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 .
This application is the national stage entry of PCT/CA2021/050068, filed 22 Jan 2021; which claims benefit of provisional application 63/118,715, filed 26 Nov 2020; and claims benefit of provisional application 62/965,289, filed 24 Jan 2020.
Claims 1-11, 14, 16-19, and 21-25 are pending in the current application and are examined on the merits herein.
Election/Restrictions
Applicant’s election of species of compound to be that of formula (III) and species of isolated graft of photoreceptor precursor cell in the reply filed on 01 Dec 2025 is acknowledged.
In response to Applicant’s remarks regarding claims 6, 14, and 22, as detailed below the elected species is interpreted to read upon claim 6, and the language of claims 14 and 22 is interpreted to encompass the elected species as an alternative.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the details of the black-and-white images in figures 3 and 4 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 1 is objected to because of the following informalities: claim 1 at step c) recites “discontinue said immune suppressant drug therapy…” (emphasis added) This verb tense should be “discontinuing” to be consistent with “a) contacting” and “b) transplanting”.
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.
Claims 14, 16, and 23-24 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 14 recites the limitation "said isolated pancreatic cell" in line 1; claim 16 recites the limitation "said neurosensory precursor cell" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claims 14 and 16 depend from claim 10 which recites “an isolated cell” broadly. The specific isolated cells are recited in claim 11. For purpose of examination, claims 14 and 16 will be interpreted as depending from claim 11 in order to find antecedent basis.
Claim 23 depends from canceled claim 13. Claim 24 depends from claim 23 which depends from canceled claim 13. It is unclear what is required by these claims. For the purpose of examination, claim 23 will be interpreted as depending from claim 10 in order to find antecedent basis for the claim language.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-11, 14, 16-18, and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Young (WO 2017/130148 A1, published 03 Aug 2017, provided by Applicant in IDS filed 18 July 2022) in view of Taylor (Frontiers in Immunology, 2016, 7, article 37, 7 pages, cited in PTO-892).
Young teaches an in vitro method for enhancing engraftment of neurosensory precursor cell comprising the step of contacting an isolated neurosensory precursor cell prior to a transplantation in a subject in need thereof, with a gem-difluorinated C-glycopeptide compound of general formula I (abstract), addressing claim 1 step a). In one embodiment the glycopeptide compound has the formula
PNG
media_image1.png
402
358
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Greyscale
(page 16, paragraph 10), or the elected species of compound and addressing limitations of claim 7. This compound also corresponds to claim 6 formula (II) wherein N is 1, R3 = R2 = CH3, and R1 is the recited formula where n=4, Y and Y’ are OR where R = H, R6 is CH2OH, R7 = OH, and R8 is a free alcohol function; and the compound is the pharmaceutically acceptable salt as specified in claim 1. The isolated neurosensory precursor cell may be a photoreceptor precursor cell (paragraph 14), or the elected species of isolated graft and addressing limitations of claims 10-11 and 16. The invention also provides a method of transplanting isolated neurosensory precursor ceil in a subject in need thereof comprising the steps of a) transplanting an isolated neurosensory precursor cell prepared according to the method of the present invention, in the subject in need thereof. The subject may be receiving an immunosuppressant drug such as daclizumab, sirolimus, tacrolimus, cyclosporine, or a combination thereof (paragraphs 16-17) addressing claim 1 step b) and claim 3. The cells are isolated using methods known in the art for their preparation. For example, the cells may be isolated from donors, and the isolated ceils may then be cultured under normal tissue culture conditions in standard tissue culture flasks (paragraph 118), addressing limitations of claim 2. The subject may be a human subject (paragraph 19), addressing claim 4. The concentration of the glycopeptide compound in the contacting step may be from about 1 mg/ml to about 5 mg/ml (paragraph 12-13; paragraph 119), addressing limitations of claims 8-9. The cells are contacted with the glycopeptide compound for a time sufficient to effect improvements on ceil viability and survival rate. In embodiments the time may be from about 12 hours to about 24 hours, for 1 hour, or for 30 mins (paragraph 120), addressing claims 17-18. The photoreceptor precursor cell may be used for treating a retinal degenerative disease such as age-related macular degeneration (AMD), retinitis pigmentosa (RP), retinal vasculitis, or sarcoidosis (paragraphs 45-46), addressing limitations of claims 23-24. The isolated neurosensory precursor cell prior to a transplantation is washed to remove the glycopeptide compound (paragraph 6, 33, and 79), addressing limitations of claim 25. Young teaches pre-incubation of the isolated cells with the glycopeptide compound for 10 days (example 1 at paragraph 125-134).
