiner.
Regarding claim 20, Nazhat and Kaplan together teach all the elements of the current invention as applied to claim 19. As above, Nazhat teaches a mixture of silk fibroin and silk fibroin polypeptides (Nazhat, page 11, paragraph 0111, “example 10”), but does not teach a specific ratio of the silk fibroin peptide (i.e., Cs) to silk fibroin protein (i.e., SF). Jiang teaches hydrogels comprising pure silk fibroin with an amphiphilic peptide (Jiang, claim 1) and further teaches that one of ordinary skill in the art would select suitable amounts of silk fibroin and peptide based on several factors including the desired kinetics for delivery (Jiang, page 10, paragraph 0085). Jiang does not specifically teach a dry weight ratio between the two components, but does teach a wide ranging molar ratio of peptide to silk fibroin of from 100 to 0.01 (Jiang, page 9, paragraph 0078). Based on the molecular weights provided by Nazhat of approximately 350 kDa for silk fibroin (Nazhat, page 10, paragraphs 0106) and approximately 2-10 kDa for the peptides (Nazhat, page 1, paragraph 0011), the molar ratio taught by Jiang would result in a potential weight ratio of approximately 0.005:99 to approximately 63:37, which encompasses the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Nazhat, Kaplan, and Jiang are all considered to be analogous to the claimed invention, because all are in the same field of silk fibroin based biomaterials. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Nazhat and Kaplan to have utilized a specific ratio of peptide to silk fibroin protein, because Nazhat teaches it will be apparent to those skilled in the art to use different relative concentrations (Nazhat, page 7, paragraph 0089), and Jiang teaches the amounts can affect several factors such as kinetic release, biodegradation, and absorption (Jiang, page 10, paragraph 0085).
Regarding claim 23, Nazhat and Kaplan together teach all the elements of the claimed invention as applied to claim 19. As above, Nazhat does not teach a specific amount of the silk fibroin. Jiang, however, exemplifies a composition comprising 25% of the silk component by weight (Jiang, page 43, table 11, “6PUR25”), which lies within the claimed range of at least 21% for the dry weight percentage. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Nazhat and Kaplan to have utilized a specific amount of silk fibroin protein, because Nazhat teaches it will be apparent to those skilled in the art to use different relative concentrations (Nazhat, page 7, paragraph 0089), and Jiang teaches the amounts can affect several factors such as kinetic release, biodegradation, and absorption (Jiang, page 10, paragraph 0085).
Regarding claim 34, Nazhat, Kaplan, and Jiang together teach all the elements of the claimed invention as applied to claim 20. As above, Kaplan teaches the penetrating tip can have a diameter ranging from about 200 nm to about 30 micrometers (Kaplan, column 2, lines 37-42), which lies within the claimed range. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the silk biomaterial of Nazhat as a microneedle device with the diameter size as taught by Kaplan, because Nazhat teaches the use of the silk biomaterial as a medical device, and Kaplan teaches silk fibroin microneedles with the claimed tip diameter are highly stable and implantable and can be modulated to control the rate of active agent delivery (Kaplan, abstract).
Regarding claim 35, Nazhat, Kaplan, and Jiang together teach all the elements of the claimed invention as applied to claim 23. As above, Kaplan teaches the penetrating tip can have a diameter ranging from about 200 nm to about 30 micrometers (Kaplan, column 2, lines 37-42), which lies within the claimed range. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the silk biomaterial of Nazhat as a microneedle device with the diameter size as taught by Kaplan, because Nazhat teaches the use of the silk biomaterial as a medical device, and Kaplan teaches silk fibroin microneedles with the claimed tip diameter are highly stable and implantable and can be modulated to control the rate of active agent delivery (Kaplan, abstract).
Regarding claim 38, Nazhat, Kaplan, and Jiang together teach all the elements of the claimed invention as applied to claim 34. As above, Kaplan teaches the silk fibroin microneedles can comprise at least one active agent which can be proteins, peptides, and small molecules (Kaplan, column 10, lines 44-60). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the silk biomaterial of Nazhat as a microneedle device as taught by Kaplan with an active agent, because Nazhat teaches the use of the silk biomaterial as a medical device, and Kaplan teaches such silk fibroin microneedles to be highly stable and implantable and can be modulated to control the rate of active agent delivery (Kaplan, abstract).
