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, 25-28, 33, and 36-48 are pending and represent all claims currently under consideration.
Response to Amendment
The amendment filed 06/26/2026 has been entered.
Claims 20, 23, and 34-35 were canceled. Claims 19, 27, and 38-39 were amended. Claims 41-48 were newly added. No new material was added.
The previous rejections of claims 20, 23, and 34-35 are moot, because the claims are canceled.
The previous rejections of claims 19, 25-28, 33, 36-40 under 35 U.S.C. 103 have been overcome due to the amendment.
Claims 19, 25-28, 33, and 36-48 are newly rejected under 35 U.S.C. 103.
Response to Arguments
Applicant’s arguments, see Remarks (pages 6-7), filed 06/26/2026, with respect to the rejection(s) of claim(s) 19, 25-28, 33, 36-40 under 35 U.S.C. 103 over Nazhat and Kaplan have been fully considered and are persuasive due to the amendment. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nazhat, Kaplan, Jiang, and Santra.
Applicant argues that Nazhat and Kaplan do not disclose or suggest a dry weight ratio of Cs:SF of between 10:90 and 30:70 (Remarks, page 6). This argument is not persuasive, because Jiang teaches an embodiment having a molar ratio of peptide to silk fibroin of about 10:1 (Jiang, page 9, paragraph 0080). 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 of about 10:1 taught by Jiang would result in a potential weight ratio of approximately 5:95 to 22:78, which overlaps the claimed range of between 10:90 and 30:70. 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).
Applicant argues that as Jiang merely contemplated different ratios and did not test or disclose advantages to the broad range of ratios, it is not possible to show how the ranges of the present application compare. Applicant further states that the Examples in the present application show advantages to the range of 10:90 to 30:70 as compared to other ratios within the range contemplated in Jiang, and specifically that Figure 11A shows a ratio of 40:60 results in microneedle rupturing, while the recited ratio improves the microneedle’s stiffness (Remarks, page 7). This argument is not persuasive, because Jiang teaches a specific embodiment having a molar ratio of peptide to silk fibroin of about 10:1 (Jiang, page 9, paragraph 0080), which as discussed above would result in a potential weight ratio of approximately 5:95 to 22:78, overlapping the claimed range of between 10:90 and 30:70. While the data provided by the Applicant shows a beneficial effect over a ratio of 40:40, the data does not demonstrate an unexpected effect over the range of Jiang.
Applicant argues that the range taught by Jiang is so broad in light of the dissimilar characteristics of the members of the range as to not invite optimization by one of skill in the art (Remarks, page 7). This argument is not persuasive, because Jiang teaches specific embodiments within the referenced range, including a molar ratio of peptide to silk fibroin of about 10:1 (Jiang, page 9, paragraph 0080).
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, 27-28, 33, 36-37, 40-45, and 48 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) and Jiang (US 20110052695 A1). The references were 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 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 molar ratio of peptide to silk fibroin of about 10:1 (Jiang, page 9, paragraph 0080). 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 of about 10:1 taught by Jiang would result in a potential weight ratio of approximately 5:95 to 22:78, which overlaps the claimed range of between 10:90 and 30:70. 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 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). It would have also 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 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 27, Nazhat, Kaplan, and Jiang together teach all the elements of the current invention as applied to claim 19. 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 overlaps within 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). 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 28, Nazhat, Kaplan, and Jiang 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, Kaplan, and Jiang 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 36, Nazhat, Kaplan, and Jiang 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).
Regarding claim 37, Nazhat, Kaplan, and Jiang 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, Kaplan, and Jiang 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).
Regarding claim 41, Nazhat, Kaplan, and Jiang 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 molar ratio of peptide to silk fibroin of about 10:1 (Jiang, page 9, paragraph 0080). 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 of about 10:1 taught by Jiang would result in a potential weight ratio of approximately 5:95 to 22:78, which overlaps the claimed range of between 20:80 and 30:70. 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). 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 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 42, Nazhat, Kaplan, and Jiang 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 molar ratio of peptide to silk fibroin of about 10:1 (Jiang, page 9, paragraph 0080). Based on the molecular weights provided by Nazhat of approximately 350 kDa for silk fibroin (Nazhat, page 10, paragraph 0106) and approximately 2-10 kDa for the peptides (Nazhat, page 1, paragraph 0011), the molar ratio of about 10:1 taught by Jiang would result in a potential weight ratio of approximately 5:95 to 22:78, which includes the claimed amount of 20:80. 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 optimized the teachings of Nazhat 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 a ratio including the claimed amount, and states that the amounts can affect several factors such as kinetic release, biodegradation, and absorption (Jiang, page 10, paragraph 0085).
