DETAILED ACTION
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 included in prosecution are claims 1 and 4-9.
Previous Rejections
Applicants' arguments in the Request for Continued Examination, filed 6/17/26, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 103 (Maintained)
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.
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.
1. Claims 1 and 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Shantha et al. (US 2011/0052678, Mar. 3, 2011) (hereinafter Shantha) in view of Mishra et al. (Recent Applications of Liposomes in Ophthalmic Drug Delivery, 2011) (hereinafter Mishra) as evidenced by Roy (US 2005/0245856, Nov. 3, 2005) (hereinafter Roy).
Shantha teaches a method for treating age related macular degeneration comprising topically applying a therapeutically effective amount of a preparation to an affected conjunctival sac of the eye (Abstract). The method involves instilling insulin containing ophthalmic drops in the conjunctival sac for treating age related macular degeneration (satisfies methods of claims 1 and 5-9). The age related macular degeneration is treated with insulin applied topically where the therapeutically effective dose is delivered to the macula re (¶ [0043]). In other embodiments, additional therapeutic, pharmaceutical, biochemical, nutraceutical, biological agent or compound, and organic and inorganic agents are also applied to the afflicted site (¶ [0043]). Suitable medications may be used with the insulin containing ophthalmic drops and include carotenoids such as lutein and/or zeaxanthin (satisfies active of claim 1) (¶ [0069]). Compatible vehicles or carriers may be employed for preparing the compositions where suitable vehicles/carriers include liposomes (¶ [0075]). In Example 21, uptake facilitators such as iontophoresis are used along with the active agent as prophylaxis, to diagnose, prevent and to treat age related macular degeneration in humans or animals (satisfies device of claim 1 and claims 5-9) (¶ [0308]). The method of treating age related macular degeneration comprises the step of further topically instilling an additional medicine selected from a group comprising therapeutic, pharmaceutical, biochemical, nutraceuticals, biological agents, biological compounds, organic agents, and inorganic agents to the afflicted eye (Ref. Claims 1-2). The method of treating age related macular degeneration
further comprises the step of using an uptake facilitator to further enhance a therapeutic effect
such as iontophoresis (satisfies device of claim 1 and claims 5-9) (Ref. Claims 12). Specifically, suitable said therapeutic agents include lutein and zeaxanthin (Ref. Claims 14).
The prior art is not anticipatory insofar as this combination must be selected from different lists/locations in the reference. It would have been obvious, however, to have made and utilized an active containing ophthalmic liposome comprising lutein and zeaxanthin with the use of iontophoresis as an uptake facilitator in a method of depositing a bioactive molecule in ocular tissues, as instantly claimed, since all the claimed elements were 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 yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Shantha differs from the instantly recited claims insofar as not disclosing wherein the liposomes are positively charged.
However, Mishra discloses that surface charge of liposomes plays a significant role in improving the efficiency of ocular drug delivery system. Positively charged liposomes exhibited higher drug loading efficiencies as well as faster drug release rates compared to negatively charged liposomes (Page 9, Paragraph 3).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant claims, to have formulated Shantha’s liposomes to be positively charged motivated by the desire to achieve a more efficient ocular drug delivery system characterized by higher drug loading efficiencies and faster drug release rates as taught by Mishra. Therefore, the combined teachings of Shantha and Mishra meet the requirement of “positively charged liposome” as recited in claims 1 and 5.
Regarding claims 1 and 5 reciting delivering the composition via the iontophoresis device, as discussed above, Shantha discloses in an Example 21 that iontophoresis is an uptake facilitator that is used along with actives to treat age related macular degeneration. Furthermore, Shantha discloses in claim 12 that the method of treating age related macular degeneration further comprises the step of using an uptake facilitator to further enhance a therapeutic effect such as iontophoresis. As evidenced by Roy, the principle of ocular iontophoresis is applying an electric field to an electrolytic substance containing at least one medication, in order to transport the medication(s) into the body or the organ to be treated, via the biological membranes of the eye (¶ [0002]). As such, it would be reasonable for one of ordinary skill in the art to expect that the iontophoresis utilized by Shantha delivers Shantha’s composition to the target ocular tissue.
