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 1-20 are pending in the present application.
Applicant’s election without traverse of Group I, drawn to a method for treating a malignancy in a subject, the method comprising contacting a composition to enrich for TPEX cells and/or TOX+TEFF cells to a plurality of T cells to enhance anti-tumor activity of the plurality of T cells to treat the malignancy, in the reply filed on 02/05/2026 is acknowledged.
Applicant also elected the following species: (i) a decoy-resistant IL-18 (DR-18); and (ii) contacting the composition expands IFNγ+TOX+TEFF cells and promotes tumor-specific immunity.
Accordingly, claims 11-20 were withdrawn from further consideration because they are directed to a non-elected invention. Additionally, claim 4 was also withdrawn from further consideration because it is directed to a non-elected species.
Therefore, claims 1-3 and 5-10 are examined on the merits herein with the above elected species.
Claim Objections
Claim 2 is objected to because of the phrase “wherein the composition comprises an agonist immunotherapy or a decoy-resistant IL-18 (DR-18) immunotherapy”. This is because an immunotherapy is not a composition.
Claim Rejections - 35 USC § 112 (Lack of Written Description)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
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.
Claims 1-3 and 5-10 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111 (Fed. Cir. 1991), clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” Vas-Cath Inc. v. Mahurkar, 19USPQ2d at 1117. The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed” Vas-Cath Inc. v. Mahurkar, 19USPQ2d at 1116.
The instant claims encompass a method for treating a malignancy in a subject, the method comprising contacting (e.g., in vivo or ex vivo; see dependent claims 6-8) any composition (e.g., including and not necessarily limited to any agonist or any decoy-resistant IL-18 (DR-18); see dependent claim 2) as long as it has an ability to enrich for TPEX cells and/or any TOX+TEFF cells (e.g., including and not necessarily limited to TIM-3+, c-Maf+, Batf+, TOX+ CD8 T cells) to a plurality of T cells to enhance anti-tumor activity of the plurality of T cells to treat the malignancy. It is noted that the term “TOX+TEFF” cells are defined in the present application to be TOX+TIM-3+ TEX subset that produce both IFNγ and cytotoxic molecules in the TME (lines 12-14 at page 17).
Apart from disclosing generically that a DR-18 treatment in a murine model of myeloma resulted in DR-18 treated mice with a controlled myeloma and this was associated with increased frequency of IFNγ+CD8 T-cells, as well as an expansion of precursor exhausted (TPEX) and TOX+TEFF cells compared to PBS-treated mice (see at least sections titled “A decoy resistant IL-18 expands IFNγ-secreting TOX+ TEFF cells and promotes myeloma control” and “Myeloma model and stem cell transplantation” at page 19 and 23, respectively; FIGs. 3A-B and 10A-B); the instant specification fails to provide sufficient written description for any other composition that is used to enrich for TPEX cells and/or TOX+ TEFF cells to a plurality of T cells to enhance anti-tumor activity of the plurality of T cells to treat a malignancy in a subject as claimed broadly. For example, apart from DR-18 what are the essential core/critical structures or elements possessed by other agonists or other compositions that are capable of enriching TPEX and/or TOX+ TEFF cells to a plurality of T cells to enhance anti-tumor activity of the plurality of T cells to treat a malignancy in a subject as claimed broadly?
Additionally, the instant specification stated explicitly and clearly “CD8 T-cells with an exhausted phenotype are not dysfunctional in vivo and are treated according to the present disclosure to expand CD8 T-cells and enhance anti-tumor immunity” (lines 1-3 at page 15); “[t]he presence of distinct TOX+ T-cell subsets in the bone marrow tumor microenvironment with co-expression of TIM-3, c-Maf and Batf is demonstrated. Despite an exhausted transcriptional and epigenetic profile, TOX+T-cells produced granzymes, perforin, and IFNγ in vivo but lacked hallmarks of self-renewal capacity…A decoy-resistant IL-18 expanded TOX+TIM-3+ T-cells with enhanced IFNγ production and promoted anti-tumor immunity” (lines 12-19 at page 15); “TOX+CD8 T-cells produce cytotoxic molecules and IFNγ in vivo” (line 5 at page 16); and “DR-18 resistance is associated with a loss of a TOX+TEFF subset expressing Maf” (lines 19-20 at page 8). Thus, it is apparent that apart from the distinct TIM-3+, c-Maf+, Batf+, TOX+ CD8 T cells with enhanced IFNγ production and cytotoxic molecules such as granzymes and perforin in in vivo, that are expanded by a decoy-resistant IL-18 (DR-18), the instant specification also fails to completely describe other structural features of a DR-18 that enable it to enrich any other TOX+TEFF cells (e.g., TOX+ CD4 T cells) to a plurality of T cells to enhance anti-tumor activity of the plurality of T cells to treat a malignancy in a subject, let alone any other composition as encompassed broadly by the instant claims.
