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 .
Election/Restrictions
Applicant’s election without traverse of the species of an antibody that targets CCL24, the protein CXCL5 (ENA-78) and composition C32a in the reply filed on 12/23/2025 is acknowledged. The search was extended to compositions C25a and C27a. Claims 8, 10-16 and 18-21 read upon the elected species. Claims 8, 10-16 and 18-21 are under examination.
Effective Filing Date
Applicant’s claims for the benefit of a prior-filed application under 35 USC 121 and 365(c) and for foreign priority are acknowledged. Under the AIA , the effective filing date of a claimed invention is the earlier of:
The actual filing date of the application;
OR
The filing date to which the application is entitled to a right of foreign priority or domestic benefit as to such claimed invention.
Based on the information given by Applicant and an inspection of the prior patent and applications, the examiner has concluded that the subject matter defined in the instant claims is supported by the disclosures in PCT/SG2017/050408 and 16/326,417 (now US Patent 11,491,221). In addition, the certified copy of the foreign priority application supports the claimed invention under 35 USC 112(a). The effective filing date of the instant application is 08/19/2016.
Specification
The disclosure is objected to because of the following informalities. The abstract of the disclosure is objected to the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. Appropriate correction is required. See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
Claim 16 is objected to because of the following informalities. Claim 16 appears to be missing some words and phrasing from the wherein clause. Presumably the clause should recite “wherein the pharmaceutical composition results in an increase or a decrease in the concentration of at least one mesenchymal stromal cell-derived protein in a subject, which results in an immunosuppressive effect [or alternatively “resulting in an immunosuppressive effect”], wherein the mesenchymal stromal cell-derived protein is selected from the group consisting of PGE2 (prostaglandin E2), OPG, CCL7, CCL8, IL-10, CCL20, CXCL5, CXCL6, M-CSF, IL-1 R, CCL-1 and CCL24”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 10 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. Claim 10 recites “wherein the pharmaceutical composition is as shown in the table below”, which is confusing because it refers to the table as though it contains the singular composition, but the table lists 37 possible alternatives. Note that this issue could be addressed by amending claim 10 to recite something like “wherein the pharmaceutical composition is selected from the compositions
Claim Rejections - 35 USC § 112(a) – Scope of Enablement
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 8, 10-16 and 18-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating graft versus host disease (GVHD), skin transplant, kidney transplant, liver transplant, systemic lupus erythematosus (SLE), lupus nephritis, type I diabetes mellitus, inflammatory bowel disease (IBD), Crohn's disease or hemolytic disease of the fetus and newborn comprising administering a pharmaceutical composition, wherein said pharmaceutical composition comprises an anti-CCL24 (eotaxin-2) antibody and a CXCL5 (ENA-78) protein, does not reasonably provide enablement for the claims as broadly recited. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” (See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 Fed. Cir. 1988). These factors include, but are not limited to: (a) the breadth of the claims; (b) the nature of the invention; (c) the state of the prior art; (d) the level of one of ordinary skill; (e) the level of predictability in the art; (f) the amount of direction provided by the inventor; (g) the existence of working examples; and (h) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The claims are broad with respect to the recited immunological disorder and the pharmaceutical composition. The specification provides a non-limiting list of immunological disorders at paragraphs [0040]-[0042]. However, immunological disorders also encompass disorders of the central or peripheral nervous system, such as infections, Alzheimer's disease, chronic fatigue syndrome, congenital infections, encephalitis, ischemia, meningitis, multiple sclerosis, traumatic brain injury; inflammatory disorders of the urogenital system, such as endometriosis, glomerulosclerosis, intra-amniotic infection, pelvic inflammatory disease, renal inflammation/nephritis, sexually transmitted diseases, AIDS, urethritis, urinary tract infections; inflammatory disorders of the digestive system, such as, colon cancer, hepatitis, inflammatory bowel disease, ulcers; inflammatory disorders of the respiratory system such as chronic lung disease, asthma, tuberculosis, pneumonia; gingivitis, gout, myalgias, osteoarthritis, periodontitis, atherosclerosis, pericarditis, endocarditis, cat scratch disease, eye infections, Lyme disease, lymphadenopathy, radiation-induced inflammation, sarcoidosis and inflammatory disorders resulting from infections by microorganisms or inflammatory molecules. See column 29, lines 43-67 through column 30 lines 18-22 of US Patent 8,541,564 (J.W. Lillard, Jr.).
