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 .
Claim Status
Claims 1-17 are pending. Claims 7-9 and 11-17 are withdrawn. Claims 1-6 and 10 are presently considered.
Election/Restrictions
Applicant’s election without traverse of Group I (polypeptides comprising SEQ ID NOs: 1, 2, or 3; and a nanoparticle) and the species of angiopeptide-α1 (SEQ ID NO: 1) and the NP described at Example 2, in the reply filed on 2/02/2026 is acknowledged.
The originally elected specie is understood as follows: The angiopeptide-α1 (SEQ ID NO: 1) is understood to have the following sequence:
VDSGNDVTDIADDGAPKPPEIAHGYVEHSVRYQCKNYYKLRTEGDGVYTLNNEKQWINKAVGDKLPECEAVAGKPKNPANPV
Example 2 (see, e.g., Spec. filed 5/24/2023 at ¶¶[0077]-[0095] and Fig. 9) describes the elected species of product at paragraphs [0079]-[0082]. The nanoparticles are understood to be Cy5-conjugated TPP1880 Da/ LMWF8775 Da CNP with a diameter of about 100 nm to about 350 nm (see, e.g., Reply filed 2/02/2026 at 5), wherein “LMWF8775” is understood to be a depolymerized low molecular weight fucoidan, and wherein TPP1880 is understood to be a thermolysin-hydrolyzed protamine peptide as shown at instant Figure 91.
The originally elected species is understood to not read upon instant claims 7-9 because no hydrogel was identified as present in the originally elected species. The originally elected species is understood to read upon claims 1-6 and 10.
Following extensive search and examination, the originally elected species has been deemed free of the prior art. The point of novelty is understood to be SEQ ID NO: 1, which comprises a non-conservative D to E mutation at position 75 relative to the closest prior art of record (e.g., US20180036370 at SEQ ID NO: 1). Per MPEP § 803.02(III)
If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended. If prior art is then found that anticipates or renders obvious the Markush claim with respect to a nonelected species, the Markush claim shall be rejected; claims to the nonelected species would still be held withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species.
Accordingly, Examination was extended to a non-elected species of SEQ ID NO: 3 in combination with a nanoparticle carrier.
Following extensive search and examination, the non-elected species was deemed anticipated and/or obvious in view of the prior art as applied below. Per MPEP § 803.02(III), claims directed to other nonelected species have been withdrawn.
Claims 11-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/02/2026.
Claims 7-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/02/2026.
Accordingly, claims 1-6 and 10 are presently considered.
Priority
The priority claim to PCT/US2020/062809 as filed 12/02/2020 is acknowledged.
Information Disclosure Statement
The IDS filed 6/02/2024 and 8/01/2024 are each acknowledged and presently considered.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show details as described in the specification because the grayscale figures are illegible in whole or part (see, e.g., Figures 2, 9, 11 at column header). Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities:
Claims 1 and 6 comprises superfluous language (e.g., “an amino acid sequence shown as any of SEQ ID Nos: 1 to 3” is equivalent to “an amino acid sequence .
Appropriate correction is required.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Claims 1 and 6 are representative of the pending claim scope. Claim 6 is understood to be the broadest claim of record. Applicable claim interpretations are discussed below.
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
Regarding the preamble of claim 1 and 6 reciting “for treatment of ischemia disease”, per MPEP § 2111.02, “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”. Here, the body of claims 1 and 6 are each understood to recite a structurally complete invention, and therefore the preamble is deemed fully satisfied by prior art that satisfies the steps and structures recited in the body of the claim (see also MPEP § 2111.04(I), noting that “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”).
Claims 2 (“self-assembled”) and 4 (“is formed by”) appears to recite product-by-process limitations. Per MPEP § 2113(I),
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process."
In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
Accordingly, claims 2 and 4 are understood to be fully satisfied by a “complex nanoparticle” comprising fucoidan and thermolysin-hydrolyzed protamine peptide, because the resulting products are presumed to be structurally identical absent objective evidence to the contrary (see, e.g., MPEP § 2113(II), noting that the burden is on the Applicant to show product-by-process limitations result in a nonobvious difference).
At claim 1, the term “nanoparticle” is under interpreted consistent with the specification, and is any ultrafine particle having a mean particle size of 1-1000nm (see, e.g., Spec. filed 5/24/2023 at ¶[0024]).
Claim 1 recites “an amino acid sequence . . . of SEQ ID Nos: 1 to 3. The Office interprets claims directed to sequence identifiers as follows: The phrase “A biopolymer comprising a sequence of SEQ ID NO: 1” encompasses biopolymers comprising the full-length SEQ ID NO: 1 and also any subsequence of 2 or more units within SEQ ID NO: 1. The phrase “A biopolymer comprising the sequence of SEQ ID NO: 1” encompasses only biopolymers comprising the full-length of SEQ ID NO: 1. If the language is changed to closed, replacing “comprising with “consisting of, the first example above would encompass any biopolymer sequence of two or more units fully contained within SEQ ID NO: 1, whereas the second example would be limited to the exact biopolymer as specified by SEQ ID NO: 1, and nothing more or less. If qualifying language is present (i.e., “polynucleotide”, “protein”, “polypeptide”, “oligopeptide”, etc.) the specification is consulted to determine whether or not an explicit definition is provided that imposes a lower limit on the size of biopolymer encompassed by the qualifying terminology.
