DETAILED ACTION
Status of Application
Receipt of the amended claims filed 4/1/2026 are acknowledged.
Claims 1-12 and 14-18 are pending.
Claim 13 is cancelled.
Claim 19 is withdrawn.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Allowable Subject Matter
Claims 1-12 and 14-16 are free of the art in light of the claim amendments from 4/1/2026. Claim 17 would be allowable if the limitations of claim 13 that were amended into claim 1 is also applied to claim 17.
Claim Rejections – 35 U.S.C. 103
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.
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 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ketelson et al. (US 20210169781 A1) hereinafter Ketelson.
Regarding claims 17-18, Ketelson is drawn to polymeric eye inserts that may be dissolvable when placed in the cul-de-sac of the eye. These inserts may contain one or more mucoadhesive polymers polymers, a biodegradable polymer as well as softener/plasticizer so that, when inserted into the eye, they may absorb tears, and dissolve and slowly release lubricant into the tear film to lubricate and protect the ocular surface for an extended duration of time. The biodegradable polymer containing eye insert may increase dissolution time on the ocular surface for longer lasting relief, may reduce dosing frequency and patient burden typically associated with topical drop usage. These polymeric eye inserts also may include one or more pharmaceutically active agents (abstract and claims 1-20).
Ketelson discloses a polymeric eye insert, the insert comprising: a biodegradable polymer and one or more mucoadhesive polymers that are biocompatible with the ocular surface and tear film of the eye; and wherein the biodegradable polymer increases a dissolution time of the polymeric eye insert by at least 15 percent comparing to the control polymeric eye insert which is the same polymeric eye insert except the biodegradable polymer is not present [0009-0011].
Ketelson discloses a that adding a biodegradable polymer to a polymeric eye insert of mucoadhesive polymers that are biocompatible with the ocular surface and tear film of the eye increases dissolution time of the polymeric eye insert. The biodegradable polymer containing eye insert increases dissolution time on the ocular surface for longer lasting relief, may reduce dosing frequency and patient burden typically associated with topical drop usage. These polymeric eye inserts also may include one or more pharmaceutically active agents [0009-0013].
Ketelson discloses a polymeric eye insert comprising an ocular lubricant. A polymeric eye insert may be comprised of a biodegradable polymer, hyaluronic acid, hydroxypropyl guar (HP guar), and a plasticizer, such as polyethylene glycol (PEG). An insert may be inserted in the lower eye lid (also known as the cul-de-sac) of the eye, and upon insertion, the insert may rapidly absorb tears and dissolve to release the ocular lubricant into the tear film to lubricate and protect the ocular surface for an extended duration superior to previously known topical ophthalmic compositions. Pharmaceutically active agents also may be incorporated into polymeric eye inserts. Insertion of a polymeric eye insert may provide relief to the patient from symptoms of dry eye as well as other eye conditions. The biomaterial for forming a polymeric eye insert may be comprised of one or more polymers that are biocompatible with the ocular surface and tear film. Polymers that may be used in polymeric eye inserts include, but are not limited to, hyaluronic acid (in acid or salt form), hydroxypropylmethylcellulose (HPMC), methylcellulose, tamarind seed polysaccharide (TSP), Galactomannans, for examples; guar and derivatives thereof such as hydroxypropyl guar (HP guar), scleroglucan poloxamer, poly(galacturonic) acid, sodium alginate, pectin, xanthan gum, xyloglucan gum, chitosan, sodium carboxymethylcellulose, polyvinyl alcohol, polyvinyl pyrrolidine, carbomer, polyacrylic acid and/or combinations thereof. The preferred biocompatible polymers are hyaluronic acid, guar and derivatives and/or combinations thereof; a preferred hyaluronic acid is sodium hyaluronate. [0021-0023]. Ketelson discloses an example of non-ionic substitution of a galactomannan is hydroxypropyl guar, with a molar substitution of about 0.4. Anionic substitutions may also be made to the galactomannans. Anionic substitution is particularly preferred when strongly responsive gels are desired, preferred galactomannans are guar and hydroxypropyl guar [0024]. Hyaluronic acid (HA) may be blended with tamarind seed polysaccharide (TSP) because TSP has been shown to increase residence time of HA in aggregate blends and the blend has desired film mechanical and lubrication properties [0025].
Ketelson discloses the biodegradable polymer is present in amount of from about 0.5%% to about 10%, about 1% to about 5%; the one or more mucoadhesive polymers are present in an amount of from about 50% to about 95% w/w, about 60% to about 90% w/w, about 70% to about 85% w/w, or about 80% to about 90% w/w by dry weight of the polymeric eye insert, provided that the sum of the % w/w of mucoadhesive polymers and % w/w of the biodegradable polymer and other components not listed above is 100% w/w [0033]. t should be appreciated that softeners and/or plasticizers may be low or high-molecular weight compounds, including not limited to, polyethylene glycol (PEG) and derivatives thereof, water, Vitamin E, and triethyl citrate [0035].
Ketelson discloses the polymeric eye insert may be of any size or shape suitable for administration to the eye. Exemplary shapes include film, a rod, a sphere, or an irregular shape having a maximum size in any single dimension of 5-6 mm. The polymeric eye insert has a thickness of about 50-400 μm, about 100-300 μm, about 150-250 μm, or about 200 μm [0038-0039].
Ketelson does not explicitly disclose each of the components of the composition in a single embodiment.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Ketelson, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Kiel discloses all the required components and Ketelson is drawn to polymeric eye inserts that may be dissolvable when placed in the cul-de-sac of the eye. These inserts may contain one or more mucoadhesive polymers polymers, a biodegradable polymer as well as softener/plasticizer so that, when inserted into the eye, they may absorb tears, and dissolve and slowly release lubricant into the tear film to lubricate and protect the ocular surface for an extended duration of time. The biodegradable polymer containing eye insert may increase dissolution time on the ocular surface for longer lasting relief, may reduce dosing frequency and patient burden typically associated with topical drop usage. These polymeric eye inserts also may include one or more pharmaceutically active agents (abstract). Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
Conclusion
Claims 1-12 and 14-16 are allowed.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUANGLONG N TRUONG whose telephone number is (571)270-0719. The examiner can normally be reached on 8:00 am-5:00 pm.
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, Robert A Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUANGLONG N TRUONG/Examiner, Art Unit 1615
Prosecution Insights