DETAILED ACTION
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 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 31, 2026 has been entered.
Previous Rejections
Applicant’s arguments, filed March 31, 2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Status
Claims 13 – 31 are examined here-in.
Claim Objections
Claims 13, 17, 19, 21, 25, 27, and 28 are objected to because of the following informalities:
In line 3 of claim 13 “thiomer” should be plural.
Claim 17 recites “the preactivated thiomer forming the matrix is under the form of nanofibers”. The preposition “under” should be replaced with “in” or some other appropriate term.
In line 2 of claim 19, “substance” should be plural.
In claim 21, “rho” should not be capitalized.
In line 2 of claims 25 and 27, “excipient” should be plural.
Claim 28 has the phrase “comprising administering to target site of the eye of the patient” which should be changed to “comprising administer to a target site of the eye of the patient” or as otherwise appropriate.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13, 15, 16, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Iqbal (Iqbal, J. et al. “Preactivated thiomers as mucoadhesive polymers for drug delivery” Biomaterials, 2012, 33, p. 1528 – 1535).
Iqbal teaches 2-mercaptonicotinic acid side chains covalently bonded through disulfide bonds to a poly(acrylic)acid-cysteine conjugate polymer, suitable for ocular delivery, exhibiting mucoadhesive and cohesive properties (abstract, p. 1528 column 2, p. 1529 column 1), thus anticipating claim 13.
Iqbal teaches 2-mercaptonicotinic acid side chains covalently bonded through disulfide bonds to a poly(acrylic)acid-cysteine conjugate polymer (abstract, p. 1529 column 1), anticipating claim 15, which recites the polymer backbone is an acrylic acid polymer.
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Iqbal teaches 2-mercaptonicotinic acid side chains covalently bonded through disulfide bonds to a poly(acrylic)acid-cysteine conjugate polymer (abstract, p. 1529 column 1), in other words, the side chains of poly(acrylic)acid are (2-mercaptonicotinic acid)cysteine, shown in Figure 1, anticipating instant claim 16.
Iqbal teaches the formation of tablets from lyophilized poly(acrylic)acid-cysteine-2-mercaptonicotinic acid polymers (p. 1529 column 2), anticipating instant claim 30.
However, in the event that the previous does not have sufficient specificity to rise to anticipation, claims 13, 15, 16, and 30 are also rejected under 35 U.S.C. 103 below.
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 non-obviousness.
Claims 13, 15, 16, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Iqbal (as cited above).
For the purposes of this ground of rejection only, and purely arguendo, the examiner will take the position that Iqbal does not teach a specific embodiment (i.e., preferred embodiment, working example, etc.) having all of the claimed elements arranged as required by claims 13, 15, 16, and 30 without resorting to some “picking and choosing” within the prior art disclosure. That being said, although Iqbal thus would not be anticipatory by this interpretation of the facts, it nevertheless does fairly suggest the claimed invention, as shown below.
As discussed above, Iqbal teaches 2-mercaptonicotinic acid side chains covalently bonded through disulfide bonds to a poly(acrylic)acid-cysteine conjugate polymer, suitable for ocular delivery, exhibiting mucoadhesive and cohesive properties (abstract, p. 1528 column 2, p. 1529 column 1). Iqbal teaches the formation of tablets from lyophilized poly(acrylic)acid-cysteine-2-mercaptonicotinic acid polymers (p. 1529 column 2).
Iqbal’s teaching for 2-mercaptonicotinic acid side chains covalently bonded through disulfide bonds to a poly(acrylic)acid-cysteine conjugate polymer, suitable for ocular delivery, exhibiting mucoadhesive and cohesive properties (abstract, p. 1528 column 2, p. 1529 column 1) reads on instant claims 13, 15, and 16.
Iqbal’s teaching for 2-mercaptonicotinic acid side chains covalently bonded through disulfide bonds to a poly(acrylic)acid-cysteine conjugate polymer (abstract, p. 1529 column 1), reads on claim 15, which recites the polymer backbone is an acrylic acid polymer. Iqbal’s teachings also reads on instant claim 16, because the side chains of poly(acrylic)acid are (2-mercaptonicotinic acid)cysteine, also shown in Figure 1, read on instant claim 16.
Iqbal’s teaching for the formation of tablets from lyophilized poly(acrylic)acid-cysteine-2-mercaptonicotinic acid polymers (p. 1529 column 2) reads on instant claim 30.
Claims 14, 17 – 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Iqbal (as cited above) in view of Wirostko (US 2015/0157563 A1, of record).
Iqbal’s teachings are addressed above.
Iqbal does not teach the mucoadhesive solid is an ocular insert or film, that it is in the form of nanofibers, that it includes a pharmaceutically active substance, or a method for treating and/or preventing an ocular disease.
Wirostko teaches the missing elements of Wang.
