DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 59 and 106-129, in the reply filed on September 16, 2025 is acknowledged.
Claims 61 and 81 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 16, 2025.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figure 1A-2 shows reference numbers 124 and 126. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a) because: Figure 1 fails to show pars plana 25 as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 59 is objected to because of the following informalities: “eye of a having”.
Claim 111 is objected to because of the following informalities: non-trademarked agent names need not be capitalized, e.g., Human Serum Albumin. Also some of the commas raise confusion, e.g., “Insulin, porcine,…” for porcine insulin, and “Interferon Alfa-2a, Recombinant, … Alfa-2b, Recombinant, …”.
Appropriate correction is required.
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 129 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.
The term “substantially removed” in claim 129 is a relative term which renders the claim indefinite. The term “substantially removed” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification uses “substantially removed” or “substantially replaced” in the context of injecting an active agent into the container (paras.0145, 0155, pre-grant publication US 20230338282). However the phrases are used without any elaboration or some information indicating what “substantially removed” means.
For the purposes of examination now this claim term is construed as “removed”.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 59, 106-111, 113-117, 119-123, and 126-128 are rejected under pre-AIA 35 U.S.C. 102(a)(1) and (a)(2) as being clearly anticipated by Weiner (US 5466233).
Weiner teaches a method of treating an eye using a “tack for intraocular drug delivery and a method for insertion and removal of an intraocular device for sustained release of a drug” (abstract; see entire document including title; col.3 lines 26-47, col.10 line 33-col.11 line 8; Figs.2, 9, 14 and accompanying text). The tack is a therapeutic device. “The tack comprises a post, an anchoring region and a head” with the post “positioned within the vitreous region” (abstract) and thus “away from the retina”, comprising a first and second ends, and including a drug to be administered (col.2 lines 54-67; col.13 lines 65-67). In one embodiment the tack comprises “a post having a membrane, a hollow central portion and a head”, wherein the membrane is at least semi-permeable and forms a hollow void”, i.e., a container (col. 3 lines 11-14). Examples of permeable materials which may be used for the membrane 70 include microporous, biocompatible materials” (col.8 lines 52-67) and thus the membrane is a porous structure.
The void is filled with a first portion of a liquid drug to be administered. The first end of the post is for positioning in the vitreous region of the eye. The hollow central portion is affixed to the second end of the post and is filled with a second portion of the liquid drug to be administered. The void and hollow central portion are in fluid communication with one another. The central portion is for being positioned within at least one of the retina, the choroid and the sclera. The head extends from the central portion in the manner described above, and has an opening for injection of subsequent doses of the liquid drug. The opening is in fluid communication with the hollow central portion. (Col.3 lines 14-25.)
In one embodiment of the porous structure a solid, non-erodible polymeric matrix comprises drug particles in a biocompatible polymer matrix which is preferably porous to release drug via diffusion through the pores and into the vitreous (col.8 lines 42-46, col.9 lines 54-64).
“The first portion of the device is maintained in the vitreous region until the first portion of the device has delivered a predetermined dosage of the drug into the vitreous region” (col.3 lines 39-42). The present claims recite identifying a target location of the retina for treatment; however Weiner teaches treating diseases involving the retina (col.10 lines 23-27) and standard medical practice would require identifying an optimal location of the retina for treatment rather than a random location. Also “convective flow of the vitreous humor” is a natural fluid movement caused by temperature/pressure differences in the posterior chamber and therefore inherent to an eye. The skilled person would understand that the drug once released into the vitreous would reach a region of the retina.
