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 .
Election/Restrictions and Claim Status
Applicant’s election without traverse of Group 1 and losartan in the reply filed on 8/17/26 is acknowledged.
Claims 13-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/17/26.
Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution.
Claims 1-12 are being examined.
Priority
The priority information is found in the filing receipt of 5/8/24.
Information Disclosure Statement
The 6 page information disclosure statement filed 9/10/24 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. In the instant case, NPL references 2-15, 19 and 21-22 recite specific pages (for example NPL reference 2 is listed as pages 2875-80). However, what is provided for NPL references 2-15, 19 and 21-22 is only the abstract. Thus a copy of non-patent literature publication for NPL references 2-15, 19 and 21-22 has not been provided.
The 4 page information disclosure statement (IDS) submitted on 9/10/24 has been considered by the examiner.
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 1-12 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 1 line 1 recites ‘patch’. The specification (section 0023 page 4) defines patch in terms of ‘generally small’. The term “generally small” is a relative term which renders the claim indefinite. The term “generally small” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. None of dependent claims 2-12 clarify the claim scope.
Claim 1 recites ‘the collagen carbon dot nanocomposite is absorbable though a mucosa’. All dependent claims encompass the functional limitations ‘the collagen carbon dot nanocomposite is absorbable though a mucosa’. The specification states that “Mucosal membranes allow the passage of molecules below 1000 Da with ease” (section 0056 page 13). The specification states that the molecular weight includes the active agent and then recites that the molecular weight of recombinant growth hormone as 848.9 Da (section 0056 page 13). Pettis et al. (US 2003/0100885) teach that recombinant growth hormone has a molecular weight of about 22,600 Da (section 0076). Thus, applicants assertion that recombinant growth hormone has a molecular weight of 848.9 Da is inaccurate.
Hernuss P (US 2011/0097316) states that “For polypeptides a molecular size corresponding to a length of roughly 80 amino acids and a molecular weight of roughly 10,000 Dalton presents the upper limit for intake via the mucous membrane” (section 0005). Hernuss teach that somatotropin with a molecular weight of 21,500 Da is too large to be absorbed via human or animal mucous membranes (section 0026).
Ricard-Blum S (‘The collagen family’ Cold Spring Harb Perspect Biol v3 2011 pages 1-19) teach various collagens (Table 1 on page 2) and teach that collagens consist of three polypeptide chains including alpha (page 4 first complete paragraph). Ricard-Blum teach that collagen alpha chains vary in size from 662 up to 3152 amino acids (page 4 first complete paragraph of column 2).
Claim 1 requires a collagen carbon dot nanocomposite that is absorbable though a mucosa. However, Hernuss P (US 2011/0097316) states that “For polypeptides a molecular size corresponding to a length of roughly 80 amino acids and a molecular weight of roughly 10,000 Dalton presents the upper limit for intake via the mucous membrane” (section 0005) and Ricard-Blum teach that collagen is at least 662 amino acids in length (well above the approximate 80 amino acid threshold). The claim appears to require collagen and the functional language appears to exclude collagen. As such, what falls within the scope of the claims is unclear.
In the instant case, the recited functional characteristic (‘absorbable through a mucosa’) does not necessarily follow from the structure recited in the claim (‘collagen carbon dot nanocomposite’) and it is unclear what provides the functional characteristic.
Claim language that merely states a result to be obtained without providing boundaries on the claim scope (e.g., by not specifying any way to achieve those results) is unclear. The recited functional characteristics do not necessarily occur in all collagens or collagen carbon dot nanocomposites recited in the claims. Thus, one of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claims. See MPEP 2173.05(g) for more information. The last sentence of MPEP 2173.05(g) recognizes that applicant can amend the claims to recite the particular structure that accomplishes the function.
Claim 1 recites ‘carbon dot’. The specification defines carbon dot as having a particle size of less than 10 nm but then goes on to recite that ‘Applicant’s use of carbon dots throughout this application is understood as being an equivalent of any type of carbon nanotube..’ (section 0024 page 4). The size of a carbon nanotube is not necessarily less than 10 nm. The scope of what falls within ‘carbon dot’ is unclear. None of the dependent claims clarify the claim scope.
