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 .
Claims 1-12 are pending as originally filed and are considered herein.
Formalities:
The drawings of 3/12/24 are accepted.
The specification of 3/12/24 are accepted.
The IDS filings and references therein have been considered. A signed copy of each IDS is provided herewith.
Applicant’s priority is noted to be:
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Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “remained after”, while proper English is “remaining after”. Appropriate correction is required.
Applicant is advised that should claim 1 be found allowable, claim 5 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 5 limits the structure of the cells obtained from Claim 1 to specific characteristic markers being highly expressed, and that is compared to a NK population from peripheral blood that has not been substantially cultured. The problem here is that Examiner reads this is characteristics of the cells obtained from the method, not the method itself, and thus, this does not further limit the scope of Claim 1, which is the method. Second, the “judged” step is not really a step, but can be read as an immeasurable process which may simply be mental. Thus, these claims have substantially the same scope. (The same rejection is made below in the rejections for clarity, as “judged” appears to imply something, but it is not clear if anything is required.)
Applicant is advised that should claim 1 be found allowable, claims 6-8 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claims 6-8 teaches that the obtained cells from the method of Claim 1 have distinct characteristic requirements. However, the method is what is claimed, and there is no structure required of the method that further limits the scope of Claim 1 in any of these claims. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 1 be found allowable, claim 9 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 9 requires that the obtained cells of Claim 1, further have cells removed that express one of five markers. However, this does not change the method, it is a requirement of the cells, and thus may occur after the method, or before the method, and this then does not alter the scope of the method claimed. Therefore, despite a slight difference in wording, these claims have substantially the same scope.
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 5 and 9 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 states that the cells further highly express CD11a and CD11c, and they are judged by comparison to NK cells from peripheral blood that are not substantially cultured. The issue here is whether the “judg[ing]” is a physical step added to the method, or if it is simply a mental process and has no tangible way of being measured and therefore is of the same scope as Claim 1. To wit, the statement that the cells obtained also highly express CD11a and CD11c does not appear to indicate any specific limitations on the scope of the claim from which it depends, i.e., Claim 1. Also, the second part, where the properties are judged by comparison to NK populations from peripheral blood and not substantially cultured, also does not appear to be requirement performed in the method, as it is a statement of how to compare, but not a requirement that the comparison is performed. Thus, the Examiner considered whether the claim adds more steps/material or limits the steps/material of Claim 1 and finds that it does not limit Claim 1 to a smaller scope. Therefore, this rejection for clarity is proper, and it is also repeated as a double patenting warning on Claim 1, as it also appears to be of the same scope.
Claim 9 recites “the cell population” in Claim 1. This lacks sufficient antecedent basis. To wit, is this the cells prepared in step (a), or the obtained population of the method, or somewhere in the steps (b)..(c)?
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 1-2 and 5-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,987,812. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 1-2: Patent Claim 1 teaches CCR5+, CCR6+, CXCR3+ and CD3- cell populations. As part of the essential written description for making the claimed compositions, the specification teaches that a primary mononuclear cell population is taken, CD3-positive cells are removed from the population, then monocytes and/or B cells are removed from the population, and the remaining population is cultured in a medium containing IL-2 (Section “Means for Achieving the Object”, found in the paragraph before the Brief Description of the Drawings).
Claim 5: Claim 2 teaches the population so-obtained may highly express CD11a and CD11c, compared to NK cells from peripheral blood and not substantially cultured.
Claim 6: Claim 3 teaches the cells obtained may be CCR5-positive, CCR6-positive, CXCR3-positive, and CD3-negative cells are further integrin al-positive, integrin α3-positive, and integrin β3-negative.
Claim 7: Claim 4 teaches the cells obtained may have a ratio of the CCR5-positive, CCR6-positive, CXCR3-positive, and CD3-negative cells is 30% or higher in the cell population.
Claim 8: Claim 5 teaches the cells obtained may have a ratio of cells positive for any selected from the group consisting of CD3 and CD19 is lower than 5%.
Claim 9: Claim 6 teaches that cells positive for any selected from the group consisting of CD4, CD8, CD14, CD19, and CD36 have been removed from the cell population.
Thus, in light of the essential written description for the claimed invention of the patent, the invention is obvious. The Artisan would do so to obtain the cells of the patent. The Artisan would expect success, as it is found in the essential written description for the invention.
It is further noted that MPEP 804.01 states:
The following are situations where the prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply:
The applicant voluntarily files two or more applications without a restriction requirement by the examiner. In order to obtain the benefit of 35 U.S.C. 121, claims must be formally entered, restricted in, and removed from an earlier application before they are filed in a divisional application . Geneva Pharms. Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1379, 68 USPQ2d 1865, 1870 (Fed. Cir. 2003) (For claims that were not in the original application and are first formally entered in a later divisional application, 35 U.S.C. 121 "does not suggest that the original application merely needs to provide some support for claims that are first entered formally in the later divisional application." Id.); In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968).
Claims 1-3 and 5-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,987,812 in view of Amber Dance (2013) “Isolate Specific Cell Populations with Magnetic Separation Systems”, published by Biocompare, San Francisco, CA, https:// www.biocompare.com/Editorial-Articles/138015-Isolate-Specific-Cell-Populations-with-Magnetic-Separation-Systems/, no volume or issue number, 3 pages as printed.
As shown above, the various claims are NSDP over the patent alone, however, the aspect of Claim 3, that of the use of magnetic beads for removing monocytes and B cells is not claimed specifically in the patent, and it is not part of the essential written description, because other methods of removal are possible.
On the other hand, Dance teaches that the use of magnetic beads for isolating cell types, is a quick inexpensive purification method (paragraph 2).
Thus, at the time of invention, it would have been obvious to perform these purifications using magnetic beads. The Artisan would do so as the patent teaches the isolation, and Dance teaches that the method of magnetic beads is quick and inexpensive. The Artisan would expect success, as the components are utilized for art-recognized purposes.
Claims 1-2 and 4-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,987,812 in view of GenDEPOT Cat. No. H0900-010 “Human AB Serum, Male, Sterile Filtered”, Published at HTTPS:// gendepot.com/products/human-ab-serum-male-sterile-filtered, 3 pages long, and recognized by google as published by 3/5/2011:
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As shown above, the various claims are NSDP over the patent alone, however, the aspect of Claim 4, i.e., the use of human AB serum in the growth culture, is not specifically claimed.
On the other hand, as shown by GenDEPOT, the same was known for expansion of immune cells (e.g., DESCRIPTION on page 2).
Thus, at the time of invention, it would have been obvious to utilize GenDEPOT’s human AB serum in expanding the obtained immune cells. The Artisan would do so because it was known in the Art that such helped with expansion of the same. The Artisan would expect success, as the components are utilized for art-recognized purposes.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/ Primary Examiner, Art Unit 1638
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