DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 7/29/2026 has been entered.
Withdrawn Rejection
The rejection of claims 28-36, 38-39, 41, and 42, under pre-AIA 35 U.S.C. 103(a) as being unpatentable over El haj (WO2004/000369 of record in IDS 12/14/2020), is withdrawn. The PTAB overturned this rejection. See PTAB decision dated 6/1/2026.
The rejection of claims 28, 31, 32, 38, and 39, on the ground of nonstatutory double patenting as being unpatentable over claims 12 of U.S. Patent No. 9,833,517. Although the claims at issue are not identical, they are not patentably distinct from each other because patent claims disclose a species of the instant claims. Claim 29 was not included in this rejection. As such, the rejection is withdrawn.
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 42 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 42 is indefinite because its scope is not clearly defined. The claim states that “the animal has a skin wound” but does not state that the skin wound is the site of cellular degeneration. Independently the claims states “the site of degeneration is in the skin of the animal”. While one would understand inherently that this recitation is a skin wound, it does not imply that skin wound had by the animal has earlier is the skin wound of the site of degeneration. The claim further recites, “the magnetic particle-comprising cells integrate the damaged or diseased tissue”. This is not the same recitation of site of degeneration or the skin wound. As such, the damaged or diseased tissue is not further limited to a skin wound. As such, it is not apparent if the magnetic particle-comprising cells in being integrate into the skin wound or another damaged or diseased tissue. Lastly the claim recites “the magnetic particle-comprising cells”. However, the base claim recites one or more magnetic particle-comprising cells”. This recitation lacks adequate antecedent basis and is indefinite because it is not apparent which one of the one or more magnetic particle-comprising cells would be deemed “the magnetic particle-comprising cells”.
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 29, 30, 33-36 and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9 and 12 of U.S. Patent No. 9,833, 517 in view of El haj (WO2004/000369 of record in IDS 12/14/2020).
Regarding claim 29, patent claim 9 teaches A method comprising: (a) administering to a target tissue of an animal a magnetic nanoparticle-comprising cell comprising an ocular cell or optic nerve cell having at least one magnetic nanoparticle with a diameter of no more than about 500 nm bound, affixed or attached thereto, said animal having been diagnosed with a disease or disorder selected from retinal degenerations, retinal ganglion cell degenerations, optic nerve degenerations, corneal endothelial cell degenerations, corneal epithelial cell degenerations and ocular cancers; and (b) applying a magnetic field to said target tissue such that said magnetic nanoparticle-comprising cell is delivered to specific regions of said target tissue, wherein the target tissue is eye tissue. As such, patent claim 9 teaches the limitations of a method of delivering a cells to a damaged or diseased target tissue in an animal having a site of cellular degeneration comprising administering one or more magnetic particle comprised cells having at least one magnetic nanoparticle affixed to the surface of a cell, applying a magnetic field as claimed, maintaining the magnetic field as claimed and delivering the one or more magnetic particle-comprising cells to the target tissue as claimed. Patent claim 9 does not specifically teach that the that the magnetic nanoparticle is affixed to the cell surface by means of a cell-surface specific binding agent. However, “cell-surface specific binding agent” is a generic term that can include covalent and non-covalent means of binding the nanoparticle to the cell surface. Means of affixing, attaching, or binding a magnetic nanoparticle to a cell were established and predictable in the prior art. For example, the directly associating a magnetisable particle with a cell. In particular, the particle can be directly attached to the cell by an antibody, enzyme, etc... (p. 3, line 25 top. 4, line 11). El haj discloses that the particle can be a nanoparticle (p. 7, lines 11-14). As such, it would have been obvious to an artisan of ordinary skill at the time of the patent to directly attached a magnetized nanoparticle to a cell for in vivo use via an antibody, enzyme, etc or any other types of covalent or non-covalent cell-surface specific binding agent, as taught by El Haj to predictably arrive at the limitations of instant claim 29. An artisan would have a reasonable expectation of success because El Haj provide specific successful attachment of a nanoparticle to a cell surface using an antibody. As such, instant claim 29 is render obvious by patent claim 9 in view of El Haj.
Regarding claim 30, El Haj teaches an antibody cell surface binding agent as discussed above. As such, patent claim 9 in view of El Haj also teaches and renders obvious claim 30.
Regarding claim 33, patent claim 9 more generically teaches a magnetic nanoparticle. It does not teach species of a ferromagnetic form of the magnetic nanoparticle. El haj teaches that the particle can be any ferromagnetic form (p. 7, lines 1-15). As such, it would have been obvious to an artisan of ordinary skill at the time of the patent to use a ferromagnetic form of the nanoparticle and attach it directly to the cell by means discussed in El Haj to predictably arrive at the limitations of claim 33. An artisan would have a reasonable expectation of success because El Haj teaches means of attaching a ferromagnetic nanoparticle to the surface of a cell via an antibody binding agent that can successfully be used for in vivo use. As such, patent claim 9 in view of El Haj renders claim 33 obvious.
