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 .
DETAILED ACTION
Election/Restrictions
1. Applicant's election of Group III, claims 31, 35, 42, 48, and 51-56, without traverse, filed May 26, 2026 is acknowledged and has been entered. Species election of A) X15 NCAM (CD56) Protein sequence isoform 1 (SEQ ID NO. 27) and Species B) Y6 (CD109) Protein sequence isoform 1 (SEQ ID NO. 66) which are readable on claims 42, 48, 52, and 54 so as to be directed to CD56+/CD109- combination, is also acknowledged. Claims 21, 23, 24, and 27 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being claims drawn to a non-elected invention. Accordingly, claims 21, 23, 24, 27, 30, 31, 35, 42, 48, and 51-56 are pending. Claims 31, 35, 42, 48, and 51-56 are under examination.
Priority
2. This application is a continuation of U.S. Patent Application 16/877,176 filed May 18, 2020, now U.S. Patent Number 11,740,239, which is a continuation of U.S. Patent Application 14/888,875 filed November 3, 2015, now U.S. Patent Number 10,655,102, which is a 371 National Stage application of PCT/US2014/36616 filed 5/2/2014, which claims the benefit of Provisional Application Number 61/819,146 filed 5/3/2013. Based on the filing receipt, the effective filing date of the instant application is March 3, 2013 which is the effective filing date of Provisional Application Number 61/819,146 from which the benefit of domestic priority is claimed.
Claim Objections
3. Claim 51 is objected to in reciting “selecting cells to which the second positive affinity reagent differs from the first positive affinity reagent.” It should recite “selecting cells to which the second positive affinity reagent is bound, wherein the second positive affinity reagent differs from the first positive affinity reagent.” Appropriate correction is required.
4. Claim 53 is objected to in reciting “wherein said cell population containing human corneal cells is contacted with said second positive affinity reagent and selecting cells to which the second positive affinity reagent is bound are selected.” It should recite “wherein said cell population containing human corneal cells is contacted with said second positive affinity reagent and selecting cells to which the second positive affinity reagent is bound.” 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.
5. Claims 35, 42, 48, and 51-56 are 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 pre-AIA the applicant regards as the invention.
Claim 35 is indefinite in reciting “protein product of gene X5 of Table 2”, “protein product of gene X15 of Table 2”, and “protein product of X25 of Table 2” because it is unclear what this “protein product” is and what should be encompassed in the protein product, as claimed. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim 42 is indefinite in reciting “protein product of gene X5 of Table 2”, “protein product of gene X15 of Table 2”, and “protein product of X25 of Table 2” because it is unclear what this “protein product” is and what should be encompassed in the protein product, as claimed. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim 48 is indefinite in reciting “protein product of gene Y6 of Table 2” because it is unclear what this “protein product” is and what should be encompassed in the protein product, as claimed. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim 51, step c) lacks clear antecedent basis in reciting “contacting the cell population with a second positive affinity reagent” because it is unclear as to whether the recitation refers back to the cell population in a) which contains human corneal cells or the cell population in b) from which bound cells are selected. See also claim 53.
Claim 51, step d) also lacks clear antecedent basis in reciting “contacting said cell population … with a first negative affinity reagent” because it is unclear as to whether the recitation refers back to the cell population in a) which contains human corneal cells or the cell population in b) from which bound cells are selected or the cell population in c) from which bound cells are selected. See also claim 55.
Claim 51, step d) is confusing in reciting, “a first negative affinity reagent” because there does not appear to be any “second negative affinity reagent” in the given set of claims.
Claim 52 is indefinite in reciting “protein product of gene X5 of Table 2”, “protein product of gene X15 of Table 2”, and “protein product of X25 of Table 2” because it is unclear what this “protein product” is and what should be encompassed in the protein product, as claimed. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim 54 is indefinite in reciting “protein product of gene X5 of Table 2”, “protein product of gene X15 of Table 2”, and “protein product of X25 of Table 2” because it is unclear what this “protein product” is and what should be encompassed in the protein product, as claimed. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim 55 is confusing in reciting, “said first negative affinity reagent” because there does not appear to be any “second negative affinity reagent” in the given set of claims.
Claim 56 is confusing in reciting, “the … first negative affinity reagent” because there does not appear to be any “second negative affinity reagent” in the given set of claims.
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.
