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 .
Disclaimer
Please note that the Examiner of Record for the present application has changed.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 4, 2025, has been entered.
Election/Restrictions
Applicant’s election of Group III (i.e., claims 1-27 drawn to a method of treatment) in the reply filed on February 9, 2024, is acknowledged. Additionally, Applicant’s election of Formula (III) and contacts lens of ocular implant as the elected species in the reply filed on February 9, 2024, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Please note that since there is no indication that Applicant’s election of Group III and election of Formula (III) have been withdrawn, the Examiner is interpreting that these elections are maintained. However, with respect to Applicant’s election of a contacts lens of ocular implant, it appears that this species has been withdrawn since all claims were rejected under the 112(a) rejection. Thus, the Examiner is interpreting that this species has been withdrawn.
Status of Claims
Claims 1-27 were originally filed on November 22, 2022.
The amendment received on February 9, 2024, amended claims 1-17, 20-22, and 24-27; and added new claims 28-29. The amendment received on November 22, 2024, amended claims 2 and 17. The amendment received on August 4, 2025, amended claim 17.
Claims 1-27 are currently pending and under consideration.
PLEASE NOTE: the amendment received on 2/9/24 added new claims 28-29. However, the amendments received on 11/22/24 and 8/4/25, do not include any status of claims 28-29. As such, the Examiner is interpreting that these claims have been canceled. It is respectfully requested that Applicant include the status identifier for both claims for clarity of the record.
Priority
The present application is a continuation of U.S. Non-Provisional Application No. 16/355,233, filed on March 15, 2019, now abandoned, which claims the benefit under 35 U.S.C. 119(e) to U.S. Provisional Application No. 62/647,184 filed March 23, 2018. Applicant’s 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.
Sequence Interpretation
For claims 2 and 17, with respect to the amino acid sequence of Formula (III), it is noted that the scope requires 100% identity to an amino acid sequence of Formula (III) with any N- and/or C-terminal additions. It is noted that amino an acid sequence of Formula (III) corresponds to: ((R/K-A/L/I)1-4(D/E-A/L/I) 1-4)1-5 where each termini can contain one or more additional amino acid residues.
Response to Arguments
Applicant’s arguments, see Response, filed 8/4/25, with respect to 112(a), scope of enablement rejection have been fully considered and are persuasive. The rejection of claims 1-27 as failing the enablement requirement has been withdrawn.
New Objections
Claim Objections
Claim 11 is objected to because of the following informalities: claim 11 recites, “wherein the composition comprises a device selected from the group consisting of ocular implants, intraocular lenses, contact lenses, coatings on a medical device, eye patches, and woven or non- woven fiber wound coverings.” It is respectfully requested that claim 11 recites, “wherein the composition comprises a device selected from the group consisting of ocular implants, intraocular lenses, contact lenses, a coated medical device, eye patches, and woven or non-woven fiber wound coverings.” Such amendment would provide clarity of the type of device and corrects a grammatical error. Appropriate correction is required.
New Rejections
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.
Claim 6 is 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 6, the phrases "preferably" and “most preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Please note that the Examiner is interpreting the scope of claim 6 such that the limitations following the phrases are not examined since the limitations would raise additional indefinite issues, e.g., less than 10 mM does not overlap with between 5 nM and 5 nM, in order to advance prosecution.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 6 recites the limitation "the concentration of ions in the composition" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is noted that claim 6 is dependent upon claim 17, which does not recite the inclusion of ions in the composition.
Please note that the Examiner is interpreting the scope such that the composition of claim 17 also comprises ions in order to advance prosecution.
Claims 8 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 8 recites that the composition comprises a device comprising a backing material or support structure. Claim 11 recites that the composition comprises a device selected from a Markush group including ocular implants, contact lenses, coatings on a medical device, eye patches, and fiber wound coverings. However, it is unclear how a composition can comprise a peptide and a device, e.g., a composition comprises a self-assemble peptide of Formula (III) and coatings on a medical device or a composition comprises a self-assemble peptide of Formula (III) and eye patches. A device is a physical object with a defined structure whereas a peptide can be in different forms such as a solution or dried powder. As such, it is unclear how both the peptide and a device can be components of the same composition. Therefore, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently claimed invention with respect to how a composition comprises a peptide and a device.