The tack is inserted by making an incision through the scleral tissue into the vitreous region “such that an opening for insertion of the device is created” (col.3 lines 26-37; col.14 line 52-col.15 line 8). Regarding claims 113 and 114, “[a]s shown in FIG. 14, the tack 10 of the present invention is preferably inserted into those portions of the sclera 24 on either side of the eye 18 posterior to the ciliary bodies 44 known as the ciliary pars plana35.” (col.14 lines 24-27). Figure 14 shows that the length of the incision is greater than the diameter of the tack or the “distance across the pars plana”. Regarding claims 115 and 116, the “portion of the conjunctival membrane [that had been separated to cut the scleral tissue for inserting the tack] is reattached to the portion of the scleral tissue underlying the portion of the conjunctival membrane” (col.3 lines 37-40).
Regarding claims 117 and 119-123, the anchoring region comprises the second or the proximal end of the post and has a width that anchors or retains the tack in at least one of the sclera, retina, and the choroid (col.2 lines 57-67; see Fig. 14). Figures 1-5 show a neck portion having indented profile, i.e., concave and thus of a smaller diameter.
The device may release for up to 6 months or “an indefinite period of time” (col.8 lines 12-27).
Regarding claims 126-128, the refillable chamber 58 is accessible through the head 15 by an injection port 68 …[comprising] any puncturable membrane” or septum and a “drug in liquid or gel form may be injected through the injection port 68 without unnecessary exposure to the external environment thereby aiding in the prevention of infection from subsequent injections of the drug” (col.7 lines 57-66; see, e.g., Fig.5 col.7 lines 39-43, interior space 60 prevents needle penetrating the sclera or choroid). The conjunctiva would be penetrated since Weiner teaches reattaching the portion of conjunctival membrane after implanting the device in the vitreous region (col.3 lines 28-40).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 59 and 106-129 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weiner (US 5466233).
Weiner does not specifically teach all of the limitations in claims 112, 118, 124, 125, and 129. However it would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to modify the teachings of Weiner as recited in the instant claim(s).
Regarding claim 112, Weiner teaches the septum. The refillable chamber 58 is accessible through the head 15 by an injection port 68 …[comprising] any puncturable membrane” or a septum and a “drug in liquid or gel form may be injected through the injection port 68 without unnecessary exposure to the external environment thereby aiding in the prevention of infection from subsequent injections of the drug” (col.7 lines 57-66). Weiner does not teach a needle coupled to a fill syringe wherein the needle comprises a stop configured to prevent the tip of the needle from advancing beyond the maximum stop distance. However Weiner teaches refilling the reservoir by injection and notes the head 16 as a feature “which prevents the device from being inserted too far into the eye 18” (col.6 lines 43-44). Therefore the skilled person could devise safety needle that “prevents the device from being inserted too far into the eye 18”.
Regarding claims 118, 124, and 125, Weiner teaches a “circular shape is preferred as there are no pointed edges which may irritate the eye, however, other shapes such as generally elliptical, square or triangular may be used for the head 16 and are within the scope of the present invention as long as the head 16 is configured to minimize irritation or risk of damage to the scleral surface 28” (col.7 lines 8-14). “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” MPEP §2144.06 (I) (citations omitted).Therefore the skilled person would have been motivated to combine circular and elliptical, square, or other shapes within the scope of Weiner to avoid irritation to the eye.
Regarding claim 129, “wherein liquid disposed within reservoir is [ ] removed ….when the additional quantity is injected” would occur when “the additional quantity” is sufficient to force out the liquid disposed in the reservoir. The skilled person would have been motivated to inject sufficient volume of the additional liquid depending on the treatment desired. For instance to deliver a new drug using the tack, s/he may inject a sufficient amount of a “flushing” liquid to eliminate the prior drug in the reservoir and/or condition the vitreous so as to prepare it for sustained delivery of the new drug.
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.
