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 .
Status of Application
The Amendments and Remarks filed on 02/14/26 are acknowledged.
Claims 2, 24, and 25 were cancelled.
Claims 1, 5, 10, and 14 were amended.
Claims 23 and 26-28 were previously withdrawn from consideration.
Claims 1, 3-23, and 26-28 are pending.
Claims 1 and 3-22 are included in the prosecution.
Response to Amendments/Arguments
Rejection of claims under 35 USC § 101
In light of the cancellation of claim 24, the rejection of this claim under 35 U.S.C. 101 is moot.
Rejection of claims under 35 USC § 112(b)
In light of the amendment of claim 5 to delete the term “preferably,” the rejection of this claim under 35 U.S.C. 112(b) is withdrawn.
In light of the cancellation of claim 24, the rejection of this claim under 35 U.S.C. 112(b) is moot.
Rejection of claims under 35 USC §§ 102 and 103
The rejections under 35 USC §§ 102 and 103 are maintained and updated for the reasons below. In light of the amendment of claim 14 the rejection of this claim under 35 USC § 102(a)(1) is withdrawn.
New grounds of rejection under 35 USC § 103
However, upon further consideration of the amended claim, a new ground of rejection under 35 USC § 103 is made. Since the new ground of rejection was necessitated by Applicant’s amendment, this action is made FINAL.
Notice for all US Patent Applications filed on or after March 16, 2013
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.
Maintained and Updated Rejections
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-11, 13, and 20-21 are again rejected under 35 U.S.C. 102(a)(1) as being anticipated by Capanema et al. (International Journal of Biological Macromolecules 106 (2018) 1218-1234 – “Capanema”).
Instant claim 1 is drawn to a polymer comprising a network comprising a spacer crosslinker and a polysaccharide crosslinked with the spacer crosslinker, wherein the spacer crosslinker is preformed and well-defined prior to crosslinking with the polysaccharide, wherein the spacer crosslinker comprises a first optionally substituted aliphatic moiety terminated at each end with a second moiety comprising at least two carboxylic acid groups; wherein the spacer crosslinker has the following formula (I): A-L-Z-L-A (I), wherein Z is the first optionally substituted aliphatic moiety; A is the second moiety comprising at least two carboxylic acid groups; and L is a linking group.
Capanema discloses superabsorbent crosslinked carboxymethyl cellulose-PEG hydrogels for potential wound dressing applications (Title, Abstract). The carboxymethyl cellulose (CMC) hydrogels “were prepared with two degrees of functionalization (DS = 0.77 and 1.22) and chemically crosslinked with citric acid (CA) for tuning their properties. Additionally, CMC-based hybrids were prepared by blending with polyethylene glycol (PEG, 10 wt.%). The results demonstrated that superabsorbent hydrogels (SAP) were produced with swelling degree typically ranging from 100% to 5000%, which was significantly dependent on the concentration of CA crosslinker and the addition of PEG as network modifier” (Abstract). “CMC:PEG solutions were prepared by adding 1.8 g of CMC and 0.2 g PEG (i.e., CMC/PEG10, 10%) or 1.6 g of CMC and 0.4 g of PEG (i.e., CMC/PEG20, 20%) to 100 mL of DI water and stirring at room temperature until complete solubilization occurred. After dissolution, the crosslinking agent CA was added under stirring at concentrations of 10% (CMC/PEG/CA10), 15% (CMC/PEG/CA15), 20% (CMC/PEG/CA20), and 25% (CMC/PEG/CA25) m/m% of CMC + PEG polymer and homogenized for 20 min. Afterwards, the solutions were cast in plastic molds (polystyrene petri dish, diameter = 60 mm) and dried” (Page 1221, section 2.3). Fig. 4 (Page 1222) shows the crosslinked hydrogel network.
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Fig. 11 (Page 1228) shows the polymers CMC and PEG along with the CA crosslinker and the crosslinked structures.
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Regarding instant claim 1, the limitation of a polymer comprising a polysaccharide crosslinked with a spacer crosslinker, wherein the spacer crosslinker comprises a first optionally substituted aliphatic moiety terminated at each end with a second moiety comprising at least two carboxylic acid groups is anticipated by the polymer comprising the polysaccharide CMC, the first optionally substituted aliphatic moiety PEG, and the second moiety CA, in the form of the polymer CMC-PEG crosslinked with CA (Abstract, Page 1221, section 2.3, Fig. 4 and Fig. 11), as taught by Capanema.