Please note that the Examiner is interpreting the scope of claims 8 and 11 such that the composition is either contained or coated by a device wherein the device is administered or implanted into the eye of the subject in order to advance prosecution.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
103 - KSR Examples of 'Rationales' Supporting a Conclusion of Obviousness(Consistent with the "Functional Approach" of Graham)
Further regarding 35 USC 103(a) rejections, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) (KSR) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Also, a reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976).
Claims 1-10, 12-14, 17, and 19-27 are rejected under 35 U.S.C. 103 as being unpatentable over Spiro et al. US 2006/0084607 A1 published on April 10, 2006, alone or as evidenced by, Redruello-Guerrero et al., Metabolites 15:1-28 (2025), and Dr. Chauhan, RetinaDoctor, available online at https://www.retinadoctor.com.au/surgery/surgery-for-vitreoretinal-conditions/vitrectomy-for-retinal-detachment/, 11 pages (accessed on 2/12/26).
For claims 2, 7, 10, 14, 17, 20-22, and 24-27, with respect to where the composition further comprises a pharmaceutically acceptable excipient for administration into or onto the eye as recited in instant claim 7; with respect to where the composition is in a form such as a liquid or gel as recited in instant claim 10; with respect to where the composition is injected into the globe of the eye as recited in instant claim 14; with respect to a method of treating ocular inflammation associated with one or more diseases, injuries, or disorders of the eye in a subject in need thereof by administering to or implanting into the eye of the subject a composition comprising one or more self-assembling peptides having a sequence of Formula (III) such as (RADA)4 as recited in instant claims 2 and 17; with respect to where the subject has or is at risk of retinal detachment as recited in instant claim 20; with respect to where the composition is administered topically to the eye as recited in instant claim 24; with respect to where the composition is applied as a gel as recited in instant claim 25; with respect to where the composition is administered to the retina of the eye as recited in instant claim 26; and with respect to where the composition is administered intravitreally as recited in instant claim 27:
Spiro et al. teaches methods of using a composition including amphiphilic peptide chains having alternating hydrophilic and hydrophobic amino acids that are complementary and structurally compatible and self-assemble into a beta-sheet macroscopic scaffold (See Spiro, [0013], [0027]). A specific embodiment of using the composition is in ophthalmic applications (See Spiro, [0078]). For example, gels can be used for short or long term repair of retinal detachment (See Spiro, [0078]) thereby constituting where the subject has retinal detachment as recited in instant claim 20. The gel is injected into the eyeball where the additional pressure presses the retina against the wall of the eye (See Spiro, [0078]) thereby constituting where the composition is administered to the retina of the eye as recited in instant claim 26 (note: administering to the retina is interpreted as encompassing being administered such that the retina is in proximity of the administered composition such that the administered composition has a therapeutic effect), constituting where the composition is injected into the globe of the eye as recited in instant claim 14, and constituting where the composition is administered intravitreally as recited in instant claim 27. Alternatively or in addition, peptide gels can be used for scleral buckling procedures where the gel is disposed against the outer surface of the eye to push the sclera towards the middle of the eye (See Spiro, [0078]). As such, the gel being disposed against the outer surface of the eye constitutes topical administration to the eye as recited in instant claim 24. As evidenced by Redruello-Guerrero et al. retinal detachment is caused by a separation of the photoreceptors from the retinal pigment epithelium, and is a specialized extension of the CNS where the retina relies on its laminar architecture comprising neuronal and glial layers to maintain visual processing and homeostasis (See Redruello-Guerrero, pg. 1, last paragraph). The neural tissue is housed within the immune-privileged environment of the eye, which includes the blood-retinal barrier and active immunosuppressive mechanisms that usually limit inflammation to preserve visual function (See Redruello-Guerrero, pg. 1, last paragraph to pg. 2, 1st paragraph). However, retinal detachment breaches both the anatomical integrity and immune balance of the retina, triggering inflammatory and oxidative responses that accelerate photoreceptor degeneration and compromise the delicate immune homeostasis of this CNS-derived tissue (See Redruello-Guerrero, pg. 2, 1st paragraph). As such, retinal detachment necessarily constitutes a disease, injury or disorder in which ocular inflammation is associated with as recited in instant claim 17.