Claims 59 and 106-129 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 14-18, and 24-26 of U.S. Patent No. 8298578.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method of treating an eye having a vitreous humor and a retina of a posterior chamber, the method comprising: positioning or implanting a container having a therapeutic amount of a therapeutic agent, the container comprising a porous structure to release therapeutic amounts of the at least one therapeutic agent for the extended time, wherein the porous structure is positioned in the vitreous humor (claim 17), i.e., at a location away from the retina to deliver the therapeutic agent to the target location with convective flow of the vitreous humor. The present claims recite identifying a target location of the retina for treatment; however standard medical practice would require identifying an optimal location of the retina for treatment rather than a random location. The present claims recite also “convective flow of the vitreous humor” which is a natural fluid movement caused by temperature/pressure differences in the posterior chamber and therefore inherent to an eye. The ‘578 patent’s claims recite further limitations and therefore anticipate the present claims.
Claims 59 and 106-129 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-20 and 22-26 of U.S. Patent No. 11642310.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method of treating an eye having a vitreous humor and a retina of a posterior segment, the method comprising: positioning or implanting a container having a therapeutic amount of a therapeutic agent, the container or reservoir comprising a porous structure to release therapeutic amounts of the at least one therapeutic agent for the extended time, wherein the porous structure is positioned in the vitreous humor (claim 7), i.e., at a location away from the retina to deliver the therapeutic agent to the target location with convective flow of the vitreous humor. The present claims recite identifying a target location of the retina for treatment; however standard medical practice would require identifying an optimal location of the retina for treatment rather than a random location. The present claims recite also “convective flow of the vitreous humor” which is a natural fluid movement caused by temperature/pressure differences in the posterior chamber and therefore inherent to an eye. The ‘310 patent’s claims recite further limitations and therefore anticipate the present claims.
Claims 59 and 106-129 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 9, and 10 of U.S. Patent No. 9474756.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method of treating an eye having a vitreous humor and a retina of a posterior chamber, the method comprising: positioning or implanting a container having a therapeutic amount of a therapeutic agent, the container comprising a porous structure to release therapeutic amounts of the at least one therapeutic agent for the extended time, wherein the porous structure is positioned in the vitreous humor, i.e., at a location away from the retina to deliver the therapeutic agent to the target location with convective flow of the vitreous humor. The present claims recite identifying a target location of the retina for treatment; however standard medical practice would require identifying an optimal location of the retina for treatment rather than a random location. The present claims recite also “convective flow of the vitreous humor” which is a natural fluid movement caused by temperature/pressure differences in the posterior chamber and therefore inherent to an eye. The ‘756 patent’s claims recite further limitations and therefore anticipate the present claims.
Claims 59 and 106-129 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 9895369.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method of treating an eye having a vitreous humor and a retina of a posterior chamber, the method comprising: positioning or implanting a container having a therapeutic amount of a therapeutic agent, the container comprising a porous structure to release therapeutic amounts of the at least one therapeutic agent for the extended time, wherein the porous structure is positioned in the vitreous humor, i.e., at a location away from the retina to deliver the therapeutic agent to the target location with convective flow of the vitreous humor. The present claims recite identifying a target location of the retina for treatment; however standard medical practice would require identifying an optimal location of the retina for treatment rather than a random location. The present claims recite also “convective flow of the vitreous humor” which is a natural fluid movement caused by temperature/pressure differences in the posterior chamber and therefore inherent to an eye. The ‘369 patent’s claims recite further limitations and therefore anticipate the present claims.
Claims 59 and 106-129 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15, 20, 21, and 23 of U.S. Patent No. 12251336.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method of treating an eye comprising positioning or implanting a container having a therapeutic amount of a therapeutic agent, the container comprising a porous structure to release therapeutic amounts of the at least one therapeutic agent for the extended time, wherein the porous structure is positioned in the vitreous humor or vitreal cavity of the eye, i.e., at a location away from the retina to deliver the therapeutic agent to the target location with convective flow of the vitreous humor. The present claims recite identifying a target location of the retina for treatment; however standard medical practice would require identifying an optimal location of the retina for treatment rather than a random location. The present claims recite also “convective flow of the vitreous humor” which is a natural fluid movement caused by temperature/pressure differences in the posterior chamber and therefore inherent to an eye. The ‘336 patent’s claims recite further limitations and therefore anticipate the present claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614