Young does not specifically disclose the method comprising the step c) discontinue said immune suppressant drug therapy after a time sufficient for implantation of said graft in said subject in need thereof (claim 1). Young does not specifically disclose the method wherein said subject is under an immune suppressant drug therapy for at least about 1 week prior to transplantation of the graft (claim 21).
Taylor teaches allografts are afforded a level of protection from rejection within immune-privileged tissues. Immune-privileged tissues involve mechanisms that suppress inflammation and promote immune tolerance. Taylor teaches the current understanding of how the mechanism of ocular immune privilege promotes tolerogenic activity by APC, and T cells in response to the placement of foreign antigen within the ocular microenvironment (page 1, abstract). One of the original observations about ocular immunobiology was that placement of foreign antigen into the eye of a recipient with an already established effector immune response does not elicit an inflammatory response. An additional element of immune regulation is the anti-inflammatory mechanisms of the ocular microenvironment itself that works to prevent induction of inflammation and suppress the activity of effector immune cells (paragraph spanning pages 2-3). The placement of allogeneic neuroretinal cells or stem cells into the retina shows protection but is eventually rejected. This rejection is devoid of inflammation, and how the cells are eliminated is unknown. There is no rejection if the cells differentiate into neuronal cells and make connections with other retinal cells. This suggest that while immune privilege can prevent an inflammatory response, non-integrated neurons must some how be targeted for removal, and an alloimmune response accelerates this clearance (page 3, right column, paragraph 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Young in view of Taylor in order to discontinue the immunosuppressant drug therapy after a time sufficient for implantation of said graft in said subject in need thereof. One of ordinary skill in the art would have been motivated to combine Young in view of Taylor with a reasonable expectation of success because Young teaches implantation of photoreceptor precursor cell for treating a retinal degenerative disease where the subject may be receiving an immunosuppressant drug, and Taylor teaches the mechanism of ocular immune privilege means there is no rejection after the graft cells differentiate into neuronal cells and make connections with other retinal cells, suggesting one of ordinary skill in the art would discontinue the immunosuppressant drug therapy after the cells are the implantation is successful because of this ocular immune privilege. Regarding claim 5, Young teaches the cells are isolated from donors using methods known in the art for their preparation, making obvious either isolating from live or cadaveric donors based on what was known in the art. Regarding claim 21, Young does not specify the duration of the subject is receiving an immunosuppressant drug prior to transplantation, however Young teaches pre-incubation of the isolated cells with the glycopeptide compound for 10 days, which provides guidance for treatment of the subject with the immunosuppressant drug for the same time period.
Regarding the claim preamble reciting a “method for inhibition or prevention of immune rejection of a graft”, Young teaches a method for enhancing engraftment of neurosensory precursor cell, and Taylor teaches there is no immune rejection if the cells differentiate into neuronal cells and make connections with other retinal cells, suggesting that one of ordinary skill in the art would reasonably predict that enhancing engraftment would result in the graft differentiating and making connections with other retinal cells, and thus result in inhibition or prevention of immune rejection of the graft.
Regarding claims 14 and 22, the language of these claims recite further limitations of the pancreatic cells or pancreas graft alternatives but do not specifically limit the graft to be pancreatic cells or a pancreas, therefore they are interpreted to encompass the alternative wherein the isolated graft comprises the isolated neurosensory precursor cell which is the subject matter addressed by Young in view of Taylor detailed above.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Young (WO 2017/130148 A1, published 03 Aug 2017, provided by Applicant in IDS filed 18 July 2022) in view of Taylor (Frontiers in Immunology, 2016, 7, article 37, 7 pages, cited in PTO-892) as applied to claims 1-11, 14, 16-18, and 21-25 above, and further in view of Jiang et al. (Molecular Vision, 2010, 16, p983-990, cited in PTO-892).
Young in view of Taylor teaches as above.
Young in view of Taylor does not specifically disclose the method said time sufficient for implantation is about 1 week to about 2 weeks, or at least about 2 weeks (claim 19).