Wirostko teaches an ocular composition that includes a polymer matrix and an antibiotic drug that can be a solid or semisolid (abstract, paragraph 0076). Wirostko teaches the composition in the form of an insert or film that can be inserted or applied to a desired ocular region (paragraph 0026). Wirostko teaches that a benefit of including the therapeutic composition in a formulation suitable for application is controlled release of active agent to the eye (paragraph 0026).
Wirostko teaches that the polymer matrix of the ocular composition can be tuned to provide a rate of controlled release (paragraph 0029). Wirostko teaches that the polymer matrix can include a thiolated hyaluronic acid moiety and an additional bioerodible polymer, which can be a polymer of glycolic acid, glycolide, lactic acid, lactide caprolactone, dioxane, diozanone, trimethylenecarbonate, bischloroformate, ethylene glycol, bis(p-carboxyphenoxy)propane, or sebacic acid (paragraphs 0029 – 0030). Wirostko teaches that additional ingredients can be added to the polymer to improve mucoadhesiveness (paragraphs 0056, 0082).
Wirostko teaches that the ocular composition can include small molecule therapeutic agents such as anti-inflammatories, non-steroidal anti-inflammatories, analgesics, antivirals, antifibrotics, glaucoma agents, or any other drug indicated for use in the eye (paragraphs 0059 – 0069). Wirostko teaches the ocular composition can include a pharmaceutically acceptable carrier such as a buffer (paragraph 0084).
Wirostko teaches the ocular composition can be used for treating or preventing ocular conditions such as open-angle glaucoma, macular edema, conjunctivitis, keratitis, post-surgical inflammation, and seasonal or perennial allergies, among others (paragraphs 0036 – 0037).
The combination of Iqbal and Wirostko’s teachings is prima facie obvious as combining prior art elements according to known methods to yield predictable results. A person of ordinary skill in the art would have been motivated to modify the polymer of Iqual to include additional elements as taught by Wirostko because Wirostko teaches that when in the form of an insert or film, the composition can be inserted to a desired ocular region, enabling controlled release of the active agent to the eye (paragraph 0026). In other words, a person of ordinary skill in the art would be motivated to modify the polymer of Iqbal with Wirostko’s teachings so that the mucoadhesive polymer can be easily applied. The combination of Iqbal and Wirostko’s teachings combines known elements to yield predictable results which is prima facie obvious according to MPEP 2143(I)(a).
The combination of Iqbal and Wirostko’s teachings for a poly(acrylic)acid-cysteine-2-mercaptonicotinic acid polymer (abstract, p. 1528 column 2, p. 1529 column 1) in the form of an insert or film (paragraphs 0026, 0076) reads on instant claim 14. The instant claims specify that a preactivated thiomer matrix consists of one or more preactivated thiomers having 2-mercaptonicotinic acid or 6-mercaptonicotinic acid. Iqbal’s teaching for poly(acrylic)acid-cysteine-2-mercaptonicotinic acid polymer (abstract, p. 1528 column 2, p. 1529 column 1) reads on the claimed preactivated thiomer matrix. Wirostko’s teachings that the ocular composition may contain various polymers (paragraphs 0029 – 0030) does not conflict with the “consisting of” transition phrase because there is no requirement for additional polymers to be included specifically in the preactivated thiomer matrix. In other words, Wirostko’s teaching for a polymer matrix appears able to accommodate the preactivated thiomer matrix as claimed along with additional polymers.
Wirostko’s teaching that the ocular composition can be in the form of a nanoparticle suspension (paragraphs 0027,0047,0070, claim 2) and that the ocular composition may have any shape, including that of a thread (paragraph 0079) reads on instant claim 17. A person of ordinary skill in the art would recognize that compound that can be suitably formulated in a nanoparticle suspension or various shapes could be formulated as a nanofiber via routine experimentation. Routine experimentation is prima facie obvious according to MPEP 2144.05(II)(a). Furthermore, changes in shape are generally obvious according to MPEP 2144.04(IV)(b).
The instant claim 18 recites “wherein nanofibers are obtained by electrospinning”. The limitation that the nanofibers are obtained by electrospinning is a product-by-process limitation. According to MPEP 2113, even though product-by-process claims are written as defined by the process, the determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In the instant case, the combination of Iqbal and Wirostko’s teachings for an ocular composition with a polymer matrix (Wirostko) where the polymer matrix is a preactivated thiomer with 2-mercaptonicotinic acid (Iqbal), reads on the claimed mucoadhesive solid or semisolid ocular delivery system wherein the preactivated thiomer is in the form of nanofibers. As such, the patentability of the instant composition does not depend on its method of production, and the Applicant’s limitation regarding the process of obtaining nanofibers by electrospinning is not patentable, in view of Iqbal and Wirostko.
The combination of Iqbal and Wirostko’s teachings for a poly(acrylic)acid-cysteine-2-mercaptonicotinic acid polymer (abstract, p. 1528 column 2, p. 1529 column 1) in the form of an of an insert or film (paragraphs 0026, 0076) which includes an active pharmaceutical agent (paragraphs 0059 – 0069) reads on instant claim 19.