Regarding instant claim 1, the newly added limitation of a network comprising a spacer crosslinker and a polysaccharide crosslinked with the spacer crosslinker is anticipated by the crosslinked hydrogel network depicted in Figures 4 and 11 by Capanema which contains the spacer crosslinker containing PEG and citric acid, and the polysaccharide CMC.
Regarding instant claim 1, the newly added limitation of the spacer crosslinker is preformed and well-defined prior to crosslinking with the polysaccharide is anticipated by the spacer crosslinker containing PEG and citric acid (Figures 4 and 11) as taught by Capanema since the same crosslinker (including the same constituents of the crosslinker) and the same polysaccharide are disclosed. The limitation of “preformed” is a process step that is not given patentable weight in a product claim. Applicant is reminded that process limitations cannot impart patentability to a product that is not patentably distinguished over the prior art. In re Thorpe et al. (CAFC 1985), In re Brown et al. (CCPA 1972) 459 F2d 531, 173 USPQ 685. “’[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)….The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)” (see MPEP 2113). Therefore when no structure is implied, the product-by-process recitation does not add any limitations that affect patentability. The limitation of “preformed and well-defined prior to crosslinking” does not add any clear structure to the final product. The final product taught by Capanema is a crosslinked hydrogel network containing the same components in the same arrangement recited in instant claim 1. Regardless of the spacer-crosslinker being preformed, the art nevertheless teaches its combination with the polysaccharide and a crosslinked hydrogel network is the resultant final product.
Regarding instant claim 1, the limitation of the spacer crosslinker is anticipated by the crosslinker of PEG-CA (Abstract, Page 1220, section 2.2, Page 1221, section 2.3, Fig. 4 and Fig. 11), as taught by Capanema. Fig. 11 of Capanema with the spacer crosslinker in an annotated blue box is reproduced below.
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Regarding instant claim 3, the limitation of the first optionally substituted aliphatic molecule comprising at least two hydroxy groups is anticipated by the PEG (Abstract, Page 1220, section 2.2, Page 1221, section 2.3, Fig. 4 and Fig. 11), as taught by Capanema.
Regarding instant claim 4, the limitation of the first optionally substituted aliphatic molecule having a molecular weight in the range of about 0.1 kDa to about 100 kDa is anticipated by the PEG (Abstract, Page 1220, section 2.2, Page 1221, section 2.3, Fig. 4 and Fig. 11), which has a molecular weight of 1521 Da (Page 1220, section 2.1), as taught by Capanema, which is calculated to as 1521 Da ÷ 1000 = 1.521 kDa.
Regarding instant claim 5, the limitation of the first optionally substituted aliphatic molecule which is a hydrophilic polymer is anticipated by the PEG (Abstract, Page 1220, section 2.2, Page 1221, section 2.3, Fig. 4 and Fig. 11), as taught by Capanema.
Regarding instant claim 6, the limitation of the structure of the first optionally substituted aliphatic molecule is anticipated by the PEG (Fig. 11), as taught by Capanema.
Regarding instant claims 7-9, the limitations of the second moiety are anticipated by the CA (Fig. 11), as taught by Capanema.
Regarding instant claim 10, the limitation of L being an ester is anticipated by the esterification reaction after incorporating PEG with CMC and CA (Page 1227, Col. 2, 1st ¶, last 4 lines), as taught by Capanema.
Regarding instant claim 11, the limitation of the polysaccharide being carboxymethylcellulose is anticipated by the CMC (Abstract, Page 1220, section 2.2, Page 1221, section 2.3, Fig. 4 and Fig. 11), as taught by Capanema.
Regarding instant claim 13, the limitation of a hydrogel comprising the polymer according to claim 1 and a liquid is anticipated by the CMC-PEG hydrogels (Abstract, Page 1220, section 2.2, Page 1221, section 2.3) and the swollen structure after immersion in water (Fig. 4 and Page 1233, section 4), as taught by Capanema.
