DETAILED ACTION
Examiner Note
This non-final office action replaces the previous action mailed 5/19/2026.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
No IDS is on file as of 6/3/2026.
Claim Status
Claims 1-12, 14, 16-22, and 24, filed 11/10/2022, are pending. Claims 1-12, 14, 16-22, and 24 are under examination.
Claim Objections
Claims 1, 3, 4, and 6 are objected to because of the following informalities. claims 1, 3, 4, and 6 recite polypeptide sequences that require SEQ ID NOs but do not have SEQ ID NOs listed.
Furthermore, claim 1 recites “(wherein,” twice. The intended closing parentheses appear in the very last line of the claim. However, this kind of use of parentheses is unnecessary and potentially confusing.
Appropriate correction is required.
Claim 7 is objected to because they include reference characters which are not enclosed within parentheses.
Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
In this case, the SEQ ID NOs are not enclosed in parentheses.
Also, claim 7 lacks a period.
MPEP 608.01(m) states: “ Each claim begins with a capital letter and ends with a period.”
Appropriate correction is required.
Claim Interpretation
Claim 3 recites “The composition according to claim 1, wherein the X is a peptide group consisting of an amino acid residue selected from -Phe-Hyp-Gly-Glu-Arg-Gly-, Pro-Arg-Gly-Gln-Hyp-Gly- Val-Met-Gly-Phe-Hyp-Gly-, and -Pro-Lys-Gly-His-Arg-Gly-Phe-Ser-Gly-Leu-Hyp-Gly-.”
This claim is interpreted to refer to the groups of amino acids not “an amino acid residue” based on the specification para. [0006], where these peptide groups are assigned SEQ ID NOs and are clearly meant to be referred to as groups. Furthermore, Applicant’s own example sequences appear to use this meaning as well.
Claim 4 recites the case wherein the X is a peptide group consisting of an amino acid residue selected from -Pro-Arg-Gly- or -Phe-Hyp-Gly-Glu-Arg-Gly-.
This claim is interpreted to refer to the groups of amino acids not “an amino acid residue” based on the specification para. [0006], where these peptide groups are assigned SEQ ID NOs and are clearly meant to be referred to as groups. Furthermore, Applicant’s own example sequences appear to use this meaning as well.
Claim 5 recites the case wherein the R' and R2 are each independently a peptide group consisting of an amino acid residue of two or more Cys (cysteine) residues.
This claim is interpreted to refer to the groups of amino acids not “an amino acid residue” based on the specification para. [0006], where these peptide groups are assigned SEQ ID NOs and are clearly meant to be referred to as groups. Furthermore, Applicant’s own example sequences appear to use this meaning as well.
Claim 7 is interpreted to that SEQ ID NOs: 1, 2, and 3 are each present in the composition of claim 1 in the form of P1, P2, and P3. Support for this interpretation is found in specification para. [0029], where using three different peptides in different ratios to obtain different properties is discussed.
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 3-5 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.
Regarding claim 3, claim 3 recites “The composition according to claim 1, wherein the X is a peptide group consisting of an amino acid residue selected from -Phe-Hyp-Gly-Glu-Arg-Gly-, Pro-Arg-Gly-Gln-Hyp-Gly- Val-Met-Gly-Phe-Hyp-Gly-, and -Pro-Lys-Gly-His-Arg-Gly-Phe-Ser-Gly-Leu-Hyp-Gly-.”
It is not clear if “an amino residue” refers to a single amino acid residue or if it is intended to refer to the groups of residues. The claim is currently interpreted to refer to the groups of residues as described above.
Consequently, claim 3 is rejected.
Regarding claim 4, claim 4 recites the case wherein the X is a peptide group consisting of an amino acid residue selected from -Pro-Arg-Gly- or -Phe-Hyp-Gly-Glu-Arg-Gly-.
It is not clear if “an amino residue” refers to a single amino acid residue or if it is intended to refer to the groups of residues. The claim is currently interpreted to refer to the groups of residues as described above.
Consequently, claim 4 is rejected.
Regarding claim 5, claim 5 recites the case wherein the R' and R2 are each independently a peptide group consisting of an amino acid residue of two or more Cys (cysteine) residues.
It is not clear if “an amino residue” refers to a single amino acid residue or if it is intended to refer to the groups of residues. The claim is currently interpreted to refer to the groups of residues as described above.
Consequently, claim 5 is rejected.
Claim Rejections - 35 USC § 112
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.
Claim 14 is 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 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 applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
Regarding claim 14, claim 14 recites: “The composition according to claim 1, which is in a form of gel; or a transparent form.”
MPEP 2163(II)(A)(3)(a)(ii) states: “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.”
The term “transparent form” can potentially apply to many different forms. This could be any transparent medium such as glass, plexiglass, plastics, and so forth.
The specification recites: “The composition according to any one of (1) to (13), which is in a transparent form.” (Specification, para. [0006], page 4, line 9). The specification also recites :“The peptide membrane consisting of the composition of the present invention has high transparency and is ideal for treatment of macular hole.” (Specification, para. [0007], page 4, line 26). No further elaboration is present in the specification.
Assuming this transparency is in reference to the examples provided in the example section of the specification, there is only one provided example which encompasses limited diversity of the genus “transparent form”.
Consequently, a person of ordinary skill in the art would conclude that the provided examples do not cover the breadth of the phrase “transparent form” and this does not reasonably convey to a person of ordinary skill in the art that the inventors, at the time the application was filed, had possession of the claimed invention.
Claim 14 is rejected.
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.
Claims 1-7, 14, 16, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koide et al. (US c, published 11/8/2018).
Regarding claim 1, Koide discloses a composition with two or more polymerized peptides: “The gel according to claim 6, comprising a gelling agent prepared by combining at least two kinds of triple-chain peptides with the triple-chain peptide as set forth in claim 1 being a polymerization unit.” (Koide et al., Claim 7).
Koide discloses a three-stranded polymerization unit that may be the same or different:
“That is, this polymerized peptide is the aforementioned polymerized peptide having an oxidatively cross-linked structural unit of a trimer peptide that is formed of three peptide chains and is represented by the following formula (I).
[Chemical formula 1]-(A1,A2,A3)- (I)
In the formula (I), A1, A2 and A3 may be identical to or different from one another, and independently represent peptide chains expressed by the following formula (II). A1, A2 and A3 form a trimer having a triple-helical structure, and may be cross-linked through disulfide bonds established between the cysteine (Cys) residues contained in each peptide chain.” (Koide et al., para. [0021]).
As noted above, these polymerization units may be cross-linked through cysteine residues.