Jiang et al. teaches migration and integration of grafted cells into diseased host tissue remains a critical challenge, particularly in the field of retinal progenitor cell (RPC) transplantation. This study was to investigate the integration and differentiation of murine RPCs transplanted into the subretinal space of mice with laser-induced damage to the outer retina. Three weeks after transplantation the mice were sacrificed for analysis, and 1,158±320 cells per eye had migrated into the recipient outer nuclear layer (ONL). Most of these cells resided in the ONL around the retinal laser lesion. Transplanted RPCs migrate and integrate into the laser-injured ONL where they differentiate into photoreceptors with morphological features reminiscent of mature photoreceptors, express synaptic protein, and appear to form synaptic connections with retinal bipolar neurons (page 983, abstract; page 984, right column, paragraph 4).
It would have been obvious to one of ordinary to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Young in view of Taylor further in view of Jiang et al. in order to select the time sufficient for implantation after which the immunosuppressant drug therapy is discontinued. One of ordinary skill in the art would have been motivated to combine Young in view of Taylor further in view of Jiang et al. with a reasonable expectation of success because Taylor cites Jiang et al. to teach the cells differentiate into neuronal cells and make connections with other retinal cells, and Jiang et al. teaches that at 3 weeks this implantation of retinal cells is successful, providing guidance for selecting the time sufficient for implantation after which there would be no rejection of the integrated cells and immunosuppressant drug therapy would be discontinued.
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 1-11, 14, 16-18, and 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-13 of U.S. Patent No. 11,096,968 (reference patent) in view of Young (WO 2017/130148 A1, published 03 Aug 2017, provided by Applicant in IDS filed 18 July 2022) and Taylor (Frontiers in Immunology, 2016, 7, article 37, 7 pages, cited in PTO-892).
The reference patent is issued from the national stage entry of PCT/IB2017/050444, published as WO 2017/130148 and cited as Young above.
Reference claims 1-7 and 9-13 of the reference patent are drawn to a method for enhancing engraftment of neurosensory precursor cells comprising the step of: a) contacting an isolated neurosensory precursor cell prior to a transplantation in a subject in need thereof, with a gem-difluorinated C-glycopeptide compound and then washing the isolated neurosensory precursor cell to remove the compound, and b) transplanting the treated isolated neurosensory precursor cells of step a) in a subject in need thereof, addressing limitations of claim 1 and 25. Reference claim 3 recites elected species of gem-difluorinated C-glycopeptide compound which is recited in claim 7. Reference claims 9-10 address limitations of claim 1 and correspond to claim 3. Reference claim 11 corresponds to claim 4. Reference claims 5-6 recite ranges that fall within the scope of claims 8-9. Reference claim 7 recites the neurosensory precursor cell is a photoreceptor precursor cell corresponding to the limitations of claims 10-11 and 16. Reference claim 4 addresses limitations of claims 17-18. Reference claim 13 corresponds to limitations of claims 23-24.
Reference claims 1-7 and 9-13 do not specifically disclose the method comprising the step c) discontinue said immune suppressant drug therapy after a time sufficient for implantation of said graft in said subject in need thereof (claim 1). Reference claims 1-7 and 9-13 do not specifically disclose the method wherein said subject is under an immune suppressant drug therapy for at least about 1 week prior to transplantation of the graft (claim 21).
The disclosure of Young qualifies as prior art and teaches as detailed above.
Taylor teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-7 and 9-13 in view of Young and Taylor in order to select from within the scope of the Reference claims the method which includes discontinuing the immunosuppressant drug therapy after a time sufficient for implantation of said graft in said subject in need thereof. One of ordinary skill in the art would have been motivated to combine Reference claims 1-7 and 9-13 in view of Young and Taylor with a reasonable expectation of success because Young provides guidance for embodiments encompassed within the scope of the Reference claims and for the same reasoning detailed above regarding the combined teachings of Young and Taylor addressing the examined claims.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-13 of U.S. Patent No. 11,096,968 (reference patent) in view of Young (WO 2017/130148 A1, published 03 Aug 2017, provided by Applicant in IDS filed 18 July 2022) and Taylor (Frontiers in Immunology, 2016, 7, article 37, 7 pages, cited in PTO-892), and further in view of Jiang et al. (Molecular Vision, 2010, 16, p983-990, cited in PTO-892).
Reference claims 1-7 and 9-13 in view of Young and Taylor teaches as above.
Reference claims 1-7 and 9-13 in view of Young and Taylor does not specifically disclose the method said time sufficient for implantation is about 1 week to about 2 weeks, or at least about 2 weeks (claim 19).
Jiang et al. teaches as above.