Regarding instant claim 20, the limitation of a composition comprising the polymer according to claim 1 and a pharmaceutically acceptable excipient is anticipated by the hydrogel CMC-PEG-CA polymer that is immersed in water (considered a pharmaceutically acceptable excipient) (Fig. 4 and Page 1233, section 4) and skin repair and wound dressing applications (Abstract, Page 1225, Col. 2, lines 5-12, and Page 1232, Col. 2, both ¶s), as taught by Capanema.
Regarding instant claim 21, the limitation of a polymer additive is anticipated by the PEG (Page 1221, section 2.3), as taught by Capanema.
Response to Arguments
Applicant’s arguments (see Pages 8-11, filed 02/14/26) with respect to the rejection of claims 1-11, 13-15, and 19-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Capanema have been fully considered but are not persuasive.
Applicant argues that they amended claim 1 to further define the detailed structure of the polymer “comprising a network comprising a spacer crosslinker and a polysaccharide crosslinked with the spacer crosslinker,” and to emphasize that “the spacer crosslinker is pre-formed and well-defined prior to crosslinking with the polysaccharide", and further define the specific structure of the spacer crosslinker.
The amendments of claim 1 are addressed in detail above. Each of the structural constituents of the claimed polymer, the spacer crosslinker including formula (I) and the crosslinked polysaccharide, as well as the arrangement of each of these structural constituents in a crosslinked network polymer are taught by Capanema (Figures 4 and 11). The limitation of “preformed and well-defined prior to crosslinking” does not add any clear structure to the resultant final product. The final product taught by Capanema is a crosslinked hydrogel network containing the same components in the same arrangement recited in instant claim 1. Regardless of the spacer-crosslinker being preformed, the art nevertheless teaches its combination with the polysaccharide and a crosslinked hydrogel network is the resultant final product.
Applicant argues that Capanema fails to disclose the specific structure of the spacer crosslinker, and that the polymer of the present application uses a pre-formed-well-defined spacer crosslinker.
This is not persuasive because the limitation of the spacer crosslinker having the following formula (I): A-L-Z-L-A (I), wherein Z is the first optionally substituted aliphatic moiety; A is the second moiety comprising at least two carboxylic acid groups; and L is a linking group is anticipated by the first optionally substituted aliphatic moiety PEG (corresponds to Z), and the second moiety comprising at least two carboxylic acid groups or citric acid (CA) (corresponds to A) linked with an ester group (corresponds to L) (Abstract, Page 1221, section 2.3, Fig. 4 and Fig. 11), as taught by Capanema (depicted in the annotated blue box of Figure 11 of Capanema reproduced below).
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Capanema clearly teaches that “… the incorporation of PEG increased the total amount of −OH groups available for esterification reaction, besides the interactions between terminal hydroxyls and C-O-C of PEG with -OH of CMC” (Page 1227, Col. 2, 1st ¶). The limitation of “preformed” is a product by process limitation which is not given patentable weight in a product claim. Furthermore, the same final product, i.e., a crosslinked hydrogel polymer comprising CMC, PEG, and CA is produced. The spacer crosslinker containing PEG and CA as taught by Capanema is clearly well defined as well. The same structure of the spacer crosslinker is disclosed by Capanema.
Applicant argues that the structure of the polymer/spacer crosslinker in Capanema is totally different and refers to Fig. 11 of Capanema along with Section 3.2.5 and Section 3.2.3. Applicant argues that Capanema discloses a physico-chemical hybrid crosslinked network formed from the random interactions of three components.
This is not persuasive because, as shown above, Capanema teaches the same polymer with the same constituents. Instant claim 11 recites CMC is the polysaccharide, which is taught by Capanema. Instant claim 5 recites that polyether is the first optionally substituted aliphatic molecule, and claim 6 recites PEG, which is taught by Capanema. Instant claim 8 recites citric acid as the second molecule having at least three carboxylic acid groups, which is taught by Capanema. Capanema discloses the same polymer/spacer crosslinker structure as recited in the instant claims. There is nothing in the claims to distinguish over the hydrogel polymer containing CMC, PEG, and CA as taught by Capanema. The ester linkage recited in instant claims 1 and 10 is taught by Capanema. Instant product claims do not recite any other distinguishing bond or linkage that is not taught by Capanema. Even if the physico-chemical hybrid crosslinked network is formed from the random interactions of three components, as argued by Applicants, the same resultant product is formed which is indistinguishable from the claimed product.
