Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 11/5/2025 is acknowledged. Claims 8 and 10-13 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II-VI, and there being no allowable generic or linking claim.
Status of Claims
Cancelled: 8, 10-13
Examined Herein: 1-7, 9
Priority
Acknowledgment is made of applicant's claim for priority under based upon an application filed in FR2007997 on 7/29/2020 and PCT/FR2021/051419 on 7/29/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/27/2023 and 2/28/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings received on 1/27/2023 are accepted.
Withdrawn Rejections
The objection of claims 1 and 3 is hereby withdrawn in view of Applicant’s amendments to claim 1 and 3, which provide a clear depiction of Formulas I and II.
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:
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.
Claims 1, 3, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Bae (Chitosan Oligosaccharide-Stabilized Ferrimagnetic Iron Oxide Nanocubes for Magnetically Modulated Cancer Hyperthermia, 5/15/2012, ACS Nano, Vol 6/Issue 6, 5266-5273), in view of Hwang (US 2014/0242870 A1, Published 8/28/2014).
With respect to claim 1, Bae discloses a statistical polysaccharide with a weight-average molecular weight of between 3-5 kDa of formula I:
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[Bae (Supporting Information), Page 5, Figure S1]
wherein,
Rc represents a group comprising a chelating agent, catechol,
Z is a hydrocarbon-based chain comprising 3 carbon atoms and comprises one O heteroatom,
x is 0.048 (deacetylation degree = 95.2%; See supporting Information, Page 1, Paragraph 1),
y is 0.31 (degree of substitution = 30.9%; See supporting Information, Page 1, Paragraph 2)
y/x ratio is ~6.5, which is greater than or equal to 0.05, and
the sum of x + y is ~0.36, which is greater than 0.30.
Bae further discloses that -NH-Z-Rc together form DOPA. [Bae (Supporting Information), Page 1, Paragraph 2]
With respect to claim 3, Bae discloses a statistical polysaccharide with a weight-average molecular weight of between 3-5 kDa of formula I:
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[Bae (Supporting Information), Page 5, Figure S1]
wherein,
Rc1 represents a group comprising a chelating agent, catechol,
Z1 is a hydrocarbon-based chain comprising 3 carbon atoms and comprises one O heteroatom,
x is 0.048 (deacetylation degree = 95.2%; See supporting Information, Page 1, Paragraph 1),
y is 0.31 (degree of substitution = 30.9%; See supporting Information, Page 1, Paragraph 2)
y/x ratio is ~6.5, which is greater than or equal to 0.05, and
the sum of x + y is ~0.36, which is greater than 0.30, and
z is 1.
Bae further discloses that -NH-Z1-Rc1 together form DOPA. [Bae (Supporting Information), Page 1, Paragraph 2]
With respect to claim 9, Bae discloses the polysaccharide chelates iron. [Bae, Page 5268, Figure 2]
Bae does not disclose the statistical polysaccharide has a weight-average molecular weight of between 100 kDa and 1000 kDa.
However, with respect to claim 1 and 3, Hwang discloses a composite comprising chitosan having a weight-average molecular weight of between 5 kDa and 500 kDa and DOPA or catechol, wherein the catechol or DOPA is crosslinked to the amine groups of chitosan. [Hwang, 0016, 0018]
Modifying the polysaccharide disclosed by Bae so that the polysaccharide has a weight-average molecular weight of between 5kDa and 500 kDa, results in the statistical polysaccharide of claim 1 and 3.
It would be obvious to one of ordinary skill in the art to modify the polysaccharide disclosed by Bae so that the polysaccharide has a weight-average molecular weight of between 5 kDa and 500 kDa and have a reasonable expectation of success. Bae discloses a polysaccharide, chitosan, covalently bonded to a chelator, DOPA, via the amine group of chitosan. Hwang discloses a polysaccharide, chitosan having a weight-average molecular weight of between 5 kDa and 500 kDa, crosslinked to DOPA via the amine group of chitosan. The disclosure of Hwang establishes that a conjugate comprising chitosan covalently bonded to DOPA may have a weight-average molecular weight of between 5 kDa and 500 kDa. Thus, the combined teachings of Bae and Hwang suggest that the chitosan-DOPA conjugate disclosed by Bae may have a weight-average molecular weight of between 5 kDa and 500 kDa. Therefore, it is reasonable to expect the polysaccharide disclosed by Bae may be modified so that the polysaccharide has a weight-average molecular weight of between 5kDa and 500 kDa. One would have been motivated to do so because the selection of a known material based on its suitability for its intended use is prima facie obvious. MPEP 2144.07 In the instant case, the selection of chitosan having a weight-average molecular weight of between 5 kDa and 500 kDa based on its suitability for its use in a conjugate comprising chitosan covalently bonded to DOPA is prima facie obvious.
