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
Applicants’ election without traverse of Group I, claims 1-11 and 14-25, in the reply filed on 13 March 2026 is acknowledged.
Applicants’ election without traversal of the species of polypeptide (SEQ ID NO: 1), the pharmaceutically acceptable carrier being water and the single and specific corneoscleral disease, disorder or condition being myopia in the reply filed 13 March 2026 is acknowledged.
Claims 8-23 and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 13 March 2026.
Claims 1-7 and 24-25 are under consideration.
Status of Claims
The claim listing filed 13 March 2026 is pending. Claims 12-23 and 26 are withdrawn from further consideration for the reasons set forth above, 37 CFR 1.142(b). Claims 1-11 and 24-25 are being examined on the merits of this office action.
Priority
The present application claims benefit under 35 U.S.C. 119(e) to U.S. Provisional Application No. 63/367,080 filed 27 June 2022. Applicants claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365 (c) is acknowledged.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 13 March 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statement is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See pgs. 4 [0016], 7 [0018], 51 [0497], 59 [0477], and 95 [524]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 states “A composition suitable for use in a medicament for treating or preventing a corneoscleral disease, disorder or condition in a human or veterinary animal in need of treatment or prevention thereof, said composition comprising (a) at least one collagen mimetic peptide (CMP) having, and (b) one or more pharmaceutically suitable carriers.” For improved clarity, please amend the claim to say “A composition suitable for use in a medicament for treating or preventing a corneoscleral disease, disorder or condition in a human or veterinary animal in need of treatment or prevention thereof, said composition comprising (a) at least one collagen mimetic peptide (CMP) . Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a composition comprising natural products without significantly more, due to the results of the following subject matter eligibility test using the generic claim, claim 1.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes. The claim is to “A composition suitable for use in a medicament for treating or preventing a corneoscleral disease, disorder or condition in a human or veterinary animal in need of treatment or prevention thereof, said composition comprising (a) at least one collagen mimetic peptide (CMP) having, and (b) one or more pharmaceutically suitable carriers”.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon or an abstract idea?
Yes. The claim is directed to a natural phenomenon (a collagen mimetic peptide and one or more pharmaceutically suitable carriers). A pharmaceutically suitable carrier could be water, a natural product. The natural phenomenon of the instant invention is a collagen mimetic peptide and a pharmaceutically suitable carrier. The closest natural counterpart to the instant invention as claimed would be the protein, collagen and water. According the Harvard School of Public Heath (“Collagen • The Nutrition Source.” The Nutrition Source - Harvard Chan School. (2021, May). https://nutritionsource.hsph.harvard.edu/collagen/), collagen is the most abundant protein in the body, used for connecting tissues and is a major component of bones, skin, muscles, tendons, and cartilage (pg. 1, “Collagen is the most abundant protein in the body. Its fiber-like structure is used to make connective tissue. Like the name implies, this type of tissue connects other tissues and is a major component of bone, skin, muscles, tendons, and cartilage.”). According to the FDA (“Water for pharmaceutical use.” U.S. Food and Drug Administration. (2014, August 27). https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/water-pharmaceutical-use), water can be used in the manufacture of pharmaceuticals, and that potable water used for the manufacture of drug products is primarily obtained from municipal water systems or natural sources like wells, rivers, or ponds (pgs. 1-2 ,“This ITG will cover the different types of water used in the manufacture of drug products. THE 8 TYPES OF WATER ARE:
Non-potable
Potable (drinkable) water
USP purified water
USP water for injection (WFI) …
The USP defines acceptable means of producing the various types of component waters. USP WFI may be made only by distillation or reverse osmosis.
Potable water is obtained primarily from municipal water systems but may also be drawn from wells, rivers, or ponds.”).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No. The claim recites the limitation "A composition … said composition comprising (a) at least one collagen mimetic peptide (CMP) having, and (b) one or more pharmaceutically suitable carriers". The ability of the natural phenomenon/product of nature as stated in the instant claim is drawn to an intended use, which is not sufficient to overcome the fact that the composition of claim 1 is drawn to the combination of two natural products. A composition comprising collagen and water would have the function as the
Therefore, claim 1 of the instant application does not recite a composition with elements that amount to significantly more than the judicial exception and is subject to this rejection.
Claims 2-3 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because while the claims recite specifics of what the composition could treat, the composition of claim 1 already had that function. For example, Touro College of Pharmacy (Touro College, Ozempic and Wegovy: What you need to know 2024) states Semaglutide was first developed to treat type 2 diabetes and managing bloods sugar levels, and then was approved for chronic weight management. Regardless of the initial use, Semaglutide always had the ability to manage weight (pg. 1, “Semaglutide, the active ingredient in Ozempic and Wegovy, was originally approved to treat type 2 diabetes mellitus as Ozempic, and later approved for treatment of obesity as Wegovy.”).
Claim 4 is directed toward the composition of claim 1, wherein the CMP is attached to a therapeutic compound (TC) to form a CMP-TC conjugate. The specification of the instant application described “Substance P” being a potential therapeutic compound ([0086] “One example of such a CMP-TC is a peptide conjugate in which the wound healing peptide known as Substance P and having an amino acid sequence of Arg-Pro-Lys-Pro-Gln-Gln-Phe-Phe-Gly-Leu-Met (SEQ ID NO:471), is attached to a CMP described herein.”). Li et al. teaches Substance P as a naturally occurring peptide that is released from sensory nerve endings and regulates bone metabolism, cartilage metabolism, and fracture healing (pg. 1, “Substance P (SP) is a neuropeptide that is released from sensory nerve endings and is widely present in nerve fibers. It acts on bones and related tissues by binding to receptors, thereby regulating bone metabolism, cartilage metabolism, and fracture healing.”). Therefore, the addition of “at least one therapeutic compound” does not overcome the rejection under 35 U.S.C. 101 due to each component of the composition being drawn to a natural product.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 and 24-25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Schlumpf et al., hereafter “Schlumpf” (US2018/0325977 A1).
In the restriction/species election response filed 13 March 2026, Applicants elected water as the single and specific pharmaceutically acceptable carrier.
