DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 16, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1, 6, 8 – 10, 13, 14, 19, 21, 24, 27, 28, 35, 37, 40, 73, 74, 86, 106, and 107 are pending.
Claims 27, 28, 35, 37, 40, 73, 74, 86, and 107 are withdrawn.
Claims 1, 6, 8 – 10, 13, 14, 19, 21, 24, and 106 are examined here-in.
Claim Objections
Claims 6 and 106 are objected to because of the following informalities:
In lines 8 and 9 of claim 6, the phrase “optionally wherein the cationic crosslinking agent is divalent calcium” is repeated.
In line 2 of claim 106, the prepositions “of at from about” precede the storage modulus range. The phrasing would be more clear if changed to “of from about”, deleting the “at”.
Appropriate correction is required.
Election/Restrictions
Applicant's election with traverse of Group 1 claims 1, 6, 8 – 10, 13, 14, 19, 21, 24, and 106, in the reply filed on April 24, 2026 is acknowledged. The traversal is on the ground that “there will be no additional burden to search all claims”. This is not found persuasive because search burden is not the reason for restriction; as stated in the office action dated 2/27/2026, Groups 1 – 7 lack unity of invention because the technical feature is not a special technical feature because it does not make a contribution over the prior art. As provided in 37 CFR 1.475(a), where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Claims 27, 28, 35, 37, 40, 73, 74, 86, and 107 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Groups 2 – 7.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 10 is rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 10 recites the term “preferably.” This term is considered indefinite since the scope of the claim cannot be determined. See MPEP 2173.05(c) and 2173.05(d).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1, 6, 8 – 10, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Mooney (US 6,642,363 B1).
Mooney teaches materials based on alginate polysaccharides (abstract). Mooney teaches crosslinking and covalent bonding to biologically active molecules such as cell adhesion groups modulates the properties of the material (abstract).
Mooney teaches that alginate polymers have controllable properties, such as shape memory, which are influenced by crosslinking (column 1 lines 50 – 52, lines 65 – 67).
Mooney teaches that modification of the polymer with crosslinking and biologically active molecules creates a 3-dimensional environment which is advantageous for cell adhesion (column 2 lines 2 – 7, column 20 lines 1 – 6, column 21 lines 27 – 38).
Mooney teaches covalent and ionic cross-linking (column 16 lines 55 – 56, column 17 lines 8 – 11). Mooney teaches that ionic crosslinking with divalent ions such as calcium occurs very quickly, while covalent cross-linking can occur over hours (column 16 lines 55 – 62). Mooney teaches that covalent cross-linking occurs between the carboxylic acid or alcohol groups of uronic acid of alginate units (column 12 lines 52 – 66). Mooney teaches photopolymerization as a method of cross-linking (column 3 lines 58 – 63, column 15 lines 36 – 38, column 46 line 64 to column 47 line 63).
Mooney teaches that the extent or degree of cross-linking directly impacts the structure of the material, such that it may be in the form of a viscous liquid, a swellable gel, a non-swellable gel, or a solid matrix (column 16 lines 15 – 27). Mooney teaches that low cross-linking between 1 to 20% will yield a material with super absorbent properties (column 16 lines 33 – 37, column 22 lines 54 – 56). Mooney teaches that for tissue matrices, an extent of crosslinking between 5 to 75% is appropriate, and that a person of skill in the art can select and optimize the crosslinking density to control viscosity (column 16 lines 37 – 50, column 21 lines 33 – 38).
Mooney teaches cell adhesion moieties with RGD sequences, among others (column 18 lines 40 – 44, Tables 1, 2).
Mooney teaches the molecular weight of the alginate chain influences polymer stability, with higher molecular weight chains (greater than 100,000 Da) being more stabile than lower molecular weight chains, with 30,000 to 50,000 Da being useful for biodegradability (column 11 lines 15 – 24).
Mooney teaches that the distribution of uronic acid M and G units also results in control of polymer shape or viscosity (column 7 lines 51 – 54, column 11 lines 25 – 28). Mooney teaches that increasing the number of G units will result in increased rate of gelation of alginate (column 7 lines 56 – 58, column 11 lines 28 – 36). Mooney teaches that side chains having a percentage of 10 to 100% G units (of a total M and G units) are preferred (column 7 lines 54 – 56, column 11 lines 28 – 30).
Mooney does not teach a specific embodiment having each of the claimed elements, however, claims 1, 6, 8 – 10, 13, and 14 are rendered prima facie obvious over the teachings of Mooney, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results (MPEP 2143(i)(a)). In the instant case, all the claimed elements (e.g., alginate polymers, cross-linkable moieties, cell adhesion moieties) were known in the prior art (e.g., tissue engineering) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (e.g., a controllable alginate polymer scaffold) to one of ordinary skill in the art.