Regarding claim 43, Nazhat, Kaplan, and Jiang 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 percent of the silk fibroin peptide (i.e., Cs) to silk fibroin protein (i.e., SF). Jiang teaches a polymer which can be silk fibroin (Jiang, page 10, paragraph 0084) in at least about 80% (w/w). As above, Jiang teaches hydrogels comprising pure silk fibroin with an amphiphilic peptide (Jiang, claim 1), suggesting the other 20% w/w would be contributed by the peptide, resulting in weight percentages within the claimed range. As above, it would have also 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 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 44, Nazhat, Kaplan, and Jiang 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 percent of the silk fibroin peptide (i.e., Cs) to silk fibroin protein (i.e., SF). Jiang teaches a polymer which can be silk fibroin (Jiang, page 10, paragraph 0084) in at least about 80% (w/w). As above, Jiang teaches hydrogels comprising pure silk fibroin with an amphiphilic peptide (Jiang, claim 1), suggesting the other 20% w/w would be contributed by the peptide, resulting in weight percentages 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 teachings of Nazhat 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 45, Nazhat, Kaplan, and Jiang together teach all the elements of the current invention as applied to claim 19. Nazhat teaches silk fibroin comprises a heavy chain with a molecular weight of 350 kDa, which contributes about 90% of the total weight of SF and forms the primary structure (Nazhat, page 10, paragraph 0106), which would suggest the total weight of SF would be approximately 390 kDa as claimed.
Regarding claim 48, Nazhat, Kaplan, and Jiang together teach all the elements of the current invention as applied to claim 19. As above, Nazhat teaches 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). Kaplan further teaches a plurality of microneedles can be arranged as an array (Kaplan, column 20, lines 23-25), and demonstrates the needles as an array on a surface (Kaplan, figure 7F). 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 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).
Claims 25-26 and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Nazhat (US 20140086874 A1; IDS reference, 09/28/2022), Kaplan (US 10933173 B2), and Jiang (US 20110052695 A1) as applied to claims 19, 27-28, 33, 36-37, 40-45, and 48, further in view of Santra (US 20190082615 A1). The references were previously cited by the Examiner.
Regarding claim 25, Nazhat, Kaplan, and Jiang 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, Jiang, 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, Kaplan, and Jiang 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, Kaplan, and Jiang 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 38, Nazhat, Kaplan, Jiang, and Santra together teach all the elements of the claimed invention as applied to claim 25. 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, Jiang, and Santra together teach all the elements of the claimed invention as applied to claim 26. 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).
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Nazhat (US 20140086874 A1; IDS reference, 09/28/2022), Kaplan (US 10933173 B2), and Jiang (US 20110052695 A1) as applied to claims 19, 27-28, 33, 36-37, 40-45, and 48, further in view of Estrada-Navarrete (MPMI, 2006). Nazhat, Kaplan, and Jiang were previously cited by the Examiner.
Regarding claim 46, Nazhat, Kaplan, and Jiang together teach all the elements of the current invention as applied to claim 28. Jiang teaches the silk fibroin microneedles can comprise at least one active agent, which can be a bacteria (Jiang, column 10, lines 44-59). Estrada-Navarrete teaches Rhizobium tropici CIAT899 is a known bacteria which is injected into plants (Estrada-Navarrete, page 1387, 2nd paragraph; page 1391, 3rd paragraph).
Nazhat, Kaplan, Jiang, and Estrada-Navarrete are all considered to be analogous to the claimed invention, because all are in the same field of therapeutic delivery. 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, Kaplan, and Jiang to include the specific type of bacteria taught by Estrada-Navarrete, because Jiang teaches active agent can be a bacteria (Jiang, column 10, lines 44-59), and Estrada-Navarrete teaches a specific bacteria known to be utilized for injecting plants to result in robust and quick growth (Estrada-Navarrete, abstract).
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Nazhat (US 20140086874 A1; IDS reference, 09/28/2022), Kaplan (US 10933173 B2), and Jiang (US 20110052695 A1) as applied to claims 19, 27-28, 33, 36-37, 40-45, and 48, further in view of Vinoth (Applied Biochemistry and Biotechnology, 2013). Nazhat, Kaplan, and Jiang were previously cited by the Examiner.
Regarding claim 47, Nazhat, Kaplan, and Jiang together teach all the elements of the current invention as applied to claim 28. Jiang teaches the silk fibroin microneedles can comprise at least one active agent, which can be a bacteria (Jiang, column 10, lines 44-59). Vinoth teaches Agrobacterium tumefaciens is a known bacteria which is microinjected into plants (Vinoth, abstract) to improve traits such as fungal tolerance (Vinoth, page 1174, 1st paragraph).
Nazhat, Kaplan, Jiang, and Vinoth 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, Kaplan, and Jiang to include the specific type of bacteria taught by Vinoth, because Jiang teaches active agent can be a bacteria (Jiang, column 10, lines 44-59), and Vinoth teaches a specific bacteria known to be utilized for microinjections (Vinoth, abstract).
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.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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