Regarding claim 1, Schlumpf teaches a composition comprising a collagen mimetic peptide (CMP), identical to the instant SEQ ID NO: 1 and water ([0032] “In certain embodiments of the invention, the collagen mimetic peptide comprises, consists essentially of or consists of an amino acid sequence that is or corresponds to a 21-mer comprising seven repeats of a three amino acid sequence of proline-proline-glycine ((Pro-Pro-Gly)7), i.e., an amino acid sequence of: Pro-Pro-Gly-Pro-Pro-Gly-Pro-Pro-Gly-Pro-Pro-Gly-Pro-Pro-Gly-Pro-Pro-Gly-Pro-Pro-Gly (SEQ ID NO: 1).”; [0069] “Pharmaceutically acceptable carriers or excipients suitable for use in the compositions and methods of the invention include, for example, one or more solvents (which may include water, ...”). SEQ ID NO: 1 as taught in Schlumpf is identical to the instant SEQ ID NO: 1, therefore the sequence anticipates the instant elected species of SEQ ID NO: 1.
Regarding the claims recitation of the composition being suitable for “use in a medicament for treating or preventing corneoscleral disease, disorder, or condition in a human or veterinary animal in need of treatment or prevention thereof”, the peptide of Schlumpf comprises the amino acid sequence that is claimed to treat or prevent corneoscleral diseases, disorders, or conditions and because a chemical composition and its properties are inseparable, a person of ordinary skill in the art would reasonably expect the peptide of Schlumpf to also treat or prevent corneoscleral diseases, disorders, or conditions. See MPEP 2112.01 (II).
In the restriction/species election response filed 13 March 2026, Applicants elected myopia as the corneoscleral disease, disorder or condition to be treated.
Regarding claims 2 and 3, with regard to the limitation " wherein said corneoscleral disease, disorder or condition is myopia", a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The peptide as described in Schlumpf contains the same structure as the peptide as described in SEQ ID NO: 1 of the instant claim, thus it is interpreted as being sufficient in the treatment of myopia as elected in the response filed 13 March 2026.
Regarding claim 4, Schlumpf teaches the CMP being attached to at least one therapeutic compound (TC) to form a CMP-TC conjugate ([0023] “In one aspect, the invention provides compositions comprising one or more collagen mimetic peptides (CMPs), which in certain embodiments have been conjugated one or more therapeutic compounds and/or one or more diagnostic compounds thereby forming CMP conjugates and compositions. ”).
In the restriction/species election response filed 13 March 2026, Applicants elected SEQ ID NO: 1 as the collagen mimetic peptide to be searched.
Regarding claims 5-7, Schlumpf discloses a peptide comprises the amino acid sequence of the instant SEQ ID NO: 1. See the peptide represented by SEQ ID NO: 1. ([0032] “In certain embodiments of the invention, the collagen mimetic peptide comprises, consists essentially of or consists of an amino acid sequence that is or corresponds to a 21-mer comprising seven repeats of a three amino acid sequence of proline-proline-glycine ((Pro-Pro-Gly)7), i.e., an amino acid sequence of: Pro-Pro-Gly-Pro-Pro-Gly-Pro-Pro-Gly-Pro-Pro-Gly-Pro-Pro-Gly-Pro-Pro-Gly-Pro-Pro-Gly (SEQ ID NO: 1)”).
Regarding claims 24 and 25, Schlumpf teaches that the instant invention as a medical device that can be selected from a group consisting of a wafer, mesh and a patch ([0096] “In related embodiments, the invention provides devices, particularly medical devices, suitable for treating or preventing a disease, disorder or medical condition in a human or veterinary animal suffering from or predisposed to said disease, disorder or medical condition. … Suitable such devices include, but are not limited to, artificial joints, stents, catheters, sutures, bone screws, bone plates, prosthetics (e.g., artificial limbs, body structures, organs, etc.), absorbable or non-absorbable meshes, absorbable or non-absorbable patches, drug-releasing wafers, brain neurostimulators (e.g., deep brain neurostimulators), gastric stimulators, cochlear implants, cardiac defibrillators, cardiac pacemakers, insulin pumps, internal infusion pumps, and the like. ”).
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, , 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 (, 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 and 24-25 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, and 13 of U.S. Patent No. 12419936, hereafter “‘936”, in view of Schlumpf et al., hereafter “’977” (US2018/0325977 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the claim an overlapping composition.
Regarding claim 1, ‘936 claims a composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. (See claim 1)
Regarding claims 2-3, ‘936 claims a composition for treating a posterior segment ocular disease or disorder, a paraocular disease, disorder or medical condition, an extraocular disease, disorder or medical condition, or an anterior segment ocular disease or disorder, but does not teach a composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers treating myopia. (See claim 1)
‘977 teaches a composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition being suitable for treating ocular diseases ([0071] “Ocular diseases or disorders that can be treated, prevented, ameliorated or diagnosed using the compositions and methods of the invention include but are not limited to glaucoma, cataracts, vitreous adhesions or floaters, macular degeneration, …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of ‘936 containing a CMP and a pharmaceutical carrier by substituting the CMP of ‘936 with SEQ ID NO: 1 of ‘977. The rationale for substitution comes from the compounds being in the same family of collagen mimetic peptides and the ‘977 teaching (Pro-Pro-Gly)7 (instant SEQ ID NO: 1) as a CMP that can be used to treat ocular disease. There would have been a reasonable expectation of success because the compounds are highly related to each other. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claims 2-3, these claims merely refine the patient population of the preamble statement and are intended use limitations.
With respect to claim 4, ‘936 claims the composition of claim 1 where the mimetic peptide is attached to at least one therapeutic compound to form a CMP-TC conjugate (see claim 2).
