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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on May 16, 2024 and November 11, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Status
Claims 1 – 9, 13, 14, 16, 18 – 21, 23 – 25, and 28 are examined here-in.
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.
Claims 14, 21, and 23 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Regarding claims 14, 21, and 23, the phrase "such as" 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).
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 1, 2, 8, 24, 25, and 28 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Spector (US 6,013,623 A).
Spector teaches a method for treating a condition, such as cataracts, corneal pathology, glaucoma, retinal degeneration, or vitreal degeneration, by administering a heme-peptide (claims 1 and 6), anticipating instant claims 1 and 2.
Spector teaches the heme-peptide compositions can be administered via liposome-mediated delivery (claim 9), anticipating instant claim 8.
Spector teaches the heme-peptide composition can be administered via injection or applied topically (claim 9), anticipating instant claims 24 and 25.
Spector teaches a pharmaceutical composition comprising a heme-peptide (claims 1, 6, 45), anticipating instant claim 28.
However, in the event that the previous does not have sufficient specificity to rise to anticipation, claims 1, 3, 8, 24, 25, and 28 are also rejected under 35 U.S.C. 103 below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1, 2, 8, 9, 16, 18 – 21, 23 – 25, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Spector (as cited above).
For the purposes of this ground of rejection only, and purely arguendo, the examiner will take the position that Spector does not teach a specific embodiment (i.e., preferred embodiment, working example, etc.) having all of the claimed elements arranged as required by claims 1, 2, 8, 24, 25, and 28 without resorting to some “picking and choosing” within the prior art disclosure. That being said, although Spector thus would not be anticipatory by this interpretation of the facts, it nevertheless does fairly suggest the claimed invention, as shown below.
Spector teaches a method for treating a condition associated with oxidative stress, such as cataracts, corneal pathology, glaucoma, retinal degeneration, or vitreal degeneration, by administering a heme-peptide (column 1 lines 47 – 54, column 4 lines 53 – 64, column 6 lines 47 – 51, claims 1, 6, 35).
Spector teaches the heme-peptide can be heme with various short peptides, microperoxidase, a degradation product of cytochrome C, a heme-protein, or a compound that has antioxidant properties like heme-peptide (column 4 line 65 to column 5 line 16, column 5 line 65 to column 6 line 3, column 6 lines 27 – 33, column 6 lines 51 – 57, column 7 lines 2 – 11, claims 7 and 39). Spector teaches that the heme-peptide microperoxidase can function to eliminate peroxidase and thus oxidative stress (column 9 lines 8 – 15). Similarly, Spector teaches that heme-peptide derived from cytochrome C shows peroxidase activity and degrades reactive oxygen species (column 9 lines 8 – 57).
Spector teaches that the composition should also include a reducing agent such as ascorbic acid as an active agent (column 7 lines 12 – 17, column 8 lines 10 -11, lines 41 – 48, column 9 lines 23 – 27, claim 49).
Spector teaches the heme-peptide compositions can be administered by any standard method known in the art, including injection or topical application and also gives the example of liposome-mediated delivery (column 5 lines 17 – 21, 36 – 40, column 6 lines 6 – 8, 21 – 24, claim 9).
As discussed above, for the purposes of this ground of rejection only, and purely arguendo, the examiner will take the position that Spector does not teach a specific embodiment (i.e., preferred embodiment, working example, etc.) having all of the claimed elements arranged as required by claims 1, 2, 8, 24, 25, and 28 without resorting to some “picking and choosing” within the prior art disclosure. Claims 1, 2, 8, 9, 16, 18 – 21, 23 – 25, and 28 are rendered prima facie obvious over the teachings of Spector because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results. In the instant case, all the claimed elements (e.g., heme-peptides) were known in the prior art (e.g., methods of treating diseases that are associated with oxidative stress) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143(i)(a)).
Spector’s teaching for a method of treating a condition associated with oxidative stress, including various ophthalmological disorders, by administering a heme-peptide (column 1 lines 47 – 54, column 4 lines 53 – 64, column 6 lines 47 – 51, claims 1, 6, 35) reads on instant claims 1 and 2. Spector’s heme-peptide reads on the instantly claimed heme conjugate, which is described as “heme covalently or non-covalently associated with a protein or peptide” on page 5 of the instant specification.