Regarding Formula (II), Koide discloses SEQ ID NO: 10:
CCCPHypGPHypGPHypGPHypGPHypGPRGPHypGPHypGHypPGPHypGCCC, aligned against Applicant SEQ ID NO: 1 below:
Qy 1 CCCPXGPXGPXGPXGPXGPRGPXGPXGPXGPXGCCC 36
|||| || || || || ||||| || || || ||||
Db 1 CCCPPGPPGPPGPPGPPGPRGPPGPPGPPGPPGCCC 36
The “X” residues are hydroxyproline.
With respect to Formula (II), R1 here is three cysteines, m=5, X is PRG repeated once, n=4 and R2 is also three cysteines.
Consequently, claim 1 is anticipated by Koide et al. and rejected.
Regarding claim 2, claim 1 is anticipated as described above. Claim 2 further recites the case wherein P1, P2, and P3 are the same peptide. As described above, Koide discloses that the peptides may be the same or different.
Consequently, claim 2 is anticipated by Koide et al. and rejected.
Regarding claim 3, claim 1 is anticipated as described above. Claim 3 further recites the case wherein the X is a peptide group consisting of an amino acid residue selected from -Phe-Hyp-Gly-Glu-Arg-Gly-, Pro-Arg-Gly-Gln-Hyp-Gly- Val-Met-Gly-Phe-Hyp-Gly-, and -Pro-Lys-Gly-His-Arg-Gly-Phe-Ser-Gly-Leu-Hyp-Gly-.
Koide et al. discloses SEQ ID NO: 11:
CCCPHypGPHypGPHypGPHypGFHypGERGPHypGPHypGPHypGPHypGCCC, wherein X is FHypGERG.
Consequently, claim 3 is anticipated by Koide et al. and rejected.
Regarding claim 4, claim 1 is anticipated as described above. Claim 4 further recites the case wherein the X is a peptide group consisting of an amino acid residue selected from -Pro-Arg-Gly- or -Phe-Hyp-Gly-Glu-Arg-Gly-.
Koide discloses SEQ ID NO: 10:
CCCPHypGPHypGPHypGPHypGPHypGPRGPHypGPHypGHypPGPHypGCCC.
Here, X is PRG.
Consequently, claim 4 is anticipated by Koide et al. and rejected.
Regarding claim 5, claim 1 is anticipated as described above. Claim 5 further recites the case wherein the R' and R2 are each independently a peptide group consisting of an amino acid residue of two or more Cys (cysteine) residues.
As described above, SEQ ID NO: 10 of Koide has groups of three cysteines, which reads on two more.
Consequently, claim 5 is anticipated by Koide et al. and rejected.
Regarding claim 6, claim 1 is anticipated as described above. Claim 6 further recites the case wherein the peptide chain represented by formula (II) is selected from Rl- (Pro-Hyp-Gly) m-Pro-Arg-Gly- (Pro-Hyp-Gly) n-R2 (i) and R1- (Pro-Hyp-Gly) m-Phe-Hyp-Gly-Glu-Arg-Gly- (Pro-Hyp-Gly) n-R2 (ii).
Koide discloses SEQ ID NO: 10:
CCCPHypGPHypGPHypGPHypGPHypGPRGPHypGPHypGHypPGPHypGCCC.
Here, R1 is 3 cysteines, m=5, X is PRG, n=4, and R2 is 3 cysteines.
Consequently, claim 6 is anticipated by Koide et al. and rejected.
Regarding claim 7, claim 1 is anticipated as described above. Claim 7 further recites the case wherein the peptide chain represented by formula (II) is indicated by the following SEQ ID NOs. H-Cys-Cys-Cys-(Pro-Hyp-Gly)5-Pro-Arg-Gly-(Pro-Hyp-Gly)4-Cys-Cys-Cys-OH SEQ ID NO: 1 H-Cys-Cys-(Pro-Hyp-Gly) 5-Pro-Arg-Gly-(Pro-Hyp-Gly) 4-Cys-Cys-OH SEQ ID NO: 2 H-Cys-Cys-Cys-(Pro-Hyp-Gly)4-Phe-Hyp-Gly-Glu-Arg-Gly-(Pro-Hyp-Gly)4-Cys-Cys- Cys-OH SEQ ID NO: 3.
Koide discloses SEQ ID NO: 10:
CCCPHypGPHypGPHypGPHypGPHypGPRGPHypGPHypGHypPGPHypGCCC, aligned against Applicant SEQ ID NO: 1 below:
Qy 1 CCCPXGPXGPXGPXGPXGPRGPXGPXGPXGPXGCCC 36
|||| || || || || ||||| || || || ||||
Db 1 CCCPPGPPGPPGPPGPPGPRGPPGPPGPPGPPGCCC 36
Koide discloses SEQ ID NO: 23:
CCPHypGPHypGPHypGPHypGPHypGPRGPHypGPHypGPHypGPHypGCC, aligned against Applicant SEQ ID NO: 2 below:
Qy 1 CCPXGPXGPXGPXGPXGPRGPXGPXGPXGPXGCC 34
||| || || || || ||||| || || || |||
Db 1 CCPPGPPGPPGPPGPPGPRGPPGPPGPPGPPGCC 34
Koide discloses SEQ ID NO: 11: CCCPHypGPHypGPHypGPHypGFHypGERGPHypGPHypGPHypGPHypGCCC, aligned against Applicant SEQ ID NO: 3 below:
Qy 1 CCCPXGPXGPXGPXGFXGERGPXGPXGPXGPXGCCC 36
|||| || || || || ||||| || || || ||||
Db 1 CCCPPGPPGPPGPPGFPGERGPPGPPGPPGPPGCCC 36
In each case, X is Hyp.
Koide discloses that these may all be present in the polymerized peptide: “In the invention of the above polymerized peptide, the aforementioned peptide chains may be selected from the peptides having the amino acid sequences selected from the SEQ ID NOs: 1, 2, 5 to 7, 10 to 18, and 23.” (Koide et al., para. [0036]).
Consequently, claim 7 is anticipated by Koide et al. and rejected.
Regarding claim 14, claim 1 is anticipated as described above. Claim 14 further recites the case wherein the composition of claim 1 is in the form of a gel or transparent form.
Koide discloses usage of the composition in a hydrogel, which is a gel: ““The material containing the present polymerized peptide can be used after being processed into a hydrogel or a sheet.” (Koide et al., para. [0011]).
Consequently, claim 14 is anticipated by Koide et al. and rejected.