Regarding claim 1 reciting a method of depositing lutein and zeaxanthin in ocular tissue, as discussed above, Shantha discloses that suitable actives for use include lutein and zeaxanthin and further discloses that iontophoresis is an uptake facilitator that is used along with actives to treat age related macular degeneration. Accordingly, Shantha satisfies the method of depositing lutein and zeaxanthin in ocular tissue as instantly claimed.
Regarding claim 4 reciting wherein the liposome has a positive zeta potential, as discussed above, it would have been obvious for one of ordinary skill in the art to have formulated Shantha’s liposomes to be positively charged since positively charged liposomes exhibited higher drug loading efficiencies as well as faster drug release rates compared to negatively charged liposomes.
Regarding the treatment methods recited in instant claims 5-9, as discussed above, Shantha’s method for treating involves treating age related macular degeneration using actives such as lutein and zeaxanthin. Accordingly, the Shantha’s treatment method satisfies the recited limitations.
Therefore, claims 1 and 4-9 are rendered obvious by the combined teachings of Shantha, as evidenced by Roy, and Mishra.
2. Claims 1 and 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Shantha et al. (US 2011/0052678, Mar. 3, 2011) (hereinafter Shantha) in view of Mishra et al. (Recent Applications of Liposomes in Ophthalmic Drug Delivery, 2011) (hereinafter Mishra) and Roy (US 2005/0245856, Nov. 3, 2005) (hereinafter Roy).
The teachings of Shantha and Mishra are discussed above.
It is believed that the teachings of Shantha in view of Mishra satisfy the limitation of delivering the composition via the iontophoresis device. However, purely arguendo and for the purposes of this rejection, Shantha in view of Mishra does not disclose delivering actives to ocular tissue via iontophoresis.
However, Roy discloses an ocular iontophoresis device for delivering medication (Abstract). Techniques of locally administering medication to the eye such as direct injection and topical application of drops are known but have their drawbacks. These drawbacks include such techniques being very traumatic, the drug diluting rapidly, risks of infection or bleeding, limited penetration, and/or the need for frequent application (¶ [0005-0007]). Ocular iontophoresis is a technique for local administration of medication into the eye which enables for most of the drawbacks of the other techniques to be mitigated. It also makes it possible in a noninvasive manner to obtain concentrations and residence times in the eye that are equal to or greater than such techniques (¶ [0011]). Medications and molecules which benefit from this administration technique include those which treat age-related degenerative diseases of the retina and degenerative pathologies of the retina (¶ [0143-0144]). The medication to be administered may be in the form of liposomes which are positively or negatively charged (¶ [0157]).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant claims, to have utilized the iontophoresis device of Roy to administer the positively charged liposomes of Shantha in view of Mishra motivated by the desire to utilize a local administration technique that avoids the many major drawbacks of other known techniques and to achieve the desired concentrations and residence times in the eye as taught by Roy.
Therefore, claims 1 and 4-9 are rendered obvious by the combined teachings of Shantha, Mishra, and Roy.
Response to Arguments
Applicant’s arguments filed 6/17/26 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments that Shantha allegedly does not seem to use lutein or zeaxanthin and that lutein/zeaxanthin are only described as a medicine, typically taken as an oral supplement, the Examiner submits that a reference is relied upon for all it teaches and suggests, even non-preferred embodiments. See MPEP § 2141.02 (VI). As discussed above, Shantha discloses a method of treating age related macular degeneration comprising the step of topically instilling an additional medicine selected from a group comprising therapeutic, pharmaceutical, biochemical, nutraceuticals, biological agents, biological compounds, organic agents, and inorganic agents to the afflicted eye (Ref. Claims 1-2). Specifically, suitable said therapeutic agents include lutein and zeaxanthin (Ref. Claims 14). Instilling to the afflicted eye indicates that the additional medicine is applied topically to the eye.
Regarding Applicant’s argument that lutein/zeaxanthin are not suitable for administration as an eye drop, as discussed above, Shantha discloses that these are suitable actives for use to instill in the eye as part of treating macular degeneration. As such, Shantha discloses that lutein/zeaxanthin are indeed suitable for administration as an eye drop.
