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 .
DETAILED ACTION
This action is in response to papers filed November 19, 2025 in reply to the Non-final Office Action mailed May 20, 2025. Claims 6, 7, 24, 25, 30, and 33 have been amended; and claims 1-5, 8-18, 20, 23, 27, 31, and 32 have been canceled. Claims 21, 22, 26, and 28-30 have been withdrawn. Claims 6, 7, 19, 24, 25, and 33 are currently under examination.
Claim Objections
Claims 7 and 25 are objected to because of the following:
i) In claim 7, the expression “about 4.9% DS to about 5.3% of thiol group DS” should be, for clarity and consistency of expression “about 4.9% of thiol group DS to about 5.3% of thiol group DS”.
ii) In claim 25, there should be a comma between “about 25.6% of thiol group DS” and “or about 31% of thiol group DS”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6, 7, 19, 24, 25, and 33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
1. Claim 6 stipulates in a wherein clause that “said thiolated HA” has “about 5.2% to about 15.3% degree of substitution (DS) with a thiol group” and “said thiolated CS has about 17.7% to about 36% DS with a thiol group”***. Applicant points to Table 2 and paragraph [0088] for support. Claim 6, however, is limited to tricopolymer hydrogels comprising thiolated HA, thiolated CS, and PEGDA with MW 700-8000 Da. Table 2 is not directed specifically to such hydrogels. Rather, Table 3 is directed to these specific hydrogels, and the DS values in Table 3 are different in scope from the DS values in claim 6. Table 2 and Table 3 show entirely different sets of data. Moreover, the DS values depicted in Table 2 are for very specific DTT and pH values, and the present claims are much, much broader in scope. Indeed, the present claims place no limits whatsoever on DTT and pH.
***It is noted that paragraph [0088} states that “By altering the pH of reaction mixture, the thiol group DS of CS—SH could be controlled from 17.7% to 36.0% (Table 2)”, thus referring to the data in Table 2. However, Table 2 actually discloses DS for CS-SH of 17.7% to 34.1%, not 17.7% to 36%. Regardless, since the original specification does make the statement that “the thiol group DS of CS—SH could be controlled from 17.7% to 36.0%”, this is being treated as the disclosure.
2. Claim 24, as now amended, which depends from claim 6, provides in a wherein clause that “the cartilage mimic has a storage modulus ranging from 410 ± 10 Pa to 1810 ± 106 Pa”. By claim 6, the cartilage mimic comprises a PEGDA of 700-8000 Da. The original specification discloses specifically that HCP 700, HCP3400, and HCP8000 have a storage modulus of 410 ± 30 Pa, 1300 ± 190 Pa, and 1810 ± 106 Pa, respectively (see paragraph 0104). Hence, while Applicant could be said to have adequate support for a storage modulus of 410 ± 30 Pa to 1810 ± 106 Pa, the specification does not provide adequate support for a storage modulus ranging from 410 ± 10 Pa to 1810 ± 106 Pa.
This constitutes new matter.
Claims 7, 19, 24, 25, and 33 depend from claim 6.
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 7, 25, and 33 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.
Claims 7, 25, and 33, each of which depends from claim 6, stipulate that “the thiolated HA has about 4.9% DS to about 5.3% DS or about 10.3% DS to about 12.1% DS. Claim 6, however, limits the thiolated HA DS to “about 5.2% to about 15.3%”. Hence, one of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7, 25, and 33 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 7, 25, and 33, each of which depends from claim 6, stipulate that “the thiolated HA has about 4.9% DS to about 5.3% DS or about 10.3% DS to about 12.1% DS. Claim 6, however, limits the thiolated HA DS to “about 5.2% to about 15.3%”. Hence, claims 7, 25, and 33 are broader in scope than claim 6 from which they depend.
Claim Rejections - 35 USC § 103 (I and II)
***The prior art rejections from the Non-final Office Action mailed April 25, 2024 have been reinstated. It is noted that these prior art rejections were withdrawn when Applicant added the limitation of a porous structure with pores of 2-50 µm. However, this limitation has been removed by the present amendment.
