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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/24/25 has been entered.
Previous Rejections
Applicants' arguments, filed 09/24/25 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
Claims 1-2, 8, 21, 32, 39 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Stefater et al. (USP 10,874,767B2) in view of Kleinberg at al. (Vitreous Substitutes: A Comprehensive Review. July 2011, presented in IDS) and further in view of Tezel et al. (WO 2014/081969A1) and Feng et al. (A Novel Vitreous Substitute of Using a Foldable Capsular Vitreous Body Injected with Polyvinyl alcohol Hydrogel. 14 May 2013, presented in IDS).
Stefater et al. discloses methods and polymer compositions for treating retinal detachment, see title. Stefater teaches the polymer compositions form hydrogels in the eye of a subject, see abstract. Stefater teaches in certain stances the subject may have undergone a vtrectomy or surgery to repair discontinuity or, tear or break in retinal tissue, see column 3, lines 15-25. The injectable ocular formulation for forming hydrogel in the eye can comprise electro functional polymer of formula:
PNG
media_image1.png
364
436
media_image1.png
Greyscale
The formula above wherein R* is independently for each occurrence hydrogen reads on the claimed polymer composition with one or more residues of poly(ethylene glycol)diacrylate, see column 23, lines 15-35 and column 4, lines 20-22 and column 26, lines 50-54.The reference also teaches above that the molecular weight of the polymer residue can range 750 to 1000 and thus creates a case of obviousness because in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A. The electro-functional polymer can be purchased from commercial sources or prepared based on procedures described in the literature, such as by treating a nucleo-functional polymer with reagent(s) to install one or more electrophilic groups (e.g., by reacting polyethylene glycol with acrylic acid in an esterification reaction to form polyethylene glycol diacrylate), see column 24, lines 55-64. The composition can comprise antioxidant, see column 27, lines 42-43.
Stefater et al. does not teach use of the specific antioxidant ascorbic acid and glutathione.
Kleinberg discloses a similar vitreous substitute (see abstract, Advances in vitreoretinal surgery have included the development and characterization of suitable substitutes for the vitreous; Pg. 316 Co. 1 2. Para. 2 develop vitreous substitutes as long-term drug delivery media) comprising a gel (Pg. 314 Col. 1 Para. 3, Hydrogels offer significant advantages over previous substitutes because they can be injected in aqueous form and then transform into a gel in situ) and at least one antioxidant (Pg. 303, Col. 1 Para. 1, ascorbic acid may play an important role as a potent antioxidant, decreasing the amount of free oxygen present in the vitreous near the lens and thus preventing early cataract formation).
Tezel teaches compositions and methods for reducing oxidative damage, see title. The reference teaches use of polymerized form of poly(ethylene glycol) and antioxidant particles which provided the refractive index of about 1.30 to about 1.40, see abstract. The reference teaches use of poly(ethylene glycol)diacrylate, see claim 6. The reference teaches use of ascorbic acid and glutathione, see claim 16.Tezel teaches antioxidants which also read on therapeutic agents.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the known antioxidants such as ascorbic acid and glutathione into the vitreous replacement composition of Stefater et al. as taught by Kleinberg at al. and Tezel et al. One of ordinary skill would have been motivated to do so because Stefater et al suggests use of antioxidants and Kleinberg at al. and Tezel et al. teach use of the specific antioxidants ascorbic acid and glutathione wherein in Kleinburg teaches ascorbic acid may play an important role as a potent antioxidant, decreasing the amount of free oxygen present in the vitreous near the lens and thus preventing early cataract formation and Tezel teaches use of antioxidants for reducing oxidative damage. Regarding vitreous substitute having a loss tangent ranging from about 0.1 to about 0.5, the property of the composition would necessarily be present because property cannot be separated from the chemistry of the composition. Since the art teaches the claimed composition, it would appear reasonable to conclude that loss tangent of less than 1 would be implicit.
However, regarding the loss tangent, Feng et al. teaches a vitreous substitute (see title, abstract; Pg. 2 Col. 2 Para. 1, the 3% PVA hydrogel would be the best candidate as a vitreous substitute) comprising a gel (Pg. 2 Col. 2 Para. 1 the 3% PVA hydrogel would be the best candidate as a vitreous substitute) wherein the vitreous substitute is defined by having a loss tangent of less than 1 (Pg. 2 Col. 1 Para. 4. The loss tangent loss of all samples are recorded as a function of frequency. The lower the loss tangent, the higher the resilience is; Fig. 2A. The 3% PVA hydrogel had a loss tangent of less than 1 from a frequency between 0.041 and 10H7z) and a refractive index from about 1.33 to about 1.34 (Table 2, The 3% PVA hydrogel had a refractive index of 1.3361).
Therefore, since it is known that natural vitreous has a loss tangent between 0.1 and 0.5 and the skilled person would have aimed to values falling in that range in order to approximate more closely the properties of natural vitreous. Therefore, the claimed values of loss tangent do not render the subject matier inventive.
Claims 16, 21, 27 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Stefater et al. (USP 10,874,767B2) in view of Kleinberg at al. (Vitreous Substitutes: A Comprehensive Review. July 2011, presented in IDS), Tezel et al. (WO 2014/081969A1), Feng et al. (A Novel Vitreous Substitute of Using a Foldable Capsular Vitreous Body Injected with Polyvinyl alcohol Hydrogel. 14 May 2013, presented in IDS) and Texier-Nogues et al. (EP 3103485 A1).
The references discussed above do not teach use of polymer with residues comprising poly(ethylene glycol)methacrylate.
Texier teaches a material comprising a polymer capable of forming a hydrogel and nanoparticles, the process for the preparation thereof and the uses thereof, in particular for tissue engineering, cell culture, dressing-design applications and for the delivery of therapeutic agents, see [0001]. Texier teaches that generally, the synthetic (co)polymers capable of forming a hydrogel are obtained by polymerizing monomers chosen from hydroxyethyl methacrylate (HEMA), methoxyethyl methacrylate (MEMA), poly (ethylene glycol) acrylate (PEGA), poly (ethylene glycol) methacrylate (PEGMA), poly (ethylene glycol) diacrylate (PEGDA), and a mixtures thereof, see [0010]. Various therapeutic agents can be used, [0170] and [0163].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the known drug delivery hydrogels made by poly(ethylene glycol)methacrylate and poly (ethylene glycol) diacrylate (PEGDA), and a mixtures thereof as taught by Texier et al. Into the hydrogels of Stefater et al. One of ordinary skill would have been motivated to do so because Stefater teaches methacrylate hydrogels by vitreous replacement compositions and Texier teaches sue of known hydrogel forming acrylates such as PEGMA, HEMA and PEDGA used in drug delivery composition for therapeutic agents. Use of therapeutic agents would have been obvious to one of ordinary skill in the art because the refence teaches use of therapeutic agents within hydrogels for drug delivery compositions and methods. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Applicant’s arguments are moot in view of the new rejections made above necessitated by claim amendments.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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, Sahana S Kaup can be reached at 571-272-6897. 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.
/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612