Regarding claim 16, claim 1 is anticipated as described above. Claim 16 further recites a pharmaceutical product comprising the composition according to claim 1.
Koide discloses the usage of the composition in pharmaceutical products such as wound dressings: “Furthermore, the present invention provides a method for producing a hydrogel and a sheet-shaped processed product, and uses as a composition of cell cultures, wound dressings, regenerative medical materials, research materials and the like using them.” (Koide et al., para. [0011]).
Consequently, claim 16 is anticipated by Koide et al. and rejected.
Regarding claim 17, claim 1 is anticipated as described above. Claim 17 further recites a device comprising the composition according to claim 1.
Koide discloses the usage of the composition in devices such as cell cultures and wound dressings: “Furthermore, the present invention provides a method for producing a hydrogel and a sheet-shaped processed product, and uses as a composition of cell cultures, wound dressings, regenerative medical materials, research materials and the like using them.” (Koide et al., para. [0011]).
Consequently, claim 17 is anticipated by Koide et al. and rejected.
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.
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 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Koide et al. (US 20180319867, published 11/8/2018) in view of Kaur et al. (Kaur, et al. Bioactive natural products in drug discovery : 517-545 (2020)) and Hemamalini et al. (Hemamalini, et al. International journal of biological macromolecules 106: 712-718 (2018).
Regarding claim 8, claim 1 is anticipated as described above. Koide contemplates the usage of the disclosed peptide in a hydrogel and usage for drug delivery and wound dressings: “The material containing the present polymerized peptide can be used after being processed into a hydrogel or a sheet. Further, by incorporating a functional amino acid sequence present on a biopolymer such as an integrin-binding sequence, it is possible to endow the material with specific physiological functions such as cell adhesiveness. Furthermore, the present invention provides a method for producing a hydrogel and a sheet-shaped processed product, and uses as a composition of cell cultures, wound dressings, regenerative medical materials, research materials and the like using them.” (Koide et al., para. [0011]).
Koide does not explicitly disclose an aqueous filler as described by the current specification.
However, Kaur discloses that starch is used as an inert filler in the pharmaceutical industry: “Native starch is frequently employed in the pharmaceutical industry in the manufacturing of tablets where it acts as an inert filler, binder, glidant, lubricant, and disintegrating agent. Starch is also used in capsules as inert filler and in topical formulations to impart a thick consistency.” (Kaur et al., page 525, para. 4).
Kaur also discloses that “Starch fibers, nanoparticles, microparticles, and hydrogels are also being evaluated as scaffolds for tissue engineering, drug delivery, and wound dressings.” (Kaur et al., page 526, para. 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the starch filler of Kaur with the peptide of Koide to arrive at the claimed invention.
A person of ordinary skill in the art would be motivated to used starch because it is common: “Among all the polysaccharides, starch is the second abundant compound available in the green plants next to cellulose.” (Hemamalini et al., page 713, col. 2, para. 1). Furthermore, starch, and polysaccharides in general have many desirable properties as fillers:
PNG
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332
598
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Greyscale
(Hemamalini et al., page 714, Fig. 2)
A person of ordinary skill in the art would have a reasonable expectation of success because Hememalini discloses that starches are used in hydrogels:
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media_image2.png
204
368
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Greyscale
(Hemamalini et al., page 714, Fig. 3)
Consequently, claim 8 is obvious over Koide et al. in view of Kaur et al. and Hemamalini et al. and rejected.
Regarding claim 9, claim 8 is obvious as described above. Claim 9 further recites the case wherein the aqueous filler is a sugar. Starch is sugar: “Starch is α(1 → 4)- and α(1 → 6)-linked D-glucose units resulting in formation of two components: amylose and amylopectin.” (Kaur et al., page 524, para. 2).
Consequently, claim 9 is obvious over Koide et al. in view of Kaur et al. and Hemamalini et al. and rejected.
Regarding claim 10, claim 9 is obvious as described above. Claim 10 further recites the case wherein the sugar is one or more of glucose, lactose, sucrose, mannitol, trehalose, and sorbitol. Starch is glucose: “Starch is α(1 → 4)- and α(1 → 6)-linked D-glucose units resulting in formation of two components: amylose and amylopectin.” (Kaur et al., page 524, para. 2).
Consequently, claim 10 is obvious over Koide et al. in view of Kaur et al. and Hemamalini et al. and rejected.
Regarding claim 11, claim 10 is obvious as described above. Claim 11 further recites the case wherein the sugar is glucose. Starch is glucose: “Starch is α(1 → 4)- and α(1 → 6)-linked D-glucose units resulting in formation of two components: amylose and amylopectin.” (Kaur et al., page 524, para. 2).
Consequently, claim 11 is obvious over Koide et al. in view of Kaur et al. and Hemamalini et al. and rejected.
Claims 12 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Koide et al. in view of Kaur et al. (Kaur, et al. Bioactive natural products in drug discovery : 517-545 (2020)) and Hemamalini et al. (Hemamalini, et al. International journal of biological macromolecules 106: 712-718 (2018) as applied to claim 8 above, and further in view of Wang et al. (Wang, et al. Food chemistry 216: 209-216 (2017).
Regarding claim 12, claim 8 is obvious as described above. Claim 12 further recites the case wherein the aqueous filler is present in an amount of 10 to 50% relative to the total weight of the composition.
Koide, Kaur, and Hemamalini do not disclose a specific weight percent of aqueous filler.
However, Wang et al. discloses collagen blend with starch with the follow weight percentages:
“The collagen slurry with 30 wt% of glycerol (on the basis of the dry collagen fiber) was mixed with high amylose corn starch, waxy corn starch, and normal corn starch, each at the concentrations of 10 wt%, 50 wt%, and 0 wt% (i.e. neat collagen film as the control).” (Wang et al., page 210, col. 2, para. 2). Wang also discloses the resulting physical properties in Table 1. (Wang et al. page 212, Table 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the starch weight scheme of Wang with the composition of Koide, Kaur, and Hemamalini to arrive at the claimed invention.
A person of ordinary skill in the art would be motivated to make this combination to create a film or gel with the properties recited by Wang.
A person of ordinary skill in the art would have a reasonable expectation of success because Wang is creating collagen films and the peptides of the instant application are collagen-like peptides.
Consequently, claim 12 is obvious over Koide et al. in view of Kaur et al, Hemamalini et al. as applied to claim 8, further in view of Wang et al. and rejected.
Regarding claim 22, claim 8 is obvious as described above. Claim 22 further recites a method for producing the composition according to claim 8 , which comprises making the polymerized peptide represented by the formula (1) and the aqueous filler into a homogeneous physical mixture.