The specification teaches that the 2F cocktail (CCL24 antibody + CXCL5) improved graft-versus host disease (GVHD) survival by “suppressing the proliferation and differentiation of multiple effector cells” and resulted in significantly better results than bone marrow mesenchymal stromal cells (see paragraph [00124]). In addition, the 2F cocktail reduced a number of inflammatory cytokines (see paragraph [00125]). Administering the anti-CCL24 antibody or CXCL5 alone was effective in treating mild, but not severe GVHD, thus suggesting the 2F cocktail has greater than additive effects in severe disease (see [00126]). Finally, the 2F cocktail treatment significantly improved the 10 weeks post-treatment survival in an SLE mouse model (see [00127]). In summary, the specification provides strong evidence that the combination of CCL24 antibody + CXCL5 improves survival in animal models of GVHD and SLE, but not any combination of cytokine antibody and chemokine to treat any immunological disorder.
The nature of the invention is complex and unpredictable. For instance, Beilder et al. (WO 2014149733) suggest that CXCL5 (ENA-78) antibodies, and not the chemokines themselves are useful for treating inflammatory diseases (see p. 1, 1st three paragraphs and claims). Beilder et al. teach that chemokines such as CXCL5 induce “the migration of neutrophils to sites of inflammation and angiogenesis” thereby “[contributing] to the pathogenesis of several acute and chronic inflammatory/ autoimmune diseases” (see p. 1, 1st-3rd paragraphs). The instant specification also discloses:
[T]he immunosuppressive effect of chemokine CXCL5 found in the present application appears to run against the general understanding of what CXCL5 does. Normally, CXCL5 is a neutrophil chemoattractant and will recruit more neutrophils if its concentration is increased. However, as shown herein, CXCL5 suppresses the proliferation of multiple effector cells, and reduces the pro-inflammatory cytokine secretion.
The instant specification discloses the mesenchymal stromal cell-derived proteins up- and down-regulated by mesenchymal stem cells (MSCs—see paragraphs [0093]-[0094]) and identified the combination of factors that best resulted in immunosuppression similarly to MSCs, which were cocktails containing CXCL5 and anti-CCL24 antibody (see paragraph [0026] and Figure 4):
Figure 4 shows column graphs depicting data of the efficacy of the combination of determined factors used in optimal soluble factor cocktails, which was determined by serial factorial design experiments (FDs). (A) The full panel of 12 factors were screened in a 212 factional FD (n=1). Condition-6 (C6) containing 7 factors was more effective than full panel control and MSC physical contact in repressing cell mediated cytotoxicity (p<0.05). (B) A second 27 fractional FD identified C6 with 4 factors was even more effective than full panel control in repressing cell mediated cytotoxicity (n=3, p<0.05). (C) These 4 factors were further tested in a 24 full FD (n=2). C10 containing two factors-CXCL5 and anti-CCL24 antibody exhibited equivalent effect in repressing cell mediated cytotoxicity as compared to 4 factor full panel control.
Table 1 of the instant specification indicates that the 7 factor, 4 factor and 2 factor cocktails shown in Figure 4 all comprise CXCL5 and anti-CCL24 antibody. The post-filing date art of Fan et al. (Biol Blood Marrow Transplant 24 (2018) 1971-1980) confirms the finding of the instant specification with respect to GVHD, reporting: “against expectations that CXCL5 would act as a proinflammatory reagent, we found that CXCL5 could work synergistically with anti-CCL24 antibody to exert immunosuppressive effects” (see p. 1978, left column, last paragraph). In summary, the evidence of record supports administering a pharmaceutical composition comprising anti-CCL24 antibody and CXCL5 in order to treat GVHD, skin transplant, kidney transplant, liver transplant, SLE, lupus nephritis, type I diabetes mellitus, IBD, Crohn's disease or hemolytic disease of the fetus and newborn, but it is not commensurate in scope with the breadth of possible compositions and immunological disorders encompassed by the broad claims.