At claim 2 the term “complex nanoparticle” is undefined on record, but would be reasonably understood by one of skill in the art to encompass any nanoparticle comprising two or more components (see, e.g., Spec. filed 5/24/2023 at ¶¶[0077]-[0095] and Fig. 9).
Claim 3 is understood to recite active method steps within a product claim (i.e., “the nanoparticle targets”), which renders the claims indefinite per MPEP § 2173.05(p)(II). For purposes of applying prior art, claim 3 is understood to recite an intended and expected result that the compound of claim 1 is capable of performing.
The term “about” at claim 5 is not defined on record. The term “about” is therefore given its ordinary meaning in view of the biochemical arts, and is understood to mean at least “within 20 percent” (see, e.g., US 2009/0028832 A1 at ¶[0111]; see also US 2012/0178676, at ¶[0277]). Accordingly, the range at claim 5 of “about 50 nm and about 750 nm” is understood to encompass at least the range 40 to 900 nm.
At claim 6, the term “carrier” is undefined, bur exemplified as including nanoparticles and hydrogels (see, e.g., Spec. filed 5/24/2023 at ¶[0033]). The term is given it’s ordinary meaning, and is understood to include any pharmaceutically acceptable carrier (e.g., water, saline, etc.).
Additional claim interpretations are discussed below.
Claim Rejections
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 is understood to recite active method steps within a product claim (i.e., “the nanoparticle targets”), which renders the claims indefinite per MPEP § 2173.05(p)(II), because it is unclear if infringement occurs before, during, or after the completion of the targeting step. Accordingly, claim 3 is indefinite. For purposes of applying prior art, it is reasonably inferred that the limitation is satisfied by any prior art that specifically identifies a nanoparticle capable of targeting p-selectin, or otherwise satisfies the requirements of claim 4.
Claim 3 attempts to limit the scope of nanoparticles by reciting a functional outcome achievable by unspecified structures encompassed by the claims, namely claim 3 includes only embodiments of nanoparticles capable of “target[ing] inflammatory tissues and/or ischemic tissues overexpressing p-selectin”, but excludes all other types of nanoparticles. The subgenus of nanoparticles capable of (or not capable of) “target[ing] inflammatory tissues and/or ischemic tissues overexpressing p-selectin” does not correspond to any structure/function relationship of record, and does not appear to have a single, unambiguous art-recognized definition prior to the time of filing commensurate in scope with the claims. Although presumably the limitation is satisfied by nanoparticles comprising fucoidan and protamine, such as those disclosed by Lu et al2, it is unclear what other nanoparticles satisfy the limitation (i.e., do any nanoparticles lacking fucoidan and protamine achieve the functional outcome?). Per MPEP § 2173.05(g),
[T]he use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. . .
Here, the claims merely recite a description of functions or results to be achieved by the invention rather than a description of the structures capable of achieving the desired functions, and therefore the claims are indefinite per MPEP § 2173.05(g). This is reasonable because MPEP § 2173 identifies that the primary purpose of the requirement is to inform the public of the boundaries of what constitutes infringement of the patent, but here it is unclear what compounds do or do not infringe upon the scope of claim 2 other than the originally elected species. Notably, the courts have stated that
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
Accordingly, because it is unclear what compounds do or do not satisfy the functional limitations of claim 3, and an artisan would be unable to identify infringing from non-infringing compounds, claim 3 is rejected as indefinite. For purposes of applying prior art, it is reasonably inferred that the limitation is satisfied by any prior art that specifically identifies a nanoparticle capable of targeting p-selectin, or otherwise satisfies the requirements of claim 4.
Claim 5 is indefinite because it conflates qualitative and quantitative language in a manner that obscures the metes and bounds of the claim scope, such that an artisan would not be reasonably apprised of what does or does not constitute infringement. More specifically, claim 5 recites “between about 50 nm and about 750 nm”, wherein “about” is qualitative language and “between” is quantitative language. Accordingly, assuming arguendo that “about” implies ±10% or ±20% of a value, the claim scope is rendered indefinite because “between 45 nm and 825 nm” (i.e., where “about” is ±10%) excludes values less than 45 nm or over 825 nm. However, if about is reasonably understood to mean ±20%, then the claim scope is arbitrarily changed to “between 40 nm and 900 nm”, which includes values such as 40-44.9 nm and 826-900 nm. This rejection could be overcome by simply deleting either “between” or otherwise deleting “about” from the phrase “between about 50 nm and about 750 nm”.