The composition of claim 8 is obvious as described above.
Wang discloses:
“The collagen slurry with 30 wt% of glycerol (on the basis of the dry collagen fiber) was mixed with high amylose corn starch, waxy corn starch, and normal corn starch, each at the concentrations of 10 wt%, 50 wt%, and 0 wt% (i.e. neat collagen film as the control). After mixing, 65 ml of the dispersion (pH = 2) were quickly cast onto a pre-leveled polyacrylic plate (12 × 12 cm) and then air-dried in a ventilation hood at room temperature for 24 h. The newly formed film was peeled off from the plate and kept in a desiccator at 25 °C and 52% relative humidity (RH) for 48 h. In order to study the affect of heat on film performance, some films were firstly heated in a water bath at 80 °C for 30 min then air-dried at room temperature. All experiments were carried out immediately after removal from the chamber in order to avoid variation caused by moisture.” (Wang et al., page 210, col. 2, para. 2)
The described mixing would result in a homogenous mixture. Furthermore, Wang treats the mixtures as homogenous for the rest of the disclosure. (Wang et al. page 212, Table 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the method of Wang to arrive at a homogeneous mixture by mixing.
A person of ordinary skill in the would be motivated to create a homogeneous mixture to ensure quality control and ensure consistent physical characteristics as described by Wang.
A person of ordinary skill in the art would have a reasonable expectation of success because the mixing of Wang resulted in such a mixture.
Consequently, claim 22 is obvious over Koide et al. in view of Kaur et al, Hemamalini et al. as applied to claim 8, further in view of Wang et al. and rejected.
Claims 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Koide et al. (US 20180319867, published 11/8/2018) as applied to claim 1 above, and further in view of Khan, et al (Khan, et al. Journal of Indian Society of Periodontology 17.4: 539-542 (2013)) and Liao et al. (Liao, et al. International journal of ophthalmology 12.4: 660 (2019)).
Regarding claim 18, claim 1 is anticipated as described above. Claim 18 further recites a therapeutic agent for an eye disease comprising the composition according to claim 1.
Koide discloses that the composition of claim 1 is a collagen-like peptide: “The present invention relates to a polymerized peptide containing a collagen-like peptide, a gel and a polymerized peptide membrane containing the polymerized peptide, a method for producing the same and uses thereof.” (Koide et al., para. [0001]).
Koide does not specifically disclose usage of this composition for an eye disease.
However, Liao discloses the usage of drugs for treatment of retinal detachment: “Currently, drugs are mainly used as an auxiliary therapy for retinal detachment. Western medicines used in treatment include tenecteplase, acetazolamide, and triamcinolone acetonide.” (Liao, et al., page 665, col. 1, para. 1).
Furthermore, Khan discloses the usage of collagen shields for drug delivery: “The collagen shield was designed for bandage contact lenses, which are gradually dissolved in the cornea. The use of collagen‑based drug delivery systems is the ease with which the formulation can be applied to the ocular surface and its potential for self‑administration.” (Khan et al., page 540, col. 1, para. 5).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the composition of Koide to create a collagen shield as disclosed by Khan for the treatment of retinal detachment as disclosed by Liao.
A person of ordinary skill in the art would be motivated to make this combination to deliver drugs safely to the eye in the case of retinal detachment.
A person of ordinary skill in the art would have a reasonable expectation of success because Koide discloses that these are collagen-like peptides and that they can form membranes. These collagen-like peptides would reasonably be expected to be usable as collagen shields as suggested by Khan to deliver the drugs of Liao.
Consequently, claim 18 is obvious over Koide et al. as applied to claim 1, further in view of Khan et al. and Liao et al. and rejected.
Regarding claim 19, claim 18 is obvious as described above. Claim 19 further recites the case wherein the eye disease is macular hole or retinal detachment.
The drugs of Liao treat retinal detachment as described above.
Consequently, claim 19 is obvious over Koide et al. as applied to claim 1, further in view of Khan et al. and Liao et al. and rejected.
Regarding claim 20, claim 1 is anticipated as described above. Claim 20 further recites: “A method for treating an eye disease, comprising a step of administering to a subject a therapeutically effective amount of the composition according to claim 1.”
A therapeutic agent for an eye disease is obvious as described above in claim 18.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to use a therapeutic agent for an eye disease comprising the composition according to claim 1 in a method for treating an eye disease.
A person of ordinary skill in the art would be motivated to treat an eye disease with a composition that can be used in an obvious therapeutic agent for eye disease.
A person of ordinary skill in the art would have a reasonable expectation of success because said obvious therapeutic agent is intended for use with eye diseases.
Consequently, claim 20 is obvious over Koide et al. as applied to claim 1, further in view of Khan et al. and Liao et al. and rejected.
Regarding claim 21, claim 20 is obvious as described above. Claim 21 further recites the case wherein the eye disease is macular hole or retinal detachment.
The drugs of Liao treat retinal detachment as described above.
Consequently, claim 21 is obvious over Koide et al. as applied to claim 1, further in view of Khan et al. and Liao et al. and rejected.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Koide et al. (US 20180319867, published 11/8/2018) as applied to claim 1 above, and further in view of Kaur et al. (Kaur, et al. Bioactive natural products in drug discovery : 517-545 (2020)), Hemamalini et al. (Hemamalini, et al. International journal of biological macromolecules 106: 712-718 (2018)), and Wang et al. (Wang, et al. Food chemistry 216: 209-216 (2017)).
Regarding claim 24, claim 1 is anticipated as described above. Claim 24 further recites the case wherein the polymerized peptide is present in an amount of 50% to 90% relative to the total weight of the composition.
Koide does not explicitly disclose an aqueous filler as described by the current specification.
However, Kaur discloses that starch is used as an inert filler in the pharmaceutical industry: “Native starch is frequently employed in the pharmaceutical industry in the manufacturing of tablets where it acts as an inert filler, binder, glidant, lubricant, and disintegrating agent. Starch is also used in capsules as inert filler and in topical formulations to impart a thick consistency.” (Kaur et al., page 525, para. 4).
Kaur also discloses that “Starch fibers, nanoparticles, microparticles, and hydrogels are also being evaluated as scaffolds for tissue engineering, drug delivery, and wound dressings.” (Kaur et al., page 526, para. 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the starch filler of Kaur with the peptide of Koide to arrive at the claimed invention.