It would have been obvious to one of ordinary to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-7 and 9-13 in view of Young and Taylor further in view of Jiang et al. in order to select the time sufficient for implantation after which the immunosuppressant drug therapy is discontinued. One of ordinary skill in the art would have been motivated to combine Reference claims 1-7 and 9-13 in view of Young and Taylor further in view of Jiang et al. with a reasonable expectation of success for the same reasoning detailed above regarding Young in view of Taylor further in view of Jiang et al.
Claims 1-11, 14, 16-18, and 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-13 of U.S. Patent No. 11,826,387 (reference patent) in view of Young (WO 2017/130148 A1, published 03 Aug 2017, provided by Applicant in IDS filed 18 July 2022) and Taylor (Frontiers in Immunology, 2016, 7, article 37, 7 pages, cited in PTO-892).
The reference patent is a continuation of the application issued as US 11,096,968 detailed above.
Reference claims 1-7 and 9-13 of the reference patent are drawn to a method for protecting isolated neurosensory precursor cells from prostaglandin E2 toxicity comprising the step of: a) contacting an isolated neurosensory precursor cell prior to a transplantation in a subject in need thereof, with a gem-difluorinated C-glycopeptide compound and then washing the isolated neurosensory precursor cell to remove the compound, and b) transplanting the treated isolated neurosensory precursor cells of step a) in a subject in need thereof, addressing limitations of claim 1 and 25. Reference claim 3 recites elected species of gem-difluorinated C-glycopeptide compound which is recited in claim 7. Reference claims 9-10 address limitations of claim 1 and correspond to claim 3. Reference claim 11 corresponds to claim 4. Reference claims 5-6 recite ranges that fall within the scope of claims 8-9. Reference claim 7 recites the neurosensory precursor cell is a photoreceptor precursor cell corresponding to the limitations of claims 10-11 and 16. Reference claim 4 addresses limitations of claims 17-18. Reference claim 13 corresponds to limitations of claims 23-24.
Reference claims 1-7 and 9-13 do not specifically disclose the method comprising the step c) discontinue said immune suppressant drug therapy after a time sufficient for implantation of said graft in said subject in need thereof (claim 1). Reference claims 1-7 and 9-13 do not specifically disclose the method wherein said subject is under an immune suppressant drug therapy for at least about 1 week prior to transplantation of the graft (claim 21).
The disclosure of Young qualifies as prior art and teaches as detailed above.
Taylor teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-7 and 9-13 in view of Young and Taylor in order to select from within the scope of the Reference claims the method which includes discontinuing the immunosuppressant drug therapy after a time sufficient for implantation of said graft in said subject in need thereof. One of ordinary skill in the art would have been motivated to combine Reference claims 1-7 and 9-13 in view of Young and Taylor with a reasonable expectation of success because Young provides guidance for embodiments encompassed within the scope of the Reference claims and for the same reasoning detailed above regarding the combined teachings of Young and Taylor addressing the examined claims.
Regarding the Reference claim preamble reciting the “method for protecting isolated neurosensory precursor cells from prostaglandin E2 toxicity”, for similar reasons detailed above regarding Young and Taylor, based on the disclosure of Young one of ordinary skill in the art would reasonably predict this method would also enhance engraftment, and thus result in inhibition or prevention of immune rejection of the graft.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-13 of U.S. Patent No. 11,826,387 (reference patent) in view of Young (WO 2017/130148 A1, published 03 Aug 2017, provided by Applicant in IDS filed 18 July 2022) and Taylor (Frontiers in Immunology, 2016, 7, article 37, 7 pages, cited in PTO-892), and further in view of Jiang et al. (Molecular Vision, 2010, 16, p983-990, cited in PTO-892).
Reference claims 1-7 and 9-13 in view of Young and Taylor teaches as above.
Reference claims 1-7 and 9-13 in view of Young and Taylor does not specifically disclose the method said time sufficient for implantation is about 1 week to about 2 weeks, or at least about 2 weeks (claim 19).
Jiang et al. teaches as above.
It would have been obvious to one of ordinary to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-7 and 9-13 in view of Young and Taylor further in view of Jiang et al. in order to select the time sufficient for implantation after which the immunosuppressant drug therapy is discontinued. One of ordinary skill in the art would have been motivated to combine Reference claims 1-7 and 9-13 in view of Young and Taylor further in view of Jiang et al. with a reasonable expectation of success for the same reasoning detailed above regarding Young in view of Taylor further in view of Jiang et al.
Conclusion
No claim is found to be allowable.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693