Accordingly, claims 3 and 5 are rejected as indefinite.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
[Prior Art Rejection 01]
Claim 6 is rejected under 35 U.S.C. 102(a)(1)/(2) as being clearly anticipated by US20180036370 (Feb. 8, 2018; corresponding to US 10188700).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claim 6 and instant SEQ ID NO: 3, the primary reference teaches and discloses SEQ ID NO: 3, which shares 100% sequence identity with instant SEQ ID NO: 3 (compare instant SEQ ID NO: 3 with US’370 at SEQ ID NO: 3):
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Accordingly, SEQ ID NO: 3 is a prior art element. Regarding instant claim 6 and the combination of SEQ ID NO: 3 and a “carrier”, the primary reference explicitly claims methods of administering SEQ ID NO: 3 to subjects (see, e.g., US’370 at claims 14-20), and therefore an artisan would at once envisage SEQ ID NO: 3 with a carrier, namely a pharmaceutically acceptable excipient suitable for administration of a polypeptide sequence to a patient. In addition or alternatively, the primary reference discloses that SEQ ID NO: 3 was combined with cell culture medium (see, e.g., US’370 at ¶[0040]).
Accordingly, claim 6 is anticipated by the prior art.
[Prior Art Rejection 02]
Claim 6 is rejected under 35 U.S.C. 102(a)(1)/(2) as being clearly anticipated by US20180036373A1 (Feb. 8, 2018; corresponding to US10195248B2).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claim 6 and instant SEQ ID NO: 3, the primary reference teaches and discloses SEQ ID NO: 3, which shares 100% sequence identity with instant SEQ ID NO: 3 (compare instant SEQ ID NO: 3 with US’373 at SEQ ID NO: 3):
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Accordingly, SEQ ID NO: 3 is a prior art element. Regarding instant claim 6 and the combination of SEQ ID NO: 3 and a “carrier”, the primary reference explicitly claims methods of administering SEQ ID NO: 3 to subjects (see, e.g., US’373 at claims 9-13), and therefore an artisan would at once envisage SEQ ID NO: 3 with a carrier, namely a pharmaceutically acceptable excipient suitable for administration of a polypeptide sequence to a patient.
Accordingly, claim 6 is anticipated by the prior art.
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 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.
[Prior Art Rejection 03]
Claims 1-6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over US20180036370 (Feb. 8, 2018; corresponding to US 10188700) as applied to claim 6 above, and further in view of Lu et al3.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
The teachings of the primary reference as applied to claim 6 has been discussed above, and those teachings are incorporated into the instant rejection.
The primary reference differs from instant claims as follows: Although the primary reference teaches instant SEQ ID NO: 3 for use in compositions suitable for administration to a patient, the primary reference does not teach nor disclose a nanoparticle as recited at instant claims 1-5 and 10.
Regarding instant claims 1, 10, and a nanoparticle carrier, Lu discloses a nanoparticle capable of delivering therapeutic agents to cells (see, e.g., Lu at title, abs, 412 at Fig. 1, 414 at Fig. 2, passim). Regarding instant claim 2 and a “self-assembled complex nanoparticle”, Lu describes the nanoparticle as “a multi-stimuli-responsive nanoparticle self-assembled by fucoidan and a cationic polypeptide (protamine)” (see Lu at abs), and explains that the nanoparticle is a “self-assembled colloidal nanocomplex formed by electrostatic interactions between the oppositely charged polysaccharide and polypeptide at different fucoidan-to-protamine weight ratios” (see, e.g., Lu at 413 at col I at § 3.1; see also id. at 412 at Fig. 1, 414 at Fig. 2). Accordingly, the Lu nanoparticle is understood to be a complex, and is also a self-assembled nanoparticle. Regarding instant claim 3 and the capability to “target[] …. Tissues overexpressing p-selectin”, Lu explains that Fucoidan is a P-selectin targeting ligand, and notes that the “potential anti-inflammatory, antithrombotic and anticoagulant activities of fucoidan” are known, and that P-selectin expression is “induced in activated platelets and endothelial cells” (see, e.g., Lu at 410 at col I-II at bridging ¶ and 410-411 at bridging ¶, explaining that Fucoidan has been used to prepare nanoparticles for the delivery of therapeutics). Lu explains that the nanoparticles function by P-selectin mediated endocytosis (see, e.g., Lu at abs, 412 at Fig. 1), and therefore an artisan would readily appreciate and conclude that such nanoparticles could be utilized to target P-selectin expressing cells. Regarding instant claim 4 and “wherein the self-assembled complex nanoparticle is formed by fucoidan and thermolysin-hydrolyzed protamine peptide”, as an initial matter, it is noted that this is product-by-process language (see, e.g., MPEP § 2113(I), which explains that "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process."). Here, the nanoparticles disclosed by Lu comprise fucoidan and protamine (see, e.g., Lu at 412 at Fig. 1, 414 at Fig. 2), and are understood to be “self-assembled colloidal nanocomplex formed by electrostatic interactions between the oppositely charged polysaccharide and polypeptide at different fucoidan-to-protamine weight ratios” (see, e.g., Lu at 413 at col I at § 3.1; see also id. at 412 at Fig. 1, 414 at Fig. 2). Although Lu does not specify that the protamine utilized is “thermolysin-hydrolyzed”, Lu does identify that the protamine has a molecular weight of 5 kDa (see, e.g., Lu at 411 at col I at §2.1), and therefore would be readily understood to be a low molecular weight protamine. Accordingly, in the absence of identification of how the product-by-process recitation of “thermolysin-hydrolyzed” differentiates the claim scope relative to the low molecular weight protamine of Lu, then it is reasonably inferred that Lu satisfies such limitations. Regarding instant claim 5 and a “mean particle size of between about 50 nm and about 750 nm”, Lu identifies that the nanoparticles have a hydrodynamic radius ranging from about 50 to 300 nm (see, e.g., Lu at 415 at Fig. 3(A); compare id. with instant claim 5), and therefore the disclosed nanoparticles are understood to fall within and overlap with the claimed range (see, e.g., MPEP § 2144.05(I), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists ). In sum, Lu identifies that P-selectin targeting, self-assembling, nanoparticles comprising fucoidan and protamine, capable of delivering therapeutic agents to P-selectin expressing cells, were already known in the prior art.