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
Claims 1-4, 6, 7, 9, 10, 57, 58 and 61-70 are pending in the Claim Set filed 10/20/2025.
Claim 70 is newly added.
Claims 1, 2, 4, 7, 62, 63, 64, 67 and 69 have been amended.
Herein, claims 1-4, 6, 7, 9, 10, 57, 58 and 61-70 are for examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/20/2025 has been considered by the examiner and an initialed copy of the IDS is included with the mailing of this office action.
Withdrawn Rejections
The rejection of claims 1-4, 6, 7, 9, 10, 57, 58 and 61under 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 pre-AIA the applicant regards as the invention directed to ‘A composition, comprising: a first component and a second component, wherein at least one of the first component and/or the second component is dissolved in a solvent at a wt% of 15 wt% to 40 wt%’ is withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 103
(New Rejection in view of the claim amendments)
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 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
Claims 1-4, 6, 7, 9, 10, 57, 58 and 61-70 are rejected under 35 U.S.C. 103(a) as being unpatentable over Yu et al (In situ covalently cross-linked PEG hydrogel for ocular drug delivery applications, International Journal of Pharmaceutics 470, April, p.151, 2014, of record) [Yu] in view of Kaplan et al (US 20130287742, of record) [Kaplan], Surber et al (US 20090196930, of record) [Surber] and as evidenced by the Specification.
Regarding claims 1, 2, 62, 64 and 70
Yu teaches a composition comprising PEG hydrogels was formed via thiol-maleimide reaction using 4-arm PEG-Mal (about 10,000 Da = 10 kDa) and 4-arm PEG-SH (about 20,000 = 20 kDa). Yu teaches PEG hydrogels were synthesized by mixing the various weight ratios of 4-arm PEG-Mal and 4-arm PEG-SH (1:1; 1:2; 1:4 w/w).
Yu teaches crosslinking of 4-arm PEG-SH and 4-arm PEG-Mal to provide hydrogels; See Scheme 1 below. (Section 2: p.152)
PNG
media_image1.png
290
557
media_image1.png
Greyscale
Thus, the teachings of Yu make prima facie obvious a composition comprising a first component: 4-arm PEG-Mal, and a second component: 4-arm PEG-SH, wherein the first component and the second component are dissolved in a solvent at a weight percentage within the solvent at weight ratios of 1:1; 1:2; 1:4 w/w (Section 2.,2); i.e., a first component and the second component configured to react by crosslinking upon contact to form a hydrogel, wherein the first component comprises a multi-arm polyethylene glycol terminated with a thiol and the second component comprises a multi-arm polyethylene glycol terminated with a maleimide. It would necessarily follow that the hydrogel as taught by Yu would have an initial volume. Furthermore, the compositional taught by Yu does not comprise silk.
Yu teaches the mechanical property of PEG hydrogel was investigated by oscillatory rheology experiments at 37 oC, 4-arm PEG-SH and 4-arm PEG-Mal aqueous solutions were mixed by a double-barreled syringe with a mixing chamber and quickly transferred to the rheometer. Thereafter, the storage modulus (G’) and loss modulus (G’’) of system was monitored as a function with time. As presented in Fig. 2A, it was observed that the G’ and G’’ of system increased significantly after mixing 4-arm PEG-SH (75 mg/ml; 7.5 w/v) and 4-arm PEG-Mal (100 mg/ml; 10% w/v) (i.e., 1:1 weight ratio of PEG-Mal:4-arm PEG-SH) aqueous solutions, wherein the gelling time is 95 seconds for S3, and a ratio of the gelation G’’ to the gelation of G’ is less than about 1 (Section 3.See Fig. 2A), i.e., G’ is greater than G”.