Claim 2 recites ‘dense’ and ‘highly dense’. The terms “dense” and “highly dense” are relative terms which renders the claim indefinite. The terms ““dense” and “highly dense” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 9 recites ‘the patch comprising an adhesive’. There is insufficient antecedent basis for this limitation in the claim. Although claim 1 recites a patch, it does not require a patch with an adhesive.
Claim 12 recites ‘group consisting of’. However, the last options are not separated by the word ‘and’ so it is unclear if other options are possible.
Although unclear, the claims have been given the broadest reasonable interpretation consistent with the specification. Although unclear, the claims have been interpreted as being enabled.
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.
Claims 1-12 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
Further, to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include: a) the scope of the invention; b) actual reduction to practice; c) disclosure of drawings or structural chemical formulas; d) relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation; e) method of making the claimed compounds; f) level of skill and knowledge in the art; and g) predictability in the art.
(1) Scope of the invention/Partial structure/disclosure of drawings:
Claim 1 recites ‘the collagen carbon dot nanocomposite is absorbable though a mucosa’.
Ricard-Blum S (‘The collagen family’ Cold Spring Harb Perspect Biol v3 2011 pages 1-19) teach various collagens (Table 1 on page 2) and teach that collagens consist of three polypeptide chains including alpha (page 4 first complete paragraph). Ricard-Blum teach that collagen alpha chains vary in size from 662 up to 3152 amino acids (page 4 first complete paragraph of column 2).
Hernuss P (US 2011/0097316) states that “For polypeptides a molecular size corresponding to a length of roughly 80 amino acids and a molecular weight of roughly 10,000 Dalton presents the upper limit for intake via the mucous membrane” (section 0005). Hernuss teach that somatotropin with a molecular weight of 21,500 Da is too large to be absorbed via human or animal mucous membranes (section 0026).
There do not appear to be any working examples. Table 1 (pages 13-14) and figure 3 (figure 3 caption refers to ‘if delivered’) appears to recite properties of active agents not necessarily of any collagen carbon dot nanocomposite as claimed. There are many possible sources of the carbon dot and many possible active agents.
(2) Level of skill and knowledge in the art/predictability in the art:
The level of skill in the art is high.
Claim 1 requires a collagen carbon dot nanocomposite that is absorbable though a mucosa. However, Hernuss P (US 2011/0097316) states that “For polypeptides a molecular size corresponding to a length of roughly 80 amino acids and a molecular weight of roughly 10,000 Dalton presents the upper limit for intake via the mucous membrane” (section 0005) and Ricard-Blum teach that collagen is at least 662 amino acids in length (well above the approximate 80 amino acid threshold). The claim appears to require collagen and the functional language appears to exclude collagen.
(3) Physical and/or chemical properties and (4) Functional characteristics:
Claim 1 recites ‘the collagen carbon dot nanocomposite is absorbable though a mucosa’. All dependent claims encompass the functional limitations ‘the collagen carbon dot nanocomposite is absorbable though a mucosa’. The specification states that “Mucosal membranes allow the passage of molecules below 1000 Da with ease” (section 0056 page 13). The specification states that the molecular weight includes the active agent and then recites that the molecular weight of recombinant growth hormone as 848.9 Da (section 0056 page 13). Pettis et al. (US 2003/0100885) teach that recombinant growth hormone has a molecular weight of about 22,600 Da (section 0076). Thus, applicants assertion that recombinant growth hormone has a molecular weight of 848.9 Da is inaccurate.
Claims 4 and 6-8 recite additional functional properties.
Hernuss P (US 2011/0097316) states that “For polypeptides a molecular size corresponding to a length of roughly 80 amino acids and a molecular weight of roughly 10,000 Dalton presents the upper limit for intake via the mucous membrane” (section 0005). Hernuss teach that somatotropin with a molecular weight of 21,500 Da is too large to be absorbed via human or animal mucous membranes (section 0026).
Ricard-Blum S (‘The collagen family’ Cold Spring Harb Perspect Biol v3 2011 pages 1-19) teach various collagens (Table 1 on page 2) and teach that collagens consist of three polypeptide chains including alpha (page 4 first complete paragraph). Ricard-Blum teach that collagen alpha chains vary in size from 662 up to 3152 amino acids (page 4 first complete paragraph of column 2).