With respect to claims 5-7, ‘936 claims the composition of claim 1 wherein the collagen mimetic peptide is disclosed in SEQ ID NO: 6, which is different than the instant SEQ ID NO: 1. (See claim 1)
‘977 teaches a composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition being suitable for treating ocular diseases ([0071] “Ocular diseases or disorders that can be treated, prevented, ameliorated or diagnosed using the compositions and methods of the invention include but are not limited to glaucoma, cataracts, vitreous adhesions or floaters, macular degeneration, …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of ‘936 containing a CMP and a pharmaceutical carrier by substituting the CMP of ‘936 with SEQ ID NO: 1 of ‘977. The rationale for substitution comes from the compounds being in the same family of collagen mimetic peptides and the ‘977 teaching (Pro-Pro-Gly)7 as a CMP that can be used to treat ocular disease. There would have been a reasonable expectation of success because the compounds are highly related to each other. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 24, ‘936 teaches the composition of claim 1 in the form of a wafer, film, gel, mesh or patch. (See claim 13)
‘936 does not teach a general medical device comprising the composition.
‘977 teaches composition (comprising a sequence identical to SEQ ID NO: 1 of ‘936) suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition as a medical device, including the use of a wafer, mesh and a patch ([0096] “In related embodiments, the invention provides devices, particularly medical devices, suitable for treating or preventing a disease, disorder or medical condition in a human or veterinary animal suffering from or predisposed to said disease, disorder or medical condition. … Suitable such devices include, but are not limited to, artificial joints, stents, catheters, sutures, bone screws, bone plates, prosthetics (artificial limbs, body structures, organs, etc.), absorbable or non-absorbable meshes, absorbable or non-absorbable patches, drug-releasing wafers, …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the species of medical devices of ‘936 with the genus of medical devices of ‘977. The rationale for substitution comes from the compounds being identical and both references teaching that the composition could be made into a medical device. There would have been a reasonable expectation of success because the compounds are identical to each other. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 25, ‘936 teaches the composition of claim 1 in the form of a wafer, film, gel, mesh or patch. (See claim 13)
Claims 1-7 and 24-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8 and 10 of U.S. Patent No. 10632168 (hereinafter referred to as “‘168”), in view of Schlumpf et al., hereafter “’977” (US2018/0325977 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the claim an overlapping composition.
Regarding claim 1, ‘168 teaches a composition comprising at least one collagen mimetic peptide (CMP) comprising the amino acid sequence of SEQ ID NO: 1, and one or more pharmaceutically suitable carriers. (See claim 1)
Regarding claims 2-3, ‘168 claims a composition used for treating ocular disease, disorder or wound selected from the group consisting of glaucoma, dry eye syndrome, conjunctivitis, corneal keratitis, corneal laceration, corneal erosion, and corneal abrasion. (See claim 1)
‘977 teaches a composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition being suitable for treating ocular diseases ([0071] “Ocular diseases or disorders that can be treated, prevented, ameliorated or diagnosed using the compositions and methods of the invention include but are not limited to glaucoma, cataracts, vitreous adhesions or floaters, macular degeneration, …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of ‘168 containing a CMP and a pharmaceutical carrier by substituting the CMP of ‘168 with SEQ ID NO: 1 of ‘977. The rationale for substitution comes from the compounds being in the same family of collagen mimetic peptides and the ‘977 teaching (Pro-Pro-Gly)7 (instant SEQ ID NO: 1) as a CMP that can be used to treat ocular disease. There would have been a reasonable expectation of success because the compounds are identical to each other. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claim 4, ‘168 claims the composition of claim 1 where the mimetic peptide is attached to at least one therapeutic compound to form a CMP-TC conjugate (see claim 10).
With respect to claims 5-7, ‘936 claims the composition of claim 1 wherein the collagen mimetic peptide is disclosed in SEQ ID NO: 1. (See claim 1)
Regarding claim 24, ‘168 teaches the composition of claim 1 in the form of a wafer, film, gel, mesh or patch. (See claim 8)
‘168 does not teach a general medical device comprising the composition.
‘977 teaches composition (comprising a sequence identical to SEQ ID NO: 1 of ‘168) suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition as a medical device, including the use of a wafer, mesh and a patch ([0096] “In related embodiments, the invention provides devices, particularly medical devices, suitable for treating or preventing a disease, disorder or medical condition in a human or veterinary animal suffering from or predisposed to said disease, disorder or medical condition. … Suitable such devices include, but are not limited to, artificial joints, stents, catheters, sutures, bone screws, bone plates, prosthetics (artificial limbs, body structures, organs, etc.), absorbable or non-absorbable meshes, absorbable or non-absorbable patches, drug-releasing wafers, …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the species of medical devices of ‘168 with the genus of medical devices of ‘977. The rationale for substitution comes from the compounds being identical and both references teaching that the composition could be made into a medical device. There would have been a reasonable expectation of success because the compounds are identical to each other. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 25, ‘168 teaches the composition of claim 1 in the form of a wafer, film, gel, mesh or patch. (See claim 8)
Claims 1-7 and 24-25 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12 of U.S. Patent No. 11389513, hereafter “‘513”, in view of Schlumpf et al., hereafter “’977” (US2018/0325977 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the claim an overlapping composition.
Regarding claim 1, ‘513 teaches a composition comprising at least one collagen mimetic peptide (CMP) and one or more pharmaceutically suitable carriers. (See claim 1)
Regarding claims 2-3, ‘513 claims a composition used for treating a posterior segment disease, disorder or wound, a paraocular disease, disorder or medical condition, an extraocular disease, disorder or medical condition, or an anterior segment ocular disease, disorder or wound. (See claim 1)
‘977 teaches a composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition being suitable for treating ocular diseases, including keratoconus ([0071] “Ocular diseases or disorders that can be treated, prevented, ameliorated or diagnosed using the compositions and methods of the invention include but are not limited to glaucoma, cataracts, vitreous adhesions or floaters, macular degeneration, dry eye syndrome, corneal keratitis, non-infectious corneal ulceration, non-infectious corneal melting, infectious corneal ulceration, infectious corneal melting, conjunctivitis, Stevens-Johnson Syndrome, scleritis, episcleritis, ectasia, keratoconus, …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the composition of ‘513 containing a CMP and a pharmaceutical carrier to treat myopia due to the disclosure of ‘977 teaching that a CMP and a pharmaceutically suitable carrier can be used to treat keratoconus, as required by claims 2 and 3. The rationale for substitution comes from the compounds being in the same family of collagen mimetic peptides and the ‘977 teaching (Pro-Pro-Gly)7 (instant SEQ ID NO: 1) as a CMP that can be used to treat ocular disease. There would have been a reasonable expectation of success because the compounds are identical to each other. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claim 4, ‘513 does not claim that a CMP is attached to at least one therapeutic compound (TC) to form a CMP-TC conjugate.