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s): The claimed invention is the combination of prior art elements (e.g., a therapeutic agent of SEQ ID NO: 3 as taught by the primary reference, and a nanoparticle delivery method as taught by Lu), according to known methods of delivering therapeutic agents using nanoparticles as disclosed and suggested by Lu, wherein such combination would yield predictable results, namely the therapeutic agent of SEQ ID NO: 3 encapsulated by a nanoparticle, wherein the combination would be predictably usable in the therapeutic methods taught and claimed by the primary reference, but would desirably and advantageously have improved ability to target the encapsulated therapeutic agent to activated platelets and endothelial cells expressing p-selectin (see, e.g., MPEP § 2143(I)(A), (B), (C), (D), and (G)). Furthermore, each prior art element would merely perform its art-recognized function in combination.
No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well-within the ordinary skill in the art to practice a known method of treatment using a known peptide delivered using a known drug delivery system, in order to achieve the known and expected outcomes, namely a successful treatment.
Accordingly, claims 1-6 and 10 are rejected.
[Prior Art Rejection 04]
Claims 1-6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over US20180036373A1 (Feb. 8, 2018; corresponding to US10195248B2) as applied to claim 6 above, and further in view of Lu et al4.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claims 1, 10, and a nanoparticle carrier, Lu discloses a nanoparticle capable of delivering therapeutic agents to cells (see, e.g., Lu at title, abs, 412 at Fig. 1, 414 at Fig. 2, passim). Regarding instant claim 2 and a “self-assembled complex nanoparticle”, Lu describes the nanoparticle as “a multi-stimuli-responsive nanoparticle self-assembled by fucoidan and a cationic polypeptide (protamine)” (see Lu at abs), and explains that the nanoparticle is a “self-assembled colloidal nanocomplex formed by electrostatic interactions between the oppositely charged polysaccharide and polypeptide at different fucoidan-to-protamine weight ratios” (see, e.g., Lu at 413 at col I at § 3.1; see also id. at 412 at Fig. 1, 414 at Fig. 2). Accordingly, the Lu nanoparticle is understood to be a complex, and is also a self-assembled nanoparticle. Regarding instant claim 3 and the capability to “target[] …. Tissues overexpressing p-selectin”, Lu explains that Fucoidan is a P-selectin targeting ligand, and notes that the “potential anti-inflammatory, antithrombotic and anticoagulant activities of fucoidan” are known, and that P-selectin expression is “induced in activated platelets and endothelial cells” (see, e.g., Lu at 410 at col I-II at bridging ¶ and 410-411 at bridging ¶, explaining that Fucoidan has been used to prepare nanoparticles for the delivery of therapeutics). Lu explains that the nanoparticles function by P-selectin mediated endocytosis (see, e.g., Lu at abs, 412 at Fig. 1), and therefore an artisan would readily appreciate and conclude that such nanoparticles could be utilized to target P-selectin expressing cells. Regarding instant claim 4 and “wherein the self-assembled complex nanoparticle is formed by fucoidan and thermolysin-hydrolyzed protamine peptide”, as an initial matter, it is noted that this is product-by-process language (see, e.g., MPEP § 2113(I), which explains that "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process."). Here, the nanoparticles disclosed by Lu comprise fucoidan and protamine (see, e.g., Lu at 412 at Fig. 1, 414 at Fig. 2), and are understood to satisfy the claim requirement because the nanoparticles are described as a “self-assembled colloidal nanocomplex formed by electrostatic interactions between the oppositely charged polysaccharide and polypeptide at different fucoidan-to-protamine weight ratios” (see, e.g., Lu at 413 at col I at § 3.1; see also id. at 412 at Fig. 1, 414 at Fig. 2). Although Lu does not specify that the protamine utilized is “thermolysin-hydrolyzed”, Lu does identify that the protamine has a molecular weight of 5 kDa (see, e.g., Lu at 411 at col I at §2.1), and therefore would be readily understood to be a low molecular weight protamine. Accordingly, in the absence of identification of how the product-by-process recitation of “thermolysin-hydrolyzed” differentiates the claim scope relative to the low molecular weight protamine of Lu, then it is reasonably inferred that Lu satisfies such limitations. Regarding instant claim 5 and a “mean particle size of between about 50 nm and about 750 nm”, Lu identifies that the nanoparticles have a hydrodynamic radius ranging from about 50 to 300 nm (see, e.g., Lu at 415 at Fig. 3(A); compare id. with instant claim 5), and therefore the disclosed nanoparticles are understood to fall within and overlap with the claimed range (see, e.g., MPEP § 2144.05(I), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists ). In sum, Lu identifies that P-selectin targeting, self-assembling, nanoparticles comprising fucoidan and protamine, capable of delivering therapeutic agents to P-selectin expressing cells, were already known in the prior art.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s): The claimed invention is the combination of prior art elements (e.g., a therapeutic agent of SEQ ID NO: 3 as taught by the primary reference, and a nanoparticle delivery method as taught by Lu), according to known methods of delivering therapeutic agents using nanoparticles as disclosed and suggested by Lu, wherein such combination would yield predictable results, namely the therapeutic agent of SEQ ID NO: 3 encapsulated by a nanoparticle, wherein the combination would be predictably usable in the therapeutic methods taught and claimed by the primary reference, but would desirably and advantageously have improved ability to target the encapsulated therapeutic agent to activated platelets and endothelial cells expressing p-selectin (see, e.g., MPEP § 2143(I)(A), (B), (C), (D), and (G)). Furthermore, each prior art element would merely perform its art-recognized function in combination.