Regarding Applicant’s argument that allegedly nothing in Shantha suggests that a carotenoid, such as lutein/zeaxanthin, can be administered directly to the ocular tissue, this is contradicted by the Shantha disclosure where Shantha discloses that the method of treating age related macular degeneration comprises the step of further topically instilling an additional medicine selected from a group comprising therapeutic agents to the afflicted eye (Ref. Claims 1-2). Specifically, suitable said therapeutic agents include lutein and zeaxanthin (Ref. Claims 14). Additionally, Shantha discloses that additional therapeutic, pharmaceutical, biochemical, nutraceutical, biological agent or compound, and organic and inorganic agents are also applied to the afflicted site (paragraph 0043). Therefore, Shantha does indeed disclose/suggest that lutein/zeaxanthin can be administered directly to the ocular tissue.
Regarding Applicant’s argument with respect to Shantha’s example(s), the Examiner submits that disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. See MPEP § 2123 (II). As such, while Shantha’s example(s) compositions may not have contained lutein/zeaxanthin, this does not necessarily constitute a teaching away from a method of treating age related macular degeneration comprising topically instilling a composition comprising said components.
Regarding Applicant’s argument that there is no mention of an iontophoresis device charged with lutein, the Examiner submits that a reference is relied upon for all it teaches and suggests, even non-preferred embodiments. See MPEP § 2141.02 (VI). While the Shantha disclosure does not explicitly spell out an iontophoresis device charged with lutein, the method of treating age related macular degeneration comprises the step of further topically instilling an additional medicine selected from a group comprising therapeutic agents to the afflicted eye. The method of treating age related macular degeneration further comprises the step of using an uptake facilitator to further enhance a therapeutic effect such as iontophoresis. Specifically, suitable said therapeutic agents include lutein and zeaxanthin. As such, the Shantha disclosure provides enough guidance and motivation for one of ordinary skill in the art to formulate an iontophoresis device charged with the claimed actives.
Regarding Applicant’s argument that Mishra does not cure the alleged deficiencies of Shantha, the Examiner submits that Mishra cures any alleged deficiencies of Shantha where Mishra provides strong motivation for one of ordinary skill in the art to formulate positively charged liposomes.
Regarding Applicant’s argument that Roy does not cure the alleged deficiencies of Shantha, the Examiner submits that Roy cures any alleged deficiencies of Shantha where Roy provides strong motivation for one of ordinary skill in the art to utilize an iontophoresis device to administer positively charged liposomes.
Regarding Applicant’s arguments that the Examiner’s conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from the applicant’s disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As discussed above, where the method of treating age related macular degeneration comprises the step of further topically instilling an additional medicine selected from a group comprising therapeutic agents to the afflicted eye, where the method of treating age related macular degeneration further comprises the step of using an uptake facilitator to further enhance a therapeutic effect such as iontophoresis, and where suitable said therapeutic agents include lutein and zeaxanthin, it would have been obvious for one of ordinary skill in the art to have used those components to have formulated a method/composition containing those components. Accordingly, no improper hindsight was used in the conclusion of obviousness in the rejection of record.
In light of the foregoing, the Examiner does not find Applicant’s arguments to be persuasive and the rejection is maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
1. Claims 1 and 4-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,327,946 B2 (hereinafter ‘946).
Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite methods of depositing an active molecule in ocular tissues and methods of treating or ameliorating. The difference between the instant claims and the claims of ‘946 lies in the fact that the instant claims require both lutein and zeaxanthin in claim 1 while the claims of ‘946 require at least one of the two in the independent claim. However, the claims are obvious over each other since the methods have the same steps and utilize the same actives in treating the same diseases.
Response to Arguments
Regarding the rejection of claims 1 and 4-9 on the grounds of non-statutory double patenting, Applicants have not submitted arguments or documentation (i.e. terminal disclaimer) in response to the double patenting rejection. Applicant requested that the double patenting rejection(s) recited above be held in abeyance until otherwise allowable subject matter is identified. Therefore, the previous rejection of non-statutory double patenting is maintained.
Conclusion
Claims 1 and 4-9 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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/A.A./Examiner, Art Unit 1612
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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