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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/08/2025 has been entered.
Status of the Application
Claims 1-5 and 7-16 are pending.
Claim Rejections - 35 USC § 112 (New matter)
The following is a quotation of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-5 and 7-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The subject matter of instant claims is not properly described in the application as filed. In particular, there was no indication in original specification as filed or in canceled claims that “SBE-βCD monotherapy or SBE-βCD salt monotherapy” and therefore raise doubt as to possession of the claimed invention at the time of filing. Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11, 12 and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims 11, 12 and 16 are directed to a “method of preventing, treating an eye disease ----- (claim 1)---wherein SBE-βCD or SBE-βCD salt is coupled to an agent that targets ---epithelium cells (claim 11); agent target endosomes----epithelium cells (claim 12); ---coupled to a fluorophore(claim 16).
Said genus of agent or fluorophore is not adequately defined in the instant specification. Thus, raise the issue of whether the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Further, the claim uses functional definition for broadly defining agent or a fluorophore and fails to comply with the written description requirement. The MPEP states that for a generic claim, the genus can be adequately described if the disclosure presents a sufficient number of representative species in examples that encompass the genus. (MPEP § 2163). A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus."). An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that "[w]ithout such disclosure, the claimed methods cannot be said to have been described."). If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. Furthermore, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Additionally, in Carnegie Mellon University v. Hoffman-La Roche Inc., Nos. 07-1266, -1267 (Fed. Cir. Sept. 8, 2008), the Federal Circuit affirmed that a claim to a genus described in functional terms was not supported by the specification’s disclosure of species that were not representative of the entire genus. The Guidelines for Examination of Patent Applications under the 35 USC § 112, first paragraph, “Written Description” Requirement”, published at Federal Register, Vol. 66, No. 4, pp. 1099-1111 outline the method of analysis of claims to determine whether adequate written description is present. The first step is to determine what the claim as a whole cover, i.e., discussion of the full scope of the claim. Second, the application should be fully reviewed to understand how applicant provides support for the claimed invention including each element and/or step, i.e., compare the scope of the claim with the scope of the description. Third, determine whether the applicant was in possession of the claimed invention as a whole at the time of filing. Each of these factors has been considered, with the most relevant factors discussed below. For each claim drawn to a genus, each of these factors is to be considered to determine whether there is disclosure of a representative number of species that would lead one skilled in the art to conclude that applicant was in possession of the claimed invention. Where skill and knowledge in the art is high, adequate written description would require fewer species to be disclosed than in an art where little is known; further, more species would need to be disclosed to provide adequate written description for a highly variable genus.
With respect to the scope of the claims, the full scope of the instant claims 11, 12 and 16 is to a “method of preventing, treating an eye disease ----- (claim 1)---wherein SBE-βCD or SBE-βCD salt is coupled to an agent that targets ---epithelium cells (claim 11); agent target endosomes----epithelium cells (claim 12); ---coupled to a fluorophore(claim 16). The claim uses functional definition for broadly defining coupled portion of the compound and fails to comply with the written description requirement.” For example, the instant claims do not include a structures of agent and/or fluorophore that satisfies the functional definition of the genus. "The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention."). Problems satisfying the written description requirement for original claims often occur when claim language is generic or functional, or both. Ariad, 593 F.3d at 1349, 94 USPQ2d at 1171 ("The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus." Functional language at the point of novelty, as herein employed by applicants, is admonished in University of California v. Eli Lilly and Co. 43 USPQ2d 1398 (CAFC, 1997) at 1406: stating this usage does “little more than outline goal appellants hope the recited invention achieves and the problems the invention will hopefully ameliorate”. The CAFC further clearly states that “[A] written description of an invention involving a chemical genus, like a description of a chemical species, requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials” at 1405 (emphasis added), and that “It does not define any structural features commonly possessed by members of the genus that distinguish from others. One skilled in the art therefore cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus. A definition by function, as we have previously indicated, does not suffice to define the genus…” at 1406 (emphases added).
Comparison of the scope of the claims and the scope of the specification reveals that the scope of the claims is broader than that supported by the specification. Applicants have disclosed broadly agents, and a diverse number of fluorophores (paragraph 0011). However, the specification lacks single example where SBE-βCD or its salt is linked to any agent or linked to any fluorophore or a chemical synthesis to prepare such coupling product. In other words, there is not even a single example where any of the agent defined by functional definitions or fluorophore is coupled to SBE-βCD or its salt Vs. millions of coupled compounds claimed in the instant claims.