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.
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.
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 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.
I. Claims 6, 19, 24, 25, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Daniloff et al. (U.S. Patent Application Pub. No. 2009/0017091), in view of Prestwich et al. (U.S. Patent Application Pub. No. 2008/0025950), Park et al. (Acta Biomaterialia. 2009; 5: 3394-3403), Wang et al. (Mater. Sci. and Eng. C. 2009; 29: 2502-2507), Xiao et al. (J Biomater Tissue Engr. 2014; 4(4): abstract), and Suchaoin et al. (Eur J Pharm Biopharm. 2016; 101: 25-32).
I. Applicant Claims
Applicant’s elected subject matter is directed to a composite comprising a first component that is a 3D porous poly (lactide-co-glycolide) (PLGA) scaffold comprising sintered microspheres with interconnected porosity; a second component that is a hydrogel comprising thiolated hyaluronic acid (HA) with amino groups, thiolated chondroitin sulfate (CS) with amino groups, and polyethylene glycol diacrylate (PEGDA) with molecular weight of about 700-8000 Da; wherein the thiolated HA and the thiolated CS are crosslinked via the PEGDA, and wherein the thiolated HA has 5.2-15.3% DS with a thiol group, and wherein the thiolated CS has 17.7-36% DS with a thiol group; and wherein the said 3d porous PLGA scaffold and the said hydrogel are linked via NH2 groups from the said crosslinked thiolated HA and thiolated CS; and wherein molar ratio of the total thiol group of the thiolated HA and the thiolated CS to the acrylate groups of the PEGDA is about 1.07.
I. Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Daniloff et al. disclose a polymer gel composition comprising e.g. thiolated hyaluronic acid (HA), thiolated chondroitin sulfate (CS), and polyethylene glycol diacrylate (PEGDA); wherein the HA and CS can be further functionalized with amino groups, the PEGDA crosslinks the thiolated HA and the thiolated CS, and wherein the composition can further contain a polylactide.
Prestwick et al. disclose a polymer gel composition comprising e.g. thiolated glycosaminoglycans such as e.g. hyaluronic acid (HA) and chondroitin sulfate (CS), and polyethylene glycol diacrylate (PEGDA); wherein the HA and CS can be further functionalized with amino groups, the PEGDA crosslinks the thiolated HA and the thiolated CS, and wherein the molecular weight of the PEGDA is e.g. 1000 Da and the PEGDA:thiol ratio is e.g. 1:2 (i.e. acrylates:thiol ratio of 1:1 since there are two acrylate groups per PEGDA) (abstract; paragraphs 0103, 0203, 0417; Figures 1, 2, and 4)
Park et al. disclose that compositions composed of poly (lactide-co-glycolide) (PLGA) grafted via an –NH2 group to hyaluronic acid (HA) degrade relatively slowly compared to compositions composed of PLGA and HA-coated PLGA, and are more effective for guided bone regeneration. The HA NH2 group varied from 24-80 mol% and was correlated with HA degradation rate, with a lower HA NH2 group mol% corresponding to a higher degradation rate. The HA-PLGA composite had a PLGA conjugation degree of 37%. The PLGA degradation rate can be controlled in part by the specific ratio of lactic acid to glycolic acid in PLGA.
Wang et al. disclose that a 3D porous poly (lactide-co-glycolide) (PLGA) scaffold fabricated via sintered microspheres with porosity greater than 30% and interconnected pores with pore size of 10-180 µm support mesenchymal stem cell proliferation and are a suitable scaffold for bone repair applications (see abstract).
Xiao et al. disclose thiolated HA with a 7-74% DS with a thiol group, and that such thiolated HA derivatives exhibit long-term stability in body fluid and thus show promise for applications in tissue engineering and regenerative medicine (abstract).
Suchaoin et al. disclose thiolated CS with about 421-675 µmols of free thiol groups per gram of polymer (i.e. equivalent to about 21-33% DS with a thiol group), and that such thiolated CS derivatives exhibit enhanced bioadhesive properties and stability in body fluids, and thus show promise for applications in tissue engineering and treatment of osteoarthritis (abstract).
I. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Daniloff et al. do not explicitly disclose that the polymer composite contains a 3D porous poly (lactide-co-glycolide) (PLGA) scaffold fabricated via sintered microspheres with porosity which could be covalently bonded via –NH2 groups to the hydrogel, that the hydrogel is specifically composed of thiolated HA with 5.2-15.3% DS with a thiol group, and thiolated CS with 17.7-36% DS with a thiol group, that the molecular weight of the PEGDA is 700-8000 Da and that the thiol:acrylate ratio is about 1.07. These deficiencies are cured by the teachings of Park et al., Prestwich et al., Wang et al., Xiao et al., and Suchaoin et al.
I. Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Daniloff et al., Prestwich et al., Park et al., Wang et al., Xiao et al., and Suchaoin et al., outlined supra, to devise Applicant’s claimed composite.
Daniloff et al. disclose a polymer composition comprising e.g. thiolated hyaluronic acid (HA), thiolated chondroitin sulfate (CS), and polyethylene glycol diacrylate (PEGDA); wherein the thiolated HA and the thiolated CS are crosslinked via PEGDA; wherein the thiolated HA and thiolated CS can further contain amino functional groups, and wherein the composition can further contain a polylactide component and be employed to treat a defect in bone and/or cartilage. Since Prestwick et al. disclose that e.g. crosslinking of thiolated glycosaminoglycans such as e.g. hyaluronic acid (HA) and chondroitin sulfate (CS) with polyethylene glycol diacrylate (PEGDA) for the production of hydrogels for tissue repair and delivery of e.g. bioactive agents can be achieved using PEGDA with a molecular weight of e.g. 1000 Da and a PEGDA:thiol ratio is e.g. 1:2 (i.e. acrylates:thiol ratio of 1:1 since there are two acrylate groups per PEGDA); since Park et al. disclose that compositions composed of poly (lactide-co-glycolide) (PLGA) grafted via an –NH2 group to e.g. hyaluronic acid degrade relatively slowly and are more effective for guided bone regeneration; since Wang et al. disclose that a 3D porous poly (lactide-co-glycolide) (PLGA) scaffold fabricated via sintered microspheres with porosity greater than 30% support mesenchymal stem cell proliferation and are a suitable scaffold for bone repair applications; since Xiao et al. disclose that thiolated HA with a 7-74% DS exhibit long-term stability in body fluid and thus show promise for applications in tissue engineering and regenerative medicine; and since Suchaoin et al. disclose that thiolated CS with about 421-675 µmols of free thiol groups per gram of polymer (i.e. equivalent to about 21-33% DS) exhibit enhanced bioadhesive properties and stability in body fluids, and thus show promise for applications in tissue engineering and treatment of osteoarthritis; one of ordinary skill in the art would be motivated to tailor the Daniloff et al. composite to include a 3D porous poly (lactide-co-glycolide) (PLGA) scaffold fabricated via sintered microspheres with porosity greater than 30%, and to covalently bond this 3D porous PLGA scaffold via –NH2 groups to the hydrogel comprising thiolated HA with 7-74% DS with a thiol group, and thiolated CS with 21-33% DS with a thiol group, which thiolated HA and thiolated CS are crosslinked by PEGDA having a molecular weight of e.g. 1000 Da and with a acrylate:thiol ratio of 1:1, with the reasonable expectation of success that the resulting composite will be more effective for guided bone regeneration.
Daniloff et al. disclose that their crosslinking methodology with PEGDA is based on the methodology described in International Patent Application No. WO 2005/056608 (see e.g. paragraph [0186]). The U.S. National Stage Entry of the very same application is published as Prestwich et al., U.S. Patent Application Pub. No. 2008/0025950. Since Prestwich et al. disclose that the PEGDA MW employed is e.g. 700-10,000 Da, one of ordinary skill in the art would thus be motivated to employ PEGDA with a MW of 700-10,000 Da. Since the properties described in claim 16, i.e. “a crosslinking efficiency of about 79% to about 96%” and “an average storage modulus of about 410-1810 Pa”, are based on employing a PEGDA with MW 700-8,000 Da, the properties do not distinguish the claimed composition from the cited prior art.