The peptide chains in solution spontaneously self-assemble into scaffolds through electrostatic interactions to form a hydrogel that remains ductile and amenable to flow upon application of an appropriate stimulus (See Spiro, [0049]). Examples of the self-assembling peptides include RAD16-I having an amino acid sequence of (RADA)4, RADA8-I having an amino acid sequence of (RADA)2, RAE16-I having an amino acid sequence of (RAEA)4, RAEA8-I having an amino acid sequence of (RAEA)2, KAD16-I having an amino acid sequence of (KADA)4, KADA8-I having an amino acid sequence of (KADA)2, and KLD12 having an amino acid sequence of (KLDL)3 (See Spiro, [0027]; Table 1). Each of these sequences constitute an amino acid sequence of instant Formula (III) as recited in instant claim 17, and the RAD16-I sequence constitutes an amino acid sequence of instant Formula (III) as recited in instant claim 2. The composition can be in the form of an aqueous solution, which can form a hydrogel that is stable with respect to mechanical agitation (See Spiro, [0014]) thereby constituting where the composition further comprises a pharmaceutically acceptable excipient (i.e., water) for administration into or onto the eye as recited in instant claim 7 and where the composition is in a form such as a liquid (i.e., aqueous solution) or a gel (i.e., hydrogel) as recited in instant claims 10 and 25.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to follow the teachings of Spiro et al. and administer to an eye of a subject who has retinal detachment a composition comprising a self-assembling peptide such as RAD16, RADA8, RAE16, KAD16, KADA8, or KLD12 in order to provide pressure to push the retina back into place thereby necessarily treating ocular inflammation associated with retinal detachment. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because a composition comprising self-assembling peptides in the form of a hydrogel were known to be administered to the eye of a subject in order to treat retinal detachment as taught by Spiro et al. One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success given that the composition of Spiro et al. comprised self-assembling peptides in the form of a hydrogel and were used in ophthalmic applications, and therefore, administering a composition comprising RAD16, RADA8, RAE16, KAD16, KADA8, or KLD12 as self-assembling peptides to an eye of a patient suffering from retinal detachment would support the treatment of retinal detachment thereby necessarily treating ocular inflammation associated with the retinal detachment by constituting the simple substitution of one known element for another to obtain predictable results and/or some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention pursuant to KSR.
For claims 1 and 5, with respect to where the composition comprises a formulation suitable for ophthalmological administration comprising between about 0.1% w/v to 6% w/v, inclusive, of the self-assembling peptides or self-assembling peptidomimetics as recited in instant claim 1; and with respect to where the concentration of self-assembling peptides of self-assembling peptidomimetics in the composition is between about 0.1% w/v and about 1% w/v, inclusive as recited in instant claim 5:
As discussed supra, Spiro et al. teaches that the composition comprising the self-assembling peptide can be in the form of an aqueous solution, which can form a hydrogel that is sable with respect to mechanical agitation (See Spiro, [0014]). Spiro et al. teaches that the concentration of the peptide chains can be at least about 1% by weight (See Spiro, [0014]-[0015]). Moreover, Spiro et al. teaches that the concentration of peptide chains in water can be between about 0.25% and about 7% by weight (See Spiro, [0048]). As such, the teachings of Spiro et al. satisfy the claim limitation with respect to where the composition comprises a formulation suitable for ophthalmological administration, i.e., aqueous solution, and teaches an peptide concentration that overlaps with the instantly claimed invention. MPEP 2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges discloses by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%". The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.) Moreover, the Federal Circuit found that a prima facie case existed where a claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms and the prior art taught that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." In re Geisler, 116 F.3d 1465, 1469-82, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Therefore, the claimed concentration range of the peptide in the composition would have been obvious to one of ordinary skill in the art since the claimed range (i.e., about 0.1% to 6% as recited in instant claim 1; about 0.1% to about 1%) overlaps with the prior art concentration range of the peptide in the composition (i.e., at least about 1% or between about 0.25% and about 7%).
Regarding the unit of the concentration being w/v, it is noted that Spiro et al. teaches that the peptide concentration in the composition is a percent by weight. It is further noted that a percent by weight can either correspond to a w/w or w/v unit. As such, there are a finite number of units that the peptide concentration taught by Spiro et al. can be. Thus, given that the peptide composition of Spiro et al. is in the form of an aqueous solution and given that there are finite number of weight concentration units, an ordinary skilled artisan would be motivated, at a minimum, to try to formulate a composition comprising self-assembling peptides of instant Formula (III) such as RAD16 in an aqueous solution such that the concentration of the self-assembling peptides is at least 1% w/v with a reasonable expectation of success.