No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well-within the ordinary skill in the art to practice a known method of treatment using a known peptide delivered using a known drug delivery system, in order to achieve the known and expected outcomes, namely a successful treatment.
Accordingly, claims 1-6 and 10 are rejected.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
[NSDP Rejection 01]
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10188700. Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an anticipation analysis.
Regarding instant claim 6 and instant SEQ ID NO: 3, the primary reference teaches and discloses SEQ ID NO: 3, which shares 100% sequence identity with instant SEQ ID NO: 3 (compare instant SEQ ID NO: 3 with US’700 at SEQ ID NO: 3 and claims 1-7):
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Accordingly, SEQ ID NO: 3 is a prior art element. Regarding instant claim 6 and the combination of SEQ ID NO: 3 and a “carrier”, the primary reference explicitly claims methods of administering SEQ ID NO: 3 to subjects (see, e.g., US’700 at claims 1-7), and therefore an artisan would at once envisage SEQ ID NO: 3 with a carrier, namely a pharmaceutically acceptable excipient suitable for administration of a polypeptide sequence to a patient.
Therefore, although the issued claims and the instant claims are not identical, they are not patentably distinct
Accordingly, claim 6 is rejected under an anticipation analysis.
[NSDP Rejection 02]
Claims 1-6 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10188700 in view of Lu et al5.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Regarding instant claims 1-6, 10, and instant SEQ ID NO: 3, the primary reference teaches and discloses SEQ ID NO: 3, which shares 100% sequence identity with instant SEQ ID NO: 3 (compare instant SEQ ID NO: 3 with US’700 at SEQ ID NO: 3 and claims 1-7):
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Accordingly, SEQ ID NO: 3 is a prior art element. Regarding instant claim 6 and the combination of SEQ ID NO: 3 and a “carrier”, the primary reference explicitly claims methods of administering SEQ ID NO: 3 to subjects (see, e.g., US’700 at claims 1-7), and therefore an artisan would at once envisage SEQ ID NO: 3 with a carrier, namely a pharmaceutically acceptable excipient suitable for administration of a polypeptide sequence to a patient.
The issued patent scope differs from instant claims as follows: Although the issued patent claims methods of administering SEQ ID NO: 3 to patients, the claims do not explicitly recite a nanoparticle delivery compound as recited and required at instant claims 1-5 and 10.