‘977 teaches the CMP being attached to at least one therapeutic compound (TC) to form a CMP-TC conjugate and that the attachment of a TC would provide an elegant, rapid and reproducible way of overcoming many limitations in drug delivery ([0020] “Treatments for diseases/disorders are expensive, difficult to deliver with specificity, and may have deleterious effects at sites distal to the intended site of action. … administered parenterally in a non-targeted fashion and must diffuse or otherwise find their way to the site of the affliction before they are able to provide their therapeutic benefits. This “shotgun approach” to therapy necessarily requires higher dosing and can result in longer periods of therapy and reduced patient compliance than a therapeutic approach which would deliver therapeutic compounds and compositions in a more targeted fashion which would allow for controlled or programmable release at or near the site of the affliction in a human or veterinary animal.”;[0022] “… the conjugation of a variety of therapeutic compounds and/or diagnostic compounds to collagen or collagen mimetic peptides would provide an elegant, rapid and reproducible way of overcoming many of the above-referenced limitations in drug delivery …”; [0023] “In one aspect, the invention provides compositions comprising one or more collagen mimetic peptides (CMPs), which in certain embodiments have been conjugated one or more therapeutic compounds and/or one or more diagnostic compounds thereby forming CMP conjugates and compositions. ”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inventive medical device of ‘513 with the teachings of ‘977. The rationale for addition comes from the compounds being similar, and ‘977 teaching that the addition of therapeutic compounds provides an elegant way of overcoming many drug delivery limitations. There would have been a reasonable expectation of success because the addition takes a known compound and improves it with a known technique to yield a predictable result (overcoming drug delivery limitations). The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claims 5-7, ‘513 teaches the CMP as SEQ ID NO: 6. (See claim 1)
‘513 does not claim that the CMP is SEQ ID NO: 1.
‘977 teaches a composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition being suitable for treating ocular diseases, including macular degeneration ([0071] “Ocular diseases or disorders that can be treated, prevented, ameliorated or diagnosed using the compositions and methods of the invention include but are not limited to glaucoma, cataracts, vitreous adhesions or floaters, macular degeneration, dry eye syndrome, corneal keratitis, non-infectious corneal ulceration, non-infectious corneal melting, infectious corneal ulceration, infectious corneal melting, conjunctivitis, Stevens-Johnson Syndrome, scleritis, episcleritis, ectasia, keratoconus, …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of ‘513 containing a CMP and a pharmaceutical carrier by substituting the CMP of ‘513 with SEQ ID NO: 1 of ‘977. The rationale for substitution comes from the compounds being in the same family of collagen mimetic peptides and the ‘977 teaching (Pro-Pro-Gly)7 as a CMP that can be used to treat ocular disease. There would have been a reasonable expectation of success because the compounds are highly related to each other due to both ‘513 and ‘977 teaching that macular degeneration can be treated or prevented using their inventions. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 24, ‘513 teaches the composition of claim 1 in the form of a wafer, film, gel, mesh or patch. (See claim 12)
‘513 does not teach a general medical device comprising the composition.
‘977 teaches composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition as a medical device, including the use of a wafer, mesh and a patch ([0096] “In related embodiments, the invention provides devices, particularly medical devices, suitable for treating or preventing a disease, disorder or medical condition in a human or veterinary animal suffering from or predisposed to said disease, disorder or medical condition. … Suitable such devices include, but are not limited to, artificial joints, stents, catheters, sutures, bone screws, bone plates, prosthetics (artificial limbs, body structures, organs, etc.), absorbable or non-absorbable meshes, absorbable or non-absorbable patches, drug-releasing wafers, …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the species of medical devices of ‘513 with the genus of medical devices of ‘977. The rationale for substitution comes from the compounds being identical and both references teaching that the composition could be made into a medical device. There would have been a reasonable expectation of success because the compounds are identical to each other. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 25, ‘513 teaches the composition of claim 1 in the form of a wafer, film, gel, mesh or patch. (See claim 12)
Claims 1-7 and 24-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46-48, 54, 56-58, and 64 of copending Application No. 18/932,246, hereafter “‘246” ”, in view of Schlumpf et al., hereafter “’977” (US2018/0325977 A1).
Regarding claim 1, ‘246 teaches a composition comprising at least one collagen mimetic peptide (CMP) and one or more pharmaceutically suitable carriers. (See claims 46 and 56)
Regarding claims 2-3, ‘246 claims a composition used for treating or preventing a nervous system disease, disorder or injury, or treating or preventing a cardiovascular disease, disorder or injury (See claims 46 and 56)
‘977 teaches a composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition being suitable for treating ocular diseases, including keratoconus ([0071] “Ocular diseases or disorders that can be treated, prevented, ameliorated or diagnosed using the compositions and methods of the invention include but are not limited to glaucoma, cataracts, vitreous adhesions or floaters, macular degeneration, dry eye syndrome, corneal keratitis, non-infectious corneal ulceration, non-infectious corneal melting, infectious corneal ulceration, infectious corneal melting, conjunctivitis, Stevens-Johnson Syndrome, scleritis, episcleritis, ectasia, keratoconus, …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the composition of ‘246 containing a CMP and a pharmaceutical carrier to treat keratoconus due to the disclosure of ‘977 teaching that a CMP and a pharmaceutically suitable carrier can be used to treat keratoconus, as required by claims 2 and 3. The rationale for substitution comes from both compounds being collagen mimetic peptides and the ‘977 teaching (Pro-Pro-Gly)7 (instant SEQ ID NO: 1) as a CMP that can be used to treat ocular disease. The instant SEQ ID NO: 1 is described in SEQ ID NO: 1 of ‘246 (see claim 48). There would have been a reasonable expectation of success because the compounds are identical to each other. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claim 4, ‘246 teaches that a CMP is attached to at least one therapeutic compound (TC) to form a CMP-TC conjugate. (See claims 47 and 57)
With respect to claims 5-7, ‘246 teaches the CMP as SEQ ID NO: 1. (See claims 48 and 58)
Regarding claim 24, ‘246 teaches the composition of claim 46 and 56 in the form of a medical device. (See claims 54 and 64)
Regarding claim 25, ‘246 does not teach the medical device being a stent, a shunt, a suture, an absorbable mesh, an absorbable patch, a drug-releasing wafer, a film, and an internal infusion pump.