For claim 3, with respect to where between about 70% and 100% of the self-assembling peptides within the composition are of the same size and have the same amino acid sequence:
Spiro et al. teaches that the peptide chains contain at least 8 amino acids such as RAD16-I having an amino acid sequence of (RADA)4, RADA8-I having an amino acid sequence of (RADA)2, RAE16-I having an amino acid sequence of (RAEA)4, RAEA8-I having an amino acid sequence of (RAEA)2, KAD16-I having an amino acid sequence of (KADA)4, KADA8-I having an amino acid sequence of (KADA)2, and KLD12 having an amino acid sequence of (KLDL)3, and at least about 75% of the peptide chains have the same sequence (See Spiro, [0013]; [0027]; Table 1). As such, Spiro et al.’s composition can contain the same sequence, e.g., RAD16, whereby the same sequence would necessarily have the same size. Furthermore, the percent of the peptide chains in the composition overlap with the instant percent range. MPEP 2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges discloses by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%". The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.) Moreover, the Federal Circuit found that a prima facie case existed where a claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms and the prior art taught that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." In re Geisler, 116 F.3d 1465, 1469-82, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Therefore, the claimed percent range of the peptide in the composition would have been obvious to one of ordinary skill in the art since the claimed range (i.e., between about 70% and 100%) overlaps with the prior art percent range of the peptide in the composition (i.e., at least about 75%). Therefore, the teachings of Spiro et al. satisfy the claim limitations as recited in instant claim 3.
For claim 4, with respect to where the composition further comprises a pH-adjusting agent:
Spiro et al. teaches that the aqueous solution can be injectable and have a pH between about 4.5 and about 8.5 (See Spiro, [0014]-[0015]). Moreover, Spiro et al. teaches that the high purity gels are also stable at physiological pH (See Spiro, [0057]). Gels can be brought to physiological pH by equilibrating them with a buffer solution (See Spiro, [0057]). Spiro et al., thus, teaches that it is desirable to modify the pH of a peptide solution, e.g., to raise the pH to a physiological pH of ~7-8.5 prior to introducing the peptide solution into a subject (See Spiro, [0058]). Examples of buffers able to increase the pH of the peptide solution without destroying the ability of the peptide chains to assemble into a scaffold, either before or after the addition of an electrolyte, include tris-HCl, PBS without Ca or Mg, THAM, sodium citrate, sodium acetate, ammonium acetate, sodium bicarbonate, and HEPES (See Spiro, [0059]-[0068]). Therefore, the teachings of Spiro et al. satisfy the claim limitation as recited in instant claim 4.
For claims 6 and 23, with respect to where the concentration of ions in the composition is between 5 nM and less than 5 mM as recited in instant claim 6; and with respect to where the peptides are assembled by contacting the self-assembling peptides with a solution of cations as recited in instant claim 23:
Spiro et al. teaches that the peptide chains consist of alternating hydrophilic and hydrophobic amino acids that are capable of self-assembling to form an exceedingly stable beta-sheet macroscopic structure in the presence of electrolytes such as monovalent cations, e.g., Li+, Na+, K+ or Ca+ (note: assuming Cs+ should be Ca+) (See Spiro, [0027], [0052]). Sufficient electrolyte is added to the solution to initiate self-assembly of the peptides into a beta-sheet macroscopic structure (See Spiro, [0052]). The solution can contain at least 0.1 mM of an electrolyte (See Spiro, [0014]), or a concentration range of 0.1 to 1 mM (See Spiro, [0052]). As such, the teachings of Spiro et al. satisfy the claim limitation as recited in instant claim 23, and teach a cation concentration range that overlaps with the instantly claimed range. MPEP 2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges discloses by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%". The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.) Moreover, the Federal Circuit found that a prima facie case existed where a claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms and the prior art taught that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." In re Geisler, 116 F.3d 1465, 1469-82, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Therefore, the claimed concentration range of the cation in the composition would have been obvious to one of ordinary skill in the art since the claimed range (i.e., about 0.1% to 6% as recited in instant claim 1; about 0.1% to about 1%) overlaps with the prior art concentration range of the peptide in the composition (i.e., at least about 1% or between about 0.25% and about 7%).