As evidenced by the Specification at para. [000111]: the first component and the second component being formulated to have a gelation storage modulus (gelation G') and a gelation loss modulus (gelation G' ') at a gelation time after the first component and the second component are combined, a ratio of the gelation G" to the gelation G' being less than about 1, the gelation time being less than about 120 seconds; [000135]: In particular embodiments, compositions are provided comprising: a first component and a second component capable of combination to form a hydrogel. Such compositions can in particular comprise a first component and a second component capable of combination to form a hydrogel, wherein, at a gelation time after the combination, the combination has a storage modulus (G') and a loss modulus (G"), such that a ratio of G" to G' is less than about 1; and/or wherein the combination is capable of forming the hydrogel within a gelation rate of less than about 120 seconds; [000155]: In some embodiments, the delivered G' can be greater than the delivered G'' (i.e., a ratio of the delivered G'' to the delivered G' is less than 1 ), thus indicating that the delivered product is more solid than liquid; [000164]: The first component and the second component are formulated to have a gelation storage modulus (gelation G') and a gelation loss modulus (gelation G' ') at a gelation time after the first component and the second component are combined such that a ratio of the gelation G'' to the gelation G' is less than about 5, such as less than about 1. At para. [00063] Aspect 48 is the delivery system of any of Aspects 40-47, wherein the first component and the second component being formulated to have a gelation storage modulus (gelation G') and a gelation loss modulus (gelation G' ') at a gelation time after the first component and the second component are combined, a ratio of the gelation G" to the gelation G' being less than about 1, the gelation time being less than about 120 seconds.
Particularly, Specification at para. [000157]: In one embodiment, the device/hydrogel/delivered product swells upon contact with one or more fluids inside the body. Swelling allows for the device to secure itself or "lock" within the body part, duct, organ, cavity/space or lumen to form a good occlusion. The device can swell greater than 100%, such as 100-200%, 200-300%, 300-400%, and so on; and para. [000178]: the biomaterial/hydrogel swells within the implantation space to lock or secure its placement. For example, a biomaterial in the form of a hydrogel may swell from about 1.5x - 10x its initial volume.
Specification at para. [000177]: In some embodiments, if two components are injected to form the biomaterial/hydrogel, then the ratio of the components may be varied such as 1:1, 1:2, 3:1, 1:3, 4:1, 1:4, and up to 10:1 or 1:10.
As described above, Yu teaches it was observed that the G’ and G’’ of system increased significantly after mixing 4-arm PEG-SH (75 mg/ml; 7.5 w/v) and 4-arm PEG-Mal (100 mg/ml; 10% w/v) (i.e., 1:1 weight ratio of PEG-Mal:4-arm PEG-SH) aqueous solutions, wherein the gelling time is 95 seconds for S3, and a ratio of the gelation G’’ to the gelation of G’ is less than about 1 (Section 3.See Fig. 2A).
Accordingly, there is no unobvious distinction between the structural and functional characteristics of the claimed composition and the composition of the prior art of Yu. Therefore, the properties claimed in the present invention, i.e., hydrogel, upon implantation, is configured to increase in volume by more than 100% of the initial volume, would necessarily be present for the PEG hydrogels formed via thiol-maleimide reaction using 4-arm PEG-Mal and 4-arm PEG-SH (1:1; 1:2; 1:4 w/w), wherein the gelling time is 95 seconds having a ratio of the gelation G’’ to the gelation of G’ is less than about , as taught by Yu.
Yu does not explicitly teach ‘at least one of the first component and/or the second component is dissolved in a solvent at a wt% within the solvent of 15 wt% to 40 wt%. However, Thus, the teachings of Yu make prima facie obvious a composition comprising PEG hydrogels 1:1 weight ratio of PEG-Mal:4-arm PEG-SH, wherein the gelling time is 95 seconds for S3, and a ratio of the gelation G’’ to the gelation of G’ is less than about 1. However, Yu does not explicitly teach at least one of the components 4-arm PEG-Mal and/or and 4-arm PEG-SH is provided at 15 wt% to 40 wt% within the solvent.
However, Kaplan cures the deficiency.