Suchaoin et al. disclose thiolated CS with about 421-675 µmols of free thiol groups per gram of polymer. The molecular weight of CS is 475.4 g/mol. Hence, the thiolated CS contains about 0.00042-0.00067 moles thiol per 0.002 moles of CS, or about 21-33 moles thiol groups per 100 moles of CS units, which is thus equivalent to about 21-33% DS with a thiol group.
Moreover, both Daniloff et al. and Prestwich et al. disclose hydrogels, including microarrays of hydrogels, that are produced by crosslinking macromolecules to produce a porous network or sponge. One of ordinary skill in the art would thus readily understand that the hydrogel has a porous structure with micron-sized pores.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
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 was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
II. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Daniloff et al. (U.S. Patent Application Pub. No. 2009/0017091), in view of Park et al. (Acta Biomaterialia. 2009; 5: 3394-3403), Park (Biomaterials. 1995; 16(15): 1123-1130), Wang et al. (Mater. Sci. and Eng. C. 2009; 29: 2502-2507), Xiao et al. (J Biomater Tissue Engr. 2014; 4(4): abstract), and Suchaoin et al. (Eur J Pharm Biopharm. 2016; 101: 25-32).
II. Applicant Claims
Applicant’s elected subject matter is directed to a composite comprising a first component that is a 3D porous poly (lactide-co-glycolide) (PLGA) scaffold with a lactide/glycolide ratio of 85:15 comprising sintered microspheres with interconnected porosity; a second component that is a hydrogel comprising thiolated hyaluronic acid (HA) with amino groups, thiolated chondroitin sulfate (CS) with amino groups, and polyethylene glycol diacrylate (PEGDA); wherein the thiolated HA and the thiolated CS are crosslinked via the PEGDA, and wherein the thiolated HA has 5.2-15.3 DS with a thiol group, and wherein the thiolated CS has 17.7-36 DS with a thiol group; and wherein the said 3d porous PLGA scaffold and the said hydrogel are linked via NH2 groups from the said crosslinked thiolated HA and thiolated CS.
II. Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Daniloff et al. disclose a polymer composition comprising e.g. thiolated hyaluronic acid (HA), thiolated chondroitin sulfate (CS), and polyethylene glycol diacrylate (PEGDA); wherein the PEGDA crosslinks the thiolated HA and the thiolated CS, and wherein the composition can further contain a polylactide.
Park et al. disclose that compositions composed of poly (lactide-co-glycolide) (PLGA) grafted via an –NH2 group to hyaluronic acid (HA) degrade relatively slowly compared to compositions composed of PLGA and HA-coated PLGA, and are more effective for guided bone regeneration. The HA NH2 group varied from 24-80 mol% and was correlated with HA degradation rate, with a lower HA NH2 group mol% corresponding to a higher degradation rate. The HA-PLGA composite had a PLGA conjugation degree of 37%. The PLGA degradation rate can be controlled in part by the specific ratio of lactic acid to glycolic acid in PLGA.
Park discloses that poly (lactide-co-glycolide) (PLGA) with a lactide/glycolide ratio of 80:20 to 90:10 degrade much slower over the course of a 53 day period than PLGA with a lactide/glycolide ratio of 50:50 to 70:30 (see Figure 5).
Wang et al. disclose that a 3D porous poly (lactide-co-glycolide) (PLGA) scaffold fabricated via sintered microspheres with porosity greater than 30% and interconnected pores with pore size of 10-180 µm support mesenchymal stem cell proliferation and are a suitable scaffold for bone repair applications (see abstract).
Xiao et al. disclose thiolated HA with a 7-74% DS with a thiol group, and that such thiolated HA derivatives exhibit long-term stability in body fluid and thus show promise for applications in tissue engineering and regenerative medicine (abstract).