Claims 1-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Guo (Radiolabeling of folic acid-modified chitosan with 99mTc as potential agents for folate-receptor-mediated targeting, 8/24/2011, Bioorganic & Medicinal Chemistry Letters, Volume 21, Issue 21, 6446-6450), in view of Borbely (US 2013/0302255 A1, 11/14/2013).
With respect to claim 1, Guo discloses a statistical polysaccharide with a weight-average molecular weight of 6 kDa of formula I:
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426
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[Gao, Page 6447, Scheme 1]
Wherein,
Rc represents a chelating agent comprising pteridine-p-aminobenzoic acid,
Z is a hydrocarbon-based chain comprising 3 carbon atoms and comprises O and N heteroatoms,
x is 0.297, (MW = 6000 Da; degree of deacetylation = 70%)
y is 0.162, (MW = 6000 Da; degree of deacetylation = 70%; folic acid monomer units = 6)
y/x ratio is ~0.55, which is greater than 0.05, and
the sum of x + y is ~0.50, which is greater than 0.30. [Gao, Page 6447, Scheme 1 and Page 6447, Col. 1, Paragraph 2 and Page 6450, Col. 2, #23]
Guo further discloses that -NH-Z1-Rc1 together form folic acid. [Gao, Page 6447, Scheme 1]
With respect to claim 3, Guo discloses a statistical polysaccharide with a weight-average molecular weight of 6 kDa of formula I:
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[Gao, Page 6447, Scheme 1]
Wherein,
Rc1 represents a chelating agent pteridine-p-aminobenzoic acid,
Z1 is a hydrocarbon-based chain comprising 3 carbon atoms and comprises O and N heteroatoms,
x is 0.297, (MW = 6000 Da; degree of deacetylation = 70%)
y is 0.162, (MW = 6000 Da; degree of deacetylation = 70%; folic acid monomer units = 6)
y/x ratio is ~0.55, which is greater than 0.05, and
the sum of x + y is ~0.50, which is greater than 0.30, and
z is 1. [Gao, Page 6447, Scheme 1 and Page 6447, Col. 1, Paragraph 2 and Page 6450, Col. 2, #23]
Guo further discloses that -NH-Z1-Rc1 together form folic acid. [Gao, Page 6447, Scheme 1]
With respect to claim 5, Guo discloses x is 0.297, which is between 0.25 and 0.4.
With respect to claim 6, Guo discloses y is 0.162, which is between 0.05 and 0.2.
Guo does not disclose the statistical polysaccharide has a weight-average molecular weight of between 100 kDa and 1000 kDa.
However, with respect to claim 1-4, Borbely discloses a polysaccharide, chitosan, having a weight-average molecular weight of between 20 kDa and 600 kDa conjugated with folic acid, DOTA, NOTA, TETA, or DFO. [Borbely, 0049-0056]
With respect to claim 7, Borbely discloses the polysaccharide is formulated in a composition in hydrogel form. [Borbely, 0120-0123]
With respect to claim 9, Borbely discloses the chitosan-complexing agent conjugate chelates a lanthanide or a transition metal ion. [Borbely, 0049-0056]
Modifying the polysaccharide disclosed by Guo so that the polysaccharide has a weight-average molecular weight of between 20-600 kDa, results in the statistical polysaccharide of claim 1 and 3.
Further modifying the polysaccharide disclosed by Guo by replacing folic acid, with a chelator, DOTA, NOTA, TETA, or DFO results in the statistical polysaccharide of claim 1-4 and 9, wherein Rc and Rc1 represent a chelating group DOTA, NOTA, TETA, or DFO that chelates lanthanide or a transition metal ion.
Further modifying the polysaccharide disclosed by Guo by formulating the polysaccharide (chitosan) in hydrogel form results in the statistical polysaccharide of claim 7.