Due to the large quantity of experimentation necessary to determine all of the immunological disorders that can be treated with the encompassed pharmaceutical compositions, the lack of direction/guidance presented in the specification regarding the same, the absence of working examples directed to same (other than the combination of anti-CCL24 antibody and CXCL5 to treat GVHD or SLE), the complex nature of the invention, the contradictory state of the prior art with regard to proinflammatory chemokines like CXCL5 and the breadth of the claims which fail to recite limitations on the pharmaceutical composition or the immunological disorders treated, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
Notice for all US Patent Applications filed on or after March 16, 2013: 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.
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 8, 10, 12 and 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by George (WO2010/086854—on IDS filed 11/03/2022). Claim 8 recites treating an immunological disorder comprising administering a pharmaceutical composition comprising at least one antibody and/or at least mesenchymal stromal cell (MSC) derived protein, thus claim 8 only requires the composition comprise an antibody or an MSC derived protein. Claim 10 also recites composition C25a, which comprises an anti-CCL24. George teaches a method of treating an inflammatory or autoimmune disorder comprising administering an antibody to CCL24 (eotaxin-2), referred to therein as “D8” (see claims 1-7). George contemplates treatment of inflammatory bowel disease, type I diabetes mellitus, Crohn’s disease and systemic lupus erythematosus (see p. 4, lines 3-6; p. 13, lines 9-20).
Although the WO document by George does not explicitly teach the anti-CCL24 antibody has the same effects recited in claims 15 and 16, because it teaches administration of the same antibody to treat the same conditions, (i.e., they treat the same patient population with the same agent), the same clinically significant improvements as recited in the claims must have been inherently occurring in the prior art. See Ex parte Novitski, 26 USPQ2d 1389 (BPAI 1993); see also Integra LifeSciences I Ltd. V. Merck KGaA, (DC SCalif) 50 USPQ2d 1846). Therefore, the treatment methods set forth in the WO document by George must, by definition, achieve the same clinically significant improvements as recited in claims 15 and 16 absent evidence to the contrary.
Claims 8, 10, 12 and 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lillard (US Patent 8,541,564). As noted above, claim 8 only requires the composition comprise an antibody or an MSC derived protein. Claim 10 also recites composition C27a, which comprises CXCL5. Lillard discloses treating inflammation and chemokine receptor mediated disorders with chemokines, including CXCL5 as part of a chemokine-immunoglobulin fusion (see column 2, lines 2-52; column 4, lines 22-30). Inflammatory disorders include inflammatory bowel disease, systemic lupus erythematosus, Crohn’s disease and rheumatoid arthritis (column 29, lines 55-62 and column 30, line 19).
Although the Lillard patent does not explicitly teach CXCL5 has the same effects recited in claims 15 and 16, because it teaches administration of the same protein to treat the same conditions, (i.e., they treat the same patient population with the same agent), the same clinically significant improvements as recited in the claims must have been inherently occurring in the prior art. See Ex parte Novitski, 26 USPQ2d 1389 (BPAI 1993); see also Integra LifeSciences I Ltd. V. Merck KGaA, (DC SCalif) 50 USPQ2d 1846). Therefore, the treatment methods set forth in the Lillard patent must, by definition, achieve the same clinically significant improvements as recited in claims 15 and 16 absent evidence to the contrary.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8, 10, 12, 14-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over George (WO2010/086854—on IDS filed 11/03/2022). The first factor to consider when making a rejection under 35 U.S.C. 103(a) is to determine the scope and contents of the prior art. George teaches a method of treating an inflammatory or autoimmune disorder comprising administering an antibody to CCL24 (eotaxin-2), referred to therein as “D8” (see claims 1-7). George contemplates treatment of inflammatory bowel disease, type I diabetes mellitus, Crohn’s disease and systemic lupus erythematosus (see p. 4, lines 3-6; p. 13, lines 9-20).
The second factor to consider is to ascertain the differences between the prior art and the instant claims. Although the WO document by George does not explicitly teach the antibody is in a concentration of 5μg/ml to treat an immunological disorder, it does strongly suggest it. Specifically, George teaches an in vitro assay, in which mouse and rat splenocytes were exposed to increasing concentrations of D8 between 5-50μg/ml (see p. 18, lines 30-33).