6. Claims 31, 35, 42, 48, and 51-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,740,239. Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions recite a composition enriched with human corneal endothelial cells (hCECs) comprising: (a) human corneal cells expressing hCEC-specific surface proteins/antigens including CD56 (NCAM1: Neural cell adhesion molecule 1); and (b) a first positive affinity reagent that selectively or specifically binds to hCEC-specific surface protein including CD56 (anti-CD56). Albeit not recited in Applicant’s claimed invention, the patent disclosure provides that the hCEC surface protein to which the first positive affinity reagent binds to is CD56 or NCAM1 as shown in Table 2. Albeit not recited in Applicant’s claimed invention, the patent disclosure provides that the non-hCEC surface protein to which the negative affinity reagent binds to is CD109 as shown in Table 2. Both inventions further recite a method of forming a composition enriched with hCECs comprising contacting a cell population containing human corneal cells with a positive affinity reagent comprising an antibody that binds to an hCEC surface protein including CD56 (anti-CD56 or anti-NCAM1); then selecting the cells to which the antibodies bound, and wherein the hCECs express the surface protein CD56. The method further comprises contacting the cell population with a negative affinity reagent comprising an antibody that binds to cells that are not hCECs; wherein the non-hCECs express surface proteins that are NOT present in hCECs; and then selecting and removing the non-hCECs to which the negative affinity reagent bound. Albeit not recited in Applicant’s claimed invention, the patent disclosure provides that the non-hCEC surface protein to which the negative affinity reagent binds is CD109 as shown in Table 2.
7. Claims 31, 35, 42, 48, and 51-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,655,102. Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions recite a composition enriched with human corneal endothelial cells (hCECs) comprising: (a) human corneal cells expressing hCEC-specific surface proteins/antigens including CD56 (NCAM1: Neural cell adhesion molecule 1); and (b) a first positive affinity reagent that selectively or specifically binds to hCEC-specific surface protein including CD56 (anti-CD56). Albeit not recited in Applicant’s claimed invention, the patent disclosure provides that the hCEC surface protein to which the first positive affinity reagent binds to is CD56 or NCAM1 as shown in Table 2. Albeit not recited in Applicant’s claimed invention, the patent disclosure provides that the non-hCEC surface protein to which the negative affinity reagent binds to is CD109 as shown in Table 2. Both inventions further recite a method of forming a composition enriched with hCECs comprising contacting a cell population containing human corneal cells with a positive affinity reagent comprising an antibody that binds to an hCEC surface protein including CD56 (anti-CD56 or anti-NCAM1); then selecting the cells to which the antibodies bound, and wherein the hCECs express the surface protein CD56. The method further comprises contacting the cell population with a negative affinity reagent comprising an antibody that binds to cells that are not hCECs; wherein the non-hCECs express surface proteins that are NOT present in hCECs; and then selecting and removing the non-hCECs to which the negative affinity reagent bound. Albeit not recited in Applicant’s claimed invention, the patent disclosure provides that the non-hCEC surface protein to which the negative affinity reagent binds is CD109 as shown in Table 2.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
8. Claims 31, 35, 42, 48, and 51-56 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McCabe et al. (US 2018/0072989 A1).
McCabe et al. teach a composition enriched with human corneal endothelial cells (hCECs) (Abstract; [0033, 0093, 0107, 0108, 0116, 0121, 0370]. McCabe et al. teach that the hCECs positively express CD56 (NCAM1, NCAM-1: Neural cell adhesion molecule 1), Na+/K+ATPase, ZO-1, KLF13, AQP1, CA2, CA4, CA12, SLC14A2, SLC16A1, SLC16A3, SLC16A7, CFTR, NHEI, ADCY10, PITX2, Collagen VIII (COL8A2), and FOXC1 ([0074, 0075, 0083, 0093]; claim 130). The human CECs further positively express KLF13, NBC1, and ZO1 [0074, 0075, 0093]. McCabe et al. teach forming (purifying) the composition enriched with hCECs [0009] by contacting a population containing human corneal cells with a first positive affinity antibody or aptamer (i.e. affinity reagent) that selectively binds to the hCECs supra relative to cells other than hCECs, and selecting cells to which the first positive affinity antibody is bound. McCabe et al. teach further contacting the cell population containing human corneal cells with a second positive affinity antibody or aptamer that selectively binds to hCECs supra relative to cells other than hCECs and selecting cells to which the second positive affinity antibody is bound [0009, 0074, 0075, 0083, 0093]. McCabe et al. teach also contacting the cell population containing human corneal cells with a negative affinity antibody (antibodies that bind to CD271, SSEA-1, TRA-1-60, SSEA-4, CD326, vWF and CD31 marker) that selectively binds to non-hCEC cells, relative to hCECs, and removing the cells to which the negative affinity antibody is bound [0031, 0075, 0083, 0093, 0239]. McCabe et al. teach labeling the antibodies with a label (i.e. enzyme, substrate) and separating the cells to which they bound by affinity-based depletion [0031, 0075, 0239].
With regards to the claim language in claims 35, 42, 48, 52, and 54 referencing “protein products of Table 2” disclosed in the specification to which the affinity reagents bind, it is deemed that these proteins are not properly recited in Applicant’s claimed invention. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Accordingly, it is proper for purposes of this anticipation rejection to interpret the recitations of “protein products of Table 2” in claims 35, 42, 48, 52, and 54 to encompass the hCEC surface proteins as taught by McCabe et al. to which positive affinity antibodies bind and non-hCEC surface proteins to which negative affinity antibodies bind because unpatented claims are given the broadest reasonable interpretation consistent with the specification.
9. Claims 31, 35, 42, 48, and 51-56 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hayashi et al. (US 2014/0170751).