It would be obvious to one of ordinary skill in the art to modify the polysaccharide disclosed by Guo so that the polysaccharide has a weight-average molecular weight of between 20 kDa and 600 kDa and have a reasonable expectation of success. Guo discloses a polysaccharide, chitosan, conjugated with folic acid. Borbely discloses a polysaccharide, chitosan having a weight-average molecular weight of between 20 kDa and 600 kDa, conjugated with folic acid. The disclosure of Borbely establishes that a chitosan-folic acid conjugate may have a weight-average molecular weight of between 20 kDa and 600 kDa. Thus, the combined teachings of Guo and Borbely suggest the chitosan-folic acid conjugate disclosed by Guo may have a weight-average molecular weight of between 20 kDa and 600 kDa. Therefore, it is reasonable to expect the polysaccharide disclosed by Guo may be modified so that the polysaccharide has a weight-average molecular weight of between 20 kDa and 600 kDa. One would have been motivated to do so because the selection of a known material based on its suitability for its intended use is prima facie obvious. MPEP 2144.07 In the instant case, the selection of chitosan having a weight-average molecular weight of between 20 kDa and 600 kDa based on its suitability for its use in a chitosan-folic acid conjugate is prima facie obvious.
It would be obvious to one of ordinary skill in the art to modify the polysaccharide disclosed by Guo by replacing folic acid with DOTA, NOTA, TETA, or DFO and have a reasonable expectation of success. Guo discloses a chitosan-folic acid conjugate. Borbely discloses a conjugate comprising chitosan and folic acid, DOTA, NOTA, TETA, or DFO. The disclosure of Borbely establishes that a conjugate comprising chitosan conjugated to folic acid may alternatively be conjugated to DOTA, NOTA, TETA, or DFO. Thus, the combined teachings of Guo and Borbely suggest the chitosan of the chitosan-folic acid conjugate disclosed by Guo may alternatively be conjugated to DOTA, NOTA, TETA, or DFO. Therefore, it is reasonable to expect the polysaccharide disclosed by Guo may be modified by replacing folic acid with DOTA, NOTA, TETA, or DFO. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II) In the instant case, Borbely discloses that a composition comprising chitosan conjugated to DOTA, NOTA, TETA, or DFO yields an MR contrast agent. [Borbely, 0038, 0046, 0049, 0048, 0058] Therefore, one would have been motivated by the expectation that modifying the polysaccharide disclosed by Guo by replacing folic acid with DOTA, NOTA, TETA, or DFO would yield a MR contrast agent useful for imaging and diagnosis.
It would be obvious to one of ordinary skill in the art to modify the polysaccharide disclosed by Guo and Borbely by formulating the chitosan in hydrogel form and have a reasonable expectation of success. Guo and Borbely disclose a chitosan-chelator conjugate, wherein the chelator is DOTA, NOTA, TETA, or DFO. Borbely discloses a chitosan-chelator conjugate that is formulated in hydrogel form, wherein the chelator is DOTA, DTPA, or EDTA. The disclosure of Borbely establishes that a chitosan-chelator conjugate, like chitosan-DOTA, may be formulated in hydrogel form. Thus, the combined teachings of Guo and Borbely suggest the chitosan-DOTA conjugate disclosed by Guo and Borbely may be formulated in hydrogel form. Therefore, it is reasonable to expect the polysaccharide disclosed by Guo and Borbely may be modified by formulating the chitosan in hydrogel form. One would have been motivated to do so because it is prima facie obvious to modify or combine references when the rationale for doing so is expressly stated in the prior art. MPEP 2144(I) In the instant case, Borbely discloses the aforementioned chitosan conjugate forms self-assembled polyelectrolytes that produce stable polyelectrolyte complexes and can appear in hydrogels. [Borbely, 0026, 0049-0051] Therefore, one would have been motivated to modify the polysaccharide disclosed by Guo and Borbely by formulating the chitosan in hydrogel form because the prior art expressly teaches this modification.
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.
Claims 1, 2, 5, and 6 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of copending Application No. 19/495,920 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 1 and 3 are drawn to a statistical polysaccharide of Formula I and II, respectively.
Reference claim 14 is drawn to a statistical polysaccharide wherein;
Rc represents a group comprising a chelating agent, DOTAGA,
Z represents a linker which is a single bond,
X is 0.25 to 0.4,
Y is 0.05 to 0.2,
the y/x ratio being greater than or equal to 0.05, and
the sum x + y being greater than or equal to 0.30.
Reference claim 14 is also drawn to a statistical polysaccharide wherein;
Rc1 represents a group comprising a chelating agent, DOTAGA,
Z1 represents a linker which is a single bond,
X is 0.25 to 0.4,
Y is 0.05 to 0.2,
the y/x ratio being greater than or equal to 0.05,
the sum x + y being greater than or equal to 0.30, and
Z is 1.