Suchaoin et al. disclose thiolated CS with about 421-675 µmols of free thiol groups per gram of polymer (i.e. equivalent to about 21-33% DS with a thiol group), and that such thiolated CS derivatives exhibit enhanced bioadhesive properties and stability in body fluids, and thus show promise for applications in tissue engineering and treatment of osteoarthritis (abstract).
II. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Daniloff et al. do not explicitly disclose that the polymer composite contains a 3D porous poly (lactide-co-glycolide) (PLGA) scaffold with a lactide/glycolide ratio of 85:15 fabricated via sintered microspheres with porosity which could be covalently bonded via –NH2 groups to the hydrogel, and that the hydrogel is specifically composed of thiolated HA with 5.2-15.3 DS with a thiol group, and thiolated CS with 17.7-36 DS with a thiol group. These deficiencies are cured by the teachings of Park et al., Park, Wang et al., Xiao et al., and Suchaoin et al.
II. Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Daniloff et al., Park et al., Park, Wang et al., Xiao et al., and Suchaoin et al., outlined supra, to devise Applicant’s claimed composite.
Daniloff et al. disclose a polymer composition comprising e.g. thiolated hyaluronic acid (HA), thiolated chondroitin sulfate (CS), and polyethylene glycol diacrylate (PEGDA); wherein the thiolated HA and the thiolated CS are crosslinked via PEGDA; wherein the thiolated HA and thiolated CS can further contain amino functional groups, and wherein the composition can further contain a polylactide component and be employed to treat a defect in bone and/or cartilage. Since Park et al. disclose that compositions composed of poly (lactide-co-glycolide) (PLGA) grafted via an –NH2 group to hyaluronic acid degrade relatively slowly and are more effective for guided bone regeneration; since Park discloses that poly (lactide-co-glycolide) (PLGA) with a lactide/glycolide ratio of 80:20 to 90:10 degrades much slower over the course of a 53 day period than PLGA with a lactide/glycolide ratio of 50:50 to 70:30; since Wang et al. disclose that a 3D porous poly (lactide-co-glycolide) (PLGA) scaffold fabricated via sintered microspheres with porosity greater than 30% support mesenchymal stem cell proliferation and are a suitable scaffold for bone repair applications; since Xiao et al. disclose that thiolated HA with a 7-74% DS exhibit long-term stability in body fluid and thus show promise for applications in tissue engineering and regenerative medicine; and since Suchaoin et al. disclose that thiolated CS with about 421-675 µmols of free thiol groups per gram of polymer (i.e. equivalent to about 21-33% DS) exhibit enhanced bioadhesive properties and stability in body fluids, and thus show promise for applications in tissue engineering and treatment of osteoarthritis; one of ordinary skill in the art would be motivated to tailor the Daniloff et al. composite to include a 3D porous poly (lactide-co-glycolide) (PLGA) scaffold with a lactide/glycolide ratio of 80:20 to 90:10 fabricated via sintered microspheres with porosity greater than 30%, and to covalently bond this 3D porous PLGA scaffold via –NH2 groups to the hydrogel comprising thiolated HA with 7-74% DS with a thiol group, and thiolated CS with 21-33 DS with a thiol group, with the reasonable expectation of success that the resulting composite will be more effective for guided bone regeneration.
Suchaoin et al. disclose thiolated CS with about 421-675 µmols of free thiol groups per gram of polymer. The molecular weight of CS is 475.4 g/mol. Hence, the thiolated CS contains about 0.00042-0.00067 moles thiol per 0.002 moles of CS, or about 21-33 moles thiol groups per 100 moles of CS units, which is thus equivalent to about 21-33% DS with a thiol group.
Moreover, both Daniloff et al. and Prestwich et al. disclose hydrogels, including microarrays of hydrogels, that are produced by crosslinking macromolecules to produce a porous network or sponge. One of ordinary skill in the art would thus readily understand that the hydrogel has a porous structure with micron-sized pores.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
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 was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 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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/DAVID BROWE/Primary Examiner, Art Unit 1617