‘977 teaches composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition as a medical device that can be selected from a group consisting of ([0096] “In related embodiments, the invention provides devices, particularly medical devices, suitable for treating or preventing a disease, disorder or medical condition in a human or veterinary animal suffering from or predisposed to said disease, disorder or medical condition. … Suitable such devices include, but are not limited to, artificial joints, stents, catheters, sutures, bone screws, bone plates, prosthetics (e.g., artificial limbs, body structures, organs, etc.), absorbable or non-absorbable meshes, absorbable or non-absorbable patches, drug-releasing wafers, brain neurostimulators (e.g., deep brain neurostimulators), gastric stimulators, cochlear implants, cardiac defibrillators, cardiac pacemakers, insulin pumps, internal infusion pumps, and the like. ”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inventive medical device of ‘246 with the species of medical devices of ‘977. The rationale for substitution comes from the compounds being identical and both references teaching that the composition could be made into a medical device. There would have been a reasonable expectation of success because the compounds are identical. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-11 and 24-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, and 10 of U.S. Patent No. 11426440 (hereinafter referred to as “‘440”), in view of Schlumpf et al., hereafter “’977” (US2018/0325977 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the claim an overlapping composition.
Regarding claim 1, ‘440 teaches a composition comprising at least one collagen mimetic peptide (CMP) and one or more pharmaceutically suitable carriers. (See claim 1)
Regarding claims 2-3, ‘440 teaches the composition treating an ocular disease, disorder or wound selected from the group consisting of glaucoma, dry eye syndrome, conjunctivitis, corneal keratitis, corneal laceration, corneal erosion, and corneal abrasion. (See claim 1)
‘977 teaches a composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition being suitable for treating ocular diseases, including keratoconus and dry eye syndrome ([0071] “Ocular diseases or disorders that can be treated, prevented, ameliorated or diagnosed using the compositions and methods of the invention include but are not limited to glaucoma, cataracts, vitreous adhesions or floaters, macular degeneration, dry eye syndrome, corneal keratitis, non-infectious corneal ulceration, non-infectious corneal melting, infectious corneal ulceration, infectious corneal melting, conjunctivitis, Stevens-Johnson Syndrome, scleritis, episcleritis, ectasia, keratoconus, …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the composition of ‘440 containing a CMP and a pharmaceutical carrier to treat keratoconus due to the disclosure of ‘977 teaching that a CMP and a pharmaceutically suitable carrier can be used to treat keratoconus, as required by claims 2 and 3. The rationale for substitution comes from both compounds being collagen mimetic peptides and the ‘977 teaching (Pro-Pro-Gly)7 (instant SEQ ID NO: 1) as a CMP that can be used to treat ocular disease. The instant SEQ ID NO: 1 is described in SEQ ID NO: 1 of ‘440 (see claim 1). There would have been a reasonable expectation of success because the compounds are identical to each other. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 4, ‘440 claims the method of claim 1 where the mimetic peptide is attached to at least one therapeutic compound to form a CMP-TC conjugate (see claim 10).
Regarding claims 5-7, ‘440 teaches a SEQ ID NO: 1, identical to the elected SEQ ID NO: 1. (See claim 1)
With respect to claims 24-25, ‘440 claims the method of claim 1 where the composition is administered to the eye in the form of a wafer, film, gel, mesh or patch (see claim 8).
‘440 does not teach the medical device being a stent, a suture, an absorbable mesh, an absorbable patch, a drug-releasing wafer, a film, and an internal infusion pump.
‘977 teaches composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition as a medical device that can be selected from a group consisting of stents, sutures, meshes, wafers and pumps ([0096] “In related embodiments, the invention provides devices, particularly medical devices, suitable for treating or preventing a disease, disorder or medical condition in a human or veterinary animal suffering from or predisposed to said disease, disorder or medical condition. … Suitable such devices include, but are not limited to, artificial joints, stents, catheters, sutures, bone screws, bone plates, prosthetics (e.g., artificial limbs, body structures, organs, etc.), absorbable or non-absorbable meshes, absorbable or non-absorbable patches, drug-releasing wafers, brain neurostimulators (e.g., deep brain neurostimulators), gastric stimulators, cochlear implants, cardiac defibrillators, cardiac pacemakers, insulin pumps, internal infusion pumps, and the like.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inventive medical device of ‘440 with the species of medical devices of ‘977. The rationale for substitution comes from the compounds being identical and both references teaching that the composition could be made into a medical device. There would have been a reasonable expectation of success because the compounds are highly related to each other. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 1-7 and 24-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, and 14 of U.S. Patent No. 11433112 (hereinafter referred to as “‘112”) in view of Schlumpf et al., hereafter “’977” (US2018/0325977 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the claim an overlapping composition.
Regarding claim 1, ‘112 teaches a composition comprising at least one collagen mimetic peptide (CMP) and one or more pharmaceutically suitable carriers. (See claim 1)
Regarding claims 2 and 3, ‘112 teaches the composition treating keratoconus. (See claim 1)
Regarding claim 4, ‘112 teaches that the mimetic peptide is attached to at least one therapeutic compound to form a CMP-TC conjugate (see claim 14).
Regarding claims 5-7, ‘112 teaches a SEQ ID NO: 1, identical to the elected SEQ ID NO: 1. (See claim 1)
Regarding claims 24-25, ‘112 claims the method of claim 1 where the composition is administered to the eye in the form of a wafer, film, gel, mesh or patch (see claim 12).