Thus, the entire scope of the reference claim falls within the scope of the instant claims. Therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species of the reference claim should the genus issue as a patent after the species. MPEP 804(II)(B)(2)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 4/8/2026 have been fully considered but they are not persuasive.
Applicant asserts “Hwang does not disclose a chitosan-DOPA conjugate. In Hwang, the DOPA is not conjugated to one chitosan; rather, DOPA is a crosslinker. That means that the DOPA is covalently bonded to at least two chitosans.” [Remarks 4/8/2026, Page 5]
The fact that DOPA functions as a cross-linker by being conjugated to two chitosans does not mean it is not conjugated to chitosan. DOPA functions as a crosslinker because it is conjugated to chitosan.
Applicant asserts “Hence, Bae discloses that the "chitosan" has to be water soluble, while Hwang discloses that the chitosan has to remain strong under wet conditions i.e. not water soluble. Bae and Hwong cannot be combined properly, as one of ordinary skill in the art would recognize the differences in solubility would make the chitosan for one not useful in the other.” [Remarks 4/8/2026, Page 6, Paragraph 3]
"It is well-established that a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements." MPEP 2145(III). The rejection of record does not propose physically extracting the chitosan disclosed by Hwang and importing it into the polysaccharide disclosed by Bae. Accordingly, the alleged insolubility of the chitosan disclosed by Hwang is immaterial to and fails to undermine the instant rejection.
Applicant asserts ”Since in Hwang the DOPA is a crosslinker, the hydroxyl groups of the DOPA are involved in a covalent bond since DOPA is linked to two chitosans, this is the purpose of a crosslinker. Hence, no more hydroxyl group is available for chelating, for instance ferrimagnetic iron oxide nanotubes as in Bae. As a consequence, the overall teaching of Hwang is not applicable to Bae. A person having ordinary skill in the art would not consider Hwang so as to expect to improve the teaching of Bae since the essential feature of Bae, i.e. the encapsulation of ferrimagnetic iron oxide nanotubes would be lost with the chitosan disclosed in Hwang.” [Remarks 4/8/2026, Page 6, Paragraph 4]
Hwang is not relied on for any of the teachings outlined by the Applicant. Accordingly, none of the teachings negate or undermine the fact that Hwang discloses chitosan having a weight average molecular weight between 5 kDa to 500 kDa covalently bound to DOPA.
Moreover, a reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). MPEP 2141.01(a). Hwang is reasonably pertinent to the problem faced by the inventor because it is drawn to chitosan covalently bound to a chelating agent, as is the claimed invention. Most importantly, references need to be analogous to the claimed invention, not each other.
Applicant asserts “As explained above, the chitosan DOPA conjugate of Bae encapsulates ferrimagnetic iron oxide nanotubes (feature A), and has to be water soluble (feature B)." [Remarks 4/8/2026, Page 7, Paragraph 1-3]
Applicant’s argument appears to be unsupported by Bae. Applicant is asked to provide the teachings in Bae that support these conclusions. Alternatively, Applicant is asked to provide evidence demonstrating the chitosan having a weight average molecular weight between 5kDa to 500 kDa would be unable to uniformly coat a ferrimagnetic iron oxide nanotube disclosed by Bae.
Moreover, Applicant relies on relative terms like “too heavy,” “too long,” and “less soluble” but does not identify the degree to which these characteristics would render the modified polysaccharide disclosed by Bae inoperable. In the absence of adequate support for this conclusion, Applicant has not established that chitosan having a molecular weight between 5kDa to 500 kDa crosses a threshold that would materially render the modified polysaccharide disclosed by Bae inoperable.
Applicant asserts “However, replacing the folic acid in the polysaccharide disclosed by Guo would result in the withdrawal of the targeting moiety of the polysaccharide disclosed by Guo. Indeed, the polysaccharide of Guo is designed for folate receptor (see abstract). Removing the acid folic moiety would render the polysaccharide of Guo unsuitable for its use. The combined teaching of Guo and Borbely does not lead to the advantage or expected beneficial result highlighted by the Examiner.” [Remarks 4/8/2026, Page 8, Paragraph 3]
Applicant mischaracterizes the “intended use” of Guo. Guo discloses “The objective of this study is to evaluate the feasibility of chitosan (CS) as a backbone for the design of 99mTc-labeled targeting agent.” [Guo, Page 6650, Col. 1, Paragraph 2] Folate is merely a targeting modality that targets the polysaccharide to a specific receptor. Removing folate does not affect chitosan’s ability to be used as a backbone for the targeting agent.
