DETAILED ACTION
1. The present application is being examined under the pre-AIA first to invent provisions.
2. Applicant's amendment and remarks filed on 03/05/2026 are acknowledged.
Claims 27, 33-35 and 37-51 are pending.
3. 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.
4. Claims 27, 33-35 and 37-51 are rejected under 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 applicant regards as the invention.
(i) Claim 27 is indefinite in the recitation of a method for increasing T cell numbers "in a subject in need thereof," because the subject population is not defined.
(ii) Claim 27 is further indefinite in the following recitation in subclause (c) (emphasis added): “stimulating a CD28 co-stimulatory molecule on the surface in vitro with a ligand that binds the CD28 co-stimulatory molecule on the surface.”
Both the “agent” defined in subclause (b) and the “ligand” defined in subclause (c) are attached on a surface, such as the surface of a bead or a tissue-culture dish (e.g. claim 41). For T cells to be stimulated, CD28 co-stimulatory molecule must be present on the surface of the T cells, rather than on the surface of a bead or tissue-culture dish, as recited. Applicant is invited to consider amending the claims to recite “CD28 co-stimulatory molecule on the autologous T cells,” to avoid confusion.
(iii) Claims 33-35 and 37-51 are indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
5. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 27, 39, 41, 44, 45 and 47 are rejected under 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contain(s) subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized in In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, limited working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to make and use the claimed invention.
(i) Regarding claims 27, 41, 44, 45 and 47, the specification does not provide a sufficient enabling description of a method of activating and stimulating T cells using a cell line expressing PD-L1 or PD-L2.
As pointed out in subsection 4(x) of the previous office action, PD-L1 and PD-L2 are co-inhibitory rather than co-stimulatory molecules, as one of skill in the art would be aware. Applicant’s argument that applicant is permitted to act as their own lexicographer and may define terms in a manner specific to the application is acknowledged. While applicant may define inhibitory molecules as stimulatory, that definition does not change the functional properties of these molecules, and cells expressing PD-L1 or PD-L2 would suppress T cells, rather than activate or stimulate them.
Based on this, a skilled artisan would reasonably conclude that experimentation aimed at activating and stimulating T cells using a cell line expressing PD-L1 or PD-L2 would be unsuccessful, and as such unnecessary, improper and undue.
(ii) Further regarding claims 27, 41, 44, 45 and 47, the specification does not provide a sufficient enabling description of a fragment of 4-1BBL, OX40L, ICOS-L, ICAM, PD-L1, or PD-L2 that binds CD28.
As pointed out in subsection 4(xi) of the previous office action, the above listed molecules do not bind CD28, as one of skill in the art would be aware. Based on this, a skilled artisan would reasonably conclude that experimentation aimed at making a CD28-binding fragment of 4-1BBL, OX40L, ICOS-L, ICAM, PD-L1, or PD-L2 would be unsuccessful, and as such unnecessary, improper and undue.
(iii) Regarding claim 39, the specification does not provide a sufficient enabling description of growth factors, cytokine, adhesion molecules, L-selectin, LFA-3, CD54, LFA-1, chemokines, or small molecules “in a form suitable to trigger a primary activation signal in the T cell when complexed with the TCR/CD3 complex.”
As pointed out in subsection 4(vi) of the previous office action, the above-listed agents do not bind TCR/CD3 complex, as a person of skill in the art would be aware. Based on this, a skilled artisan would reasonably conclude that experimentation aimed at converting these agents into “a form suitable to trigger a primary activation signal in the T cell when complexed with the TCR/CD3 complex” would be unsuccessful, and as such unnecessary, improper and undue.
7. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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.
8. Claims 27, 33-35, 37, 39-42 and 49-51 stand rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 6905680 in view of Rosenberg et al. (2008), and over the claims of U.S. Patent No. 7232566 in view of Rosenberg et al. (2008) (all of record).
The grounds of rejection presented in sections 6 and 7 of the previous office action are maintained, and are incorporated by reference herein as if reiterated in full.
Applicant’s arguments have been fully considered but have not been found convincing. Applicant argues that a person of ordinary skill in the art would not simply import oncologic lymphodepleting regimens into HIV infected patients without undermining the very objective of preserving and expanding uninfected CD4 T cells.
Applicant’s argument is directed to a limitation which is not claimed. Instant generic claims are not limited to treatment of any disease, and as such encompass HIV patients recited in US ‘680 claims and in US ‘566 claims. Accordingly, the rejections are maintained.
9. Conclusion: no claim is allowed.
10. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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