A person of ordinary skill in the art would be motivated to used starch because it is common: “Among all the polysaccharides, starch is the second abundant compound available in the green plants next to cellulose.” (Hemamalini et al., page 713, col. 2, para. 1). Furthermore, starch, and polysaccharides in general have many desirable properties as fillers:
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(Hemamalini et al., page 714, Fig. 2)
A person of ordinary skill in the art would have a reasonable expectation of success because Hememalini discloses that starches are used in hydrogels:
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(Hemamalini et al., page 714, Fig. 3)
Koide, Kaur, and Hemamalini do not disclose a specific weight percent of aqueous filler.
However, Wang et al. discloses collagen blend with starch with the follow weight percentages:
“The collagen slurry with 30 wt% of glycerol (on the basis of the dry collagen fiber) was mixed with high amylose corn starch, waxy corn starch, and normal corn starch, each at the concentrations of 10 wt%, 50 wt%, and 0 wt% (i.e. neat collagen film as the control).” (Wang et al., page 210, col. 2, para. 2). Wang also discloses the resulting physical properties in Table 1. (Wang et al. page 212, Table 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the starch weight scheme of Wang with the composition of Koide, Kaur, and Hemamalini to arrive at the claimed invention. In the case where the starch is at 50% weight, the collagen peptide would also be at 50% weight, which reads on this claim.
A person of ordinary skill in the art would be motivated to make this combination to create a film or gel with the properties recited by Wang.
A person of ordinary skill in the art would have a reasonable expectation of success because Wang is creating collagen films and the peptides of the instant application are collagen-like peptides.
Consequently, claim 24 is obvious over Koide et al. as applied to claim 1, further in view of Kaur et al, Hemamalini et al., and Wang et al. and rejected.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7, 14, 16, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,851,152 in view of Koide et al. US 20180319867, published 11/8/2018.
Regarding claim 1, claim 1 of the ‘152 patent discloses: “A gelling agent comprising at least one kind of a polymerized peptide that has, as a polymerization unit, a triple-chain peptide having a triple-helical structure, and is polymerized by oxidative cross-linking, wherein peptide chains composing the triple-chain peptide are identical to or different from one another, and each peptide chain has:
one or more triple helix forming peptidyl groups each having a repeating structure in which -(Xaa-Yaa-Gly)- as a basic unit is repeated at least 5 times; and
one or more cross-link forming peptidyl groups each comprising at least two cysteine (Cys) residues within 6 residues from each of an amino-terminus and a carboxy-terminus, and wherein
each of Xaa and Yaa is independently selected from a proline (Pro or P) residue, a hydroxyproline (Hyp or O) residue, an arginine (Arg or R) residue, a lysine (Lys or K) residue, a valine (Val or V) residue, a leucine (Leu or L) residue, an isoleucine (Ile or I) residue, a serine (Ser or S) residue, a threonine (Thr or T) residue, an alanine (Ala or A) residue, a glycine (Gly or G) residue, an N-isobutyl glycine residue, a phenylalanine (Phe or F) residue, a methionine (Met or M) residue, a glutamate (Glu or E) residue, an aspartate (Asp or D) residue, an asparagine (Asn or N) residue, a glutamine (Gln or Q) residue, a histidine (His or H) residue, a tryptophan (Trp or W) residue or a tyrosine (Tyr or Y) residue, the proline residue may be modified by an amino group or fluorine atom.”
This claim is broader than Applicant claim 1. However, Koide et al. discloses that the polymerized peptide may be one of a finite number of sequences: “In the invention of the above polymerized peptide, the aforementioned peptide chains may be selected from the peptides having the amino acid sequences selected from the SEQ ID NOs: 1, 2, 5 to 7, 10 to 18, and 23.”
Specifically, Koide et al. discloses SEQ ID NO: 10:
CCCPHypGPHypGPHypGPHypGPHypGPRGPHypGPHypGHypPGPHypGCCC, aligned against Applicant SEQ ID NO: 1 below:
Qy 1 CCCPXGPXGPXGPXGPXGPRGPXGPXGPXGPXGCCC 36
|||| || || || || ||||| || || || ||||
Db 1 CCCPPGPPGPPGPPGPPGPRGPPGPPGPPGPPGCCC 36
The “X” residues are hydroxyproline.
With respect to Formula (II), R1 here is three cysteines, m=5, X is PRG repeated once, n=4 and R2 is also three cysteines.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the specific sequence disclosed by Koide et al. in the gelling agent of the ‘152 patent to arrive at the claimed invention.
A person of ordinary skill in the art would be motivated to use this sequence because the sequences recited by Koide et al. meet the limitations of the ‘152 patent and Koide et al. discloses a finite number of exemplary peptides to choose from: SEQ ID NOs: 1, 2, 5 to 7, 10 to 18, and 23.
A person of ordinary skill in the art would have a reasonable expectation of success because the sequences recited by Koide et al. meet the limitations of the ‘152 patent.
Consequently, claim 1 is obvious over the ‘152 patent in view of Koide et al. and rejected.
Regarding claim 2, claim 1 is obvious as described above. Claim 2 further recites the case wherein P1, P2, and P3 are the same peptide. As described above, Koide discloses that the peptides may be the same or different.
Consequently, claim 2 is obvious over the ‘152 patent in view of Koide et al. and rejected.
Regarding claim 3, claim 1 is obvious as described above. Claim 3 further recites the case wherein the X is a peptide group consisting of an amino acid residue selected from -Phe-Hyp-Gly-Glu-Arg-Gly-, Pro-Arg-Gly-Gln-Hyp-Gly- Val-Met-Gly-Phe-Hyp-Gly-, and -Pro-Lys-Gly-His-Arg-Gly-Phe-Ser-Gly-Leu-Hyp-Gly-.
Koide et al. discloses SEQ ID NO: 11:
CCCPHypGPHypGPHypGPHypGFHypGERGPHypGPHypGPHypGPHypGCCC, wherein X is FHypGERG.
Consequently, claim 3 is obvious over the ‘152 patent in view of Koide et al. and rejected.
Regarding claim 4, claim 1 is obvious as described above. Claim 4 further recites the case wherein the X is a peptide group consisting of an amino acid residue selected from -Pro-Arg-Gly- or -Phe-Hyp-Gly-Glu-Arg-Gly-.
Koide discloses SEQ ID NO: 10:
CCCPHypGPHypGPHypGPHypGPHypGPRGPHypGPHypGHypPGPHypGCCC.
Here, X is PRG.
Consequently, claim 4 is obvious over the ‘152 patent in view of Koide et al. and rejected.
Regarding claim 5, claim 1 is obvious as described above. Claim 5 further recites the case wherein the R' and R2 are each independently a peptide group consisting of an amino acid residue of two or more Cys (cysteine) residues.