Therefore, the anticipation rejection over instant claims 1, 3-11, 13, and 20-21 is maintained.
Applicant’s arguments (Pages 11-13) regarding the steps of making the polymer are addressed following the obviousness rejections below.
Maintained Rejections and New Rejections Necessitated by Amendment
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 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 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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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.
Maintained Rejection
Claim 12 is again rejected under 35 U.S.C. 103 as being unpatentable over Capanema et al. (International Journal of Biological Macromolecules 106 (2018) 1218-1234 – “Capanema”), as applied to claims 1, 3-11, 13, and 20-21 above, in view of Wang et al. (US 2017/0106125 A1 – “Wang”).
Instant claim 12 is drawn to the polymer according to claim 1, wherein the
polymer is in the form of a powder having a particle size in the range of about 0.05 mm to about 5 mm.
The teaching of Capanema is discussed above.
Capanema does not expressly teach that the polymer is in the form of a powder having a particle size in the range of about 0.05 mm to about 5 mm.
Wang teaches a polymer hydrogel composition comprising PEG ([0024]), CMC ([0018], [0039]-[0040], and Table 1). The hydrogel may be a powder and the particle size of the powder is between 0.1 µm and 1 mm ([0021]). The hydrogel is dissolved in water or a phosphate buffered saline (PBS) to become a liquid ([0021]) and has the advantage of forming a gel after injection due to the body temperature and forming a barrier protection layer, that helps to reduce adhesion occurring after a surgery ([0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the polymer hydrogel CMC-PEG crosslinked with CA, as taught by Capanema, in view of the hydrogel which is a powder and has a particle size of between 0.1 µm and 1 mm, as taught by Wang, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Wang teaches the advantage of having a powder hydrogel including its dissolution in water or a phosphate buffered saline (PBS) to become a liquid ([0021]), and forming a gel after injection due to the body temperature and forming a barrier protection layer, that helps to reduce adhesion occurring after a surgery ([0080]). The range of the particle size of the powder hydrogel taught by Wang, i.e., between 0.1 µm and 1 mm, overlaps the claimed range of about 0.05 mm (or 50 µm) to about 5 mm, and renders it obvious. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 12, the limitation of the polymer in the form of a powder having a particle size in the range of about 0.05 mm (or 50 µm) to about 5 mm would have been obvious over the hydrogel which may be a powder having an overlapping particle size of between 0.1 µm and 1 mm ([0021]), as taught by Wang.
New Rejection
Claims 14, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Capanema et al. (International Journal of Biological Macromolecules 106 (2018) 1218-1234 – “Capanema”), as applied to claims 1, 3-11, 13, and 20-21 above.
Instant claim 14 is drawn to a method of forming the polymer according to claim 1, comprising the following sequential steps of:
a) pre-forming the spacer crosslinker having the formula (I) by reacting a first optionally substituted aliphatic molecule comprising at least two hydroxyl groups with a second molecule comprising at least three carboxylic acid groups; and then
b) crosslinking the spacer crosslinker pre-formed in step a) with a polysaccharide to form the polymer of claim 1.
The teaching of Capanema is discussed above.
Capanema does not expressly teach sequential steps a) and b) or pre-forming the spacer crosslinker as recited in instant claim 14.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the polymer network hydrogel CMC-PEG crosslinked with CA, as taught by Capanema, use the spacer crosslinker PEG-CA as a preformed component, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because all the components, i.e., CMC, PEG, CA, and the final product, i.e., the resultant polymer network hydrogel, are taught by Capanema (Figures 4 and 11). According to MPEP 2144.04 (IV) (C), “In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).”
Applicant has not provided any comparative evidence that shows new or unexpected results that are achieved by the sequential steps a) and b) recited in instant claim 14 when compared to the closest prior art, i.e., the network hydrogel polymer taught by Capanema.
Regarding instant claim 14, the limitations of sequential steps a) and b) in a method of forming the polymer according to claim 1 would have been obvious over the preparation of the polymer comprising the polysaccharide CMC, the first optionally substituted aliphatic moiety PEG, and the second moiety CA, in the form of the polymer CMC-PEG crosslinked with CA (Page 1221, section 2.3), as taught by Capanema.