Additionally, Applicant conflates targeting with targeting specificity. Folate does not enable chitosan to exhibit targeting capabilities. Folate enables chitosan to target a specific receptor. Chitosan itself is a recognized targeting agent. The chitosan backbone retains targeting functionality regardless of whether folate is attached or not.
To that end, Guo discloses “In the medicine field chitosan and its derivatives have been widely accepted for the application of drug and gene delivery, tissue engineering, wound healing and as a backbone for various bioactive compounds. Up to now, only a few of radiolabeled chitosan derivatives were reported for nuclear imaging or radiotherapy (99mTc-GMC,13 99mTc-HGC,14 18F-FB-GC,15 153Sm/166Ho-CS-AA,16 etc.).” [Guo, Page 6646, Col. 1, Paragraph 1] All of the listed radiolabeled chitosan derivatives lack folic acid but still retain their utility in nuclear imaging or radiotherapy.
Applicant asserts “Hence, the statement of the Examiner: "In the instant case, Borbely discloses conjugating chitosan to DOTA, NOTA, TETA, or DFO yields an MR contrast agent that may internalize into the targeted tumor cells and enhance relaxivity, improve the signal-to-noise and therefore facilitate the early tumor diagnosis. [Borbely, 0046, 0049, 0048, 0058] " is incorrect. Indeed, removing the folic acid moiety deprive the composition of its "targeting" behavior and the disclosure of Borbely relates to a composition that comprises more than one biopolymers, the advantage or expected beneficial result mentioned by the Examiner is not related to only one constituent of the composition of Borbely, but related to the whole composition.” [Remarks 4/8/2026, Page 8, Paragraph 4-5]
The assertion made by the Examiner is correct.
Borbely states “Li et al. (U.S. Pat. No. 6,896,874 B2) describe a coating that emits magnetic resonance signals… The invention claimed paramagnetic-metal ion/chelate complexes encapsulated by a hydrogel. The chelate could be several well-known complexing agents, such as DTPA or DOTA, and the paramagnetic ion could be lanthanide or transition metal ions, such as Gd-ion. The first hydrogel is selected from chitosan hyaluronate, alginate, poly(acrylic acid), etc.” [Borbely, 0038]
Thus, Borbely establishes that the following elements are associated with MR contrast functionality: (1) a paramagnetic-metal ion, (2) a chelating agent (DOTA or DTPA), and (3) a hydrogel (chitosan, hyaluronate, or alginate). Accordingly, Borbely suggests that a complex comprising said elements could reasonably be expected to emit magnetic resonance signals and be useful as a MR contrast agent.
Guo discloses an agent that comprises a paramagnetic-metal ion (99mTc), folate, and a hydrogel (chitosan, hyaluronate, or alginate). The rejection proposes replacing folic acid with DOTA, NOTA, TETA, or DFO does yield an MR contrast agent. Thus, modifying Guo accordingly results in an agent that comprises the following three elements: (1) a paramagnetic-metal ion (99mTc), (2) a chelating agent (DOTA, NOTA, TETA, or DFO), and (3) a hydrogel (chitosan). Accordingly, the modified polysaccharide disclosed by Guo comprises all three elements associated with MR contrast functionality. Therefore, it is reasonable to reasonable to expect the modified polysaccharide may function as a MR contrast agent. Moreover, MR contrast agents are in fact used in the art for imaging and tumor diagnosis.
Applicant mischaracterizes the statement made by the Examiner, as if it is the motivation behind the proposed modification. The statement made by the Examiner is merely a summary of the teachings of Borbely, not an assertion that the modified polysaccharide disclosed by Guo would achieve the functionality described. By doing so, Applicant improperly projects the structural limitations of Borbely onto Guo and suggests that if the modified polysaccharide disclosed by Guo does not comprise said structure, then it cannot be expected to achieve the benefit that Borbely achieves. However, notably, the rejection does not state that a POSITA would expect the modified polysaccharide disclosed by Guo to achieve the same benefit that Borbely achieves. The rejection states that the modification would yield a MR contrast agent useful for imaging, which is fully supported by the art.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
Prosecution Insights