DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Withdrawn Rejections
The rejection of claims 28-36, 38, 39, 41, 42, and 45, under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn. The amendment to the claims remove the recitations deemed new matter.
The following rejection of record is being modified to take into consideration the amendments to the claims as follows:
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 negative by the manner in which the invention was made.
Claims 28-36, 38-39, 41, and 42, as amended or previously presented, is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over El haj (WO2004/000369 of record in IDS 12/14/2020).
Regarding claim 28, El Haj teaches that they magnetically manipulate a cell by 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). These teachings encompass the limitations of a magnetic particle-comprising cell having at least one magnetic nanoparticle affixed to the surface of the cell. El haj teaches an in vivo method for delivering a cell to a target tissue by administering the above described cell associated with a magnetized particle to a patient and remote (i.e. outside the body) manipulation of the administered cells using a magnetic field (p. 5, lines 1-3; p. 8, lines 35 to p. 9 line 6). These teachings encompass administering the magnetic particle-comprising cell to an animal and applying a magnetic field to said target tissue under conditions such that the magnetic particle comprising cell is delivered to specific regions of said target tissue. El haj teaches that the method may be a method of regenerating tissue in need thereof, such as skin (i.e. skin wounds) and wound healing and tissue adhesion (p. 14, lines 5-25) These teachings expressly disclose a method of delivering a cell to a target tissue (skin or skin wound) in an animals having a skin wound.
The claims further recite a final step of maintaining said magnetic field over said target tissue to cause said magnetic particle-comprising cells to remain at said target tissue. El haj does not expressly teach that this maintaining step. However, el Haj does discuss the use of static magnetic field application (paragraph bridging pp. 9-10). An artisan of ordinary skill in the art would understand that static magnetic field application means maintaining a continuous magnetic field in one place over a target tissue. El haj does not expressly state that this static magnetic field causes the magnetic particles comprising cells to remain at said target tissue. However, the mechanism by which remote magnetism exacts their function is rudimentary knowledge and has long been established in the prior art. The ordinary artisan would understand that if a magnetic field is applied as a static magnetic field remotely to a magnetic cell, that cell will reasonably be expected to be held in place by the static magnetic field. El haj does teach the static magnetic field application at the wound site for the intended use of tissue regeneration in a skin wound. Further it is noted that the claims do not require anything more than delivering the cell and maintaining it at the target tissue for a claimed time duration (i.e. no actual cell integration into the tissue, no wound healing is required). As such, an artisan of ordinary skill in the skin wound healing art could easily determine the amount of time needed to apply the field to exact wound healing using routine experimentation (i.e. observing the skin healing process at different time point until desired wound healing and tissue regeneration has occurred.
As such, one of ordinary skill in the art would arrive would be capable of arriving at the limitations of amended claim 28 with routine optimization. Thus the claim is still an obvious variant of El haj.
Regarding claim 29, El haj expressly teaches the magnetic particles is affixed to the cell surface by means of a cell-surface binding agent ( antibody, enzyme, etc…) as described above.
Regarding claim 30, El haj teaches an antibody as discussed above.
Regarding claims 31 and 32, El haj teaches the particle can have a diameter size of 5000 nm or less, e.g. from 1 nm to 5000, preferably from 1 nm to 100 nm, more preferably from 1 nm to 100 nm, or from 2 to 10 nm (p. 7, lines 18-21). Thus, El haj expressly teaches that the magnetic particle has a mean diameter of no more than 500 nm (claim 31) or 200 nm (claim 32).
Regarding claim 33, El haj teaches that the particle can be any ferromagnetic form (p. 7, lines 1-15). Thus, El haj expressly teaches the limitations of claim 33.
Regarding claim 34, El Haj teaches that the magnetic nanoparticle can be coated or uncoated (p. 7, lines 23-24). Thus, El haj expressly teaches the limitations of claim 34.
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, El haj expressly teaches the required limitations of claim 35.
Regarding claim 36, El haj does not teach that the magnetic particle comprising cells are administered by injection or infusion or surface application. However, El haj teaches the use for skin tissue regeneration and wound healing as discussed. As such, it would have been obvious to an artisan of ordinary skill at the time the invention was made to administer the magnetic particle comprising cell to a skin wound by means well known in the art, which includes injection, infusion, or surface application to the skin wound. The El haj renders the limitations of claim 36 obvious.
Regarding claim 38 and 39, El Haj teaches that the subject is a mammal, more particularly a human (p. 5, last paragraph).
Regarding claim 41, El Haj teaches that method can also be used for selectively killing cells, such as tumor cells in vivo. The magnetizable particles in conjunction with the cell can be used for destroying or inhibiting cells grow (p. 14, lines 25-31). El Haj teaches delivery a magnetized cell to a tumor cell may comprising killing of cells by holding ion channels open with a targeted static magnetic field or cyclically opening and closing ion channels with a targeted, time-varying magnetic field (p. 15, lines 1 to 10). This disclosure encompasses administering and delivering the magnet particles to a tumor target site. El Haj does not expressly state that the replacement cell is intended injection in close proximity to the tumor. However, at the time of the El Haj, injecting a treatment into the tumor or in close proximity thereof was the known to the most effective and reliable means of delivering a treatment to a cancer. As such, one of ordinary skill in the art would choose injecting the magnetized cell intended to kill the tumor directly into or in close proximity to the tumor because it is the most reliable and effective means of delivery.