Regarding instant claim 15, the limitation of a polymer additive would have been obvious over the PEG (Page 1221, section 2.3), as taught by Capanema.
Regarding instant claim 19, the limitation of adding a liquid to the polymer would have been obvious over the polymer that is immersed in water (Fig. 4 and Page 1233, section 4), as taught by Capanema.
Maintained Rejection
Claims 16-18 are again rejected under 35 U.S.C. 103 as being unpatentable over Capanema et al. (International Journal of Biological Macromolecules 106 (2018) 1218-1234 – “Capanema”), as applied to claims 1, 3-11, 13, and 20-21 above, in view of Wang et al. (CN 111690156 A – English translation from Espacenet – “Wang ‘156”).
Instant claim 16 is drawn to the method according to claim 14, wherein the
reacting step (a) and crosslinking step (b) are independently performed
at a temperature in the range of 80°C to 180°C.
The teaching of Capanema is discussed above.
Capanema does not expressly teach that the reacting step (a) and crosslinking step (b) are independently performed at a temperature in the range of 80°C to 180°C.
Wang ‘156 teaches a super-absorbent polymer hydrogel (Abstract and [0002]). The polysaccharide polymer includes cellulose ([0019]), cellulose derivatives ([0020]) and the cellulose derivative is sodium CMC or CMC ([0021]). Additional polymers include polyacrylic acid ([0018] and [0056]) and polyvinyl alcohol ([0017] and [0056]). The crosslinking agent includes citric acid ([0026]). The crosslinking reaction temperature is 50-150°C ([0028] and [0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the polymer hydrogel CMC-PEG crosslinked with CA, as taught by Capanema, in view of the reaction temperature of 50-150°C, as taught by Wang ‘156, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because both Capanema and Wang ‘156 teach the preparation of polymer hydrogels having the same components of CMC polysaccharide, polymer, and crosslinking citric acid, and it is obvious to apply a known technique (using a reaction temperature of 50-150°C, as taught by Wang ‘156) to a known method (preparing a polymer hydrogel, as taught by Capanema) to yield predictable results. Please see MPEP 2141(III)(D).
Regarding instant claim 16, the limitation of the temperature in the range of 80°C to 180°C would have been obvious over the overlapping crosslinking reaction temperature of 50-150°C ([0028] and [0066]), as taught by Wang ‘156. Please see MPEP 2144.05 for obviousness of overlapping ranges.
Regarding instant claim 17, the limitations of a1) – a3) would have been obvious over the step of mixing the water-absorbing polymer with a solvent ([0030] and [0062]), the removal of excess purified water by filtration and drying at 100°C, cooling until completely dried, grinding the dried product and screening to obtain a superabsorbent hydrogel with a size of 200 - 4000 micrometers (or 0.2 – 4 mm) ([0082]), as taught by Wang ‘156.
Regarding instant claim 18, the limitation of step a1) further comprising the polymer additive would have been obvious over the PEG (Page 1221, section 2.3), as taught by Capanema.
Maintained Rejection
Claim 22 is again rejected under 35 U.S.C. 103 as being unpatentable over Capanema et al. (International Journal of Biological Macromolecules 106 (2018) 1218-1234 – “Capanema”), as applied to claims 1, 3-11, 13, and 20-21 above, in view of Heshmati et al. (US 2018/0153925 A1).
Instant claim 22 is drawn to a capsule comprising the polymer according to claim 1.
The teaching of Capanema is discussed above.
Capanema does not expressly a capsule comprising the polymer.
Heshmati teaches citric acid crosslinked carboxymethylcellulose (“CMC/CA”) powder that was loaded into gelatin capsules ([0072]-[0075]), and methods of managing weight, and treating overweight or obesity by orally administering the CMC/C to a subject (Abstract, [0082]-[0094], Example 2, Tables 4-7, claim 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the polymer hydrogel CMC-PEG crosslinked with CA, as taught by Capanema, in view of the gelatin capsule containing crosslinked CMC/CA, as taught by Heshmati, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Heshmati teaches the advantage of administering the capsule containing crosslinked CMC/CA of managing weight and treating overweight or obesity (Abstract, [0082]-[0094], Example 2, Tables 4-7, claim 1). Furthermore, it is obvious to combine prior art elements (the CMC-PEG-CA crosslinked hydrogel polymer of Capanema and the CMC-CA crosslinked polymer in a gelatin capsule as taught by Heshmati) according to known methods to yield predictable results. Please see MPEP 2141(III)(A). One of ordinary skill in the art would have found it obvious to include the CMC-PEG-CA crosslinked hydrogel polymer of Capanema in a gelatin capsule as taught by Heshmati to facilitate oral administration of the polymer.