For claim 8, with respect to where the composition is contained in a device comprising a backing material or support structure and where the device is suitable for administration into an eye:
Spiro et al. teaches a kit for delivering a peptide composition to a patient that includes a purified peptide composition, which can be in the form of an aqueous solution or in a dry form, and at least one item selected from an electrolyte, a buffer, a delivery device, a vessel suitable for mixing the peptide composition with one or more other agents (See Spiro, [0020], [0087]). The delivery device can be a needle or syringe (See Spiro, [0020]), which necessarily contain a backing material or support structure. As such, Spiro et al. teaches a device comprising a backing material or support structure that would contain the peptide composition that is suitable for delivery to a patient’s eye. Thus, the teachings of Spiro et al. satisfy the claim limitations as recited in instant claim 8.
For claim 9, with respect to where the composition further comprises one or more therapeutic agents:
Spiro et al. teaches that either the aqueous solution or the peptide chains can further include one or more biologically active agents (See Spiro, [0015]). The biologically active agent can be an anti-inflammatory, an antibiotic, an anti-cancer agent, an analgesic, a drug, etc. (See Spiro, [0019], [0080]). Thus, the teachings of Spiro et al. satisfy the claim limitation with respect to where the composition further comprises one or more therapeutic agents as recited in instant claim 9.
For claim 12, with respect to where the composition is dried, dehydrated or vacuum packaged:
As discussed supra for claim 8, Spiro et al. teaches a kit for delivering a peptide composition to a patient that includes a purified peptide composition, which can be in the form of an aqueous solution or in a dry form, and at least one item selected from an electrolyte, a buffer, a delivery device, a vessel suitable for mixing the peptide composition with one or more other agents (See Spiro, [0020], [0087]). Spiro et al. teaches that the purified product, e.g., RAD16 peptide, can be stored as a powder or can be redissolved in aqueous solution (See Spiro, [0048]). As such, the composition can be in a dried form when stored. Thus, the teachings of Spiro et al. satisfy the claim limitation as recited in instant claim 12.
For claim 13, with respect to where the composition is formulated for administration into the eyes in the form of eye drops:
As discussed for claims 21-22 below, Spiro et al. teaches that the peptide solutions can be injected before gelation where ions will be able to migrate into the peptide solution from the surrounding tissue and cause it to gel (i.e., self-assemble into a stable beta-sheet macroscopic structure) (See Spiro, [0079]). Although described as being administered via injection as solution, as discussed for claim 17, the peptide composition can be disposed against the outer surface of the eye to push the sclera towards the middle of the eye (See Spiro, [0078]) thereby constituting topical administration. As such, Spiro et al. teaches that the peptide composition can be administered to an eye of a patient topically or via injection. A peptide solution that is administered topically before gelation would necessarily constitute eye drops. Thus, the teachings of Spiro et al. satisfy the claim limitation as recited in instant claim 13.
For claim 19, with respect to where the subject is undergoing or has undergone a vitrectomy:
As discussed supra, Spiro et al. teaches that the peptide composition can be administered into the eye via an injection or topically onto the surface of an eye of a subject in order to treat retinal detachment. As evidenced by Dr. Chauhan, surgery for a retinal detachment consists of a vitrectomy, which is the removal of vitreous gel from the retina (See Chauhan, pg. 3, 4th paragraph). As such, the subject to be treated by Spiro et al. would also undergo or has undergone a vitrectomy given that conventional treatment of retinal detachment required a vitrectomy. Thus, the teachings of Spiro et al. satisfy the claim limitation as recited in instant claim 19.
For claims 21-22, with respect to where the self-assembling peptides are self-assembled at the time of or after administration as recited in instant claim 21; and with respect to where the self-assembling peptides are assembled immediately prior to administration as recited in instant claim 22:
As discussed supra for claims 6 and 23, Spiro et al. teaches that the peptide chains consist of alternating hydrophilic and hydrophobic amino acids that are capable of self-assembling to form an exceedingly stable beta-sheet macroscopic structure in the presence of electrolytes such as monovalent cations, e.g., Li+, Na+, K+ or Ca+ (note: assuming Cs+ should be Ca+) (See Spiro, [0027], [0052]). Sufficient electrolyte is added to the solution to initiate self-assembly of the peptides into a beta-sheet macroscopic structure (See Spiro, [0052]). In some embodiments, Spiro et al. teaches that the peptide solutions can be injected before gelation where ions will be able to migrate into the peptide solution from the surrounding tissue and cause it to gel (i.e., self-assemble into a stable beta-sheet macroscopic structure) (See Spiro, [0079]). Such embodiments constitute where the self-assembling peptides are self-assembled after administration as recited in instant claim 21. Alternatively, were the ionic strength of fluid at the injection site is insufficient, the peptide solution may be injected after gelation (i.e., self-assemble into a stable beta-sheet macroscopic structure) (See Spiro, [0079]) thereby constituting where the self-assembling peptides are assembled prior to administration as recited in instant claim 22.