Claim 1 requires a collagen carbon dot nanocomposite that is absorbable though a mucosa. However, Hernuss P (US 2011/0097316) states that “For polypeptides a molecular size corresponding to a length of roughly 80 amino acids and a molecular weight of roughly 10,000 Dalton presents the upper limit for intake via the mucous membrane” (section 0005) and Ricard-Blum teach that collagen is at least 662 amino acids in length (well above the approximate 80 amino acid threshold). The claim appears to require collagen and the functional language appears to exclude collagen. As such, what falls within the scope of the claims is unclear.
When functional claim language is found indefinite as set forth above, it typically lacks an adequate written description under § 112(a), because an indefinite, unbounded functional limitation would cover all ways of performing a function and indicate that the inventor has not provided sufficient disclosure to show possession of the invention.
There is no specific disclosed correlation between structure and function particularly related to what structures are adequate to result in the functions as recited in the claims. It is unclear what structural elements are required for the recited function. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus and that there is a lack of the predictability in the art thus that the applicant was not in possession of the claimed genus.
(5) Method of making the claimed invention/actual reduction to practice:
There do not appear to be any working examples. Table 1 (pages 13-14) and figure 3 (figure 3 caption refers to ‘if delivered’) appear to recite properties of active agents not necessarily of any collagen carbon dot nanocomposite as claimed.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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.
Claim(s) 1 and 4-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou et al. (‘Hydroxyapatite-collagen-carboxylic carbon quantum dot composite loaded with chrysin supported the proliferation and differentiation of human bone marrow derived mesenchymal stem cells’ Frontiers in Materials October 17 2022 pages 1-16; ‘Zhou’).
Zhou teach a scaffold comprising collagen that is lined with carbon quantum dots and chrysin (abstract and scheme 1 on page 3). Zhou teach that quantum dots are known to be used in drug delivery and teach that chrysin is known to have anti-inflammatory, anti-cancer, anti-diabetic, antioxidant, hepatoprotective and antimicrobial properties (page 2 first 2 paragraphs of column 2). Zhou teach various sizes of the nanocomposite including sizes on the order 10nm and around 100 nm (figure 5e) and crystalline size on the order of nm (page 8 paragraph connecting columns 1-2).
In relation to the collagen carbon dot nanocomposite of claim 1, Zhou teach a scaffold comprising collagen that is lined with carbon quantum dots (abstract and scheme 1 on page 3).
In relation to the active agent of claim 1, Zhou teach that quantum dots are known to be used in drug delivery and teach that chrysin is known to have anti-inflammatory, anti-cancer, anti-diabetic, antioxidant, hepatoprotective and antimicrobial properties (page 2 first 2 paragraphs of column 2).
In relation to the active layer, Zhou teach a scaffold comprising collagen that is lined with carbon quantum dots and chrysin (abstract and scheme 1 on page 3).
In relation to the support layer, Zhou teach a scaffold comprising hydroxyapatite (abstract and scheme 1 on page 3).
In relation to claims 4-5, Zhou expressly teach collagen (abstract and scheme on page 3).
In relation to a protective layer of claims 6-8, Zhou teach a scaffold comprising hydroxyapatite (abstract and scheme 1 on page 3).
In relation to an adhesive of claims 9-10, Zhou expressly teach carboxy groups on the carbon quantum dots (scheme 1).
In relation to claim 11, Zhou teach hydrogen bonds with chrysin (scheme 1).
In relation to any functional recitations of claims 1, 4, 6-10 and 12, as set forth above the claims are unclear. Zhou teach various sizes of the nanocomposite including sizes on the order 10nm and around 100 nm (figure 5e) and crystallize size on the order of nm (page 8 paragraph connecting columns 1-2).
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.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. (‘Hydroxyapatite-collagen-carboxylic carbon quantum dot composite loaded with chrysin supported the proliferation and differentiation of human bone marrow derived mesenchymal stem cells’ Frontiers in Materials October 17 2022 pages 1-16; ‘Zhou’) in view of Xiao et al. (WO 2020/243768; 12-2020; ‘Xiao’) in view of Linder BJ (US 2006/0210616; ‘Linder’).