Since the prior art failed to provide adequate description for the above issues as evidenced at least by the teachings of Khan et al (Nature 571:211-218, 2019; IDS), Scott et al (Nature 571:270-274, 2019; IDS), Ring et al (US 2019/0070262) and Nakamura et al (Immunology & Cell Biology 98:434-436, 2020); it is incumbent upon the instant specification to do so. The present application also fails to provide at least a representative number of species for a broad genus of a composition to enrich for TPEX cells and/or TOX+ TEFF cells to a plurality of T cells to enhance anti-tumor activity of the plurality of T cells to treat a malignancy in a subject as claimed broadly.
The claimed invention as a whole is not adequately described if the claims require essential or critical elements which are not adequately described in the specification and which are not conventional in the art as of Applicants’ filing date. Possession may be shown by actual reduction to practice, clear depiction of the invention in a detailed drawing, or by describing the invention with sufficient relevant identifying characteristics such that a person skilled in the art would recognize that the inventor had possession of the claimed invention. Pfaff v. Wells Electronics, Inc., 48 USPQ2d 1641, 1646 (1998). The skilled artisan cannot envision at least the complete detailed structure of a representative number of species for a broad genus of a composition to enrich for TPEX cells and/or TOX+ TEFF cells to a plurality of T cells to enhance anti-tumor activity of the plurality of T cells to treat a malignancy in a subject as claimed broadly, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method. Adequate written description requires more than a mere statement that it is part of the invention and reference to a method of isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991). One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481, 1483.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
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.
Claim 8 is 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.
The term “high tumor burden” in claim 8 is a relative term which renders the claim indefinite. The term “high tumor burden” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear about a threshold to which a tumor burden is considered to be high or not high. Clarification is requested because the metes and bounds of the claim are not clearly determined.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-7 and 9 are rejected under 35 U.S.C. 102(a)(a) as being anticipated by Ring et al (US 2019/0070262).
The instant claims are drawn to a method for treating a malignancy in a subject, the method comprising contacting a composition (e.g., a decoy-resistant IL-18 or DR-18) to enrich for TPEX cells and/or TOX+ TEFF cells to a plurality of T cells to enhance anti-tumor activity of the plurality of T cells to treat the malignancy.
Ring et al already disclosed at least a method of treating a disease or disorder (e.g., a cancer such as solid tumor cancers, liquid cancers, blood cancers that include malignant glioma, multiple myeloma, myeloma, T-cell lymphoma) in a subject in need thereof, comprising administering to the subject a composition comprising an IL-18 variant polypeptide (DR-18 polypeptide), wherein the IL-18 variant polypeptide specifically binds to IL-18 receptor (IL-18R) and wherein the IL-18 variant polypeptide exhibits substantially reduced binding to IL-18 binding protein (IL-18BP) (see at least Abstract; Summary; particularly paragraphs [0004], [0016]-[0019], [0126]-[0146], [0188]-[0190]; and Example 1). Ring et al also taught that the treatment includes administering a combination (co-administration) of a DR-18 polypeptide with another agent (e.g., an immune stimulant such as IL-2, IL-12, IL-15, IL-21, a cytotoxic agent, an anti-cancer agent) (paragraphs [0202] and [0210]); and/or the DR-18 is co-administered with an engineered immune cell such as a CAR-T or CAR-NK cell or T or NK cell transduced with an engineered T cell receptor (paragraph [0220]). In an exemplification of anti-tumor efficiency of DR-IL18 variants, Ring et al stated “WT IL-18 had no effect as a monotherapy and showed no enhancement of anti-PD1 efficacy. By contrast, DR-IL-18 showed robust monotherapeutic activity commensurate with or superior to anti-PD1, and the two therapies given together showed exceptional synergism, producing complete regression in all treated mice (FIG. 17)” (paragraph [0353]); and “As seen in FIG. 18B, DR-IL-18 treatment increased systemic levels of Interferon-gamma, IL-7, and IL-15 by over 100-fold relative to WT IL-18 treatment” (paragraph [0354]).
Since the treatment method of Ring et al has the same administering step to a subject having a malignancy such as multiple myeloma with the same composition comprising a decoy-resistant IL-18 (DR-18) as the claimed treatment method of the present application, the treatment method of Ring et al would necessarily result in an enrichment for TPEX cells and/or TOX+ TEFF cells to a plurality of T cells in said subject to enhance anti-tumor activity of the plurality of T cells to treat the malignancy, including expansion of IFNγ+TOX+TEFF cells (dependent claim 3), and wherein the TOX+TEFF cells express BATF (dependent claim 5).