The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)). Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). See M.P.E.P. § 2163.02. In this case, the skilled artisan would not have reasonably concluded at the time of the invention that applicant was in possession of the entire invention as claimed.
In University of Rochester v. G.D. Searle & Co., 68 USPQ2d 1424 (W.D.N.Y. 2003), at issue was a patent directed to method for inhibiting prostaglandin (PGHS-2) synthesis in a patient using an unspecified compound. The District Court of Western New York evaluated the level of disclosure required to satisfy the written description. In their decision (which was later affirmed by the Court of Appeals for the Federal Circuit), the District Court wrote, “The real issue here is simply whether a written description of a claimed method of treatment is adequate where a compound that is necessary to practice that method is described only in terms of its function, and where the only means provided for finding such a compound is essentially a trial-and-error process.”
The patent in Rochester does no more than describe the desired function of the compound called for, and it contains no information by which a person of ordinary skill in the art would understand that the inventors possessed the claimed invention. At best, it simply indicates that one should run tests on a wide spectrum of compounds in the hope that at least one of them will work. The specification of the patent in Rochester states that the invention comprises, inter alia, “assays for screening compounds, including peptides, polynucleotides, and small organic molecules to identify those that inhibit the expression or activity of the PGHS-2 gene product; and methods of treating diseases characterized by aberrant PGHS-2 activity using such compounds.” Nowhere, however, does it specify which “peptides, polynucleotides, and small organic molecules” have the desired characteristic of selectively inhibiting PGHS-2.
The Rochester court cited the CAFC in Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 1316 (63 U.S.P.Q.2d 1609), which adopted the standard set forth in the Patent and Trademark Office (“PTO”) Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, 1 “Written Description” Requirement (“Guidelines”), 66 Fed. Reg. 1099 (Jan. 5, 2001), which state that the written description requirement can be met by “showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics,” including, inter alia, “functional characteristics when coupled with a known or disclosed correlation between function and structure ... .” Enzo, 296 F.3d at 1324-25 (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)).
The Rochester court also cited the CAFC in Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 [43 U.S.P.Q.2d 1398] (Fed. Cir. 1997), in which the court drew a distinction between genetic material and other chemicals; in drawing this distinction, however, the court also stated that “[i]n claims involving [non-genetic] chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus.” 119 F.3d at 1568 (emphasis added). There is no such specificity here, nor could one skilled in the art identify any particular compound encompassed by the claims.
The “written description” requirement may be satisfied by using such descriptive means as words, structures, figures, diagrams, formulas, etc., that fully set forth the claimed invention. See Noelle v. Lederman, 355 F.3d 1343, 1349, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) and Lockwood v. American Airlines, Inc., 107 F.3d at 1572, 41 U.S.P.Q.2d at 1966. A definition by function alone “does not suffice” to sufficiently describe a coding sequence “because it is only an indication of what the gene does, rather than what it is.” Regents of the University of California v. Eli Lilly & Co., 119 F.3 at 1568, 43 USPQ2d at 1406 (Fed. Cir. 1997) (discussing Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 U.S.P.Q.2d 1016 (Fed. Cir. 1991)). In Fiers v. Ravel, 984 F.2d at 1169-71, 25 U.S.P.Q.2d at 1605-06 (1993), the CAFC found that “a mere wish or plan for obtaining the claimed chemical invention” is not sufficient to describe a chemical invention (discussed in Eli Lilly at 1404).
For this reason, the rejection due to lack of written description is proper.
Claim Interpretation
Claims 5, 7-9, 11-12 uses clauses “wherein; configured to”, these claims and claims dependent on these claims (i.e., 10 and 13) suggests or makes limitations optional but does not require any steps to be performed or limit claim to a particular structure. These limitations do not carry patentatble weight, when these limitations simply express the intended result.