Zhou teach a scaffold comprising collagen that is lined with carbon quantum dots and chrysin (abstract and scheme 1 on page 3). Zhou teach that quantum dots are known to be used in drug delivery and teach that chrysin is known to have anti-inflammatory, anti-cancer, anti-diabetic, antioxidant, hepatoprotective and antimicrobial properties (page 2 first 2 paragraphs of column 2). Zhou teach various sizes of the nanocomposite including sizes on the order 10nm and around 100 nm (figure 5e) and crystalline size on the order of nm (page 8 paragraph connecting columns 1-2).
Zhou does not recite the components of instant claims 2-3.
Xiao teach implants specifically those that comprise collagen and applications for teeth (abstract and sections 0002 and 0168) and teach bioresorbable implants (claim 1). Xiao teach the use of layers of the implant (claim 8). Xiao teach problems with weakness in current layers (sections 0006-0007). Xiao teach the use of layers that include e-PTFE and d-PTFE with increased strength (section 0010 pages 2-3).
Linder teach the use of therapeutic patches for delivery (abstract). Linder teach that the therapeutic substance can be activated by heat or moisture (section 0007). Linder teach the use of layers including an adhesive layer (section 0008).
It would have been obvious to one of ordinary skill in the art to modify the teachings of Zhou because Zhou teach scaffolds for delivery and suggest clinical investigations (abstract). Since Xiao and Linder teach specific components and/or configurations with advantages for delivery one would have been motivated to incorporate such teachings. For example, Xiao teach the use of layers that include e-PTFE and d-PTFE with increased strength (section 0010 pages 2-3) so one would have been motivated to use and optimize the amounts of such components. One would have had a reasonable expectation of success since the components and their function was known.
In relation to the collagen carbon dot nanocomposite of claim 1, Zhou teach a scaffold comprising collagen that is lined with carbon quantum dots (abstract and scheme 1 on page 3).
In relation to the active agent of claim 1, Zhou teach that quantum dots are known to be used in drug delivery and teach that chrysin is known to have anti-inflammatory, anti-cancer, anti-diabetic, antioxidant, hepatoprotective and antimicrobial properties (page 2 first 2 paragraphs of column 2).
In relation to the active layer, Zhou teach a scaffold comprising collagen that is lined with carbon quantum dots and chrysin (abstract and scheme 1 on page 3).
In relation to the support layer, Zhou teach a scaffold comprising hydroxyapatite (abstract and scheme 1 on page 3).
In relation to claims 2-3, Xiao teach the use of layers that include e-PTFE and d-PTFE with increased strength (section 0010 pages 2-3).
In relation to claims 4-5, Zhou expressly teach collagen (abstract and scheme on page 3).
In relation to a protective layer of claims 6-8, Zhou teach a scaffold comprising hydroxyapatite (abstract and scheme 1 on page 3).
In relation to an adhesive of claims 9-10, Zhou expressly teach carboxy groups on the carbon quantum dots (scheme 1).
In relation to claim 11, Zhou teach hydrogen bonds with chrysin (scheme 1).
In relation to any functional recitations of claims 1, 4, 6-10 and 12, as set forth above the claims are unclear. Zhou teach various sizes of the nanocomposite including sizes on the order 10nm and around 100 nm (figure 5e) and crystallize size on the order of nm (page 8 paragraph connecting columns 1-2). Linder teach that the therapeutic substance can be activated by heat or moisture (section 0007).
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. (‘Hydroxyapatite-collagen-carboxylic carbon quantum dot composite loaded with chrysin supported the proliferation and differentiation of human bone marrow derived mesenchymal stem cells’ Frontiers in Materials October 17 2022 pages 1-16; ‘Zhou’) in view of Xiao et al. (WO 2020/243768; 12-2020; ‘Xiao’) in view of Linder BJ (US 2006/0210616; ‘Linder’) in view of Huang et al. (‘Intradermal delivery of an angiotensin II receptor blocker using a personalized microneedle patch for treatment of hypertrophic scars’ Biomater Sci v11 November 25 2022 pages 583-595; ‘Huang’).