Accordingly, the teachings of Ring et al meet every limitation of the instant claims. Therefore, the reference anticipates the instant claims.
Claim Rejections - 35 USC § 103
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.
Alternatively, claims 1-3, 5-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ring et al (US 2019/0070262).
The instant claims are drawn to a method for treating a malignancy in a subject, the method comprising contacting a composition (e.g., a decoy-resistant IL-18 or DR-18) to enrich for TPEX cells and/or TOX+ TEFF cells to a plurality of T cells to enhance anti-tumor activity of the plurality of T cells to treat the malignancy.
Ring et al already disclosed at least a method of treating a disease or disorder (e.g., a cancer such as solid tumor cancers, liquid cancers, blood cancers that include malignant glioma, multiple myeloma, myeloma, T-cell lymphoma) in a subject in need thereof, comprising administering to the subject a composition comprising an IL-18 variant polypeptide (DR-18 polypeptide), wherein the IL-18 variant polypeptide specifically binds to IL-18 receptor (IL-18R) and wherein the IL-18 variant polypeptide exhibits substantially reduced binding to IL-18 binding protein (IL-18BP) (see at least Abstract; Summary; particularly paragraphs [0004], [0016]-[0019], [0126]-[0146], [0188]-[0190]; and Example 1). Ring et al also taught that the treatment includes administering a combination (co-administration) of a DR-18 polypeptide with another agent (e.g., an immune stimulant such as IL-2, IL-12, IL-15, IL-21, a cytotoxic agent, an anti-cancer agent) (paragraphs [0202] and [0210]); and/or the DR-18 is co-administered with an engineered immune cell such as a CAR-T or CAR-NK cell or T or NK cell transduced with an engineered T cell receptor (paragraph [0220]). In an exemplification of anti-tumor efficiency of DR-IL18 variants, Ring et al stated “WT IL-18 had no effect as a monotherapy and showed no enhancement of anti-PD1 efficacy. By contrast, DR-IL-18 showed robust monotherapeutic activity commensurate with or superior to anti-PD1, and the two therapies given together showed exceptional synergism, producing complete regression in all treated mice (FIG. 17)” (paragraph [0353]); and “As seen in FIG. 18B, DR-IL-18 treatment increased systemic levels of Interferon-gamma, IL-7, and IL-15 by over 100-fold relative to WT IL-18 treatment” (paragraph [0354]).
Although Ring et al did not explicitly mention a composition to enrich for TPEX cells and/or TOX+TEFF cells to a plurality of T cells to enhance anti-tumor activity of the plurality of T cells, including the composition expands IFNγ+TOX+TEFF cells (claim 3), or the TOX+TEFF cells express BATF (claim 5), it would have been obvious for an ordinary skill in the art to recognize that since the treatment method of Ring et al is indistinguishable from the claimed treatment method of the present application, the treatment method of Ring et al would necessarily result in an enrichment for TPEX cells and/or TOX+ TEFF cells to a plurality of T cells in said subject to enhance anti-tumor activity of the plurality of T cells to treat the malignancy, including expansion of IFNγ+TOX+TEFF cells (dependent claim 3), and wherein the TOX+TEFF cells express BATF (dependent claim 5).
Therefore, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ring et al (US 2019/0070262) as applied to claims 1-3, 5-7 and 9 above, and further in view of Hay et al (Blood 130:2295-2306, 2017).
The teachings of Ring et al were presented above. However, Ring et al did not teach specifically that administering the composition occurs prior to a state of high tumor burden of the malignancy.
Before the effective filing dated of the present application (02/23/2022), Hay et al already taught that tumor burden is significantly related to the safety of CAR-T cell clinical treatment (see at least Abstract). Hay et al stated “Multivariable analysis identified baseline and treatment-related risk factors for CRS, including those associated with more robust CAR T-cell expansion, such as higher marrow tumor burden, cyclophosphamide/fludarabine lymphodepletion and higher CAR T-cell dose. Other pretreatment factors that were associated with CRS, such as thrombocytopenia and manufacturing of CAR T cells from bulk CD8+T cells, may be a reflection of the higher tumor burden in these patients; however, distinct mechanisms cannot be excluded” (left column, second paragraph at page 2305).
Accordingly, it would have been obvious for an ordinary skill in the art to further modify the teachings of Ring et al by also administering a combination (co-administration) of a DR-18 polypeptide with an engineered immune cell such as a CAR-T or CAR-NK cell or T or NK cell transduced with an engineered T cell receptor prior to a state of high tumor burden of the malignancy in the subject to avoid severe cytokine release syndrome (CRS), in light of the teachings of Hay et al as presented above.