Regarding claim 34, Patent claim 9 does not expressly teach that the magnetic nanoparticles have a surface coat. However, at the time of the patent claim, El Haj teaches that the magnetic nanoparticle can be coated or uncoated (p. 7, lines 23-24). As such, it would have been obvious to choose from a finite number of predictable options of using magnetic nanoparticle that is coated or uncoated, as taught by El Haj in the method of patent claim 9 to predictable arrive at the limitations of claim 34. As such, patent claim 9 in view of El Haj renders claim 34 obvious.
Regarding claim 35, El Haj teaches that the surface coat for antibody, antibody fragment, protein, or sugar fragment binding to a cell as discussed above. Thus, patent claim 9 in view of El haj teaches the required limitations of claim 35 and renders it obvious for reasons discussed above.
Regarding claim 36, patent claim 9 in view of El Haj does not specifically teach the route of administration is via injection, infusion, or surface application. However, patent claim 9 does expressly teach, albeit generically, “administering to a target tissue”. Further the target tissue in patent claim 9 is the eye. An ordinary artisan would know that administering a medicament, including cellular medicament, to the would be done by infection, infusion, or topical surface application due to the acceptability of the eye. As such, claim 36 is an obvious variant of patent claim 9 in view of El Haj.
Regarding claim 41, patent claim 9 teach ocular cancers (i.e. the site of cellular degeneration is a tumor). As such, patent claim 9 in view of El haj renders claim 41 obvious. Further patent claim 12 more specifically teaches ocular melanoma and ocular lymphoma. Thus patent claim 12 in view of El Haj also renders claim 41 obvious.
(2) Claims 29, 30, 33-36 and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of copending Application No. 18/839,414 (reference application) in view of El haj (WO2004/000369 of record in IDS 12/14/2020). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims disclose an anticipatory species of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 29 and 30, copending claim 9 discloses a method of administering a therapeutic agent to the subretinal space of the eye of a subject: creating a local retinal detachment in the subretinal space of an eye of the subject; injecting a composition comprising a magnetized therapeutic agent and a volume of a pharmaceutically acceptable carrier; and applying a magnetic force to the eye, wherein the magnetic force adheres the magnetized therapeutic agent to the subretinal space of the eye, wherein the magnetized therapeutic agent is a magnetized ocular cell, the application of the magnetic force to the eye is stopped once the magnetized ocular cell has localized to the Bruch's membrane, or to the retinal pigment epithelium layer, or to the posterior layer of the neural retina. The copending claim does not specify that a diseases or damaged target tissue having a site of degeneration. However, the copending claim does specify that a magnetizable therapeutic agent that is a magnetized ocular cell. Further degenerative ocular diseases are well established in the prior art. As such it would have been obvious to apply the magnetizable therapeutic agent comprising a magnetized ocular cell to one of a finite number of art established ocular degenerative diseased tissues to predictably arrive at the limitations of instant claim 1 from copending claim 1. Further copending claim 9 does not teach that the magnetized ocular cells is formed by attaching the cell to the magnetized nanoparticle via a cell surface binding substrate (claim 29), more specifically via an antibody (claim 30). However as discussed above, El Haj teaches the use of multiple binding surfaces agent, more particularly an antibody to affix a ferromagnetic nanoparticle to the surface of a cell. As such, it would have been obvious to use a magnetized ocular cell produced by affixing a nanoparticle to the surface of the ocular cell via an antibody as taught by El Haj for use in copending claim 9 to predictably arrive at the limitations of claims 29 and 30.
Regarding claim 33, copending claim 9 in view of El haj teach a ferromagnetized nanoparticle as discussed above.
Regarding claim 34, Patent claim 9 does not expressly teach that the magnetic nanoparticles have a surface coat. However, at the time of the patent claim, El Haj teaches that the magnetic nanoparticle can be coated or uncoated (p. 7, lines 23-24). As such, it would have been obvious to choose from a finite number of predictable options of using magnetic nanoparticle that is coated or uncoated, as taught by El Haj in the method of patent claim 9 to predictable arrive at the limitations of claim 34. As such, patent claim 9 in view of El Haj renders claim 34 obvious.
Regarding claim 35, El Haj teaches that the surface coat for antibody, antibody fragment, protein, or sugar fragment binding to a cell as discussed above. Thus, patent claim 9 in view of El haj teaches the required limitations of claim 35 and renders it obvious for reasons discussed above.