‘112 does not teach the medical device being a stent, a shunt, a suture, an absorbable mesh, an absorbable patch, a drug-releasing wafer, a film, and an internal infusion pump.
‘977 teaches composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition as a medical device that can be selected from a group consisting of ([0096] “In related embodiments, the invention provides devices, particularly medical devices, suitable for treating or preventing a disease, disorder or medical condition in a human or veterinary animal suffering from or predisposed to said disease, disorder or medical condition. … Suitable such devices include, but are not limited to, artificial joints, stents, catheters, sutures, bone screws, bone plates, prosthetics (, artificial limbs, body structures, organs, etc.), absorbable or non-absorbable meshes, absorbable or non-absorbable patches, drug-releasing wafers, brain neurostimulators (, deep brain neurostimulators), gastric stimulators, cochlear implants, cardiac defibrillators, cardiac pacemakers, insulin pumps, internal infusion pumps, and the like. ”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inventive medical device of ‘112 with the species of medical devices of ‘977. The rationale for substitution comes from the compounds being identical and both references teaching that the composition could be made into a medical device. There would have been a reasonable expectation of success because the compounds are identical to each other. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 1-7 and 24-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, and 14 of U.S. Patent No. 11684651 (hereinafter referred to as “‘651”), in view of Schlumpf et al., hereafter “’977” (US2018/0325977 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the claim an overlapping composition.
Regarding claim 1, ‘651 teaches a composition comprising at least one collagen mimetic peptide (CMP) and one or more pharmaceutically suitable carriers. (See claim 1)
Regarding claims 2-3, ‘651 teaches the composition treating an ocular disease, disorder or wound selected from the group consisting of cataracts, vitreous adhesions or floaters, macular degeneration, non-infectious corneal ulceration, non-infectious corneal melting, infectious corneal ulceration, infectious corneal melting, Stevens-Johnson Syndrome, scleritis, episcleritis, ectasia, keratoconus, and post-operative afflictions of the eye resulting from eye surgery. (See claim 1)
Regarding claim 4, ‘651 claims the method of claim 1 where the mimetic peptide is attached to at least one therapeutic compound to form a CMP-TC conjugate (see claim 14).
Regarding claims 5-7, ‘651 teaches the composition comprising SEQ ID NO: 1, identical to the elected SEQ ID NO: 1. (See claim 1)
Regarding claims 24-25, ‘651 claims the method of claim 1 where the composition is administered to the eye in the form of a wafer, film, gel, mesh or patch (see claim 12).
‘651 does not teach the medical device being a stent, a suture, an absorbable mesh, an absorbable patch, a drug-releasing wafer, a film, and an internal infusion pump.
‘977 teaches composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition as a medical device that can be selected from a group consisting of stents, sutures, meshes, wafers and pumps ([0096] “In related embodiments, the invention provides devices, particularly medical devices, suitable for treating or preventing a disease, disorder or medical condition in a human or veterinary animal suffering from or predisposed to said disease, disorder or medical condition. … Suitable such devices include, but are not limited to, artificial joints, stents, catheters, sutures, bone screws, bone plates, prosthetics (e.g., artificial limbs, body structures, organs, etc.), absorbable or non-absorbable meshes, absorbable or non-absorbable patches, drug-releasing wafers, brain neurostimulators (e.g., deep brain neurostimulators), gastric stimulators, cochlear implants, cardiac defibrillators, cardiac pacemakers, insulin pumps, internal infusion pumps, and the like.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inventive medical device of ‘651 with the species of medical devices of ‘977. The rationale for substitution comes from the compounds being identical and both references teaching that the composition could be made into a medical device. There would have been a reasonable expectation of success because the compounds are highly related to each other. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 1-11 and 24-25 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, and 14 of U.S. Patent No. 12280086, hereafter “‘086”, in view of Schlumpf et al., hereafter “’977” (US2018/0325977 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the claim an overlapping composition.
Regarding claim 1, ‘086 teaches a composition comprising at least one collagen mimetic peptide (CMP) and one or more pharmaceutically suitable carriers. (See claim 1)
Regarding claims 2-3, ‘086 teaches the composition treating an ocular disease, disorder or wound selected from the group consisting of glaucoma, dry eye syndrome, conjunctivitis, corneal keratitis, corneal laceration, corneal erosion, corneal abrasion, cataracts, vitreous adhesions or floaters, non-infectious corneal ulceration, non-infectious corneal melting, infectious corneal ulceration, infectious corneal melting, Stevens-Johnson Syndrome, scleritis, episcleritis, ectasia, keratoconus, and post-operative afflictions of the eye resulting from eye surgery. (See claim 1)
Regarding claim 4, ‘086 teaches a composition where the mimetic peptide is attached to at least one therapeutic compound to form a CMP-TC conjugate (see claim 14).
Regarding claims 5-7, ‘086 claims a composition wherein the collagen mimetic peptide is disclosed in SEQ ID NO: 6, which is different than the instant SEQ ID NO: 1. (See claim 1)
‘977 teaches a composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition being suitable for treating ocular diseases, including keratoconus and dry eye syndrome ([0071] “Ocular diseases or disorders that can be treated, prevented, ameliorated or diagnosed using the compositions and methods of the invention include but are not limited to glaucoma, cataracts, vitreous adhesions or floaters, macular degeneration, dry eye syndrome, corneal keratitis, non-infectious corneal ulceration, non-infectious corneal melting, infectious corneal ulceration, infectious corneal melting, conjunctivitis, Stevens-Johnson Syndrome, scleritis, episcleritis, ectasia, keratoconus, …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of ‘086 containing a CMP and a pharmaceutical carrier by substituting the CMP of ‘086 with SEQ ID NO: 1 of ‘977. The rationale for substitution comes from the compounds being in the same family of collagen mimetic peptides and the ‘977 teaching (Pro-Pro-Gly)7 as a CMP that can be used to treat ocular diseases described in claim 1 of ‘086. There would have been a reasonable expectation of success because the compounds are highly related to each other and they both teach a method of treating the same ocular diseases. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claims 24-25, ‘086 claims the method of claim 1 where the composition is administered to the eye in the form of a wafer, film, gel, mesh or patch (see claim 12).