An ordinary skill in the art would have been motivated to carry out the above modification because Hay et al already taught at least that tumor burden such as high marrow tumor burden is significantly related to the safety of CAR-T cell clinical treatment.
An ordinary skill in the art would have a reasonable expectation of success in light of the teachings of Ring et al and Hay et al as set forth above, coupled with a high level of skill for an ordinary skilled artisan in the relevant art.
The modified method resulting from the combined teachings of Ring et al and Hay et al is indistinguishable from the treatment method of the present application.
Therefore, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ring et al (US 2019/0070262) as applied to claims 1-3, 5-7 and 9 above, and further in view of Ai et al (Int. J. Environ. Rs. Public Health 10:3834-3842, 2013).
The teachings of Ring et al were presented above. However, Ring et al did not teach specifically that the method further comprising administering a restimulation composition comprising phorbol 12-myristate 13-acetate (PMA) and ionomycin to restimulate the plurality of T cells.
Before the effective filing dated of the present application (02/23/2022), Ai et al already determined that PMA/ionomycin (25 ng/mL PMA and 1 ug/mL ionomycin) was the optimal stimulant, and could significantly increase a rapid increase of five cytokines (IL-2, IFN-γ, TNFα, RANTES and TGF-β) secretion within 6 h after stimulation without significant damage to immune cells (Abstract; particularly first paragraph at page 3840). Ai et al also taught that PMA activates protein kinase C, while ionomycin is a calcium ionophore, and stimulation with these compounds bypasses the T cell membrane receptor complex and will lead to activation of several intracellular signaling pathways, resulting in T cell activation and production of a variety of cytokines; and many clinical studies have also confirmed that PMA could specifically increase the production of certain cytokines (especially TH1-type cytokines) (first paragraph at page 3840).
Accordingly, it would have been obvious for an ordinary skill in the art to further modify the teachings Ring et al by also stimulate/restimulate engineered immune cell such as a CAR-T or CAR-NK cell or T or NK cell transduced with an engineered T cell receptor with a restimulation composition comprising PMA and ionomycin ex vivo prior to co-administering with DR-18 into the subject in need of malignancy treatment, in light of the teachings of Ai et al as presented above.
An ordinary skill in the art would have been motivated to carry out the above modification because Ai et al taught that PMA/ionomycin was the optimal stimulant, and could significantly increase a rapid increase of five secretion within 6 h after stimulation without significant damage to immune cells; and stimulation with these compounds bypasses the T cell membrane receptor complex and will lead to activation of several intracellular signaling pathways, resulting in T cell activation and production of a variety of cytokines that are useful for malignancy treatment.
An ordinary skill in the art would have a reasonable expectation of success in light of the teachings of Ring et al and Ai et al as set forth above, coupled with a high level of skill for an ordinary skilled artisan in the relevant art.
The modified method resulting from the combined teachings of Ring et al and Ai et al is indistinguishable from the treatment method of the present application.
Therefore, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
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 1-3 and 5-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-37 of copending Application No. 18/062.522 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because a method for treating myeloma or leukemia or a condition associated with malignant myeloid cells in a subject in need thereof without exacerbating graft versus host disease, said method comprising the step of administering a therapeutically effective amount of decoy-resistant interleukin-18 (DR-18) to the subject in claims 21-37 of copending Application No. 18/062.522 anticipates or encompasses a method for treating a malignancy in a subject in the application being examined and, therefore, a patent to the genus would, necessarily, extend the rights of the species or sub- should the genus issue as a patent after the species of sub-genus.
Please note that since the treatment methods of in claims 21-37 of copending Application No. 18/062.522 having the same administering step to a subject having a malignancy such as multiple myeloma with the same composition comprising a decoy-resistant IL-18 (DR-18) as the claimed treatment method of the present application, the treatment methods of copending Application No. 18/062.522 would necessarily result in an enrichment for TPEX cells and/or TOX+ TEFF cells to a plurality of T cells in said subject to enhance anti-tumor activity of the plurality of T cells to treat the malignancy, including expansion of IFNγ+TOX+TEFF cells (dependent claim 3), and wherein the TOX+TEFF cells express BATF (dependent claim 5).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusions
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Quang Nguyen, Ph.D., at (571) 272-0776.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s SPE, James Douglas (Doug) Schultz, Ph.D., may be reached at (571) 272-0763.
To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Group Art Unit 1631; Central Fax No. (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
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/QUANG NGUYEN/
Primary Examiner, Art Unit 1631