However, such nanoparticles were already known in the prior art. Regarding instant claims 1, 10, and a nanoparticle carrier, Lu discloses a nanoparticle capable of delivering therapeutic agents to cells (see, e.g., Lu at title, abs, 412 at Fig. 1, 414 at Fig. 2, passim). Regarding instant claim 2 and a “self-assembled complex nanoparticle”, Lu describes the nanoparticle as “a multi-stimuli-responsive nanoparticle self-assembled by fucoidan and a cationic polypeptide (protamine)” (see Lu at abs), and explains that the nanoparticle is a “self-assembled colloidal nanocomplex formed by electrostatic interactions between the oppositely charged polysaccharide and polypeptide at different fucoidan-to-protamine weight ratios” (see, e.g., Lu at 413 at col I at § 3.1; see also id. at 412 at Fig. 1, 414 at Fig. 2). Accordingly, the Lu nanoparticle is understood to be a complex, and is also a self-assembled nanoparticle. Regarding instant claim 3 and the capability to “target[] …. Tissues overexpressing p-selectin”, Lu explains that Fucoidan is a P-selectin targeting ligand, and notes that the “potential anti-inflammatory, antithrombotic and anticoagulant activities of fucoidan” are known, and that P-selectin expression is “induced in activated platelets and endothelial cells” (see, e.g., Lu at 410 at col I-II at bridging ¶ and 410-411 at bridging ¶, explaining that Fucoidan has been used to prepare nanoparticles for the delivery of therapeutics). Lu explains that the nanoparticles function by P-selectin mediated endocytosis (see, e.g., Lu at abs, 412 at Fig. 1), and therefore an artisan would readily appreciate and conclude that such nanoparticles could be utilized to target P-selectin expressing cells. Regarding instant claim 4 and “wherein the self-assembled complex nanoparticle is formed by fucoidan and thermolysin-hydrolyzed protamine peptide”, as an initial matter, it is noted that this is product-by-process language (see, e.g., MPEP § 2113(I), which explains that "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process."). Here, the nanoparticles disclosed by Lu comprise fucoidan and protamine (see, e.g., Lu at 412 at Fig. 1, 414 at Fig. 2), and are understood to be “self-assembled colloidal nanocomplex formed by electrostatic interactions between the oppositely charged polysaccharide and polypeptide at different fucoidan-to-protamine weight ratios” (see, e.g., Lu at 413 at col I at § 3.1; see also id. at 412 at Fig. 1, 414 at Fig. 2). Although Lu does not specify that the protamine utilized is “thermolysin-hydrolyzed”, Lu does identify that the protamine has a molecular weight of 5 kDa (see, e.g., Lu at 411 at col I at §2.1), and therefore would be readily understood to be a low molecular weight protamine. Accordingly, in the absence of identification of how the product-by-process recitation of “thermolysin-hydrolyzed” differentiates the claim scope relative to the low molecular weight protamine of Lu, then it is reasonably inferred that Lu satisfies such limitations. Regarding instant claim 5 and a “mean particle size of between about 50 nm and about 750 nm”, Lu identifies that the nanoparticles have a hydrodynamic radius ranging from about 50 to 300 nm (see, e.g., Lu at 415 at Fig. 3(A); compare id. with instant claim 5), and therefore the disclosed nanoparticles are understood to fall within and overlap with the claimed range (see, e.g., MPEP § 2144.05(I), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists ). In sum, Lu identifies that P-selectin targeting, self-assembling, nanoparticles comprising fucoidan and protamine, capable of delivering therapeutic agents to P-selectin expressing cells, were already known in the prior art.
Obviousness analysis: Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)), and that the differences are that the instant claims attempt to claim a therapeutic peptide (i.e., SEQ ID NO: 3) recited in the issued claims of the primary reference, but wherein the known peptide is in combination with a known prior art carrier system suitable for delivering therapeutic agents (i.e., the nanoparticles of Lu). Accordingly, under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)(B)), the present claims are directed to obvious variants of the issued claims because it is well-within the ordinary skill in the art to combine a known therapeutic agent with a known carrier suitable for delivering therapeutic agents, to arrive at a modified/improved/combined composition suitable for use in the same applied methods set forth in the issued claims, wherein such modification/improvement/substitution/combination would merely yield the predicted and expected results, namely instant SEQ ID NO: 3 combined with the nanoparticles of Lu, wherein such compositions would predictably be useful in the same treatment methods and wherein the nanoparticles of Lu would convey the benefits of the carrier system as disclosed by Lu (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(I)(A),(B), (C), (D), (F), and (G)).
As issued claims in a U.S. patent, the reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to an obvious, claimed variant of the patent claims, namely the claims are directed to modified/improved/combined compositions comprising SEQ ID NO: 3 and a known nanoparticle carrier suitable for delivering therapeutics as set forth in the issued claims. Therefore, the instant claims substantially overlap in scope with the issued claims and unambiguously encompass obvious variants of the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the reference patent and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 1-6 and 10 are rejected.
[NSDP Rejection 03]
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10195248. Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an anticipation analysis.
Regarding instant claim 6 and instant SEQ ID NO: 3, the primary reference teaches and discloses SEQ ID NO: 3, which shares 100% sequence identity with instant SEQ ID NO: 3 (compare instant SEQ ID NO: 3 with US’248 at SEQ ID NO: 3 and claims 1-5):
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Accordingly, SEQ ID NO: 3 is a prior art element. Regarding instant claim 6 and the combination of SEQ ID NO: 3 and a “carrier”, the primary reference explicitly claims methods of administering SEQ ID NO: 3 to subjects (see, e.g., US’248 at claims 1-5), and therefore an artisan would at once envisage SEQ ID NO: 3 with a carrier, namely a pharmaceutically acceptable excipient suitable for administration of a polypeptide sequence to a patient.
Therefore, although the issued claims and the instant claims are not identical, they are not patentably distinct
Accordingly, claim 6 is rejected under an anticipation analysis.
[NSDP Rejection 04]
Claims 1-6 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10195248 in view of Lu et al6.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Regarding instant claims 1-6, 10, and instant SEQ ID NO: 3, the primary reference teaches and discloses SEQ ID NO: 3, which shares 100% sequence identity with instant SEQ ID NO: 3 (compare instant SEQ ID NO: 3 with US’248 at SEQ ID NO: 3 and claims 1-5):
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Accordingly, SEQ ID NO: 3 is a prior art element. Regarding instant claim 6 and the combination of SEQ ID NO: 3 and a “carrier”, the primary reference explicitly claims methods of administering SEQ ID NO: 3 to subjects (see, e.g., US’248 at claims 1-5), and therefore an artisan would at once envisage SEQ ID NO: 3 with a carrier, namely a pharmaceutically acceptable excipient suitable for administration of a polypeptide sequence to a patient.