I. "ADAPTED TO," "ADAPTED FOR," "WHEREIN," and "WHEREBY"
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) "adapted to" or "adapted for" clauses;
(B) "wherein" clauses; and
(C) "whereby" clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps"). In In re Giannelli, 739 F.3d 1375, 1378, 109 USPQ2d 1333, 1336 (Fed. Cir. 2014), the court found that an "adapted to" clause limited a machine claim where "the written description makes clear that 'adapted to,' as used in the [patent] application, has a narrower meaning, viz., that the claimed machine is designed or constructed to be used as a rowing machine whereby a pulling force is exerted on the handles." In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 7-16 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 pre-AIA the applicant regards as the invention.
Claims 1-5 and 7-16 are indefinite as claims 1 and 4 recites “comprising --- SBE-βCD monotherapy or SBE-βCD salt monotherapy”. This is because such recitation reflects the use of broad “comprising” and narrower “monotherapy” limitations within the same claim, making scope of claim unclear.
Since dependent claims doesn’t cure the above deficiency, the claims are also indefinite.
Appropriate correction required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11-13 and 16 are rejected under 35 U.S.C. 112(d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 11-13 and 16 are in an improper dependent form because:
According to claim 1, administration is “SBE-βCD monotherapy or SBE-βCD salt monotherapy”. Claim 11-13 dependent on claim 1 recites “SBE-βCD or SBE-βCD salt coupled to an agent”, which makes claim improper and broader than claim 1.
Similarly, Claim 16 dependent on claim 1 recites “SBE-βCD or SBE-βCD salt --coupled to a fluorophore”, which makes claim improper and broader than claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(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 1-5, 7-12, 14 and 16 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Jordan (US 20120302601 A1).
Jordan discloses a method of treating macular degeneration and retinal damage caused by genetic, non-genetic or age-related diseases with examples Stargardt’s disease, AMD caused by A2E toxicity leading to accumulation of lipofuscin in retinal pigment epithelial cells (RPE) containing A2E (same diseases as in the instant claims) comprising administering to the subject an effective amount of beta-cyclodextrin sulfobutyl ether sodium or potassium salt combined (equivalent to “coupled” of the instant claims) with another agent compound of formula Ia (considered as fluorophore as it has a conjugated system):
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, topically, or topical ocular (intraocular), thereby reducing A2E, bis-retinoids by reacting covalently with all-trans retinaldehyde (RAL) (Entire application, especially paragraphs 0002-0004, 0008, 0014, 0015, 0018-0020, 0022-0026, Examples and claims). Since the cited prior art teaches a method of treating AMD caused by A2E toxicity leading to accumulation of lipofuscin in retinal pigment epithelial cells (RPE) containing A2E and a method of reducing A2E (same mechanism as in the instant claims 9), method of the cited prior art is expected to also reduce lipofuscin accumulation, treating lipofuscin accumulation, blocks---reverses –lipofuscin in ---cells and thereby prevents lipofuscin-associated retinal damage whether or not realized by the cited prior art.
With regards to limitation “without impairing visual acuity”-Since the cited prior art teaches treating same disease caused by same biomolecules, biopathways, biomarkers using same compound as in the instant claims, the treatment method of the cited prior art is expected to be “without impairing visual acuity” whether or not realized by the cited prior art.
With regards to limitation “SBE-- configured to localize---cells; SBE – configured to complex---cells”-Since the cited prior art teaches treating using same compound as in the instant claims, the compound of the cited prior art is also capable to be “configured to localize---cells; SBE – configured to complex---cells”. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000). Thus, the cited prior art reads on all limitations of the instant claims.
With regards to limitation “an agent –targets –cells; agent targets lysosomes---cells”-Since the cited prior art teaches treating using same compound as in the instant claims, the compound of the cited prior art is also capable of “targets –cells; agent targets lysosomes---cells”. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000). Thus, the cited prior art reads on all limitations of the instant claims.
Since the cited prior art reads on all the limitations of the instant claims 1-5, 7-12, 14 and 16, these claims are anticipated.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 and 7-16 are rejected under 35 U.S.C. 103 as being unpatentable over Jordan (US 20120302601 A1) and Rodriguez-Boulan (US2014/0038918) in combination.