Regarding claim 39, Nazhat, Kaplan, and Jiang together teach all the elements of the claimed invention as applied to claim 35. As above, Kaplan teaches the silk fibroin microneedles can comprise at least one active agent which can be proteins, peptides, and small molecules (Kaplan, column 10, lines 44-60). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the silk biomaterial of Nazhat as a microneedle device as taught by Kaplan with an active agent, because Nazhat teaches the use of the silk biomaterial as a medical device, and Kaplan teaches such silk fibroin microneedles to be highly stable and implantable and can be modulated to control the rate of active agent delivery (Kaplan, abstract).
Claims 25-27 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Nazhat (US 20140086874 A1; IDS reference, 09/28/2022) and Kaplan (US 10933173 B2) as applied to claims 19, 28, 33, 37, and 40, further in view of Santra (US 20190082615 A1). Nazhat and Santra were previously cited by the Examiner.
Regarding claim 25, Nazhat and Kaplan together teach all the elements of the current invention as applied to claim 19. Kaplan teaches the penetrating tips can have a dimension based upon various factors including the type of biological barrier to be penetrated (Kaplan, column 19, lines 59-64). Santra teaches a microneedle device comprising a base and needle tip (Santra, figures 3A and 3B) for delivery of a composition through the microneedles to the phloem of a plant (Santra, abstract). Santra teaches the microneedles may penetrate the effective area of the plant between 1-5 mm deep into the phloem tissue (Santra, page 2, paragraph 0036) and teaches delivery of a composition through the microneedles to the phloem of a plant (Santra, abstract), suggesting this length is suitable.
Nazhat, Kaplan, and Santra are all considered to be analogous to the claimed invention, because all are in the same field of microneedle delivery of therapeutics. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biomaterial of Nazhat and Kaplan to use the microneedle length taught by Santra, because Kaplan teaches penetrating tips can have a dimension based upon the type of biological barrier to be penetrated (Kaplan, column 19, lines 59-64), and Nazhat teaches injection to obtain a less invasive procedure (Nazhat, page 10, paragraph 0103), while Santra teaches injection with this length to the phloem to be minimally-invasive with efficient delivery of therapeutic cargo (Santra, page 2, paragraph 0035).
Regarding claim 26, Nazhat and Kaplan together teach all the elements of the current invention as applied to claim 19. As above, Kaplan teaches the penetrating tip can have a diameter ranging from about 200 nm to about 30 micrometers (Kaplan, column 2, lines 37-42), but does not specify penetration of a xylem or phloem. Santra teaches the composition can be delivered to either the phloem or the xylem (Santra, claim 9) and teaches a tip diameter of approximately 20 micrometers (Santra, page 4, paragraph 0063). According to the instant specification, a penetrating dip of less than 35 micrometers is appropriate (specification, page 9, line 15), so it would be reasonable to expect a tip that falls within this size range would not disrupt the flow of material in the xylem or phloem as claimed. As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biomaterial of Nazhat and Kaplan to use the microneedle diameter taught by Santra, because Nazhat teaches injection to obtain a less invasive procedure (Nazhat, page 10, paragraph 0103) and Santra teaches this diameter to be minimally-invasive with efficient delivery of therapeutic cargo (Santra, page 2, paragraph 0035).
Regarding claim 27, Nazhat, Kaplan, and Santra together teach all the elements of the current invention as applied to claim 26. As above, Kaplan teaches the penetrating tip can have a diameter ranging from about 200 nm to about 30 micrometers (Kaplan, column 2, lines 37-42), which lies within the claimed range. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the silk biomaterial of Nazhat as a microneedle device with the diameter size as taught by Kaplan, because Nazhat teaches the use of the silk biomaterial as a medical device, and Kaplan teaches silk fibroin microneedles with the claimed tip diameter are highly stable and implantable and can be modulated to control the rate of active agent delivery (Kaplan, abstract).
Regarding claim 36, Nazhat, Kaplan, and Santra together teach all the elements of the current invention as applied to claim 27. As above, Kaplan teaches the silk fibroin microneedles can comprise at least one active agent which can be proteins, peptides, and small molecules (Kaplan, column 10, lines 44-60). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the silk biomaterial of Nazhat as a microneedle device as taught by Kaplan with an active agent, because Nazhat teaches the use of the silk biomaterial as a medical device, and Kaplan teaches such silk fibroin microneedles to be highly stable and implantable and can be modulated to control the rate of active agent delivery (Kaplan, abstract).
Conclusion
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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