Zhou teach a scaffold comprising collagen that is lined with carbon quantum dots and chrysin (abstract and scheme 1 on page 3). Zhou teach that quantum dots are known to be used in drug delivery and teach that chrysin is known to have anti-inflammatory, anti-cancer, anti-diabetic, antioxidant, hepatoprotective and antimicrobial properties (page 2 first 2 paragraphs of column 2). Zhou teach various sizes of the nanocomposite including sizes on the order 10nm and around 100 nm (figure 5e) and crystallize size on the order of nm (page 8 paragraph connecting columns 1-2).
Zhou does not recite the components of instant claims 2-3 or the elected species.
Xiao teach implants specifically those that comprise collagen and applications for teeth (abstract and sections 0002 and 0168) and teach bioresorbable implants (claim 1). Xiao teach the use of layers of the implant (claim 8). Xiao teach problems with weakness in current layers (sections 0006-0007). Xiao teach the use of layers that include e-PTFE and d-PTFE with increased strength (section 0010 pages 2-3).
Linder teach the use of therapeutic patches for delivery (abstract). Linder teach that the therapeutic substance can be activated by heat or moisture (section 0007). Linder teach the use of layers including an adhesive layer (section 0008).
Huang teach patches that comprise losartan a drug that can effectively inhibit the proliferation and migration of hypertrophic scar fibroblasts (abstract).
It would have been obvious to one of ordinary skill in the art to modify the teachings of Zhou because Zhou teach scaffolds for delivery and suggest clinical investigations (abstract). Since Xiao and Linder teach specific components and/or configurations with advantages for delivery one would have been motivated to incorporate such teachings. For example, Xiao teach the use of layers that include e-PTFE and d-PTFE with increased strength (section 0010 pages 2-3) so one would have been motivated to use and optimize the amounts of such components. Since Zhou teach that quantum dots are known to be used in drug delivery and teach that chrysin is known to have anti-inflammatory, anti-cancer, anti-diabetic, antioxidant, hepatoprotective and antimicrobial properties (page 2 first 2 paragraphs of column 2) one would have been motivated to use known drugs such as losartan as taught by Huang. One would have had a reasonable expectation of success since the components and their function was known.
In relation to the collagen carbon dot nanocomposite of claim 1, Zhou teach a scaffold comprising collagen that is lined with carbon quantum dots (abstract and scheme 1 on page 3).
In relation to the active agent of claim 1, Zhou teach that quantum dots are known to be used in drug delivery and teach that chrysin is known to have anti-inflammatory, anti-cancer, anti-diabetic, antioxidant, hepatoprotective and antimicrobial properties (page 2 first 2 paragraphs of column 2). Huang teach patches that comprise losartan a drug that can effectively inhibit the proliferation and migration of hypertrophic scar fibroblasts (abstract).
In relation to the active layer, Zhou teach a scaffold comprising collagen that is lined with carbon quantum dots and chrysin (abstract and scheme 1 on page 3).
In relation to the support layer, Zhou teach a scaffold comprising hydroxyapatite (abstract and scheme 1 on page 3).
In relation to claims 2-3, Xiao teach the use of layers that include e-PTFE and d-PTFE with increased strength (section 0010 pages 2-3).
In relation to claims 4-5, Zhou expressly teach collagen (abstract and scheme on page 3).
In relation to a protective layer of claims 6-8, Zhou teach a scaffold comprising hydroxyapatite (abstract and scheme 1 on page 3).
In relation to an adhesive of claims 9-10, Zhou expressly teach carboxy groups on the carbon quantum dots (scheme 1).
In relation to claim 11, Zhou teach hydrogen bonds with chrysin (scheme 1).
In relation to any functional recitations of claims 1, 4, 6-10 and 12, as set forth above the claims are unclear. Zhou teach various sizes of the nanocomposite including sizes on the order 10nm and around 100 nm (figure 5e) and crystallize size on the order of nm (page 8 paragraph connecting columns 1-2). Linder teach that the therapeutic substance can be activated by heat or moisture (section 0007).
Conclusion
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
