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 .
Claims 11 and 18-20 are presented for examination.
Continued Examination Under 37 CFR 1.114
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 05/08/2026 has been entered.
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.
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.
Claim 11 is 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.
Claim 11 is indefinite as to the phrase “active ingredient”. The phrase fails to set forth what is meant by “active ingredients”. It is not clear if the active ingredients are drugs, polymers, excipients…etc. Clarification is requested.
Claims 18-20, which are dependent on claim 11 are also rejected, since they have all the limitations of claim 11.
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 nonobviousness.
Claim(s) 11 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (US 20160144038) In view of Horm (US 20180098937) and CN 108295318.
Lu teaches the present invention relates to water-soluble supramolecular complexes for the delivery of pharmaceutical agents or cosmetics active ingredients, specifically water-soluble supramolecular complexes in the form of solids that, when hydrated are able to form transparent hydrogels or solutions. Lu teaches Exemplary water soluble block copolymers comprising at least two blocks of polyethylene oxide and at least at least one block of polypropylene oxide that may be used in the present invention are tri-block copolymers commercially available under the trade name PLURONIC®, also known as Poloxamer from BASF Corporation, Mount Olive, N.J. Preferred Poloxamer polymers, having the general formula of HO-(EO).sub.a(PO).sub.b(EO).sub.a—H, are PLURONIC® F127 (also known as Poloxamer 407) with average values of a at about 101, and b at about 56, and PLURONIC® F108 (also known as Poloxamer 338) with average values of a at about 141, and b at about 44, respectively. See Para [0052]. The concentration of poloxamer is taught to be 18-20%. See Paras [0005], [0006] and [0065]. The concentration of gelling adjuvants is taught to be 0.1-12%. See Para [0073]. Lu teaches Suitable associative gelling adjuvants for use herein include, but are not limited to, laureth-2, laureth-3, laureth-4, laureth-5, laureth-6, and the like; Oleth-2, Oleth-5, Oleth-10, and the like; C.sub.12-13 pareth-2, C.sub.12-13 pareth-3, C.sub.12-13 pareth-4, C.sub.12-13 pareth-5, C.sub.12-13 pareth-6,; di-PPG-2 myreth-9 adipate, di-PPG-2 myreth-10 adipate, di-PPG-2 myreth-11 adipate. See para [0071]. Lu teaches that Hydrogel formulations may be applied as drops which gel upon contact with eye or as a shear sensitive gel. See Para [0116]. Such teaching indicates the lack of an active ingredient.
Lu does not specifically teach the use of the claimed hydrogel for treating dry eye. However, Horn teaches a mild dry eye artificial tear composition, moderate dry eye artificial tear compositions, severe dry eye artificial tear compositions, extreme dry eye artificial tear compositions. See the abstract. The use of poloxamer by itself or in combination with other gelling agents is taught in Paras [0016], [0018] and [0019]. Horn teaches the use of poloxamer as an artificial tear. See Para [0026], claims 7, 8, 21 and 37. Horn teaches that the artificial tear compositions comprising from about 1.5% to about 5.9% w/v total concentration of one or more nonionic surfactants and one or more excipient selected from the group consisting of a viscosity enhancer, a polyol and an electrolyte. See Para [0037]. The treatment of dry eye is taught in Paras [0051], [0052] and claims 38-39.
CN ('318) teaches a temperature-sensitive injectable lacrimal passage embolus and preparation method thereof, wherein the injectable lacrimal passage embolus made of temperature-sensitive composite hydrogel material, in a liquid state when injected into the human or animal eye of the lower lacrimal duct nozzle depending on the human or animal body temperature the liquid injectable lacrimal passage embolus solidification and blockage of lacrimal pipe, wherein temperature sensitive composite hydro- gel material with the concentration of poloxamer 407, poloxamer 188, and water is prepared, adding viscosity enhancers and/or strength enhancers according to the need. The invention of injectable lacrimal passage embolus has good flowing under low temperature conditions under the small lacrimal pipe through injector injection into human or animal, human or animal body temperature the compound temperature-sensitive hydrogel congealed, blockage in the lacrimal pipe so as to relieve dry eye, has simple and convenient in application, the advantages convenient for operation and popularization. See the abstract. CN (318) makes clear that poloxamer has been previously used for the treatment of dry eye.
It would have been obvious to a person skilled in the art to use the composition of Lu for the treatment of dry eye, motivated by the teachings of the secondary references, which teach the use of poloxamer in human or animal for the treatment of dry eye syndrome. The selection of patient population is considered to be within the skill of the artisan. The determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary. The relied upon references make clear that poloxamer and di-PPG-2myreth-10 adipate have been used in an ophthalmic formulation. The treatment of dry eye using poloxamer in combination with gelling adjuvants is taught by Horn. CN Patent teaches the use of a hydrogel having poloxamer 407 in combination with a gelling agent in a hydrogel for treating dry eye. Applicant has presented no evidence to establish the unexpected or unobvious nature of the claimed invention. The examples in the specification are not limited to specific components of the claimed invention. The examples contain more ingredients than the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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