Hayashi et al. teach a composition enriched with human corneal endothelial cells (human CECs, or hCECs). Hayashi et al. teach that the hCECs positively express p75 marker (Abstract; [0018, 0023, 0024, 0030]). The hCECs further positively express type VIII collagen, N-cadherin, Na+/K+ATPase, FOXC2, SOX9, ZO+1, and COL8A2 [0036, 0037, 0043, 0054-0057]. Hayashi et al. also teach a human CEC composition wherein the CECs positively express ZO-1, KLF13, AQP1, CA2, CA4, CA12, SLC14A2, SLC16A1, SLC16A3, SLC16A7, CFTR, NHEI, ADCY10, PITX2, Collagen VIII (COL8A2), and FOXC1; and a method of forming the composition using antibodies that bind to Na+/K+ATPase, ZO-1, KLF13, AQP1, CA2, CA4, CA12, SLC14A2, SLC16A1, SLC16A3, SLC16A7, CFTR, NHEI, ADCY10, PITX2, COL8A2, and FOXC1 [0036, 0037, 0043, 0054-0057].
Hayashi et al. teach forming (purifying) the composition enriched with hCECs by contacting a population containing human corneal cells with a first positive antibody or aptamer (i.e. affinity reagent) that selectively binds to human CECs that express p75 marker relative to cells other than hCECs, and selecting cells to which the first positive antibody is bound. Hayashi et al. teach further contacting the cell population containing human corneal cells with a second positive antibody or aptamer that selectively binds to hCECs that express type VIII collagen relative to cells other than hCECs and selecting cells to which the second positive antibody is bound [0091, 0092]. Hayashi et al. teach optionally further contacting the cell population containing hCECs with a negative antibody (antibody that binds to K1-67 marker) that selectively binds to cells other than hCECs relative to hCECs, and removing the cells to which the negative antibody is bound. According to Hayashi et al. K1-67 marker is seen not to be expressed at the early stage of the hCECs [0018]. Hayashi et al. teach labeling the antibodies with fluorescent label and separating the cells to which they bound using fluorescence activated cell sorting (FACS) [0091].
With regards to the claim language in claims 35, 42, 48, 52, and 54 referencing “protein products of Table 2” disclosed in the specification to which the affinity reagents bind, it is deemed that these proteins are not properly recited in Applicant’s claimed invention. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Accordingly, it is proper for purposes of this anticipation rejection to interpret the recitations of “protein products of Table 2” in claims 35, 42, 48, 52, and 54 to encompass the hCEC surface proteins as taught by Hayashi et al. to which positive affinity antibodies bind and non-hCEC surface proteins to which negative affinity antibodies bind because unpatented claims are given the broadest reasonable interpretation consistent with the specification.
10. No claims are allowed.
Remarks
11. Prior art made of record are not relied upon but considered pertinent to the applicants' disclosure:
Foets et al.(A comparative immunohistochemical study of human corneotravecular tissue. Graefe’s Arch Clin Exp. Ophthalmol 230: 269-274 (1992)) teach a human corneal endothelial cell (hCEC) composition comprising hCECs expressing CD56 (NCAM: Neural Cell Adhesion Molecule) marker (Abstract). Foets et al. also teach a positive affinity reagent which is specifically an antibody against CD56 surface protein (anti-CD56, anti-NCAM: Leu19) expressed on the hCECs (Table 1; Figure 1F). The positive affinity reagent is in the form of monoclonal antibodies: mAb 9.3E and mAb 5.52H, raised against hCECs which specifically bind to hCEC surface proteins; wherein the CD56 marker expressed on the hCECs is different from the surface protein bound and detected by mAb 9.3E and mAb 5.52H positive affinity reagent (p. 270, col. 1; p. 271, col. 1; Table 2; Figure 2). Foets et al. teach that the positive affinity reagents are coupled to different labels (peroxidase, immunostain, hematoxylin (p. 269, col. 2; p. 270, col. 2; Figure 1).
Foets et al. teach forming a hCEC composition by contacting hCECs expressing CD56 or NCAM marker with anti-CD56 or anti-NCAM (i.e. Leu19) (i.e. positive affinity reagent) that specifically binds to CD56 surface protein expressed on the hCECs; and then detecting and selecting the bound cells expressing CD56 or NCAM (Abstract; Table 1; Figure 1F). The positive affinity reagent as taught by Foets et al. which comprises mAb 9.3E and mAb 5.52H which specifically bind to hCEC surface proteins are different from the anti-CD56 or Leu19 that bind to CD56 marker expressed on the hCECs (p. 270, col. 1; p. 271, col. 1; Table 2; Figure 2).
Kisselbach et al. (CD90 Expression on human primary cells and elimination of contaminating fibroblasts from cell cultures. Cytotechnology 59: 31-44 (2009)) teach that CD90 is found in different levels on fibroblasts, and that 50% of hCECs express CD90 (Abstract; p. 39, col 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory S. Emch can be reached at (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GAILENE GABEL/Primary Examiner, Art Unit 1678
June 18, 2026
Prosecution Insights