As described above, SEQ ID NO: 10 of Koide has groups of three cysteines, which reads on two more.
Consequently, claim 5 is obvious over the ‘152 patent in view of Koide et al. and rejected.
Regarding claim 6, claim 1 is obvious as described above. Claim 6 further recites the case wherein the peptide chain represented by formula (II) is selected from Rl- (Pro-Hyp-Gly) m-Pro-Arg-Gly- (Pro-Hyp-Gly) n-R2 (i) and R1- (Pro-Hyp-Gly) m-Phe-Hyp-Gly-Glu-Arg-Gly- (Pro-Hyp-Gly) n-R2 (ii).
Koide discloses SEQ ID NO: 10:
CCCPHypGPHypGPHypGPHypGPHypGPRGPHypGPHypGHypPGPHypGCCC.
Here, R1 is 3 cysteines, m=5, X is PRG, n=4, and R2 is 3 cysteines.
Consequently, claim 6 is obvious over the ‘152 patent in view of Koide et al. and rejected.
Regarding claim 7, claim 1 is obvious as described above. Claim 7 further recites the case wherein the peptide chain represented by formula (II) is indicated by the following SEQ ID NOs. H-Cys-Cys-Cys-(Pro-Hyp-Gly)5-Pro-Arg-Gly-(Pro-Hyp-Gly)4-Cys-Cys-Cys-OH SEQ ID NO: 1 H-Cys-Cys-(Pro-Hyp-Gly) 5-Pro-Arg-Gly-(Pro-Hyp-Gly) 4-Cys-Cys-OH SEQ ID NO: 2 H-Cys-Cys-Cys-(Pro-Hyp-Gly)4-Phe-Hyp-Gly-Glu-Arg-Gly-(Pro-Hyp-Gly)4-Cys-Cys- Cys-OH SEQ ID NO: 3.
Koide discloses SEQ ID NO: 10:
CCCPHypGPHypGPHypGPHypGPHypGPRGPHypGPHypGHypPGPHypGCCC, aligned against Applicant SEQ ID NO: 1 below:
Qy 1 CCCPXGPXGPXGPXGPXGPRGPXGPXGPXGPXGCCC 36
|||| || || || || ||||| || || || ||||
Db 1 CCCPPGPPGPPGPPGPPGPRGPPGPPGPPGPPGCCC 36
Koide discloses SEQ ID NO: 23:
CCPHypGPHypGPHypGPHypGPHypGPRGPHypGPHypGPHypGPHypGCC, aligned against Applicant SEQ ID NO: 2 below:
Qy 1 CCPXGPXGPXGPXGPXGPRGPXGPXGPXGPXGCC 34
||| || || || || ||||| || || || |||
Db 1 CCPPGPPGPPGPPGPPGPRGPPGPPGPPGPPGCC 34
Koide discloses SEQ ID NO: 11: CCCPHypGPHypGPHypGPHypGFHypGERGPHypGPHypGPHypGPHypGCCC, aligned against Applicant SEQ ID NO: 3 below:
Qy 1 CCCPXGPXGPXGPXGFXGERGPXGPXGPXGPXGCCC 36
|||| || || || || ||||| || || || ||||
Db 1 CCCPPGPPGPPGPPGFPGERGPPGPPGPPGPPGCCC 36
In each case, X is Hyp.
Koide discloses that these may all be present in the polymerized peptide: “In the invention of the above polymerized peptide, the aforementioned peptide chains may be selected from the peptides having the amino acid sequences selected from the SEQ ID NOs: 1, 2, 5 to 7, 10 to 18, and 23.” (Koide et al., para. [0036]).
Consequently, claim 7 is obvious over the ‘152 patent in view of Koide et al. and rejected.
Regarding claim 14, claim 1 is obvious as described above. Claim 14 further recites the case wherein the composition of claim 1 is in the form of a gel or transparent form.
Koide discloses usage of the composition in a hydrogel, which is a gel: ““The material containing the present polymerized peptide can be used after being processed into a hydrogel or a sheet.” (Koide et al., para. [0011]).
Consequently, claim 14 is obvious over the ‘152 patent in view of Koide et al. and rejected.
Regarding claim 16, claim 1 is obvious as described above. Claim 16 further recites a pharmaceutical product comprising the composition according to claim 1.
Koide discloses the usage of the composition in pharmaceutical products such as wound dressings: “Furthermore, the present invention provides a method for producing a hydrogel and a sheet-shaped processed product, and uses as a composition of cell cultures, wound dressings, regenerative medical materials, research materials and the like using them.” (Koide et al., para. [0011]).
Consequently, claim 16 is obvious over the ‘152 patent in view of Koide et al. and rejected.
Regarding claim 17, claim 1 is obvious as described above. Claim 17 further recites a device comprising the composition according to claim 1.
Koide discloses the usage of the composition in devices such as cell cultures and wound dressings: “Furthermore, the present invention provides a method for producing a hydrogel and a sheet-shaped processed product, and uses as a composition of cell cultures, wound dressings, regenerative medical materials, research materials and the like using them.” (Koide et al., para. [0011]).
Consequently, claim 17 is obvious over the ‘152 patent in view of Koide et al. and rejected.
Claims 8-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,851,152 in view of Koide et al. US 20180319867, published 11/8/2018 as applied to claim 1 above, further in view of in view of Kaur et al. (Kaur, et al. Bioactive natural products in drug discovery : 517-545 (2020)) and Hemamalini et al. (Hemamalini, et al. International journal of biological macromolecules 106: 712-718 (2018).
Regarding claim 8, claims 1 is obvious as described above. Koide contemplates the usage of the disclosed peptide in a hydrogel and usage for drug delivery and wound dressings: “The material containing the present polymerized peptide can be used after being processed into a hydrogel or a sheet. Further, by incorporating a functional amino acid sequence present on a biopolymer such as an integrin-binding sequence, it is possible to endow the material with specific physiological functions such as cell adhesiveness. Furthermore, the present invention provides a method for producing a hydrogel and a sheet-shaped processed product, and uses as a composition of cell cultures, wound dressings, regenerative medical materials, research materials and the like using them.” (Koide et al., para. [0011]).
The ‘152 patent and Koide do not explicitly disclose an aqueous filler as described by the current specification.
However, Kaur discloses that starch is used as an inert filler in the pharmaceutical industry: “Native starch is frequently employed in the pharmaceutical industry in the manufacturing of tablets where it acts as an inert filler, binder, glidant, lubricant, and disintegrating agent. Starch is also used in capsules as inert filler and in topical formulations to impart a thick consistency.” (Kaur et al., page 525, para. 4).