Mooney’s teaching for an alginate polymer which is covalently and ionically cross-linked with cell adhesion moieties (abstract, column 1 lines 50 – 52, lines 65 – 67, column 2 lines 2 – 7, column 20 lines 1 – 6, column 21 lines 27 – 38) reads on instant claim 1.
Mooney’s teaching for photopolymerization as a method of cross-linking (column 3 lines 58 – 63, column 15 lines 36 – 38, column 46 line 64 to column 47 line 63) reads on the recitation for the crosslinkable groups to be photocrosslinkable as recited in claim 1.
Mooney’s teaching for covalent cross-linking between the carboxylic acid or alcohol groups of alginate in an amount of 5 to 75% (column 12 lines 52 – 66, column 16 lines 37 – 50, column 21 lines 33 – 38) reads on the recitation of “about 16 to 68.8% of the hydroxyl groups of the alginate polymer are functionalized” as recited in instant claim 1. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Mooney’s teaching for cell adhesion moieties on the alginate polymer (column 18 lines 40 – 44, Tables 1, 2) reads on the recitation of “a plurality of cell adhesion moieties each linked to the alginate polymer” as recited in claim 1.
Mooney teaches that the number, type, and location of cell adhesion ligands on alginate will affect cell adhesion and viability, and that such factors can be varied to suit a particular application (column 20 lines 7 – 11), thus suggesting that a person of ordinary skill in the art has the necessary expertise to determine an appropriate amount, reading on the recitation of “wherein from about 2 to 9% of the photocrosslinkable moieties are functionalized with the plurality of cell adhesion moieties” of claim 1. Said differently, Mooney teaches that the properties of the polymer composition can be tuned with the amount of cell adhesion moieties used, and that the desired properties depend on the desired application. As such, it is within the expertise of one of ordinary skill in the art to determine and appropriate number of photocrsslinkable moieties and cell adhesion moieties for the desired properties via routine experimentation. Routine experimentation is prima facie obvious according to MPEP 2144.05(ii).
Mooney’s teaching that the alginate polymer is capable of ionic cross-linking with divalent ions such as calcium (column 16 lines 55 – 62, column 17 lines 8 – 11) reads on the recitation “capable of ionic crosslinking with an ionic crosslinking agent” as recited in claim 1.
Mooney’s teaching for covalent and ionic cross-linking (column 16 lines 55 – 56, column 17 lines 8 – 11); wherein ionic crosslinking with divalent ions such as calcium occurs very quickly, while covalent cross-linking can occur over hours (column 16 lines 55 – 62) reads on instant claim 6. Mooney’s teaching that the extent or degree of cross-linking directly impacts the structure of the material, such that it may be in the form of a viscous liquid, a swellable gel, a non-swellable gel, or a solid matrix (column 16 lines 15 – 27) would motivate a person of ordinary skill in the art to keep the polymers uncrosslinked for ease of handling, reading on “the plurality of photocrosslinkable moieties linked to the polymer in uncrosslinked form” as recited in claim 6.
Mooney teaches photopolymerizable polyacrylamides and polyacrylates (column 3 lines 60 – 62, column 5 lines 29 – 38, Example 26) reading on instant claim 8.
Mooney’s teaching for cell adhesion moieties with RGD sequences, among others (column 18 lines 40 – 44, Tables 1, 2) reads on instant claim 9.
Mooney teaches that inclusion of cell adhesion moieties to facilitate cell adhesion and matrix interactions (column 1 lines 36 – 41), and teaches the inclusion of living cells in implantable parts or devices is advantageous (column 2 lines 59 – 62), thereby reading on the limitation “comprising cells adhered to the cell adhesion moieties” as recited in claim 10.
Mooney’s teaching that alginate side chains having a percentage of 10 to 100% G units (of a total M and G units) are preferred (column 7 lines 54 – 56, column 11 lines 28 – 30) reads on the instantly claimed ratio of M/G in the range of 0.3 to about 2.6 as recited in claim 13. For example, a percentage of 50% G units would be an M/G ratio of 0.5. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Mooney’s teaching for alginate side chains of greater than 100 kDa to promote polymer stability (column 11 lines 15 – 24) overlaps on the instantly claimed range of 68 to 780 kDa as recited in claim 14.
Claims 19, 21, and 106 are rejected under 35 U.S.C. 103 as being unpatentable over Mooney (as cited above) and further in view of Samorezov (Samorezov, et al. “Dual ionic and photo-crosslinked alginate hydrogels for micropatterned spatial control of material properties and cell behavior” Bioconjuage Chemistry, 2015, 26, p. 1339 – 1347).
Mooney’s teachings are addressed above.