Regarding instant claim 22, the limitation of the capsule comprising the polymer would have been obvious over the CMC/CA powder that was loaded into gelatin capsules ([0072]-[0075]), as taught by Heshmati.
Response to Arguments
Applicant’s arguments (Pages 11-13, filed 02/14/26) regarding the steps of making the polymer as they relate the rejections under 35 USC § 103 listed below, as well as the new ground of rejection of claim 14 over Capanema, have been fully considered but are not persuasive.
Maintained rejection of claim 12 under 35 U.S.C. 103 as being unpatentable over Capanema in view of Wang
New rejection of claims 14, 15, and 19 under 35 U.S.C. 103 as being unpatentable over Capanema
Maintained rejection of claims 16-18 under 35 U.S.C. 103 as being unpatentable over Capanema in view of Wang ‘156
Maintained rejection of claims 22 and 24 under 35 U.S.C. 103 as being unpatentable over Capanema in view of Heshmati
Applicant argues (Page 11, filed 02/14/26) that the spacer crosslinker in Capanema is not pre-formed; instead, all starting components (CMC,PEG, CA) are present together in the initial reaction mixture; and it’s clear that Capanema discloses a “one-pot” process for preparing hydrogels. Applicant argues (Page 12, filed 02/14/26) that Capanema is absolutely silent on a separate and preceding step of “preforming the spacer crosslinker” let alone the detailed structure of a pre-formed spacer cross linker.
This is not persuasive because all the components and the final product are taught by Capanema. Modifying the sequence of steps a) and b) recited in instant claim 14 would have been obvious based on MPEP 2144.04 (IV) (C), which states: “In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).” One of ordinary skill in the art would have found it obvious to prepare the polymer by first preparing the space crosslinker and then adding it to the polysaccharide as an obvious variant over the method taught by Capanema. The same final product is produced by Capanema and one of ordinary skill in the art would have found it obvious to modify the steps based on the desired yield and properties of the resultant polymer.
Applicant has not provided any comparative evidence that shows new or unexpected results that are achieved by the sequential steps a) and b) recited in instant claim 14 when compared to the closest prior art, i.e., the network hydrogel polymer taught by Capanema. The limitations of sequential steps a) and b) in a method of forming the polymer according to claim 1 would have been obvious over the preparation of the polymer comprising the polysaccharide CMC, the first optionally substituted aliphatic moiety PEG, and the second moiety CA, in the form of the polymer CMC-PEG crosslinked with CA (Page 1221, section 2.3), as taught by Capanema.
Applicant argues that the technical field and the technical problem of Capanema are different; while the present invention requires the material to swell flexibly and retain integrity in simulated gastric fluid (SGF), the approach in Capanema directly cases a drastic drop in swelling degree; and that this is diametrically opposed to the present invention’s goal of maintaining both high swelling capacity and high strength.
This is not persuasive because the intended use of swelling flexibly and retention integrity in SGF does not alter the structure of the claimed polymer and does not introduce any new steps in the method of forming the polymer. Also, instant claims do not recite any limitations regarding specific swelling degrees or strength. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Since Capanema teaches the same network polymer hydrogel as recited in the instant claims, one of ordinary skill in the art would have expected the same properties associated with the network polymer hydrogel, including swelling degree and strength, absent evidence of criticality or unexpected results. Capanema clearly teaches that results demonstrated that superabsorbent hydrogels (SAP) were produced with swelling degree typically ranging from 100 to 5000% (Abstract). One of ordinary skill in the art would have found it obvious to modify the swelling degree based on the desired application of the resultant polymer. Applicant’s reliance on Section 3.2.1 of Capanema and the argument that increasing crosslinker concentration causes a drastic drop in swelling degree is not persuasive because instant claim 14 does not recite any swelling parameters.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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