Kaplan teaches a composition comprising biomaterials prepared through crosslinking by chemically reacting active polyethylene glycols (PEGs) comprising different chemical groups, e.g., thiols and maleimides functionalized PEGs, wherein the crosslinked polymer forms a hydrogel of which is stabilized by chemical crosslinking between the thiols and maleimides functionalized PEG components, wherein hydrogels are formed from 4-arm PEG-thiol and 4-arm- PEG-Maleimide (Abstract; See, Fig. 1A’ [0011]; [0060]; 0067]; claim 1). Similar to the teachings of YU, Kaplan teaches that the two functionally activated PEG components can be combined in a ratio of 1:1. Further, Kaplan teaches the concentration of each PEG component before mixing ranges from about 1 % to about 20%. Kaplan teaches that an ordinary artisan can optimize the concentrations of PEG components for various applications [0054]. Accordingly, the teachings of Kaplan make prior facie obvious that the concentration of each PEG component before mixing ranges from about 1 wt% to about 20 wt%, of which overlaps with claimed amounts. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257,191 USPQ 90 (CCPA 1976); In re Woodruff, 91 9 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05. Moreover, it would have been well within the purview of one of ordinary skill in art to optimize the weight percent amounts of 4-arm PEG-Mal and/or and 4-arm PEG-SH in a ratio of 1:1; 1:2; 1:4 w/w that are 15 wt% to 40 wt% within the solvent. One skilled in the art would have been motivated to do so in order to provide a composition that would be expected to form a fast-gelling hydrogel comprising a gelling time of about 95 seconds having a ratio of the gelation G'' to the gelation G' is less than about 1 by following the guidance provided by Yu and Kaplan, as a whole, having a reasonable expectation of success. Optimization of parameters is a routine practice that would be obvious to a person of ordinary skill in the art to employ and reasonably expect success; See In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself.
The PTO can require an applicant to establish that a prior art product does not necessarily possess the characteristics of the claimed product, e.g., hydrogel, upon implantation, that is configured to increase in volume by more than 100% of the initial volume, when the prior art and claimed products are identical or substantially identical. An applicant's burden under these circumstances was described in In re Best, 562 F.2d 1252, 1255, 195 USPQ 430,433-434 (CCPA 1977) as follows: Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily possess the characteristics of his claimed product. Its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products.
Further, Yu teaches the encapsulation of avastin (therapeutic agent: known as Bevacizumab, of which is a biologic) into the PEG network of which does not affect the sol–gel transition of system (p.153, top right col.). Yu teaches that approximately 25% Avastin was released from PEG hydrogel within 1 day, while nearly 70% Avastin was released from PEG hydrogel in the following 14 days (p155-156; Fig. 5), of which overlaps within the claimed ranges, i.e., wherein the hydrogel is configured to release the one or more therapeutic agent(s) to a patient over a period of at least 5 days.
While Yu and Kaplan do not explicitly disclose the hydrogel is configured to release one or more of the therapeutic agent: avastin (biologic), to the patient over a period of at least a month, however, the composition comprising PEG hydrogels formed via thiol-maleimide reaction using 4-arm PEG-Mal and 4-arm PEG-SH (1:1; 1:2; 1:4 w/w), wherein the gelling time is 95 seconds having a ratio of the gelation G’’ to the gelation of G’ is less than about, as taught by the prior art is structurally and functionally indistinguishable from the claimed composition. Thus, it would have been well within the purview of one of ordinary skill in art to optimize the concentration to provide a ratio of the 4-arm PEG-Mal and 4-arm PEG-SH to provide a hydrogel that is configured to release avastin to the patient over a period of at least a month by following the guidance provided by the teachings of prior art having a reasonable expectation of success. This property would be the natural result of the combination of the prior art elements. Moreover, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer. Atlas Powder Co. v. lreco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Accordingly, the claiming of a new use, new function or unknown property which is present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977)." MPEP § 2112, I. Therefore, in the absence of evidence to the contrary, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of Yu and Kaplan, as a whole.