Regarding claim 36, patent claim 9 in view of El Haj does not specifically teach the route of administration is via injection, infusion, or surface application. However, patent claim 9 does expressly teach, albeit generically, “administering to a target tissue”. Further the target tissue in patent claim 9 is the eye. An ordinary artisan would know that administering a medicament, including cellular medicament, to the would be done by infection, infusion, or topical surface application due to the acceptability of the eye. As such, claim 36 is an obvious variant of patent claim 9 in view of El Haj.
Regarding claim 41, patent claim 9 teach ocular cancers (i.e. the site of cellular degeneration is a tumor). As such, patent claim 9 in view of El haj renders claim 41 obvious. Further patent claim 12 more specifically teaches ocular melanoma and ocular lymphoma. Thus patent claim 12 in view of El Haj also renders claim 41 obvious.
(3) Claims 29-30 and 33-36 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 5-7 of U.S. Patent No. 9,078,932. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims disclose an anticipatory species of the instant claims.
Regarding claim 29, patent claim 1 a method of delivering a cell to a target tissue in an animal, said method comprising, (a) affixing, binding, or attaching at least one magnetic nanoparticle to the surface of said cell to obtain a magnetic particle-comprising cell, wherein the at least one magnetic nanoparticle is affixed to the cell surface by a cell-surface specific binding agent, by a covalent bond, or by a surface coating on the at least one magnetic nanoparticle comprising one or more antibodies, antibody fragments, proteins or sugar fragments that bind to said cells; (b) administering said magnetic particle-comprising cell to the target tissue of the animal; (c) applying a magnetic field to said target tissue such that said magnetic particle comprising cell is delivered to specific regions of said target tissue; and (d) maintaining said magnetic field over said target tissue to cause said cell to remain at the target tissue until the cell becomes affixed to the target tissue, wherein the cell is an ocular cell or optic nerve cell and the target tissue is eye tissue. Patent claim 9 does not teach that the method is for delivery to a damage or diseased tissue. However, both method are delivery methods and do not require a therapeutic response. Further, as such it would have been obvious to an artisan of ordinary skill that the method of patent claim 9 could be also applied to a disease or damage tissue of the eye to predictably arrive at an obvious species variant of instant claim 29.
Regarding claim 30, patent claim 2 specifies an antibody.
Regarding claim 33, patent claim 5 specifies a ferromagnetic form.
Regarding claim 34, patent claim 6 specifies a coating.
Regarding claim 36, patent claim 7 specifies injection, infusion, or surface application.
(4) Claims 29-30 and 33-36 rejected on the ground of nonstatutory double patenting as being unpatentable over 7 of U.S. Patent No. 10,406,242 in view of El haj (WO2004/000369 of record in IDS 12/14/2020). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims have overlapping, non-exclusive subject matter.
Regarding claims 29 and 30, patent claim 7 teaches a method of delivering a cell to a target tissue in an animal, said method comprising, (a) affixing, binding, or attaching at least one magnetic nanoparticle(s) to the surface of said cell to obtain a magnetic particle-comprising cell; (b) administering said magnetic particle-comprising cell to target tissue in the animal; (c) applying a magnetic field to said target tissue such that said magnetic particle-comprising cell is delivered to and held in place at specific regions of said target tissue, wherein the cell is a smooth muscle cell; and (d) maintaining said magnetic field over said target tissue to cause said cell to remain at the target tissue, wherein the magnetic nanoparticles have a surface coating, wherein the surface coating allows the binding of an antibody, antibody fragment, protein or sugar fragment that binds to cells. Patent claim 7 does not teach that the cells is delivered to damaged or diseased target tissue. However the method of instant claim 29 and 30 are delivery method and do not require any particular therapeutic impact but rather solely delivery. As such, it would have been obvious that one of ordinary skill could predictably apply the method of patent claim 7 to any disease that is accessible, health or damaged/diseased/degenerated to predictable arrive at delivery to a damaged or diseased target tissue as the instant claims require.
Regarding claim 33, patent claim 7 does not specify the magnetic particle as a ferromagnetic nanoparticle, as claimed. However as seen above, ferromagnetic nanoparticles were effectively being affixed to cell by surface binding agent, such as an antibody as claimed (El Haj) for in vivo application. As such, it would have been obvious to choose a ferromagnetic nanoparticle, as taught by El Haj for use in the method of patent claim 7, to successfully deliver the cell to damaged or disease target tissue as claimed.
Regarding claim 34, patent claim 7 teaches a surface coating that bind antibodies.
Regarding claim 35, patent claim 7 teaches an antibody, antibody fragment, sugar coating, or protein as claimed.
Regarding claim 36, patent claim 7 does not specify the route of administration is injection, infusion, or surface application. However, the ordinary artisan would understand that these routes of administration are established in the prior art and used depending upon the tissue location. As such, it would be obvious to choose these routes of administration in claim 7 depending upon the location of the damage or disease tissue with a reasonable expectation of success.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/ Primary Examiner, Art Unit 1632
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