Mooney does not teach the photocrosslinkable moiety is methacrylate or the storage modulus of the polymer.
Samorezov teaches the missing elements of Mooney.
Samorezov teaches methacrylated alginate hydrogels that were crosslinked ionically or with ultraviolet light (abstract). Samorezov teaches methacrylated alginate is a unique material because it allows for both ionic and covalent crosslinking, leading to independent control of swelling profiles and mechanical properties (page 1340 column 1).
Samorezov teaches the storage modulus for these dual-crosslinked methacrylated alginate hydrogels is 15.7 – 22.3 kPa (page 1341 column 1).
The combination of Mooney and Samorezov’s teachings renders claims 19, 21, and 106 prima facie obvious as combining prior art elements according to known methods to yield predictable results (MPEP 2143(i)(a)). A person of ordinary skill in the art would be motivated to use methacrylate as photocrosslinkable moiety for alginate as taught by Mooney becase Samorezov teaches that methacrylated alginate has free carboxylic acids that can interact with calcium ions to form additional crosslinks (page 1340 column 1). Therefore, the combination of Mooney and Samorezov’s teachings is prima facie obvious according to MPEP 2143(i)(a) as combining known prior art elements (alginate polymers, methacrylate, cell adhesion moieties) according to known methods (ionic crosslinking, photo crosslinking) to yield predictable results (a dual-crosslinked alginate hydrogel).
The combination of Mooney’s teaching for an alginate polymer which is covalently and ionically cross-linked with cell adhesion moieties (abstract, column 1 lines 50 – 52, lines 65 – 67, column 2 lines 2 – 7, column 20 lines 1 – 6, column 21 lines 27 – 38) with Samorezov’s teaching for methacrylate as the photocrosslinkable moiety (page 1340 column 1) reads on instant claim 19.
The instant claim 21 recites “wherein the plurality of photocrosslinkable moieties are each derived from a reagent for providing the photocrosslinkable moiety that has reacted with a hydroxyl group of the polymer”. The limitation that the photocrosslinkable moieties are derived from a reagent for providing reaction with a hydroxyl group of the polymer is a product-by-process limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps according to MPEP 2113.
Even though product-by-process claims are written as defined by the process, the 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 the instant case, Mooney and Samorezov’s teachings that the crosslinkable group reacts with the carboxylic acid or alcohol groups of alginate (Mooney column 12 lines 52 – 66, column 16 lines 37 – 50, column 21 lines 33 – 38, Samorezov page 1340 column 1) reads on the claimed functionalized polymer. As such, the patentability of the instant composition does not depend on its method of production, and the Applicant’s limitation regarding the process of deriving photocrosslinkable moieties from a reagent for providing reaction with a hydroxyl group of the polymer is not patentable under 35 U.S.C. 103, in view of Mooney and Samorezov.
Samorezov’s teaching that the storage modulus for these dual-crosslinked methacrylated alginate hydrogels is 15.7 – 22.3 kPa (page 1341 column 1) overlaps on the instantly claimed range of 5 to 50 kPa recited in claim 106. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Mooney (as cited above) and further in view of Marko (Marko, et al. “A novel synthetic peptide polymer with cyclic RGD motifs supports serum-free attachment of anchorage-dependent cells” Bioconjugate Chemistry, 2008, 19, p. 1757 – 1766).
Mooney’s teachings are addressed above.
Mooney does not teach the cell adhesion moieties are conjugated with a thioether bond.
Marko teaches the missing elements of Mooney.
Marko teaches that a thioether linkage between cell adhesion moiety and polymer backbone has several advantages, including easy and selective formation and high stability (page 1761 column 2 to page 1762 column 1).
The combination of Mooney and Marko’s teachings renders claim 24 prima facie obvious as combining prior art elements according to known methods to yield predictable results (MPEP 2143(i)(a)). A person of ordinary skill in the art would be motivated to connect a cell adhesion moiety with polymer backbone via a thioether linkage because Marko teaches that thioether linkages are easily and selectively formed and have high stability (page 1761 column 2 to page 1762 column 1). Therefore, the combination of Mooney and Marko’s teachings is prima facie obvious according to MPEP 2143(i)(a) as combining known prior art elements (alginate polymers, cell adhesion moieties) according to known methods (thioether linkages) to yield predictable results (a polymer functionalized with cell adhesion moieties).
The combination of Mooney’s teaching for an alginate polymer which is covalently and ionically cross-linked with cell adhesion moieties (abstract, column 1 lines 50 – 52, lines 65 – 67, column 2 lines 2 – 7, column 20 lines 1 – 6, column 21 lines 27 – 38) with Marko’s teaching for a thioether linkage between cell adhesion moiety and polymer backbone (page 1761 column 2 to page 1762 column 1) reads on instant claim 24.
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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