With respect to where the self-assembling peptides are assembled immediately prior to administration, the time at which the self-assembling peptide is self-assembled prior to administration is clearly a result specific parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal time at which the self-assembling peptide self-assembles prior to administration needed to achieve the desired results. Thus, an ordinary skilled artisan would have been motivated to adjust the timing at which the self-assembling peptide self-assembles prior to administration such that the peptides self-assemble immediately prior to administration because an ordinary skilled artisan would have been able to utilize the teachings of Spiro et al. to obtain various timeframe parameters regarding peptide self-assembly with a reasonable expectation of success. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of time at which the self-assembling peptide self-assembles prior to administration would have been obvious at the time of applicant's invention. Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, because the combined teachings of the prior art are fairly suggestive of the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Spiro et al. US 2006/0084607 A1 published on April 10, 2006, alone or as evidenced by, Redruello-Guerrero et al., Metabolites 15:1-28 (2025), as applied to claim 17 above, and further in view of Phelps et al., Arch. Opthalmol. 95:418-422 (1977), as applied to claim 18 herewith.
For claim 17, please see discussion of Spiro et al. supra.
For claim 18, with respect to where the subject has or is at risk of developing glaucoma:
It is noted that the scope of claim 18 only requires that the subject has or is at risk of developing one of the recited diseases or disorders. There is no requirement that the disease or disease associated with ocular inflammation in claim 17 is the disease or disorder recited in claim 18. In other words, the disease or disorder recited in claim 18 does not need to be the disease or disorder to be treated.
As discussed supra for claim 17, Spiro et al. teaches that a composition comprising a self-assembling peptide such as RAD16 can be administered to a subject’s eye to treat retinal detachment. However, Spiro et al. does not expressly teach that the subject has or is at risk of developing glaucoma.
Phelps et al. further teaches that an eye with both glaucoma and retinal detachment is threatened with blindness unless each condition is quickly recognized and promptly treated (See Phelps, pg. 418, col. 1, 1st paragraph). Since the signs of one condition can mask those of the other, Phelps et al. teaches that recognition of the problem is made easier if the ophthalmologist remembers that the two conditions often do occur together (See Phelps, pg. 418, col. 1, 1st paragraph). One study found that retinal detachment and glaucoma occurred together in 12.3% of 530 patients with detached retinas (See Phelps, pg. 418, col. 1, last paragraph to col. 2, 1st paragraph). This percentage is about 12 times the prevalence of glaucoma in the general population (See Phelps, pg. 418, col. 2, 1st paragraph). Phelps et al. also found in a survey of 817 patients undergoing primary operations for retinal detachment, glaucoma was present in 9.5% (See Phelps, abstract; pg. 419, col. 1, 3rd paragraph). As such, Phelps et al. concludes that their study confirms previous reports that glaucoma occurs in a high percentage of patients with retinal detachments (See Phelps, pg. 420, col. 2, 2nd paragraph). Therefore, the teachings of Phelps et al. suggest that a subject suffering from retinal detachment is at a greater risk of having or already having glaucoma.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the teachings of Spiro et al. and administer to an eye of a subject who has retinal detachment and who has or is at risk of having glaucoma a composition comprising a self-assembling peptide such as RAD16, RADA8, RAE16, KAD16, KADA8, or KLD12 in order to provide pressure to push the retina back into place thereby necessarily treating ocular inflammation associated with retinal detachment. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because glaucoma was known to occur in a high percentage of patients with retinal detachments as taught by Phelps et al.; and because a composition comprising self-assembling peptides in the form of a hydrogel were known to be administered to the eye of a subject in order to treat retinal detachment as taught by Spiro et al. One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success given that the composition of Spiro et al. comprised self-assembling peptides such as RAD16, RADA8, RAE16, KAD16, KADA8, or KLD12 in the form of a hydrogel and were administered to treat retinal detachment, and therefore, administering this composition to this subject suffering from retinal detachment would support that the subject has or is at risk of glaucoma given the increased prevalence of glaucoma and retinal detachment by constituting some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention pursuant to KSR.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claims 11 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Spiro et al. US 2006/0084607 A1 published on April 10, 2006, alone or as evidenced by, Redruello-Guerrero et al., Metabolites 15:1-28 (2025), as applied to claim 17 above, and further in view of Nagai et al. US 2012/0058066 A1 published on March 8, 2012, as applied to claims 11 and 15-16 herewith.