‘086 does not teach the medical device being a stent, a suture, an absorbable mesh, an absorbable patch, a drug-releasing wafer, a film, and an internal infusion pump.
‘977 teaches composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition as a medical device that can be selected from a group consisting of stents, sutures, meshes, wafers and pumps ([0096] “In related embodiments, the invention provides devices, particularly medical devices, suitable for treating or preventing a disease, disorder or medical condition in a human or veterinary animal suffering from or predisposed to said disease, disorder or medical condition. … Suitable such devices include, but are not limited to, artificial joints, stents, catheters, sutures, bone screws, bone plates, prosthetics (e.g., artificial limbs, body structures, organs, etc.), absorbable or non-absorbable meshes, absorbable or non-absorbable patches, drug-releasing wafers, brain neurostimulators (e.g., deep brain neurostimulators), gastric stimulators, cochlear implants, cardiac defibrillators, cardiac pacemakers, insulin pumps, internal infusion pumps, and the like.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inventive medical device of ‘086 with the species of medical devices of ‘977. The rationale for substitution comes from the compounds being identical and both references teaching that the composition could be made into a medical device. There would have been a reasonable expectation of success because the compounds are highly related to each other. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 1-7 and 24-25 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, and 14 of U.S. Patent No. 12551525, hereafter “‘525”, in view of Schlumpf et al., hereafter “’977” (US2018/0325977 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the claim an overlapping composition.
Regarding claim 1, ‘525 teaches a composition comprising at least one collagen mimetic peptide (CMP) and one or more pharmaceutically suitable carriers. (See claim 1)
Regarding claims 2-3, ‘525 teaches the composition treating an ocular disease, disorder or wound in a human or veterinary animal suffering from said ocular disease, disorder, or wound wherein said ocular disease, disorder or wound can be keratoconus. (See claim 1)
Regarding claim 4, ‘525 claims the method of claim 1 where the mimetic peptide is attached to at least one therapeutic compound to form a CMP-TC conjugate (see claim 14).
With respect to claims 5-7, ‘525 claims a composition wherein the collagen mimetic peptide is disclosed in SEQ ID NO: 6, which is different than the instant SEQ ID NO: 1. (See claim 1)
‘977 teaches a composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition being suitable for treating ocular diseases, including keratoconus and dry eye syndrome ([0071] “Ocular diseases or disorders that can be treated, prevented, ameliorated or diagnosed using the compositions and methods of the invention include but are not limited to glaucoma, cataracts, vitreous adhesions or floaters, macular degeneration, dry eye syndrome, corneal keratitis, non-infectious corneal ulceration, non-infectious corneal melting, infectious corneal ulceration, infectious corneal melting, conjunctivitis, Stevens-Johnson Syndrome, scleritis, episcleritis, ectasia, keratoconus, …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of ‘525 containing a CMP and a pharmaceutical carrier by substituting the CMP of ‘525 with SEQ ID NO: 1 of ‘977. The rationale for substitution comes from the compounds being in the same family of collagen mimetic peptides and the ‘977 teaching (Pro-Pro-Gly)7 as a CMP that can be used to treat ocular diseases described in claim 1 of ‘525. There would have been a reasonable expectation of success because the compounds are highly related to each other and they both teach a method of treating the same ocular diseases. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claims 24-25, ‘525 teaches the composition being administered to the eye in the form of a wafer, film, gel, mesh or patch (see claim 12).
‘525 does not teach the medical device being a stent, a suture, an absorbable mesh, an absorbable patch, a drug-releasing wafer, a film, and an internal infusion pump.
‘977 teaches composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition as a medical device that can be selected from a group consisting of stents, sutures, meshes, wafers and pumps ([0096] “In related embodiments, the invention provides devices, particularly medical devices, suitable for treating or preventing a disease, disorder or medical condition in a human or veterinary animal suffering from or predisposed to said disease, disorder or medical condition. … Suitable such devices include, but are not limited to, artificial joints, stents, catheters, sutures, bone screws, bone plates, prosthetics (e.g., artificial limbs, body structures, organs, etc.), absorbable or non-absorbable meshes, absorbable or non-absorbable patches, drug-releasing wafers, brain neurostimulators (e.g., deep brain neurostimulators), gastric stimulators, cochlear implants, cardiac defibrillators, cardiac pacemakers, insulin pumps, internal infusion pumps, and the like.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inventive medical device of ‘525 with the species of medical devices of ‘977. The rationale for substitution comes from the compounds being identical and both references teaching that the composition could be made into a medical device. There would have been a reasonable expectation of success because the compounds are highly related to each other. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 1-7 and 24-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, and 14 of copending Application No. 19/085,438, hereafter “‘438”, in view of Schlumpf et al., hereafter “’977” (US2018/0325977 A1).
Regarding claim 1, ‘438 teaches a composition comprising at least one collagen mimetic peptide (CMP) and one or more pharmaceutically suitable carriers. (See claim 1)
Regarding claims 2-3, ‘438 teaches the composition treating an ocular disease, disorder or wound selected from the group comprising keratoconus. (See claim 1)
Regarding claim 4, ‘438 teaches the composition of claim 1 where the mimetic peptide is attached to at least one therapeutic compound to form a CMP-TC conjugate (see claim 14).
Regarding claim 5-7, ‘438 teaches the CMP as SEQ ID NO: 12, a sequence different than the instant SEQ ID NO: 1.
‘977 teaches a composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition being suitable for treating ocular diseases, including keratoconus and dry eye syndrome ([0071] “Ocular diseases or disorders that can be treated, prevented, ameliorated or diagnosed using the compositions and methods of the invention include but are not limited to glaucoma, cataracts, vitreous adhesions or floaters, macular degeneration, dry eye syndrome, corneal keratitis, non-infectious corneal ulceration, non-infectious corneal melting, infectious corneal ulceration, infectious corneal melting, conjunctivitis, Stevens-Johnson Syndrome, scleritis, episcleritis, ectasia, keratoconus, …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of ‘438 containing a CMP and a pharmaceutical carrier by substituting the CMP of ‘438 with SEQ ID NO: 1 of ‘977. The rationale for substitution comes from the compounds being in the same family of collagen mimetic peptides and the ‘977 teaching (Pro-Pro-Gly)7 as a CMP that can be used to treat ocular diseases described in claim 1 of ‘438. There would have been a reasonable expectation of success because the compounds are highly related to each other and they both teach a method of treating the same ocular diseases. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claims 24-25, ‘438 also claims the composition in comprising a CMP and a pharmaceutically acceptable carrier in the form of a wafer, film, gel, mesh or patch (see claim 12).