Kaur also discloses that “Starch fibers, nanoparticles, microparticles, and hydrogels are also being evaluated as scaffolds for tissue engineering, drug delivery, and wound dressings.” (Kaur et al., page 526, para. 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the starch filler of Kaur with the peptide of Koide to arrive at the claimed invention.
A person of ordinary skill in the art would be motivated to used starch because it is common: “Among all the polysaccharides, starch is the second abundant compound available in the green plants next to cellulose.” (Hemamalini et al., page 713, col. 2, para. 1). Furthermore, starch, and polysaccharides in general have many desirable properties as fillers:
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(Hemamalini et al., page 714, Fig. 2)
A person of ordinary skill in the art would have a reasonable expectation of success because Hememalini discloses that starches are used in hydrogels:
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(Hemamalini et al., page 714, Fig. 3)
Consequently, claim 8 is obvious the ‘152 patent in view of Koide et al. as applied to claims 1 above, further in view of Kaur et al. and Hemamalini et al. and rejected.
Regarding claim 9, claim 8 is obvious as described above. Claim 9 further recites the case wherein the aqueous filler is a sugar. Starch is sugar: “Starch is α(1 → 4)- and α(1 → 6)-linked D-glucose units resulting in formation of two components: amylose and amylopectin.” (Kaur et al., page 524, para. 2).
Consequently, claim 9 is obvious the ‘152 patent in view of Koide et al. as applied to claims 1-7 above, further in view of Kaur et al. and Hemamalini et al. and rejected.
Regarding claim 10, claim 9 is obvious as described above. Claim 10 further recites the case wherein the sugar is one or more of glucose, lactose, sucrose, mannitol, trehalose, and sorbitol. Starch is glucose: “Starch is α(1 → 4)- and α(1 → 6)-linked D-glucose units resulting in formation of two components: amylose and amylopectin.” (Kaur et al., page 524, para. 2).
Consequently, claim 10 is obvious the ‘152 patent in view of Koide et al. as applied to claims 1-7 above, further in view of Kaur et al. and Hemamalini et al. and rejected.
Regarding claim 11, claim 10 is obvious as described above. Claim 11 further recites the case wherein the sugar is glucose. Starch is glucose: “Starch is α(1 → 4)- and α(1 → 6)-linked D-glucose units resulting in formation of two components: amylose and amylopectin.” (Kaur et al., page 524, para. 2).
Consequently, claim 11 is obvious the ‘152 patent in view of Koide et al. as applied to claims 1-7 above, further in view of Kaur et al. and Hemamalini et al. and rejected.
Claims 12 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,851,152 in view of Koide et al. US 20180319867, published 11/8/2018, Kaur et al. (Kaur, et al. Bioactive natural products in drug discovery : 517-545 (2020)) and Hemamalini et al. (Hemamalini, et al. International journal of biological macromolecules 106: 712-718 (2018) as applied to claim 8 above, and further in view of Wang et al. (Wang, et al. Food chemistry 216: 209-216 (2017).
Regarding claim 12, claim 8 is obvious as described above. Claim 12 further recites the case wherein the aqueous filler is present in an amount of 10 to 50% relative to the total weight of the composition.
The ‘152 patent, Koide, Kaur, and Hemamalini do not disclose a specific weight percent of aqueous filler.
However, Wang et al. discloses collagen blend with starch with the follow weight percentages:
“The collagen slurry with 30 wt% of glycerol (on the basis of the dry collagen fiber) was mixed with high amylose corn starch, waxy corn starch, and normal corn starch, each at the concentrations of 10 wt%, 50 wt%, and 0 wt% (i.e. neat collagen film as the control).” (Wang et al., page 210, col. 2, para. 2). Wang also discloses the resulting physical properties in Table 1. (Wang et al. page 212, Table 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the starch weight scheme of Wang with the composition of Koide, Kaur, and Hemamalini to arrive at the claimed invention.
A person of ordinary skill in the art would be motivated to make this combination to create a film or gel with the properties recited by Wang.
A person of ordinary skill in the art would have a reasonable expectation of success because Wang is creating collagen films and the peptides of the instant application are collagen-like peptides.
Consequently, claim 12 is obvious over the ‘152 patent in view of Koide et al., Kaur et al, and Hemamalini et al. as applied to claim 8, further in view of Wang et al. and rejected.
Regarding claim 22, claim 8 is obvious as described above. Claim 22 further recites a method for producing the composition according to claim 8 , which comprises making the polymerized peptide represented by the formula (1) and the aqueous filler into a homogeneous physical mixture.
The composition of claim 8 is obvious as described above.
Wang discloses:
“The collagen slurry with 30 wt% of glycerol (on the basis of the dry collagen fiber) was mixed with high amylose corn starch, waxy corn starch, and normal corn starch, each at the concentrations of 10 wt%, 50 wt%, and 0 wt% (i.e. neat collagen film as the control). After mixing, 65 ml of the dispersion (pH = 2) were quickly cast onto a pre-leveled polyacrylic plate (12 × 12 cm) and then air-dried in a ventilation hood at room temperature for 24 h. The newly formed film was peeled off from the plate and kept in a desiccator at 25 °C and 52% relative humidity (RH) for 48 h. In order to study the affect of heat on film performance, some films were firstly heated in a water bath at 80 °C for 30 min then air-dried at room temperature. All experiments were carried out immediately after removal from the chamber in order to avoid variation caused by moisture.” (Wang et al., page 210, col. 2, para. 2)
The described mixing would result in a homogenous mixture. Furthermore, Wang treats the mixtures as homogenous for the rest of the disclosure. (Wang et al. page 212, Table 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the method of Wang to arrive at a homogeneous mixture by mixing.
A person of ordinary skill in the would be motivated to create a homogeneous mixture to ensure quality control and ensure consistent physical characteristics as described by Wang.
A person of ordinary skill in the art would have a reasonable expectation of success because the mixing of Wang resulted in such a mixture.
Consequently, claim 22 is obvious over the ‘152 patent in view of Koide et al., Kaur et al, and Hemamalini et al. as applied to claim 8, further in view of Wang et al. and rejected.
Claims 18-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,851,152 in view of Koide et al. US 20180319867, as applied to claim 1 above, and further in view of Khan, et al (Khan, et al. Journal of Indian Society of Periodontology 17.4: 539-542 (2013)) and Liao et al. (Liao, et al. International journal of ophthalmology 12.4: 660 (2019)).
Regarding claim 18, claim 1 is anticipated as described above. Claim 18 further recites a therapeutic agent for an eye disease comprising the composition according to claim 1.