Spector’s teaching that the heme-peptide composition can be administered by any standard method known in the art, including injection or topical application (column 5 lines 17 – 21, 36 – 40, column 6 lines 6 – 8, 21 – 24, claim 9) reads on instant claims 8, 20, 24, and 25.
Spector’s teaching that the heme-peptide composition can be administered by liposome-mediated delivery (column 5 lines 17 – 21, 36 – 40, column 6 lines 6 – 8, 21 – 24, claim 9) reads on instant claims 9 and 21, because liposomes are particles formed from biocompatible polymers.
Spector’s teaching that the heme-peptide microperoxidase can function to eliminate peroxidase and thus oxidative stress (column 9 lines 8 – 15) and that the heme-peptide derived from cytochrome C shows peroxidase activity and degrades reactive oxygen species (column 9 lines 8 – 57) reads on instant claim 16. Although Spector does not specifically teach that heme is released upon exposure to reactive oxygen species, Spector does teach that the heme-peptide responds to exposure of reactive oxygen species. In other words, the functional limitation recited for claim 16 (i.e. wherein the heme is released upon exposure of the particles to reactive oxygen species) appears to be the result of a method of treating an ophthalmological disorder by administering a heme-peptide composition as taught by Spector since it does not appear from the instant disclosure that additional elements are required to cause the functional limitations (examples 2 and 3 discuss release of heme upon contact with ROS, but does not seem to require additional stimuli to prompt release on page 37 lines 28 – 33, page 38 lines 14 – 16, page 45 lines 1 – 8, page 48 lines 16 – 29). According to MPEP 2112(III) and 2163.07(a), an inherent feature of a composition or method does not need to be explicitly recognized in the prior art for the prior art to be applied. Said differently, “By disclosing in a patent application a device that inherently performs a function or has a property, operates according to a theory or has an advantage, a patent application necessarily discloses that function, theory or advantage, even though it says nothing explicit concerning it” MPEP 2163.07(a).
Since the method of treating an ophthalmological disorder by administering a heme-peptide composition as taught by Spector appears to overlap with the claimed method, the skilled artisan would have expected that the method of Spector would have had the same ability to release heme upon exposure of the particles to reactive oxygen species as that which is instantly claimed. Something which is old (e.g., the method of Spector) does not become patentable upon the discovery of a new property (e.g., the ability to release heme upon exposure of the particles to reactive oxygen species) and this feature need not have been recognized at the time of the invention. See MPEP 2112(I) and 2112(II). Put another way, "When the claimed compositions are not novel they are not rendered patentable by recitation of properties, whether or not these properties are shown or suggested in the prior art." In re Spada, 911 F .2d 705, 709, (Fed. Cir. 1990). Therefore, since Spector’s prior art teachings recite the administration of a heme-peptide composition to treat an ophthalmological disorder, the functional limitation of claim 16 is obvious.
Spector’s teaching that the composition should also include a reducing agent such as ascorbic acid as an active agent (column 7 lines 12 – 17, column 8 lines 10 -11, lines 41 – 48, column 9 lines 23 – 27, claim 49) reads on instant claims 18 and 19. Ascorbic acid is known to be an anti-inflammatory agent, therefore reading on claim 19.
Age related macular degeneration (AMD) is a form of retinal degeneration, therefore Spector’s teaching for a method of treating a condition associated with oxidative stress, such as retinal degeneration, by administering a heme-peptide (column 1 lines 47 – 54, column 4 lines 53 – 64, column 6 lines 47 – 51, claims 1, 6, 35) reads on instant claim 23.
Spector’s teaching for a pharmaceutical composition comprising a heme-peptide (claims 1, 6, 45) reads on instant claim 28.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Spector (as cited above) and further in view of Soares (WO 2012/050874 A2).
Spector’s teachings are discussed above.
Spector does not teach heme conjugated to human serum albumin.
Soares teaches the missing element of Spector.
Soares teaches heme-binding proteins are useful for reducing harmful effects of free heme in the treatment of disease (page 4 lines 19 – 31). Soares teaches albumin is a heme-binding protein (page 4 lines 2- 3, page 21 lines 11 – 16, page 27 lines 5 – 9, page 65 lines 17 – 30, claim 5).