The issued patent scope differs from instant claims as follows: Although the issued patent claims methods of administering SEQ ID NO: 3 to patients, the claims do not explicitly recite a nanoparticle delivery compound as recited and required at instant claims 1-5 and 10.
However, such nanoparticles were already known in the prior art. Regarding instant claims 1, 10, and a nanoparticle carrier, Lu discloses a nanoparticle capable of delivering therapeutic agents to cells (see, e.g., Lu at title, abs, 412 at Fig. 1, 414 at Fig. 2, passim). Regarding instant claim 2 and a “self-assembled complex nanoparticle”, Lu describes the nanoparticle as “a multi-stimuli-responsive nanoparticle self-assembled by fucoidan and a cationic polypeptide (protamine)” (see Lu at abs), and explains that the nanoparticle is a “self-assembled colloidal nanocomplex formed by electrostatic interactions between the oppositely charged polysaccharide and polypeptide at different fucoidan-to-protamine weight ratios” (see, e.g., Lu at 413 at col I at § 3.1; see also id. at 412 at Fig. 1, 414 at Fig. 2). Accordingly, the Lu nanoparticle is understood to be a complex, and is also a self-assembled nanoparticle. Regarding instant claim 3 and the capability to “target[] …. Tissues overexpressing p-selectin”, Lu explains that Fucoidan is a P-selectin targeting ligand, and notes that the “potential anti-inflammatory, antithrombotic and anticoagulant activities of fucoidan” are known, and that P-selectin expression is “induced in activated platelets and endothelial cells” (see, e.g., Lu at 410 at col I-II at bridging ¶ and 410-411 at bridging ¶, explaining that Fucoidan has been used to prepare nanoparticles for the delivery of therapeutics). Lu explains that the nanoparticles function by P-selectin mediated endocytosis (see, e.g., Lu at abs, 412 at Fig. 1), and therefore an artisan would readily appreciate and conclude that such nanoparticles could be utilized to target P-selectin expressing cells. Regarding instant claim 4 and “wherein the self-assembled complex nanoparticle is formed by fucoidan and thermolysin-hydrolyzed protamine peptide”, as an initial matter, it is noted that this is product-by-process language (see, e.g., MPEP § 2113(I), which explains that "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process."). Here, the nanoparticles disclosed by Lu comprise fucoidan and protamine (see, e.g., Lu at 412 at Fig. 1, 414 at Fig. 2), and are understood to be “self-assembled colloidal nanocomplex formed by electrostatic interactions between the oppositely charged polysaccharide and polypeptide at different fucoidan-to-protamine weight ratios” (see, e.g., Lu at 413 at col I at § 3.1; see also id. at 412 at Fig. 1, 414 at Fig. 2). Although Lu does not specify that the protamine utilized is “thermolysin-hydrolyzed”, Lu does identify that the protamine has a molecular weight of 5 kDa (see, e.g., Lu at 411 at col I at §2.1), and therefore would be readily understood to be a low molecular weight protamine. Accordingly, in the absence of identification of how the product-by-process recitation of “thermolysin-hydrolyzed” differentiates the claim scope relative to the low molecular weight protamine of Lu, then it is reasonably inferred that Lu satisfies such limitations. Regarding instant claim 5 and a “mean particle size of between about 50 nm and about 750 nm”, Lu identifies that the nanoparticles have a hydrodynamic radius ranging from about 50 to 300 nm (see, e.g., Lu at 415 at Fig. 3(A); compare id. with instant claim 5), and therefore the disclosed nanoparticles are understood to fall within and overlap with the claimed range (see, e.g., MPEP § 2144.05(I), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists ). In sum, Lu identifies that P-selectin targeting, self-assembling, nanoparticles comprising fucoidan and protamine, capable of delivering therapeutic agents to P-selectin expressing cells, were already known in the prior art.
Obviousness analysis: Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)), and that the differences are that the instant claims attempt to claim a therapeutic peptide (i.e., SEQ ID NO: 3) recited in the issued claims of the primary reference, but wherein the known peptide is in combination with a known prior art carrier system suitable for delivering therapeutic agents (i.e., the nanoparticles of Lu). Accordingly, under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)(B)), the present claims are directed to obvious variants of the issued claims because it is well-within the ordinary skill in the art to combine a known therapeutic agent with a known carrier suitable for delivering therapeutic agents, to arrive at a modified/improved/combined composition suitable for use in the same applied methods set forth in the issued claims, wherein such modification/improvement/substitution/combination would merely yield the predicted and expected results, namely instant SEQ ID NO: 3 combined with the nanoparticles of Lu, wherein such compositions would predictably be useful in the same treatment methods and wherein the nanoparticles of Lu would convey the benefits of the carrier system as disclosed by Lu (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(I)(A),(B), (C), (D), (F), and (G)).