For claim 17, please see discussion of Spiro et al. supra.
For claims 11 and 15-16, with respect to where the composition is administered/implanted into an eye of a subject via contact lenses as recited in instant claim 11; with respect to where the method comprises (i) administering the composition onto a surface of the eye of the subject, and (ii) administering a contact lens onto the composition as recited in instant claim 15; and with respect to where the surface of the eye comprises the cornea as recited in instant claim 16:
As discussed supra, Spiro et al. teaches that peptide gels can be used for scleral buckling procedures where the gel is disposed against the outer surface of the eye to push the sclera towards the middle of the eye (See Spiro, [0078]). As such, the gel being disposed against the outer surface of the eye constitutes topical administration to the cornea as recited in instant claims 15(i) and 16. However, Spiro et al. does not teach that the hydrogel can coat a contact lens.
Nagai et al. teaches a peptide gel with practically sufficient mechanical strength and a self-assembling peptide capable of forming the peptide gel (See Nagai, [0004]). A self-assembling peptide is defined as a peptide that assembles spontaneously via an interaction between peptide molecules in a solvent (See Nagai, [0035]). Examples of the interaction include a hydrogen bond, an interionic interaction, an electrostatic interaction such a van der Waals force, and a hydrophobic interaction (See Nagai, [0035]). Moreover, Nagai et al. teaches an aqueous solution including the self-assembling peptide is capable of forming a peptide gel excellent in mechanical strength (See Nagai, [0050], [0063]). Nagai et al. teaches that preferred applications of the self-assembling peptide and peptide gel include substrates for cell culture, cosmetics such as skin care products and hair care products, medical products such as decubitus preparations, bone fillers, injectable agents for aesthetic, adjuvant to ophthalmic operation, artificial vitreous bodies, artificial lenses, joint lubricants, ophthalmic solutions, DDS substrates, and hemostasis, water retention materials for moistening, desiccants, and coating agents for medical devices such as contact lenses (See Nagai, [0073]). Broadly, Nagai et al. teaches that the self-assembling peptide can be applied for regenerative medicine, a drug delivery system, a cosmetic, an artificial vitreous body, a hemostat, an injection for cosmetic surgery, bone filling, a joint lubricant, or a water retention material for moistening (See Nagai, [0133]). Nagai et al. also teaches methods of coating an article, e.g., contact lenses, with the peptide gel (See Nagai, [0086]). Thus, the teachings of Nagai et al. suggest that a peptide gel comprising self-assembling peptides can be used in for ophthalmic applications including where the peptide gel coats contact lenses.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the teachings of Spiro et al. and administer to an eye of a subject who has retinal detachment a composition comprising a self-assembling peptide such as RAD16, RADA8, RAE16, KAD16, KADA8, or KLD12 that is coated onto contact lenses onto the surface of the eye in order to push the sclera towards the middle of the eye thereby pushing the retina back into place thereby necessarily treating ocular inflammation associated with retinal detachment. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because a peptide gel comprising self-assembling peptides was known to be useful for ophthalmic applications and was known to coat contact lenses as taught by Nagai et al.; and because a composition comprising self-assembling peptides in the form of a hydrogel were known to be administered to the eye of a subject in order to treat retinal detachment as taught by Spiro et al. One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success given that the composition of Spiro et al. comprised self-assembling peptides such as RAD16, RADA8, RAE16, KAD16, KADA8, or KLD12 in the form of a hydrogel and were topically administered to surface of an eye of a subject in order to treat retinal detachment by pushing the sclera towards the middle of eye thereby pushing the retina back into place, and therefore, coating contact lenses with the composition and topically administering the coated contact lenses onto the surface of the eye of the subject would support the treatment of ocular inflammation associated with retinal detachment by pushing the sclera towards the middle of the eye thereby pushing the retina back into place by constituting some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention pursuant to KSR.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Conclusion
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/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654