Determining the scope and contents of the prior art
Jordan discloses a method of treating macular degeneration and retinal damage caused by genetic, non-genetic or age-related diseases with examples Stargardt’s disease, AMD caused by A2E toxicity leading to accumulation of lipofuscin in retinal pigment epithelial cells (RPE) containing A2E (same diseases as in the instant claims) comprising administering to the subject an effective amount of beta-cyclodextrin sulfobutyl ether sodium or potassium salt combined (equivalent to “coupled” of the instant claims) with another agent compound of formula Ia (considered as fluorophore as it has a conjugated system):
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, topically, or topical ocular (intraocular), thereby reducing A2E, bis-retinoids by reacting covalently with all-trans retinaldehyde (RAL) (Entire application, especially paragraphs 0002-0004, 0008, 0014, 0015, 0018-0020, 0022-0026, Examples and claims). Since the cited prior art teaches a method of treating AMD caused by A2E toxicity leading to accumulation of lipofuscin in retinal pigment epithelial cells (RPE) containing A2E and a method of reducing A2E (same mechanism as in the instant claims 9), method of the cited prior art is expected to also reduce lipofuscin accumulation, treating lipofuscin accumulation, blocks---reverses –lipofuscin in ---cells and thereby prevents lipofuscin-associated retinal damage whether or not realized by the cited prior art.
With regards to limitation “without impairing visual acuity”-Since the cited prior art teaches treating same disease caused by same biomolecules, biopathways, biomarkers using same compound as in the instant claims, the treatment method of the cited prior art is expected to be “without impairing visual acuity” whether or not realized by the cited prior art.
With regards to limitation “SBE-- configured to localize---cells; SBE – configured to complex---cells”-Since the cited prior art teaches treating using same compound as in the instant claims, the compound of the cited prior art is also capable to be “configured to localize---cells; SBE – configured to complex---cells”. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000).
With regards to limitation “an agent –targets –cells; agent targets lysosomes---cells”-Since the cited prior art teaches treating using same compound as in the instant claims, the compound of the cited prior art is also capable of “targets –cells; agent targets lysosomes---cells”. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000).
Rodriguez-Boula teaches treating lipofuscin-associated diseases caused by genetic, non-genetic or age-related diseases accumulation of lipofuscin with examples Stargardt’s disease, AMD by binding with A2E in retinal pigment epithelial cells (RPE) thereby reducing accumulation of lipofuscin (same diseases as in the instant claims) comprising administering using a slow-release subscleral administration to a subject an effective amount of beta-cyclodextrin or its derivatives (entire application, especially abstract, paragraphs 0015-0019, 0042-0059 and claims) . The cited prior art further teaches that cyclodextrin may be coupled with mannose-6-phosphate and/or fluorophore, which targets endosomes or lysosomes in RPE cells (paragraphs 0015-0019, 0042-0059 and claims).
Ascertaining the differences between the prior art and the claims at issue
Jordan discloses a method of treating macular degeneration and retinal damage caused by genetic, non-genetic or age-related diseases with examples Stargardt’s disease, AMD caused by A2E toxicity leading to accumulation of lipofuscin in retinal pigment epithelial cells (RPE) containing A2E (same diseases as in the instant claims) comprising administering to the subject an effective amount of beta-cyclodextrin sulfobutyl ether sodium or potassium salt, but fails to teach the process wherein beta-cyclodextrin sulfobutyl ether sodium or potassium salt is coupled with mannose-6-phosphate; and administration using a slow-release subscleral administration.
Rodriguez-Boula teaches treating lipofuscin-associated diseases caused by genetic, non-genetic or age-related diseases accumulation of lipofuscin with examples Stargardt’s disease, AMD by binding with A2E in retinal pigment epithelial cells (RPE) thereby reducing accumulation of lipofuscin (same diseases as in the instant claims) comprising administering using a slow-release subscleral administration to a subject an effective amount of beta-cyclodextrin or its derivatives. However, the cited prior art is silent about using beta-cyclodextrin sulfobutyl ether derivative.