As issued claims in a U.S. patent, the reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to an obvious, claimed variant of the patent claims, namely the claims are directed to modified/improved/combined compositions comprising SEQ ID NO: 3 and a known nanoparticle carrier suitable for delivering therapeutics as set forth in the issued claims. Therefore, the instant claims substantially overlap in scope with the issued claims and unambiguously encompass obvious variants of the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the reference patent and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 1-6 and 10 are rejected.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Byun et al.7 pertains to low molecular weight protamine (see, e.g., Byun at title, abs, passim).
Pugsley et al.8, pertains to low molecular weight protamine and its known utility in the prior art (see, e.g., Pugsley et al. at title, abs, passim).
Tsai et al.9, pertains to LMW fucoidan comprising nanoparticles (see, e.g., Tsai at title, abs, passim).
He et al.10, discloses low molecular weight protamine created by enzymatic digestion of native protamine using thermolysin, having an average molecular weight of approximately 1880 Da (see, e.g., He at title, abs, 64 at col I at last two ¶¶). Accordingly, such product-by-process steps were known in the prior art, and the resulting compounds had known utility and advantages over higher molecular weight protamine (see, e.g., He at title, abs, 64 at col I at last three ¶¶ at § 1. “Introduction”).
US 7892761 discloses sequences highly similar to instant SEQ ID NO: 1 (compare US’761 at SEQ ID NO: 8 with instant SEQ ID NO: 1, showing 138/141 identities, or ~98% identity).
US 9260497 discloses sequences highly similar to instant SEQ ID NO: 1 (compare US’497 at SEQ ID NO: 6 with instant SEQ ID NO: 1, showing 138/141 identities, or ~98% identity).
US 10471086 discloses sequences highly similar to instant SEQ ID NO: 1 (compare US’086 at SEQ ID NO: 12 with instant SEQ ID NO: 1, showing 138/141 identities, or ~98% identity).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RANDALL L BEANE/Primary Examiner, Art Unit 1654
1 See, e.g., Cheng et al., Synthesis and characterization of Gd-DTPA/fucoidan/peptide complex nanoparticle and in vitro magnetic resonance imaging of inflamed endothelial cells. Mater Sci Eng C Mater Biol Appl. 2020 Sep;114:111064. doi: 10.1016/j.msec.2020.111064. Epub 2020 May 11. PMID: 32994013; hereafter “Cheng”, describing the nanoparticle at instant Figure 9 at Fig. 1 of Cheng and page 2 at col I-II, which is understood to describe the nanoparticle utilized, except Gd-DTPA is replaced with Cy5.
2 Lu et al. (2017). Development of a new type of multifunctional fucoidan-based nanoparticles for anticancer drug delivery. Carbohydrate Polymers, 165, 410-420. https://doi.org/10.1016/j.carbpol.2017.02.065; hereafter “Lu”; cited in IDS filed 8/01/2024 as Cite No. 4.
3 Lu et al. (2017). Development of a new type of multifunctional fucoidan-based nanoparticles for anticancer drug delivery. Carbohydrate Polymers, 165, 410-420. https://doi.org/10.1016/j.carbpol.2017.02.065; hereafter “Lu”; cited in IDS filed 8/01/2024 as Cite No. 4.
4 Lu et al. (2017). Development of a new type of multifunctional fucoidan-based nanoparticles for anticancer drug delivery. Carbohydrate Polymers, 165, 410-420. https://doi.org/10.1016/j.carbpol.2017.02.065; hereafter “Lu”; cited in IDS filed 8/01/2024 as Cite No. 4.
5 Lu et al. (2017). Development of a new type of multifunctional fucoidan-based nanoparticles for anticancer drug delivery. Carbohydrate Polymers, 165, 410-420. https://doi.org/10.1016/j.carbpol.2017.02.065; hereafter “Lu”; cited in IDS filed 8/01/2024 as Cite No. 4.
6 Lu et al. (2017). Development of a new type of multifunctional fucoidan-based nanoparticles for anticancer drug delivery. Carbohydrate Polymers, 165, 410-420. https://doi.org/10.1016/j.carbpol.2017.02.065; hereafter “Lu”; cited in IDS filed 8/01/2024 as Cite No. 4.
7 Byun et al., Low Molecular Weight Protamine, Thrombosis Research, 2004; 94, 53-61; hereafter “Byun”.
8 Pugsley et al., Protamine is a low molecular weight polycationic amine that produces actions on cardiac muscle. Life Sci. 2002 Dec 6;72(3):293-305. doi: 10.1016/s0024-3205(02)02245-2. PMID: 12427488.
9 Tsai et al., Synthesis and evaluation of antibacterial and antioxidant activity of small molecular chitosan–fucoidan conjugate nanoparticles, Res Chem Intermed (2018) 44:4855–4871,
https://doi.org/10.1007/s11164-018-3341-0; hereafter “Tsai”.
10 He et al., Low molecular weight protamine (LMWP): a nontoxic protamine substitute and an effective cell-penetrating peptide. J Control Release. 2014 Nov 10;193:63-73. doi: 10.1016/j.jconrel.2014.05.056. Epub 2014 Jun 3. PMID: 24943246.; hereafter “He”.