Regarding claims 3 and 57,
Yu differs from the claims in that the documents does not teach that the one or more of the therapeutic agents are chosen from hormones, anti-HIV drugs, antibiotics, and/or anti-viral; or, the therapeutic agent has pharmacological activity against one or more sexually transmitted diseases.
However, Kaplan cures the deficiency.
Kaplan teaches a 4-arm PEG crosslinked hydrogel comprising an encapsulated bioactive agent (e.g., therapeutic agent) [0083]. Kaplan teaches the composition comprises one or more therapeutic agents selected from the group consisting of cells, proteins, peptides, nucleic acids, nucleic acid analogs, nucleotides or oligonucleotides, peptide nucleic acids, aptamers, antibodies or fragments or portions thereof, antigens or epitopes, hormones, hormone antagonists, growth factors or recombinant growth factors and fragments and variants thereof, cell attachment mediators, cytokines, enzymes, antibiotics or antimicrobial compounds, viruses, toxins, prodrugs, chemotherapeutic agents, small molecules, drugs, hemostatic agents, and any combinations thereof (claim 22). Particularly, Kaplan teaches that active agent represents any material desirable capable of being embedded in the cross-linked biomaterial comprising antibiotics, e.g., doxycycline (used against sexually transmitted disease), antimicrobial compounds, anti-inflammation agents, antifungals, viruses, anti-viral, toxins, prodrugs, chemotherapeutic agents, hemostatic agents, or combinations thereof [0071]. Accordingly, one of ordinary skill in the art before the effective filing date of the claimed invention would have recognized that Kaplan similarly teaches crosslinking of 4-arm PEG-SH and 4-arm PEG-Mal polymers to provide hydrogels that are structurally and functionally alike to the PEG hydrogels as taught by Yu. Thus, one skilled in the art would have been motivated to modify the teaching of Yu to further include additional therapeutic agents in these hydrogels to further include one or more therapeutic that comprise hormones, antibiotics and/or anti-viral in view of the teachings of Kaplan. Further, one skilled in the art would have been motivated to do so because the gelling time, pore size, swelling ratio and mechanical properties, e.g., release of drug profile, of the hydrogels as taught by Yu can be optimized simply by varying the concentration of 4-arm PEG-SH, then PEG hydrogels as taught by Yu. Thus, one skilled in the art would have recognized the benefit of further including one or more therapeutic agent that comprise hormones, anti-HIV drugs, antibiotics, anti-viral and antibiotic, e.g., drug used against one or more sexually transmitted disease, in accordance with the teachings of the prior art.
Regarding claims 4 and 63,
Yu teaches that gelling time decreases is optimized by increasing the concentration of 4-arm PEG-SH concentration, wherein the sol–gel transition to faster gelation time is attributed to more efficient cross-linking reaction at high 4-arm PEG-SH concentration in the system (Section 3.1, left col.). Thus, it would have been well within the purview of one of ordinary skill in art to optimize the relative amounts of 4-arm PEG-SH and/or 4-arm PEG-Mal to lessen the time it takes for gelation that is less than about 60 seconds to form a PEG hydrogel having a reasonable expectation of success in view of the teachings of the cited prior art. Optimization of parameters is a routine practice that would be obvious to a person of ordinary skill in the art to employ and reasonably expect success; See In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955).
Regarding claims 6 and 7,
Yu teaches in situ covalently cross-linked PEG hydrogels (p.152), i.e., capable of being disposed in a cavity/space, to treat disease, e.g., corneal neovascularization (blood vessels) (Abstract).
Regarding claims 9 and 10,
Yu teaches PEG-Mal was dissolved in a phosphate buffer solution (PBS, pH 7.4) to form 10% (w/v) 4-arm PEG-Mal aqueous solution. Thereafter, a 4-arm PEG-SH aqueous solution was mixed with 4-arm PEG-Mal aqueous solution (p.152).