It would have been obvious to the person of ordinary skill in the art at the time of the filing of the invention that the 5μg/ml concentration taught by George could be used to treat an immunological disorder because splenocytes make up various immune cells that play a critical role in an organism’s immune system, and the cells were exposed to a 5μg/ml concentration of D8 antibody. Further, it is obvious to optimize concentrations within prior art conditions. MPEP 2144.05(II)(A) instructs that “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical: ‘where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation’”, citing In re Aller. The person of ordinary skill in the art would have been motivated to administer that concentration because George teaches an in vivo colitis model in which a dose of 5μg of D8 antibody was effective at attenuating weight loss and reducing inflammation (see p. 28, lines 16-25). For this reason, as well, the person of ordinary skill in the art could have reasonably expected success.
Thus, the claims do not contribute anything non-obvious over the prior art.
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 8, 10-16 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,246,910 in view of George (WO2010/086854—cited above). Although the claims at issue are not identical, they are not patentably distinct from each other because in both cases the claims encompass methods of treating systemic lupus erythematosus (SLE) or modulating the immune system comprising administering CXCL5 (ENA-78), wherein the pharmaceutical composition results in a decrease in a concentration of one or more of circulating pro-inflammatory cytokines selected from the group consisting of IFN-γ, IL-6, IL-17A, IL-8, MIP-1β, and MCP-1 in the subject, wherein the pharmaceutical composition results in an increase or a decrease in a concentration of at least one mesenchymal stromal cell-derived protein in the subject, which results in an immunosuppressive effect and wherein the mesenchymal stromal cell-derived protein is selected from the group consisting of PGE2 (prostaglandin E2), OPG, CCL7, CCL8, IL-10, CCL20, CXCL5, CXCL6, M-CSF, IL-1β, CCL-1, and CCL24.
The differences between the claim sets are as follows. The claims of the reference patent recite administering CXCL5 to treat SLE, but not the combination of CXCL5 and CCL24 as recited in instant claim 11. George teaches a method of treating an inflammatory or autoimmune disorder such as SLE comprising administering an antibody to CCL24 (eotaxin-2), referred to therein as “D8” (see claims 1-7; p. 4, lines 3-6; p. 13, lines 9-20). It would have been obvious to the person of ordinary skill in the art at the time of the filing of the invention to co-administer the anti-CCL24 antibody as taught in George to treat SLE because the prior art taught that anti-CCL24 antibody is also useful for the same purpose, namely treating SLE. The MPEP 2144.06(I) instructs that “[i]It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art”, citing In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
The claims of the reference patent do not recite the concentration administered is 5μg/ml. The WO document by George strongly suggests this concentration because it teaches an in vitro assay in which mouse and rat splenocytes were exposed to increasing concentrations of D8 between 5-50μg/ml (see p. 18, lines 30-33). It would have been obvious to the person of ordinary skill in the art at the time of the filing of the invention that the 5μg/ml concentration taught by George could be used to treat an immunological disorder because splenocytes make up various immune cells that play a critical role in an organism’s immune system, and the cells were exposed to a 5μg/ml concentration of D8 antibody. Further, it is obvious to optimize concentrations within prior art conditions. MPEP 2144.05(II)(A) instructs that “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical: ‘where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation’”, citing In re Aller. The person of ordinary skill in the art would have been motivated to administer that concentration because George teaches an in vivo colitis model in which a dose of 5μg of D8 antibody was effective at attenuating weight loss and reducing inflammation (see p. 28, lines 16-25). For this reason, as well, the person of ordinary skill in the art could have reasonably expected success.
Finally, the claims of the reference patent do not explicitly recite treating GVHD. The claims of the reference patent, do, however recite a method of modulating the immune system. Using the specification of the reference patent as a lexicon, modulation of immune reaction is discussed in the context of treating GVHD (see column 37, lines 23-47).
In summary, when read in light of the teachings of George and the definition in the specification of the reference patent, the instant claims are not patentably distinct from those of USP 11,246,910.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675