Regarding claim 42, El haj teaches treating a skin wound as discussed above. El haj does not expressly teach that the cell is fibroblast cell, epithelial cell, or a combination thereof. However, it is well established in the prior art that fibroblast and epithelial cells are tissues present in skin tissue. Further, skin fibroblast and epithelial cells are easily accessible for use in a method of treating skin tissue degeneration as in a skin wound. As such, it would have been obvious to an artisan of ordinary skill at the time the invention was made to choose skin fibroblasts or epithelial cells from a finite number of predictably obtained and use skin cells for use in the method of treating a skin wound taught by El Haj to predictably arrive at the method of claim 42 with a reasonable expectation of success.
The amendments to the claim further specify the replacement cell integrates into the integrates into damaged or diseased tissue, the replacement cell facilitates regeneration of the skin of the animal. The claims do not specify a particular way in which the replacements cell integrates into the damaged or disease tissue. As such any type and degree of integration into the damaged or disease tissue encompasses the limitations of “integrates”. In El Haj the magnetized cells are present in the target site and in contact with the cells of the target site, more specifically a skin wound site. As such, El Haj teaches integration of the magnetized cell as claimed. Regarding the ability of the replacement cell to facilitate regeneration of the skin of the animal, the claim does not specify how the replacement cell facilitates regeneration of the skin. So “facilitates” can be any direct or indirect role the cell plays or is associated with the healing of the skin. As discussed above, El Haj teaches that the administration of the magnetized cell to a skin wound and application of a magnetic field promotes skin tissue regeneration. As such El Haj teaches the limitations of claim 42 as amended.
As such, El Haj renders the instant claims obvious.
Response to Arguments
Applicant's arguments filed 7/18/2024 have been fully considered but they are not persuasive.
Applicant submits that El haj does not teach delivering a cell to a target tissue in a patient; rather, El haj only teaching administering a cell to a patient. Applicant refers to line 1 on page 2, lines 9-31 of page 3 and lines 29 of page 8 to line 2 of page 9. Applicant then states, “Thus El haj teaches administration of “magnetisable nanoparticles” but fails to teach delivering a cell comprising a magnetic particles to damaged or diseased tissue. Applicant submits that El haj describes a kit or a system that comprises a therapeutically active agent and a source of “magnetisable nanoparticles” (examples lines 18-29 of page 15 and lines 1-100 of page 16). The therapeutically active agent in El haj is not associated with a cell or used to deliver a cell to a damaged or diseased target tissue. Applicant refers to lines 7-10 of page 11, lines 12-16 or page 11, lines 18-21 of page 15, and claim 71 of El haj.
In response, Examiner agrees that El haj teaches “a novel method of magnetically manipulating cells in vivo and methods of treatment thereof”, selectively activating cells which enables the cells to be manipulated mechanically from outside of the body and comprises “the association of a magnetisable particles with a cell.”. Examiner also agree that El haj teaches “administration to such a patient of magnetisable nanoparticles” as Applicant states in their remarks. Nothing explicit or implicit in these recitations from El haj negate that El haj teaches the active steps of “administering” a cell tethered to a magnetized nanoparticle as claimed, “applying a magnetic field to said damaged or diseased tissue” as claimed and “maintaining said magnetic field to said magnetic field over said target tissue” claimed. Further, Applicant appears to suggest that only the magnetisable nanoparticle is delivered not the cell. However, the cell is tethered to said magnetic nanoparticle. Therefore, if the magnetic nanoparticle is delivered the cell must be delivered as well. Further, Applicant’s statement that “the therapeutically active agent in El haj is not associated with a cell or used to delivery a cell to damaged or diseased target [sic] tissue.” is incorrect. First, the method does not require any therapeutic effect, only delivery. Second, Applicant appear to be suggesting the magnetisable particle is the therapeutic agent. Regardless of whether the “magnetisable particle” is the therapeutic agent or not, the cell is tethered to the magnetisable particles and therefore is physically “associated with a cell or used to deliver a cell to” damaged or diseased tissue. As such, Applicant is not giving the teachings of El haj the full contextual understanding of their disclosure and is not giving the claims their broadest reasonable interpretation.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 28, 31, 32, 38, and 39, as amended or previously presented, are rejected 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.
Regarding claim 28, patent claims 12 administers 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 bound, affixed, or attached to the cell, said animals having been diagnosed with a disease or disorder selected from retinal degeneration, retinal ganglion cell degeneration, corneal endothelial cell degeneration, corneal epithelial degenerations, and ocular cancer and applying a magnetic field to dais target tissue such that the magnetic nanoparticle comprising cells is delivered to specific regions of said target tissue, wherein the target tissue is eye tissue. Patent claim 12 specifies that the disease is ocular melanoma or ocular lymphoma. Thus, patent claims 28 discloses a species of instant claim 28.
Regarding claim 31, patent claim 12 species that the magnetic nanoparticle has a diameter of no more than about 500 nm. Thus, patent claim 12 discloses a species of instant claim 31.
Regarding claim 32, patent claim 12 discloses about 500nm. 200nm is with this range of about 500nm. Thus, patent claim 12 renders claim 32 obvious.
Regarding claims 38 and 39, patent claim 12 discloses a human, which encompasses the limitations of a mammal (claim 38) and a human (claim 39).
Applicant requests the provisional rejection be held in abeyance until all other rejections have been addressed and withdrawn and the allowed claims are finalized. Applicant’s request is considered and the rejection of record is maintained.
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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