Wirostko’s teaching that active pharmaceutical agent may be anti-inflammatories, non-steroidal anti-inflammatories, antivirals, antiallergenics, glaucoma agents, or any other drug indicated for use in the eye (paragraphs 0059 – 0069) reads on instant claims 20 and 22 – 24.
Wirostko’s teaching that the glaucoma agents for inclusion in the ocular composition can be Latanoprost, Bimatopost, Travaprost, Timolol, Betaxalol, Dorzolamide, Brinzolamide, or Briminodine (paragraph 0067) reads on instant claim 21.
Wirostko’s teaching that the ocular composition can include an additional bioerodible polymer such as polyethylene glycol(paragraphs 0029 – 0030) and/or a pharmaceutically acceptable carrier such as a buffer (paragraph 0084) reads on instant claims 25 – 27.
Iqbal’s teaching for a poly(acrylic)acid-cysteine-2-mercaptonicotinic acid polymer (abstract, p. 1528 column 2, p. 1529 column 1) in combination with Wirostko’s teachings for an ocular composition that includes a polymer matrix and an antibiotic drug for treating or preventing ocular conditions such as open-angle glaucoma, macular edema, conjunctivitis, keratitis, post-surgical inflammation, and seasonal or perennial allergies, (abstract, paragraphs 0036 – 0037, 0076) reads on instant claims 28 and 29. As discussed above, a person of ordinary skill in the art would have been motivated to modify the polymer of Iqual to include additional elements as taught by Wirostko because Wirostko teaches that when in the form of an insert or film, the composition can be inserted to a desired ocular region, enabling controlled release of the active agent to the eye (paragraph 0026).
As discussed above, Iqbal teaches the formation of tablets from lyophilized poly(acrylic)acid-cysteine-2-mercaptonicotinic acid polymers (p. 1529 column 2), reading on instant claim 30. With consideration to Wirostko’s teachings that ocular compositions in the form of an insert or film can be administered to a desired ocular region (paragraph 0026), a person of ordinary skill in the art would be motivated to formulate Iqbal’s polymer in a formulation of Wirostko’s ocular insert or film because such formulations can be easily administered to the desired ocular region (paragraph 0026), thus reading on instant claim 31.
Examiner’s Reply to Attorney Arguments Dated March 2, 2026
Applicant’s arguments have been considered but are moot because the ground of rejection over Wang and Wirostko has been withdrawn. The above rejections over Iqbal alone, and Iqbal in view of Wirostko, address each limitation of the claims as described.
Double Patenting
The judicially created doctrine for non-statutory double patenting rejections has been described in detail in the previous action.
Double Patenting over Application No. 18/294,739
Claims 13 – 31 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 16 – 33 of copending Application No. 18/294,739.
Although the claims at issue are not identical, they are not patentably distinct from each other because: instant claim 13 is drawn to a mucoadhesive solid or semisolid ocular delivery system comprising a preactivated thiomer matrix, wherein the matrix consists of one or more preactivated thiomers selected from the polymeric compounds bearing 2-mercaptonicotinic acid or 6-mercaptonicotinic acid side chains covalently bonded through disulfide bonds to a thiolated polymer backbone.
Conflicting claim 16 is drawn to a mucoadhesive solid or semisolid ocular delivery system comprising one or more anti-glaucoma drugs and at least one preactivated thiomer of hyaluronic acid and a covalently bonded mercapto- group as sidechain.
The instant and conflicting claims differ because conflicting claim 16 specifies the polymer backbone is hyaluronic acid and requires the inclusion of one or more anti-glaucoma drugs. Conflicting claim 16 also does not recite 2-mercaptonicotinic acid or 6-mercaptonicotinic acid side chains (but does use “comprising” language).
The requirement for polymer backbone to be hyaluronic acid in conflicting claim 16 reads on instant claim 15.
The requirement to include an anti-glaucoma drug in the composition of conflicting claim 16 reads on instant claims 19 – 25.
Conflicting claim 18 recites the side chains of the preactivated thiomer of hyaluronic acid recited in claim 16 are selected from options including 2- or 6-mercaptonicotinic acid, reading on instant claims 13 and 16.
Conflicting claim 33 recites a method for treating glaucoma by administering the ocular delivery system, overlapping on instant claims 28 and 29.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner’s Reply to Attorney Arguments Dated March 2, 2026
Applicant appears to argue that the provisional non-statutory double patenting rejection is moot in view of the claim amendments (Remarks page 10). The Examiner disagrees, because as discussed above, although conflicting claim 16 also does not recite 2-mercaptonicotinic acid or 6-mercaptonicotinic acid as possible side chains, conflicting claim 18 recites the side chains recited in claim 16 are selected from options including 2- or 6-mercaptonicotinic acid, reading on instant claims 13 and 16.
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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