Resolving the level of ordinary skill in the pertinent art
Since Jordan teaches a method of treating macular degeneration and retinal damage caused by genetic, non-genetic or age-related diseases with examples Stargardt’s disease, AMD caused by A2E toxicity leading to accumulation of lipofuscin in retinal pigment epithelial cells (RPE) containing A2E (same diseases as in the instant claims) comprising administering to the subject an effective amount of beta-cyclodextrin sulfobutyl ether sodium or potassium salt and Rodriguez-Boula teaches treating lipofuscin-associated diseases caused by genetic, non-genetic or age-related diseases accumulation of lipofuscin with examples Stargardt’s disease, AMD by binding with A2E in retinal pigment epithelial cells (RPE) thereby reducing accumulation of lipofuscin (same diseases as in the instant claims) comprising administering using a slow-release subscleral administration to a subject an effective amount of beta-cyclodextrin or its derivatives, it would have been prima facie obvious to a person of ordinary skill in the art that beta-cyclodextrin derivative sulfobutyl ether sodium or potassium salt may be useful in treating diseases associated with lipofuscin accumulation. This is because Jordan specifically teaches using beta-cyclodextrin derivative sulfobutyl ether sodium or potassium salt. Further, it would have been prima facie obvious to a person of ordinary skill in the art that beta-cyclodextrin derivative sulfobutyl ether sodium or potassium salt may be coupled with mannose-6-phosphate and/or a fluorophore and administration may be performed using a slow-release subscleral administration as taught by Rodriguez-Boula .
Therefore, combination reads applicants claims.
Based on the above established facts, it appears that the combination of teachings of above cited prior art read applicants’ process.
Therefore, all the claimed elements were known in the prior art and one skilled person in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Jordan teaches a method of treating macular degeneration and retinal damage caused by genetic, non-genetic or age-related diseases with examples Stargardt’s disease, AMD caused by A2E toxicity leading to accumulation of lipofuscin in retinal pigment epithelial cells (RPE) containing A2E (same diseases as in the instant claims) comprising administering to the subject an effective amount of beta-cyclodextrin sulfobutyl ether sodium or potassium salt and Rodriguez-Boula teaches treating lipofuscin-associated diseases caused by genetic, non-genetic or age-related diseases accumulation of lipofuscin with examples Stargardt’s disease, AMD by binding with A2E in retinal pigment epithelial cells (RPE) thereby reducing accumulation of lipofuscin (same diseases as in the instant claims) comprising administering using a slow-release subscleral administration to a subject an effective amount of beta-cyclodextrin or its derivatives. So, the combination of prior art read applicants claims.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 -Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try”– choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.” KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. Further, there is a reasonable expectation of success that beta-cyclodextrin derivative sulfobutyl ether sodium or potassium salt may be useful in treating diseases associated with lipofuscin accumulation and can be made by combination of the above cited prior art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed process with a reasonable expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5 and 7-16 in the instant application are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10463687 B2 in view of Jordan (US 20120302601 A1), since the claims, if allowed, would improperly extend the “right to exclude" already granted in the patent.
Although the conflicting claims are not identical, they are not patentably distinct from each other because of the following reasons:
Determining the scope and contents U.S. Patent No. 10463687 B2 and Jordan (US 20120302601 A1)
Jordan discloses a method of treating macular degeneration and retinal damage caused by genetic, non-genetic or age-related diseases with examples Stargardt’s disease, AMD caused by A2E toxicity leading to accumulation of lipofuscin in retinal pigment epithelial cells (RPE) containing A2E (same diseases as in the instant claims) comprising administering to the subject an effective amount of beta-cyclodextrin sulfobutyl ether sodium or potassium salt combined (equivalent to “coupled” of the instant claims) with another agent compound of formula Ia (considered as fluorophore as it has a conjugated system):
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, topically, or topical ocular (intraocular), thereby reducing A2E, bis-retinoids by reacting covalently with all-trans retinaldehyde (RAL) (Entire application, especially paragraphs 0002-0004, 0008, 0014, 0015, 0018-0020, 0022-0026, Examples and claims). Since the cited prior art teaches a method of treating AMD caused by A2E toxicity leading to accumulation of lipofuscin in retinal pigment epithelial cells (RPE) containing A2E and a method of reducing A2E (same mechanism as in the instant claims 9), method of the cited prior art is expected to also reduce lipofuscin accumulation, treating lipofuscin accumulation, blocks---reverses –lipofuscin in ---cells and thereby prevents lipofuscin-associated retinal damage whether or not realized by the cited prior art.
With regards to limitation “without impairing visual acuity”-Since the cited prior art teaches treating same disease caused by same biomolecules, biopathways, biomarkers using same compound as in the