Soares teaches that albumin conjugated to heme prevents heme’s pro-oxidant effects but does not interfere with heme catabolism and its products HO-1, CO, biliverdin, or bilirubin (page 21 lines 15 – 16, Figure 28, page 24 lines 7 – 10). Soares teaches that HO-1, CO, biliverdin, or bilirubin appear to offer therapeutic or protective effects for some diseases (page 2 lines 24 – 27).
The combination of Spector and Soares’ teachings renders claim 3 prima facie obvious according to MPEP 2143(i)(g) because a person of ordinary skill in the art would be motivated to conjugate heme with human serum albumin because Soares’ teaches that albumin is a heme-binding protein mitigates the cytotoxic effects of heme (page 65 lines 24 – 30, Figure 28). Further, Soares’ teaches that a heme-albumin conjugate can be administered in higher amounts than heme conjugated with other proteins because it has a relatively high concentration in human blood, therefore it is well tolerated in the body (page 21 lines 11 – 15). By using heme-albumin as heme conjugate in the method of Spector, a person of ordinary skill in the art would expect the administration of heme-conjugate heme-albumin to be relatively well tolerated by the body and to protect against the pro-oxidant effects of free heme (page 21 lines 11 – 16, page 24 lines 7 – 10, page 65 lines 24 – 30, Figure 28).
The combination of Spector’s teaching for a method of treating a condition associated with oxidative stress, including various ophthalmological disorders, by administering a heme-peptide (column 1 lines 47 – 54, column 4 lines 53 – 64, column 6 lines 47 – 51, claims 1, 6, 35) with Soares’ teaching for heme-albumin as a heme-conjugate (page 4 lines 2- 3, page 21 lines 11 – 16, page 27 lines 5 – 9, page 65 lines 17 – 30, claim 5) reads on instant claim 3.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Spector (as cited above) in view of Sahiner (Sahiner, N. et. Al “Polydopamine particles as nontoxic, blood compatible, antioxidant and drug delivery materials” Colloids and Surfaces B: Biointerfaces, 2018, 172, p. 618 – 626).
Spector’s teachings are discussed above.
Spector does not teach the biocompatible polymer is polydopamine, or a particle size of 10 to 1000 nm.
Sahiner teaches a missing element of Spector.
Sahiner teaches polydopamine particles of 100 nm in size, which show blood compatibility and antioxidant activity (abstract, page 621 column 2, page 625 column 2). Sahiner teaches polydopamine particles are suitable for drug delivery (abstract).
Sahiner teaches polydopamine particles have functional groups such as hydroxyl and amines, which renders is possible to modify the characteristics of the particle surface (page 621 column 2).
Sahiner teaches polydopamine particles are suitable drug delivery tools (page 624 column 2).
The combination of Spector and Sahiner’s teachings renders claims 13 and 14 prima facie obvious as combining prior art elements according to known methods to yield predictable results. A person of ordinary skill in the art would be motivated to use polydopamine particles as a delivery agent as taught by Sahiner because Sahiner teaches these particles show blood compatibility and antioxidant activity (abstract, page 621 column 2, page 625 column 2). Using polydopamine particles as taught by Sahiner in the method of Spector, would lead a person of ordinary skill in the art to expect the administration of heme-conjugate with polydopamine particles to have good blood compatibility and antioxidant activity (Sahiner abstract, page 621 column 2, page 625 column 2).
The combination of Spector’s teaching for a method of treating a condition associated with oxidative stress, including various ophthalmological disorders, by administering a heme-peptide (column 1 lines 47 – 54, column 4 lines 53 – 64, column 6 lines 47 – 51, claims 1, 6, 35) with Sahiner’s teaching that polydopamine particles have blood compatibility and antioxidant activity, and are suitable drug delivery tools (abstract, page 621 column 2, page 624 column 2, page 625 column 2) reads on instant claim 13.
Sahiner’s teaching that the polydopamine particles are 100 nm in size (abstract, page 621 column 2, page 625 column 2) overlaps on the instantly claimed range of 10 to 1000 nm as recited in claim 14. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Potentially Allowable Subject Matter
Claims 4 – 7 appear to be free of prior art as Spector, Soare, and Sahiner alone or in combination do not teach methemoglobin or methemoglobin conjugation to human serum albumin. Therefore, claims 4 – 7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612