Regarding claim 58,
Yu teaches encapsulated Avastin (i.e., therapeutic agent) was sustained release from PEG hydrogels (p.155-156), i.e., the first and second components comprise one or more of the therapeutic agents.
Regarding claim 61, 65 and 66,
Yu teaches that by varying the concentration of 4-arm PEG-SH relative to the concentration of 4-arm PEG-Mal, then PEG hydrogels with different gelling time, pore size, swelling ratio and mechanical property could be obtained. Since this modification of the prior art represents nothing more than “the predictable use of prior art elements according to their established functions” a prima facie case of obviousness exists. Accordingly, by following the guidance provided by Yu, one skilled in the art have had a reasonable expectation of success of varying the conditions for preparing a hydrogel comprising cross-linking 4-arm PEG-SH and 4-arm PEG-Mal to provide a hydrogel comprising pores, wherein the no pores have a size exceeding 3 µm in diameter. Optimization of parameters is a routine practice that would be obvious to a person of ordinary skill in the art to employ and reasonably expect success.
Regarding claim 69,
Kaplan teaches suitable buffers are phosphate buffer [0026] and also Tris, citrate, succinate acetate, or histidine [0087]. Thus, it would have been obvious to modify the teachings of Yu to use a citrate (CA) buffer (i.e., salt of citric acid, of which an equilibrium mixture of citric acid and citrate salt would be necessarily be present) as taught by Kaplan in place of a phosphate buffer in which to perform the crosslinking of PEG-SH and 4-arm PEG-Mal polymers to form hydrogels as taught by Yu. It is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985). The mere fact that a reference suggests a multitude of possible combinations does not in and of itself make any one of those combinations less obvious, see Merck v. Biocraft, 10 USPQ2d 1843 (Fed Cir 1985). Accordingly, it would have been prima facie obvious to use citrate (CA) buffer in the crosslinking reaction of PEG-SH and 4-arm PEG-Mal polymers to form hydrogels as taught by Yu in view of Kaplan. Moreover, it has been held that though a specific embodiment is not taught as preferred makes it no less obvious, also, the mere fact that a reference suggests a multitude of possible combinations does not in and of itself make any one of those combinations less obvious, see Merck v. Biocraft, 10 USPQ2d 1843 (Fed Cir 1985). The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. lnterchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). (See MPEP 2144.07).
Yu and Kaplan do not explicitly teach that the citrate is sodium citrate.
However, Surber cures the deficiency.
Surber teaches pH buffer and/or pH adjusting agent that is sodium citrate, wherein sodium citrate is the salt of citric acid, wherein sodium citrate is preferred over a phosphate buffer (Abstract; [0282]; See entire document). Thus, it would have been prima facie obvious to provide sodium citrate as the citrate as taught by Kaplan in view of the teaching of Surber, for at least for the reason that sodium citrate is the salt of citric acid that is a weak organic of which is a preferred buffer over a phosphate buffer as disclosed by Surber. All the claimed elements herein are known in the prior art 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Therefore, it would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. In the absence of evidence to the contrary, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by Yu and Kaplan, as a whole. Furthermore, it would have been well within the purview of one skilled in the art to select the sodium salt of citric acid to provide sodium citrate to use as buffering agent that would dissolve the 4-arm PEG-Mal and 4-arm PEG-SH for crosslinking to form a hydrogel having a reasonable expectation of success.
Regarding claims 67 and 68,
As described above, Yu teaches it was observed that the G’ and G’’ of system increased significantly after mixing 4-arm PEG-SH (75 mg/ml; 7.5 w/v) and 4-arm PEG-Mal (100 mg/ml; 10% w/v) (i.e., 1:1 weight ratio of PEG-Mal:4-arm PEG-SH) aqueous solutions, wherein the gelling time is 95 seconds for S3, and a ratio of the gelation G’’ to the gelation of G’ is less than about 1 (Section 3.See Fig. 2A), i.e., G’ is greater than G”.