Koide discloses that the composition of claim 1 is a collagen-like peptide: “The present invention relates to a polymerized peptide containing a collagen-like peptide, a gel and a polymerized peptide membrane containing the polymerized peptide, a method for producing the same and uses thereof.” (Koide et al., para. [0001]).
The ‘152 patent and Koide do not specifically disclose usage of this composition for an eye disease.
However, Liao discloses the usage of drugs for treatment of retinal detachment: “Currently, drugs are mainly used as an auxiliary therapy for retinal detachment. Western medicines used in treatment include tenecteplase, acetazolamide, and triamcinolone acetonide.” (Liao, et al., page 665, col. 1, para. 1).
Furthermore, Khan discloses the usage of collagen shields for drug delivery: “The collagen shield was designed for bandage contact lenses, which are gradually dissolved in the cornea. The use of collagen‑based drug delivery systems is the ease with which the formulation can be applied to the ocular surface and its potential for self‑administration.” (Khan et al., page 540, col. 1, para. 5).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the composition of Koide to create a collagen shield as disclosed by Khan for the treatment of retinal detachment as disclosed by Liao.
A person of ordinary skill in the art would be motivated to make this combination to deliver drugs safely to the eye in the case of retinal detachment.
A person of ordinary skill in the art would have a reasonable expectation of success because Koide discloses that these are collagen-like peptides and that they can form membranes. These collagen-like peptides would reasonably be expected to be usable as collagen shields as suggested by Khan to deliver the drugs of Liao.
Consequently, claim 18 is obvious over the ‘152 patent in view of Koide et al. as applied to claim 1, further in view of Khan et al. and Liao et al. and rejected.
Regarding claim 19, claim 18 is obvious as described above. Claim 19 further recites the case wherein the eye disease is macular hole or retinal detachment.
The drugs of Liao treat retinal detachment as described above.
Consequently, claim 19 is obvious over the ‘152 patent in view of Koide et al. as applied to claim 1, further in view of Khan et al. and Liao et al. and rejected.
Regarding claim 20, claim 1 is anticipated as described above. Claim 20 further recites: “A method for treating an eye disease, comprising a step of administering to a subject a therapeutically effective amount of the composition according to claim 1.”
A therapeutic agent for an eye disease is obvious as described above in claim 18.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to use a therapeutic agent for an eye disease comprising the composition according to claim 1 in a method for treating an eye disease.
A person of ordinary skill in the art would be motivated to treat an eye disease with a composition that can be used in an obvious therapeutic agent for eye disease.
A person of ordinary skill in the art would have a reasonable expectation of success because said obvious therapeutic agent is intended for use with eye diseases.
Consequently, claim 20 is obvious over the ‘152 patent in view of Koide et al. as applied to claim 1, further in view of Khan et al. and Liao et al. and rejected.
Regarding claim 21, claim 20 is obvious as described above. Claim 21 further recites the case wherein the eye disease is macular hole or retinal detachment.
The drugs of Liao treat retinal detachment as described above.
Consequently, claim 21 is obvious over the ‘152 patent in view of Koide et al. as applied to claim 1, further in view of Khan et al. and Liao et al. and rejected.
Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,851,152 in view of Koide et al. US 20180319867, as applied to claim 1 above, and further in view of Kaur et al. (Kaur, et al. Bioactive natural products in drug discovery : 517-545 (2020)), Hemamalini et al. (Hemamalini, et al. International journal of biological macromolecules 106: 712-718 (2018)), and Wang et al. (Wang, et al. Food chemistry 216: 209-216 (2017)).
Regarding claim 24, claim 1 is obvious as described above. Claim 24 further recites the case wherein the polymerized peptide is present in an amount of 50% to 90% relative to the total weight of the composition.
The ‘152 patent and Koide do not explicitly disclose an aqueous filler as described by the current specification.
However, Kaur discloses that starch is used as an inert filler in the pharmaceutical industry: “Native starch is frequently employed in the pharmaceutical industry in the manufacturing of tablets where it acts as an inert filler, binder, glidant, lubricant, and disintegrating agent. Starch is also used in capsules as inert filler and in topical formulations to impart a thick consistency.” (Kaur et al., page 525, para. 4).
Kaur also discloses that “Starch fibers, nanoparticles, microparticles, and hydrogels are also being evaluated as scaffolds for tissue engineering, drug delivery, and wound dressings.” (Kaur et al., page 526, para. 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the starch filler of Kaur with the peptide of Koide to arrive at the claimed invention.
A person of ordinary skill in the art would be motivated to used starch because it is common: “Among all the polysaccharides, starch is the second abundant compound available in the green plants next to cellulose.” (Hemamalini et al., page 713, col. 2, para. 1). Furthermore, starch, and polysaccharides in general have many desirable properties as fillers:
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(Hemamalini et al., page 714, Fig. 2)
A person of ordinary skill in the art would have a reasonable expectation of success because Hememalini discloses that starches are used in hydrogels:
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204
368
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(Hemamalini et al., page 714, Fig. 3)
The ‘152 patent, Koide, Kaur, and Hemamalini do not disclose a specific weight percent of aqueous filler.
However, Wang et al. discloses collagen blend with starch with the follow weight percentages:
“The collagen slurry with 30 wt% of glycerol (on the basis of the dry collagen fiber) was mixed with high amylose corn starch, waxy corn starch, and normal corn starch, each at the concentrations of 10 wt%, 50 wt%, and 0 wt% (i.e. neat collagen film as the control).” (Wang et al., page 210, col. 2, para. 2). Wang also discloses the resulting physical properties in Table 1. (Wang et al. page 212, Table 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the starch weight scheme of Wang with the composition of Koide, Kaur, and Hemamalini to arrive at the claimed invention. In the case where the starch is at 50% weight, the collagen peptide would also be at 50% weight, which reads on this claim.
A person of ordinary skill in the art would be motivated to make this combination to create a film or gel with the properties recited by Wang.
A person of ordinary skill in the art would have a reasonable expectation of success because Wang is creating collagen films and the peptides of the instant application are collagen-like peptides.
Consequently, claim 24 is obvious over the ‘152 patent in view of Koide et al. as applied to claim 1, further in view of Kaur et al, Hemamalini et al., and Wang et al. and rejected.
Conclusion
No claim is allowed.
Claims 1-12, 14, 16-22, and 24 are rejected.
Claims 1, 3, 4, 6, and 7 are objected to.
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/DAVID PAUL BOWLES/ Examiner, Art Unit 1654
/LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654
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