‘438 does not teach the medical device being a stent, a shunt, a suture, an absorbable mesh, an absorbable patch, a drug-releasing wafer, a film, and an internal infusion pump.
‘977 teaches composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition as a medical device that can be selected from a group consisting of ([0096] “In related embodiments, the invention provides devices, particularly medical devices, suitable for treating or preventing a disease, disorder or medical condition in a human or veterinary animal suffering from or predisposed to said disease, disorder or medical condition. … Suitable such devices include, but are not limited to, artificial joints, stents, catheters, sutures, bone screws, bone plates, prosthetics (, artificial limbs, body structures, organs, etc.), absorbable or non-absorbable meshes, absorbable or non-absorbable patches, drug-releasing wafers, brain neurostimulators (deep brain neurostimulators), gastric stimulators, cochlear implants, cardiac defibrillators, cardiac pacemakers, insulin pumps, internal infusion pumps, and the like.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inventive medical device of ‘438 with the species of medical devices of ‘977. The rationale for substitution comes from the compounds being identical and both references teaching that the composition could be made into a medical device. There would have been a reasonable expectation of success because the compounds are highly related to each other in structure and intended function. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 and 24-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46-6 of copending Application No. 19/317,699, hereafter “‘699” ”, in view of Schlumpf et al., hereafter “’977” (US2018/0325977 A1).
Regarding claim 1, ‘699 teaches a composition comprising at least one collagen mimetic peptide (CMP) and one or more pharmaceutically suitable carriers. (See claim 1)
Regarding claims 2-3, ‘699 teaches the composition treating a nerve or nervous system disease, disorder or wound, involving the eye selected from the group comprising macular degeneration. (See claim 5)
‘699 does not show the composition treating myopia, presbyopia, or keratoconus.
‘977 teaches a composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition being suitable for treating ocular diseases, including macular degeneration and keratoconus ([0071] “Ocular diseases or disorders that can be treated, prevented, ameliorated or diagnosed using the compositions and methods of the invention include but are not limited to glaucoma, cataracts, vitreous adhesions or floaters, macular degeneration, dry eye syndrome, corneal keratitis, non-infectious corneal ulceration, non-infectious corneal melting, infectious corneal ulceration, infectious corneal melting, conjunctivitis, Stevens-Johnson Syndrome, scleritis, episcleritis, ectasia, keratoconus, …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the composition of ‘699 containing a CMP and a pharmaceutical carrier to treat myopia due to the disclosure of ‘977 teaching that a CMP and a pharmaceutically suitable carrier can be used to treat keratoconus, as required by claims 2 and 3. The rationale for substitution comes from the compounds being collagen mimetic peptides and the ‘977 teaching (Pro-Pro-Gly)7 (instant SEQ ID NO: 1) as a CMP that can be used to treat ocular disease. There would have been a reasonable expectation of success because the compounds are both collagen mimetic peptides that treat macular degeneration. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 4, ‘699 teaches the composition of claim 1 where the mimetic peptide is attached to at least one therapeutic compound to form a CMP-TC conjugate (see claim 19).
Regarding claim 5-7, ‘699 teaches the CMP as SEQ ID NO: 6, a sequence different than the instant SEQ ID NO: 1.
‘977 teaches a composition suitable for use in a medicament for treating or preventing a disease or disorder in a human or veterinary animal in need of treatment or prevention of said disease or disorder, said composition comprising at least one collagen mimetic peptide (CMP), and one or more pharmaceutically suitable carriers. ‘977 also teaches the composition being suitable for treating ocular diseases, including macular degeneration (as disclosed in instant claim 2 and claim 5 of ‘699) ([0071] “Ocular diseases or disorders that can be treated, prevented, ameliorated or diagnosed using the compositions and methods of the invention include but are not limited to glaucoma, cataracts, vitreous adhesions or floaters, macular degeneration, dry eye syndrome, corneal keratitis, non-infectious corneal ulceration, non-infectious corneal melting, infectious corneal ulceration, infectious corneal melting, conjunctivitis, Stevens-Johnson Syndrome, scleritis, episcleritis, ectasia, keratoconus, …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the composition of ‘699 containing a CMP and a pharmaceutical carrier to treat myopia due to the disclosure of ‘977 teaching that a CMP and a pharmaceutically suitable carrier can be used to treat macular degeneration, as required by instant claim 2. The rationale for substitution comes from the compounds being in the same family of collagen mimetic peptides and the ‘977 teaching (Pro-Pro-Gly)7 (instant SEQ ID NO: 1) as a CMP that can be used to treat ocular diseases like macular degeneration, similar to how SEQ ID NO: 6 of ‘699 does. There would have been a reasonable expectation of success because the compounds are used in the process of treating macular degeneration. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 24, ‘699 claims a medical device comprising a CMP and a pharmaceutically acceptable carrier. (See claim 20)
Regarding claim 25, ‘699 claims a medical device comprising a CMP and a pharmaceutically acceptable carrier in the form of a stent, a shunt, a suture, an absorbable mesh, an absorbable patch, a drug-releasing wafer, a film, and an internal infusion pump (See claim 21).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Status of Claims
Claim 1 is objected to. Claims 1-4 are rejected under 35 U.S.C. 101. Claim(s) 1-7 and 24-25 are rejected under 35 U.S.C. 102(a)(2). Claims 1-7 and 24-25 are rejected on the ground of nonstatutory double patenting. Claims 1-7 and 24-25 are provisionally rejected on the ground of nonstatutory double patenting.
No claims are allowed.
Conclusion
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/Daliyah M. Brown/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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