Accordingly, there is no unobvious distinction between the structural and functional characteristics of the claimed composition and the composition of the prior art of Yu. Therefore, the properties claimed in the present invention, i.e., hydrogel, upon implantation, is configured to increase in volume by more than 1.5x -10x, would necessarily be present for the PEG hydrogels formed via thiol-maleimide reaction using 4-arm PEG-Mal and 4-arm PEG-SH (1:1; 1:2; 1:4 w/w), wherein the gelling time is 95 seconds having a ratio of the gelation G’’ to the gelation of G’ is less than about , as taught by Yu. While Yu and Kaplan do not explicitly disclose the hydrogel is configured to release one or more of the therapeutic agent: avastin (biologic), to the patient over a period of at least a month, however, the composition comprising PEG hydrogels formed via thiol-maleimide reaction using 4-arm PEG-Mal and 4-arm PEG-SH (1:1; 1:2; 1:4 w/w), wherein the gelling time is 95 seconds having a ratio of the gelation G’’ to the gelation of G’ is less than about, as taught by the prior art is structurally and functionally indistinguishable from the claimed composition. Thus, it would have been well within the purview of one of ordinary skill in art to optimize the concentration to provide a ratio of the 4-arm PEG-Mal and 4-arm PEG-SH to provide a hydrogel that is configured to release avastin to the patient over a period of at least a month by following the guidance provided by the teachings of prior art having a reasonable expectation of success. This property would be the natural result of the combination of the prior art elements. Moreover, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer. Atlas Powder Co. v. lreco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Accordingly, the claiming of a new use, new function or unknown property which is present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977)." MPEP § 2112, I.
All the claimed elements herein are known in the prior art 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Thus, it would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, 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 Yu, Kaplan and Surber, as a whole.
Response to Arguments
Applicants argue that the Office has not shown how 1) the references in the Office Action either individually or in combination teach or suggest all the limitations claimed; and 2) how one of ordinary skill in the art would have found it obvious to overcome the differences between the cited references and the claimed invention. The Office must make "a searching comparison of the claimed invention-including all its limitations-with the teachings of the prior art." In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995). And "there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." KSR Int'lCo. v. Teleflex Inc., 550U.S. 398,418 (2007). Applicant argue that they have amended claim 1 to recite "the hydrogel, upon implantation, is configured to increase in volume by more than 100% of the initial volume." The Examiner has not shown how either Yu or Kaplan teach or suggest this claimed feature. Independent claims 62 and 67 are similarly amended.
Applicant’s arguments have been fully considered but they are not persuasive, there is no unobvious distinction between the structural and functional characteristics of the claimed composition and the composition of the cited prior art. Therefore, the properties claimed in the present invention, i.e., hydrogel, upon implantation, is configured to increase in volume by more than 100% of the initial volume and/or hydrogel, upon implantation, is configured to increase in volume by more than 1.5x -10x, would necessarily be present for the PEG hydrogels as taught by the cited references. One skilled in the art would have been motivated to modify the teaching of Yu in view of Kaplan and Surber, to provide a composition comprising PEG Hydrogel comprising varied gelling times, pore sizes, functional features comprising particular swelling properties and/or mechanical properties, such that the PEG hydrogels would be configured to increase in volume by more than 100% of the initial volume and/or increase in volume by more than 1.5x -10x, upon implantation in a patient, having a reasonable expectation of success. Accordingly, all the claimed elements herein are known in the prior art 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Conclusions
No claim is allowed.
Applicants’ 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thurman Wheeler whose telephone number is (571)-207-1307. The examiner can normally be reached Monday-Friday 10:00am-6:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.W./ Examiner, Art Unit 1619
/SARAH ALAWADI/ Primary Examiner, Art Unit 1619